ISO-TS Presentation

of 244

ISO/TS 16949 :2002ISO/TS 16949 :2002Quality Management SystemQuality Management System

Awareness ProgrammeAwareness Programme

Presentation by:

of 244

INTRODUCTION OF INTRODUCTION OF

ISO 9001:2000 ISO 9001:2000

Standards & Standards & Importance of ISOImportance of ISO

of 244

Standards - A history of developmentStandards - A history of development

• NATO Standards AQAP’s 21, 24, 29

• BS 5179:1974

• BS 5750:1979

• ISO 9000:1987

• ISO 9001:1994

• ISO 9001:2000 (Dec 2000)

of 244

The new family of standardsThe new family of standards

• ISO 9000 Fundamentals

• ISO 9001 The requirements

• ISO 9004 Guidance

• ISO 19011 Auditing Quality & Environmental systems

of 244

ISO 9000:2000 family of standardsISO 9000:2000 family of standardsReasons for RevisionReasons for Revision

• ISO Protocols require review of Standards every five years to either

– Confirm or

– Revise or

– Withdraw

• Changed Customer / User needs based on experiences of 1994 version and global survey conducted in 1997.

of 244

ISO 9000:2000 family of standardsISO 9000:2000 family of standardsReasons for RevisionReasons for Revision

• Need to improve performance continuously by focussing on major processes in the organisation.

• Need to monitor Customer Satisfaction.

• Promoting use of Quality Management Principles

• Need for consistency between QMS requirement and guidelines

• Need to restructure the Standards.

of 244

Major Changes in ISO 9001:2000Major Changes in ISO 9001:2000

• Quality Management instead of Quality Assurance

• ISO 9001, 9002 & 9003 combined into one Standard

• New Process oriented structure

• Increased emphasis on the role of Top Management

• Significant reduction in mandatory documentation

• Terminology Changed and Improved to make it user friendly

• Increased compatibility with ISO 14000 family of Standards

of 244

• Establishment of Measurable Objectives at Relevant Levels and Functions

• Input to Output from Management Review Meetings has been defined

• Additional role of Management Representative (MR) to promote awareness of Customer Requirements throughout the Organisation.

• Increased attention to Resource Management and its availability

• Restructuring of ISO 9000 family Standards.

of 244

32 Clauses of ISO 9001 : 2000 are divided into five main 32 Clauses of ISO 9001 : 2000 are divided into five main clauses as given below:clauses as given below:

• Clause 4 - Quality Management System

• Clause 5 - Management Responsibility

• Clause 6 - Resource Management

• Clause 7 - Product Realisation

• Clause 8 - Measurement, Analysis and Improvement

• ISO 9001 & ISO 9004 now a consistent pair of Standards

of 244

New Requirements in New Requirements in ISO 9001 : 2000ISO 9001 : 2000

• Focus on Customer Satisfaction

• Stress on Continual Improvement

• Concept of Permissible Exclusions

• Consideration of Regulatory Requirement (Legal and Statutory)

• Specific reference to Quality Management Principles

of 244

New Requirements in New Requirements in ISO 9001 : 2000ISO 9001 : 2000

• Internal Communication

• Customer Communication

• Measurement and Monitoring extended to Process

• Analysis of Data

of 244

Management PrinciplesManagement Principles ISO 9001:2000 ISO 9001:2000

• Customer focus

• Leadership

• Involvement of people

• Continual Improvements

• Factual approach to decision making

• Mutually beneficial supplier relationships

• Process approach

• System approach to management

of 244

Customer focusCustomer focus

• You DEPEND on the customer

• Need to understand current & future needs

• Meet customer requirements

• Strive to exceed customer expectations

of 244

LeadershipLeadership

• Leaders establish the vision and direction

• Create the environment for people to become fully involved in achieving goals & objectives

of 244

Involvement of peopleInvolvement of people

• People at ALL levels are the company

• Their involvement will enable their skills & abilities to be used for company’s maximise benefits

T E A Mthe

of 244

Continual ImprovementsContinual Improvements

• A permanent objective to continually improve

• PDCA - Plan - Do - Check - Action

ActionCan we do it better ??

of 244

Factual approach to decision makingFactual approach to decision making

• Effective decisions are based on the logical or intuitive analysis of data & information

Pareto 80/20 ruleCollect data

of 244

Process ApproachProcess Approach

• Results are achieved more efficiently when resources & activities are managed as a process

of 244

A Process A Process

The Process diagram

People

Equipment

Material

Methods

Environment

INPUTS OUTPUTS

PROCESS

Product

Service

Information

Records

MONITOR

Managing the inputs - Prevention Checking - Detection

of 244

Process Control SystemProcess Control System

• Detection v Prevention

– Detection• after the event - tolerates waste

– Prevention• before the event - avoids waste

of 244

PreventionPrevention

• Are we capable of doing the job correctly– We need to know and understand the Process

of 244

System approach to managementSystem approach to management

• Identifying, understanding & managing a system of interrelated processes for a given objective contributes to the effectiveness & efficiency of the company

Quality Management System

of 244

System approach to managementSystem approach to management

of 244

System approach to management System approach to management The The Systematic ApproachSystematic Approach

• What steps to take

• Measure what we do (Quality)

• So that we can Manage more effectively (Quality)

• What system can we use?

of 244

Quality Management SystemsQuality Management Systems

ISO/TS 16949 :2002Quality Management System Standard

of 244

1.1 Scope1.1 Scope

To demonstrate the ability to provide consistent products & meet regulatory requirements

To address Customer satisfaction by effective application of the system

Process for continual Improvement

Prevention of nonconformities

of 244

1.2 Permissible exclusions1.2 Permissible exclusions

• Limited to clause 7 Product Realisation

• Exclusions cannot affect the ability to produce acceptable product that meets:

Customer requirements

Applicable regulatory requirements

The Process ActivitiesInputs Outputs

of 244

6 Resource management

INPUTS

4. Quality Management System

5. Management Responsibilities

7 Product realisation

8. Measurement, analysis & improvements

OUTPUTS

Continuous ImprovementContinuous Improvement

of 244

4 4 Quality management systemQuality management system

of 244

4.1 General 4.1 General requirementsrequirements

• The organisation shall – establish,

– document,

– implement,

– maintain and

– continually improve in accordance with the International Standard.

of 244

4.1 General requirements 4.1 General requirements

• To implement the organisation shall: identify the processes needed; determine the sequence and interaction of these processes; determine criteria and methods required to ensure the

effective operation and control of these processes;

of 244

4.1 General requirements 4.1 General requirements

availability of information to support the operation and monitoring of these processes;

measure, monitor and analyse these processes, and implement action necessary to achieve planned results and continual improvement.

The organisation shall manage these processes in accordance with the requirements of this International Standard.

of 244

4.2 General documentation 4.2 General documentation requirementsrequirements

• The quality management system documentation shall include: documented procedures required in this International

Standard. documents required by the organisation to ensure the

effective operation and control of its processes.

of 244

4.2 General documentation 4.2 General documentation requirementsrequirements

• The extent of the quality management system documentation shall be dependent on the following: size and type of the organisation; complexity and interaction of the processes; competence of personnel. In any format!

of 244

4.2.2 Quality Manual4.2.2 Quality Manual

• A quality manual shall be established and maintained that includes the following:• the scope of the quality management system, including details of,

and justification for, any exclusions (see 1.2);

• documented procedures or reference to them;

• a description of the sequence and interaction of the processes included in the quality management system.

of 244

4.2.3 Control of documents 4.2.3 Control of documents

• Documents required for the quality management system shall be controlled. A documented procedure shall be established: to approve documents for adequacy prior to issue; to review, update as necessary and re-approve documents; to identify the current revision status of documents; to ensure that relevant versions of applicable documents are

available at points of use; changes and revision status are identified

of 244

4.2.3 Control of documents 4.2.3 Control of documents

to ensure that documents remain legible, readily identifiable and retrievable;

to ensure that documents of external origin are identified and their distribution controlled;

to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

of 244

4.2.4 Control of records4.2.4 Control of records

• Records required for the quality management system shall be controlled.

• Such records shall be maintained to provide evidence of conformance to requirements and of effective operation of the quality management system.

• A documented procedure shall be established for the identification, storage, retrieval, protection, retention time and disposition of quality records.

of 244

5 Management responsibility5 Management responsibility

of 244

5.1 Management commitment 5.1 Management commitment

• Top management shall provide evidence of its commitment to the development and improvement of the quality management system by: communicating to the organisation the importance of meeting

customer as well as regulatory and legal requirements; establishing the quality policy and quality objectives; conducting management reviews;

• ensuring the availability of necessary resources.

of 244

5.25.2 Customer focusCustomer focus

• Top management shall ensure that customer requirements are determined, converted into requirements and fulfilled with the aim of achieving customer satisfaction.

