EASA-Q_2000_0403

EASA-Q:2000 QUALITY MANUAL

TABLE OF CONTENTS

Introduction

PreambleScope

Developing Your Quality Manual

Generic EASA-Q:2000 Quality Manual

APPENDIX

EASA-Q:2000 Guidelines for Compiling Documentation

A-01: Documentation

A-02: Clause 5 – Management Responsibility

A-03: Clause 6 – Resource Management

A-04: Clause 7 – Product Realization

A-05: Clause 8 – Measurement, Analysis and Improvement

A-06: Generic examples for the six mandatory documented procedures required by ISO 9001:2000

A-07: Cross reference guide ISO 9001:1994 to ISO 9001:2000

A-08: Samples of useful documentation for use in your quality management system

A-09: Reference Standards

A-10: Repair, Test, and Inspection Plan for AC Squirrel Cage Motors

A-11: Repair, Test, and Inspection Plan for DC Motors

A-12: Sample Process Control Procedures


Introduction

ISO 9000:2000 and EASA-QEASA-Q was designed around the 1994 version of ISO 9002. The 1994 ISO 9000 series Quality Management Standards are now replaced by a considerably revised set of ISO 9000 standards. Because of the significant changes, it is the author’s recommendation that EASA-Q be completely overhauled in order to remain compatible with the proposed new standards, and also to reflect changes in evaluating quality since EASA-Q was launched.

The EASA-Q manual is a guide to developing a quality system based on currently applicable ISO standards. It follows, therefore, that the EASA-Q guidelines should accurately reflect the new standard requirements.

By way of introduction to this revised edition of EASA-Q, the following overview of the International Organization for Standardization's ISO 9000 system is provided.

The revision and replacing of the current ISO 9000 standards issued in 1994 is a natural process and part of the mandate of the ISO 9000 committee TC176 to review and revise where necessary for continuing compatibility to user and commercial needs. This review process occurs approximately every five years. The revision process is governed by:

The evolution of the needs of customers and organizations. Quality management concepts and practices. The deliverables of standardization and conformity assessment.

The revised edition of the standards is identified by the suffix 2000, i.e., ISO 9000:2000.In place of the twenty requirement clauses contained in Section 4.0 (4.1 to 4.20) of the ISO 9001:1994 standard, the new standard comprises a total of eight sections.The headings for each of these sections is as follows:

1. Scope2. Normative reference3. Terms and definitions4. Quality management system5. Management responsibility6. Resource management7. Product realization8. Measurement, analysis and improvement

A key development will be a considerable reduction in the total number of standards. One of the goals of the revisions is to consolidate information currently spread across 25 standards and guidelines into a simpler structure of three new standards.

ISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary (Revision of ISO 8402:1994 and ISO 9000-1:1994)

ISO 9001:2000 Quality Management Systems - Requirements (Revision of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994)

ISO 9004:2000 Quality Management Systems - Guidelines for Performance Improvements (Revision of ISO 9004-1:1994, ISO 9004-2:1994; ISO 9004-3:1993; ISO 9004-4:1993 and ISO 9004-4:1993/Co.1:1994)

The revised version of EASA-Q is based on the requirements set out in ISO 9001:2000 and addresses Sections 4 (Quality System) through 8 (Measurement, Analysis and Improvement).

Brian C. MerrittQCS International


Preamble

The revised ISO 9000 standards are significantly different in structure to the ISO 9000:1994 edition and therefore this edition of EASA-Q:2000 is significantly different in layout.

The new guide is noticeably slimmer in volume than the last EASA-Q manual. This is mainly due to the replacement of twenty documented procedures by six documented procedures in the new ISO 9001:2000 upon which this guide is based. Despite the reduced volume of required documentation, the scope of requirements of the new standard is in fact much broader.

For those who have a documented quality system based upon the EASA-Q/ISO 9002:1994 manual there is a matrix in Appendix A-07 indicating which parts of your quality documentation that you may apply to the new requirements. Comprehensive guidelines are provided to help you modify such documentation where appropriate, or to create documentation for those starting ‘from scratch.’

Previous revisions to the ISO 9000 quality management system (QMS) standards have been evolutionary insofar that the focus and structure of the documentation has remained essentially the same for each edition.

ISO 9000:2000 represents a revolutionary change insofar that its focus is now on: the business processes and the measurement of those processes.

The new format is also designed to remove the perception of manufacturing bias from the standard. This is intended to make it more compatible to non-manufacturing and non-technical service businesses.

For the first time, there is a requirement for customer satisfaction measurement (Section 8.2.1 of the new standard).

Because EASA-Q is now based on ISO 9001:2000, the generic quality manual is set up to address each clause of the new standard and these are identified accordingly.

The first three requirements for the International Quality Management Standard ISO 9001:2000 are presented as follows:

1. Scope (of the actual ISO 9001:2000 standard)2. Normative References3. Terms and definitions

These are presented here to illustrate the strong focus on customer satisfaction and process management of the revised standard as opposed to the focus on confidence in product conformance and supplier capabilities contained in the ISO 9001:1994 version.

1. Scope1.1 General

ISO 9001:2000 specifies the requirements for a quality management system where an organization needs:

a) To demonstrate its ability to provide consistent product that meets customer and regulatory requirements.

b) To address customer satisfaction through the effective application of the system, including processes for continual improvement and prevention of nonconformity.

NOTE: Monitoring of customer satisfaction as stated in (b) requires the evaluation of information relating to customer perceptions of whether or not the organization has met the customer requirements.


1.2 Permissible ExclusionsThe organization may only exclude quality management system requirements that neither affect the organization's ability, nor absolve it from its responsibility, to provide product that meets customer and applicable regulatory requirements. These exclusions are limited to those requirements within Section 7 (Product Realization) and explained in Sub-clause 5.5.5 (Quality Manual) of the International Standard. Exclusions may be due to the following:

a) The nature of the organization's product.b) Customer requirements.c) Applicable regulatory requirements.

2. Normative ReferenceISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary replaces ISO 8402:1994 Quality Management and Quality Assurance - Vocabulary.

3. Terms and DefinitionsFor the purposes of this International Standard, the terms and definitions given in ISO 9000:2000 apply. The following terms, used to describe the supply chain, have been changed to reflect the vocabulary currently used:

Supplier Organization Customer

Note 1. The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor.”

Note 2. Throughout the text of the International Standard, wherever the term “product” occurs, it can also mean “service.”

4. Quality Management System 4.1 General Requirements:

The management of an organization must define and manage the PROCESSES necessary to ensure product and/or service conforms to customer requirements. A quality system must be established as a means of implementing and demonstrating defined processes.

General documentation requirements:A documented quality management system supports the defined processes. System procedures must be established. These will be based on the complexity of methods, skills and training involved in performing the work. These procedures must be specific and unique to organizational needs and objectives.

Note 1. Where the term “documented procedure” appears within the standard, this means a formal, documented and controlled document is required.

Note 2. Documentation can be in any form or type of medium, e.g., flowcharts, drawings, pictograms, hard or electronic data.

4.2.1 Documentation must include:a) A Quality Policy and quality objectives.b) A Quality Manual.c) Procedures required by the International Standard 9001:2000.d) Necessary documents for: planning, operations and control of the organization's

processes.e) Records.


4.2.2 Quality ManualOrganizations must have a quality manual that includes a description of the quality management system and identification of or reference to procedures. In addition, a description of the sequence and interaction of the processes is to be included.

4.2.3 Control of DocumentsRequirements for documents and data control have changed very little with several exceptions. Document control procedures must now define a mechanism for the periodic review and revision of documents. Also, there are now more specific requirements for legibility, identification and revision control for quality system documentation.

4.2.4 Control of Quality RecordsThe requirements for control of quality records have been simplified.

Sections 4 through 8 form the actual requirements for compliance to ISO 9001:2000.These are reflected in this new version of EASA-Q:2000 where they are presented as example templates addressing each of the requirements of the International Standard ISO 9001:2000.

At the end of each section document there are “Document references.” The term “SOP” is the acronym for “Standard Operating Procedure.” Examples of operating procedures are provided in the EASA-Q appendices. It is at this SOP documentation level that some of the documented procedures contained in the old version of the EASA-Q manual can be utilized. A cross reference matrix is provided to assist you with this (see Appendix A-07). However, any procedure documents considered for use in this manner must be carefully reviewed for adequacy to the new requirements.

There are a total of six documented procedures that are essential for compliance to ISO 9001:2000. These are indicated in the EASA-Q manual requirements by an asterisk (*). The actual descriptions and ISO 9001:2000 clause references are provided below:

Activity description ISO 9001:2000 referenceControl of documents 4.2.3Control of quality records 4.2.4Internal audit 8.2.2Control of nonconformity 8.3Corrective action 8.5.2Preventive action 8.5.3

Guidelines for compiling your quality documentation are contained in Appendices A-01 to A-05.

Appendix A-06 contains examples of the six mandatory documented procedures required for compliance to ISO 9001:2000.

Appendix A-07 contains a cross reference table to identify which of the ISO 9001:1994 clauses might be used to meet the ISO 9001:2000 requirements.

Appendix A-08 contains a selection of document formats that may help in setting up your quality management system. The selection is based upon feedback from an EASA-Q user survey conducted in 1999.


Developing Your Quality Manual

Quality system documents should be designed with the following characteristics in mind:

They should be simple, concise and clearly written. Where appropriate, they should truly reflect the way things are done. They should be free of excessive detail. They should fully address the quality system’s requirements.

The Quality ManualThe general policies and procedures addressing the requirements of the quality system are contained in a “Quality Manual.” All other quality system documents can be referenced by this manual’s contents. Small businesses such as repair centers can include these additional documents in the manual. It is not essential, however, to have all quality system documents in one manual.

The first four pages of your manual should address the following:

1. A “Distribution List” which identifies all function positions who are authorized to receive and maintain their controlled copy of the quality manual.

2. An “Index and Revision Status Record.” This must be updated regularly as the manual content is revised.

3. An “Introduction” which briefly describes the purpose and content of the manual. This may also include a brief profile of your Company’s history, size and product range.

4. The Organization’s “Quality Policy.” This is a formal policy document which addresses the Objectives and Commitment of your organization and should be signed by the company’s executive management.

Examples are provided.

Note: The quality manual can be composed entirely as electronically stored data providing adequate control systems are in place to meet the standard's requirements.

ProceduresThere are no specific rules for the style and layout of procedures, but they should include or address the following elements as may be required:

Purpose and Scope Responsibilities Reference to, or a description of, procedures to meet the relevant policy statement. Definitions (if acronyms or technical terms are used, or if differing categories are

involved). Date of issue and revision status Approval authority Page number References to related procedures. Note that reference is made only to the same or next

level of document throughout the document system. For example, quality policy procedures may refer to other policy procedures (sometimes called “Standard Operating Procedures”), Work Instructions or Operating Procedures.

The following templates are provided to illustrate the minimum, simplest format for quality manual documentation design. They are identified identically to each of the clauses of the ISO 9001:2000 Quality Management Standard. Examples of a manual lead page or cover and the first four pages as described above are included.

While all of the requirements of ISO 9001:2000 are addressed in this manual template, exceptions are allowed under the conditions set out under Clause 1.2 of the Scope of the Standard.

XYZ Company Quality ManualPage x of yRevision 00

Generic EASA-Q:2000 Quality Manual

A typical cover or lead page for your quality manual

Quality Manual For

XYZ Inc.

000 Any AvenueAnytown, Anywhere

Tel:xxxxxxxFx:xxxxxxx

EASA-Q:2000 Quality ManualBased on ISO 9001:2000

Originator Original issue date Revision dateApproved by: President

Approved by: Mgmt. Rep.


DISTRIBUTION

MANUAL HOLDER MANUAL NUMBER

President 001

V.P. Marketing 002

Management Representative 003

Engineering Manager 004

Service Manager 005

Human Resources Manager 006




Index and Revision Status Record

Ref. Title RevisionDistribution 00Content Revision Status Record 00Introduction 00Quality policy 00

4.0 Quality management system n/a4.1 General requirements 004.2 Documentation requirements 004.2.1 General 004.2.2 Quality manual 004.2.3 Control of documents 004.2.4 Control of quality records 005.0 Management responsibility n/a5.1 Management commitment 005.2 Customer focus 005.3 Quality policy 005.4 Planning 005.4.1 Quality objectives 005.4.2 Quality management system planning 005.5 Responsibility, authority and communication 005.5.1 Responsibility and authority 005.5.2 Management representative 005.5.3 Internal communication 005.6 Management review 005.6.2 Review input 005.6.3 Review output 006.0 Resource management n/a6.1 Provision of resources 006.2 Human resources 006.2.1 General 006.2.2 Competence, awareness and training 006.3 Infrastructure 006.4 Work environment 007.0 Product realization n/a7.1 Planning of product realization 007.2 Customer related processes 007.2.1 Determination of product related requirements 007.2.2 Review of product related requirements 007.2.3 Customer communication 007.3 Design and development 007.3.1 Design and development planning 007.3.2 Design and development inputs 007.3.3 Design and development outputs 007.3.4 Design and development review 007.3.5 Design and development verification 007.3.6 Design and development validation 007.3.7 Control of design and development changes 00




7.4 Purchasing 007.4.1 Purchasing process 007.4.2 Purchasing information 007.4.3 Verification of purchased product 007.5 Production and service provision 007.5.1 Control of production and service provision 007.5.2 Validation of processes for production and service

provision00

7.5.3 Identification and traceability 007.5.4 Customer property 007.5.5 Preservation of product 007.6 Control of monitoring and measuring devices 008.0 Measurement, analysis and improvement n/a8.1 General 008.2 Monitoring and measurement 008.2.1 Customer satisfaction 008.2.2 Internal audit 008.2.3 Monitoring and measurement of processes 008.2.4 Monitoring and measurement of product 008.3 Control of nonconforming product 008.4 Analysis of data 008.5 Improvement 008.5.1 Continual improvement 008.5.2 Corrective action 008.5.3 Preventive action 00




ORGANIZATION DESCRIPTION

XYZ Inc. has been in business since 19__ and currently operates from a __,000 sq. ft. plant and corporate headquarters in Anytown, Anywhere.

A workforce of ____ employees provides a sales and full service facility for a range of electro-mechanical equipment and rotating machinery.

XYZ Inc. has developed and implemented a quality management system to better meet the needs and expectations of its customers and to improve operational effectiveness. This quality system complies with the international standard ISO 9001:2000.

The purpose of this manual is to define and describe the quality system, to define authorities and responsibilities for the management of the system and reference general procedures for all activities covered by the quality system.

President______________________________________




4. QUALITY MANAGEMENT SYSTEMDistributionPresident V.P. Sales & Marketing V.P. EngineeringV.P. Finance Plant Manager Service ManagerExecutive Assistant Purchasing Manager Chief Inspector

4.1 General(The organization) has established a quality management system that is documented, implemented and maintained. The system is based upon the International Quality Management Standard ISO 9001:2000. The system comprises:

The identification of the processes needed for the quality system and its application throughout the organization.

A description of the sequence and interaction of these processes. A description of the criteria and methods used to ensure that both operation and

control of these processes are effective. A commitment to provide resources and information needed to ensure the

system's continuing suitability and effectiveness. Methods to monitor, measure and analyze these processes. Defined authorities and responsibilities to allow actions necessary to achieve

planned results and continual improvement of these processes.

4.2 Documentation 4.2.1 Content

The quality management system includes: A documented quality policy and quality objectives. Documented procedures required by the International Standard ISO 9001:2000. Documents required by the organization to ensure the effective planning,

operation and control of its processes. Quality records.

4.2.2 Quality ManualThe quality manual is a controlled document describing:

The scope of the quality management system. The documented procedures necessary for the effective application of the quality

system. Descriptions of the processes, their sequence and interaction used within the

organization.

4.2.3 Control of DocumentsAll documents used by the quality system are controlled. The control procedure defines:

Approval requirements prior to issue. Methods used to review and update controlled documents as necessary

including re-approval where appropriate. Identification of changes and current revision status. Methods to ensure that relevant versions of documents are available at point of

use. Identification and legibility requirements of documents. Identification of externally provided documents and their control. Methods to remove obsolete documents and, where stored for reference,

identified as to their intended use.

4.2.4 Control of Quality RecordsQuality records are maintained to provide evidence of conformity to requirements and to verify the effectiveness of the quality system. The control procedure for this includes:

Requirements for legibility.Originator Original issue date Revision dateApproved by: President



A system for clear identification and effective retrieval.

Document referencesSOP QS 3.0 Control of documents (See Appendix A-06)SOP QS 4.0 Control of quality records (See Appendix A-06)

Document end




5. MANAGEMENT RESPONSIBILITYDistribution President V.P. Sales & Marketing V.P. Engineering V.P. Finance Plant Manager Service Manager Executive Assistant Purchasing Manager Chief Inspector

General(Organization's name) is committed to consistently provide products and services that meet or exceed customer and applicable regulatory requirements and to enhance customer satisfaction by conforming to the requirements of EASA-Q:2000. This quality system is based on the International Quality Management Standard ISO 9001:2000.

Scope and ExclusionsScopeThis quality management system applies to all products and service processes conducted at the following locations. (Provide location addresses of headquarters and branch operations as applicable.)

ExclusionsThe following ISO 9001:2000 requirements are excluded. These are not considered to affect the organization's ability or responsibility to provide products and/or services that fulfill customer and applicable regulatory requirements. The exclusions are identified by their ISO 9001:2000 clause reference:(Identify relevant ISO 9001:2000 clause and/or sub-clause references.)

5.1 Management CommitmentManagement shall ensure that:

The importance of meeting customer, statutory and regulatory requirements is effectively communicated to all members of the organization using the most appropriate media.

The quality policy is established with quality objectives identified appropriate to the organization's operations and perceived customer expectations.

Reviews of the quality system are conducted at scheduled intervals and the results of reviews are recorded.

Management is committed to providing all resources necessary to maintain the quality system, continually improve its effectiveness and suitability for meeting the objectives of the organization.

5.2 Customer FocusCustomer requirements are determined and fulfilled to the complete satisfaction of the customer.

5.3 Quality Policy(The organization)'s policy is to meet or exceed customer requirements in a timely and cost effective manner. To achieve this (the organization) will:

Meet the requirements of EASA-Q:2000. Seek continual improvement in product and service quality. Set quality objectives that are based on internal and external feedback and

review these for continuing suitability at regular intervals. Maintain the highest levels of integrity in all relationships with customers and

suppliers. Respect environmental and social interfaces with the local community. Ensure that all stakeholders are fully conversant with this policy and completely

understand their respective roles in upholding it.




This policy is communicated to all interested parties including customers, employees, shareholders, suppliers and local communities affected by the organization.

5.4 Planning5.4.1 Quality Objectives

Quality objectives are established for each department and/or function within the organization. The objectives are developed from results of management reviews, product and/or process performance results, and feedback from interested parties.

The objectives are measurable and consistent with the organization's quality policy.

Each department and/or function determines these objectives, their measurable characteristics and the frequency of measurement.

The objectives are reviewed at regular intervals and the results recorded. The objectives are revised when appropriate to meet continual improvement

requirements. Quality objectives are communicated to all persons with defined responsibility

and translated into their individual and group activity contributions.

5.4.2 Quality Management System Planning The organization' s processes, their sequence and interaction are determined,

and critical stages identified. Criteria and methods required to ensure effective control are established. Appropriate measurement, monitoring and analytical tools are provided to achieve planned results and continual improvement.

Changes to the quality system are controlled through regular reviews and contingency planning designed to maintain the system's integrity.

5.5 Responsibility, Authority and Communication5.5.1 Responsibility and Authority

Management defines responsibilities, authorities and their interrelation with an organization chart and detailed job descriptions for all persons in the organization. This information is communicated to all persons within the organization and interested parties where appropriate.

5.5.2 Management RepresentativeThe (Function title) has been appointed as Management representative with the following responsibilities and authorities:

Control of the quality system to ensure that the system's requirements are established, implemented and maintained.

Reporting to executive management on the performance of the quality system and any need for improvement.

Promotion of awareness of customer requirements throughout the organization. Liaison with external parties on matters relating to the quality system.

5.5.3 Internal CommunicationEffective communication is maintained throughout the organization regarding the effectiveness of the quality system.

5.6 Management Review5.6.1 General

Management reviews the quality system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The reviews are performed according to documented procedures and the results considered quality records and controlled accordingly.




