lead auditor / auditor course for quality management...

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Lead Auditor / Auditor CourseFor Quality Management Systems

ISO 9001:2008

INSTITUTE OF QUALITY

Apr 2010

Apr 2010 2

INTRODUCTION

2

Apr 2010 3

INTRODUCTION OF PARTICIPANTSINTRODUCTION OF PARTICIPANTSParticipants are requested to find a partner each.

You are expected to find out professional information about your partner in 2 minutes. Also enquire his / her key expected learning from the programme.

Please record your findings. Write down your name and the details collected from your partner

Each participant would in turn introduce his partner to the group and his key expected learning.

Hand over your recorded findings to the tutors.

Duration : 30 Minutes

Apr 2010 4

COURSE FORMATCOURSE FORMAT

FOR A DURATION OF FIVE DAYS

COVERS THE REQUIREMENTS OF IRCA / NABET

ENABLES SUCCESSFUL CANDIDATES TO REGISTER

INCLUDES CLASSROOM SESSIONS, SYNDICATE WORKSHOPS, ROLE PLAY EXERCISES

EXTENSIVE EXAMPLES AND CASE STUDIES BASED ON INDUSTRY SITUATIONS

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Apr 2010 5

COURSE LEARNING OBJECTIVESCOURSE LEARNING OBJECTIVES• PURPOSE OF QUALITY MANAGEMENT SYSTEM & 8 QUALITY MANAGEMENT

PRINCIPLES

• STANDARDS – ISO 9000, ISO 9001, ISO 9004, ISO 19011 & THEIR INTERRELATIONSHIPS.

• INTERPRETATION OF ISO 9001 IN CONTEXT TO THE AUDIT

• ROLES AND RESPONSIBILITIES OF AUDITORS AND LEAD AUDITORS.

• PLAN AND CONDUCT AN AUDIT, GATHER OBJECTIVE EVIDENCE VIA VARIOUSMETHODS AND DETERMINE CONFORMITY TO THE REQUIREMENTS

• AUDIT REPORT WRITING

• AUDIT FOLLOW UP – EVALUATING THE EFFECTIVENESS OF CORRECTIVE ACTION IMPLEMENTATION

• CERTIFICATION AND ACCREDITATION PROCESSES

• AUDITOR CERTIFICATION AND ROLE OF IRCA / NABET

Apr 2010 6

COURSE PROGRAMMECOURSE PROGRAMME

BLEND OF LECTURES, INTERACTIVE WORKSHOPS AND PRESENTATIONS

ROLE PLAY ON OPENING AND CLOSING MEETINGS

INCLUDES PRE-COURSE MATERIAL AND COURSE MATERIAL

CONTINUOUS ASSESSMENT OF PARTICIPANTS

COURSE EXAMINATION

4

Apr 2010 7

DELEGATE RESPONSIBILITIESDELEGATE RESPONSIBILITIES

COURSE IS INTENSIVE, HENCE FULL ATTENTION AND DILIGENCE IS REQUIRED

TIME SCHEDULES ARE IMPORTANT

BE ALERT, INTERACTIVE AND CO-OPERATIVE

TAKING NOTES

USE OF MOBILE PHONES PROHIBITED

DELEGATES APPEAL AND COMPLAINT

Apr 2010 8

EVALUATION PROCESS & CRITERIAEVALUATION PROCESS & CRITERIA• CONTINUOUS ASSESSMENT• SKILL BASED PRACTICAL WORK

TUTOR MARKED PRESENTATION / ROLE PLAYQUIZZES

DAILY ASSESSMENT– CONTRIBUTION, QUESTIONING, COMMUNICATION,

REPORTING, PARTICIPATION IN TEAM– PERSONAL ATTRIBUTES: ATTITUDE,

MANNER,SUITABILITY AS AUDITOR– ATTENDANCE, PUNCTUALITY AND PARTICIPATION

RESITTING THE EXAMINATION OR THE COURSE

• WRITTEN EXAMINATION

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Apr 2010 9

ISSUE OF CERTIFICATESISSUE OF CERTIFICATESSUCCESSSFUL COMPLETION CERTIFICATE

WHEN THE DELEGATE HAS PASSSED BOTH THE WRITTEN EXAMINATION AND CONTINUOUS ASSESSMENT

ATTENDANCE CERTIFICATE

WHEN THE DELEGATE HAS NOT PASSSED THE WRITTEN EXAMINATION BUT SATISFIES THE CONTINUOUS ASSESSMENT AND ATTENDANCE REQUIREMENT

LETTER OF ATTENDANCE

WHEN THE DELEGATE IS NOT MEETING ANY OF THE ABOVE BUT SATISFIES ATTENDANCE REQUIREMENT ONLY

Apr 2010 10

SECTION SECTION –– 11Introduction to QMSIntroduction to QMS

6

Apr 2010 11

Learning ObjectivesLearning Objectives

By the end of the session successful students will be able to :

• Explain the purpose and business benefits of a quality management system.

• Explain the 8 principles of quality management.• Explain the process approach to management systems.

Apr 2010 12

Purpose of QMS

Benefits to stake holders

Certification and

recognitionStreamlining the systems

Enhanced market

standing

Improvement in

performance

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Apr 2010 13

BENEFITS OF QUALITY MANAGEMENTBENEFITS OF QUALITY MANAGEMENT

CUSTOMER CONFIDENCE

CONSISTENCY IN QUALITY

REDUCTION IN WASTE AND REWORK

EMPLOYEE PARTICIPATION

REDUCTION IN LIABILITIES

IMPROVEMENT IN PROFIT

CONTINUAL IMPROVEMENT

Apr 2010 14

Activity on understanding Activity on understanding QMPsQMPsGroup exercise :Relate the following QMPS with organizations with the attribute most identifiable to them

Duration = 15 min.

Process Approach

Factual decision makingCustomer Focus

Continual improvement

Systems Approach

Supplier relationship

Involvement of people

Leadership

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Apr 2010 15

PRINCIPLES OF QUALITY PRINCIPLES OF QUALITY MANAGEMENTMANAGEMENT

TO LEAD AND OPERATE AN ORGANIZATION SUCCESSFULLY, IT IS NECESSARY TO DIRECT AND CONTROL IT IN A SYSTEMATIC AND TRANSPARENT MANNER

MANAGING AN ORGANIZATION ENCOMPASSES QUALITY MANAGEMENT AMONGST OTHER MANAGEMENT DISCIPLINES

EIGHT QUALITY MANAGEMENT PRINCIPLES HAVE BEEN IDENTIFIED AND THEY FORM THE BASIS OF ISO 9001 : 2008 STANDARD

Apr 2010 16


• QUALITY MANAGEMENT PRINCIPLE 1

• “CUSTOMER FOCUSED ORGANIZATION”

• ORGANIZATIONS DEPEND ON THEIR CUSTOMERS AND THEREFORE SHOULD UNDERSTAND CURRENT AND FUTURE CUSTOMER NEEDS, MEET CUSTOMER REQUIREMENTS AND STRIVE TO EXCEED CUSTOMER EXPECTATIONS.

QUALITY MANAGEMENT PRINCIPLE 2

“LEADERSHIP”

LEADERS ESTABLISH UNITY OF PURPOSE AND DIRECTION OF THE ORGANIZATION. THEY CREATE THE INTERNAL ENVIRONMENT IN WHICH PEOPLE CAN BECOME FULLY INVOLVED IN ACHIEVING THE ORGANIZATION’S OBJECTIVE

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Apr 2010 17


• QUALITY MANAGEMENTPRINCIPLE 3

• “INVOLVEMENT OF PEOPLE”

• PEOPLE OF ALL LEVELS ARE THE ESSENCE OF AN ORGANIZATION AND THEIR FULL INVOLVEMENT ENABLES THEIR ABILITIES TO BE USED FOR THE ORGANISATION’S BENEFIT

QUALITY MANAGEMENTPRINCIPLE 4

“PROCESS APPROACH”

A DESIRED RESULT IS ACHIEVED MORE EFFICIENTLY WHEN RELATED RESOURCES AND ACTIVITIES ARE MANAGED AS A PROCESS

Apr 2010 18



• “SYSTEM APPROACH TO MANAGEMENT”

• IDENTIFYING, UNDERSTANDING AND MANAGING A SYSTEM OF INTERRELATED PROCESSES FOR A GIVEN OBJECTIVE IMPROVES THE EFFECTIVENESS AND EFFICIENCY OF THE ORGANIZATION


“CONTINUAL IMPROVEMENT”

CONTINUAL IMPROVEMENT SHOULD BE A PERMANENT OBJECTIVE OF THE ORGANIZATION

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Apr 2010 19



• “FACTUAL APPROACH TO DECISION MAKING”

• EFFECTIVE DECISIONS ARE BASED ON THE ANALYSIS OF DATA AND INFORMATION


“MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIP”

AN ORGANISATION AND ITS SUPPLIERS ARE INTERDEPENDENT AND A MUTUALLY BENEFICIAL RELATIONSHIP ENHANCES THE ABILITY OF BOTH TO CREATE VALUE

Apr 2010 20

PDCA APPROACHPDCA APPROACH

CONCEPT INTRODUCED BY DR.SHEWHART IN EARLY 40’S

POPULARIZED BY DR. DEMING IN THE 1950’S

BECAME KNOWN AS DEMING CYCLE

PDCA STANDS FOR PLAN, DO, CHECK AND ACT

PDCA CYCLE CAN BE APPLIED AT ALL LEVELS WITHIN THE ORGANIZATION

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Apr 2010 21

PDCA CyclePDCA Cycle

PDCA cycle can be applied at all levels within the organization

Apr 2010 22

Activity on PDCAActivity on PDCAGroup exercise

• Apply Plan, Do, Check and Act on common activities like

• Making Tea

• Organizing a Picnic

• Home budgeting

• Reaching Place of work

Duration = 30 min.