• NOTE When determining customer requirements, it is important to consider obligations related to product, including regulatory and legal requirements (see 7.2.1).

of 244

5.35.3 Quality policyQuality policy

• Top management shall ensure that the quality policy: is appropriate to the purpose of the organisation; includes a commitment to meeting requirements and to

continual improvement; provides a framework for establishing and reviewing

quality objectives; is communicated and understood at appropriate levels in

the organisation; is reviewed for continuing suitability.

of 244

5.4 5.4 PlanningPlanning

of 244

5.4.1 5.4.1 Quality objectives Quality objectives

• Top management shall ensure that quality objectives are established at relevant functions and levels within the organisation.

of 244

5.4.1 Quality 5.4.1 Quality objectivesobjectives

• The quality objectives shall be measurable, and consistent with the quality policy including the commitment to continual improvement.

of 244

5.4.1 Quality objectives 5.4.1 Quality objectives

• Quality objectives shall include those needed to meet requirements for product (see 7. 1a).

of 244

5.4.2 Quality Planning 5.4.2 Quality Planning

• Top management shall ensure that the resources needed to achieve the quality objectives are identified and planned.

of 244

5.4.2 Quality planning 5.4.2 Quality planning

• Quality planning shall ensure that: the planning of the management system is carried

out to meet the requirements in clause 4.1

– change is conducted in a controlled manner and that the integrity of the quality management system is maintained during this change.

of 244

5.5 5.5 Responsibility, authority, and Responsibility, authority, and communicationcommunication

of 244

5.5.1 5.5.1 Responsibility and Responsibility and AuthorityAuthority

• Top management shall ensure that responsibilities and authorities are defined and communicated within the organisation.

of 244

5.5.2 5.5.2 Management representativeManagement representative

• Top management shall appoint a member of the management team who, irrespective of other responsibilities, shall have responsibility and authority that includes: ensuring that processes of the quality management system are

established and maintained; reporting to top management on the performance of the

quality management system, including needs for improvement;

ensuring the promotion of customer requirements

of 244

5.5.3 Internal communication5.5.3 Internal communication

• The organisation shall ensure communication between its various levels and functions regarding the processes of the quality management system and their effectiveness.

Department A Department B

of 244

5.6 Management review5.6 Management review

• 5.6.1 General

• Top management shall review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.

• The review shall evaluate the need for changes to the organisation's quality management system, including quality policy and quality objectives.

• Records shall be maintained

of 244

5.6.2 Review input5.6.2 Review input

• Inputs to management review shall include information on: results of audits; customer feedback; process performance and product conformance; status of preventive and corrective actions; follow-up actions from earlier management reviews; changes that could affect the quality management system. Recommendations for improvement

of 244

5.6.3 Review output5.6.3 Review output

• The output from the management review shall include decisions and actions related to: improvement of the management system and its

processes; improvement of product related to customer

requirements; resource needs.

of 244

6 6 Resource managementResource management

of 244

6.1 Provision of resources6.1 Provision of resources

• The organisation shall determine and provide the resources needed: to implement and improve the processes of the quality

management system, and to enhance customer satisfaction by meeting customer

requirements.

of 244

6.2 Human resources6.2 Human resources

• 6.2.1 Assignment of personnel • Personnel performing work affecting product

quality shall be competent on the basis of applicable education, training, skills and experience.

of 244

6.2.2 Training, awareness and 6.2.2 Training, awareness and competencycompetency

• The organisation shall: determine competency needs for personnel performing activities

affecting quality; provide training, or other actions, to satisfy these needs; evaluate the effectiveness of the actions taken; ensure that its employees are aware of their role in contributing to

the achievement of the quality objectives; maintain appropriate records of education, experience, training

and qualifications (see 5.5.7).

of 244

6.3 Infrastructure6.3 Infrastructure

• The organisation shall identify, provide, and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes as applicable: buildings, workspace and associated utilities; process equipment (hardware and software); supporting services (transport,etc).

of 244

6.4 Work environment6.4 Work environment

• The organisation shall determine and manage the work environment needed to achieve conformity of product.

of 244

7 Product realization7 Product realization

of 244

7.1 Planning of realization 7.1 Planning of realization processesprocesses

• The organisation shall determine the following as appropriate:

– quality objectives and requirements for the product

– need to establish processes, documents, and provide resources specific to the product

– inspection and testing activities specific to the product and the acceptance criteria

– records to provide evidence that the realisation processes and the resulting product meet requirements

– planning output shall be in a form suitable for the methods of operation of the organisation

of 244

7.2 Customer - related processes7.2 Customer - related processes

of 244

7.2.1 Identification of customer 7.2.1 Identification of customer requirementsrequirements

• The organisation shall determine:

– customer requirements including requirements for delivery and post-delivery activities

– requirements not specified by the customer but necessary for intended or specified use

– including regulatory and legal requirements

– any additional requirements determined by the organisation

of 244

7.2.2 Review of product 7.2.2 Review of product requirements requirements

• The organisation shall review the requirements related to the product

• The review shall be conducted prior to the commitment to supply a product to the customer (e.g. submission of a tender, acceptance of a contract or order) to ensure that:

– the requirements are defined

– contract or order differences are resolved

– the organisation has the ability to met the defined requirements

• Records of the review shall be maintained

of 244

7.2.2 Review of product 7.2.2 Review of product requirementsrequirements

The organisation shall ensure that:

– where requirements are changed, relevant documentation is amended.

– relevant personnel are made aware of the changed requirements.

of 244

7.2.3 Customer communication7.2.3 Customer communication

• The organisation shall identify and implement arrangements for communication with customers relating to: product information; enquiries, contracts or order handling, including

amendments; customer feedback, including customer

complaints.

of 244

7.3 Design and development7.3 Design and development

of 244

7.3.1 Design and/or development 7.3.1 Design and/or development planningplanning

• Shall plan and control design and/or development of the product. Design and/or development planning shall determine: the design and development stages review, verification and validation activities

appropriate to each design and/or development stage

of 244

7.3.1 Design and/or development 7.3.1 Design and/or development planningplanning

responsibilities and authorities for design and development activities.

interfaces between different groups involved in design and development shall be managed to ensure effective communication and clarity of responsibilities.

• Planning output shall be updated, as appropriate, as the design and development progresses.

of 244

7.3.2 Design and/or development 7.3.2 Design and/or development inputsinputs

• Inputs requirements shall be defined and documented. These shall include: functional and performance requirements; applicable regulatory and legal requirements; applicable information derived from previous similar

designs, and other requirements essential for design and development.

• Inputs shall be reviewed for adequacy. Incomplete, ambiguous or conflicting requirements shall be resolved

of 244

7.3.3 Design and/or development 7.3.3 Design and/or development outputsoutputs

• The outputs shall be documented in a manner that enables verification against the design and development inputs.

• Output shall: meet the input requirements provide appropriate information for purchasing, production,

and service operations contain or reference product acceptance criteria specify the characteristics that are essential for safe and

proper use. Output documents shall be approved prior to release.

of 244

7.3.4 Design and/or development 7.3.4 Design and/or development reviewreview

• At suitable stages, systematic reviews shall be conducted to: evaluate the ability of the results of the design process to

meet requirements; identify problems and propose necessary actions.

• Participants shall include representatives of functions concerned with the design stage(s) being reviewed.

• Results of the reviews and any necessary actions shall be recorded

of 244

7.3.5 Design and/or development 7.3.5 Design and/or development verificationverification

• Verification shall be performed to ensure that the design outputs meets the input requirements.

• The results of the verification and any necessary actions shall be recorded.

of 244

7.3.6 Design and/or development 7.3.6 Design and/or development validationvalidation

• Validation shall be performed to confirm that resulting product is capable of meeting the requirements for the intended use.

• Wherever applicable, validation shall be completed prior to the delivery or implementation of the product.

• Validation records shall be maintained.

of 244

7.3.7 Control of design and 7.3.7 Control of design and development changesdevelopment changes

• Changes shall be verified and validated, and approved before implementation.

• Control includes evaluation of the effect of the changes on constituent parts and products already delivered.

• Identified, documented and controlled

• The results of the review of changes and any necessary actions shall be documented.

of 244

7.4 Purchasing7.4 Purchasing

of 244

7.4.1 Purchasing process7.4.1 Purchasing process

• Shall control purchasing processes to ensure purchases product conforms to requirements.

• The type and extent of control shall be dependent upon the effect on subsequent realisation processes and to the final product.

• The organisation shall evaluate and select suppliers, in accordance with specified criteria, based on their ability to supply in accordance with the requirements.

• Records shall be maintained

of 244

7.4.1 Purchasing control7.4.1 Purchasing control

• Criteria for supplier selection and periodic evaluation shall be defined.

• The results of evaluations and any necessary actions arising shall be recorded.

of 244

7.4.2 Purchasing information7.4.2 Purchasing information

• Purchasing documents shall contain information describing the product to be purchased, including where appropriate: requirements for approval or qualification of

- product, procedures, processes, equipment and personnel; quality management system requirements.

• Shall ensure the adequacy of specified requirements contained in the purchasing documents prior to their communication to the supplier.

of 244

7.4.3 Verification of purchased 7.4.3 Verification of purchased productsproducts

• Shall identify and implement the activities necessary for verification.

