ISO 9001 Training Material

Welcome to Internal Auditing Training Course

Delegates Introductions

Please introduce yourself Your name A brief description of Education &

Experience. A brief Job description Your involvement in QHSE

Assurance.

Aim

• To provide training for potential auditors and prepare them for that role

• Enable delegates to be aware of QHSE system requirements

• Satisfy the requirement of ISO 9001:2008, 14001:2004 & OHSAS 18001:2007

for auditor training• Enable delegates to be prepared to act as

auditees

Course Structure Lectures and discussions on each topic. Exercises/ case studies to enable

delegates to experience audit practices and report findings.

Ongoing assessment to evaluate delegates’ ability based on participation, teamwork, application and comprehension..

Course competence test - to ensure retention of knowledge of auditing.

Auditor

A person who has the qualification to perform quality audits

• A auditor must be authorized for each audit

• Persons selected as auditor shall be

Free from bias Independent

of the activity being audited

Free from influence

Auditors’ Responsibilities

Comply with auditing requirements Communicate and clarify audit

requirements Plan and carry out assigned

responsibilities Assess effectiveness of quality system Document audit observations Report audit results Co-operate with team and support lead

auditor Maintain confidentiality Retain and safeguard documents Verify corrective action

Additional Abilities

Address searching questions Display an authoritative

presence Think quickly Stand their ground Remain calm and polite When required make

suggestions for improvement

Lead Auditor

An auditor authorised and appointed to manage a quality audit

Duties include:• Assisting with the team selection• Controlling, planning and co-ordinating the audit• Representing the audit team with the auditees

management• Writing and submitting the report

Additional Lead Auditor Tasks

Review quality documentation for compliance to standard

Assess extent of comformance Review contents of teams’

checklists Decide on the validity and

categories of noncompliances Make clear written and verbal

reports to management

Auditor Training

Specialist knowledge of applicable specifications, standards, codes, procedures, industrial practices in the areas to be audited

Ability to manage an audit team An in-depth knowledge of quality

system requirements That they will audit objectively and

thoroughly without bias They have appropriate experience in

the area being audited

Section 2Introduction to Quality

What is Quality ?

What does Quality mean to you ?

What does Quality mean to your organisation ?

Quality

The totality of characteristics of an entity that bear on its ability to

satisfy stated and implied needs

Introduction to Quality

To be successful, an organisation must offer a service and/or products which :-

Meet a well defined purpose or need

Satisfy its users’ / customers’ expectations and contractual requirements

Comply with applicable standards and specifications

Introduction to Quality

To be successful, an organisation must offer a service and/or product which :-

Will yield a profit on the resources invested

Is supplied within delivery timescales agreed / required by the user / customer.

In other words - “Provide a Product and/or Service which is totally fit for the purpose”

Definition: an audit by an organization of its

own systems and procedures Objective:

to assure maintenance, development and improvement of the Quality System

Requirement: ISO 9001; 4.17 guidelines found in ISO 10011

FIRST PARTY (INTERNAL AUDIT)

Definition an audit by organization on

suppliers and sub-contractors Objectives

to determine suitability of suppliers / sub-contractors

to appraise supplier / sub-contractor performance

SECOND PARTY (EXTERNAL AUDIT)

Definition an audit by a body which is

independent of the organization, its suppliers and customers

Objective to determine whether an

organisation’s Quality System has been documented and implemented in accordance with a specified standard

THIRD PARTY (EXTERNAL AUDIT)

Accreditation Scheme

Department of Trade and IndustryDTI

Accredit

Certification BodiesCalibration & Test Houses

Certify

Companies / Organisations

United Kingdom Accreditation ServiceUKAS

EXAMPLES SHOWN FOR UK REGISTRATION

Section 3Quality Management System

Document Control

Typical Documents Requiring Control: the quality manual Procedures Work Instructions including works

orders/route cards Quality Plans Drawing - including “as built” Specifications

Quality Management SystemDocumentation

QualityManual

Quality SystemProcedures Work

Instructions

Forms

Quality Manual

Quality Policy Objectives Overview Organisation Responsibilities Requirements

Policy/Responsibility/Procedure Reference

QUALITY MANUAL CONTENTS

Title page Scope Amendments page Table of contents Introduction to organisation Quality Policy Policies for specific aspects of Quality System Organisation structure Quality system outline Cross-reference to Standard requirements

Title page

Index of procedures

Amendments record

Procedures

Cross-reference to associated

documents

QUALITY PROCEDURES MANUAL

Quality System Procedures

A set of procedures which detail how the requirements of the quality manual are to be implemented

Detailed procedures which define how the processes are to be performed and controlled

Specifying who is responsible for doing what

Department, orFunction, orGroup of functions

Understandable

Useable

Written for

Written In an agreed format

QUALITY SYSTEM PROCEDURES

PROCEDURE FORMAT

PURPOSE

SCOPE

REFERENCES

DEFINTIONS

PROCEDURE/METHODS

ASSOCIATEDDOCUMENTS

Objectives/intention

applicability, boundaries

who, what, where, when,

how

other documents quoted

explain confusing terms

list those referred to / used

who is responsible ?

what is actioned / controlled ?

what methods / equipment / records ?

how is information processed ?

where - location ?

when - timing / frequency ?

PROCEDURE/ METHOD SECTION

Title Number Issue status Page numbers - paginated Approval authority Issuing authority Issue date

ESSENTIAL INFORMATION ON A PROCEDURE

Work Instructions

Detailed Instructions for the performance of specific tasks

Such Instruction may cover Materials Processes Verification

These must be:

documented

implemented

controlled

WORK INSTRUCTIONS

Operating instructions Job cards User manuals Inspection plans/instructions Technical manuals Manufacturer’s

recommendations Performance standards

EXAMPLES OF WORK INSTRUCTIONS

Quality Management System

Sales Design Purchasing Manufacture Accounts Personnel After Sales

Level 1

Level 2

Level 3

Level 4

Quality Manual

Procedures

Work Instructions

Forms

StandardISO 9000

Policy Statement Commitment, Organisation, Responsibilities

Company Practice & Interfaces

Written Instructions to Control Tasks

Quality Records

Documenting Procedures

Say what you do

Do what you say

and where necessary

Show what you did

Document Control Inspection and test plans records Purchasing specifications, orders &

acknowledgements Quotes, tenders, contracts / contract

reviews Audit plans & records Management reviews Design reviews

Document Control Control requirements Responsibility for the creation,

authorization, revision and issuing of controlled documents

Formats to be used Identification of issue, revision for the

change Instructions for removal of superseded

documents

Document control A controlled document is: Properly authorized by approved

signatories Serial numbered for identification Issue/revision referenced and dated Issued within a registered circulation subject to control of all changes Updated to the same distribution

Document Control Uncontrolled document UNCONTROLLED COPY - Will not be

maintained THIS COPY WILL NOT BE KEPT UP

TO DATE CHECK FOR LATEST ISSUE BEFORE

USE

Document Control

Typical Audit Questions Do the documents conform with

statements made in the Quality Manual? Are the appropriate to the user? Do they cover the scope required? Are they properly authorized? Are the responsibilities adequately

defined? Are they communicated to the people

who need them?