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Apr 2010 23

PROCESS PROCESS

SET OF INTERRELATED OR INTERACTING ACTIVITIES WHICH TRANSFORM INPUTS INTO OUTPUTS (ISO 9000-2008)

OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTS INTO OTHER PROCESSES,

PROCESSES MAY BE INTERRELATED OR INDEPENDENT,

OVERALL AIM IS TO ADD VALUE BY PLANNING AND CONTROLLING PROCESSES

Apr 2010 24

BASIC PROCESS MODELBASIC PROCESS MODEL

DESIRED

OUTPUTS

(RESULTS)

CUSTOM ER

SATISFACTIO N

CONTROL / PROCEDURES

MANAG EM ENT

PROCESS ACTIVITIES

ENABLERS

CUSTOM ER

INPUT

MO NITO RING M EASUREM ENTS

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Apr 2010 25

PRODUCTPRODUCT

THE RESULT OF A PROCESS (ISO 9000-2008)

4 GENERIC PRODUCT CATEGORIES

HARDWARE

PROCESSED MATERIAL

SOFTWARE

SERVICE

MOST PRODUCTS ARE COMBINATION OF THESE

TANGIBLE PRODUCTS

Apr 2010 26

PROCESS APPROACHTHE APPLICATION OF A SYSTEM OF PROCESSES WITHIN AN ORGANIZATION, TOGETHER WITH THE IDENTIFICATION AND INTERACTIONS OF THESE PROCESSES AND THEIR MANAGEMENT, CAN BE REFERRED AS THE PROCESS APPROACH

PROCESSAN ACTIVITY USING RESOURCES, AND MANAGED IN ORDER TO ENABLE THE TRANSFORMATION OF INPUTS INTO OUTPUTS, CAN BE CONSIDERED AS A PROCESS. OFTEN, THE OUTPUT FROM ONE PROCESS DIRECTLY FORMS THE INPUT TO THE NEXT PROCESS

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Apr 2010 27

DOCUMENTING A PROCESS DOCUMENTING A PROCESS • DOCUMENTING A PROCESS INVOLVES :

• IDENTIFY THE PROCESS OWNER

• IDENTIFY INPUTS AND EXPECTED OUTPUTS / RESULTS

• DEFINE THE CHARACTERISTICS OF INPUTS AND OUTPUTS

• DEFINE THE BOUNDARIES OF THE PROCESS

• DETERMINE THE ACTIVITIES AND THE SEQUENCE

• IDENTIFY RESOURCES AND RESPONSIBILITIES

• DETERMINE THE CRITERIA AND METHODS TO ENSURE THE OPERATION AND CONTROL ARE EFFECTIVE (SOPs AND CHECKING POINTS)

• DETERMINE PROCESS PERFORMANCE MEASURES

Apr 2010 28

QMS PROCESSESQMS PROCESSES

QMS TYPICALLY INCLUDES PROCESSES FOR

MANAGEMENT ACTIVITIES

PROVISION OF RESOURCES

PRODUCT REALIZATION

MEASUREMENT

Processes are not restricted to production or service delivery activities only

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Apr 2010 29

• Actions on vendor related quality problem

• Improvement project with vendor

• Training needs of dept. Personnel & vendors

• Review of pending payments beyond agreed time

• Review incoming material go rate w.r.t. goal (item wise)

• Chronic vendor problems• Cost reduction achievement review• Status of inventory item wise &

reduction of prod. Lead Time. (item wise)

• Review of matl. With Material Requirement Planning % (MRP) delivery adherance

• Review inspection cycle time incoming (itemwise SRV)

P

A D

C

• Procure material as per required specs and at required date

• Improve quality of incoming material

• Improve turn over• Optimise inventory• Cost reduction• Timely payment of vendors

• Vendor selection and evaluation

• Cost reduction project allotment

• Procure products as per drgand tech specs.

• Periodic process audit and periodic Rating

• Processing of bill/invoice• Inventory management• Disposal of receipt rejection

PROCUREMENT PROCESSPROCUREMENT PROCESS

Apr 2010 30

EVALUATING A PROCESS WITHIN THE QMSEVALUATING A PROCESS WITHIN THE QMSINCLUDES AUDIT OF :

PROCESS INPUTS, OUTPUTS & RESULTSPROCESS MEASURES, LINKAGE WITH QUALITY OBJECTIVES & MEASURES FOR CONTINUAL IMPROVEMENT

THROUGH THE 4 BASIC QUESTIONSIS THE PROCESS IDENTIFIED & APPROPRIATELY DEFINED ?ARE RESPONSIBILITIES ASSIGNED ?ARE THE PROCEDURES IMPLEMENTED & MAINTAINED ?IS THE PROCESS EFFECTIVE IN ACHIEVING THE REQUIRED RESULTS?

PROCESSES MAY OR MAY NOT BE DEFINED BY DOCUMENTATION

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Apr 2010 31

Activity on understanding and documenting Activity on understanding and documenting Process ApproachProcess Approach

Team exercise

Identify the inter-linkages of a tutor given Process of an organization with the other relevant processes

Present on Flip Charts

Duration = 30 min.

Apr 2010 32

ProcurementProcess

Any other

process

Raw MaterialPlanningStorage

Production

Processes

Incoming

Inspection

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Apr 2010 33

SECTION SECTION –– 22

Apr 2010 34

Learning ObjectiveLearning Objective

• By the end of the session successful students will be able to :

Explain the purpose, content & inter-relationship of ISO 9000, ISO 9001 & ISO 9004

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Apr 2010 35

Session 2aPurpose, content & inter – relationship

of ISO 9000 family of Standards

Apr 2010 36

Activity on identifying the Purpose of Activity on identifying the Purpose of ISO 9000 Series of StandardsISO 9000 Series of Standards

• Read section 0.1 of ISO 9000:2005 of Pre-course reading material

• In your syndicate groups discuss and list down the purpose of ISO 9000 series of Standards for an organization

Duration = 20 min.

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Apr 2010 37

ISO 9000 FamilyISO 9000 Family

ISO 9000:2005 – Quality Management Systems - Fundamentals And Vocabulary

ISO 9001:2008 – Quality Management Systems - Requirements

ISO 9004:2009 – Managing for Sustained success of an organization – a quality management approach

ISO 19011 : 2002 – Guidelines On Quality And / Or Environmental Management Systems Auditing

Apr 2010 38

ISO 9004

ISO 9001

ISO 9004 PerspectiveWider focus on quality management than ISO 9001.Addresses the needs and expectations of all relevant Interested parties.Systematic and continual improvement of the organization's overall performance.

ISO 9001 PerspectiveQuality of product and customer satisfaction (effectiveness)

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Apr 2010 39

ISO 9001 & 9004 : Relationship diagramISO 9001 & 9004 : Relationship diagram

O

Apr 2010 40

Auditing Standards (Guidelines)Auditing Standards (Guidelines)

Guideline Standards originally published by ISOQuality Management

• ISO 10011-1:1990 Guidelines for auditing quality systems -- Part 1: Auditing

• ISO 10011-2:1991 Guidelines for auditing quality systems -- Part 2: Qualification criteria for quality systems auditors

• ISO 10011-3:1991 Guidelines for auditing quality systems -- Part 3: Management of audit programmes

Environmental Management

• ISO 14010:1996 Guidelines for environmental auditing -- General principles

• ISO 14011:1996 Guidelines for environmental auditing -- Audit procedures -- Auditing of environmental management systems

• ISO 14012:1996 Guidelines for environmental auditing -- Qualification criteria for environmental auditors

Now superseded by ISO 19011

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Apr 2010 41

ISO 19011:2002ISO 19011:2002

• Guidelines for Quality and/or Environmental Management Systems auditing

• Published in October 2002 jointly ISO/TC 176, Quality management and Quality Assurance and ISO/TC 207 Environmental Management

• Replaced ISO 10011-1:1990, ISO 10011-2:1991, ISO 10111-3:1991, ISO 14010:1996,14011:1996,ISO 14012:1996 and combined all aspects into generic guidelines

• The standard is intended to act as a guide to all auditors, including those who audit internally within their own organization.