• Where the organisation or its customer proposes to perform verification activities at the supplier's premises, the organisation shall specify the intended verification arrangements and method of product release in the purchasing information.

of 244

7.5 Production and service provision7.5 Production and service provision

of 244

7.5.1 Operations control7.5.1 Operations control

• The organisation shall control operations through: the availability of information that specifies the characteristics of

the product; where necessary, the availability of work instructions; the use of suitable equipment the availability and use of measuring and monitoring devices., the implementation of monitoring activities; the implementation of release, delivery and post- delivery

activities.

of 244

7.5.2 Validation of processes7.5.2 Validation of processes

• Shall validate any production and service processes where the resulting output cannot be verified by subsequent measurement or monitoring.

• This includes any processes where deficiencies may become apparent only after the product is in use or the service has been delivered.

of 244

7.5.2 Validation of processes7.5.2 Validation of processes

• Validation shall demonstrate the ability of the processes to achieve planned results by the following, as applicable: qualification of processes; qualification of equipment and personnel; use of defined methodologies and procedures; requirements for records; re-validation

of 244

7.5.3 Identification and Traceability7.5.3 Identification and Traceability

• Shall identify, where appropriate, the product by suitable means throughout production and service operations.

• Shall identify the status of the product with respect to measurement and monitoring requirements.

• Shall control and record the unique identification of the product, where Traceability is a requirement.

of 244

7.5.4 Customer property7.5.4 Customer property

• Shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product.

• Occurrence of any customer property that is lost, damaged or otherwise found to be unsuitable for use shall be recorded and reported to the customer.

NOTE Customer property may include intellectual property (e.g. information provided in confidence).

of 244

7.5.4 Preservation of product7.5.4 Preservation of product

• Shall preserve conformity of product with customer requirements during internal processing and final delivery to the intended destination.

• Include identification, handling, packaging, storage and protection. Shall also apply to the constituent parts of a product.

of 244

7.6 Control of measuring and 7.6 Control of measuring and monitoring devicesmonitoring devices

• Shall identify the measurements to be made and the measuring and monitoring devices required to assure conformity of product to specified requirements.

• Processes shall be established to ensure that measuring and monitoring devices are used in a manner that is consistent with the measurement requirements.

of 244

• Where applicable, measuring and monitoring devices shall: be calibrated and adjusted periodically or prior to use, against

devices traceable to international or national standards; where no such standards exist, the basis used for calibration shall be recorded;

be safeguarded from adjustments that would invalidate the calibration;

be identified to enable the calibration status to be determined

of 244

be protected from damage and deterioration during handling, maintenance and storage;

have the results of their calibration recorded (see 5.5.7); have the validity of previous results re-assessed if they are

subsequently found to be out of calibration, and corrective action taken.

Software used for measuring and monitoring of specified requirements shall be validated prior to use.

of 244

8 Measurement, analysis and 8 Measurement, analysis and improvementimprovement

of 244

8.1 General8.1 General

• Shall define, plan and implement the measurement, monitoring, analysis and improvement processes:– needed to ensure conformity of the product– needed to ensure conformity of the management system – needed to continually improve the effectiveness of the

management system• Shall include the determination of the need for, and use of,

applicable methodologies including statistical techniques.

of 244

8.2 Measurement and monitoring8.2 Measurement and monitoring

of 244

8.2.1 Customer satisfaction8.2.1 Customer satisfaction

• Shall monitor information on customer satisfaction and/or dissatisfaction as one of the measurements of performance of the quality management system.

• The methodologies for obtaining and using this information shall be determined.

of 244

8.2.2 Internal audit8.2.2 Internal audit

• Conduct periodic internal audits to determine whether the system has been effectively implemented and maintained.

• Plan the audit program taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits.

• The audit scope, frequency and methodologies shall be defined.

of 244

• Shall be conducted by personnel other than those who performed the activity being audited.

• Documented procedure shall include the responsibilities and requirements for conducting audits, ensuring their independence, recording results and reporting to management.

of 244

• Management shall take timely corrective action on deficiencies found during the audit.

• Follow-up actions shall include the verification of the implementation of corrective action, and the reporting of verification results.

of 244

8.2.3 Monitoring and measurement of 8.2.3 Monitoring and measurement of processesprocesses

• Shall apply suitable methods for measurement and monitoring of the management system processes necessary to meet customer requirements.

• When results are not achieved, corrective actions shall be implemented.

of 244

8.2.4 Monitoring and measurement of 8.2.4 Monitoring and measurement of productproduct

• Measure and monitor the characteristics of the product to verify that requirements are met.

• Carried out at appropriate stages of the process.

• Evidence of conformity with the acceptance criteria shall be documented.

of 244

8.2.4 Measurement and monitoring8.2.4 Measurement and monitoring

• Records shall indicate the authority responsible for release of product

• Product release and service delivery shall not proceed until all the specified activities have been completed, unless otherwise approved by the customer.

of 244

8.3 Control of Non-conformances8.3 Control of Non-conformances

of 244

8.3 Control of nonconforming 8.3 Control of nonconforming productproduct

• Product which does not conform is identified and controlled to prevent unintended use or delivery.

• Defined in a documented procedure. • Nonconforming product shall be corrected and subject to

re-verification after correction to demonstrate conformity.

of 244

8.3 Control of nonconformity8.3 Control of nonconformity

• When nonconforming product is detected after delivery or use has started, appropriate action shall be taken regarding the consequences of the nonconformity.

• The proposed rectification of non-conforming product be reported for concession to the customer, the end user, regulatory body or other body.

of 244

8.3 Control of nonconformity8.3 Control of nonconformity

• Non-conforming product shall be :

– reworked to met the original requirements

– re-graded or re-categorised

– the subject of a concession

of 244

8.4 Analysis of data8.4 Analysis of data

• Collect and analyse appropriate data to determine the suitability and effectiveness of the management system and to identify where continual improvements may be made.

• Data generated by measuring and monitoring activities and other relevant sources

of 244

8.4 Analysis of data8.4 Analysis of data

• Shall analyse this data to provide information on: customer satisfaction and/or dissatisfaction; conformance to customer requirements; characteristics of processes, products and opportunities

for preventive action suppliers.

of 244

8.5 Improvement8.5 Improvement

of 244

8.5.1 Continual improvement8.5.1 Continual improvement

The organisation shall continually improve the effectiveness of the management system through the use of:– the quality policy– quality objectives– audit results– analysis of data– corrective and preventive actions– management review.

of 244

8.5.2 Corrective action8.5.2 Corrective action

• The organisation shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

• Corrective action shall be appropriate to the effect of the non-conformities encountered.

of 244

8.5.2 Corrective action8.5.2 Corrective action

• A documented procedure shall be established to define requirements for:

reviewing non-conformities (including customer complaints),

determining the causes of nonconformity; evaluating the need for actions to ensure that

nonconformities do not recur, determining and implementing the corrective action

needed; recording results of action taken; reviewing of corrective action taken.

of 244

8.5.3 8.5.3 Preventive actionPreventive action

• Preventive action to eliminate the causes of potential nonconformities to prevent occurrence and be appropriate to the effects of the potential problems.

• A documented procedure shall define identifying potential nonconformities and their causes evaluating the need for action to prevent occurrence of non-

conformities determining and implementing the actions needed recording results of action taken reviewing preventive action taken

of 244

An Introduction to ISO/TS 16949:2002

of 244

ISO/TS 16949:2002 Basics – What ISO/TS 16949:2002 Basics – What is ISO/TS 16949:2002?is ISO/TS 16949:2002?

• Incorporates ISO 9001:2000

• Replaces US, and European Standards– QS-9000, VDA, etc.

• Document reflecting worldwide automotive requirements – US, Europe, and Asia

of 244

What is ISO/TS 16949:2002?What is ISO/TS 16949:2002?

TS 16949 is a Technical Standard expressing “particular requirements for the application of ISO 9001:2000 for automotive production and relevant service part organizations”

…which means...

ISO 9001:2000 requirements plus additional requirements specific to automotive production

In the standard document ISO 9001:2000 text is shown in boxes

of 244

ISO/TS 16949:2002 BasicsISO/TS 16949:2002 Basics – –Documents Auditors Documents Auditors and Implementers need to Knowand Implementers need to Know

• ISO/TS 16949:2002 Technical Standard

• ISO/TS 16949:2002 Guidance Document

• Rules for Automotive Certification Scheme

• Quality System Checklist

• Customer Specific Requirements

of 244

OutlineOutline

• ISO/TS 16949:2002 Transition Overview

– ISO 9000 Background and Evolution

– TS 16949 Background and Objectives

– Overview of Quality Management Principles

– Overview of the TS 16949/ISO 9000 Standards

– Transitioning to ISO/TS 16949:2002

of 244

ISO 9000 Is . . .ISO 9000 Is . . .

• An international quality management system standard which adopts a process approach for:

– developing, implementing and improving the effectiveness of a quality management system

– enhancing customer satisfaction by meeting customer customer requirements

of 244

ISO/TS 16949:2002 Is . . .ISO/TS 16949:2002 Is . . .• A process approach for:

– Implementing an effective and efficient quality management system, and

– Enhancing customer satisfaction through continual improvement of the QMS and “customer-owned” processes (primarily manufacturing process)

• Includes all requirements of ISO 9001:2000 and:

– Automotive / customer specific requirements

of 244

The Objectives of ISO 9000 are to...The Objectives of ISO 9000 are to...