5.6.2 Review InputInput to management reviews include:

Audit results. Customer feedback. Process records. Corrective and preventive action records. Records of prior reviews. Changes that may affect the system. Recommendations for improvement from all sources.

5.6.3 Review OutputOutputs will comprise:

Actions and decisions to improve the quality management system and business processes.

Product improvement decisions. Identified additional resource requirements.

Document referencesSOP MR 5.0 ObjectivesSOP MR 6.0 PlanningSOP MR 7.0 Responsibilities, authorities and communicationSOP MR 9.0 Management Review




6.0 RESOURCE MANAGEMENTDistribution President V.P. Sales & Marketing V.P. Engineering V.P. Finance Plant Manager Service Manager Executive Assistant Purchasing Manager Chief Inspector

6.1 Provision of ResourcesThe resources needed to implement and maintain the quality system, continually improve its effectiveness, and enhance customer satisfaction are provided by management.

6.2 Human Resources6.2.1 General

All persons performing work affecting product and/or service quality are competent in skills, education and experience. This is ensured through a comprehensive selection and training process applied throughout the organization.

6.2.2 Competence, Awareness and TrainingThe organization provides:

Customized training where deemed necessary for product and/or service quality assurance and customer satisfaction.

Competence assessment following training or retraining applications. Awareness of relevance and consequences of activities and their contribution to

meeting the organization's quality objectives. Records of all training, skills and experience that are available to employees,

management and, where appropriate, interested parties affected by the quality system.

6.3 InfrastructureManagement is committed to the provision of:

Buildings, work areas and associated utilities. Process and measuring/monitoring equipment. Communication and transportation services to ensure effective workflow and

product and/or service conformity to requirements.

6.4.1 Work EnvironmentWorkflow is organized for optimum performance and conformance to product requirements.

Document referencesSOP RM 2.0 Job descriptionsSOP RM 3.0 TrainingSOP RM 4.0 Buildings and equipment maintenance




7. PRODUCT REALIZATION Distribution President V.P. Sales & Marketing V.P. Engineering V.P. Finance Plant Manager Service Manager Executive Assistant Purchasing Manager Chief Inspector

7.1 Planning of Product RealizationThe organization has identified the processes necessary to realize products and/or services that satisfy the requirements of customers and other interested parties. These processes and combinations thereof are planned with the following elements incorporated as appropriate:

The quality objectives and requirements of the product and/or service. The processes, documentation and resources specifically required for each

product and/or service category. The required verification, validation, monitoring, inspection and/or test activities

specific to the product and/or service including the criteria for acceptance.

The appropriate elements are documented as quality plans and take the form of either: Hard copy documentation (work orders; sales orders; drawings). Electronically processed documentation (disk/diskette; CD; tape).

7.2 Customer Related Processes7.2.1 Determination of Product Related Requirements

In order to determine product related requirements, the following information is considered:

Customer defined requirements including delivery and post delivery activities. Requirements that are not stated but may be essential to specified product

application. Statutory and/or regulatory requirements related to a product and/or service. Any unique requirements as may be determined outside of the foregoing. The organization's ability to meet these requirements.

7.2.2 Review of Product Related RequirementsA review of contractual information (contract review) is performed for all customer inquiries prior to submission of tenders, quotations, acceptance of orders or changes to contracts.

Note 1. Where the customer does not provide documented statements of requirements but relies on verbal communication, drawings or samples, the requirements are documented and confirmed prior to acceptance.

Note 2. Where differences occur between stated requirements and the organization's capability to meet those requirements, such differences are resolved prior to acceptance of the order. Results of the reviews are recorded and maintained as quality records and controlled accordingly.

7.2.3 Customer CommunicationProduct information and/or changes to orders are effectively communicated to customers. Customer feedback, including complaints, are recorded for Management Review input.




7.3 Design and Development7.3.1 Design and Development Planning

The following activities are conducted by those responsible for the activities involved in the design and development process.

An evaluation of the organization's design and development ability to fulfill requirements, and identification of any problem(s) and their resolution.

The necessary design and development stages are determined. The review, verification and validation appropriate to each stage is determined. The responsibilities and authorities for the design and development are allocated.

The resulting plans are updated as appropriate as the work progresses.

7.3.2 Design and Development InputsThe following inputs are determined and recorded in a clear and unambiguous format:

Function and performance requirements. Applicable statutory and regulatory requirements for the product. Previous design information.

7.3.3 Design and Development OutputsDesign and development outputs are formatted to enable verification against design and development inputs and are approved by (an authorized person) before release. Design and development outputs meet the following criteria:

Meet input requirements. Provide adequate and appropriate information for purchasing, production and

service provisions. Include reference and/or acceptance criteria where applicable. Specify adequate safety and operating instruction for correct product use.

7.3.4 Design and Development ReviewReview includes:

An evaluation of the results of design and development for the ability to fulfill requirements.

The identification of any problems and their resolution.

Reviews are conducted by those responsible* for the activities involved in the design and development process. *The person(s) or function(s) title(s) may be inserted here

The results of reviews and any necessary actions are recorded as quality records and controlled accordingly.

7.3.5 Design and Development VerificationA verification of the design and development is performed to establish if the product and/or service meets:

The stated functional and performance requirements. Applicable regulatory and/or statutory requirements.

7.3.6 Design and Development ValidationThe validation of designed and developed products and/or services are planned where such activities are deemed appropriate. The results of these activities are recorded and controlled as quality records. Where practicable, validation is completed prior to delivery of the product or implementation of the service.




7.3.7 Control of Design and Development ChangesAny changes to original design or development characteristics are identified, reviewed and recorded. An impact evaluation of the changes on other components and the final product performance is included in the review. Where appropriate, the results of changes and any actions arising as a consequence of the changes are recorded and communicated to interested parties. (Examples of this are service bulletins, product recall notices, etc.)

7.4 Purchasing7.4.1 Purchasing Process

(The organization) ensures that all purchased products and services meet the requirements specified on the purchase order and supporting documentation. The degree to which these controls are applied is dependent upon the effect of the purchased product or service on final product realization. Procurement is only authorized from approved suppliers. Special authorization is required for procurement from other sources or to substitute for originally specified products.

(The organization) evaluates its suppliers and purchases only from those that can meet the organization's quality requirements. Quality performance of suppliers is continuously monitored and performance data maintained as quality records. Appropriate criteria is established for selection, evaluation and re-evaluation of suppliers and supplied products and/or services.

7.4.6 Purchasing InformationPurchasing documentation completely describes the product and/or service requested. This information includes where appropriate:

Dimensional measurement, type, model, serial number or drawing reference(s). Application in final product realization or intended use. Requirements for approval of product, procedures, processes and equipment. Required qualification of personnel involved in the supply process. Quality system requirements. Required compliance to applicable regulatory requirements. Agreed price. Delivery requirements. Notification of intent to verify at supplier's location.

Where appropriate, the adequacy of the specified purchased product and/or service is evaluated prior to placing the order.

Purchase orders are approved by (enter title or function) prior to release to a supplier.

7.4.3 Verification of Purchased ProductAll purchased product is subject to inspection upon receipt. The scope of receiving inspection is appropriate to the complexity and/or nature of the purchased product and criticality to final product realization.

When it is determined that verification of supplier's capabilities to provide a product is to be conducted at the supplier location, this information is contained in the purchase document information.




7.5 Production and Service Provision7.5.1 Control

Manufacturing and/or the provision of service is planned and controlled. Input to the process includes, but is not limited to:

Description of the product or service. The availability and need for work instructions. Availability of suitable equipment and work environment. The need and application of measuring and monitoring equipment. The scope and application of release, delivery and post delivery activities.

7.5.2 Validation of Processes for Production and Service ProvisionWhere outputs of the processes cannot be verified by subsequent measurement, validation demonstrates the ability to achieve the planned results. Inputs to the validation process include as appropriate:

Defined criteria for review and approval of the process. Approval of equipment and personnel qualification. Specific methods and/or procedures. Records. Re-validation need.

7.5.3 Identification and TraceabilityProduct or service identification is by means of unique service order number allocation. The status of the product or service with respect to monitoring or measurement is recorded on the service order or accompanying documents. These documents bear the same unique number as the original service order. The service order number is used where traceability of the product is required.

7.5.4 Customer PropertyAny product, material or document owned by a customer, while under (the organization's) control, is identified and protected. Any loss, damage or other reason to render the customer owned item unsuitable for use by (the organization) is reported to the customer and recorded.

7.5.5 Preservation of ProductProduct integrity is preserved using appropriate methods. These include:

Identification Handling Packaging Storage Protection

7.6 Control of Measuring and Monitoring EquipmentWhere evidence of product conformity requires the application of measuring and/or monitoring equipment, this equipment is controlled to ensure valid results. The control includes:

Calibration or verification at specified intervals, or prior to use, against measurement standards that are traceable to international or national standards; where no standards exist, the basis used for the calibration is recorded.

Adjustment or re-adjustment as required. Unique identification of each item of equipment to establish calibration status. Protection from unauthorized adjustment. Protection from damage and deterioration during use and while in storage.




Document referencesSOP PR 2.0 Contract reviewSOP PR 3.0 Design and developmentSOP PR 4.0 PurchasingSOP PR 5.0 Supplier assessmentSOP PR 7.0 Verification of purchased productSOP PR 8.0 Production and service provisionSOP PR 9.0 Identification and traceabilitySOP PR 10.0 Customer owned propertySOP PR 11.0 Preservation of productSOP PR 12.0 Control of measuring and monitoring equipment




8. MEASUREMENT, ANALYSIS AND IMPROVEMENTDistribution President V.P. Sales & Marketing V.P. Engineering V.P. Finance Plant Manager Service Manager Executive Assistant Purchasing Manager Chief Inspector

8.1 General Monitoring, measurement, analysis and improvement processes are planned to:

Demonstrate the conformity of the product or services. Ensure conformity of the quality system. Continually improve the effectiveness of the quality system. Determine applicable methods, including statistical techniques, and the extent to

which they are applied.

8.2 Monitoring and Measurement8.2.1 Customer Satisfaction

Customer satisfaction is monitored in the following categories: External customers (recipients and/or end users of the organization's products

and/or services). Internal customers (persons with defined activities affecting the quality system

directly employed by the organization).

8.2.2 Internal AuditInternal audits are conducted at planned intervals to determine the effectiveness and continuing suitability of the quality system. The audits are conducted with the following characteristics:

Consideration for the status and importance of the areas and processes to be audited.

Criteria, scope, frequency and methods to be used are defined and planned. Auditors are adequately trained and do not audit their own activities. Auditors are selected to ensure objectivity and impartiality of the audit process.

8.2.3 Monitoring of Processes Appropriate methods, equipment and trained personnel are selected to ensure that processes are monitored to ensure that planned results are achieved and maintained. Where planned results are not achieved, appropriate corrective action is initiated.

8.2.4 Monitoring of ProductProducts are not released until:

Key characteristics have been verified. Records indicate authorized release. Planned results are achieved unless specifically authorized in writing by a

customer.

8.3 Control of Nonconforming ProductProducts that are found to not conform to requirements are identified, controlled and recorded as a nonconforming item to prevent further processing and/or delivery. The controls include, but are not limited to:

Action to eliminate the detected nonconformity. Action to preclude the original intended use or application. Authorizing use, release or acceptance under concession by a defined authority,

and where appropriate, by the customer. Re-verification of conformity following corrective action.




The nature of the nonconformity and corrective action(s) taken, including any concessions, is recorded and maintained as a quality record.

8.4 Analysis of DataAppropriate data is defined, collected and analyzed to ensure the effectiveness of the quality system. This data comprises input from:

Customer satisfaction records. Nonconformance records. Trend analysis of processes. Supplier performance records.

8.5 Improvement8.5.1 Continual Improvement

The continual improvement of the effectiveness of the quality system is established through the following activities:

Review of the quality policy and quality objectives. Review of internal and external audit records. Data analysis from sources identified in Clause 2.0 of this document. Review of corrective and preventive action records. Evaluation of employee suggestions. Evaluation of customer needs and expectations.

8.5.2 Corrective ActionTo prevent repetition of nonconformance, corrective actions are defined, developed and applied. The corrective action taken is appropriate to the effect of the nonconformity to which it applies. The procedure for corrective action includes:

Establishing the root cause of the nonconformity. Determining the action necessary to correct the nonconformity. Recording the action taken. Reviewing the effectiveness of the action taken.

8.5.3 Preventive ActionPotential problems are identified and their occurrence prevented by acting pro-actively. The procedure for preventive action includes:

Determining the root cause of potential nonconformity. Developing preventive action plans. Recording the result of actions taken. Evaluation of the effectiveness of the preventive action taken.

Document referencesSOP MA 2.0 Customer satisfaction monitoringSOP MA 3.0 Internal auditing* (See Appendix A-06)SOP MA 4.0 Monitoring of processes and productSOP MA 5.0 Control of nonconforming product* (See Appendix A-06)SOP MA 6.0 Analysis of dataSOP MA 7.0 Continual improvementSOP MA 8.0 Corrective action* (See Appendix A-06)SOP MA 9.0 Preventive action* (See Appendix A-06)

NOTE: Documents identified with an asterisk (*) are required procedures for ISO 9001:2000.




APPENDIX A-01This guideline is applicable to the templates contained in the generic EASA-Q:200 Quality Manual.

GeneralWhile EASA-Q is prepared for application to typical activities of EASA member operations, many users will note that the clause identification system adopted is that of ISO 9001:2000. This is to facilitate an easy transition for members who wish to pursue full ISO 9001:2000 registration beyond the EASA-Q assessment stage.

Distribution Header on DocumentsMost organizations have some form of distribution list for 'who gets what information.' The quality system documentation is part of that information package. Obviously some people will need certain documentation to perform their work (i.e., instructions, drawings etc.) while others may need the entire quality manual as a reference.

In order that the right documents are made available to the appropriate persons, it is handy to have each document contain a list of recipients. In order to facilitate this where appropriate, the EASA-Q manual templates contain a table where these recipients can be listed.

The distribution header for each requirement section template contains typical function positions that may exist in an organization:

President V.P. Sales & Marketing V.P. Engineering V.P. Finance Plant Manager Service Manager Executive Assistant Purchasing Manager Chief Inspector

Never lose sight of the fact that your organization's quality manual must reflect what is appropriate to your organization. Therefore only the functions in your organization that actually need the relevant document should appear in this distribution list. The table is optional and provided only as a suggested format.

You should insert appropriate function titles according to the needs of your organization. You do not have to fill every cell in the header; you can add more if required and they don't need to be the same for all sections.

OrganizationWherever you see the term “Organization” in a template you must replace it with the registered name of your business.

Page and Revision IdentificationEach page should be numbered. How you number them is up to the individual organization. The template uses the format “X of Y” only as an example. Each section document set should have its own number sequence. For example:

“The Quality System” comprises 'page 1 of 1.' “Management Responsibility” comprises pages 1, 2, 3 of 3.

The reason the template pages are not numbered is simply that the compilation of your organization's manual may result in more or fewer pages per section.

Revision identification is a requirement of document control and is indeed essential in order to maintain control. The templates provide this information in the header block. The footer block supports the revision number with a date of revision. The “original issue date” contained in the footer block is not an essential requirement, but can prove to be handy for reference purposes.


Both page numbering and revision identification must be described adequately in the procedure ref. SOP QS 3.0 Control of Documents or the appropriate document in your organization's quality system.

Document ReferencesSOP is the acronym for “Standard Operating Procedure.” It is used in EASA-Q:2000 to refer to the documented procedures necessary for compliance and also to any other documented procedure deemed necessary for the effective application and operation of your quality system.

If you already have documented procedures that are known and accepted in your organization by some other title or description, you can replace the SOP references with your own identifiers. However, care must be taken that the content of those procedures required by ISO 9001:2000 fully meet the requirements identified in the ISO 9001:2000 International Standard (the six are identified in the preamble section of EASA-Q:2000).

All SOP category documents fall within the document control requirements of EASA-Q:2000 and ISO 9001:2000.

With the advent of the computer, it is no longer considered essential to create a ‘hard copy’ of documentation requirements. Some organizations have their complete quality system and operational documentation stored and utilized electronically.

While it is not the intention of this guide to address electronic document control systems, some software allows users access to procedures, work instructions and help menus by simply calling up the appropriate file. Screen touch display features are also sometimes a part of the process. A number of good software systems developed specifically for ISO document control were available for the ISO 9001:1994 standards and no doubt will become available for the new standards.


APPENDIX A-02This guideline is applicable to Clause 5 requirements for “Management Responsibility.”

Scope and ExclusionsScopeIf there are activities in your organization that you do not want included within the EASA-Q system you must clearly identify them in this section. For example you may wish to have repairs and service of electrical/mechanical equipment covered, but not the sale of commercial finished products. The scope of your quality system's application should indicate this.

ExclusionsBecause the three 'levels' of ISO 9001, 2 and 3 no longer exist, the new standard allows you to have exceptions where the requirement cannot or need not be met or applied. There are two conditions applicable, however:1. Any exceptions selected must not reduce your organization's ability or responsibility

to meet customer and applicable regulatory requirements.2. Exceptions are limited to only the requirements listed in Section 7, Product

Realization.

For example, if your organization does not normally design product from concept to final production status, your organization has no need to address the requirement criteria for design contained in the “Product Realization” section. You do, however, need to fully explain why, and this explanation must be provided in the “Management Responsibility” section.

Management CommitmentPrevious ISO standards dealt with management commitment lightly. Many ISO 9000:1994 quality systems were accepted for registration where the senior management of such organizations paid scant attention to visibly and consistently leading the quest for quality. In most cases that responsibility was pushed down to a ‘management representative’ who quite often wasn't appointed from management ranks and subsequently had responsibility without the required authority!

ISO 9001:2000 has now made that situation a thing of the past. If you want your quality system recognized, then there must be adequate proof of consistent management leadership and support. ISO system registrars and EASA-Q assessors will now require objective evidence that the organization's managers are in fact leaders and not just ‘suits’ in the corner office!

5.1 Management CommitmentTop Management must now demonstrate commitment to the development and improvement of the quality management system through:

Communication of the importance of meeting customer as well as regulatory/legal requirements.

Establishing a Quality Policy and Quality Objectives. Conducting management reviews. Ensuring the availability of necessary resources.

What objective evidence is expected?Here are some examples:Managers must exhibit a thorough understanding of:

The organization's quality system requirements. Customer focus. The need to provide adequate resources to allow the quality system to function

correctly. The intended results from objective setting. The impact on the objectives from trend analyses results.


A familiarity with activities and processes that can lead to continual improvement within the organization and in meeting customer expectations.

The records of Management Review are extremely critical in the assessment of management commitment!

During a registration or surveillance audit, employees may be asked for input to evaluating management leadership, so management must ensure that their report line employees are made fully conversant with the goals and objectives of the organization.

5.2 Customer FocusTop management is required to ensure that customer requirements are determined in the form of defined requirements for use within the organization. This requirement focuses on the means by which the organization “translates” customer information into readable, understandable information on an organizational level.

Every person involved in the process of meeting customer requirements must fully understand what the customer's needs are and how their work influences the fulfillment of those needs.

This can best be accomplished by developing a comprehensive training plan for every function within the organization – from executive to shop floor positions.

What objective evidence is expected?Auditors will talk to employees to establish their understanding of customer requirements and verify that documented instructions such as specifications, dimensions etc. are provided in clear terminology.

5.3 Quality PolicyThis requirement is now more specific. Top management must ensure that the quality policy:

Is appropriate to the purpose of the organization. Include a commitment to comply with requirements and continually improve the

effectiveness of the quality system. Provides a framework for establishing and reviewing quality objectives. Is communicated and understood at all levels of the organization. Is reviewed for continuing suitability.

The organization's quality policy must be dynamic and not something ‘cast in stone.’ The policy should link up with stated objectives and describe how these objectives are reviewed and improved upon.

Example for a typical service facilityXYZ Inc.’s policy is to meet or exceed customer requirements in a timely and cost effective manner. To achieve this we will:

Meet the requirements of the International Standard ISO 9001:2000. If the system is registered with an accreditation agency this will be subject to regular compliance audits.

Seek continual improvement in service quality. (A measurable characteristic.) Set service quality objectives that are based on internal and external

feedback and review these for continuing suitability at regular intervals. (Can be evaluated by regular review. Were the objectives met?)