• Can be applied to Management systems other than QMS and EMS

Apr 2010 42

ISO 9000 SERIES 19879001 9002 9003

α

EN29001 29002 29003

ISO 9000 SERIES 19949001 9002 9003

ISO 9001 : 2000

ISO 9000ISO 9004EN 29000EN 29004

ISO 9000-1, 9000-2ISO 9004-1, 9004-2, 9004-3

ISO 9000 : 2005ISO 9004 : 2009

(CONTRACTUAL) (NON-CONTRACTUAL)

NATIONALSTANDARDS

ISO 9001 : 2008

ISO 9004 : 2000

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Apr 2010 43

How is ISO Standard RevisedHow is ISO Standard RevisedInternational organization for standardization (ISO) is a federation of national standards bodiesISO works through technical committees. (TC–176 has the responsibility to issue and update ISO 9000 standards )TC – 176 is supported by Sub Committees and Working Groups (WG)The standard progresses from Preliminary Working Draft (PWD) Committee Draft (CD) Draft International Standard (DIS) Finalized Draft International Standard (FDIS) Published International StandardThe standard is published only after positive votes from members

Apr 2010 44

Activity on identifying differences between Auditable Activity on identifying differences between Auditable Standard (AS) & Guidance Documents (GD)Standard (AS) & Guidance Documents (GD)

Duration = 20 min.

ISO 19011

ISO 9004

ISO 9001

ISO 9000

Standard Why?AS/ GD

Identify the auditable standards & the guidance documents from the table

Discuss the rationale for this distinction in your syndicate group

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Apr 2010 45

Auditable Standards / Auditable Standards / Guidance DocumentsGuidance Documents

Auditable standard - ISO 9001:2008Requirements for a QMS as specified

Audits are carried out against the requirements of ISO 9001.

Guidance documentsISO 9000 - fundamentals & vocabulary

ISO 9004 - Managing for Sustained success of an organization – a quality management approach

“Notes” under requirement specified in ISO 9001 standard

ISO 9001:2008 Requirements

Apr 2010 46

Legal compliance Legal compliance vsvs conformance to ISO 9001(1)conformance to ISO 9001(1)

The statutory & regulatory requirements applicable to products, as specified by the controlling authorities are to be complied under all circumstances.

– Euro norms for the automobile vehicles

– Safety for medical equipments

– Intrinsically safe equipment in gas dangerous zone

– FDA regulations for food products & medicines

Exa

mpl

es

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Apr 2010 47

Voluntary decision

Vendor selection by

corporate

Market image & entry into new markets

Customer driven

Conformance to QMS

standard

Legal compliance Legal compliance vsvs conformance to ISO 9001(2)conformance to ISO 9001(2)

Apr 2010 48

Session 2bQMS Terminology

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Apr 2010 49

Activity on vocabularyActivity on vocabulary

• Match the key phrases of the definitions with the vocabulary in the table provided within your respective teams

• List your points of doubt on the flip charts

Duration = 30 min.

Apr 2010 50

Terminology Definition

U. The fulfillment of a requirement

T. Part of quality management, focused on setting quality objectives and specifying necessary operational process and related resources to fulfill the quality objectives

S. Part of quality management focused on Fulfilling quality requirementsR. The non – fulfillment of a requirement, related to an intended or specified useQ. Customer’s perception ……customer’s requirements have been fulfilledP. Relationship between the result achieved and resources usedO. Category or rank given …. having the same functional useN. Overall intentions and direction of an organization…….M. Part of quality management focused on providing confidence …...

L. Document stating results achieved or providing evidence ……K. The non – fulfillment of a requirement

J. Co-ordinated activities to direct and control an Organization ……I. Management system to direct and control an organization …. H. Extent to which planned activities are realized and planned results achieved

G. Document specifying .. procedure and associated resources …… a specific project, product, process or contract

F. ……… aimed for, related to qualityE. …..inherent characteristics fulfills requirements D. Document specifying the quality management system of an organizationC. ……. who directs and controls an organization, at the highest levelB. ………….. increasing the ability to fulfill quality requirementsA. Information and its supporting medium

21. Efficiency

20. Effectiveness19. Record18. Quality Manual17. Quality Plan16. Document15. Defect14. Non – Conformity13. Conformity

12. Quality Management Systems

11. Quality Improvement10. Quality Planning9. Quality Assurance8. Quality Control

7. Quality Management6. Top Management5. Quality Objectives4. Quality Policy3. Customer Satisfaction

2. Grade1. Quality

Definition

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Apr 2010 51

CUSTOMER SATISFACTIONCUSTOMER’S PERCEPTION OF THE DEGREE TO WHICH

THE CUSTOMER’S REQUIREMENTS HAVE BEEN FULFILLED

GRADECATEGORY OR RANK GIVEN TO DIFFERENT QUALITY

REQUIREMENTS FOR PRODUCTS, PROCESSES OR SYSTEMS HAVING THE SAME FUNCTIONAL USE

QUALITYDEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS

FULFILLS REQUIREMENTS

Apr 2010 52

QUALITY POLICYOVERALL INTENTIONS AND DIRECTION OF AN ORGANIZATION

RELATED TO QUALITY, AS FORMALLY EXPRESSED BY TOP MANAGEMENT

QUALITY OBJECTIVESSOMETHING SOUGHT OR AIMED FOR, RELATED TO QUALITY

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Apr 2010 53

TOP MANAGEMENTTOP MANAGEMENT

PERSON OR GROUP OF PEOPLE WHO DIRECTS AND CONTROLS AN ORGANIZATION,

AT THE HIGHEST LEVEL

Apr 2010 54

QUALITY ASSURANCEPART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING

CONFIDENCE THAT QUALITY REQUIREMENTS WILL BE FULFILLED

QUALITY CONTROLPART OF QUALITY MANAGEMENT FOCUSED ON

FULFILLING QUALITY REQUIREMENTS

QUALITY MANAGEMENTCO-ORDINATED ACTIVITIES TO DIRECT AND CONTROL AN

ORGANIZATION WITH REGARD TO QUALITY

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Apr 2010 55

QUALITY PLANNING

PART OF QUALITY MANAGEMENT, FOCUSED ON SETTING QUALITY OBJECTIVES AND SPECIFYING NECESSARY

OPERATIONAL PROCESS AND RELATED RESOURCES TO FULFILL THE QUALITY OBJECTIVES

QUALITY IMPROVEMENT

PART OF QUALITY MANAGEMENT, FOCUSED ON INCREASING THE ABILITY TO FULFIL QUALITY REQUIREMENTS

Apr 2010 56

QUALITY MANAGEMENT SYSTEMSQUALITY MANAGEMENT SYSTEMS

MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN

ORGANIZATION WITH REGARD TO QUALITY

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Apr 2010 57

CONFORMITYTHE FULFILLMENT OF A REQUIREMENT

DEFECTTHE NON – FULFILLMENT OF A REQUIREMENT, RELATED TO AN

INTENDED OR SPECIFIED USE

NON – CONFORMITYTHE NON – FULFILLMENT OF A REQUIREMENT

Apr 2010 58

DOCUMENTINFORMATION AND ITS SUPPORTING MEDIUM

RECORDDOCUMENT STATING RESULTS ACHIEVED OR PROVIDING EVIDENCE

OF ACTIVITIES PERFORMED

QUALITY MANUALDOCUMENT SPECIFYING THE QUALITY MANAGEMENT SYSTEM OF AN

ORGANIZATION

QUALITY PLANDOCUMENT SPECIFYING WHICH PROCEDURE AND ASSOCIATED

RESOURCES SHALL BE APPLIED BY WHOM AND WHEN TO A SPECIFIC PROJECT, PRODUCT, PROCESS OR CONTRACT

30

Apr 2010 59

EFFECTIVENESS

EXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED AND PLANNED RESULTS ACHIEVED

EFFICIENCY

RELATIONSHIP BETWEEN THE RESULT ACHIEVED AND RESOURCES USED

Apr 2010 60

Session 2cISO 9001: 2008 QMS Requirements

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Apr 2010 61

Customers

Requirements

Satisfaction

Customers

Continual improvement ofthe quality management system

Managementresponsibility

Product Realization

Resourcemanagement

Measurement,analysis and improvement

ProductInput Output

Value adding activities

Information flow

Apr 2010 62

1. Scope and general2. Normative references3. Terms & definitions4. Quality management system5. Management responsibility6. Resource management7. Product realization8. Measurement, analysis and improvement

Clauses

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Apr 2010 63

Scope of ISO 9001Scope of ISO 9001General

This international standard specifies requirements for a qualitymanagement system where an organization

Needs to demonstrate its ability to consistently provide productthat meets customer and applicable statutory & regulatory requirements, andAims to enhance customer satisfaction through the application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory & regulatory requirements.

Note : 1a in this international standard, the term “product” applies only to the product intended for, or required by, a customer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Apr 2010 64

Scope of ISO 9001Scope of ISO 9001Application

All requirements of this international standard are generic and are intended to be applicable to all organizations regardless of type, size and the product provided

Where any requirements of the standard cannot be applied due to the nature of an organization and its products, this can be considered for exclusion.

Exclusions are limited to requirements stated in clause 7.

Permissible exclusions are those that do not affect the organization’s ability or responsibility to provide product that meets customer and applicable statutory & regulatory requirements

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Apr 2010 65

Justification of ExclusionsJustification of ExclusionsWhen an organization limits the application of the requirements of the ISO 9001: 2008, this must be detailed and justified in the organization’s quality manual.