• Achieve, sustain, and improve product quality by managing the processes that create them

• Give the organization confidence that customer requirements are being met

• Give the customer confidence that products consistent meet requirements

• Provide or sustain market entry

of 244

The Objectives of TS 16949 are to ...The Objectives of TS 16949 are to ...

• Specify Automotive Customer requirements

• Provide automotive industry with revised ISO 9001:2000 based QMS standard

• Provide a worldwide, standardized approach for all automotive suppliers

• Expand ISO 9001:2000 focus on process management by emphasizing

- defect prevention and

- reduction of variation in the supply chain

of 244

ISO 9000:2000 standards include ...ISO 9000:2000 standards include ...

ISO 9000:2000Quality Management Systems -Fundamentals and Vocabulary

ISO 9004:2000Quality Management Systems -

Guidelines for Performance Improvements

ISO 9001:2000Quality Management Systems -

Requirements

of 244

TS 16949 incorporates all TS 16949 incorporates all ISO 9000:2000 standards and ...ISO 9000:2000 standards and ...

Customer Requirements / Guidance•Advanced Product Quality Planning (APQP) & Control Plan•Failure Mode Effects Analysis (FMEA)•Production Part Approval Process (PPAP)•Fundamental Statistical Process Control (SPC)•Measurement Systems Analysis (MSA)•Quality System Assessment (QSA) Checklist

ISO/TS 16949:2002Quality Management Systems - particular requirements for the application of ISO 9001:2000 for automotive production

and relevant service part organizations

of 244

A Quality System must be … “ SEDA”A Quality System must be … “ SEDA”

• Suitable

• Documented

Words of wisdom from Victor Schur (Sears)

• Effective

• Auditable

of 244

ISO 9000 StatusISO 9000 Status

• 500,000+ Companies Registered Worldwide

• 37,000+ Companies Registered in the U.S.

• 20,000+ U.S. Companies pursuing Registration

• DoD, “Big 3” & many other “sectors”or industries have adopted ISO 9000 based standards

• Automotive manufacturers have imposed deadlines on Tier 1, 2 and 3 suppliers to achieve ISO 9001:2000 and/or ISO/TS 16949:2002 registration at various times over the next three years

of 244

‘‘Deadlines’Deadlines’

• ISO 9001:2000 (replaces ISO 9001/2:1994)

- All ISO 9001/2:1994 registered companies must make the transition by December 2003

• ISO/TS 16949:2002 (Replaces QS- 9000:1998)

- DaimlerChrysler suppliers must make the transition by July 2004

- General Motors and Ford suppliers must make the transition by December 2006

of 244

Performance Excellence Starts with an Performance Excellence Starts with an Effective QMSEffective QMS

Competitive

Advantage

Efficient

Effective

Business Vision

Performance Excellence

Nation Quality Award Criteria (such as Baldrige)

Performance Improvement

ISO/TS 16949:2002

Baseline Performance:

ISO 9001:2000

of 244

The Basis of a Quality System is to ...The Basis of a Quality System is to ...

say what you do,

do what you say,

record what you did,

check the results, and

act on the difference

Words of wisdom from Ian Durand(US Technical Advisory Group to ISO TC 176)

of 244

ISO/TS 16949:2002 and ISO 9004ISO/TS 16949:2002 and ISO 9004are the “Consistent Pair”are the “Consistent Pair”

comprised of the following 8 clauses:

1. Scope

2. Normative references (part of the requirements)

3. Terms and definitions

4. Quality management system

5. Management responsibility

6. Resource management

7. Product (and/or service) realization

8. Measurement, analysis & improvement

of 244

Clause 4.1 Clause 4.1 QMS General RequirementsQMS General Requirements

• 4.1 The organization must establish, document, implement, maintain and continually improve the QMS processes; this includes:

define processes to be managed (including out-sourced processes - which typically include design, training, calibration, heat treat, etc.)

define the sequence and interaction of these processes

determine the criteria and methods needed to manage these processes and ensure their effectiveness;

take actions to improve these processes.

of 244

TS 16949 and ISO 9000 are based on Eight TS 16949 and ISO 9000 are based on Eight Quality Management PrinciplesQuality Management Principles

• Customer Focus

• Leadership

• Involvement of People

• Process Approach

• System Approach

• Continual Improvement

• Factual Approach to Decision Making

• Mutually Beneficial Supplier Relationships

of 244

Customer FocusCustomer Focus

• Organizations depend on their customers and therefore should:

understand current and future customer needs,

meet customer requirements, and

strive to exceed customer expectations.

of 244

LeadershipLeadership

• Leaders should:

establish unity of purpose and direction of the organization, and

create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

of 244

Clause 5.1Clause 5.1Management CommitmentManagement Commitment

• Top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness through specific activities:

communicate importance of meeting customer (and statutory/regulatory) requirements

establish quality policy and objectives

conduct management reviews

ensure availability of necessary resources

TS also requires management be committed to continual improvement of the effectiveness and efficiency of ‘customer oriented’ manufacturing processes

of 244

Clause 5.2Clause 5.2Customer FocusCustomer Focus

• Top management must:

ensure customer needs and expectations are determined, turned into requirements, and

ensure customer requirements (identified per Clause 7.2.1) are met with the aim of enhancing customer satisfaction (a “perception” that must be measured per Clause 8.2.1)

of 244

Clause 5.3Clause 5.3Quality PolicyQuality Policy

• 5.3 Top management must establish quality policy that:

is appropriate for the organization’s purpose,

includes a commitment to meeting requirements and continual improvement of the effectiveness of the QMS,

provides a framework for establishing/reviewing measurable quality objectives, and,

is communicated and understood and implemented at appropriate levels, and

is periodically reviewed for continuing suitability

of 244

Clause 5.4Clause 5.4PlanningPlanning

• 5.4 Top management must establish quality objectives and identify resources needed to meet them:

5.4.1 Quality objectives. First, measurable quality objectives consistent with the quality policy must be established at relevant functions and levels in the organization; TS 16949 also requires these objectives to be included in the organization’s Business Plan; and specifies ‘minimum’ metrics that must be monitored

5.4.2 Quality management system planning. Secondly, resources required to meet the objectives and carry out the processes (identified per clause 4.1) must be identified and planned

of 244

Clause 5.5 Responsibility, Authority and Clause 5.5 Responsibility, Authority and CommunicationCommunication

• 5.5 Top management must establish clear responsibilities, authorities and communication systems regarding the QMS:

5.5.1 Responsibility and authority. First, responsibilities and authorities must be defined and communicated with the organization.

5.5.2 Management representative. Secondly, a management representative appointed by top management must ensure the QMS is implemented, report to top management on performance of the QMS, and promote awareness of customer requirements throughout the organization. TS 16949 also requires a customer representative be designated to ensure compliance with all applicable requirements.

5.5.3 Internal communication. Finally, internal communications regarding the effectiveness of the quality system must be established

of 244

Clause 5.6Clause 5.6Management ReviewManagement Review

5.6.1 Top management must review the suitability, effectiveness, and adequacy of the QMS at planned intervals; and must evaluate the need for change, including changes to policy and objectives.

5.6.2 Review input. Specific review inputs are required including current performance and improvement opportunities related to audit results, customer feedback, performance of product and processes, status of actions, changes that could affect the QMS, and recommendations for improvement. TS 16949 also requires Business Plan objectives be reviewed, including an evaluation of the cost of poor quality and progress in reducing variation in ‘customer owned’ manufacturing processes

5.6.3 Review output. Specific review outputs must be recorded including actions and resources related to improvement of product, the QMS, and QMS processes

of 244

Involvement of PeopleInvolvement of People

• People at all levels are the essence of an organization, and

their full involvement enables their abilities to be used for the organization’s benefit.

- TS also requires that the organization define their system for employee motivation and empowerment

of 244

Process ApproachProcess Approach

• Organizations need to do more than simply monitor process outputs, (typically through inspection activities)

they must also control all process inputs, (people, facilities/equipment, material and methods)

and, they must establish appropriate controls over

the transformation activities (if desired results are to be consistently achieved)

of 244

Process Approach and TS 16949Process Approach and TS 16949• Organizations need to provide evidence that the

control of “product realization processes” is effective AND efficient

they must document, measure, monitor and improve “customer oriented processes”

i.e. processes used to create and produce products or services for the customer … from concept to delivery

and, they must ensure the availability of resources and information to support functioning of these processes

NOTE: ISO/TS 16949;2002 audits will almost entirely consist of process based assessments … which consist of auditing the process, its objectives and linkages to related processes.

of 244

What is a Process?What is a Process?

Activity that transforms input into output

ActivityInput Output

Resources:PeopleFacilities/EquipmentMaterialMethods

Results:ProductsServicesPerformance

of 244

How is a Process Managed?How is a Process Managed?

Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction

Monitor & Measure the Processmake sure the inputs are right, the transformation

activities consistently work, and the desired results are achieved, then - improve the process as needed

of 244

How is a Process Measured?How is a Process Measured?

Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction

EfficientNo Waste

EffectiveDesired Results Achieved

of 244

System ApproachSystem Approach

• Organizations must understand a system is a set of interrelated processes, and

the output of one process is the input to one or more subsequent processes, so ...