Document Control Are they updated when

necessary ? Are there any gaps or overlaps

which could cause confusion? Are interfaces properly defined?

Document Control

Desktop Assessment Are the documents in evidence and

being worked to? Are the documents in evidence

applicable to the activity in which they are being used?

Is the correct issue in use? Are they circulated in a timely manner? Are they superseded or obsolete issues

withdrawn?

DOCUMENTATION MUST BE

Readable

Useable

Accessible

Usually a control document Provides a statement of the

operation Identifies procedures used Defines “hold” points Indicates monitoring process Indicates the record system may be a Level 2 or Level 3

document

QUALITY PLAN

Section 4Introduction to ISO 9001:2000

01. General To address customer satisfaction

by meeting customer and applicable regulatory requirements.

Standard can be use for external/internal parties to audit.

QMS requirements are complementary to technical requirements for product.

0.2 Process Approach Process approach to quality

management encouraged. When used within Quality

Management System it include... Introduces and explain the process

model as conceptual presentation of QMS requirements specified.

Managementresponsibility

Measurement,analysis,

improvement

Resourcemanagement

Product(and/or service)

realization

Customer

Requirements

Customer

Satisfaction

QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT

Fig. 1 Quality Management Process Model

Input Output Product/ Service

ISO 9001:2000 Management

1 Scope 1.1 General

Standard specifies QMS requirements for use .

demonstrate organization’s ability to consistently provide product meeting customer and applicable regulatory requirements.

Address customer’s satisfaction through effective application of the system .

1.2 Application Requirements are generic. Requirements may be excluded in

case of non-applicability Exclusions must:

Not affect ability to provide conforming product.

Be limited to clause 7.

2. Normative reference Replica of present clause 2 Users encouraged to use most

recent revisions. ISO 8402:1994 replaced by ISO

9000:2000,Quality management systems-Fundamentals and vocabulary.

3. Terms and definitions ISO 9000 :2000 applies

3. Terms and definitions “Organization” replaces “Supplier” “Supplier” replaces “Sub-

contractor” The term Product may also refer to

Service.

4. Quality management system

4.1 General requirements Establish,document,implement,maintain

and continually improve QMS in accordance with the standard.

The organization shall identify the process Determine sequence and interaction Determine criteria and methods for

operation and control

Ensure availability of resources and information.

Monitor ,measure and analyze the process

Implement actions necessary

4.2 Documentation requirements

4.2.1 General Documented Policy and Objectives A quality Manual Documented procedures required by the

standard Documents to ensure effective planning,

operation and control of its processes Records

4.2 General Documentation Requirements

Extend Size and type of organization Complexity and interaction of

processes. Competence of personnel.

To Include Documented procedures required by

standard. Documents required by organization to

ensure effective operation and control process.

4.2.2 Quality Manual

Establish and maintain a quality manual which includes

The Scope The documented procedures and

their reference. Description of interaction between

the processes of QMS

4.2.3 Control of DocumentsDocuments shall be controlled A documented procedure shall be

established to define the controls needed

to approve documents for adequacy prior to issue.

to review and update, and re approve documents.

Changes and revisions are identified. Availability of documents at points of

use. Documents are legible and readily

identifiable. Documents of external origin are

identified and their distribution controlled.

Suitable identification of obsolete documents and unintended usage.

Control of Documents (Contd..)

4.2.4 Control of records

Records shall be established and maintained

Documented procedures for identification, storage, retrieval, protection, retention time and disposition of quality records.

5 Management responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality policy 5.4 Planning 5.4.1Quality objectives 5.4.2 Quality Planning 5.5 Responsibility,authority and communication 5.5.1 Responsibility & authority

5.5.3Internal communication

5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output 6.0 Resource Management 6.1 Provision of resources 6.2 .1 general 6.2.2

Competence,awareness and training

6.3Infrastructure 6.4 Work environment

5.1 Management Commitment Top management shall provide evidence

of commitment to the development and improvement of QMS by: Communicating the importance of meeting

customer and legal/regulatory requirements.

Establishing quality policy and objectives. Management Reviews Provision of resources.

5.2 Customer Focus

Customer requirements are met with the aim of enhancing customer satisfaction.

5.3 Quality Policy Appropriate to the purpose of

organization. Commitment to meet requirements and

continual improvements. Frame work for establishing and reviewing

quality objectives. Communicated and understood within the

organization. Is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality Objectives Establish quality objectives at

relevant functions and levels. Objectives must be measurable

and consistent with the quality policy.

5.4.2 Quality Planning

Planning of Quality Management System to meet the requirement given as well as quality objectives.

Integrity of Quality Management System is maintained when changes occur.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority Define and communicate the

responsibilities and authorities.

5.5.2 Management representative Member of the management who

has responsibility and authority for ensuring that processes of the QMS are

established and maintained. Reporting on performance of QMS including

needs for improvement. Promoting awareness of customer needs

and requirements..

5.5.3 Internal Communication Ensure communication between

various levels and functions regarding the processes of the QMS and their effectiveness.

5.6 Management Review5.6.1 General Review of QMS by top

management at planned interval. Ensure QMS suitability ,adequacy

and effectiveness. Evaluate the need for changes and

improvements to QMS including policy and objectives.

5.6.2 Review InputReview performance and improvement

opportunities related to: Audit results Customer feedback Process performance Product conformance Status of preventive and corrective actions. Follow up actions from earlier reviews. Change that could affect the QMS. Recommendations for improvements.

5.6.3 Review output

Output to include decisions and actions related to

Improvement of QMS and its process

improvement of product resources needs

6 Resource management 6.1 Provision of resources 6.2 Human resources 6.2.1 Assignment of personnel 6.2.2 Training,awareness and competency 6.3 Infrastructure 6.4 Work environment

6.1 provision of resources

Determine and provide To implement and maintain the

Quality Management System and continually improve effectiveness.

To enhance customer satisfaction by meeting customer requirements.

6.2 Human resources

6.2.1 General Those who have responsibilities

defined in the QMS must be competent on the basis of applicable education,training,skills and experience.

6.2 Competence, awareness and training Identify competency needs Provide required training Evaluate the effectiveness of training

provided. Ensure staff aware of relevance and

importance of their activities and contribution to achieving objectives.

Maintain appropriate records education,training,qualification and experience.