This must also be clear in any other publicly available document, such as certification/registration document or marketing material

Apr 2010 66

Most Likely ExclusionsMost Likely ExclusionsWithin clause 7 (product realization), the following are the most likely requirements, though not the only ones.

7.5.3 Identification &

traceability(traceability may

not be applicable)

7.5.4 Customer property

7.6 Control of monitoring

& measuring devices.

7.3 Design & development Most Likely

Exclusions

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Apr 2010 67

Scope of AuditScope of Audit

• Extent and Boundaries

Product

Physical location

Organizational units

Activities/ Processes

Apr 2010 68

Activity on Understanding ISO 9001 Activity on Understanding ISO 9001 RequirementsRequirements

• Refer to E01 of Work Book & Case Study

Total Duration = 90 min.

Individual Work = 30 min; Group Work= 30 min; Feedback from Exercise = 30 min

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Apr 2010 69

4.0 Quality 4.0 Quality Management SystemManagement System

4.1 General Requirements

4.2 Documentation Requirement

4.2.1 General

4.2.2 Quality Manual

4.2.3 Control of Documents

4.2.4 Control of Records

Apr 2010 70

4.1 General Requirements 4.1 General Requirements Organization shall establish, document, implement, maintain and continually improve the effectiveness of a quality management system. The organization shall:

a. Determine the processes needed for quality management systems, and its application.b. Determine the sequence and interaction of these processes.c. Determine criteria and methods needed to ensure that both the operation and control of

these processes are effective.d. Ensure the availability of resources and information necessary to support these

processes.e. Monitor, measure where applicable and analyze these processes.f. Implement actions necessary to achieve planned results and continual improvements of

these processes. These processes shall be managed by the organization in accordance with the requirements of this international standard.Where an organization chooses to outsource any process, then control the outsourced processes.

Note : processes needed for the quality management systems referred to above, should include processes for management activities, provision of resources, product realization and measurement analysis & improvement

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Apr 2010 71

5.0 Management Responsibility5.0 Management Responsibility

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, Authority And Communication

5.6 Management Review

Apr 2010 72

6.0 Resource Management6.0 Resource Management

6.1 Provision of Resources

6.2 Human Resources

6.3 Infrastructure

6.4 Work Environment

Work Environment

Training

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Apr 2010 73

7.0 Product Realization7.0 Product Realization

7.1 Planning of Product Realization7.2 Customer – Related Processes7.3 Design And Development7.4 Purchasing7.5 Production & Service Provision7.6 Control of Monitoring & Measuring Devices

Apr 2010 74

7.5 Production & 7.5 Production & Service ProvisionService Provision

7.5.1 Control of Production & Service Provision

7.5.2 Validation of Processes For Production & Service Provision

7.5.3 Identification & Traceability

7.5.4 Customer Property

7.5.5 Preservation of Product

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Apr 2010 75

8.0 Measurement, Analysis 8.0 Measurement, Analysis & Improvement& Improvement

8.1 General

8.2 Monitoring & Measurement

8.3 Control of Nonconforming Product

8.4 Analysis of Data

8.5 Improvement

Apr 2010 76

8.2 Monitoring & Measurement8.2 Monitoring & Measurement

8.2.1 Customer Satisfaction

8.2.2 Internal Audit

8.2.3 Monitoring & Measurement of Processes

8.2.4 Monitoring & Measurement of Product

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Apr 2010 77

Activity on identifying relationship between Quality Activity on identifying relationship between Quality Management Principles (Management Principles (QMPsQMPs) & ISO 9001) & ISO 9001

• In your syndicate groups identify the allocated QMPs to the relevant clauses & sub clauses and list down in the flip chart

Total Duration = 60 min.

Apr 2010 78

RELATIONSHIP BETWEEN THE QMPs AND ISO 9001 ISO 9001 Clauses P1 P2 P3 P4 P5 P6 P7 P8 4.1

4.2 5.1 5.2 5.3 5.4.1 5.4.2 5.5.1 5.5.2 5.5.3 5.6 6.1 6.2 6.3 6.4 7.1 7.2 7.3 7.4 7.5 7.5.4 7.6 8.1 8.2.1 8.2.3 8.2.4 8.3 8.4 8.5.1 8.5.2 8.5.3

The above relationship are indicative - not exhaustive LEGEND P1 Customer Focus P5 System Approach P2 Leadership P6 Continual Improvement P3 People Involvement P7 Fact Based Approach P4 Process approach P8 Supplier Relationship

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Apr 2010 79

Session 2dDocumentation for QMS

Apr 2010 80

Documentation Documentation RequirementsRequirements

ISO 9001: 2008 requires

• Documented statements of quality policy and quality objectives.

• A quality manual.

• Documented procedures & records required by the standard.

• Documents needed by the organization to ensure effective planning, operation and control of its processes.

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Apr 2010 81

Activity on DocumentationActivity on Documentation• Read through 4.2.1 of ISO 9001:2008

in your syndicate groups

• What differences would you expect to see in the documentation of

A large scale industry

A small scale industry

• What in your opinion are the reasons for these differences ?

• Tutor lead discussion

Duration 10 mins

Apr 2010 82

Areas of differencesAreas of differences• Degree of Formality

ContentNumberIssue procedures

• Hierarchy of documents• Document numbering system• Style of presentation• Medium• Distribution of responsibilities

for document approval

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Apr 2010 83

Typical Quality Management System Typical Quality Management System Documentation HierarchyDocumentation Hierarchy

Source: lS/lSO/TR 10013:2001

Apr 2010 84

AA TypicalTypical Quality ManualQuality Manual


1. Title and scope2. Table of contents3. Review, approval and revision4. Quality policy and objectives5. Organization, responsibility and authority6. References7. Quality management system description8. Appendices

QualityManual

43

Apr 2010 85

Structure of a typical Documented procedureStructure of a typical Documented procedure


• Text• Flow charts,• Tables• A combination of the

above,• Or any other suitable

method

Apr 2010 86

Content of a typical Documented procedureContent of a typical Documented procedure


• Title• Purpose• Scope• Responsibility and authority• Description of activities• Records• Appendices• Review, approval and revision• Identification of changes

•Xmxmxmx mxm xmmxmm

mmxmxm m

•Xm mxmmxm xmmxm mm

•Xmmmxmxmmmxmmmxm mmxm

mmxmm•

X,xmxm mmxmxm mmxmm

xmmmxm mm

•Xm mxm xmxmxm xmmm mxm m

•Xm mxm xmxmxmxm mx

44

Apr 2010 87

Work InstructionsWork Instructions


• The structure, format and level of detail used in the work instructions should be tailored to the needs of the organization’s personnel and depends on the complexity of the work

Apr 2010 88

Value of DocumentationValue of Documentation

Enables communication of intent and consistency of actionDefinition of roles for membersEnhancement of understandingControl and measurementSystem becomes auditableEvaluation of the effectiveness and continuing suitability of QMSInformation useful for training and competence buildingProvides confidence in the QMSHelps in continual improvementProvides repeatability and traceability

45

Apr 2010 89

SECTION SECTION –– 33Auditing QMSAuditing QMS

Section Section –– 33• LEARNING OBJECTIVES:• By the end of the section, successful students will be able to

:

Understand the Audit process

Explain the role of auditor to plan, conduct, report and follow up a QMS audit in accordance with ISO 19011

Understand audit responsibilities

Develop the skills required to plan, prepare, conduct and report on audits

Understand the certification / registration and accreditation processes

IRCA / NABET Schemes for Auditor certification

46

SessionsAccreditation certificate and auditor certification (3 a)Role of IRCA / NRBPT and Auditor certification (3 b)Introduction to Auditing (3 c)Auditor responsibilities (3 d)Audit Programmes (3 e)Planning of Audits (3 f)

Checklists (3 g)Conducting Audits

Opening meeting (3 h)Onsite auditing and audit skills (3 i)Closing meeting (3 j)

Audit reporting (3 k)Audit follow up (3 l)

Section Section –– 33

Apr 2010 92

Learning Objective Learning Objective –– Session 3Session 3

• By the end of the session, successful students will be able to :

Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011.