Maintain the highest levels of integrity in all relationships with customers and suppliers. (Can be evaluated from customer and/or supplier complaints/compliments received and recorded.)


Respect environmental and social interfaces with the local community. (Can be documented and evaluated.)

Ensure that all stakeholders are fully conversant with this policy and completely understand their respective roles in upholding it. (Internally this can be achieved by having the policy included in training plans and by having all employees sign a “read and understood” agreement.)

What objective evidence is expected?Obviously the presence of a documented policy is expected. Examination of Management Review records should reveal that regular reviews of the policy's suitability and stated objectives have been conducted.Employee’s level of understanding of the quality policy and how it affects them will be verified.

5.4 Planning5.4.1 Quality Objectives

The organization must have WRITTEN quality objectives at each relevant department or functional level that are consistent with the Quality Policy commitment to continual improvement.

Departmental and/or function level quality objectives must be measurable and aligned to supporting the organization’s quality policy.

Example for a typical service facilityExecutive management objectives:

To grow profits by x% per year. To maintain employee turnover to less than y% per year.

Accounting Dept. To post all receivables within x days of receipt. To pay all accounts due to maintain zero penalties for late payment. Maintain zero defects for payroll.

Sales Dept. Increase sales through new business by x% per year. Increase sales from existing customers by y% per year. Reduce customer attrition by z% per year.

Service Dept. Reduce warranty work by x% per year. Reduce re-work by y% per year. Aim for zero customer complaints. Resolve customer dissatisfaction within z hours/days of receipt of complaint.

What objective evidence is expected?Auditors will look for records that indicate measurement towards objectives and verify that these are consistent with the organization's overall quality policy.

5.4.2 Quality Management System PlanningThe organization must determine the resources needed to achieve quality objectives are identified and planned. The output of this planning must be documented. Planning must cover as a minimum:

Processes required in the Quality Management System. Resources needed. Continual improvement of the Quality Management System.


Planning activities must ensure that organizational change is conducted in a controlled manner in order to ensure that the existing quality management system effectiveness is maintained.

An effective method of developing QMS planning is to create a comprehensive flowchart of the organization’s entire business process. This chart should form a process ‘loop’ starting with the expression of a customer’s need, how that need is received and processed within the organization, and feeding back to the customer the fulfillment of their need in a timely and cost effective manner. The stages in the process should be identified and include the scope of resources needed for each stage.

It is also recommended that consideration be given to developing “contingency plans” for handling emergency situations, relocation and/or expansion of existing facilities. These would be considered as ‘organizational change.’ Elements of such contingency planning may address the following:

Continuity of service throughout the emergency/move/expansion phases. Employee health and safety throughout the emergency/move/expansion. Impacts on local resources/environment from such activities/situations.

What objective evidence is expected? Quality system plans in whatever format adopted should be available for

inspection by an auditor. It should be clearly indicated how the quality management system's integrity will

be preserved throughout any significant changes. There should be records to indicate that the plans are reviewed on a regular

basis and updated/modified when appropriate.

5.5 Responsibility, Authority and Communication5.5.1 Responsibility and Authority

This clause is the abbreviated requirement of 4.1.2 in the 1994 standard. This requirement does emphasize that responsibilities and authorities are to be defined and communicated.

The requirement is best met with a comprehensive job description for each person in the process (including top management) that clearly sets out:

The functional responsibilities and authority levels needed to perform the function.

Evidence of training to a defined level of competency.

EASA member organizations range from the very small to large multi-division units. They have much in common, however, when it comes to “Management Responsibility.” Management has to be effective!There a number of parameters where this effectiveness can be measured, such as:

Customer loyalty. Customer satisfaction. Employee retention. Growth and/ or diversity of products and/or services offered. Safety record for the organization. Corporate citizenship role. Profitability.*

*Profitability of course depends greatly on how well the other parameters are managed.


When developing management job descriptions, the foregoing parameters should be considered in the scope.

What objective evidence is expected? Comprehensive documented job descriptions clearly indicating each function's

scope of responsibility and authority, together with identified measurement characteristics.

An organization chart depicting report lines.

5.5.2 Management RepresentativeSpecific duties of the management representative have been defined. In addition to the existing requirements of the management representative the 2000 version of the standard requires that the management representative:

Ensures that the processes of the quality management system are established, implemented and maintained.

Reports to top management the quality management system’s performance and needs for improvement.

Promote awareness of customer requirements throughout the organization.

It is critically important that authority levels sufficient to perform the requirements of this function are incorporated into the job description and visibly supported by top management.

5.5.3 Internal CommunicationOrganizations must ensure internal communication between levels and functions within the organization.All communications must be clearly stated. In addition to process related communications, bulletin boards, newsletters, and customized screensavers for computers are all recommended methods for effective internal communications.

What objective evidence is expected? Where documents are used to convey information they must be clearly worded. Evidence of posted notices on bulletin boards and/or menu driven screen

displays on computer systems. Evidence of adequate understanding of communications by employees.

5.5.4 Management Review5.5.5 General

The description of the purpose of the management review has not changed from the 1994 version of the standard, but the requirements of management review activity have been more clearly defined as follows:

5.5.6 Review InputsA management review must consist of, as a minimum, an evaluation and comparison of inputs such as:

Audit reports. Customer feedback. Process reports and production conformance analysis. The status of corrective and preventive actions. Follow-up actions from earlier management reviews. Changes that could affect the quality system. Recommendations for improvement.


5.5.7 Review OutputsThe outputs from a management review shall include, as a minimum, any decisions and actions related to:

Improvement of the effectiveness of the quality management system and its processes.

Improvement of product related customer requirements. Resource needs.

It is recommended that specific quality meetings be scheduled to address management review activities rather than ‘tacking on’ the topic to production meetings or general meetings.

A formal record of the meeting activity and action planning resulting from the meeting must be documented. As stated in Clause 5.3, a review of the organization’s Quality Policy and objectives shall be included in the management review meeting agenda.

SummaryThe management review can be considered as the vehicle of control in the ISO 9001:2000 QMS. Everything of significance should be evaluated by use of the review process and records. The quality of this process and its records provides clear indication of management effectiveness.

What objective evidence is expected? Clear evidence of records that indicate the scheduling, content and results of the

management review process.


APPENDIX A-03This guideline is applicable to Clause 6 requirements for “Resource Management.”

6.1 Provision of ResourcesResources fall into the following categories:

Human resources. Infrastructure (buildings, equipment, utilities, transportation, software and

hardware allied to electronic data processing). Work environment.

6.2 Human Resources6.2.1 General Requirements

All persons performing work within the organization's processes are expected to be competent on the basis of appropriate education, training and experience.

6.2.2 Competence, Awareness and TrainingThe focus of the new standard includes a much more comprehensive requirement in the area of training. (See Clause 6.2.2 ISO 9001:2000.) Accordingly, EASA-Q requirements are now more specific.

The keys to achieving and maintaining effectiveness in all functions of any organization are:

Appropriate training for each function position. Effective demonstration of desired levels of competence. Regular reviews to determine future training needs.

Example of a general training plan related to “Customer Focus” (Clause 5.2 ISO 9001:2000).

ApplicationAll personnel.

PurposeTo ensure that all employees are aware of, and understand how, they as individuals and/or their respective departments act and interact to meet specified customer requirements.

Responsibility and Authority The Executive Management has overall responsibility and authority to evaluate

and approve training plans. The Human Resource Manager is responsible for identifying, developing and

providing all training programs. The Human Resource Department is responsible for maintaining records of

training and evidence of demonstrated competence resulting from training applications.

Note. Small business organizations that do not have a Human Resource Department may identify the function title for these responsibilities and authorities.

ScopeThe scope of this training shall include as a minimum, but not be limited to, the following:

Product orientation with emphasis on customer quality expectations. Presentation of the organization's quality system. The role of employees in maintaining the quality system and continually

improving its effectiveness.


Appropriate interpretation of customer expectations related to specific functions within the organization and the interactions between functions needed to meet those expectations.

Handling complaints/nonconformance reporting or detection that may impact upon customer satisfaction.

Verification of CompetenceEach person receiving training shall be required to demonstrate the degree of competence expected from receiving training. Evidence of demonstration may comprise, where appropriate, written and oral examination and/or performance of specific tasks under typical working conditions and witnessed by a suitably qualified supervisor/trainer and the results recorded.

Acceptance standards shall be determined using a combination of input from appropriate levels within the organization.

Where outside suppliers are utilized to provide training, the training package shall include adequate means of establishing competence and records of both results and test content.

A training matrix addressing all functions within the organization is a useful support tool. This does not need to be overly detailed. The following simple matrix is provided as an example.

Example Matrix for Training

PEOPLE

TOPIC

EXECUTIVEMANAGERS

DEPARTMENTMANAGERS

ADMINISTRATIVESTAFF

PROCESSEMPLOYEES

PRODUCT ORIENTATION

A A C C

QUALITY SYSTEM A AB CB C

CONTINUAL IMPROVEMENT

A AB CB CB

CUSTOMER EXPECTATIONS

A AB C C

COMPLAINTS AND NONCONFORMANCE

A AB CB C

ROLE IN THE QUALITY PROCESS

A A A A

A - Comprehensive knowledge and understandingB - UseC - General understandingNote: The format shown may be used for any form of training conducted within the organization.


Employee InvolvementThe management of resources addresses those items that are essential to the implementation and achievement of your organization's quality objectives. These may include:

Employees. Suppliers. Information and communication systems. Plant buildings, equipment, tools. Transport.

Significant emphasis is placed on the quality of human resource in the new standard. Employee involvement is required in:

The identification of competence needs for process activities. Career planning and selection of appropriate training. The definition of responsibilities and authorities. The establishment of departmental and individual objectives and the evaluation

of performance results. Recognition of contributory process improvement. Investigation of employee attrition. Where appropriate, involvement of subcontracted and/or temporary employees

should also be considered.

Competence and TrainingThe new standard amplifies the importance of training by requiring demonstrated competence of personnel and a continual evaluation of the effectiveness of the training provided.

How do you do this? Consider the following examples:1. Training in the form of a seminar where an audio-visual presentation is made to the

attendees. This is supported with handout materials containing essential information covered.

In this form of training there is no direct indication that the attendees have absorbed the necessary information/skills presented unless some form of testing or evaluation is applied.

2.Training in the form of instruction followed by practical or written testing.This format allows both the trainer and trainee to establish the effectiveness of the training provided. The follow-up evaluation can be as simple as an attendee report describing the training and reviewed by a manager, or it can be more structured, as in the form of a written test.

No organization can function effectively with inadequately trained employees and yet in many organizations training is considered to be an expense to be limited to essentials only. Often training is limited to management and sales personnel.

To obtain maximum benefit from any training investment (note the term investment - not cost!), an organization must first identify where training is needed and then the type of training that will produce desired results.

Appropriate performance standards for individual tasks must be established. These are essential to the accurate measurement of the effectiveness of the training application.

Wherever possible, performance standards should be established in cooperation between the worker and his/her supervisor. The standards should also relate directly to the departmental and organizational quality objectives.


SummaryThe organization must:

Determine the level of expertise required to consistently meet product requirements.

Provide appropriate training. Evaluate the training effectiveness. Make the trainee aware of the importance of their work performance relative to

objectives (departmental and organizational). Maintain records to provide objective evidence of the foregoing.

What objective evidence is expected?Evidence of training must include:

A record of training, its scope and methodology. Proof of effectiveness of the training (a test paper or record of skill test signed by

an authorized person). Records of performance reviews.

6.3 InfrastructureThe term 'infrastructure' refers to all resources other than 'human resources' required to achieve and maintain product conformity to requirements. These may include:

Buildings (offices, workshops, test bays, shipping and warehouse spaces) and their utilities.

Process equipment such as shop equipment, machine tools, lifting and transporting equipment, software and hardware for logistic support.

Supporting services such as transport and communication services.

These infrastructure elements must be determined, managed and planned to provide optimum conditions for the continuous meeting of product conformity to requirements.

What objective evidence is expected? Equipment maintenance records. Control procedures for transportation, communication and other support services

where considered appropriate. Procedures for the selection of equipment and where appropriate, software

applied to the process.

6.4 Work EnvironmentAdequate spaces, lighting, cleanliness and safety are all elements of creating a suitable work environment. Workflow effectiveness is affected by plant and office layout. Poor design of workflow can mean delay, safety hazards and unnecessary production costs.

It is an established fact that a clean, orderly workspace results in lower operating costs for the organization and higher productivity from its users.

If customers see a dirty, poorly laid out facility, it is understandable that they may question the quality of the work performed in it!

What objective evidence is expected? Clean and orderly work areas. Logical and effective work flows. High safety standards observed.


APPENDIX A-04This guideline is applicable to Clause 7 requirements for “Product Realization.”

The overall intent of a quality system that meets the requirements of ISO 9000:2000 is to enhance business performance by continual improvement of the processes involved. One might say that the goal is a “Zero Defect” condition throughout the organization. Anyone who is familiar with “Total Quality” disciplines will recognize the term.

In order to facilitate this, your entire business process needs defining and set up to identify opportunities for improvement. This definition will involve the development of flowcharts including an overall chart showing the key stages of your business process and sub-charts addressing individual product lines.

Product realization, as you can probably guess, is 'ISOese' for 'the individual process flows needed to produce a finished product.'

7.1 Planning of Product RealizationWhether the product is a rewound motor, rebuilt circuit breaker, electronic control panel or a preventive maintenance service package, there is a general process of creating the product that comprises a number of distinct steps from start to finish. These steps represent the logical flow of activities required to produce the final product to the customer's satisfaction. This is the business process. (Flowchart example: ref. A-04-01.) Where this starts and finishes will be unique to your organization.

This general process will incorporate discrete processes of “product realization” where your organization handles more than one product. While these need to be identified and mapped out individually, they can be identified in your organizational flowchart as one stage, namely “Product Realization” (Flowchart example: ref. A-04-02).

A typical start point could be the receipt of a firm customer order. The finishing point could be where the customer receives delivery of the finished product or service.You may want to extend these to begin at the initial customer contact and finish only when your customer expresses complete satisfaction with the product supplied.

Both your organization's general business process and the “Product Realization” processes related to motor repair, motor sales, service contracts, refurbishing of circuit breakers, transformers, manufacture of custom control system, etc., generally start when the order is received from the customer. From this point the following is a typical sequence of activities that might occur for the general business process:

Order entry. Order evaluation. Order approval. Design. Production planning. Production. Final testing. Packaging and shipping. Billing.

In addition, the activities of marketing and sales would be integral to the general process.

The product realization for individual products might have the following typical activities: Evaluation of capacity to meet the customer's expectations (Contract Review of

the 1994 ISO/EASA-Q requirements). Acceptance of the order as is or with mutually agreed changes. Design of the product (where appropriate). Ordering parts, etc.


Planning the work into your schedule (resources, material availability etc.). Performing verification activities during the realization process. Packaging and shipping.

In addition, training and equipment maintenance would be integral to the product realization processes.

The key stages of your organization's processes need to be identified based on the foregoing and the following characteristics considered:

What are the quality objectives for the product? What are the required 'inputs'; resources; actions; and expected 'outputs' of each

stage? Are documented work instructions needed throughout the process? What are the verification requirements and criteria for acceptability? What resources are needed? (skills and equipment) What records are required to provide evidence of conformity of the process and

resulting product? How are changes to the process recorded and communicated to maintain

product integrity and provide a basis for improvement?

In addition, there will be customer-related expectations and maybe regulatory/legal requirements that need to be identified and factored in to the process. This section of the new standard expands on the “Contract Review” requirements of ISO 9001:1994.

The organization should also define processes needed to ensure adequate understanding of needs and expectations of interested parties. These processes would include identification and review of information from various sources, such as:

Market research. Competitor analyses. Contract requirements. Benchmarking. Statutory and/or regulatory requirements.

Communication with the customer and other interested parties also needs to be defined within the documented quality system. In particular, communication related to:

Product information. Recent technological developments available. Rework or re-grade characteristics. Inquiries. Order handling, including changes to the original order. Customer feedback, including complaints.

Process verification incorporates the “Inspection and test” and “Inspection and test status” requirements of the old standard, but goes beyond those with requirements to consider, where appropriate, the validation of:

Product life-cycle. Defined methodologies and procedures. Process equipment qualification. End use of the finished product. Environmental impact of the product. Disposal of the product after its useful life is ended.

Converting the foregoing requirements into a simple, easy-to-follow plan will entail the following activities:

Identify the activities, resources and equipment needed for each stage. For example:


o What is the activity? (Describe what needs to happen at this stage)o Who performs the activity? (Title, skills)o What resources are needed? (Documents, communication devices, facilities)o What equipment is needed? (Computers, telephones, fax machine, machine

tooling, test equipment etc.)o What are the required inputs needed for each stage? o What are the expected outcomes of the activity?o How are the outputs converted to the 'input' for the next step?

As can be seen from the foregoing, considerable effort must go into the development of process details for your organization.

What objective evidence is expected? An easily understood description of the business process. As stated, graphic flow

charts are suggested as the simplest and clearest depiction of your organization's processes. These, however, should be supported with references to:

o Appropriate procedures, work instructions, documented drawings and any other items essential to the relevant stages of the process.o Stated quality objectives and requirements for the product.o Relevant verification, inspect, test, validation and monitoring points identified for each product.o Records of status/compliance to verification, inspection/test, validation and monitoring criteria.

7.2 Customer Related Processes7.2.1 Determination Requirements Related to the Product

This requires that before any commitment to supply a product is made, the customer’s requirements should be determined.

7.2.2 Review of Requirements Related to the ProductCustomer requirements must be carefully matched with your organization's capability to provide the product. The 1994 version of EASA-Q and ISO 9001 contained this requirement as Clause 4.3 “Contract Review.”

This entails getting a clear and adequately detailed specification of the customer's requirements. Any applicable regulatory requirements must also be considered as should delivery and post-delivery requirements.Note: This process is extremely critical to “Getting it right the first time.” Failure to perform an effective and comprehensive evaluation of your customer's needs at this stage can cost a lot and may lose you a customer.

What objective evidence is expected? Records indicating that adequate care has been taken to ensure that all aspects

of customer requirements have been evaluated and accepted prior to acceptance of the contract to supply the required product.

7.2.3 Customer CommunicationEnsure that open communications exist to communicate product information, amendments to contract and response to customer complaints.

What objective evidence is expected? Records contained in customer files and non-conformance files should support

communication effectiveness. Auditors may include direct customer input in their scope of audit data collection.


7.3 Design and Development7.3.1 Design and Development Planning

A design plan should indicate: The stages required for design and development. Those responsible for design and development. What review, verification and validation is required at each stage.

What objective evidence is expected? A design and development planning document containing or referencing the

above requirements.

7.3.2 Design and Development InputsDesign and development inputs should include:

The functional and performance requirements for the product. Applicable statutory/ regulatory requirements. Information derived from previous similar designs. Any other pertinent requirements considered essential to the design.

What objective evidence is expected? Records to confirm that the required inputs have been identified, reviewed and

found adequate without conflict or ambiguity.

7.3.3 Design and Development OutputsDesign and development outputs should:

Meet the input requirements. Provide adequate information for purchasing requirements. Provide adequate service provision criteria. Identify the characteristics essential to safe and correct use of the product.

What objective evidence is expected? Records to confirm that the required outputs have been established and that they

meet input requirements.

7.3.4 Design and Development ReviewSystematic reviews are required throughout the design and development to:

Evaluate the ability of the results of the design and development to fulfil stated requirements.

Identify and resolve any problems.

What objective evidence is expected? Records to confirm that the required reviews have been conducted and adequate

proof that the design and development meets stated criteria. Records that identify problems and their solutions related to the design and

development reviews.

7.3.5 Design and Development VerificationVerification that design and development meet the stated input requirements is needed to ensure that specified requirements have been fulfilled.

What objective evidence is expected? Records of conformance such as test/inspection records, material certificates,

regulatory authority approvals.

7.3.6 Design and Development Validation


The design and development planning includes the requirement for product validation. Validation should indicate that the product meets the stated needs of the user.Generally validation is performed on the final (finished) product prior to delivery but may involve on-site validation (commissioning, load testing, etc.).

What objective evidence is expected? Records that indicate that the characteristics of the finished product meet the

needs of the user (generally the customer). These records may comprise witness testing, load testing, environmental performance testing, etc.