6.3 InfrastructureIdentify ,provide and maintain the

facilities needed to achieve product conformity.This shall include

Building, workspace & associated facilities

Process equipment, hardware and software

supporting services.

6.4 Work environment Identify and manage human and

physical factors of the work environment needed to achieve product conformity.

7 Product Realization 7.1 Planning of product realization 7.2 Customer related processes 7.3 Design & development 7.4 Purchasing 7.5 Production & service provision 7.6 Control of measuring &

monitoring devices.

7.1 Planning of realization processesPlan and develop processes for product

realization consistent with this standardWhile planning product realization determine

the following Quality objectives and requirements for the

product the need for

processes,documentation,resources and facilities specific to the product.

Required verification, validation, monitoring, inspection and test activities specific to the product and acceptance criteria.

Records.

7.2 Customer related process7.2.1 Determination of

requirements related to the product.

Product requirements specified by the customer including delivery and post delivery activities.

Requirements not specified but necessary for intended or specified use.

Obligations related to product, including regulatory and legal requirements.

Any additional requirements determined by the organization.

7.2.2 Review of Product requirementsReview identified requirements

and ensure before commitment to supply product that; product requirements are defined. Difference between tender and contract are

resolved. Organization has ability to meet the

requirements. In case of no documented customer

requirements, they shall be confirmed by the organization before acceptance.

In case of any changes concerned personnel and documents are up dated.

7.2.3 Customer communicationIdentify and implement

arrangements for communication with customers relating to:

product information inquiries contract and order

handling including amendments. Customer feedback including

complaints.

7.3 Design & development 7.3.1 Design & development

planning 7.3.2 Design & development input 7.3.3 Design & development

output 7.3.4 Design & development

review 7.3.5 Design & development

verification 7.3.6 Design & development

validation 7.3.7 Control of changes.

7.3.1 Design & development planning

Plan & control D&D of the productPlanning to include: D&D stages required review ,verification and

validation activities responsibilities and authorities for D&D.Interfaces between groups must be

managed.Planning to be updated as the D &D

progresses.

7.3.2 Design & development input

Define & document product requirements including

Functional and performance requirements.

Applicable regulatory and legal requirements.

Information from previous similar designs.

Any other essential requirements.Review input for adequacyReview for adequacy and resolve any

ambiguous,incomplete or conflicting requirements.

7.3.3 Design & development outputDocument D & D output allowing

verification.Provide information for production or

operations. D & D outputs shall

meet the input requirements Provide appropriate information for

purchasing, production and for service provision,

Contain or reference product acceptance criteria.

Specify the characteristics of the product that are essential for its safe and proper use.

7.3.4 Design & development review

At suitable stages review D &D to; evaluate the ability to fulfil

requirements. Identify problems and propose

follow-up.Involve all functions concerned.Record the results and follow up

actions.

7.3.5 Design & development verification Verify D & D to ensure that out put

meets the input requirements. Record the results of verification

and subsequent follow up actions.

7.3.6 Design & development validation Perform D & D validation to confirm that

product is capable of meeting the requirements for intended use.

Whenever applicable to be done prior to delivery.

Results of validation and follow up actions must be recorded.

7.3.7 Control of Design and Development changes Design and development changes

shall be identified and records maintained

Before implementation changes would be reviewed, verified, and validated.

Evaluation of the effect of the changes.

Record results of review of changes and follow up actions.

7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased

product.

7.4.1 Purchasing Process Control purchasing process to ensure that

purchased product meets requirements. Type & extent of control . Select suppliers based on their ability to

supply conforming product. Define criteria for selection and periodic

evaluation of suppliers. Results of evaluation and follow up actions

must be recorded.

7.4.2 Purchasing InformationPurchasing information shall describe Requirements for approval of product

.procedure, processes,equipment and personnel.

Requirements for qualification of personnel.

Quality management system requirements.

Ensure adequacy of specified purchase requirements prior to communication to supplier.

7.4.3 Verification of purchased product Identify and implement activities

needed to verify purchased product.

Where organization or its customer purpose verification at supplier premises,organization must specify in purchasing information:.

7.5 Production & service operations 7.5.1 Control of production and

service provision 7.5.2 Validation of processes 7.5.3 Identification &

Traceability 7.5.4 Customer property 7.5.5 Preservation of product.

7.5.1 Control of Production and service provisionControlled conditions for production &

services operations through: Availability of information specifying product

characteristics. Work instructions available where necessary. Use of suitable equipment. Availability & use of measuring and monitoring

devices. Implementation of monitoring and

measurements activities. Implementation of release,delivery and post

delivery activities.

7.5.2 Validation of Processes for Production and Service Provision

Shall validate process when… defined criteria for review and

approval approval of equipment and

qualification of personnel use of defined methods &

procedure requirements for record re-validation

7.5.3 Identification and tracebility Where appropriate identify product

through all stages of operations. Identify status with respect to

measurement & monitoring requirements.

Where traceability is required control & record unique identification of product.

7.5.4 Customer property Care for customer’s property being

under organization’s control or being used by organization.

Identification,verification,protection & maintenance of customer property provided for use or incorporation.

Any customer property that is lost,damaged or found un suitable must be recorded & reported to customer and record maintained.

7.5.5 Preservation of product Preserve conformity of product

during internal processing and final delivery to intended destination.

Include identification, handling, packaging, storage and protection.

This applies to constituent parts of product.

7.6 Control of monitoring & measuring devices

Shall establish process Calibrate & adjust measuring and monitoring

devices at specified intervals as prior to use. Traceability to international or national

standards.Where no such standard exist record the basis.

Safeguard MMD from adjustments invalidating calibration.

Protect MMD from damage or deterioration during handling,maintenance or storage.

Record results of calibration Assess validity of previous results when devices

found to be out of calibration.

7.6 (Significant addition or Modifications).The following specific requirements have been

omitted from the ISO 9001-1994 standard. “Documented Procedures” – omitted “measurement uncertainty is known” –

replaced with “measurement capability is consistent with the measuring requirements”

“test software” replaced with “validated prior to use”

“comparative references” – omitted “technical data.. Made available.. To

customer” omitted

“prescribed intervals” – replaced with “periodically or prior to use”

“define the process employed for the calibration…. Unsatisfactory” replaced with “ the basis used for calibration shall be recovered”

“identify… with a suitable indicator or approved identification record to show the calibration status” omitted.

“Ensure environmental conditions are suitable..” now covered by devices shall be used and controlled to ensure that measurement capability is consistent with the measuring requirements.”