It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective

of 244

Continual Improvement of theQuality Management System

The Process-Based QualityManagement System

ManagementResponsibility

ProductRealization

ResourceManagement

MeasurementAnalysis &

Improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Product

Input Output

of 244

Continual ImprovementContinual Improvement

• Continual improvement of the organization’s overall performance should be a permanent objective:

improvement must be a planned activity if the organization desires to improve overall performance and capabilities.

of 244

TS 16949 implements the PDCA TS 16949 implements the PDCA improvement cycleimprovement cycle

• PlanClause 5. Management responsibility - everything flows from

Management who define the requirements for the system

Clause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system

• DoClause 7. Product (and/or service) realization - the necessary

process are established and carried out

of 244

TS 16949 implements the PDCA TS 16949 implements the PDCA improvement cycleimprovement cycle

• CheckClause 8. Measurement, analysis and improvement - processes

and products will be monitored and measured against policies, objectives and requirements for the product and results/opportunity for improvement reported

• ActClause 8. Measurement, analysis and improvement - acting upon

data reported in the check cycle, improvement actions can be taken - directly, or as an output of the Management Review process (Clause 5.6)

of 244

Plan Do

Act Check

Results

Baseline Performance

Improvement Objective

Improve Process

through PDCA Cycle

Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed to

Achieve and Sustain Desired Results

The QMS must be used for continual improvement ...

of 244

Factual Approach toFactual Approach toDecision MakingDecision Making

• Effective decisions are:

based on the analysis of data and information.

- TS 16949 also requires the monitoring of certain ‘metrics’ including but not limited to:

- parts per million (PPM) defect rate reduction,

- product cost reduction,

- improved delivery performance, and

- shortened product launch cycle times

of 244

Mutually BeneficialMutually BeneficialSupplier RelationshipsSupplier Relationships

• An organization and its suppliers are truly inter-dependent, and

a mutually beneficial relationship enhances the ability of both to create value.

- TS 16949 also requires that all suppliers achieve ISO 9001:2000 registration (note: the jury is still ‘out’ on if/how this requirement can/should be enforced as long as meaningful supplier development activities are in place)

of 244

the Role of Internal Audits has also the Role of Internal Audits has also shifted to a process approach...shifted to a process approach...

ISO 90011

Internal audit

Effectiveness of Quality System

Elements assessed in audit

report

Management review

ISO 90012000

Customer satisfaction

Management determines

effectiveness of their processes by

analyzing all available data and

information

Management review

Internal audit

Other data

of 244

Conducting Process AuditsConducting Process Audits• Identify QMS Process “Owners”

“Deployment Flowcharts” can be invaluable in defining the sequence, interrelationship and responsibilities associated with QMS Processes

• Evaluate “Conformance”

“Checklists” can be invaluable in verifying that the documented procedure or process complies with ISO 9001:2000 requirements

• Evaluate “Performance”

Verify that the organization is collecting and using process performance data to monitor, measure and improve processes in accordance with objectives

of 244

IATF View on ISO/TS 16949:2002IATF View on ISO/TS 16949:2002• Automotive Industry – Value added requirements

• Global Quality System Content

• Global Recognition Certificate

• Common Registration Requirement and Oversight Body for registrars

• Reduced number of registrars- one contract and certification committee centralized in one office

• Common Auditor Qualification

Process Approach to auditing is key to the transition from QS-9000 to ISO/TS 16949:2002!

of 244

Comparison of ISO/TS 16949 and Comparison of ISO/TS 16949 and QS-9000QS-9000

• QS-9000– Released in 1994

– 22,500 Certifications

– 174 Registrars with multiple offices

– 22 Accreditation Bodies

• ISO/TS 16949– First edition released in

– 1724 Certifications

– 48 Registrars

– 5 Regional Offices for Accreditation

of 244

Facts About ISO/TS 16949:2002Facts About ISO/TS 16949:2002

• QS-9000 goes away 2006, Dec. 15– Note: DCX deadline is July, 2004

• Past Dec. 15, 2003 the organization needs to get QS-9000 audits and ISO 9001:2000 audits to maintain ISO standing– Chad’s note: If you are going to implement QS with ISO

9001:2000, why then not go directly to ISO/TS 16949:2002. Imagine the conflicts between the ISO 1994 version and the ISO 2000 version.

• Includes Vehicle Assembly Centers

For all practical purposes, ISO/TS 16949:2002 deadline is Dec. 15, 2003.

of 244

What happens after Dec. 15, 2003?What happens after Dec. 15, 2003?

• ISO 9001:1994 will no longer be a certifiable standard

• QS-9000 will become a stand alone certificate– Note if you seek ISO 9001:2000 registration you must

get a separate certification

• ISO/TS 16949:1999 will end in 2004

of 244

QMS Process ModelQMS Process Model

of 244

Business Excellence Model

Interested Parties

Knowledge Management

CustomerSatisfaction

Customer Expectation &Requirements

of 244

CustomersCustomers

Managementresponsibility

Measurement,analysis andimprovement

Resourcemanagement

Requirements

Satisfaction

ProductProductrealization

Input Output

Continual improvement of the qualitymanagement system

Value-adding activities

Information flow

Organization

This is a processŸ An interface Organizational/External environment input (I)Ÿ An interface Organizational/External environment output (O)

Notice how this is a literalapplication of the process model.

Check inputagainstoutput.

Customer Oriented ProcessesCustomer Oriented Processes

of 244

The Octopus ModelThe Octopus Model

of 244

FinishedPrototype

ProductRealization

Warranty

Product Design

ProductValidation

Order / Request

Bid / TenderMarket Analysis

CustomerFeedback

WarrantyRequest

PerformanceReports

Corrective actions,Preventive actions,

ContinualImprovement

Sales andMarketing

Research ofMarket

Production Runand Optimized

ProductSpecifications

Determined

Bid Proposal

WarrantyRequestAccepted

Informationabout Product

Line(s)

Order Accepted

Bid Awardedwith

Specifications

Request forQuote fromCustomer

PrototypeRequested

ProductAnalyzed andRequest for

Change Issued

PrototypeDelivered

Examples of COPsExamples of COPs

of 244

Our View of the ProcessesOur View of the Processes

• Our believes there are four types of processes.– Customer Oriented Processes (COPs)

– Management Oriented Processes (MOPs)

– Support Processes (SOPs)

– ISO/TS 16949:2002 Related Processes

of 244

Documentation ApproachDocumentation Approach

• Document BMS Quality Manual– Need for process map or equivalent

• Document Processes including COPS, MOPS, and SOPS– Use flow charts

• Document “all requirements of the ISO/TS 16949:2002” including customer specific requirements – Ford, GM, and DCX Requirement

• Document work instructions and forms/checklists

of 244

Learning objectivesLearning objectives• Appreciating key aspects of ISO/TS 16949 + market drivers• Comparing ISO/TS 16949:2002 with ISO 9001:2002• Approaches to assessing where you are now• Appreciating the techniques to support ISO/TS 16949;

– Statistical Analysis

• Statistical Process Control• Measurement Systems Analysis

– FMEA– Control Plans

• Considering the next steps

of 244

Where did ISO/TS 16949:2002 come from?Where did ISO/TS 16949:2002 come from?

Prepared by International Automotive Task Force (IATF) + Japan Automobile Manufacturers Assoc. (JAMA)

ISO 9000series

QS 9000

VDA 6.1

ISO 9001:1994 ISO 9001:2000

Automotive

1994 1999 2000 2002

ISO/TS16949:1999

ISO/TS16949:2002

of 244

Key Aspects – Scope & goalKey Aspects – Scope & goal

SCOPE: “This technical specification is applicable to

sites of the organization where production and/or service parts

specified by the customer are manufactured…

…throughout the supply chain.”

GOAL: “The goal of this specification is the development of a quality

management system that provides for;

– continual improvement,

– emphasizing defect prevention and

– the reduction of variation and waste in the supply chain.”

of 244

Key Aspects – OverviewKey Aspects – Overview• Top management involvement including;

– implementing a business plan linked to defined measurable quality objectives

• Clear definition of responsibilities including;– Authority to stop production to correct quality problems

• Top management review of the performance of the quality system including;– reporting and evaluation of the cost of poor quality

of 244

Key Aspects – OverviewKey Aspects – Overview

• Focus on Human Resource management including– processes for defining competence requirements,– providing training (including on the job training for employed, temporary

and agency personnel),– verifying effectiveness of actions taken

• A process to motivate employees to – achieve quality objectives,– make continual improvement, and– create an environment to promote innovation.