7.3.7 Control of Design and Development ChangesChanges to design and development must be identified and documented. Changes must be reviewed, verified and validated as appropriate, then approved before implementation.This applies to changes brought about through service bulletins, product recall notices or product failures.

What objective evidence is expected? Records identifying the change, reason for change, authority to change and

evidence of communication to interested parties. It is suggested that each product design incorporates a documented log containing such information.

7.4 Purchasing7.4.1 The Purchasing Process

The quality, reliability, availability and price of essential materials and/or products required for your organization must be monitored and controlled to maintain optimum effectiveness in product realization and customer satisfaction. Some criteria might include:

Logistic capability, location and resources of the supplier. Performance references from other users of the supplier. Financial viability of the supplier. This is of special importance when in the

process of supplier selection.

Suppliers must be selected upon their ability to consistently meet your organization's needs in product quality, reliability, availability and price. Criteria for selection, evaluation and re-evaluation needs to be established.

Strong relationships with carefully selected suppliers should be developed. Opportunities to develop such relationships can include:

The establishment of effective two-way communications at appropriate levels in both organizations to allow rapid problem solving and avoid delays or disputes.

Monitoring supplier ability to consistently meet your requirements. Developing joint strategies and mutual understanding of purchasing needs. Sharing knowledge and encouraging cooperation in design of products. Evaluation and recognition of quality performance of suppliers.

What objective evidence is expected? Clearly stated requirements for acceptance as a supplier of products and

services to the organization. The extent of this criteria should be dependent upon the effect of the supplied products or services on product realization.

A current list of approved suppliers. Records of regular evaluation/re-evaluation of approved suppliers. Records indicating that effective two-way communication exists between the

organization and suppliers.

7.4.2 Purchasing Information


Adequate information must be communicated to a supplier to enable the supplier to fully meet requirements. Some criteria considered to be essential comprises:

All pertinent dimensional and performance related characteristics. Quantity, delivery and packaging requirements, and where appropriate:

o approval requirements for the product and the procedures, processes and equipment needed to produce it. o Qualifications of personnel associated with the supply of product.o Quality management system requirements.

What objective evidence is expected? Copies of purchase orders (hard copy or electronically stored records). Records of standard purchasing requirements for frequently ordered products.

7.4.3 Verification of Purchased ProductAll purchased product should be subject to acceptance inspection upon receipt. There may be a need to perform acceptance inspection at the supplier's premises before the product is shipped. Where this is a requirement it shall be clearly stated in the purchasing information communicated to the supplier.

What objective evidence is expected? Records of inspection of incoming product. Records indicating results of product inspection at the supplier's premises and

the method of release following such inspection.

7.5 Production and Service Provision7.5.1 Control of Production and Service Provision

The effective control of product or service realization demands attention to a number of key aspects. In order to meet the needs and expectations of the customer your organization should review the following:

The organization's capability to meet contractual requirements. The level and quality of available skills and training capabilities within the

organization. Process equipment reliability and suitability. Communication quality. Relevant statutory/regulatory requirements. Problem prevention capability.

Production and service provision should be planned and controlled with regard to: The availability of information describing the product or service. The need for work instructions. The use of suitable equipment. The need and availability of measuring or monitoring devices. The need for release, delivery and post-delivery activities.

What objective evidence is expected? Records that indicate that effective review and evaluation of customer

requirements are matched with the organization's capacity to meet customer requirements.

Records of regular and periodic management review of the organization's processes, equipment and skills inventory to ensure that customer requirements are capable of being met.

7.5.3 Identification and TraceabilityIt is common sense to have some form of traceability for work and documentation sufficient to satisfy customers and internal requirements. Unique identification may be required for:


Traceability. Process status. Monitoring and measurement requirements. Contract requirements. Hazardous materials. Risk control.

For the majority of organizations, identification and traceability are accomplished using unique identifiers of numerical or alpha-numerical combinations. Usually a key identifier is linked with related references as with a work order number cross referenced to drawing numbers, special certification of material and certain activity codes.

An effective way of checking your existing identification/traceability effectiveness is to examine the system for potential 'black holes' where items might 'disappear.’ Work in process holding areas and quarantine areas for nonconforming products are typical for physical items, while 'in trays' throughout the office are often repositories where documentation becomes 'lost.'

What objective evidence is expected? A clearly understood methodology for identification and traceability. Physical evidence of correctly applied tags, labels, signage and document

references identifying product status.

7.5. Customer PropertyAny property or asset (including “intellectual property”) owned by your customer must be identified, protected and maintained as would any of the organization's property or asset.Should any customer owned item become lost, damaged or otherwise become unsuitable for use it must be recorded and reported to the customer.

What objective evidence is expected? Clearly understood instructions regarding control of customer property. Correctly identified customer property.

7.5.5. Preservation of the ProductAll aspects of handling, packaging, storage, preservation and delivery that are designed to prevent damage, deterioration or misuse during internal processing and final delivery must be defined and implemented. Special requirements in this regard for sensitive, fragile of hazardous products should also be considered.

Where appropriate there should be adequate instruction to the end user of the finished product to identify resources needed to maintain the product's effectiveness throughout its life cycle. Operation manuals are typical documents to contain this information. Other forms of guidance are instructional data plates mounted at strategic places on the finished product.

What objective evidence is expected? Work instructions or evidence of training that addresses the important aspects of

preserving the product as required. Nameplates, labels or labels attached to the finished product when considered a

requirement to ensure effective and safe operation.

7.6 Control of Measuring and Monitoring DevicesThe various methods for measuring and monitoring the verification of products and validation of processes must be defined.


Devices that are used to verify outputs, dimensions, physical conditions (flow, pressure, heat, etc.) must be controlled by regular calibration to acceptable standards. Adequate storage must be provided to protect the devices. Adequate safeguards are required to prevent unauthorized adjustment where feasible, and a system that allows a re-assessment of previous results if the device is found to be out of calibration for any reason must be in place.

Software used to measure or monitor specified requirements shall be validated prior to use.

Note: For those presently using a recognized quality management system such as ISO 9001/2:1994, the documented procedures for control of measuring and test equipment (Clause 4.11) will address only the second part of the new requirements. The need to identify methods is additional.

What objective evidence is expected? Records of measuring, monitoring and test equipment that is required to be

calibrated to maintain accuracy. A schedule indicating frequency of calibration required and calibration status Supporting certification as evidence of calibration. Procedures describing calibration methodologies, care of equipment and

prevention of unauthorized adjustment. Procedures or work instructions addressing action required to verify/re-verify.

accuracy where equipment nonconformance has been detected and a record of the results of such activity.

Note: The following sub-appendices provide examples of acceptable procedure layouts.

FLOWCHART EXAMPLESNote 1: This format is simple yet effective in presenting:

The flow, interrelationship and sequence of activities involved. The functions responsible. The related standard operating procedures.

Note 2: SOP (acronym of “Standard Operating Procedure”) is used as an example only. Relevant identification of documentation normally used in your organization can be entered in the “SOP Reference” column. Typical documentation can include:

Receiving forms and inspection status tags. Inspection/test forms. Work orders. Work in progress travelers. Drawings. Electronic data screens.


A-04-01 General Organization

FLOW ACTIVITY RESPONSIBILITY SOP REFERENCE

Order Entry

Order Evaluation

Order Approval

Design

Production Planning

Production

Final Testing

Packaging & Shipping

Billing

Inside Sales

Engineering

Accounting/Credit

Engineering

Shop Scheduling

Shop Management

Shop Management

Traffic/Warehouse

Accounting

SOP OE 001

SOP EG 001

SOP AC 001

SOP ED 001

SOP SP 001

Work Order

Work Order

SOP WH 001

SOP AR 001


A-04-02 Product RealizationExample - Random Wound Motor Repair

FLOW ACTIVITY RESPONSIBILITY SOP REFERENCE

Receive motor in shop

Initial inspect

Schedule into shop loading

Dismantle & inspect

Primary core test

Remove windings

Secondary core test

Rewind and connect

Pre-assembly inspection & test

Assembly & Final test

Prepare and ship

Shipper/Receiver

Shipper/Receiver

Shop Scheduler

Technician

Technician

Winder

Technician

Winder

Technician

Technician

Shipper/Receiver

SOP SR 001

SOP SR 002

SOP SP 002

Work Order

Work Order

Work Order

Work Order

Work Order

Work Order

Work Order

SOP SR 003


APPENDIX A-05This guideline is applicable to Clause 8, “Measurement, Analysis and Improvement.”

“If you can't measure it, you can't manage it.” In order for any organization to effectively manage its activities and control the quality of its products or services, it has to identify certain key characteristics in its processes and measure them. The results need to be analyzed and then actions taken to affect improvement. This represents a continuous cycle rather than a 'one off' activity performed on an ad hoc basis.

Measurement results can show achievement but they also reveal trends and variance from pre-established control levels. Analysis of results can involve the application of statistical techniques that can be applied to the verification of all process operations. The results should be included as input to the management review process.

Each step in your processes and link in your customer/supplier chain is a potential measurement point. The danger here is that if you apply too many measures you risk drowning in information but being starved of knowledge. What is needed is a small number of simple measures that channel your organization's focus on areas that have the highest potential return.

8.1 GeneralThe scope of ISO 9001:2000 in this regard is the requirement to:

Demonstrate product conformity. Ensure conformity of the quality management system. Continually improve the effectiveness of the quality management system.

This includes the determination of methods including statistical techniques and the extent of their use.

8.1.1 Monitoring and Measurement8.2.1 Customer Satisfaction Measurement

Far too often measurement is focused internally and aimed at reducing costs. It has been said that 'cost accounting is the number one enemy of productivity.'Effective customer satisfaction measurement can only be achieved when the measurement is focused on the customer's needs and expectations.

Who decides what to measure?Those directly dealing with customers (salespersons, shippers) and customers themselves should jointly determine the strategically key measurement characteristics for your organization!

Statistically, the five key areas for customer satisfaction measurement comprise: Reliability - The ability to meet requirements dependably and accurately. Assurance - The courtesy and knowledge of the organization's personnel and

their demonstrated ability to convey trust and confidence. Empathy - The degree of care and individual attention provided to customers. Responsiveness - The perceived willingness to help customers and provide

unique solutions to customer problems. Tangibles - The physical appearance of facilities, equipment and personnel.

Dialogue with customers should revolve around these factors.

Here are some areas for consideration. You and your customers should select and prioritize those that are key to your customer satisfaction goals:

Customer complaints. Number of error-free orders processed. Number of on-time deliveries. Back order volume.


Cycle time to process and ship an order. Volume of credit notes issued and why.* Outstanding accounts receivables.* Volume of rework.* Time of callers placed 'on hold.'

Internal customer satisfaction should also be monitored. Internal customers are persons within the organization who require various 'inputs’ from the previous person in the process and who subsequently provide a 'product' to the next person or stage in the process. Inefficiencies in this aspect of the organization's 'business process' inevitably have an adverse effect on external customer satisfaction.

*Poor quality in these areas can seriously erode profitability.

Warning! Some potential dangers to avoid are:

Overly zealous internal measurement can also be perceived as “Management Snoopervision.”

If measurement is used as a “threat” surveillance system by management the benefits will be totally negative. People will falsify results to please management.

Short term measurement. Maintain methods of measuring long enough to identify trends.

Delay can result in loss of interest. Act promptly on feedback.

Don't limit decisions on what to measure and communication of results to executive levels. Do train and support employees to identify what to measure and how to apply the results

Once your organization has determined what to measure and the data collection methodologies, the procedures should be documented.

What objective evidence is expected? Records of meaningful measurement applied to continual improvement

objectives Evidence of active participation of personnel in determining measurable

characteristics Records of internal customer surveys and application of their results to continual

improvement

8.2.2 Internal AuditThis form of measurement is critical in maintaining the benefits of using a quality management system.

Auditing the new standard moves beyond simple compliance to requirements and the “Expected objective evidence” passages included throughout these guidelines can be used as a guide in compiling internal audit scope and content.

The internal audit should assess both strengths and weaknesses of the quality management system and also evaluate the effectiveness of support activities within the organization. In addition to documenting non-conformances, internal audit reporting should also indicate recommendations for improvement and identify areas of outstanding performance.


As with the ISO 9001:1994 requirements, internal audits must be planned, implemented and have documented follow-up. Planning, however, should remain flexible to allow changes in emphasis based upon findings from previous audits.

Typical areas for consideration by internal auditing include objective evidence of: Adequate documentation. Effective implementation. Nonconformance control and documented results. Personnel competence. Opportunities for improvement. Process capability. Application of statistical techniques. Use of information technology. Analysis of quality costs. Assigned responsibilities and authorities. Performance results and expectations. Adequacy and accuracy of performance measurement. Effective relationships with other interested parties including internal customers.

Follow-up activities must include: Verification of corrective action implementation. Timeliness and effectiveness of corrective action. Effectiveness of the internal audit process and methodologies used.

A comprehensive documented procedure addressing all of the internal audit requirements is required for compliance to ISO 9001:2000.

What objective evidence is expected? A documented procedure addressing internal audits is a mandatory requirement

of ISO 9001:2000. The responsibilities, authorities, requirements for planning and conducting the audits, reporting their results and maintaining records must be adequately defined in this procedure.

A schedule indicating frequency and scope of internal audits. Training records for auditors within the organization. Records of internal audit results. Evidence of follow-up activities resulting from corrective action and verification of

corrective action effectiveness.

8.2.3 Monitoring and Measurement of ProcessesThe fact that all things begin and end with some form of financial accountability is no less a reality when operating an effective quality management system.Communicating results in financial terms to explain organizational quality performance is very effective (especially when talking to executive management and shareholders!).

All too often the implementation of a quality management system is viewed as a cost rather than an investment. However, the cost of setting up and operating an effective quality system can return many times the initial outlay and operational costs!

Identifying, tracking and communicating financial impacts of quality activities is highly recommended. Some examples of financial impact are:

Prevention, appraisal and failure cost analysis. Costs of product and/or process non-conformance. Costs of customer dissatisfaction.


All levels of the organization will benefit from knowing and understanding the financial impact of these and, perhaps more importantly, how all can play a role in minimizing such costs.

Process effectiveness characteristics can include: Timeliness (on time delivery). Overall cycle time (production cycle time or from receipt of order to delivery are

both useful measurement areas). Dependability (equipment unplanned downtime). Conformance to requirements. Production costs (see previous paragraphs). Appropriate application of technology. People skill levels.

What objective evidence is expected? Records showing that the process is managed using identified measurement of

key characteristics. Records indicating maximized 'up-time' for equipment. Well trained personnel with high motivation to produce quality work.

8.2.4 Measurement and Monitoring of Product8.2.4.1 General

Throughout the process of creating your product (product realization), measurements need to be taken to ascertain that the process is working as intended and that product conformance to requirements is maintained throughout the process.

Those of you who already have the earlier EASA-Q system or the 1994 ISO 9001 or 9002 quality system in place can adapt the inspection and test requirement activities used in those systems to this section.

For those new to quality systems, the following considerations must be addressed: Where in the process sequence is measurement needed to verify conformance. What needs to be measured.(the characteristics to be measured at each point in

the process). How measurement is applied. (what methodology and equipment is used to take

and record the measurement). Who has the authority and responsibility to perform the measurements and

release the product to the next sequential stage in the process.

Additional considerations may include: Which inspections and/or testing is required to be witnessed or performed by

regulatory or statutory authorities. Where, when and how your organization intends to utilize qualified third parties to

perform:o Testing.o Inspections.o Product verifications.o Product validations.

What pre-qualification of materials, products, processes or persons is required. How final inspection will confirm that all previous specified inspection and testing

has been completed and accepted. What the outcomes of the measurement process are and how they are to be

recorded.


Typical test and inspection records may include: Test and/or inspection reports. Mechanically and/or electronically charted data. Material release authorizations. Material certificates.

What objective evidence is expected? Test and inspection records. Material certificates. Recorded data from electronic monitoring systems. Work instructions where appropriate describing measuring techniques.

Note: The following sub-clause is not identified in the standard ISO 9001:2000. However it is referred to in the Guide ISO 9004:2000 and is included here because it is considered an important element in the measurement process.

Measurement and Monitoring of Satisfaction of Interested Parties“Interested Parties” can comprise:

Management and employees of the organization. Owners/shareholders of the organization. Suppliers. Society.

Note that the foregoing does not include customers. This section identifies a new requirement not previously addressed in former versions of either EASA-Q or ISO 9001/9002:1994 and its intent is to reinforce the fact that a well run organization needs an effective structure of well informed and motivated 'stakeholders.’ The following addresses each segment:

Management and EmployeesIt is essential that those working for the organization consider that their expectations are met, that they feel that management is interested in their contribution to the organization's objectives and that those contributions are adequately recognized.Unhappy employees are less productive, less loyal and more likely to move out of the organization than employees who feel contented and appreciated.So, how do you measure employee satisfaction?

Regular and open communication will allow employees to voice their concerns, suggestions and appreciation. This can be accomplished by:

Informal meetings of groups and/or individuals with their supervisors. Suggestion programs.

The important thing is to set up an effective recording system for capturing the inputs and applying the results. Regardless of which methods are used, if employees sense that management is not listening and acting upon their inputs, morale will deteriorate and subsequently so will quality.

It is also important that employees' performance is measured in a meaningful way and is understandable to both management and the employee. Far too many “Performance Reviews” are based upon flawed methodology and subject to personal and unquantifiable evaluations by supervisors.

All work (including management functions) can have tangible objectives and outcomes capable of measurement. These can be expressed in clear format. The following chart provides a simple and effective approach to establishing measurable performance for any task.


I PERFORM THIS TASK(ACTIVITIES)

FOR THESE PURPOSES(OBJECTIVES)

AS EVIDENCED BY THESE CONDITIONS

(STANDARDS)Format: “I” + transitive verb + object

Format: In order that/to… Format: Performance is satisfactory when….

These methods can be applied to individual or collective performance.

What objective evidence is expected?

Owners/ShareholdersThe organization should be able to:

Measure its capacity to attain defined objectives. Measure financial performance. Communicate these effectively to interested parties.

Supplier MeasurementThe organization should provide methods to:

Monitor the performance of suppliers and their compliance with your organization's purchasing policy.

Measure the quality of purchased product. Measure effectiveness of purchasing processes within the organization.

SocietyThe organization's performance as a corporate citizen is important. Part of this may be mandated by regulatory bodies (regarding environmental requirement compliance for example), while other aspects may include support and participation in community activities. Your organization should determine what methods are necessary to measure interaction with society and periodically assess the efficiencies of its actions and perception of the results by relevant parts of that society.

Control of NonconformanceWhat is nonconformance?Nonconformance can occur when:

Material or purchased product fails to meet specification. Product fails to meet specified inspection/test criteria. There is a failure in the process. Noncompliance is detected by auditing.

Those of you that have either ISO 9001:1994, ISO 9002:1994 or the EASA-Q:1994 quality systems in place can directly utilize the procedures required for Sections 4.13 of these programs.

For those who do not have any of the above systems in place, the control of nonconformance requires that you have documented procedures to identify, isolate from further use and subsequently apply a satisfactory disposition to any product/service/process covered by the quality system.

Any person in the organization should have authority to identify and report nonconformances. However, there should be defined personnel authorized to deal with the nonconformance in a satisfactory manner.

Regular review of nonconformance records can discover trends or patterns that may be considered as potential improvement opportunities.


Analysis of Data for ImprovementThe application of statistical methodologies to assess performance against objectives can help in the assessment, control and improvement of process effectiveness.Analysis of data can help determine the root cause of problems and guide effective corrective and preventive action.

Information from all parts of the organization should be integrated and analyzed to provide a picture of overall performance of the organization. This should be presented in clear terms suitable for understanding by all personnel. Some results can be used to determine:

Financial and market-related performance. Customer satisfaction. Satisfaction levels of other interested parties. Supplier contribution. Benchmarking within the industry.

Planning for ImprovementProactive effort towards improvement should replace the “If it ain't broke - don't fix it” philosophy.

Planning process improvement using the data analysis prevents unplanned interruption or failure and its associated costs. Many benefits have been gained in manufacturing industries using predictive/preventive equipment maintenance programs and the essential characteristics of these disciplines can be successfully applied to service organizations.