8 Measurement,analysis and improvement 8.1 General 8.2 Monitoring & measurement 8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring & measurement of

processes 8.2.4 Measurement and monitoring of

product

8.3 Control of non-conformity 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 preventive action

8.1 General

Plan & implement measurement and monitoring activities needed to assure

Conformance of the product Conformance to the quality

management system. Continual Improvement

8.2 Monitoring and Measurement

8.2.1 Customer satisfaction Organization shall monitor

information on customer satisfaction and /or dissatisfaction.

The methodologies for obtaining and utilizing such information must be determined.

8.2.2 Internal auditConduct periodic internal audit to

determine if QMS: Conforms to the requirements of the

standard. Has been effectively implemented &

maintained . Plan the audit program considering: Status and importance of the activity Results of previous audits

8.2.2 Internal auditAuditors shall not audit their own work The documented procedure must

cover: Responsibilities & authorities for

conducting audits Ensuring independence Recording results and reporting to

management Timely corrective actions. Follow up to verify & report

implementation of verification results.

8.2.3 Measurement and monitoring of processes Apply suitable methods for

measurement and monitoring of those realization processes necessary to meet customer’s requirements.

When planned results are not achieved

8.2.4 Measurement and monitoring of product Measure & monitor product

characteristics at appropriate stages. Evidence of conformity with the

acceptance criteria Records must indicate the authority

responsible for release of product. Release or delivery must not proceed

until all the specified activities have been completed unless otherwise approved by the customer.

8.3 Control of non conformity product Documented procedures for control non

conforming product to prevent unintended use or delivery.

The organization shall deal with non conforming product….

Taking action to eliminate the detected . Authorize under concession Preclude the original intended use Records of concession shall be maintained. Re verification Non conformity detected after delivery

8.4 Analysis of dataCollect & analyze data determine

suitability and effectiveness of QMS and to identify improvements that can be made.

Analyze data provide info on: Customer satisfaction and conformance to product requirement. Characteristics of product & process

and their trends suppliers

8.5 Improvement8.5.1 Continual Improvement Facilitate continual improvement using:

quality policy objectives audit results analysis of data corrective actions preventive actions. Management review

8.5.2 Corrective action

Action appropriate to the impact of problem.Documented procedures shall define requirements

for: Reviewing non-conformities determine the causes evaluating the need for corrective action determine corrective action needed and

implemented. Recording results of action Reviewing corrective action taken

8.5.3 Preventive actionOrganization must identify preventive action to

eliminate the causes of potential non conformances to prevent occurrences.

Actions appropriate to the impact of potential problem.

Documented procedures must define the requirements for

Determining potential nonconformaties and their causes

Evaluating the need for action to prevent occurrence of nonconformaties

Determining and ensuring implementation of preventive action needed.

Recording results of action taken. Reviewing preventive action taken.

QUALITY MANAGEMENT PRINCIPLES

PRINCIPLE 1 - CUSTOMER-FOCUSED ORGANISATION

Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.

PRINCIPLE 2 - LEADERSHIP

Leaders establish unity of purpose and direction of the organisation. They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives.


PRINCIPLE 3 - INVOLVEMENT OF PEOPLE

People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit.

PRINCIPLE 4 - PROCESS APPROACH

A desired result is achieved more efficiently when related resources and activities are managed as a process


PRINCIPLE 5 - SYSTEM APPROACH TO MANAGEMENT

Identify, understanding and managing a system of interrelated processes for a given objective improves the organization's effectiveness and efficiency

PRINCIPLE 6 - CONTINUAL IMPROVEMENT

Continual improvement should be a permanent objective of the organisation


PRINCIPLE 7 - FACTUAL APPROACH TO DECISION

MAKING

Effective decisions are based on the analysis of data and information

PRINCIPLE 8 - MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS

An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value

SECTION # 5

Internal Audit Cycle

The Audit Assign the auditors to their area Sample the system Collect objective evidence of

system effectiveness Compare findings from checklist

with requirements decide compliance or

noncompliance Audit team daily meeting

Reasons for conducting Audits To examine a Quality Management

System for improvements. To ensure ISO 9000 requirements

are being complied with. To determine compliance or non-

compliance To meet regulatory requirements

Auditing Procedure The method for planning, initiating

and conducting audits and follow up activities including corrective actions

The rules for deciding the criticality of noncompliance

Auditing Procedure The format and distribution of

audit reports, noncompliance reports, checklists or other forms required for reporting

Records, storage and retention

PHASES OF AN AUDIT

PLANNING- Information Gathering- Annual Schedule- Estimate Resource

- Findings- Required Actions- Verify effectiveness

PERFORMANCE- Opening- Assess- Review Finding- Closing Meeting

PREPARATION

- Review Documents- Checklist- Agenda

REPORT &FOLLOW-UP

QUALIFIEDEXPERIENCED

SECTION 5-1

Planning

Initial Planning Decide who shall carry out the

audit Identify the relevant quality

specification or requirements Plan the date/time Gather information

Detailed Planning

Prepare program - send copy to auditee

Decide team composition Arrange team briefing Team prepare checklists

Detailed Planning

Notify auditee of arrangements / requirements

Duration of audit Composition of audit team Facilities for review etc.

Planning

The audit team The Team Leader if possible should

have the appropriate knowledge and experience of the industry and technology involved.

The Lead Auditor shall be adequately trained and have the ability to organize and lead the audit team.

Planning The auditor team members, shall

be trained in auditing techniques and have knowledge of the industry and technology involved

Auditors may be selected on the basis of their specialist discipline or expertise.(e.g., Design, Production, Computer Systems, etc.)

Planning The audit Team must be supplied

with copies of : The specification Copies of any documents they may

have to complete (e.g non-compliance, reports, checklists,etc)

Planning Team Size and Audit duration will

depend upon The size and complexity of the

department’s operation The standard/specification to be

appliedNote: A small dept. may take half

day whereas a larger one may take a two days or more

Planning Audit Team briefingIt is good management to arrange

for a meeting of the team, prior to the audit, to brief them on the requirements.

The briefing should cover: the program allocation of individual audit areas audit policies and practices

AUDIT PLANNING AUDIT PLANNING

Team Leader Candidates should be selected from qualifiedauditors with auditing experience.

Candidates should have a demonstrated ability tocommunicate effectively both orally and in writing.