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Apr 2010 93

CERTIFICATION AND ACCREDITATION

CERTIFICATION

ACCREDITATION

REGISTRATION SCHEME FOR LEAD AUDITORS / AUDITORS

PRINCIPLES OF AUDITING

CONFIDENTIALITY

CONFLICT OF INTEREST

SESSION 3a

Apr 2010 94

AUDIT AND SURVEILLANCE BY ACCREDITATION BOARD

APPLICATION FOR ACCREDITATION

CERTIFICATION BODY (CB)

APPLICATION FOR CERTIFICATION

ORGANIZATION

AUDIT AND SURVEILLANCE BY CB

ACCREDITATION BOARD

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Apr 2010 95

CONFORMITY ASSESSMENT IN UKCONFORMITY ASSESSMENT IN UK

DTI : DEPARTMENT OF TRADE AND INDUSTRY

NAMAS : NATIONAL MEASUREMENT ACCREDITATION SCHEME

UKAS : UNITED KINGDOM ACCREDITATION SERVICES

IRCA : INTERNATIONAL REGISTER OF CERTIFICATED AUDITORS

CQI : CHARTERED QUALITY INSTITUTE

DTI

IRCA/CQIUKAS

NAMAS LABORATORY

ACCREDITATION

QUALITY MANAGEMENT SYSTEM CERTIFICATION

BODIES

TRAINING COURSES

REGISTRATION

AUDITOR

LEAD AUDITOR

PRINCIPAL AUDITOR

PROVISIONAL AUDITOR

INTERNAL AUDITOR

Apr 2010 96

CONFORMITY ASSESSMENT IN INDIACONFORMITY ASSESSMENT IN INDIAQuality Council of India

Secretariat

NABCB

National Accreditation

Board for Certification

Bodies

NABET


Board for Education &

Training

NABL

National Accreditation Board

for Testing & Calibration

Laboratories

NBQP

National Board for Quality Promotion

QIES

Quality Information & Enquiry Services

NABH


Board for Hospitals & Health

services

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Apr 2010 97

ACCREDITATIONACCREDITATION

ACCREDITATION OFFERS ASSURANCE TO THE CERTIFICATION PROCESS

REFERENCE STANDARD FOR ACCREDITATION EN 45012 / ISO 17021

Apr 2010 98

CERTIFICATIONCERTIFICATION

• CREDIBILITY OF QUALITY SYSTEM CERTIFICATION DEPENDS ON

IMPARTIALITY

WELL DEFINED SCOPE

MAINTENANCE OF THE CERTIFICATE

COMPETENCE OF THE AUDITORS

CONSISTENCY OF APPROACH

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Apr 2010 99

BENEFITS OF A CERTIFIED QMSBENEFITS OF A CERTIFIED QMS

• CUSTOMER CONFIDENCE

• ENHANCED CREDIBILITY

• NATIONAL AND INTERNAL RECOGNITION

• ACCEPTANCE IN GLOBAL MARKET

• FACILITY OF INDEPENDENT EVALUATION AND FEEDBACK

• REDUCES NEED FOR MULTIPLE AGENCY / MULTIPLE PURCHASER EVALUATION

Apr 2010 100

ROLE OF IRCA / NABET

AND

AUDITOR CERTIFICATION REQUIREMENTS

SESSION 3b

51

Apr 2010 101

INTERNATIONAL REGISTRATION SCHEME FOR INTERNATIONAL REGISTRATION SCHEME FOR AUDITORS OF QUALITY SYSTEMAUDITORS OF QUALITY SYSTEM

THE BEST KNOWN & WIDELY USED METHOD TO DEMONSTRATE AUDITOR COMPETENCE

INTERNATIONAL AUDITOR AND PERSONNEL CERTIFICATION ASSOCIATION (IPC)

IRCA (UK,) EARA(UK), NABET (INDIA), RAB (USA) ARE MEMBERS OF IPC

AUDITOR REGISTRATION IS CARRIED OUT BY SELECT MEMBERS OF IPC

Apr 2010 102

REGISTRATION AS AUDITOR / REGISTRATION AS AUDITOR / LEAD AUDITORLEAD AUDITOR

DEPENDS UPON

EDUCATIONAL QUALIFICATION

WORK EXPERIENCE

AUDIT EXPERIENCE

40 HOURS OF AUDITORS TRAINING

AUDITOR COMPETENCE

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Apr 2010 103

COMPETENCE AND EVALUATION OF AUDITORS

A COMPETENT AUDITOR

GENERIC KNOWLEDGE & SKILLS

SPECIFIC KNOWLEDGE & SKILLS

EDUCATION, WORK EXPERIENCE, TRAINING & AUDIT EXPERIENCE

AUDITOR EVALUATION

Apr 2010 104

A COMPETENT AUDITORA COMPETENT AUDITOR

DEMONSTRATES PERSONAL ATTRIBUTES

DEMONSTRATES ABILITY TO APPLY THE KNOWLEDGE & SKILLS TO CONDUCT SUCCESSFUL AUDITS & ACHIEVE THE AUDIT OBJECTIVES

GAINS COMPETENCE THROUGH

EDUCATION

WORK EXPERIENCE

AUDIT TRAINING

AUDIT EXPERIENCE

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Apr 2010 105

PERSONAL ATTRIBUTESPERSONAL ATTRIBUTES

ETHICAL

OPEN-MINDED

DIPLOMATIC

OBSERVANT

PERCEPTIVE

VERSATILE

TENACIOUS

DECISIVE

SELF RELIANT

Apr 2010 106

GENERIC KNOWLEDGE & SKILLS GENERIC KNOWLEDGE & SKILLS FOR AUDITORSFOR AUDITORS

AUDIT PRINCIPLES, PROCEDURES & TECHNIQUES

MANAGEMENT SYSTEM & REFERENCE DOCUMENTS

ORGANIZATIONAL SITUATIONS

APPLICABLE LAWS, REGULATIONS & OTHER REQUIREMENTS

Ref : ISO 19011: 2002 Section 7.3.1

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Apr 2010 107

SPECIFIC KNOWLEDGE & SKILLS SPECIFIC KNOWLEDGE & SKILLS FOR QMS AUDITORSFOR QMS AUDITORS

QUALITY RELATED METHODS AND TECHNIQUES

QUALITY TERMINOLOGY

QUALITY MANAGEMENT PRINCIPLES & THEIR APPLICATION

QUALITY MANAGEMENT TOOLS

PROCESSES AND PRODUCTS INCLUDING SERVICES

SECTOR SPECIFIC TERMINOLOGY

TECHNICAL CHARACTERISTICS OF PROCESSES & PRODUCTS

Ref : ISO 19011: 2002 Section 7.3.3

Apr 2010 108

GENERIC KNOWLEDGE & SKILLS GENERIC KNOWLEDGE & SKILLS OF LEAD AUDITORSOF LEAD AUDITORS

ABILITY TO

PLAN THE AUDIT & MAKE EFFECTIVE USE OF RESOURCES

REPRESENT THE AUDIT TEAM

ORGANIZE & DIRECT THE TEAM

DIRECT & GUIDE AUDITORS IN TRAINING

LEAD AUDIT TEAM TO REACH AUDIT CONCLUSIONS

PREVENT / RESOLVE CONFLICTS

PREPARE AUDIT REPORT

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Apr 2010 109

EDUCATION, WORK EXPERIENCE, TRAINING EDUCATION, WORK EXPERIENCE, TRAINING AND AUDIT EXPERIENCE OF AUDITORSAND AUDIT EXPERIENCE OF AUDITORS

EDUCATION TO PROVIDE GENERIC & SPECIFIC KNOWLEDGE & SKILLS

WORK EXPERIENCE TO CONTRIBUTE TO THE DEVELOPMENT OF KNOWLEDGE & SKILLS IN QUALITY MANAGEMENT FIELD

COMPLETION OF AUDITOR TRAINING

AUDIT EXPERIENCE UNDER THE GUIDANCE OF A COMPETENT LEAD AUDITOR

Apr 2010 110

EDUCATION, WORK EXPERIENCE, TRAINING EDUCATION, WORK EXPERIENCE, TRAINING AND AUDIT EXPERIENCE OF LEAD AUDITORSAND AUDIT EXPERIENCE OF LEAD AUDITORS

SHOULD HAVE ACQUIRED ADDITIONAL AUDIT EXPERIENCE TO DEVELOP THE REQUIRED KNOWLEDGE AND SKILLS

THE ADDITIONAL EXPERIENCE IS FROM ACTING IN THE ROLE OF AN AUDIT TEAM LEADER UNDER THE GUIDANCE OF ANOTHER COMPETENT AUDIT TEAM LEADER

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Apr 2010 111

LEVELS OF EDUCATION, WORK EXPERIENCE, LEVELS OF EDUCATION, WORK EXPERIENCE, AUDITOR TRAINING & AUDIT EXPERIENCEAUDITOR TRAINING & AUDIT EXPERIENCE

APPROPRIATE FOR AUDITORS CONDUCTING CERTIFICATION OR SIMILAR AUDITS.

HIGHER OR LOWER LEVELS ARE APPROPRIATE DEPENDING ON THE AUDIT PROGRAMME

Ref TABLE 1 of ISO 19011

Apr 2010 112

Table 1 Table 1 –– Example of levels of education, work experience, auditor trainiExample of levels of education, work experience, auditor training and ng and audit experience for auditors conducting certification or similaaudit experience for auditors conducting certification or similar auditsr audits

Three complete audits for a total of at least 15 days of audit experience acting in the role of an audit team leader under the direction & guidance of an auditor competent as an audit team leader.

Three complete audits for a total of at least 15 days of audit experience in the 2nd

discipline under the direction & guidance of an auditor competent as an audit leader in the 2nd discipline .The audits should be completed within the last two consecutive years.

Four complete audits for a total of at least 20 days of audit experience as an auditor– in- training under the direction & guidance of an auditor competent as an audit team leaderThe audits should be completed within the last 3 consecutive years

Audit experience

Same as for Auditor24 h. of training in the 2nd

discipline40 h. of Audit trainingAuditor training

Same as for Auditor2 years in the second discipline

At least 2 years of the total 5 years

Work experience in quality or environmental management field

Same as for AuditorSame as for Auditor5 yearsTotal work experience

Same as for AuditorSame as for AuditorSecondary education Education

Audit team leader

Auditor in both disciplinesAuditorParameter

(Contd..)