Continual ImprovementA process methodology for examining the activities with a view to possible improvement is called for. This should consist of the following activities:

Identification of areas for improvement and the reason for selecting them. Identification of problems by compiling and analyzing relevant data (include

nonconformance records if you have an ISO 9000 quality system in place already).

Prioritizing the problems if more than one and determining the root causes. Proposal and evaluation of solutions. Application of the solution(s). Evaluation of the effects (i.e., confirm that the root cause of the problem has

been removed and the improvement target has been met). Revision of any procedure or work instruction to reflect the improved processes.

The foregoing methodology should become an integral part of your organization's routine and apply to all activities critical to the process of product realization.

Corrective ActionThose of you that have either ISO 9001:1994, ISO 9002:1994 or the EASA-Q:1994 quality systems in place can directly utilize the procedures required for Sections 4.14 of these programs.

For those who do not have any of the above systems in place, the definition of corrective action is that which is applied to a nonconforming situation to prevent a recurrence of the problem. A documented procedure defining the authorities, responsibilities of personnel and the actions required to control corrective action is required.

Corrective action processes should include: A definition of the root cause of the nonconformance(s).


Appropriate actions to avoid recurrence of the problem(s). A record of the activity and results.

Sources of input to determining corrective action can include: Customer complaints. Nonconformance reports. Management review output. Internal audit reports. Data analysis results. Process measurements. Self-assessment results.

Preventive ActionSpotting potential problems and implementing actions to prevent the problem from happening contributes to a smooth running and efficient organization. Where feasible, a small team of appropriate personnel should be assembled to routinely examine all aspects of the organization's activities, analyze data and develop suitable preventive action.

Potential sources of information may include: Customer needs and expectations (awareness of changes in this area and

appropriate action can often result in gaining market share). Market trend analysis. Management review output. Relevant quality system records.

Preventive actions with high financial impact or those with significant potential impact on customer satisfaction should be included in the Management Review process.

Process ImprovementWhile small incremental improvement activities can be part of the routine operations, breakthrough projects designed to achieve specific improvement objectives should be planned.

EASA-Q:2000 Guidelines

APPENDIX A-06

TYPICAL OUTLINE OF A QUALITY PROCEDUREProcedures are the second level of documentation. They describe activities typically at the department level and their relationship to the company operations as a whole.

The ISO 9001:2000 International Standard contains six activities that need documented procedures as a mandatory requirement:

1. Clause 4.2.3 Control of Documents2. Clause 4.2.4 Control of Quality records3. Clause 8.2.2 Internal Audit4. Clause 8.3 Control of Nonconformity5. Clause 8.5.2 Corrective Action6. Clause 8.5.3 Preventive Action

Examples of each are contained in this guide.

As a guide, the following headers may be used

Standard Operating Procedure (SOP) is a generic term used to identify the document. It may be identified numerically as a further aid to reference.

Purpose/Objective: Aim of the procedure.

Scope: What the procedure does and does not cover.

Definitions: Key terms and acronyms used.

Responsibilities : Who (by job function) has responsibilities for specific tasks or action.

Documentation: What documentation is needed.

Procedures: Description(s) of the actions or tasks to be carried out, by whom and in what sequence. Standards to be met/completion criteria. What records are kept. What resources/equipment are needed.

References: To all documentation covered (include work instructions where appropriate).

Write to the task, not the individual.The purpose is to help workers perform their tasks efficiently and consistently. In certain cases, Level 2 and work instructions can be combined.

A good test of an effective procedure is to have someone not familiar with the task follow the procedure to perform the task. It should be easy to follow and produce the desired result. Both procedures and work instructions are powerful training tools if correctly written.

Work instructions should only be developed where their absence may adversely affect quality. They should be developed with full cooperation of the person(s) performing the task.

Note: Each of the following procedures are provided as examples only and will require customizing to suit your organization's requirements and operational structure.

Operating Procedure QS 4.0

Revision: 0 Issue Date: dd/mm/yy

Page x of y

Distribution President V.P. Sales & Marketing V.P. Engineering V.P. Finance Plant Manager Service Manager Executive Assistant Purchasing Manager Chief Inspector

CONTROL OF DOCUMENTSPurposeTo provide for a system and instructions, and to assign responsibilities and authorities for the establishment, review, authorization, issue, distribution, and revisions of quality system documentation.

ScopeThe following document categories are covered by this procedure:

Quality manuals. Standard operating procedures. Work instructions. Standards and other technical reference material. Drawings, specifications, work orders, purchasing documents, test and

inspection forms, wiring diagrams and other documentation defining products or services.

Quality plans.

DefinitionsSOP - Standard Operating ProcedureWI - Work InstructionHR - Historical References

ResponsibilitiesThe Quality Manager Has overall responsibility for the control of documents.

The Engineering Manager Is responsible for identification and revision of all engineering drawings and specifications.

DocumentationMaster list of controlled documents.

ProcedureIdentificationAll documents are identified by their title, code number, date of issue, revision level and issuing authority.

Documents that originate from outside the organization are identified and their distribution is controlled, as are internal documents.

Documents created and processed entirely electronically are identified in the same manner as described.

Establishment of Initial Issues and Revisions Anyone in the organization can identify a need for procedures, work instructions or additional product related documents.

All personnel are encouraged to evaluate documents in use and suggest revisions to correct errors or improve their effectiveness.

Originator:Date issued:

Approved by



Page x of y

Persons wishing to initiate a new document or revise an existing document may submit their suggestions to their supervisor who may reject, revise or accept the draft proposal for forwarding to the Quality Manager. The decision to approve the change and issue the new or revised document lies with the Quality Manager.

Initial IssuePrior to issue and release for use, documents are reviewed for accuracy, legibility, adequacy and conformity to quality policies.

A document is considered formally issued when an authorized approval signature is placed on it (or the master copy when multiples of the document are involved).

Electronically produced and processed documents have a hard copy approval and this copy is filed as a 'master' document.

RevisionsChanges to documents are reviewed and approved by the same authority that approved the initial document unless specifically designated otherwise.

Handwritten corrections are permitted only when signed and dated by an authorized person.

Revisions of documents are distributed to the same persons and locations as the original issues. Revised documents are accompanied by a cover sheet attached, describing what has been changed, and what has been added/deleted from the original. The cover also contains instructions for the disposal of the superceded document. This procedure also applies where electronically produced and processed documents are revised.

DistributionThe quality manual and operational procedures contain distribution lists. Where appropriate, other documents may have distribution lists.

Each department has a complete set of quality documentation relevant to the function of the department.

Pertinent documents are placed with the functions requiring their use or may accompany traveling work orders.

Master ListA master list is maintained of all issued documents. As a minimum the list must indicate each document's:

Title. Identification number. Date of issue. Last revision level. Distribution.

Historical/Archival documentsObsolete documents that have been retained for reference, preservation of knowledge or legal reasons are stamped “HR - Archival - Reference only” and kept separate from other documents.

Uncontrolled DistributionAny document issued to outside parties or persons not affected by their content is stamped “Uncontrolled.” This category of document is not followed up with revisions.

No person who may manage, perform, or verify work directly affected by the document can receive uncontrolled documents.


Approved by



Page x of y


CONTROL OF QUALITY RECORDSPurposeTo provide for a system and instructions, and to assign responsibilities and authorities for the establishment and storage of quality records.

ScopeThis procedure applies to all records required by the quality management system.

ResponsibilitiesThe Quality Manager Has overall responsibility for the control of quality records.

DocumentationSOP QS 3.0 Control of documents.

ProcedureIdentificationRecords are identified to the product, person or event to which they pertain.Records are dated and identify the person making the record.Records are indexed or grouped to facilitate ease of retrieval.

Storage (Hard Copy)Records are normally stored in the department in which they are established.Records considered confidential are stored in cabinets fitted with appropriate security devices and control.Records are stored in clean, dry locations. Cabinets containing records are clearly labeled as to their contents.No records are allowed to be kept in private desk drawers, toolboxes or workbench shelving.

Storage (Electronic)Storage of quality records on diskette, tape or CD is accepted where appropriate. Each diskette, tape or CD is clearly labeled as to content.Critical records have a duplicate that is stored in a secure off-site location.Records considered confidential are stored in cabinets fitted with appropriate security devices and control.


Approved by

Operating Procedure MA 3.0


Page


CONTROL OF QUALITY AUDITSPurposeTo provide for a system and instructions, and to assign responsibilities and authorities for planning and conducting internal quality audit records.

ScopeThis procedure applies to all activities within the quality management system.

ResponsibilitiesThe Quality Manager Has overall responsibility for the planning and execution of internal quality audits.

DocumentationNonconformance reports.Corrective and preventive action requests.Procedures:

MA 5.0 Control of nonconforming product MA 8.0 Corrective action MA 9.0 Preventive action

ProcedurePlanningThe Quality Manager is responsible for planning and scheduling internal audits.Each clause requirement of the international standard ISO 9001:2000 is audited at least once each year. Certain activities may be subjected to more frequent auditing depending on their status, importance and past history of compliance.

The audit plan identifies all requirement clauses for ISO 9001:2000, the activities associated with them and the locations where the activities take place within the organization.An audit date is allocated for each identified requirement.

AuditorsPersonnel assigned to perform audits are independent of those having direct responsibility for the audited activity.Personnel assigned to perform audits are qualified through training.An audit team leader is appointed by the quality manager for each audit.The quality department activities are audited by the Chief Executive Officer of the organization.

Conducting the Audit The selected audit team prepares by familiarizing themselves with the ISO

9001:2000 requirements applicable to the area(s) to be audited. The head of the department being audited is contacted one week in advance with

a proposed audit date. A response is requested to either confirm or propose an alternative date.

Throughout the audit, auditors look for objective evidence demonstrating compliance to the requirements of the documented quality system.

When noncompliance is detected, the department head is notified and the situation discussed.

Upon completion of the audit, each noncompliance is documented on a Nonconformance Report form (form I.D # _______)


Approved by

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A summary findings report is drafted and the audit results discussed at a post audit meeting with the department head.

Corrective ActionUpon receiving a noncompliance report, the department head investigates the root cause of the problem, proposes a corrective action and an implementation date. The auditor team leader reviews and approves the proposed corrective action. On or immediately following the due date for implementation of the corrective action, the audit team leader will verify that the action taken is effective in resolving the nonconformance. When there is objective evidence that the action is effective, the nonconformance report is closed out and committed to records. If more work is needed to correct the problem, a new follow-up date is agreed upon.

Document end


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CONTROL OF NONCONFORMITYPurposeTo provide for a system and instructions, and to assign responsibilities and authorities for the identification, documentation and disposition of nonconformance.

ScopeThis procedure applies to all materials, components, sub-assemblies and finished product that are subject to inspection and/or testing.

ResponsibilitiesThe Quality Manager Has overall responsibility for the control nonconformance.

DocumentationSOP QS 3.0 Control of documentsNonconformance Report FormNonconformance Record

ProcedureAnyone can report a nonconformance to their immediate supervisor who will then assess the problem. If the problem warrants a nonconformance report being made out, the report will be written up, processed and entered into the record sheet.When a product or material nonconformance is identified, it is identified with a red NONCONFORMANCE tag or label. Where practical the defective product or material is moved to a clearly identified QUARANTINE area.Review and DispositionNonconforming product or material can be:

Reworked to meet specified requirements. Accepted as-is. Regraded for alternative use. Scrapped.

The decision is determined by the Quality Manager. Other management may jointly determine the disposition according to the nature of the nonconformity. The disposition is documented on the nonconformance report. Where necessary or required by contract, the customer is contacted for concession to accept the disposition.

Re-Inspection After ReworkReworked products are inspected for compliance to original specifications. Regraded product or material is clearly marked to identify their different status.

Close-Out of the Nonconformance Report.Decisions to accept as-is, regrade or scrap allows the report to be closed out and filed. Where re-inspection is required, the verification result and date is entered on the nonconformance report which is then filed.

IdentificationRecords are identified to the product, person or event to which they pertain. Records are dated and identify the person making the record. Records are indexed or grouped to facilitate ease of retrieval.


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Storage (Hard Copy)Records are normally stored in the department in which they are established. Records considered confidential are stored in cabinets fitted with appropriate security devices and control. Records are stored in clean, dry locations. Cabinets containing records are clearly labeled as to their contents. No records are allowed to be kept in private desk drawers, toolboxes or workbench shelving.

Storage (Electronic)Storage of quality records on diskette, tape or CD is accepted where appropriate. Each diskette, tape or CD is clearly labeled as to content. Critical records have a duplicate that is stored in a secure off-site location. Records considered confidential are stored in cabinets fitted with appropriate security devices and control


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CONTROL OF CORRECTIVE ACTIONPurposeTo provide for a system and instructions, and to assign responsibilities and authorities for initiating, requesting, carrying out, and verifying the effectiveness of corrective actions.

ScopeThis procedure applies to correcting nonconformities related to material, components, sub-assemblies, finished product, production and service activities, and the quality system.

ResponsibilitiesThe Quality Manager Has overall responsibility for the control of corrective actions.

DocumentationSOP MA 5.0 Control of nonconformitySOP MA 3.0 Internal audit

ProcedureApplicationCorrective Action Requests (CARs) are directed to:

Internal departmental heads within the organization. Suppliers.

Initiation of a CAR can be proposed by any employee of the organization, but must be authorized by the Quality Manager or the organization's president (Your organization's selection). CAR requests must be in writing and contain the following minimum information:

An adequate description of the problem to be corrected. The effect upon quality of the process, product or service.

InitiationCorrective action may be requested in the following situations:

Identification of a major product nonconformity. Accumulation of minor non-conformity from a common source. Recurring problems with a process. Noncompliance detected during internal, customer, or third party audits. Service/commissioning problems. Customer complaints. Poor supplier performance.

ProcessingCorrective actions are requested using the CAR form and directed to the department or person responsible for that area of activity where the problem occurs. Upon receiving the request, the person responsible investigates the problem, determines the root cause and proposes a corrective action indicating a proposed implementation date. The proposed action and implementation date are reviewed and approved by the Quality Manager or President. Verification of corrective action is conducted by the Quality Manager on or immediately after the implementation date. Where the action is deemed successful in resolving the problem, the CAR is closed and filed as a quality record. If more work is needed to fully resolve the problem, a new verification date is agreed upon.


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Documentation and RecordClosed CARs are controlled as quality records. Pending CARs are kept by the party initiating the CAR. Storage and retention periods for closed CARs are specified in SOP QS 4.0 Control of Quality Record


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CONTROL OF PREVENTIVE ACTIONPurposeTo provide for a system and instructions, and to assign responsibilities and authorities for initiating, requesting, carrying out, and verifying the effectiveness of preventive actions.Note: Preventive action is a pro-active approach to problem resolution.

Corrective action is a reactive approach to problem resolution.

ScopeThis procedure applies to the prevention of nonconformities related to material, components, sub-assemblies, finished product, production and service activities, and the quality system.

ResponsibilitiesThe Quality Manager Has overall responsibility for the control of preventive actions.

DocumentationSOP MA 5.0 Control of nonconformitySOP MA 3.0 Internal audit

ProcedureApplicationPreventive Action Requests (PARs) are directed to:

Internal departmental heads within the organization. Suppliers.

Initiation of a PAR can be proposed by any employee of the organization, but must be authorized by the Quality Manager or the organization's president (Your organization's selection).PAR requests must be in writing and contain the following minimum information:

An adequate description of the problem that may occur if the action is not taken. The suspected cause. The potential effect upon quality of the process, product or service.

InitiationPreventive action may be requested in the following situations:

Identification of a potential major product nonconformity. Identification of a potential problem within the quality management system. Identification of a potential problem with suppliers.

ProcessingPreventive actions are requested using the PAR form and directed to the department or person responsible for that area of activity where the potential problem is identified. Upon receiving the request, the person responsible investigates the possible sources of the potential problem, proposes a preventive action and indicates a proposed implementation date. The proposed action and implementation date are reviewed and approved by the Quality Manager or President. Verification of preventive action is conducted by the Quality Manager on or immediately after the implementation date.

Where the action is deemed successful in resolving the problem, the PAR is closed and filed as a quality record. If more work is needed to fully resolve the problem, a new verification date is agreed upon.


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Documentation and RecordClosed PARs are controlled as quality records. Pending PARs are kept by the party initiating the PAR. Storage and retention periods for closed PARs are specified in SOP QS 4.0 Control of Quality Records.


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EASA-Q:2000 Quality Manual

APPENDIX A-07This guideline is intended to help identify new requirements and contains a cross reference table to indicate where requirements from the ISO 9001:1994 might be utilized in the new ISO 9001:2000 Standard.

EASA-Q:2000 CROSS APPLICATION

OF ISO 9001:1994 REQUIREMENT CLAUSES AND ISO 9001:2000 CLAUSESISO 9001:2000 ISO 9001:1994

1. Scope 11.1 General1.2 Application2. Normative reference 23. Terms and definitions 34 Quality management system 44.1 General requirements 4.2.14.2 Document requirements4.2.1 General 4.2.1 + 4.5.14.2.2 Quality manual 4.2.14.2.3 Control of documents 4.5.1 + 4.5.2 + 4.5.34.2.4 Control of quality records 4.165. Management responsibility5.1 Management commitment 4.1 + 4.1.2.2 + 4.2.15.2 Customer focus 4.3.25.3 Quality policy 4.1.15.4 Planning5.4.1 Quality objectives 4.1.1 + 4.2.15.4.2 Quality management system planning 4.2.35.5 Responsibility, authority and communication5.5.1 Responsibility and authority 4.1.2.15.5.2 Management representative 4.1.2.35.5.3 Internal communication5.6 Management review 4.1.35.6.1 General 4.1.36. Resource management6.1 Provision of resources 4.1.2.26.2 Human resources6.2.1 General 4.1.2.2 + 4.2.3 + 4.186.2.2 Competence, awareness and training 4.186.3 Infrastructure 4.1.2.2 + 4.96.4 Work environment 4.97. Product realization7.1 Planning of product realization 4.2.3 + 4.9 + 4.10.17.2 Customer related process7.2.1 Determination of product related requirements 4.3.2 + 4.4.47.2.2 Review of product related requirements 4.3.2 + 4.3.3 + 4.3.47.2.3 Customer communication 4.3.27.3 Design and development7.3.1 Design and development planning 4.4.2+4.4.3+4.4.6+4.4.7+4.4.87.3.2 Design and development inputs 4.4.47.3.3 Design and development outputs 4.4.57.3.4 Design and development review 4.4.6


ISO 9001:2000 ISO 9001:19947.3.5 Design and development verification 4.4.77.3.6 Design and development validation 4.4.87.3.7 Control of design and development changes 4.4.97.4 Purchasing7.4.1 Purchasing process 4.6.27.4.2 Purchasing information 4.6.37.4.3 Verification of purchased product 4.6.4+4.10.2+4.10.3+4.10.47.5 Production and service provision7.5.1 Control of production and service provision 4.9+4.10.3+4.15.6+4.197.5.2 Validation of production and service provision processes

4.9

7.5.3 identification and traceability 4.8+4.10.5+4.127.5.4 Customer property 4.77.5.5 Preservation of product 4.15.2+4.15.3+4.15.4+4.15.5+

4.15.67.6 Control of monitoring and measuring devices 4.11.1+4.11.28. Measurement, analysis and improvement8.1 General 4.10+4.17+4.20.18.2 Monitoring and measurement8.2.1 Customer satisfaction8.2.2 Internal audit 4.178.2.3 Monitoring and measurement of processes 4.9+4.17+4.20.18.2.4 Monitoring and measuring of product 4.10.2+4.10.3+4.10.4+4.10.5+4.2

0.18.3 Control of nonconforming product 4.13.1+4.13.28.4 Analysis of data 4.14.2+4.14.3+4.208.5 Improvement8.5.1 Continual improvement 4.1.38.5.2 Corrective action 4.14.1+4.14.28.5.3 Preventive action 4.14.1+4.14.3


Guideline to Aid in Identifying New RequirementsNew requirements are identified in italics.

ISO 9001:1994 Clause 4.2 Quality SystemThis clause of the 1994 standard is addressed in Clause 4 of the new standard. The 1994 version required only that the system be established, documented, planned and maintained to ensure product quality.

What’s new?

ISO 9001:2000 Clause 4.0 Quality Management SystemThe new standard is much more specific with regard to what constitutes the quality system.

Sub-clause 4.1 “General requirements” requires that the organization’s PROCESSES shall be defined and managed to ensure conformity to customer requirements.