Responsibilities

Make final decisions

Assist with selection of auditors

Represent audit team with management/ submit audit report

Direct follow-up activities

EXAMPLE OF AN AUDIT PLANEXAMPLE OF AN AUDIT PLAN

AUDIT PLAN

Procedure/Department

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

AUDIT KEYP - PLANNEDP/D - PLANNED & DONEU - UNSCHEDULED AUDIT PERFORMEDF - FOLLOW-UP AUDIT PLANNEDF/D - FOLLOW-UP COMPLETED

AUDIT ITINERARYAUDIT ITINERARYTime Team A (PM) Team B (WL)09:00-09:15 Opening Meeting09:15-12:00 Sales Department Engineering Department

- Contract Review - Document & Data control- Customer Complaint - Product Design & Development- Sample Control - Control of Production Fixture & ToolsPMC Department - Control of Inspection, Measuring- Production Planning & Text Equipment- Material Planning

12:00-13:)0 Lunch13:00-13:30 Auditor’s Meeting13:30-16:45 Store Production

- Material Store - Process Control- Finished Store - In-process InspectionQuality Department - Control of Non-conforming Products- Incoming Inspection & Testing Personnel Department- Final Inspection & Testing - Training- Corrective & Preventive General Manager Action - Internal Audit

- Management Review16:45-17:30 Auditors’ Meeting17:30-18:00 Closing Meeting

SECTION 5-2

Preparation

AUDITEE AUDITOR

Non-conformance Statements

Audit objectives Audit Schedule Notification of Audit

Selection of Audit Team Prepare Checklist Audit Plan

Audit team Auditee

Audit team

CAR (s) / Audit Report CAR Status Log

Team Leader

Team Leader QMR

Planning

Preparation

Conduct Audit

Complete Audit /Discuss Findings

Audit Report Back and Recording

Follow - up

Close - out

-investigate cause of nonconformance-return completed CAR

-implement necessary corrective / preventive action and monitor for effectiveness.

AUDIT PREPARATIONAUDIT PREPARATION

Selection of Audit Team

Auditor Independence

Trained Auditor

Auditor credibility


Checklists- Preparation Reflects objective and scope of the audit

Sources of information for checklists

- previous internal Audit Report / CAR (s)

- previous checklist

- auditee Quality Documents

- known quality problems


Checklist - Preparation

WHAT the auditor wants to look for

WHOM the auditor wants to speak to

WHAT the auditor wants to speak about


Checklist Questions

Based on Quality Documentation used by the Dept.to be Audited.

From the documentation Identify all thekey things involved / to be done

Record the key things on the checklistas things to be checked.

Include references to all forms and otherdocumentation, i.e. other procedures / W.I.

IDENTIFYING PROCEDURES TO AUDITIDENTIFYING PROCEDURES TO AUDIT

ISO Elements

Area

Stores x x x x o x x x x x x

Product line 1 x x x x x x x x x x x x x

Q.A.

Legend: X = Direct Relationship

O = In-direct Relationship

DocRef

Requirement Y N Comments

4.1

4.2

Doc# Purchasing - AB-Q501 / Rev: 1Stock items established via monthlymeeting - Comm. / Purch MgrNon stock via PR from dept. sent toComm. MgrCap-ex items approved by MD.

4.4

4.3

4.6

4.8

4.7

ASL held by commercial deptR.M. specifications in LabSupplier approved via Head OfficeSupplier approved Local:- satisfactory supply- on-site assessment (TP 453)- product samples- other users experiencePurchase orders approved by Comm. Mgr.

P.O. contain: - description of goods/services - type,class,grade, quality - drawings specificationsRevisions: New P.O. released identified asrevised

AUDIT PREPARATION

Study Documents

Agenda Checklist

Team Briefing

Compliance or Documentation Review An audit to determine the extent to

which the documented system meets the requirements of a specified standard.

Normally carried out in advance of an audit and may be referred to as a desktop audit

Conformance or Compliance Audit

An audit conducted to determine that the quality system is being implemented

Checklists

Used by the assessor as an aide memoire

Ensure that all elements of a specification are addressed

Are compiled from the results of a detailed study of the procedure/specification

Ensure that all relevant requirements contained in the specification are covered

Checklists Assist with obtaining proof that the

requirements contained in the specification are being implemented

Used to reference each question to the relevant clauses of the specification

Are an invaluable aid when writing the audit report.

Space should be left on the checklist so that answers to the questions can be noted for later use.

ChecklistsChecklists will be expected to ensure

that :- Each requirement of the specification to

which the auditee’s quality system has been documented is examined, to ensure that the system covers every element/requirement and that each one is effective.

Procedures and work instructions are reviewed for completeness, adequacy and issue levels against a master list.

Checklists Evidence of the implementation of

procedures and instructions in the work areas being audited. The procedures and instructions are to the required issue and their distribution controlled.

Corrective actions which have been undertaken to clear any previous noncompliances, are to be followed up.

To provide guidelines for the auditor

To ensure every part of the audit is completed

To reinforce objectives and scope

PURPOSE OF THE CHECKLISTPURPOSE OF THE CHECKLIST

Consider: the processes taking place relevant procedures documents in use records requirements of ISO 9001

PREPARING A CHECKLISTPREPARING A CHECKLIST

AUDIT CHECKLIST

Job Ref : NDB Procedure: QP008 / Issue B / Rev.1 Auditor : P.C. Chan

Sheet No. 1 of 4

Item No.

Requirement Comments/Remarks

Activity ComplianceYes/No

Receiving CheckFor small packet, By Foreman - Visual check- Identified & Marked off against the P.O.- Until required (what does it means?), unpacked/ inspected / put into storeFor Plant / Equipment, By Foreman- Quantity check against Engineers order- Damage check- For specialised equipment, need to sign DN, may be by Chargehand- Equipment Acceptance Cert send to Contract EngineerBy Foreman for all items:- Check DN about Order No., Quantity or Weight Supplier’s name & her Order No. Description

4.01

4.02

4.01

AUDIT CHECKLIST

Job Ref. : NDB Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan

Sheet No. 2 of 4

Item No.



- Check DN against PO- Send test Cert to site eng.If all Ok, sign Material Received Copy, send to Engg:Dept with D.N.

IF Non-conformity found

Inform Contract EngineerIndicated with Red Label with defect’s detail, separately locatedDisposition by Site EngineerFill Non-conforming item input sheet (Distribution required?)If found after stored, remedial work.Record on either one- Non-Conforming Item Report Sheet- Non-Conforming Workmanship Report Sheet

4.014.06

4.11

4.09

AUDIT CHECKLIST

Item No.



Storage / Issuance

Site/Contract Engg ensure suitable stores facilitiesGoods Received Register fill by Foreman- Date received- Supplier- Item description- Quantity record- NDB order No.- Remark of shortage / defectsEstablish item location with identification.Location of major item to be agreed by site Engg.Label of acceptable item used and with necessary description.Who’s responsibility

4.034.04

4.05

Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan

Job Ref. : NDB Sheet No. 3 of 4

AUDIT CHECKLIST

Item No.

Requirement Activity ComplianceYes/No

Comments/Remarks

Item issued by Foreman or Site Engg with Material issued Register- Item description- Quantity- Stock balance- Recipient- Issue date- Foreman or Engg SignedHow about Plant / Equipments? (Not mentioned in QP)

Stores Foreman conduct regular check on stock item for - Condition- Quantity Vs Balance of Material Issued RegisterInform Engg to Re-order.