• A process to measure the extent to which personnel are aware of the relevance & importance of their activities - how they contribute to achieving the quality objectives

of 244

Key Aspects – OverviewKey Aspects – Overview• Focus on product & process design to meet requirements

• Use of automotive core tools – Statistical Process Control (SPC),– Measurement System Analysis (MSA)– Failure Mode Effect Analysis (FMEA)

• Controlling production processes by use of – control plans– work instructions

• Ensuring effective control of internal & external laboratories

of 244

Key Aspects – OverviewKey Aspects – Overview

• Focus on process for measurement of customer perception and satisfaction

• All processes need to take into account any customer specific requirements

• Development of suppliers using ISO/TS16949: 2002

• Focus on continual improvement– Undertaking effective system, process & product audits– Effective analysis of data to drive improvement– Evidence of continual improvement throughout the organisation’s processes,

not just manufacturing

of 244

Key Aspects – 8 QM principlesKey Aspects – 8 QM principles• Process Approach [ 4.1, 5.1.1 ]

• Customer focus [ 5.1, 5.2, 5.6.1.1, 8.2.1, 8.3.3 ]

• Leadership [ 5.3, 5.4.1 ]

• Involvement of people [ 5.5.3, 6.2.2.4 ]

• System approach [ 4.1, 5.1.1, 5.4.1, 5.6.1 ]

to management

• Continual improvement [ 5.1, 5.3, 8.5.1 ]

• Factual approach [ 5.6.1, 8.2.2, 8.4 ]

to decision making

• Mutually beneficial [ 7.4.1.2 ]

supplier relationship

of 244

Key Aspects – Process focusKey Aspects – Process focus

Process – “any activity or set of activities that uses resources to transform inputs into outputs.”

[4.1] “The organisation shall

– identify processes needed for the quality management system and their application throughout the organisation

– determine the sequence and interaction of these processes

– measure, monitor and improve these processes.”

of 244

• Examples of ‘customer orientated processes’– Bid/Tender, Order/Request– Production– Product/Production verification

• For your own operations, consider such processes -– inputs– outputs– possible indicators of process effectiveness from the customer

and/or organisations (internal customer) perspective– what management/support processes are needed for this process

to work effectively

of 244

Management & support processes – examples

– Management Review & Business Planning– Internal Audit– Production Engineering– Quality– Purchasing– Finance– Maintenance– Human Resources

of 244

• Customer measures of process effectiveness

– Delivered part quality performance

– Customer disruptions including field returns

– Delivery schedule performance (including instances of premium freight)

– Customer notification of quality or delivery issues

• Organisation measures of process effectiveness

– Reports & reviews of performance against objectives

– Evaluation of the cost of poor quality

of 244

Key Aspects – Customer focusKey Aspects – Customer focus

• Customer specific requirements are included in an audit for ISO/TS 16949– “Customer specific quality management system

requirements supplemental to ISO/TS 16949 shall be included in the audit in order to obtain customer recognition of such certification”

• What is your process for identifying and using customer specific quality management system requirements?

of 244

Key aspects – required documentsKey aspects – required documents

• Quality policy & objectives [4.2.1] + Quality manual [4.2.2]

• Procedures & documents to ensure effective planning, operation and control of processes + records [4.2.1]

• Procedure for document control [4.2.3]

• Procedure for identifying training needs and achieving competence of all personnel performing activities affecting product quality [6.2.2.2]

• Procedure for internal audits, reporting results & keeping records [8.2.2]

• Procedure for control of nonconforming product + responsibilities [8.3]

• Procedure for reviewing nonconformities, determining causes with action to prevent recurrence [8.5.2]

• Procedure for determining potential nonconformities & causes, action to prevent occurrence [8.5.3]

of 244

Market Drivers – the goalMarket Drivers – the goal

“The goal of this Technical Specification is the development of a quality management system that provides for;- continual improvement- emphasising defect prevention and- the reduction of variation and waste in the supply

chain.”

Process approach of ISO 9001:2000 complements ISO/TS 16949:2000 – many common requirements (less paper?)

of 244

Comparing ISO/TS 16949

with ISO 9001

of 244

Comparing ISO/TS 16949 with ISO 9001Comparing ISO/TS 16949 with ISO 9001

Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

Applying to– Quality Management System

– Management Responsibility

– Resource Management

– Product Realisation

– Measurement, Analysis and Improvement

of 244

Quality Management System• Retain responsibility for all outsourced processes [4.1.1]• Review customer engineering specifications & changes within 2

weeks [4.2.3.1]• Control records of regulatory and customer requirements

[4.2.4.1]

of 244

Management Responsibility

• Top management shall review product realisation and support processes [5.1.1]

• Top management shall define quality objectives in the business plan and their use to deploy quality policy [5.4.1(.1)]

• Managers responsible for corrective action shall– be promptly informed of products or processes that do not conform

to requirements. – appoint ‘quality representatives’ with authority to stop production

(all shifts) to correct quality problems [5.5.1.1]

of 244

Management Responsibility (cont’d)

• Top management shall appoint ‘customer representatives’ with specific responsibility to ensure compliance with customer requirements, including selection of special characteristics, corrective/preventative actions and design/development. [5.5.2.1]

• Management reviews shall include;– monitoring of performance trends, the cost of poor quality, the achievement of

quality objectives, [5.6.1.1]– review of actual and potential field failures. [5.6.2.1]

of 244

Resource Management• Personnel with product design responsibility shall be competent to achieve

design requirements and skilled in applicable tools and techniques. [6.2.2.1]

• Document procedures for identifying training needs and achieving competence of personnel [6.2.2.2]

• Provide on-the-job training, including the consequences to the customer of nonconformities [6.2.2.3]

• Have a process to motivate employees to; achieve quality objectives, make continual improvements & create an innovative environment. [6.2.2.4]

of 244

Resource Management (cont’d)• Ensure all skilled staff in the factory are involved in deciding plant layout and

handling methods; include lean manufacture using minimum work in progress & minimum movement of parts [6.3.1]

• Have contingency plans for emergency situations that could affect customer requirements, including power failure, communication failure, raw material or parts supply failure, equipment failure, labour shortage and handling returned product. [6.3.2]

• Ensure that the plant layout and working methods are designed with safety to employees in mind. [6.4.1]

• Ensure that workplaces are tidy and appropriately clean. [6.4.2]

of 244

Comparing ISO/TS 16949 with ISO 9001Comparing ISO/TS 16949 with ISO 9001Additional Requirements of ISO/TS 16949:2002 vs ISO 9001:2000

Product Realisation• Include customer requirements and reference to spec.s in the planning of

product realisation [7.1(.1)]• Define and approve acceptance criteria with the customer [7.1.2]• Ensure confidentiality of customer contracted products and product information

during design & development and production. [7.1.3]• Have change control process that;

– prevents any change to product, materials or processes without customer approval,– includes testing the validation or effectiveness of the change before implementation.For a proprietary design, review impact on form fit and function with the customer.

[7.1.4]

of 244

Product Realisation (cont’d)• Obtain customer approval for any waiving of a review of requirements related

to the product [7.2.2.1]• Review manufacturing feasibility within contract review [7.2.2.2]• Communicate necessary information in a customer specified language and

format [7.2.3.1]• Document and include the following in ‘product design input’

– customer requirements including performance and special characteristics– experience from previous products– targets for product quality, life, reliability, durability, maintainability, time scales

and cost. [7.3.2.1]

of 244

– Product Realisation (cont’d)

• Document and include the following in ‘manufacturing design input’

– product design outputs that have to be met by manufacturing– experience from previous products– targets for productivity, process capability and cost. [7.3.2.2]

• Identify special characteristics [7.3.2.3]

of 244

– Product Realisation (cont’d)

• Document and include the following in ‘product design output’ in ways that demonstrate that all design inputs have been met

– design FMEAs including diagnostic guidelines to predict failure modes– reliability results– special characteristics– an analysis of error proofing– product drawings, specifications and calculations– product design reviews [7.3.3.1]

of 244

Product Realisation (cont’d)

• Document and include the following in ‘manufacturing design output’ in ways that demonstrate all design inputs have been met

– design FMEAs including diagnostic guidelines to predict failure modes– a control plan, specifications, drawings, instructions and flowcharts– plant & workstation layouts– an analysis of error proofing– manufacturing process validity and approval method including acceptance

criteria [7.3.3.2]

of 244

• Report measurements of design & development at management review [7.3.4.1]

• Perform validation in accordance with customer requirements [7.3.6(.1)]• Prototype programme required using manufacturing processes [7.3.6.2]• Approval procedure required as recognised by the customer [7.3.6.3]• All purchased products shall conform to regulatory requirements [7.4.1.1]

of 244

Product Realisation (cont’d)• Work in partnership with suppliers to develop the supplier quality management

system. Conformity to ISO 9001:2000 is required. [7.4.1.2]• As specified in the contract, use approved sources for purchased material

[7.4.1.3]• Monitor the quality of purchased product by one or more of the following;

– evaluation of the statistical data received from the supplier– receiving inspection– 2nd or 3rd part audits with records of acceptable delivered performance– part evaluation by a designated laboratory [7.4.3.1]

of 244

• Monitor supplier performance by;– delivered product quality performance– customer disruptions that have occurred– returns or other feedback from end users– delivered schedule performance [7.4.3.2]

• Use Control Plans to the format specified in Appendix A [7.5.1.1]• Work instructions for operations that impact on quality are required [7.5.1.2]• Verify job set ups [7.5.1.3]

of 244

• Use predictive and preventative maintenance for key processes [7.5.1.4]• Resources for tool and gauge design, fabrication and verification are required

[7.5.1.5]• Schedule production to meet customer requirements e.g. just-in-time [7.5.1.6]• Establish a process for communication of information on service concerns

[7.5.1.7]• Verify the effectiveness of any customer service agreements [7.5.1.8]

of 244

• Validate all processes for product and service provision to demonstrate the ability of these processes to achieve planned results – where applicable through;