Sub-clause 4.2 “Documentation requirements’Specifies that an organization shall have:

A quality manual. A quality policy and quality objectives. Documented procedures required by ISO 9000:2000 (there are six). Documentation necessary for planning, operations and control of the

organization’s processes. Records.

The Control of Documents (Clause 4.5 ISO 9001:1994) is essentially the same with some exceptions. Procedures must now define a mechanism for review and revision as necessary. There are also more specific requirements for legibility, identification and revision control for quality system documentation.

The Quality Manual is now a requirement and must include a description of the quality system and a reference to, or identification of procedures. A description of the sequence and interaction of the organization’s processes are also to be included.

The Control of Records (Sub-clause 4.16 ISO:1994) has been simplified.

ISO 9001:1994 Clause 4.1 Management ResponsibilityThe 1994 standard requirements for 4.1 “Management Responsibility” do not clearly indicate what commitment is required to ensure the development and improvement of the Quality Management System (QMS).

SECTION 5.0 MANAGEMENT RESPONSIBILITYWhat's new?

ISO 9001:2000 Clause 5.0 Management ResponsibilitySub-clause 5.1 “Management Commitment”Top Management is expected to demonstrate commitment to the development and improvement of the QMS through:

Adequate communication of the importance of meeting customer, legal and regulatory requirements.

Establishing a Quality Policy and quality objectives. Conducting management reviews. Ensuring the availability of necessary resources.


Sub-clause 5.2 “Customer Focus”Top management is required to ensure that customer requirements are determined and defined as requirements for use within the organization. The focus here is on the means by which organizations convert customer requirements into clearly written information that is understandable throughout the organizational levels.

Sub-clause 5.3 “Quality Policy”The requirements are more specific. Top management must ensure that the policy:

Is (and remains through regular review) appropriate to the purpose of the organization.

Includes a commitment to comply with requirements of, and continually improve the QMS.

Is effectively communicated and understood throughout all levels of the organization.

Sub-clause 5.4 “Planning”5.4.1 Quality Objectives: The organization must have documented quality objectives for each

department or functional level that are consistent with the Quality Policy commitment to continual improvement.

5.4.2 QMS Planning: Resources needed to achieve quality objectives must be identified, planned and documented. The scope of this planning must cover as a minimum:

Resources needed. Processes needed within the QMS. How continual improvement of the QMS will be achieved.

The plan must ensure that change occurs in a controlled manner to preserve the integrity of the QMS.

Sub-clause 5.5 “Responsibility, Authority and Communication” (Note the addition of communication!)

5.5.1 Responsibility and Authority: This is essentially the same as the 1994 requirement 4.1.2.

Management Representative: In addition to the requirements in the 1994 requirement 4.1.2.3, the ISO 9001:2000 requirement includes:

Report to top management on QMS performance and need for improvement. Promote awareness of customer requirements throughout the organization.

5.5.2 Internal Communication: Organizations must ensure that effective communication exists between levels and functions within the organization.

Sub-clause 5.6 “Management Review”The requirements essentially remain the same as in the 1994 standard.

5.6.1 General: The activities are more clearly stated requiring defined inputs and outputs.

5.6.2 Review Inputs: As a minimum, the review must evaluate and compare the following input:

Audit reports. Customer feedback. Process and production conformance analyses. Corrective and preventive actions status. Follow-up from prior reviews. Recommended changes to affect improvement.


5.6.3 Review Outputs: As a minimum, outputs shall document any decisions and actions related to:

Improvement of the effectiveness of the QMS and its processes. Improvement of product related customer requirements. Resource needs.

SECTION 6.0 RESOURCE MANAGEMENTThe ISO 9001:1994 Standard does not directly address “Resource Management” as a separate requirement.

What’s new?ISO 9001:2000 Clause 6.0 “Resource Management” directly addresses resource management and is much more specific in its requirements.

Sub-clause 6.1 “Provision of Resources”Requires that resources must be provided to ensure the establishment and maintenance of the quality system and also for the improvement of the system. Resources to address customer satisfaction are also mandatory.

Sub-clause 6.2 “Human Resources” (Sub-clause 4.1.2.2 and Clause 4.18 in ISO 9001:1994) essentially remains the same but, the terminology now focuses upon competence of those impacting upon the quality of the product.

In addition to the training requirements, the standard now requires the organization to demonstrate the competence of personnel after training and must evaluate the effectiveness of training on a continual basis. Quality awareness is strongly emphasized.In summary, the organization must now:

Provide appropriate training. Evaluate the training. Determine the necessary competence. Ensure that all personnel are aware of the impact of their work on product quality. Maintain adequate records of the above.

Sub-clause 6.3 “Infrastructure” (Sub-clause 4.1.2.2 and 4.9 in ISO 9001:1994)The new standard is more specific in requiring that organizations must determine, provide and maintain the necessary infrastructure to ensure conformity to product requirements.

Infrastructure can comprise: Buildings and essential associated utilities. Workspaces. Process equipment including computer hardware and associated software. Support services such as transportation and communications.

Sub-clause 6.4 “Work Environment” (Sub-clause 4.9 in ISO 9001:1994)The new standard requires that the work environment requirements are managed to ensure conformity to product requirements.

SECTION 7.0 PRODUCT REALIZATIONThe ISO 9001:1994 Standard does not directly address “Product Realization” as a separate requirement.

What’s New?ISO 9001:2000 Clause 7.0 “Product Realization” (extracts from 4.2; 4.3; 4.4; 4.6; 4.9; 4.10; 4.11; 4.15 in ISO 9001:1994) addresses the overall aspects of production related processes and is much more specific in its requirements.


Sub-clause 7.1 “Planning of Realization Processes” specifies that an organization shall consider:

Quality objectives for the product(s). The establishment of documented processes. The provision of specified resources and facilities for the product(s). Verification and validation procedures and criteria for acceptability. Records that provide evidence of process conformity and resulting product(s).

Sub-clause 7.2 “Customer Related Processes” now places the onus on the organization to identify and consider ‘fit for purpose requirements’ for the product(s) and also legal/regulatory obligations. The ISO 9001:1994 Clause 4.3 “Contract Review” requirements remain the same in the new standard but the capability to meet contractual requirements extends to any amendment to contract.

Customer communications are now required to be defined. The scope includes: Product information. Inquiries, order processing and changes to original orders. Customer feedback, including complaints.

Sub-clause 7.3 “Design and Development” maintains the ISO 9001:1994 requirements of: Design inputs. Design outputs. Design verification and validation.

The new standard reinforces the design and development requirements of Clause 4.4 in ISO 9001:1994 in the following areas:

7.3.1 “Planning”: Design planning documentation must now include as a MINIMUM: Identification of design changes Identified review, verification and validation activities Responsibilities and authorities for design activities Availability of design plans to all personnel who require them Reviews and updating when necessary

7.3.4 “Design Review”: Results and follow up actions stemming from design reviews must now be recorded.

7.3.7 “Control of Design Changes”: The impact of design changes on constituent parts and the delivered product must now be considered before the implementation of design changes.

Sub-clause 7.4 “Purchasing” generally reinforces the ISO 9001:1994 requirements of sub-clauses:

4.6.2 ‘Evaluation of subcontractors’ (addressed in the new standard under sub-clause 7.4.1)

4.6.3 ‘Purchasing data’ (addressed in 7.4.2) and 4.6.4 ‘Verification of purchased products’ (addressed in 7.4.3)

Sub-clause 7.5 “Production and Service Operations” reinforces ISO 9001:1994 Clause 4.9 (process control) and contains additional requirements in the following areas:

7.5.1 “Control of Production and Service” contains the requirement for identified processes for release, delivery and, where appropriate, post-delivery activities.The new standard elaborates the installation aspect of ISO 9001:1994.


7.5.2 “Validation of Processes for Production and Service” defines requirements for ‘special processes’ in greater detail.Special processes must be validated to demonstrate their effectiveness of their control.This may require:

Process qualification. Equipment and/or personnel qualification. Use of specific procedures. Records of validated processes. Re-validation processes.

7.5.3 “Identification and Traceability” reinforces the 4.8 clause requirements of the ISO 9001:1994 standard and includes the requirement to identify product status that was in clause 4.12 of the 1994 standard.

7.5.4 “Customer Property” This expands the Clause 4.7 requirement of the ISO 9001:1994 standard to products and/or services provided by a customer for USE OR INCORPORATION into the finished product. This now includes “intellectual property provided in confidence.”

7.5.5 “Preservation of Product” reinforces and clarifies the Clause 4.15 of ISO 9001:1994.

Sub-clause 7.6 “Control of Measuring and Monitoring Devices” essentially reinforces Clause 4.11 of ISO 9001:1994 with the additional requirement for control of test software. Software used for verification must be validated before use.

SECTION 8.0 MEASUREMENT, ANALYSIS & IMPROVEMENT

What’s New?This element gathers requirements from ISO 9001:1994 clauses 4.1; 4.9; 4.10; 4.13;4.14; 4.17 and 4.20. The most significant change is the requirement of a process to measure customer satisfaction.

Sub-clause 8.1 “General” requires that an organization defines, plans and implements measurement and monitoring systems to assure conformity of:

The quality management system. The product. Improvement.

Sub-clause 8.2 “Monitoring and Measurement”8.2.1 “Customer Satisfaction” A process is required to obtain and monitor customer

satisfaction information and data.

8.2.2 “Internal Audit” Essentially these requirements remain the same as those in clause 4.17 of ISO 9001:1994.

8.2.3 “Measurement and Monitoring of Processes” reinforces 4.9(d)of ISO 9001:1994 by defining the requirement for performance measurement of product realization to ensure conformance or to apply corrective action.

8.2.4 “Measurement and Monitoring of Product” replaces the inspection requirements of Clause 4.10 of ISO 9001:1994 with a more generic scope.

Sub-clause 8.3 “Control of Nonconformity” reinforces the requirements of Clause 4.13. Terminology has been introduced to apply the requirement more easily to service activities.

Sub-clause 8.4 “Analysis of Data” strengthens the requirement of Clause 4.20 of ISO 9001:1994 with more specific requirements:


There must be a defined procedure for data collection and analysis as a means for identifying opportunities for improvement in the following areas:

Customer satisfaction. Conformance to customer requirements. Characteristics of processes, products (and their trends.) Supplier performance.

Sub-clause 8.5 “Improvement” The definitions for improvement were never really clarified in the ISO 9001:1994 standard.

8.5.1 “Planning for Continual Improvement” The new standard categorically defines that improvement of the quality management system should be continual and facilitated through the use of:

The quality policy and objectives. Audit results. Data analysis. Corrective and preventive action. Regular management reviews.

8.5.2 “Corrective Action” There are now MINIMUM requirements for procedures addressing corrective action which must now include:

Identification of nonconformity (including customer complaints). The root cause of the nonconformity. Evaluating action to ensure that the nonconformity does not recur. Determining and implementing the corrective action needed. Recording the action taken. Reviewing the corrective action taken for effectiveness.

8.5.3 “Preventive Action” There are now MINIMUM requirements for procedures addressing preventive action which must now include:

Identification of potential nonconformity and their root cause. Determining and ensuring the implementation of preventive action needed. Recording the actions taken. Reviewing the actions taken for effectiveness.


APPENDIX A-08: Samples of Useful Documents Approved Supplier Record Supplier Evaluation Form Registrar Selection Table Specimen Form Letter – ISO Advisory to a Supplier Nonconformance Record Example Work Instruction: Application Area – Warehouse Nonconformance Report Corrective/Preventive Action Request

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Revision 00

APPROVED SUPPLIER RECORD

Subcontractor Product or Service Quality Rating Approved by

Originator: Original issue date: Approved by: Issued by:

Quality Rating

A – ISO registered

B – Preferred

C – Sole Supplier

D – Restricted to 2nd

choice from preferred

EASA-Q:2000

SUPPLIER EVALUATION

To be completed by SUPPLIER

NAME: FAX:

STREET: TEL:

CITY:

PROVINCE/STATE: POSTAL/ZIP:

PRIMARY CONTACTS FOR:

SALES:

EXT#: TITLE:

TECHNICAL SUPPORT:

EXT#: TITLE:

QUALITY SYSTEM:

EXT#: TITLE:

SUPPLIER TYPE: MANUFACTURER ( ) DISTRIBUTOR ( ) SERVICE ( )

PRODUCT(S)/SERVICE PROVIDED:

NUMBER OF YEARS IN BUSINESS:

DO YOU HAVE A QUALITY SYSTEM IN PLACE? YES ( ) NO ( )

IF YES, TO WHICH STANDARD?

IS THE SYSTEM REGISTERED WITH AN APPROVED AGENCY? YES ( ) NO ( )

INDICATE WHICH AGENCY:

PLEASE COMPLETE THE FOLLOWING QUESTIONNAIRE:

INSPECTION:

Are inspection procedures conducted: upon receipt?______ -in process?______ -before shipping?______

2. Is specific criteria applied to inspection?

3. Are inspection procedures in writing?

4. Are records kept of inspection results?

DOCUMENTATION

1. Are procedures for document control in place? ______

2. Are manufacturing, service, inspection and test procedures available at point of use? ______

3. Are records kept of warranty and customer complaints? ______

EASA-Q:2000

NONCONFORMANCE:

1. Do you have a system of reporting and recording -

- Nonconformance?______ - Corrective Action?______

TRAINING

1. Are training records kept for all employees?______

2. Is training focused on quality improvement in manufacture and customer service?______

Thank you for completing this brief quality survey. Please return it to:

Insert your organization's contact and postal address

EASA-Q:2000

Registrar SelectionPart 1: Questionnaire

The following questions should be considered when selecting a Quality System Registrar.

1. How many firms similar to ours have been registered by you?2. Can you provide references from these organizations?3. What is your philosophy regarding ISO 9000 registration?4. How and where do you publicize the firms that you register?5. What recourse do we have if we don’t agree with audit results?6. How frequently do you schedule surveillance audits?7. What flexibility do you have regarding scheduled audit dates?8. What are your initial fees for registration?9. What other fees are involved and what are they applied to?10. Do you perform the initial ‘desk audit’ of our documentation on site?

Part 2Registrar Comparison Table

Did the registrar:RATING ITEM #1 #2 #3

Respond to your query promptly? yes/no yes/no yes/noAnswer all questions to your satisfaction? yes/no yes/no yes/noIndicate experience in your type of business? yes/no yes/no yes/noFocus on your needs? yes/no yes/no yes/noOffer publication of your registrations? yes/no yes/no yes/noQuote a firm registration fee? $ $ $Advise you of additional costs? $ $ $Provide recourse if audit results challenged? yes/no yes/no yes/noIndicate the number of surveillance visits per year? 1 2 1 2 1 2Demonstrate a respectful, supportive philosophy? yes/no yes/no yes/noProvide flexible scheduling? yes/no yes/no yes/no

SummaryOnce selected, your registrar and your organization will have a long term relationship (for so long as you maintain your ISO registration).

Remember that your selected registrar becomes your “Supplier of Registration Services” and as such should be treated like any other subcontractor, i.e.:

They become part of your Approved Subcontractor List. Their performance should be measured against criteria which you decide upon. They are subject to having nonconformances related to their performance just

like any other organization providing services or products to you, and can be replaced if considered unsatisfactory.

EASA-Q:2000

SPECIMEN FORM LETTER – ISO ADVISORY TO A SUPPLIER

Dear____________:

To further our commitment to customer satisfaction by developing an effective quality management system for our organization, (Name your organization) has initiated a quality process designed to meet the requirements of the International Standard Organization’s ISO 9001:2000 quality management system standard.

An ISO requirement is that our suppliers be evaluated and their performance monitored for compliance to our defined requirements. As an initial step towards meeting our needs, we respectfully ask you to complete the enclosed supplier evaluation form and return it to us as soon as possible. You will be notified in due course of our specific quality requirements for the supply of goods and/or services.

We have appointed (enter name of person and title) as our Management Representative to whom all quality matters should be referred.

We look forward to our mutually beneficial relationship being enhanced by our decision to implement ISO 9001:2000.

Sincerely,

NB: This letter should be addressed to the CEO of the supplier's organization and, where applicable, to their Quality Manager.

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NONCONFORMANCE RECORD

NC # Description Date Open Date Closed CAR ref. Approved by

Originator: Original issue date: Approved by: Issued by:

EXAMPLE WORK INSTRUCTION

APPLICATION AREA - WAREHOUSE

DATE ISSUED:REVISION #:APPROVED BY: Note: this level of documentation is normally a controlled document within the quality system. If needed, you can include a distribution list for it.STEPS ACTIVITY RESPONSIBILITY

1 Remove all loose items from the unit to be shipped Shipper/Receiver

2 Secure all items subject to damage during transportation. Use strapping bolts as needed.

Shipper/Receiver

3 Install all “Keepers” as indicated on Bill of Materials and/or Engineering Drawings.

Mechanic

4 If shipment is by open flatbed, ensure skid is protected from weather during transit.

Shipper/Receiver

5 Center the item on the skid to minimize protrusion beyond skid dimensions and support any item subject to damage during transportation.

Shipper/Receiver

6 Strap or bolt the unit securely to the skid. Shipper/Receiver

7 Place loose items in suitable cartons. Use suitable fill to protect items in the carton. Secure the cartons to the skid.

Shipper/Receiver

8 Cover the skid contents with stretch wrap. Shipper/Receiver

9 Affix cautionary labels to all sides, e.g., “DO NOT STACK,” “LIFT HERE ONLY,” etc.

Shipper/Receiver

10 Verify shipping documentation is correctly filled out Shipper/Receiver

DATE NONCONFORMANCE REPORT Report #

Part/Item Part #Dept./Supplier W.O.# / P.O.#Qty. rejected Serial #s

DESCRIPTION OF NONCONFORMANCE

Reported by:

DISPOSITION

Use as-is Re-grade Rework Scrap Other (specify)

Comments

Approved (Quality Manager) Approved (Inspector)

CLOSE OUTDue date: Inspector. Re-inspected Corrective action

Inspection Report #CAR #

Approved (Quality Manager)

Date:

Approved (Inspector)

Date:

Additional notes

DATE CORRECTIVE/ PREVENTIVE ACTION REQUEST Request #

Dept./Supplier: Person responsible:Area / operation:Originator:

NONCONFORMING CONDITION

Reported by:CORRECTIVE/PREVENTIVE ACTION

Approved (Quality Manager) Approved (Inspector)

FOLLOW UPDue date: New due date:Approved Yes No

Approved Yes No

Approved (Quality Manager)

Date:

Approved (Inspector)

Date:

Additional notes

Appendix A-09: Reference StandardsIt is recommended that current copies of reference documents and standards applicable to the technical operations and processes of the business be kept on-hand. The following is a list of standards that may apply to your business. It is not intended to be a complete list of all applicable standards.

EASA Documents

EASA-Q Quality Manual

Mechanical Repair Fundamentals

Internal Connection Diagrams

Principles of Large AC Motors

Root Cause Failure Analysis

Technical Manual

EASA Reference Standards

ANSI/ABMA 7 Shaft and Housing Fits for Metric Radial Ball and Roller Bearings (Except Tapered Roller Bearings) Conforming to Basic Boundary Plans.

ANSI S2.41 Mechanical Vibration of Large Rotating Machines With Speed Ranges From 10 to 200 RPS. Measurement And Evaluation of Vibration Severity In Situ.

ANSI/EASA AR 100 Recommended Practice for the Repair of Rotating Electrical Apparatus

ANSI/NCSL Z540-1 Calibration—Calibration Laboratories and Measuring and Test Equipment—General Requirements.

ABMA 20 Radial Bearings of Ball, Cylindrical Roller and Spherical Roller Types - Metric Design

API 541 Form-Wound Squirrel Cage Induction Motors—250 Horsepower and Larger

EASA AR 200 Guide for the Repair of Power and Distribution Transformers

IEC 60034-8 Rotating Electrical Machines, Part 8: Terminal Markings and Direction of Rotation of Rotating Machines.

IEC 60072-1 Part 1—Frame Numbers 56 to 400 and Flange Numbers 55 to 1080.

IEC 60136 Dimensions of Brushes and Brush-holders for Electric Machinery.

IEEE 4 Standard Techniques for High-Voltage Testing.

IEEE 43 IEEE Recommended Practice for Testing Insulation Resistance of Rotating Machinery.