4.07

4.08

Procedure : QP008 / Issue B / Rev 1 Auditor: P.C. Chan

Job Ref. : NDB Sheet No. 4 of 4

SECTION 5-3

AUDIT Conduction

AUDITEE AUDITOR


Audit objectivesAudit ScheduleNotification of AuditSelection of Audit TeamPrepare ChecklistAudit PlanAudit teamAuditeeAudit teamCAR (s) / Audit Report

CAR Status LogTeam LeaderTeam LeaderQMR

Planning

Preparation

Conduct Audit



Follow - up

Close - out

-investigate cause of nonconformance

-return complete CAR

-implement necessary corrective / preventive action and monitor foreffectiveness.

The Audit

REMEMBER : THE AUDIT TEAM IS ATTEMPTING TO APPROVE THE SYSTEM BASED UPON AN UNBIASED ASSESSMENT.

IT IS NOT ATTEMPTING TO FAIL IT!

The Audit

ESTABLISHING THE FACTS AND FINDING THE PROOF WITHOUT NONCOMPLIANCES THE EVIDENCE MAY BE THE EFFECT AND NOT THE CAUSE

Sampling

Scope Duration of

Audit Requirements of

the standard Complexity of

the process

Considerations:

• Previous Problems• Important aspects• Auditor skills /

knowledge• Sample size and its

significance

Auditor

Auditee

PERSONAL CONDUCT

positive, professional, constructive approach

co-operative, open, honest

Support from management Trained auditors Independence of audit

function Timely access to facilities,

documents, personnel Access to all levels of

management Defined audit procedures

FUNDAMENTAL REQUIREMENTS FOR EFFECTIVE AUDITINGFUNDAMENTAL REQUIREMENTS FOR EFFECTIVE AUDITING

The Opening Meeting Punctuality - arrive on time The meeting should be brief and to the

point General introductions by the audit team

and management A review of the program

good communication

co-operation openness

THE OPENING MEETING

NECESSARY FOR:

People Processes Equipment / tools /

materials Documentation

AN AUDITOR "VERIFIES" BY OBTAINING OBJECTIVE EVIDENCE

Record Past implementation

Examined / Observed Current implementation

Method Stated Staff knowledge &

understanding

OBJECTIVE EVIDENCEOBJECTIVE EVIDENCE

Objective Evidence

Try to establish :- That authorised documents are in

use That superseded drawings have

been removed That good housekeeping is practised That facilities are adequate That supervision is adequate

IAC S7 . 5 . 1

Objective Evidence

That orderly records are kept That staff are adequately trained Assess attitude of management

and staff towards the quality system

Well prepared checklists will assist when answering these questions

LAC S7 . 6 . 1

Objective EvidenceObjective Evidence

Establish the fact and find the proof

With nonconformities the evidence may be the effect and not the cause

meet the area representative first

always talk to those performing the task

explain the purpose of the visit

be calm, polite, reassuring never talk down speak clearly and carefully

THE AUDITOR'S APPROACH

examine objective evidence ask open-ended questions refer to checklists make notes consider impact on other

activities examine physical

conditions

CONDUCTING THE AUDIT

ASK

LOOK

LISTEN

How Whe

re Whe

n Wha

t Why Who

QUESTIONING TECHNIQUES

6 important words

Audit Techniques

Ask Questions Examine Objective

Evidence Observe Activities Listen to Reactions Record Findings

The Auditors Six FriendsThe Auditors Six Friends

When asking questions…..Who ?

What ?Where ?

When ? Why ?

How ? and the seventh Ok Show Me ?

Question Technique

YES / NO questions Often elicit dead end answers - you gain

nothing - Only useful as a leader questionHow - What - Why - When - Where - Who ? Direct questions - will achieve more detailed

answers.Explanation questions Useful for comparing interfaces

Questioning Techniques

Keeps conversation going Repeat last word or phrase - say

something niceAvoid double questions (2 questions

in 1) Only one answer is likely to result

IAC S7 . 4 . 1

Audit Techniques Forward Trace - An audit which

follows the natural flow of a product or service process

Background Trace - An audit which traces records back through the system

Observations Notes made by an auditor during

assessment may lead to noncompliances being raised or to provide information for the audit report.

Notes provide Objective Evidence back up

Observations

Observations may be obtained through any of the following methods:

Seeking objective evidence that the system is functioning as prescribed.

Samples taken of the system will allow the auditor to obtain the required evidence

Observations Always establish objective evidence

when an apparent noncompliance is found remember the occurrence discovered may be the effect and not the cause.

Where processes are involved the audit may examine the process controls and records to establish conformance with the specification

Both positive and negative observations are recorded

Observations Throughout the entire audit the

evidence collected in the form of OBSERVATIONS is to be recorded on the auditors checklists.

This evidence is then to be examined to determine if there are any noncompliances which need to be reported.

ObservationsObservations

A statement of fact made during an audit and substantiated by objective evidence

Observations are recorded on the auditors checklist throughout the audit

Both positive and negative observations are recorded

Negative observations may lead to noncompliances being raised where evidence exists, indicating a deviation from the standard

Observations may be included in the audit report to draw management’s attention to improvement opportunities

Definition

Noncompliance Reporting

Complete audit findings Must be factual Must be understandable and traceable Raise noncompliances on completion of an

audit The auditee is requested to sign signifying an

understanding and acceptance of the noncompliance.

MAJOR total breakdown of a procedure, work

instruction or operation of the Quality System total absence of a procedure required by

Standard number of minor lapses indicating a total

breakdown of system immediate hazard to the quality of the product

or service MINOR

· a single observed lapse in a procedure, work instruction or operation of the Quality System

CLASSIFICATION OF CARsCLASSIFICATION OF CARs

NoncomplianceNoncompliance

Nonfulfilment of a specified requirement

It is important to establish the ownership of each noncompliance

Nonconpliances are owned by the auditee not the auditor

It is important to establish who has the authority to sanction the corrective action resulting from noncompliances

Definition

NoncomplianceNoncompliance

The opening meeting should establish the authority and the reporting routes

The auditee should have an internal system for dealing with corrective actions

The noncompliance report is the method used to indicate the devations to the system

Noncomformities arise from observations made during the audit


What is the Problem ?describe clearly, concisely and

factually Why is it a noncompliance ?

i.e. against what requirement Where did it occur ?

i.e. which department or activity

Who ? - avoid apportioning blame(i.e. naming individuals)


Complete audit findings Must be factual Must be understandable and traceable Raise noncompliances on completion of an

audit The auditee is requested to sign, signifying

an understanding and acceptance of the noncompliance

Noncompliance ReportingNoncompliance Reporting

Information to be recorded Identification /Serial number The nature of the noncompliance Where,