– defined criteria for review and approval of the process– approval of equipment and qualification of personnel– use of specific methods & procedures– requirements for records– revalidation [7.5.2(.1)]

of 244

• In all cases;– identify the product throughout product realisation– identify the product status with respect to monitoring & measurement

requirements– where traceability required, control and record unique product identification

[7.5.3(.1)]

• Permanently mark customer owned tooling• Assess the condition of stock. Assure stock rotation (FIFO). Control obsolete

stock as nonconforming. [7.5.5.1]• Perform statistical studies on measuring equipment to analyse variation

[7.6.1]

of 244

• Maintain calibration records including– Equipment identification– The standard against which the equipment is calibrated– Revisions following changes to equipment– Assessments of the impact of out-of-specification equipment– Notifications to customer of any product that may have been affected by out-of-

specification measuring equiment– A positive statement of the acceptance of the calibration for the intended

purpose [7.6.2]

of 244

• Define the scope of any internal laboratory to include its ability to perform the required duties and be managed by a documented management system either within or separate from the main system [7.6.3.1]

• Use only external laboratories that– have a suitable scope– are accredited to ISO 17025 or acceptable to the customer [7.6.3.2]

of 244

Measurement, Analysis and Improvement

• Identify appropriate statistical tools for each process [8.1.1]• Understand statistical concepts [8.1.2]• Monitor customer satisfaction and produce performance indicators

[8.2.1(.1)]• Audit the quality management system to verify compliance with the standard

[8.2.2.1]• Audit each manufacturing process [8.2.2.2]• Include in internal audits all quality management related processes, activities

and shifts [8.2.2.4]

of 244

Measurement, Analysis and Improvement (cont’d)

• Internal auditors shall be suitable qualified [8.2.2.5]

• Perform process capability studies and include the conclusions in the quality or control plan. Studies shall include the;

– stability of the process– capability of the inspection and test process– capability of the reaction plans to contain the effect of any nonconformity [8.2.3]

of 244

• Conduct product audits [8.2.2.3] and ‘layout inspections’ i.e. checking every measurement and parameter shown on the approved design drawings. [8.2.4.1]

• Conduct appearance inspections on items for which customer specifies this i.e. checking every aspect of the appearance of the finished product as perceived by the end user. Maintain master samples and means of making comparisons. [8.2.4.2]

• Class product with unidentified status as nonconforming. Make instructions for rework available. [8.3(.1), 8.3.2]

• Inform customers promptly if nonconforming product is shipped [8.3.3]

of 244

Measurement, Analysis and Improvement (cont’d)• Obtain a customer concession before proceeding with any further processing

if any part or material is not fully in accordance with approved requirements. This shall apply to product or material still being processes by a supplier. [8.3.4]

• Analyse trends in quality & operational performance; use data to:– manage progress towards overall objectives– identify priorities– provide a factual basis for decision making– anticipate and predict problems arising from the end users.Establish benchmarks to measure performance against competitors or other

appropriate recognised criteria.[8.4.1]

of 244

• Define a programme for continual improvement [8.5.1.1]• Focus manufacturing improvement on reducing variation [8.5.1.2]• Define a process for problem solving [8.5.2.1]• Use error proofing methods in the corrective action process [8.5.2.2]• Apply corrective action to other similar processes and products [8.5.2.3]• Minimise the time for corrective action [8.5.2.4]

of 244

Assessing where you are now

of 244

Techniques to support ISO/TS 16949Techniques to support ISO/TS 16949

Statistical Analysis

- Statistical Process Control (SPC)

- Measurement Systems Analysis (MSA)

of 244

Statistical Analysis - SPCStatistical Analysis - SPCStatistical Process Control (SPC)“ The use of statistical techniques such as control charts to analyse a process or its outputs so as to take appropriate actions to achieve and maintain a state of statistical control and to improve process capability.”

– Detects variation in process measures to enable;• reduction of variation, and,• prevention of defects / waste.

– Applied to all processes whose output measures offer• Variable data e.g. part dimensions• Attribute data – conforming; yes/no - that can be counted e.g. parts received

on-time

of 244

Statistical AnalysisStatistical AnalysisISO/TS 16949:2002 requirement for Statistical Analysis

– 8.0 Measurement, analysis and improvement

• 8.1.1 Identification of statistical tools

• 8.1.2 Knowledge of basic statistical concepts

• 8.2.3.1 Monitoring and measurement of manufacturing process

• 8.5.1.2 Manufacturing process improvement

of 244

Statistical Analysis - SPCStatistical Analysis - SPC

• Variable data forms a pattern that, if stable, can be described as a distribution. Distributions, differ in– Location– Spread– Shape …or any combination of these.

• If the shape of variable data is ‘normal’ (typical);– location is measured by the mean [ X ]– spread is measured by the range [R] or standard deviation [sd]– SPC can be applied to see if variation is unacceptable

of 244

• Variation in variable data can come from – Common causes – natural random events – which affect all values

of process output– Special causes – intermittent, often unpredictable causes making

the process output unstable

• Control charts help identify special causes by showing– Values beyond control limits– Non–random patterns or trends e.g. 7 points increasing/decreasing,

7 points one side of the average

of 244

• Before assessing process capability, special causes must be removed

• Process Capability then measures– How variable the process is [ Pp, Cp ]– How process variation fits within the specified limits [Ppk,

Cpk] - how well it meets a customer requirement

4.6 (Six sigma)2.00

2331.67

6,0001.33

66,0001.00

Approx parts per million out of specificationCpk

of 244

Attribute data can be analysis using– p chart for proportion of nonconforming parts

– u chart for nonconformities per unit

– np chart for the number of nonconforming parts

– c chart for the number of nonconformities

of 244

Statistical Analysis – SPCStatistical Analysis – SPC

Benefits of Statistical Process Control (SPC)

– Show how successfully a process is adjusted & controlled to achieve consistent and therefore predictable outputs e.g. conforming products

– Flag any special causes of variation which need to be identified and eliminated by local action

– Quantify the effects of improvements in quality, leading to reductions in waste (poor quality costs)

of 244

Statistical Analysis

- Statistical Process Control (SPC)

- Measurement Systems Analysis (MSA)

of 244

Statistical Analysis - MSAStatistical Analysis - MSA

• Why Measurement System Analysis?

“The purpose of any analysis of a measurement system should be to better understand the sources of variation that can influence the results produced by the system.”

• To quantify and communicate the limitations of specific measurement systems.

of 244

ISO/TS 16949:2002 requirement for Measurement Systems Analysis (MSA) [7.6.1]

“ Statistical studies shall be conducted to analyse the variation present in the results of each type of measuring and test equipment system. This requirement shall apply to measurement systems referenced in the control plan. The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis. Other analytical methods of acceptance criteria may be used if approved by the customer.”

of 244

Terminology

– Measurement system:

the collection of operations, procedures, gauges and other equipment, software and personnel used to assign a number to a characteristic being measured; the complete process used to obtain a measurement.

Material Man Method

Machine (Time) Environment

MEASUREMENT SYSTEM

of 244

Terminology

– Gauge: any device used to obtain measurements, frequently used to refer specifically to the devices used on the shop floor.

– Calibration: a set of operations that establish under specific operating conditions, the relationship between a measuring device and a traceable standard of a known reference and uncertainty.

– Reference Value: a reference for comparison, normally determined under laboratory conditions or using a more accurate instrument.

of 244

• Quality of measurement data– If measurements are close to the reference value the quality of the data

is high

• Measurement systems– Must be in statistical control– Must have small variability compared with specified tolerance or

manufacturing process variability*

Descrimination: the amount of change from the reference value that an instrument can detect and faithfully indicate.

• Typically the smallest graduation on the scale of the instrument• *Descrimination should be one tenth of the tolerance range, however

recently the descrimination target is one tenth of the process variation – significantly less.

of 244

Statistical Analysis - MSAStatistical Analysis - MSA• Variability characterised by

• Location - bias, linearity, stability• Width or spread – repeatability, reproducibility

• Location Errors– Bias: the difference between the mean measurement and the reference

value.

– Linearity: the difference in bias through the operating range

– Stability: the total variation in the measurements obtained from a single characteristic over time (change in bias over time)

• Check change in characteristic, such as values from Electrical Test Equipment, between calibration intervals

• Plot data and take action if bias outside a specified value

of 244

Statistical Analysis - MSAStatistical Analysis - MSASpread Errors (Gauge R & R)

– Repeatability: variation in measurements obtained with one measurement instrument, when used several times by one appraiser while measuring the identical characteristic on the same part. (‘Equipment Variation’)

• Under 10% considered acceptable• To improve, instruments may need maintenance or redesign

– Reproducibility: variation in measurements obtained with one measurement instrument, when used by different appraisers while measuring the identical characteristic on the same part.

• Under 10% considered acceptable• To improve, appraiser(s) may need training, or more ease of use

of 244

• Measurement System Study– Select appraisers – people already using the instrument

– Select measurement instrument – has it the required discrimination

– Select parts from the process that represent entire operating range e.g. several days production and number each part.