O

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Apr 2010 113

MAINTENANCE & IMPROVEMENT OF MAINTENANCE & IMPROVEMENT OF COMPETENCE OF AUDITORCOMPETENCE OF AUDITOR

CONTINUAL PROFESSIONAL DEVELOPMENT

MAINTENANCE OF AUDITING ABILITY

Apr 2010 114

AUDITOR COMPETENCE EVALUATIONAUDITOR COMPETENCE EVALUATION

INITIAL EVALUATION OF AUDITORS WHO WISH TO BECOME AUDITORS

AS PART OF THE AUDIT TEAM SELECTION PROCESS

CONTINUAL EVALUATION OF AUDITOR PERFORMANCE TO IDENTIFY NEEDS FOR MAINTENANCE & IMPROVEMENT OF KNOWLEDGE & SKILLS

O

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Apr 2010 115

RELATIONSHIP BETWEEN THE STAGES OF EVALUATIONRELATIONSHIP BETWEEN THE STAGES OF EVALUATION

Development of Competence

Initial Evaluation

Auditor

Auditing

Audit Team Selection

Maintenance & Improvement of

Competence

Criteria not metCriteria met

Criteria met

Not Selected

Continual Evaluation of Performance

Criteria not met

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Apr 2010 116

COMPETENCE EVALUATION PROCESSCOMPETENCE EVALUATION PROCESS

IDENTIFY PERSONAL ATTRIBUTES, KNOWLEDGE & SKILLS

SET EVALUATION CRITERIA (WORK EXPERIENCE, EDUCATION, NUMBER OF AUDITS, HOURS OF AUDIT TRAINING)

SELECT APPROPRIATE EVALUATION METHODS (REVIEW OF RECORDS, FEEDBACK, INTERVIEW, OBSERVATION, TESTING, POST AUDIT REVIEW)

CONDUCT EVALUATION

O

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Apr 2010 117

CONFLICT OF INTEREST CONFLICT OF INTEREST

AUDITORS SHOULD ENSURE THAT THERE IS NO CONFLICT OF INTEREST DURING THE AUDIT.

CONFLICT OF INTEREST CAN OCCUR IF AN AUDITOR IS AN INTERESTED PARTY OF THE ORGANIZATION.

CONFLICT OF INTEREST CAN ALSO OCCUR IF AUDITOR OR HIS ORGANIZATION HAS PROVIDED ADVICE, GUIDANCE OR CONSULTANCY DURING THE RECENT PAST TO THE AUDITEE ORGANIZATION.

Apr 2010 118

WITNESSING OF AUDITORSWITNESSING OF AUDITORSCOVERAGE OF THE STANDARD

KEEPING TO THE PROGRAMME

KNOWLEDGE OF THE CLIENT’S QUALITY SYSTEM

RELEVANCE OF AUDITOR’S EXPERIENCE

QUESTIONING SKILLS

PROCESS OF SAMPLE SELECTION

HANDLING UNFORESEEN OR DIFFICULT SITUATIONS

RAISING NCRs

NUMBER OF COMPANY STAFF INTERVIEWED

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Apr 2010 119

INTRODUCTION TO AUDITING

WHY AND WHAT OF AUDITS

AUDIT TERMINOLOGY

TYPES OF AUDITS

STAGES OF AUDITS

PROCESS APPROACH TO AUDITS

SESSION 3c

Apr 2010 120

WHY AUDIT?WHY AUDIT?• TO DETERMINE THE HEALTH OF THE UNIT

• TO CHECK COMPLIANCE TO A STANDARD AND / OR CONTRACTUAL REQUIREMENTS

• TO DETERMINE THE EFFECTIVENESS OF THE QUALITY SYSTEM

• TO IDENTIFY AND PRIORITISE AREAS FOR IMPROVEMENT

• TO ASSESS AN EXISTING OR A POTENTIAL SUPPLIER

• TO CHECK READINESS FOR CERTIFICATION

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Apr 2010 121

PRINCIPLES OF PRINCIPLES OF AUDITINGAUDITING

ETHICAL CONDUCT (TRUST, INTEGRITY, CONFIDENTIALITY, DISCRETION)

FAIR PRESENTATION (TRUTHFUL & ACCURATE REPORTING)

DUE PROFESSIONAL CARE (DILIGENCE & JUDGMENT IN AUDITING)

INDEPENDENCE (INDEPENDENT, FREE FORM BIAS & CONFLICT OF INTEREST OBJECTIVES)

EVIDENCE BASED APPROACH (RELIABLE & REPRODUCIBLE AUDIT CONCLUSIONS BASED ON VERIFIABLE EVIDENCE & APPROPRIATE SAMPLING)

Apr 2010 122

AUDITSYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR

OBTAINING AUDIT EVIDENCE AND EVALUATING IT OBJECTIVELY TO DETERMINE THE EXTENT TO WHICH AUDIT

CRITERIA ARE FULFILLED

AUDIT EVIDENCERECORDS, STATEMENTS OF FACT OR

OTHER INFORMATION WHICH ARE RELEVANT TO THE AUDIT CRITERIA AND VERIFIABLE.

AUDIT CRITERIASET OF POLICIES, PROCEDURES OR REQUIREMENTS,

USED AS REFERENCE

AUDIT TERMINOLOGYAUDIT TERMINOLOGY

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Apr 2010 123

AUDIT FINDINGS

RESULTS OF THE EVALUATION OF COLLECTED AUDIT EVIDENCE AGAINST AUDIT CRITERIA

AUDIT CONCLUSIONOUTCOME OF AN AUDIT PROVIDED BY THE AUDIT

TEAM AFTER CONSIDERATION OF THE AUDIT OBJECTIVES & ALL AUDIT FINDINGS

Apr 2010 124

AUDIT PROGRAMMESET OF ONE OR MORE AUDIT PLANNED FOR A

SPECIFIC TIME FRAME & DIRECTED TOWARDS A SPECIFIC PURPOSE

AUDIT PLANDESCRIPTION OF THE ACTIVITIES &

ARRANGEMENTS FOR AN AUDIT

AUDIT SCOPEEXTENT & BOUNDARIES OF AN AUDIT

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Apr 2010 125

TYPES OF AUDITTYPES OF AUDIT

• INTERNAL AUDITSFIRST PARTY AUDIT

AN AUDIT PERFORMED WITHIN AN ORGANIZATION BY THE ORGANIZATION’S OWN AUDITING RESOURCES.

• EXTERNAL AUDITSECOND PARTY AUDIT

AN AUDIT OF CONTRACTORS / SUPPLIERS UNDERTAKEN BY OR ON BEHALF OF A PURCHASING ORGANIZATION. THIS MAY INCLUDE THE AUDIT OF COMPANIES OR DIVISIONS SUPPLYING GOODS OR SERVICES TO OTHERS WITHIN THE SAME GROUP. (ALSO REFERRED TO AS SUPPLIER AUDIT)

THIRD PARTY AUDITAN AUDIT OF AN ORGANIZATION PERFORMED BY A BODY THAT IS INDEPENDENT OF THE ORGANIZATION BEING AUDITED CERTIFICATION BODY OR REGISTRAR.)

Apr 2010 126

Auditor roles• Common

To conduct audit in a professional and unbaised manner Finding evidence against defined criteriaDetermining effectiveness of processes and systems

• VaryingFirst party –to determine opportunities for improvements

Can give suggestions in the reportsSecond party –to determine capability of auditee’s systems to supply products / services

Can mutually agree on improvements specific to contractThird Party –to determine capability to meet and enhance satisfaction of all customers

First, Second and Third party auditsFirst, Second and Third party audits

O

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Apr 2010 127

Auditee roles• Common

To provide for time and resources for the audit to be conducted• Varying Objectives

First party To develop internal audit criteria and ensure its implementationTo plan and schedule audits based on importance of activitiesTo provide competent and independent internal auditorsTo take follow up actions on internal audit reports and review findings in management review

Second and third partyTo agree on audit dates, audit plans and auditorsTo provide guides during auditsTo agree on improvement actions if non conformances are raisedTo take follow up actions and report to audit client

First, Second and Third party auditsFirst, Second and Third party audits

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Apr 2010 128

First, Second and Third party auditsFirst, Second and Third party auditsAudit Client roleCommon

To establish and inform to auditee and auditorsAudit criteria which may include statutory / regulatory requirementsExpectations from auditsAudit procedure and manner of reporting

• VaryingFirst party – Top Management is Audit Client

To review audit findings during management review and take decisions for improvementsSecond party

To inform auditee of any contract specific audit criteriaTo receive a specific evaluation report from the audit team in respect of the terms of contract and / or regulatory requirements To base business decisions on the report findings

Third Party –To receive a report from the audit team with recommendations To inform decisions on certification or approval as relevant

O

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Apr 2010 129

INITIATING THE AUDIT

STAGE 1 AUDIT

STAGE 2 AUDIT

ONSITE AUDIT ACTIVITIES

REPORTING ON THE AUDIT

AUDIT COMPLETION

AUDIT FOLLOW UP

STAGES OF AUDITSTAGES OF AUDIT

Apr 2010 130

STAGE 1 AUDITSTAGE 1 AUDIT

The stage 1 audit shall be performed• to audit the client's management system documentation• to evaluate the client's location and site-specific conditions • to determine the preparedness for the stage 2 audit;• to review the client's status and understanding regarding

requirements of the standard, • to collect necessary information regarding the scope, processes and

location(s) of the client, and related statutory and regulatory aspects • to review and agree with the client the allocation of resources for

stage 2 audit • to evaluate if the internal audits and management review are being

planned and performed,• to estimate the client is ready for the stage 2 audit.