What,Why Reference numbers of Documents/ Materials etc. Auditee/ contact Clause of the standard or specification applicable Category of noncompliance (if applicable) Agreed corrective action and timescale Follow up action See Noncompliance Report Form

the audited process or procedure is being not conducted or completed as it should

NONCONFORMANCENONCONFORMANCE

comply with the Standard implement quality manual,

procedures or other documented requirements

implement a code of practice, regulation or contract

_______________

no requirement = no nonconformance

A NONCONFORMANCE MAY BE A FAILURE TO:A NONCONFORMANCE MAY BE A FAILURE TO:

include: overview of finding description of

nonconformance example of objective

evidence summary of requirement

FINDING STATEMENTFINDING STATEMENT

EXAMPLE OF NON-COMPLIANCE STATEMENTEXAMPLE OF NON-COMPLIANCE STATEMENT

Standard: ISO 9001:2000

Procedure: QP6 Issue 2

Area: Purchasing Dept.

1. The procedure is not being implemented in full in

that not all purchase orders are being fully

completed. For example; Pos 1234 and 1235

do not contain prices or delivery dates.

2. All Purchase Orders must be completed in

accordance with Procedure QP6.

Used to: report nonconformances classify nonconformances record acceptance of

nonconformances record actions taken to correct

nonconformances record auditor acceptance of

corrective action implementation

CORRECTIVE ACTION REQUESTS (CARs)CORRECTIVE ACTION REQUESTS (CARs)

CORRECTIVE ACTION REQUEST (CAR) FORMCORRECTIVE ACTION REQUEST (CAR) FORM

CORRECTIVE ACTION REQUEST

AUDIT NO.:

AUDITOR: CAR NO.: OF

DEPT. REPRESENTATIVE AUDIT DATE:

PROCEDURE NO: AREA/DEPT/FUNCTIONISSUE:

DETAILS OF NONCONFORMANCE:

SIGNED: SIGNED:AUDITOR DEPT. REP

CORRECTIVE ACTIONS:

SIGNED:DEPT. REP.:

RE-AUDIT RESULTS:

SIGNED:AUDITOR: DATE:

COMPLETING THE AUDIT

- audit team meeting to discuss all findings

Review Audit Findings:

- team leader to make final decisions- all findings to be supported by objective evidence

Write non-compliance statementsnon-conformance statements to be recorded on the CAR

Report-back meeting

NON-CONFORMANCENON-CONFORMANCE A failure to comply with a requirement. The fault

may be caused by the failure of the system to comply orfailure to implement the system itself._______________________________________

NON-CONFORMANCE STATEMENTSNON-CONFORMANCE STATEMENTS

Non-conformance statements are statements that explicitly express the identified non-conformityalong with the supporting evidence. They generallyinclude the following:

The Deficiency The Objective Evidence Details of the Deficiency

Where What

Who

NON-CONFORMANCE STATEMENTSIn the machine shop, a diameter on drawing D330 issue A

had been changed by the Forman. There was no evidencethat the change had been authorized by the designdepartment.

The operator(s) in the Machine Shop were supposed to

sign off each operation on the route card. On the routecard for batch number 134 there were no signature(s)against completing machining operations 1 and 4.

NON-CONFORMANCE STATEMENTS

L/C 341-6787 for a customer under credit grade of # 8 for the amount of USD 400,000 FOB, there was no evidence of any insurance provided.The procedure requires that for the issue of L/C’s to customers under credit grade 7-10 over USD 325,000 under FOB and C&F terms evidence of insurance is required.

For L/C 1234567 issued by a local bank for USD 65,000 no verification was done by CSC.

According to the procedure all L/C issued by local banks for values over USD 50,000 from to be verified by CSC before being sent toTPC for scanning and advising.



Customer complaint from the ABC company had not been followed up and no action had been carried out whatsoever.

According to the procedure QP 13 paragraph 4.6 all customer complaints are to be followed up in the Quality Improvement Committee.

LAC 09.08 / 05

EXAMPLE OF CORRECTIVE ACTION REQUEST

Company:

Job No:

Assessor:

Company Representative:

Procedure No:Issue:

Details of Non-Conformance:

Signed:CompanyRepresentative:

Corrective Action taken to prevent recurrence:

Signed:Company Representative

Acceptance of Corrective Action/Comments

Visit No:

Assessment Date:

Area/Dept/Function:

CAR No.: of

ISO 9001/2/3/REFClause

Major CARProposedClose out date:

Signed:Assessor:

Date:

:

not essential

effective corrective action more important

audits should be positive and constructive

purpose is system improvement

CLASSIFICATIONFIRST PARTY AUDITSCLASSIFICATIONFIRST PARTY AUDITS

Closing meeting

Thank management Explain that sample taken has

determined conclusion reached Present summary report

Quantify noncompliance Conclusion Recommendations

Closing Meeting Each team member to present

noncompliance details Invite questions - for clarification only Agree distribution of final report Make statement of confidentiality

be side-tracked be led or misled get "bogged down" let the auditee dictate

the pace make assumptions or

presumptions

CONTROL THE AUDIT

DO NOT

Be prepared Be punctual Insist on auditee answering

questions As little talking as possible Avoid misunderstandings Keep questions clear and

concise Polite and calm

CONTROL THE AUDITDO

good points which may benefit other areas of organisation

areas of concern deficiencies given the “benefit

of the doubt” suggestions for action

OBSERVATIONSOBSERVATIONS

aggressive auditees timid auditees missing people missing documents pre-prepared samples (choose your

own !)

BE AWARE OF

SECTION 5-4

Audit Follow Up & Close Out

AUDITEE AUDITOR


Audit objectivesAudit ScheduleNotification of AuditSelection of Audit TeamPrepare ChecklistAudit PlanAudit teamAuditeeAudit teamCAR (s) / Audit Report

CAR Status LogTeam LeaderTeam LeaderQMR

Planning

Preparation

Conduct Audit



Follow - up

Close - out

-investigate cause of nonconformance

-return complete CAR

-implement necessary corrective / preventive action and monitor foreffectiveness.