• Measurement System Analysis – when?– “As processes change and improve, a measurement system must be

re-evaluated for its intended purpose”

For example, when there is a new product, capability improvement, skill level change, process change e.g. new equipment, change in work environment, change in test method/procedure.

of 244

Failure Modes & Effects Analysis

of 244

Failure Mode and Effects AnalysisFailure Mode and Effects AnalysisFailure Mode and Effects Analysis (FMEA)

– A systematic group of activities to:• Recognize and evaluate potential failures of a product or process and

the effects of failure• Identify actions that could eliminate or reduce the chance of the

potential failure occurring• Document the above process

– Evidence from vehicle recalls has shown a fully implemented FMEA could have prevented many causes

– Enables action before the event (Prevention),not after (Detection)

of 244

Failure Mode and Effects AnalysisFailure Mode and Effects Analysis

ISO/TS 16949:2002 requirement for FMEA

– 4.2.3.1 Engineering specifications

– 7.3.1.1 Multidisciplinary approach

– 7.3.2.3 Special Characteristics

– 7.3.3.1 Product design outputs

– 7.3.3.2 Manufacturing process design outputs

– 7.5.1.1 Control Plan

of 244

Item Responsibility &

Function Requirements

Target Completion Date

Actions Taken Sev

Recommended Action(s)

Action Results

Potential Failure Mode

Potential Effect(s) of

Failure

Potential Cause(s)/

Mechanisms of Failure

Current Controls

(Prevention / Detection)

What are the customer related functions or requirements?

What can go wrong?

-No function

-Partial/over/ degraded function

-Intermittent function

-Unintended function

What are the effects?

How bad is it?

What are the causes?

How often does it happen?

How can cause or effect be prevented & detected?

How good is this method at detecting / preventing?

What risks are highest priority?

What should be done, by whom & when?

-design/ process change

-special controls, changes in procedures/ guides

What has been done?

Is there still a priority risk?

of 244

• Design FMEA– Focuses on designing out Potential Failures in Product Design causing

detrimental effects on functional performance– Applies when products’ design is created or revised– Uses test, production, quality, supplier & customer experience– Assumes manufacturing process would achieve specification

• Process FMEA– Focuses on preventing Potential Failures in manufacturing Process

causing detrimental effects on functional performance– Applies when manufacturing process is applied to new product or

changed– Uses test, design, quality, supplier & customer experience– Assumes if design made to spec., it would otherwise succeed

TEAM EFFORT

of 244

Design FMEA used to address potential risks in the design achieving functional performance, by:

– Identifying potential design failures, their causes & effects

– Rating the;• Severity of effects; 1 to 10 (10 = most severe),• Occurrence of effects; 1 to 10 (10 = most likely),• Detection/prevention of effects by current controls eg. analysis, test; 1 to 10 (10 =

not likely to be detected/prevented),

using guidance available in DFMEA manuals.

– Using the Risk Priority Number (RPN)

…to prioritise action – focussing on designing out failure• Customers may define triggers for action e.g. RPN >100, Severity > 8

RPN = Severity rating x Occurrence rating x Detection rating

of 244

Process FMEA used to address potential risks in the manufacturing process achieving functional performance, by:

– Identifying potential process failures, their causes & effects

– Rating the;• Severity of effects; 1 to 10 (10 = most severe),• Occurrence of effects; 1 to 10 (10 = most likely),• Detection/prevention of effects by current controls eg. test; 1 to 10 (10=unlikely

to be detected/prevented),

using guidance available in PFMEA manuals.

– Using the Risk Priority Number (RPN)

…to prioritise action – focussing on preventing failure• Customers may define triggers for action e.g. RPN >100, Severity > 8

RPN = Severity rating x Occurrence rating x Detection rating

of 244

FMEA is successful as a process & living document, if:– All links to external (& internal) customer requirements from

Design and Process elements are understood and systematically reviewed for risk of potential failure

– Informed team approach leads to multidisciplinary experience being shared to evaluate risk consistently

– Actions are planned at an early stage – before changes are considered too costly

– Actions are taken as planned and the resulting effect on the risk is evaluated and documented

of 244

FMEA appears ‘difficult’, if:– Team does not have

• common understanding of the FMEA process

• agreement/guidance on ratings

• multidisciplinary experience – particularly a history of customer concerns or internal failures to consider in evaluating a new item

• time to work through sufficient detail and agree actions

– Relationship between Design and Process elements and external (& internal) customer requirements is not understood

– Actions are not • Planned early enough

• Followed through to achieve reward in better satisfying customer

of 244

Control Plans

of 244

Control Plans - Control Plans - OverviewOverview

Control Plans

• summarize the systems used to minimize process and product variation, guiding manufacturing on how to control the process and ensure product quality

• structure the approach to design, selection and implementation of value-added control methods

• describe the actions required at each phase of the process to ensure all process outputs will be in control

• are living documents - updated as measurement systems and control methods are evaluated and improved.

of 244

Control Plans - RequirementControl Plans - Requirement

ISO/TS 16949:2002 requirement for Control Plans [7.5.1.1]

“The organization shall- develop control plans (see Annex A)… for the product supplied…- have a control plan for pre-launch & production that takes into account

the design FMEA and manufacturing process FMEA outputs.

Control plans shall be reviewed and updated when any change occurs…NOTE Customer approval may be required…”

of 244

Control Plans - ContentControl Plans - Content

ISO/TS 16949:2002 requirement for Control Plan content [7.5.1.1]

“The control plan shall- list the controls used for the manufacturing process control,- include the methods for monitoring of control exercised over

special characteristics…- include the customer required information, if any, and,- initiate the specified reaction plan when the process becomes

unstable or not statistically capable.”

of 244

Control Plans - ContentControl Plans - Content

ISO/TS 16949:2002 requirement for Control Plan content [Annex A]

– General Data; part no. & name, process step descriptions, etc

– Product Control; characteristics for control; specif’n tolerance

– Process Control; process parameters, manuf’g m/cs & tools

– Methods; evaluation of meas’t technique, sample size & freq.

– Reaction Plan & corrective actions

of 244

Control Plans - ExampleControl Plans - Example

Control Plan Example format– minimum elements required by ISO/TS 16949:2002 Annex A

CONTROL PLANPrototype Pre-launch Production Key Contact/Phone Date (orig.) Date (Rev.)

Control Plan Number Part Number / Latest Change Level Core Team Customer Engineering Approval/Date (if Req'd)

Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (if Req'd)

Supplier/Plant Supplier Code Other Approval/Date (if Req'd) Other Approval/Date (if Req'd)

Part/ Process Number

Process Name / Operation

Description

Machine, Device, Jig,

Tools for Manuf.No. Product

Process parameters

Special Char. Class

Product/Process Specification/Tolerance

Evaluation Measurement

Technique

Sample Size

Sample Frequency

Control Method

Reaction Plan / Corrective

Action

Characteristics Methods

of 244

Control PlansControl Plans

Control Plan Checklist• Have customer requirements been adopted in Control Plan format and

preparation?• Have all known customer concerns been identified to facilitate the

selection of special product/process characteristics?• Are all special product/process characteristics included in the control

plan?• Are material specifications requiring inspection identified?• Does the control plan address incoming material/components through

processing/assembly including packaging?• Are engineering performance testing requirements identified• Are gauges and test equipment available as required by the control

plan?• If required, has the customer approved the control plan?• Are gauge methods compatible between supplier & customer?

of 244

Control Plans - BenefitsControl Plans - Benefits

Benefits of Control Plans– Improved quality of products during design, manufacturing

and assembly, by identifying sources of variation

– Resources focussed on process and product characteristics important for customer satisfaction

– Communication of• changes in product/process characteristics and their control &

measurement• prepared responses to nonconformities (Reaction Plan)

of 244

Thank YouThank You for for

being Patient being Patient

ISO-TS Presentation

correct quality

address potential

quality management

iso 9001additional

enhancing

previous products

exceed customer

functional

Documents

ISO/TS 16949

Revista Iso TS

WHAT EVERY EMPLOYEE NEEDS TO KNOW ABOUT ISO - ISO … - TS.....

...TS ISO 4309 TS ISO 9927-1 TS ISO 8566-5 TS EN...

· 2020. 3. 2. · TS EN ISO 6892-1 TS EN ISO 15630-1 TS.....

Voltimum · 2019. 4. 29. · 5 KALİTE SERTİFİKALARIMIZ.....

TECHNICAL ISO/TS SPECIFICATION 22004 -...

Turlab Testturlabtest.com/sertifikalar1/cilt3.pdf · TS EN....

94 kVA - 142 kVA · 2021. 5. 29. · † TS ISO 8528, TS...

TSE ISO/TS 11602-2 - HASSA YANGIN · 2019. 3. 13. · ICS.....

TS ISO-TS 16949 Türkçe (38)

REVOX LABORATORIESTS EN ISO 21149 TS EN ISO 16212 TS EN ISO....

SLOVENSKI STANDARD SIST-TS ISO/TS 20100:2020 · 2021. 1....

YÖN BİLGİ SİSTEMLERİ · 2020-03-24 · Her tÖrlU...

МЕЖДУНАРОДНЫЙ ISO TS СТАНД АРТ...

· TS EN ISO 6892-1 TS EN ISO 4136 TS EN ISO 7438 -rs ISO....