IEEE 56 Guide for Insulation Maintenance of Large AC Rotating Machinery (10,000 kVA and Larger)

IEEE 95 IEEE Recommended Practice for Insulation Testing of Large AC Rotating Machinery with High Direct Voltage.

IEEE 112 IEEE Standard Test Procedure for Polyphase Induction Motors and Generators.

IEEE 113 Test Procedures for DC Machines

IEEE 115 IEEE Guide: Test Procedures for Synchronous Machines.

IEEE 432 IEEE Guide for Insulation Maintenance for Rotating Electric Machinery (5 hp to less than 10 000 hp).

IEEE 522 IEEE Guide for Testing Turn-To-Turn Insulation on Form-Wound Stator Coils for Alternating-Current Rotating Electric Machines.

IEEE 792 IEEE Recommended Practice for the Evaluation of the Impulse Voltage Capability of Insulation Systems for AC Electric Machinery Employing Form-Wound Stator Coils.

IEEE 841 IEEE Standard for Petroleum and Chemical Industry—Severe Duty Totally Enclosed Fan-Cooled (TEFC) Squirrel-Cage Induction Motors—Up to and Including 370 KW (500 HP)

IEEE 1068 IEEE Recommended Practice for the Repair and Rewinding of Motors for the Petroleum and Chemical Industry.

ISO 2953 Mechanical vibration -- Balancing machines -- Description and evaluation

ISO 10012-1 Quality assurance requirements for measuring equipment. International Organization for Standardization. Geneva, Switzerland, 1992.

ISO 1940-1 Mechanical Vibration - Balance Quality Requirements of Rigid Rotors.

ISO 1940-2 Determination of Permissible Residual Unbalance.

ISO 10816-1 Mechanical Vibration - Evaluation of Machine Vibration by Measurements on Non-Rotating Parts - Part 1: General Requirements.

MIL Std 167-1 Mechanical Vibrations of Shipboard Equipment

NEMA MG 1 Motors and Generators.

NEMA MG 2 Safety Standard and Guide for Selection, Installation, and Use of Electric Motors and Generators

NFPA 70B Recommended Practice for Electrical Equipment Maintenance

NFPA 70E Standard for Electrical Safety Requirements for Employee Workplaces.

29CFR1910.331 - .335 OSHA: Electrical Safety-Related Work Practices.

Appendix A-10Repair, Test, and Inspection Plan for AC Squirrel Cage Motors

The procedures for AC motor repair are included as suggested and effective means of providing a quality motor repair. They are by no means intended to cover every category of electrical rotating machine, but rather to provide examples upon which to develop similar process descriptions for any electrical apparatus. The procedures are, however, based on actual and successful application of their contents. For those service centers which may have well documented procedures already, it is acceptable to substitute those in this manual for your own providing their content meets the ISO 9001-2000 requirements.

TEST & INSPECTION PLAN-AC

REPAIR, TEST & INSPECTION PLAN FORAC SQUIRREL CAGE MOTORS

INCOMING INSPECTION - PART I

UPON RECEIPT

CONTROL TASKTo establish the condition of the motor upon receipt at the service center and record its receipt.

RESPONSIBILITYThe Shipper/Receiver.

REASON FOR CONTROLCareful examination of the motor immediately upon receipt provides safeguards for both the service center and the customer. The inspection can reveal obvious damage, evidence of transit damage, or missing parts such as connection box covers, lifting eyebolts, etc. Digital photographs are an excellent, low-cost method of recording these situations.

The motor nameplate detail is recorded which, together with the customer detail, provides positive identification and the preparation of a job card/service order set.

Recording this information prevents any potential dispute by allowing prompt detection of any damage of which the customer may not be aware (e.g., damage in transit) and thus the customer can be advised of this type of damage prior to repairs being started. This protects the customer from unexpected additional repair cost.

MEASURING EQUIPMENT REQUIREDNo measuring is normally expected. A digital camera is recommended.

RECORDING DOCUMENT(Specify document by description, form # etc.)

FREQUENCYEvery motor received for repair or servicing.

TEST SPECIFICATIONSNone applicable.

RECEIVING AREA PROCEDURE

1.0 All motors shall be visibly inspected upon receipt. When necessary, photographs may be taken to serve as records of damage, missing items or ancillary fittings.* Such photographs may be taken using a digital camera.

1.1 In all instances, details of incoming condition shall be recorded in writing on appropriate documents.

1.2 The carrier driver and the customer shall be notified immediately of any obvious damage noted upon receipt. The customer shall be notified of any obviously missing parts.

* Ancillary fittings are defined as attached or installed gearboxes, pulleys, couplings, other than the items comprising the motor itself.

INCOMING INSPECTION - PART II

INITIAL INSPECTION AND TEST (Incoming Inspection cont.)

CONTROL TASKTo establish the electrical and mechanical condition of the incoming motor prior to dismantling.

RESPONSIBILITYDismantler/Mechanic.

REASON FOR CONTROLA careful inspection and test of the motor's mechanical and electrical condition should reveal whether the motor requires rewinding, a general evaluation of the bearing condition and also the condition of the exposed shaft and keyway. This information helps reduce delay in processing the job.

MEASURING EQUIPMENT REQUIREDDial indicator, megohmmeter, outside micrometer (to suit shaft size), voltmeter, ammeter, tachometer, vibration measuring device.

RECORDING DOCUMENT(Specify document by form #, description etc.)


TEST SPECIFICATIONSSee ANSI/EASA AR100.

INITIAL INSPECTION & TEST (Incoming Inspection cont.)

2.0 Check motor shaft for freedom to turn, end play, shaft extension run out (see ANSI/EASA AR100 for guidance) and damage. Record "As Found" conditions.

2.1 Apply a megohmmeter test to the windings using a 500V megohmmeter for machines rated up to 2400V and record the results. For machines rated above 2400V, a 1000V megohmmeter is recommended. (See ANSI/EASA AR100 for guidance)

2.2 Examine all leads and connections. Record condition and any special configuration.

2.3 If the megohmmeter reading is satisfactory and the stator windings check out for continuity, an exploratory no-load run of the motor may be conducted.

2.4 Energize the motor momentarily to establish rotation direction and listen for any rubbing or excessive noise. Energize the motor with a reduced voltage and accelerate the motor by increasing the voltage slowly. Record voltage, current per phase, R.P.M., vibration levels. After the motor comes to rest, apply a reduced single-phase voltage and current. Rotate the shaft slowly and note any deflection on meters which may indicate broken bars.

2.5 Record full nameplate data.

INCOMING INSPECTION - PART III

INITIAL INSPECTION AND TEST (Incoming Inspection cont.)

CONTROL TASKTo establish the electrical and mechanical condition of all internal components of the motor.


REASON FOR CONTROLA careful inspection and test of the motor's internal mechanical and electrical condition should reveal any further problems and thus allow a detailed estimate to be prepared for the customer. It also allows the service center scheduler to plan the repair with greater efficiency, order the right amount of materials and new parts and thus reduce delay in processing the job.

MEASURING EQUIPMENT REQUIREDVarious inside and outside micrometers to suit the motor shaft and bearing sizes, feeler gauges, core loss testing equipment, high-potential tester and surge testers, growler, megohmmeter.




DISMANTLE AND INSPECT PROCEDURE

3.0 Carefully examine all parts as they are removed. Record the condition of all machined surfaces. Where applicable, record coupling/pulley/gear position on the shaft. Mark the shaft if practical also. Check fan security.

3.1 Measure and record "As Found" condition and dimensions of bearings and housings. Record position of spring or wave washers, thrust direction and any spacers within the bearing assemblies. Check and record any stator/rotor interference (rubbing/scoring caused by bearing failure).

3.2 Check shaft security to rotor. Record findings.

3.3 Check rotor for loose or broken bars (growler test). Check for damaged end rings, etc. Record findings.

3.4 If the motor is not being rewound, all parts and windings shall be thoroughly cleaned free of dirt, grit, grease and oil with appropriate cleaning agents. It is important to remove all traces of cleaning agents and to ensure that all parts are completely dry. Conduct megohmmeter, high-potential, surge and reduced voltage three-phase balance tests on the stator.

Note: For a high-potential test, leads NOT being tested should be connected to the motor frame.

3.5 If the motor windings are to be removed, conduct a core loss test prior to burn out and removal of the old winding (EASA Tech Note 17 provides guidance).

3.6 If the motor windings are to be removed, carefully measure and record the coil dimensions: inside nose-to-nose, core length and coil extensions. Cut off the connection end of the winding and put aside for reference during connection of new windings.

3.7 Prepare windings for removal from the core using a controlled heat oven. Do

not exceed a core temperature of 680oF

3.8 Remove old windings and clean out slots. Check for any raised, loose or damaged laminations (EASA Tech Note 16 provides guidance).

3.9 Conduct a second Core Loss test. Record the result and compare with initial reading. Any significant deterioration in values shall be corrected with appropriate repair methods (EASA Tech Note 17 provides guidance).

IMPORTANTWhere new windings are required, these should be manufactured using suitable winding equipment and using only new copper magnet wire of the correct dimension and dielectric coating specification. Do not change the dimensions, specification or design without careful consideration of possible effects on stray losses and winding resistance. Use a micrometer to measure bare wire diameter, not a wire gauge.

To prevent duplicating an incorrect winding, compare the data taken to data on file (EASA Winding Data CD for example), or calculate flux and current densities and compare with similar machines.

EASA Tech Note 16 provides guidance on this and other related matters.

Replacement rotor bars and end rings must have the same resistance values as the originals.

PRE-ASSEMBLY INSPECTION AND TEST (In-Process inspection)

CONTROL TASKTo establish that all components have been satisfactorily serviced or repaired prior to re-assembly of the motor.

RESPONSIBILITYAssembler/Mechanic.

REASON FOR CONTROLA careful inspection and test of the components after mechanical and electrical repairs have been completed, but before final assembly, greatly reduces the need to dismantle the motor at a later time for the purpose of making corrections. Also, careful attention to this control guards against the possible repeating of tests already made which could cause unnecessary stress to the windings.

MEASURING EQUIPMENT REQUIREDGrowler, megohmmeter, high-potential tester and surge testers.


FREQUENCYEvery motor serviced or repaired.


PRE-ASSEMBLY INSPECTION & TEST PROCEDURE

4.0 After completion of coil winding, wedging and connecting, but before treatment, the following tests shall be performed and the results recorded (refer to test criteria in ANSI/EASA AR100).

a. Megohmmeter test.b. High-potential test.c. Surge comparison test.d. Reduced voltage three-phase balance test.

If the results are satisfactory, the stator can be treated.If test failure occurs, process as nonconformance and HOLD until satisfactory disposition is complete.

4.1 On completion of the winding treatment and bake process, visually inspect the windings for satisfactory coating quality (even coating, no runs or drips).

4.2 Conduct a "growler test" on the rotor as a check prior to assembly.

4.3 Collect any new parts (e.g., bearings etc.). Verify that the parts are the correct replacements by comparing with the old parts or to manufacturer's assembly drawings or specifications. Collect all components into the assembly area. Ensure that adequate tooling and space exists to proceed with the assembly.

4.4 Check that all fitted surfaces are clean and free of nicks and burrs, and that there is no varnish build up on the rotor surfaces.

4.5 At this stage, windings and internal surfaces may be painted with appropriate paints and lacquers to improve the sealing and appearance.

ASSEMBLY

CONTROL TASKTo assemble the motor and prepare for final testing prior to returning the motor to the customer.

RESPONSIBILITYAssembler/Mechanic.

REASON FOR CONTROLRe-assembly of a motor after repair is an important stage in the process. Control at this point is essential to ensure that all components are correct and fully functional so that the motor will operate correctly and reliably when returned to service with the customer. This care in turn prevents wasted time and allows delivery as promised by removing the possibility of rework caused by poor repair or overlooked detail, thus benefiting both customer and the service center.

MEASURING EQUIPMENT REQUIREDThermometer (to establish bearing temperature for installation), feeler gauges, dial indicator




ASSEMBLY PROCEDURE

5.0 For motors with ball or roller bearings, gently heat the bearing inner races to a

maximum of 225oF using an approved service center method. Install the bearings with identification numbers facing out. After the inner race has cooled, install remaining bearing components.

5.1 Once assembled, pack the bearings with a high grade of grease to customer or motor manufacturer specifications (generally 1/3 full).

Note: Lubricating oil for sleeve-type bearing assemblies is installed as a final step prior to final test.

5.2 Check match marks on the motor frame and insert the rotor into the stator bore ensuring that the drive end of the shaft is at the drive end of the motor frame.

5.3 Check end bracket and frame spigot (frame rabbet) surfaces and lightly lubricate to facilitate installation. Check for dowel pins and align accordingly during assembly.

5.4 Install frame bolts and tighten evenly to prevent stress on brackets.

5.5 Align inner bearing caps and install outer caps. Half fill each outer cap with the same grease used to pack the bearings. Tighten bolts in a uniform manner to prevent uneven stress on the bearings.

5.6 Check overall alignment by rotating the rotor by hand to ensure freedom from rubbing or undue friction. Check and record sleeve bearing clearances.

Note: Install oil in sleeve bearings BEFORE rotating shaft.

5.7 Check and record shaft end play and run out (see ANSI/EASA AR100 for guidance).

5.8 Make all lead connections secure and ensure that identification tags have been attached (usually done by the winding dept.).

Note: Couplings, gears or pulleys should NOT be installed until after successful final tests are completed on the motor. This saves time should the motor require dismantling to correct a fault detected during the final test procedures.

FINAL TEST

CONTROL TASKTo inspect and no-load test run the repaired motor before returning the motor to the customer.

RESPONSIBILITYInspector/Tester.

REASON FOR CONTROLThe customer depends on the service center to provide a quality serviced motor which will perform reliably and within the nameplate specifications. The no-load test is a key element used to assess the motor after servicing and to determine that the above conditions are met. Careful control of the no-load test and inspection ensures compliance to these requirements by checking to see that the motor turns freely in its bearings without excessive friction or overheating, that the dynamic balance is sufficient to contain vibration within acceptable limits, that the speed is correct and that measured electrical parameters meet the given nameplate ratings.

MEASURING EQUIPMENT REQUIREDMegohmmeter, high-potential tester, volt/ohmmeter, ammeter, tachometer, wattmeter, vibration measuring equipment, thermometer, dial indicator.




FINAL TESTING PROCEDURE

6.0 Review all preceding test and inspection documentation to verify that all required test and inspections have been completed. HOLD further testing until documents have been cleared.

6.1 Perform and record a megohmmeter test on all windings in accordance with customer specifications or test criteria provided in ANSI/EASA AR100. Include RTD's, thermo-couples etc.

6.2 Perform and record a high-potential test on all windings in accordance with customer specifications or criteria provided in ANSI/EASA AR100.

Note: All leads NOT being tested must be connected to the motor frame.

6.3 Upon successful completion of the high-potential test, conduct a second megohmmeter test on the windings. Resistance measured should be equal to or greater than the first megohmmeter readings.

6.4 Check continuity and resistance of space heaters, RTD's or similar devices. Energize space heaters and check for normal current flow.

6.5 Measure and record winding resistance. Correct for temperature and compare to commercial values or calculated values. For wound rotors, record open circuit volts. (To run, short out rotor winding and operate as a squirrel cage motor.)

6.6 Conduct a single phase rotor test and record result.

6.7 After completing all pre-running inspection and testing, follow safe practice standards and connect the motor to suitable power leads for a no-load running test.

6.8 Energize the motor momentarily to establish the direction of rotation and to determine if there are any rubbing sounds or unusual noises. To keep inrush current to a minimum, use a reduced voltage and energize slowly. Check for any signs of excessive vibration or higher than normal currents. If all appears in order, bring the motor to full rated voltage. Continuously monitor the stator current to ensure that it does not become excessive.

6.9 After reaching rated voltage, monitor bearing temperature and vibration. Verify that shaft-mounted blowers are moving air in the correct direction. For sleeve bearings, check that the oil rings are free and that the lubricant is reaching the bearing surfaces.

6.10 With the motor running no-load, at its rated voltage, measure and record the following:

a. Stator line voltage;b. Stator line current;c. Input watts;d. R.P.M.;e. End play, check and mark flotation at magnetic center;f. Vibration amplitude in horizontal, vertical and axial directions;g. Safely accessible bearing housing temperatures (every 15 minutes).

FINAL TESTING PROCEDURE (cont'd)

Compare these results with commercial test values, customer specifications, nameplate data or accepted service center values.

Note: Typical running times on test should not be less than:

> One hour for sleeve bearing motors or until temperatures are stabilized.

> 15 - 30 minutes for spherical roller or ball bearing motors.> Motors with cylindrical roller bearings or bearings fitted with

cooling jackets should only be run a few minutes.

6.11 Upon completion of successful final testing, the motor shall be stopped, disconnected from the power supply, painted and prepared for shipment.

TEST & INSPECTION FLOWCHART

FOR

AC MOTORS

Å 1.0 RECEIPT

x 2.0 INITIAL INSPECTION & TEST

Å 3.0 DISMANTLE & INSPECT

x 3.5 CORE TEST

¡ 3.7 BURN OUT OLD WINDINGS

x 3.9 CORE TEST *

¡ REWIND & CONNECT

x 4.0 PRE-ASSEMBLY INSPECTION & TEST *

Å 5.0 ASSEMBLY

x 6.0 FINAL TEST *

Å PREPARE FOR SHIPPING

¡ SHIP

SYMBOLS

¡ OPERATION STAGE

o INSPECTION

Å OPERATION & INSPECTION

x INSPECTION & TEST

* DENOTES A HOLD POINT

Appendix A-11Repair, Test, and Inspection Plan for DC Motors

Note:The procedures for DC motor repair are included as suggested and effective means of providing a quality motor repair. They are by no means intended to cover every category of electrical rotating machine, but rather to provide examples upon which to develop similar process descriptions for any electrical apparatus. The procedures are, however, based on actual and successful application of their contents. For those service centers which may have well documented procedures already, it is acceptable to substitute those in this manual for your own providing their content meets the ISO 9001-2000 requirements.

TEST & INSPECTION PLAN-DC

REPAIR, TEST & INSPECTION PLAN FORDC MOTORS

INCOMING INSPECTION - PART I

UPON RECEIPT (Incoming Inspection for motor servicing)

CONTROL TASKTo establish the condition of the motor upon receipt at the service center and record its receipt.

RESPONSIBILITYThe Shipper/Receiver.

REASON FOR CONTROLCareful examination of the motor immediately upon receipt provides safeguards for both the service center and the customer. The inspection can reveal obvious damage, evidence of transit damage, or missing parts such as connection box covers, lifting eyebolts etc. Digital photographs are an excellent. low-cost method of recording these situations. The motor nameplate detail is recorded which, together with the customer detail, provides positive identification for the preparation of a job card/service order set. Recording this information prevents any potential dispute by allowing prompt detection of any damage which the customer may not be aware of (e.g., damage in transit) and thus the customer can be advised of this type of damage prior to repairs being started. This protects the customer from unexpected additional repair cost.

MEASURING EQUIPMENT REQUIREDNo measuring is normally expected. A digital camera is recommended.

RECORDING DOCUMENT(Specify document by description, form # etc.)


TEST SPECIFICATIONSNone applicable.

RECEIVING AREA PROCEDURE

1.0 All motors shall be visibly inspected upon receipt. When necessary, photographs may be taken to serve as records of damage, missing items or attached fittings. Such photographs may be taken using a digital camera.

1.1 In all instances, details of incoming condition shall be recorded in writing on appropriate documents.

1.2 The carrier driver and the customer shall be notified immediately of any obvious damage noted upon receipt. The customer shall be notified of any obviously missing parts.

INCOMING INSPECTION - PART II

INITIAL INSPECTION AND TEST

CONTROL TASKTo establish and record the electrical and mechanical condition of the incoming motor prior to dismantling.


REASON FOR CONTROLA careful inspection and test of the motor's mechanical and electrical condition should reveal whether the motor requires rewinding, a general evaluation of the bearing condition and also the condition of the exposed shaft and keyway. This information helps reduce delay in processing the job.

MEASURING EQUIPMENT REQUIREDDial indicator, megohmmeter, outside micrometer (to suit shaft size), voltmeter, ammeter, tachometer, vibration measuring device, feeler gauge set, digital low-resistance ohmmeter (DLRO) or Wheatstone bridge.