Hold an Opening Meeting

Conduct the audit

Analyse the results

Report the findings

AUDIT PROCESSAUDIT PROCESS

Action taken to eliminate the causes of an existing noncompliance, defect or other undesirable situation in order to prevent recurrence

CORRECTIVE ACTIONCORRECTIVE ACTION

Action by management of area audited:· take immediate remedial action· analyse effects on product· identify root cause· identify other areas where “problem”

may exist· develop effective actions to prevent

recurrence· implement and monitor actions

CORRECTIVE ACTION PLANCORRECTIVE ACTION PLAN

RESPONSIBILITY OF MANAGERS RECEIVING A CAR

1. Investigate the problem

2. Determine the cause

3. Decide on appropriate corrective action and target date for implementation.

4. Send the completed form to the CAR administrator

5. Implement corrective action

C.A.R. FLOWC.A.R. FLOW

C.A.R. Raised

Signed & Issued Accepted

Investigate & Analyze

Implemented

Corrective Action DocumentedReviewed

Reviewed

Reject Accept

Closed Out

RecordRecord

The Report should:· describe audit scope· identify auditors· identify departmental

representatives· state overall findings· describe deficiencies,

observations· provide objective evidence· be easy to read and

understand

AUDIT REPORTAUDIT REPORT

INTERNAL AUDIT REPORTINTERNAL AUDIT REPORT

INTERNAL QUALITY SYSTM AUDIT REPORT

AUDITOR’S NAME AUDIT REPORT NUMBER

DEPARTMENTAL REPRESENTATIVE DATE OF AUDIT

QUALITY FUNCTION or PREVIOUS AUDIT DATE AND RESULTSPROCEDURES(S) AUDITED

SUMMARY AUDIT:

SIGNED: _______________________(AUDITOR) DATE: _______________________

exists is complete operates correctly is effective

AIMS OF THE AUDIT

To verify that the quality system:

REPORTS and RECORDS Complete and sign all CAR.

Prepare Audit Report.

Prepare for the report-back meeting

explain, support and justify findings

obtain agreement on CARs

ensure good points are mentioned

state overall degree of compliance

reinforce objectives and scope

PRESENTING THE FINDINGSPRESENTING THE FINDINGS

REPORT BACK MEETING Have Your Reports Ready

Discuss Positive As Well As Negative Aspects

Make Sure Reports Are Agreed By All Parties

REPORT-BACK MEETING“CHECKLIST”

To be chaired by audit team leader.

Repeat purpose and scope of audit.

Thank auditee

Comment on good points.

State overall compliance

Read non-compliance statements.

Do not argue.

Arrange follow-up (to close out corrective actions).

Take minutes of meeting for any follow up.

Close meeting.

Checklist

Procedure QP-10

F O L L O W UPSubsequent follow up should review:

- audit file

c- corrective action file

Review should examine actions required and whether completed andwhether the actions have been effectiveto prevent recurrence.

Action by Quality Manager:· approve proposed corrective

actions· monitor progress in completing

corrective actions· arrange follow-up to verify

effectiveness· escalate to higher management

if necessary

CORRECTIVE ACTION PLANCORRECTIVE ACTION PLAN

shows status of:

· CARs

· follow-up action

· ‘close-out’

· CARs from second and third

party audits

CAR STATUS LOGCAR STATUS LOG

CAR STATUS LOG

CAR CAR DEFICIENCY AUDIT INITIALS DATE CORRECTIVE ACTION PROPOSED DATESERIAL ISSUED DATE OF REMINDER ACTION PREVENT FOLLOW- CARNO. TO AUDITOR SENT COMPLETION RECURRENCE UP DATE CLOSED

DATE

CORRECTIVE ACTION REQUEST (CAR) STATUS LOG

AUDIT FOLLOW-UPAUDIT FOLLOW-UP

audit objective evidence verify corrective action(s)

implemented ensure short and long term

effectiveness record details of follow-up

sign-off forms audit documents retained as

records

Why ??

FOLLOW-UP OF THE CORRECTIVE ACTION

WHY?

To ensure corrective action has prevented any recurrences

To determine whether corrective action has been effective?

CLOSE-OUT THE CAR? Each non-conformance is to be closed out

individually

> Ensure that the corrective action has addressed the root cause of the nonconformance

> Not treated the symptoms only but prevented recurrence of the non conformity.

> When the auditor is satisfied there is no further example of the non-conformance.

CLOSED-OUT

CAR

MANAGEMENT REVIEWMANAGEMENT REVIEW

internal audits reported

audit results analysed

status of corrective actions reported

preventive actions identified

INTERNAL AUDIT -THE SYSTEMManagement

Management Review

Follow-up/Close out

Audit Schedule

Corrective/Preventive Action

Conduct Audit

CAR Requests

SECTION 6

Auditor Desirable Characteristics

Management Style

“Tell” This approach is where the team leader

plans and makes the decisions up front and then gives clear instructions - directing the team the way he or she wants the task to proceed

This style may well be welcomed by the less experienced team members, but may not always receive approval from those more experienced who feel they have something to contribute.

Management Style

“Consult” The consult approach is where the team

leader takes time to talk to the team members first, listen to their ideas and evaluate their capabilities before making a decision.

This is probably the preferred approach, but if time is a constraint and the team ia not available then this approach may not be possible.

Management Style “Team” The team approach is when the team

leader acts more as a chairperson seeking concise opinions and allowing other team members to take an active role in the decision making process.

This approach is perhaps more useful when preparing for the final report. Giving the opportunity for the final report to be truly representative of the whole teams findings.

good listener open-minded diplomatic unbiased honest patient self-disciplined

SELECTING AUDITORSDESIRABLE TRAITSSELECTING AUDITORSDESIRABLE TRAITS

arrogant opinionated self-important lazy argumentative shy timid

SELECTING AUDITORSUNDESIRABLE TRAITSSELECTING AUDITORSUNDESIRABLE TRAITS

Auditor Characteristics

These include skills of being :

Diplomatic Patient Honest Fair minded Impartial Articulate Communicative Analytical

Helpful Co-operative Persistent Observant Ethical Professional

Code of Conduct To act in strictly trustworthy and

unbiased manner To disclose any relevant relationships Not accept inducements Not to disclose findings Not to act in any way prejudicial to the

organization In the event of an alleged breach co-

operate fully

stay within audit scope communicate audit

requirements collate objective evidence document CARs report audit findings verify effectiveness of

corrective actions retain and safeguard

documents

AUDITORS SHOULDAUDITORS SHOULD

prepare - know the subject material

learn about the auditee remain objective control the audit assist if there is a

misunderstanding listen obtain objective evidence compliment the auditee

WHAT AN AUDITOR SHOULD DOWHAT AN AUDITOR SHOULD DO

swear be sarcastic discuss/criticize company policies

personalities be negative criticise argue compare auditee with others

WHAT AN AUDITOR SHOULD NOT DOWHAT AN AUDITOR SHOULD NOT DO

introduce self and team ensure agenda is known and

understood keep to agenda keep to time keep control avoid arguments listen to others maintain records

GOOD PRACTICE AT MEETINGS

Thanks

ANIL KUMAR

ISO 9001 Training Material

Documents

rev 1auditor

qp008 issue

chan job ref

car status

return complete

audit report

post delivery

quality management