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Apr 2010 131

STAGE 2 AUDITSTAGE 2 AUDIT

To evaluate on site, the implementation, including effectiveness, of the client's management system which includes

• evidence about conformity to all requirements of ISO 9001• performance monitoring, measuring, reporting and reviewing against

key quality objectives and• targets• compliance to regulatory requirements related to product• operational control of the client's processes;• internal auditing and management review;• management responsibility• links among all of the above

Apr 2010 132

TYPICAL STAGES OF AUDIT TYPICAL STAGES OF AUDIT I. DOCUMENTATION REVIEW

REVIEW OF RELEVANT MANAGEMENT SYSTEM DOCUMENTS AND RECORDS, IF REQUIRED, AND DETERMINATION OF THEIR ADEQUACY

II. VERIFICATION OF PREPAREDENESS OF AUDITEE (OFF SITE + ON SITE)

III.ON-SITE AUDIT

CONDUCTING OPENING MEETINGCOLLECTING AND VERIFYING INFORMATION(COLLECTING AUDIT EVIDENCE)IDENTIFYING AUDIT FINDINGSCOMMUNICATION DURING THE AUDITAUDIT CONCLUSIONSPREPARATION FOR CLOSING MEETINGCONDUCTING CLOSING MEETING

STAGE1

STAGE2

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Apr 2010 133

AUDITING QMS DOCUMENTATIONAUDITING QMS DOCUMENTATION

USE CHECK LIST / MATRIX.

CAN BE DONE OFF-SITE BUT ON-SITE REVIEW PREFERRED.

SHOULD COVER ALL THE LEVELS OF QUALITY SYSTEM DOCUMENTS; MAY BE RESTRICTED TO QUALITY MANUAL, INITIALLY, IN THIRD PARTY AUDITS FOR CONFIDENTIALITY REASONS.

LOOK FOR CLARITY IN UNDERSTANDING AND INTERACTION OF THE PROCESSES ALSO.

RAISE NON-CONFORMANCE REPORTS, WHERE REQUIRED

Apr 2010 134

PURPOSE OF DOCUMENT AUDITPURPOSE OF DOCUMENT AUDIT

• TO ENSURE THAT THE QMS DOCUMENTATION PROVIDES ADEQUATE CONFIDENCE AND PROVIDES SCOPE FOR CONTINUAL IMPROVEMENT

• TO HELP IN PLANNING FOR ON-SITE AUDIT

• TO IDENTIFY SHORT-COMINGS AND INADEQUACIES IN THE QMS AND THE QMS DOCUMENTATION

• TO IDENTIFY THE LOGISTICS DURING THE ON-SITE AUDIT

• TO TAKE INTO CONSIDERATION THE SIZE, NATURE AND COMPLEXITY OF ORGANIZATION

• BASED ON THE SCOPE OF THE AUDIT

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Apr 2010 135O

DOCUM ENTATION REVIEW M ATRIX

ISO 9001 REQUIREM ENTS

DOCUM ENTATION THAT ADDRESSES THIS RQUIREM ENT

QUAITY M ANUAL PROCEDURE OTHERS 5.1 M ANAGEM ENT

COM M ITM ENT

5.2 CUSTOM ER FOCUS

5.3 QUALITY POLICY

5.4 PLANNING

5.5 RESPONSIBILITY, AUTHORITY AND COM M UNICATION

Apr 2010 136

PROCESS APPROACH TO AUDITINGPROCESS APPROACH TO AUDITINGAUDIT PLAN • includes all activities applicable to the scope of

audit and ISO 9001• enables audit trails to be established from top

level policy to all relevant functions and levels• enables links to be established between policy,

objectives, targets, monitoring and• continual improvement.• reflects the structure, sequence and

interrelationship of processes • is sufficiently flexible • enables objective evidence to be gathered to

verify activities and results.• reflects the organization's goals and priorities.

O

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Apr 2010 137

PROCESS APPROACH TO AUDITINGPROCESS APPROACH TO AUDITING

Conducting the audit

Verify that

• the purpose, inputs, outputs, controls and resources for each process are clear.

• links are established between processes and high level and localquality objectives.

• outputs are compared with purpose, desired outcomes and specific quality objectives of the process.

• steps in the process and associated responsibilities are determined, where necessary.

• inter relating processes are identified and process measures areidentified.

• evidence of continual improvement is available• needs of internal and external customers are clear.

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Apr 2010 138

AUDIT RESPONSIBILITIES• Roles and responsibilities of the auditor, auditee, client, lead

auditor, guides and observers, in accordance with ISO 19011.

• Management responsibilities of the Lead Auditor

• Effective communication with the auditee

• Auditor confidentiality.

• The IRCA code of conduct

SESSION 3d

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Apr 2010 139

WHO ARE INVOLVED IN AN AUDITWHO ARE INVOLVED IN AN AUDIT

• AUDITOR : A PERSON WITH THECOMPETENCE TO CONDUCT AN AUDIT

• AUDITEE : ORGANIZATION BEING AUDITED

• AUDIT CLIENT : ORGANIZATION OR PERSON REQUESTING AN AUDIT

Apr 2010 140

WHO ARE INVOLVED IN AN AUDIT (WHO ARE INVOLVED IN AN AUDIT (ContinuedContinued))

• AUDITOR :

A PERSON WHO IS COMPETENT AND IS AUTHORISED TO PERFORM ALL OR ANY PORTION OF QUALITY SYSTEM AUDIT

• LEAD AUDITOR :

AN AUDITOR WHO IS COMPETENT AND IS AUTHORIZED TO MANAGE A QUALITY SYSTEM AUDIT

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Apr 2010 141

WHO ARE INVOLVED IN AN AUDIT (WHO ARE INVOLVED IN AN AUDIT (ContinuedContinued))

AUDIT TEAM : ONE OR MORE AUDITORS CONDUCTING AN AUDIT SUPPORTED IF NEEDED BY TECHNICAL EXPERTS

TECHNICAL EXPERT : A PERSON WHO PROVIDES SPECIFIC KNOWLEDGE OR EXPERTISE TO THE AUDIT TEAM: Does not act as auditor

Apr 2010 142

ROLE OF LEAD AUDITORROLE OF LEAD AUDITOR

• LEAD THE THE TEAM OF AUDITORS

• REPRESENT THE AUDIT CLIENT (CERTIFICATION BODY)

• MANAGE THE AUDIT ACTIVITIES

• REPORT AUDIT FINDINGS TO AUDIT CLIENT

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Apr 2010 143

MANAGEMENT RESPONSIBILITIES OF MANAGEMENT RESPONSIBILITIES OF LEAD AUDITORLEAD AUDITOR

NEGOTIATE THE AUDIT SCOPESELECTION OF AUDIT TEAMDIRECT THE AUDIT TEAM MEMBERSPLANNING THE AUDIT & MAKE EFFECTIVE USE OF RESOURCESREPRESENTING THE AUDIT TEAMMANAGING THE AUDITREVIEW OF AUDIT TEAM’S WORKPREVENT & RESOLVE CONFLICTSTO LEAD THE AUDIT TEAM TO REACH AUDIT CONCLUSIONSPREPARATION OF THE REPORTCONTROL OF THE OPENING AND CLOSING MEETINGSSUBMISSION OF THE REPORT

Apr 2010 144

ROLE OF AUDITORROLE OF AUDITOR

COMMUNICATING AUDIT REQUIREMENTS TO THE AUDITEECONDUCTING AUDITDOCUMENTING OBSERVATIONS WITH EVIDENCEVERIFYING THE EFFECTIVENESS OF THE QUALITY SYSTEMREPORTING RESULTS TO THE LEAD AUDITORCO-OPERATING WITH AND ASSISTING LEAD AUDITOR

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Apr 2010 145

ROLE OF AUDITEEROLE OF AUDITEE

• PRE - AUDIT

• DURING THE AUDIT

• POST AUDIT

Apr 2010 146


• PRE - AUDIT1. SELECT AUDITING AGENCY, BASED ON EXPERIENCE,

ACCREDITATION IN COUNTRIES OF INTEREST AND REPUTATION.