INITIAL INSPECTION & TEST PROCEDURE

2.0 Record full nameplate data.

2.1 Check motor shaft for freedom to turn, end play and damage. Record "As Found" conditions.

Apply megohmmeter tests to the windings (e.g., winding to ground, coil to coil). See ANSI/EASA AR100.

Record the results.

Examine leads and connections. Record condition and any special configuration.

Inspect brush rigging for cracks or other damage and check if the neutral position is marked. If not, mark for reference in re-assembly.

Check and record air gaps.

Inspect commutator for loose bars or other damage.

Perform a continuity test on the field windings. Record the results.

Measure and record winding resistances.

2.2 If megohmmeter readings are satisfactory, an exploratory no-load running test may be performed. A variable DC power supply for the armature and for the field are required to perform a running test.

2.3 Prior to running tests, check neutral setting. Record input volts at brushes and output volts at A1 and A2.

2.4 During run test, check for sparking at the commutator; if severe, recheck neutral and interpole polarity. Record armature voltage and current, and field voltage and current at low speed. If safe to do so, record readings at high speed, include tachometer reading and vibration levels.

Note: Refer to paragraph 6.9 (Final Testing) for safe procedures.

INCOMING INSPECTION - PART III

DISMANTLE AND INSPECT

PURPOSETo determine the condition of internal components.

RESPONSIBILITYAssembly mechanic.

REASON FOR CONTROLA careful inspection and test of the motor's internal mechanical and electrical condition should reveal any further problems and thus allow a detailed estimate to be prepared for the customer. It also allows the service center scheduler to plan the repair with greater efficiency, order the right amount of materials and new parts, thus reducing delay in processing the job.

MEASURING EQUIPMENT REQUIREDVarious inside and outside micrometers to suit motor shaft and bearing sizes, feeler gauge set, DLRO or Wheatstone bridge, high-potential and surge testers. DC voltmeter, DC ammeter, megohmmeter, balancing equipment.




DISMANTLE & INSPECT PROCEDURE

3.0 Carefully examine all parts as they are removed. Record condition and any detail which will ensure correct reassembly after repair.

3.1 Measure and record "As Found" dimensions and condition of bearings and housings. Record positions of spring or wave washers, thrust direction and any spacers within the bearing assembly.

3.2 Check shaft security to armature. Check fan security. Record if loose.

3.3 Check security of commutator to armature assembly.

3.4 If the motor is not being rewound, all parts and windings shall be thoroughly cleaned free of dirt, grit, grease and oils with appropriate cleaning agents. It is important to remove all traces of the cleaning agents and ensure that all parts are properly dry. Volt drop test armature and DLRO test winding bar-to-bar. Perform megohmmeter, high-potential and surge tests on the armature. Perform megohmmeter, high-potential, surge, voltage drop test, polarity and coil resistance on field windings. Record the results.

3.5 If no armature dismantling is involved, check armature dynamic balance. Correct if required.

PRE-ASSEMBLY INSPECTION & TEST

IN-PROCESS INSPECTION

PURPOSETo ensure work done on components has been satisfactorily completed prior to assembly.


REASON FOR CONTROLA careful inspection and test of the components after mechanical and electrical repairs have been completed but before final assembly greatly reduces the need to dismantle the motor at a later time for the purpose of making corrections. Also, careful attention to this control guards against possible repeating of tests already made which could cause unnecessary stress to windings etc.

MEASURING EQUIPMENT REQUIREDDLRO, megohmmeter, high-potential and surge testers, voltmeter, ohmmeter, feeler gauges, polarity test device, outside micrometer (to check shims).




NOTE: Any defect or test failure noted while conducting the following tests and inspections will be processed as nonconformances and the work placed on HOLD until a satisfactory disposition is completed.

PRE-ASSEMBLY INSPECTION & TEST PROCEDURE

4.0 ArmaturesAfter completion of winding/cleaning, baking, treating, turning, undercutting and beveling processes, visually inspect the armature for cleanliness, coating quality and commutator surface condition.

4.1 Perform the following tests and record the results.a. Bar-to-bar DLRO test;b. Megohmmeter test (see ANSI/EASA AR100);c. High-potential test (see ANSI/EASA AR100);d. High frequency surge comparison test (see ANSI/EASA AR100).

4.2 DC Field CoilsBefore installation of the field poles, the field windings shall receive the following tests:

a. Measure coil resistance. Compare poles to check correct number of turns;

b. DC drop test (max. variation +/- 5%);c. AC drop test (max. variation +/- 10%);d. Megohmmeter test (see ANSI/EASA AR100);e. High-potential test (see ANSI/EASA AR100).

4.3 DC Field Coils - Stationary Field PolesRemove all sharp edges from the pole piece, and install the coil. Check the tightness of fit and shim if required. Check the mounting areas in the frame to ensure that they are clean and free of obstruction.

It is important to match each group of shims (magnetic and non-magnetic), springs and/or spacers to its corresponding field pole to ensure pole spacing and air gaps are returned to the original.

Compare the location match marks of each pole piece to its corresponding mark on the frame and install the field poles to their original location. Take care to protect the windings from knocks etc. during installation.

After all field poles are bolted in place, perform a megohmmeter test on the windings in accordance with ANSI/EASA AR100 and check insulation resistance between field coils (shunt, series etc.).

Connect field pole leads, making sure to have polarity reversed for adjacent poles of the same type. Series or interpole leads should be connected and routed first as these are easier to form and can be used as supports to tie shunt leads to.

AC volt drop test and surge test field coils. Note: If coil inductance makes the AC test inconclusive, perform a DC voltage drop test.

PRE-ASSEMBLY INSPECTION & TEST PROCEDURE (cont’d)

4.4 Conduct a polarity test to ensure that the polarity of each pole is opposite the polarity of the poles on either side (North - South).

Perform a megohmmeter test as per ANSI/EASA AR100.

Perform a high-potential test as per ANSI/EASA AR100.

Note: If not all coils have been rewound, be sure to use the reduced percentage multiplier.

Perform AC volt drop test and surge test on field coils.

ASSEMBLY

CONTROL TASKTo assemble the motor and prepare for final testing.


REASON FOR CONTROLRe-assembly of a motor after repair is an important stage in the process. Control at this point is essential to ensure that all components are correct and fully functional so that the motor will operate correctly and reliably when returned to service with the customer. This care, in turn, prevents wasted time and allows delivery as promised by removing the possibility of rework caused by poor repair or overlooked detail, thus benefiting both customer and the service center.

MEASURING EQUIPMENT REQUIREDBearing heater, thermometer, dial indicator, steel rule, feeler gauges, spring gauge.




ASSEMBLY PROCEDURE

5.0 Collect any new parts and verify that they are the correct replacements by comparing with the old parts or to manufacturer's assembly drawings or specifications.

Collect all components into an assembly area. Ensure that adequate tooling and space exists to proceed with the assembly.

5.1 Check that all fitted surfaces are clean and free of nicks and burrs, and that there is no varnish build up on the pole faces of both armature and field coils.

5.2 At this stage, windings and internal surfaces can be painted with appropriate lacquers or paint to improve sealing and appearance where required.

5.3 Install brush holder assembly. (Where assembly is adjustable, check the match mark for neutral before installing.) Adjust the brush holders to provide the maximum installation clearance over the commutator.

5.4 Check match marks on the motor frame and insert the armature into the frame bore ensuring that the drive end of the shaft is at the drive end of the frame. Protect the commutator from damage by wrapping with heavy paper.

5.5 For motors with ball or roller bearings, gently heat the bearing inner races to a

maximum 225oF using an approved service center method such as an induction bearing heater. Install bearings with identification numbers facing out. After the inner race has cooled, install remaining bearing components.

5.6 Once assembled, pack the bearings with a high grade grease to customer or motor manufacturer's specifications (usually 1/3 full).

Note: Lubricating oil for sleeve type bearing assemblies is installed as a final step prior to final testing.

5.7 Check end bracket and frame spigot surfaces and lightly lubricate to facilitate installation. Check for dowel pins and align accordingly during assembly.

5.8 Install frame bolts and tighten evenly to prevent stress on brackets.

5.9 Align inner bearing caps and install outer caps. Half fill each outer cap with the same grease used to pack the bearing. (See EASA Tech Note 19 for guidance.) Tighten bolts in a uniform manner to prevent uneven stress on the bearing.

5.10 Check and record shaft end play. Check shaft extension run out and check commutator run out (see ANSI/EASA AR100 for guidance).

5.11 Make all lead connections secure. Attach identification tags as required.

5.12 Adjust brush holders so that they are parallel with the commutator and have a clearance of not more than 1/8" and not less than 3/32". Install brushes, checking snugness and freedom to slide in their holders. Note: ensure all brushes are the same grade.

ASSEMBLY PROCEDURE (cont'd)

5.13 Adjust spring tension for uniform pressure according to the type and grade of brushes used. Check that the brushes are centered on the commutator.

Seat the brushes using various grades of garnet paper (face to brush). Finish with a fine grade. Vacuum out loose dust.

Note: Couplings, gears and pulleys should NOT be installed until after final tests have been successfully completed. This saves time should the motor require dismantling to correct a fault detected during final testing.

FINAL TEST

CONTROL TASKTo inspect and no-load test run the motor and ensure that it performs to the required specifications before returning it to the customer.

RESPONSIBILITYThe test technician (Supervisor or Quality Control inspector).

REASON FOR CONTROLThe customer depends on the service center to provide a quality serviced motor which will perform reliably and within nameplate specifications. The no-load test is a key element used to assess the motor after servicing and to determine that the above conditions have been met. Careful control of the no-load test and inspection ensures compliance to these requirements by checking to see that the motor turns freely in its bearings without excessive friction or overheating, that the dynamic balance is sufficient to contain vibration within acceptable limits, that the speed is correct and that measured electrical parameters meet the given nameplate ratings.

MEASURING EQUIPMENT REQUIREDFeeler gauges, dial indicator, megohmmeter, high-potential tester, voltmeter, ohmmeter, tachometer, thermometer, vibration measurement device.




FINAL TEST PROCEDURE

6.0 Review all preceding test and inspection documentation to verify that all required test and inspections have been completed. HOLD further testing until documents have been cleared.

6.1 Megohmmeter test all windings in accordance with customer specifications or as per criteria provided in ANSI/EASA AR100.

Record results.

6.2 High-potential test all windings in accordance with customer specifications or as per criteria provided in ANSI/EASA AR100.

Record results.

Note: All leads NOT being tested shall be connected to the motor frame.

6.3 Upon successful completion of the high-potential test, conduct a second megohmmeter test on the windings. Resistance measured should be equal to or greater than the first readings.

6.4 Check continuity and resistance of space heaters, RTD's and similar devices. Energize space heaters and check for normal current flow.

6.5 Measure and record winding resistance, correct for temperature and compare with commercial test values or calculated values.

6.6 Visually inspect brush rigging for:

> Brush holder clearance to commutator;> Security of holder to bracket;> Brush alignment;> Equal brush spacing;> Correct spring tension;> Correct seating brush to commutator.

Check that the armature and interpoles are connected to provide correct interpole polarity.

Check that the assembly has been set to the correct neutral position. If required, electrically reset neutral by using the DC kick neutral method or the AC induced voltage method.

6.7 Measure and record air gaps. The air gap length on like poles must be equal.

6.8 After completing all pre-run inspection and testing, follow safe practice standards and connect the motor to suitable power leads for a no-load run test.

Shunt or Compound Motors Apply rated voltage to the field circuit and then from a separate source, slowly increase armature voltage to rated voltage. Check for any signs of excessive vibration or higher than normal currents.

FINAL TEST PROCEDURE (cont'd)

Series MotorUsing a low-voltage, high-current source, separately excite the series field circuit to provide for its operation as a shunt motor. When and as able, apply full series field current (i.e. Rated load current) to simulate full load speed. With the series field current adjusted in this manner, gradually increase armature voltage to nameplate rating.

Caution: Care must be used when energizing an unloaded DC series motor to prevent over-speeding.

6.9 After reaching rated speed, monitor bearing temperatures and vibration. Verify that shaft mounted blowers are moving air in the right direction. For motors fitted with sleeve type bearings, check that the oil rings are free and turning, and that the lubricant is reaching the bearing surfaces.

6.10 With the motor running at its rated no-load speed, measure and record the following:

a. Armature voltage;b. Armature current;c. Field voltage;d. Field current;e. R.P.M.f. End play;g. Vibration amplitude in horizontal, vertical and axial directions;h. Bearing temperature and ambient temperature;i. For motors with dual speed operation (field weakening) repeat test

at maximum RPM.

Compare results with commercial test values, customer specifications, nameplate data or accepted service center values.

Note 1: Typical running time on test should not be less than one hour or whatever is practical to allow bearing temperatures to settle. (See Section 6.10 of TEST & INSPECTION PLAN-AC for more detailed recommendations on run times.)

Note 2: Shunt or compound motors operated at no-load with rated field and armature voltage should typically have an armature current not exceeding 5% of rated full-load current. For motors with large shaft-mounted blowers, the armature current should not exceed 10% of full-load current.

Note 3: Series motors operated at no-load and rated speed with reduced armature voltage should typically not have the product of the measured armature current and voltage exceed 5% of the full load product (10% for motors with large blowers). This test is not the same as the series motor test described in Section 6.9.

6.11 Upon completion of successful final testing, the motor shall be stopped, disconnected from the power supply and prepared for shipment.

TEST & INSPECTION FLOWCHART

FOR

DC MOTORS

Å 1.0 RECEIPT

x 2.0 INITIAL INSPECTION & TEST

Å 3.0 DISMANTLE & INSPECT

ARMATURE FIELD COILS

x 3.4 ARMATURE COILS Å INSPECT COILS

o 3.5 COMMUTATOR ¡ REWIND (IF REQ'D)

¡ REWIND (IF REQ'D) x 4.3 TEST *

o 4.1 INSPECT ¡ REASSEMBLE

x 4.2 TEST * x 4.5 INSPECT & TEST *

Å ASSEMBLE

x 6.0 FINAL TEST *

Å PREPARE FOR SHIPPING

¡ SHIP

Appendix A-12Sample Process Control Procedures

PROCESS CONTROL

The main objective of having a documented process is to help eliminate the variations which can creep into day-to-day work by providing standardized guidelines and procedures designed to assist you in meeting customer expectations of reliability and quality. The basic intent is to identify what is to be done, when and by whom.

The guidelines provide recommendations for procedures at each significant stage of the work process which can help achieve the desired service quality level. While they have been compiled from actual experience from a variety of sources, they, like anything else, can be improved upon.

TEST & INSPECTION PLAN-1

PREPARATION FOR SHIPPING

CONTROL TASKTo ensure that the motor, having successfully completed its final test and inspection, is now suitably prepared for shipping back to the customer.

RESPONSIBILITYShipper/Receiver.

REASON FOR CONTROLThe customer depends on the service center to deliver a quality serviced motor to the correct address, with correct documentation and in good condition. Proper preparation is essential to meet these expectations. The benefits to the customer are obvious. The benefits to the service center are: creating trust as a reliable and concerned supplier, and effective cost control by getting the delivery "right, the first time."

MEASURING EQUIPMENT REQUIREDNone.



TEST SPECIFICATIONSNone.

PREPARATION FOR SHIPPING PROCEDURE

1.0 Shipping personnel, under the supervision of the Service Center Foreman, shall ensure that the items to be shipped are correctly identified, marked and recorded on the appropriate documentation. This documentation would normally comprise as a minimum:

> Packing slip;> Carrier documentation (if subcontracted transport);> Where applicable, special instructions for installing, and/or commissioning

the repaired motor;> Prominently displayed warnings (if applicable) to be attached to the motor

(e.g., no oil in bearings).

1.1 Where jurisdiction requirements apply, all necessary permits, licenses and authorizations shall be obtained to allow proper delivery to the consignee.

1.2 Where required, or specified in the contract, protective measures and materials shall be applied to the items for shipment sufficient to prevent damage from environmental and normal transit damage. Protective measures may include several or all of the following:

> Securing the motor to a skid or frame to allow removal by forklift should the customer's facility not be equipped with direct lift cranes.

> Securing the shaft by "blocking" to prevent possible vibration damage to bearings, especially if the delivery is over rough road surfaces (e.g., delivery to a construction or mining site).

> Covering the motor with weatherproof material, or sealing blower vents etc.

1.3 All shipping consignments shall be recorded on appropriate documentation. (Specify your documents used).

TEST & INSPECTION PLAN-2

INSPECTION OF INCOMING MATERIAL

CONTROL TASKTo ensure that all products and material purchased by the service center for application to motor repair are verified as being correct and conforming to specified requirements, are received undamaged, and that the correct quantities have been received.

RESPONSIBILITYShipper/Receiver (Machinist for machined parts).

REASON FOR CONTROLIdentification of problems with products or material immediately upon receipt reduces the possibility of wasted time and effort in the repair process by ensuring that the items received are what was ordered and can be properly allocated to a job. If there is a problem noted upon receipt, prompt correction will prevent possible delay. Inspection of incoming items also ensures that any damage detected is corrected without delay. Benefit to the customer is that this process contributes to on-time delivery. Benefit to the service center is more effective cost control by reducing delay in the repair.

MEASURING EQUIPMENT REQUIREDScale (for weighing bulk items), measuring tape, micrometer (to verify magnet wire size).


FREQUENCYEvery incoming shipment of products or items used in the service process.

TEST SPECIFICATIONSComparison to purchase order issued, packing slip. Units of measure as applicable.

INCOMING MATERIAL INSPECTION PROCEDURE

1.0 Receiving personnel, under the supervision of the Service Center Foreman, shall ensure that items and/or materials received are verified as matching specifications and fitness for use. In addition, objective evidence that the material was produced to a specific quality standard, or certification level documentation from an approved source shall be required if the application of the received items is to a contract governed by a recognized quality assurance standard. Where applicable, jurisdictional safety regulatory documentation shall be required also (e.g., MSDS Material Safety Data Sheet).

1.1 Any damage or shortages shall be promptly reported to the Service Center Foreman who will advise purchasing department to contact the supplier and implement effective corrective action.

1.2 Where incoming materials are destined for specific jobs, they will be clearly marked with the appropriate job number.

1.3 Upon satisfactory inspection, materials documentation shall be approved and signed as accepted and located to appropriate storage facilities.

1.4 Any materials not fully conforming shall be held and, where applicable, placed in suitable quarantine storage to await satisfactory disposition. Non-conforming items shall be processed per procedures described.

1.5 Inspection upon receipt shall be applicable to, but not limited to, the following material:

> Magnet Wire (verify wire size, varnish coating criteria, damage, length on spool per label);

> Anti-friction bearings (correct specification, exterior packing damage, quantity etc.);

> Insulating materials, preformed (correct specifications, quantity, size, damage etc.);

> Preformed coils (correct specifications, quantity, damage etc.);> Machined items (correct specifications, quantity, damage etc.);> Varnishes, paints, resins (correct specifications, safety and conformance

to jurisdictional requirements governing this type of product, quantity).

TEST & INSPECTION PLAN-SP

SPECIAL PROCESS*

VARNISH DIPPING PROCESS

1.0 PERSONNELAll persons performing varnish dipping shall be suitably trained and experienced in all aspects of the process.

2.0 WORK AREASThe dipping area shall be maintained in a clean and orderly condition at all times.

2.1 The varnish tank will be covered when not in use to prevent contamination of the varnish.

2.2 The dipping area and tank shall be suitably equipped with approved fire equipment and must fully comply with applicable fire regulations.

3.0 TOOLINGSuitable apparatus to lift and lower the work in and out of the varnish shall be maintained in safe and efficient working order.

4.0 CONTROL

Preheat the stator to approximately 140oF (60oC).Mask spigot fits and plug holes in the stator frame. Lower the stator (vertically wherever possible) slowly into the varnish to allow varnish to displace air in the windings.The stator should be fully immersed and allowed to stand until all signs of trapped air escapement have ceased.The work is then lifted clear of the varnish tank surface and allowed to drain completely.Inspect the work for possible bare areas, poor varnish adhesion or other defects.If required, repeat the dipping process as described, reversing stator (end to end) for each additional dip.

* Special processes are activities such as welding, brazing, varnish dipping and VPI processes whose results cannot be directly examined to establish full conformance. Verification of conformance depends on evidence generated during the process.

EASA-Q_2000_0403

Documents

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