2. LIASE WITH AUDITING / CERTIFYING AGENCY TO PROVIDE REQUIRED INFORMATION (VERBAL AND WRITTEN)

3. AGREE ON SCOPE FOR AUDIT AND THE NOMINATED TEAM.

4. AGREE ON SUITABLE DATES FOR THE AUDIT ACTIVITY AND SITES TO BE VISITED.

5. AGREE TO PROVIDE LOGISTIC ASSISTANCE DURING AUDIT

6. DECIDE ON THOSE WHO WILL ATTEND THE OPENING AND CLOSING MEETINGS

7. INFORM ALL STAFF REGARDING THE AUDIT

O

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Apr 2010 147


• DURING THE AUDIT1. PROVIDE OFFICE FACILITIES FOR OPENING AND CLOSING MEETINGS,

AND ALSO FOR LIASION MEETINGS OF AUDITORS

2. PROVIDE GUIDES

3. SEEK CLARIFICATIONS, IN CASE OBSERVATIONS, ATTRIBUTIONS OR EXPLANATIONS OF THE AUDITORS ARE NOT CLEARLY UNDERSTOOD

4. ENSURE RELEVANT PEOPLE FROM MANAGEMENT ARE PUNCTUAL FOR ALL MEETINGS

5. INFORM MANAGEMENT OF ANY MAJOR NON-CONFORMITY OBSERVED BY THE AUDITORS

6. COOPERATE WITH THE AUDITORS, AGREE TO NON-CONFORMITIES AND COMMIT TO TIMELY CORRECTIVE ACTIONS

Apr 2010 148


• POST – AUDIT

1. IDENTIFY CAUSES FOR THE NON-CONFORMITY.

2. IDENTIFY THE CORRECTIVE ACTION ON THE CAUSES OF THE NON-CONFORMITY.

3. PROPOSE TIME-BOUND CORRECTIVE ACTIONS, AND SEEK AGREEMENT WITH AUDITORS (IN CASE REQUIRED).

4. IMPLEMENT THE CORRECTIVE ACTION

5. VERIFY THE EFFECTIVENESS OF THE ACTIONS, THROUGH INTERNAL AUDITS, INFORM AUDITORS ABOUT SATISFACTORY COMPLETION OF CORRECTIVE ACTIONS

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Apr 2010 149

ROLES & RESPONSIBILITIES OF GUIDESROLES & RESPONSIBILITIES OF GUIDES

SHOULD ASSIST THE AUDIT TEAM

SHOULD ACT ON REQUEST OF THE LEAD AUDITOR

OTHER RESPONSIBILITIES :

ESTABLISH CONTACTS &TIMINGS FOR INTERVIEWS

ARRANGE VISITS TO SPECIFIC SITES

ENSURE RULES CONCERNING SAFETY ARE FOLLOWED BY AUDITORS

WITNESS THE AUDIT ON BEHALF OF AUDITEE IF REQUIRED

PROVIDE CLARIFICATION OR ASSIST IN COLLECTING INFORMATION

GUIDES & OBSERVERS MAY ACCOMPANY THE AUDIT TEAM BUT ARE NOT PART OF IT

Apr 2010 150

GUIDE TO THE GUIDEGUIDE TO THE GUIDE

MUST HAVE GOOD KNOWLEDGE ON THE STANDARD MUST HAVE GOOD KNOWLEDGE OF QMS, IN THE AREA OF AUDITMUST HAVE OVERALL UNDERSTANDING OF QMS OF THE COMPANYMUST BE TACTFUL AND COURTEOUSACKNOWLEDGE NOT KNOWING AN ANSWERMUST BUILD RAPPORT WITH AUDITORWITNESS TO THE OBSERVATIONMUST BE BRIEF AND PRECISESHOULD HELP THE AUDITOR IN FACILITIESNOT TO ARGUE WITH THE AUDITORNOT TO VOLUNTEER OPINIONS

• AUDITORS SHOULD FIND THE NON-CONFORMANCES; IT IS NOT FOR THE GUIDES TO PROVIDE THEM

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Apr 2010 151

COMMUNICATION WITH AUDITEECOMMUNICATION WITH AUDITEE

DURING AUDITS, TEAM LEADER SHOULD COMMUNICATE TO THE AUDITEE

• PROGRESS & CONCERNS

• EVIDENCE SUGGESTING SIGNIFICANT RISKS

• ISSUES OUTSIDE AUDIT SCOPE

WHERE AUDIT OBJECTIVES ARE UNATTAINABLE• REPORT REASONS TO AUDITEE & CLIENT

• RECONFIRM / MODIFY AUDIT PLAN

• CHANGE AUDIT OBJECTIVES, SCOPE OR TERMINATE AUDIT

Apr 2010 152

CONFIDENTIALITYCONFIDENTIALITYAUDITORS HAVE TO ENSURE THAT THE

INFORMATION RECEIVED OR REVIEWED BY ANY

MEANS DURING THE AUDIT SHALL NOT BE

DISCLOSED TO ANY PARTY OR PERSON NOT

RELATED TO THE AUDIT UNLESS AGREED TO BY

THE PARTIES CONCERNED.

THIS IS ESSENTIAL SINCE CONFIDENTIAL AND

SENSITIVE INFORMATION MAY BECOME

ACCESSIBLE TO THE AUDITORS DURING THE

AUDIT

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Apr 2010 153

IRCA CODE OF CONDUCTIRCA CODE OF CONDUCTAll certificated auditors are required to comply with the following code

of conduct:

• Act in a strictly trustworthy and un-biased manner

• To disclose to their employer any prior relatinship with the auditeeorganization

• No to accept gifts, commissions, discounts or any other profits from the organization audited or its representatives

• Not to disclose audit findings / other information gained during audit to any external person

• Not to act in any way prejudicial to the interest & reputation of audit organization and IRCA

• Cooperate fully in any formal enquiry procedure

Apr 2010 154

AUDIT PROGRAMME

SET OF ONE OR MORE AUDITS

PLANNED FOR A SPECIFIC TIME FRAME &

DIRECTED TOWARDS A SPECIFIC PURPOSE

SESSION 3e

78

Apr 2010 155

PROCESS FLOW FOR MANAGEMENT OF AN AUDIT PROCESS FLOW FOR MANAGEMENT OF AN AUDIT PROGRAMMEPROGRAMME

Authority for the audit programme

Monitoring & Reviewing Audit Programme• Monitoring & reviewing• Identifying needs for Corrective & Preventive action• Identifying opportunities for implement

Implementing the Audit Programme• Scheduling audits• Evaluating Auditors• Selecting audit team• Directing audit activities• Maintaining records

Establishing the Audit Programme• Objectives• Responsibilities• Resources• Procedures

Improving the Audit Programme

Competence & Evaluation of auditors

Audit ActivitiesAudit Activities

Plan

Check

ActDo

Apr 2010 156

AUDIT PROGRAMME : OBJECTIVES & EXTENTAUDIT PROGRAMME : OBJECTIVES & EXTENT

BASED ON CONSIDERATION OF :• MANAGEMENT PRIORITIES

• COMMERCIAL INTENTIONS

• MANAGEMENT SYSTEM REQUIREMENTS

• STATUTORY, REGULATORY & CONTRACTUAL REQUIREMENTS

• SUPPLIER EVALUATIONS

• CUSTOMER REQUIREMENTS

• NEEDS OF OTHER STAKEHOLDERS

• RISKS TO THE ORGANIZATION

O

79

Apr 2010 157

EXTENT OF AN AUDIT PROGRAMMEEXTENT OF AN AUDIT PROGRAMMEGOVERNED BY :

• SIZE, NATURE, COMPLEXITY OF THE ORGANIZATION

• SCOPE, OBJECTIVE & DURATION OF EACH AUDIT

• FREQUENCY OF AUDITS

• NUMBER, IMPORTANCE, LOCATIONS

• AUDIT CRITERIA

• PREVIOUS AUDIT CONCLUSIONS & REVIEW

• LANGUAGE, CULTURE & SOCIAL ISSUE

• SIGNIFICANT CHANGES IN THE ORGANIZATION

• CONCERNS OF INTERESTED PARTIES

O

Apr 2010 158

DEFINING THE AUDIT OBJECTIVES, DEFINING THE AUDIT OBJECTIVES, SCOPE AND CRITERIASCOPE AND CRITERIA

• AN INDIVIDUAL AUDIT IS BASED ON DOCUMENTED OBJECTIVES, SCOPE & CRITERIA

• THE AUDIT OBJECTIVES DEFINE WHAT IS ACCOMPLISHED BY THE AUDIT AND MAY INCLUDE

DETERMINING EXTENT OF CONFORMITY OF THE AUDITEES MANAGEMENT SYSTEM

EVALUATING THE CAPABILITY OF MANAGEMENT SYSTEM TO ENSURE COMPLIANCE TO STATUTORY, REGULATORY & CONTRACTUAL REQUIREMENTS

EVALUATING EFFECTIVENESS OF MANAGEMENT SYSTEM IN MEETING ITS SPECIFIED OBJECTIVES

IDENTIFICATION OF AIMS FOR POTENTIAL IMPROVEMENT OF THE MANAGEMENT SYSTEM, BY AUDIT CLIENT

O

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Apr 2010 159

FEASIBILITY OF THE AUDITFEASIBILITY OF THE AUDIT

• ADEQUATE INFORMATION FOR PLANNING THE AUDIT

• ADEQUATE CO-OPERATION FROM THE AUDITEE

• AVAILABILITY OF TIME AND ADEQUATE RESOURCES

O

Apr 2010 160

RESPONSIBILITIES FOR MANAGING RESPONSIBILITIES FOR MANAGING THE AUDIT PROGRAMMETHE AUDIT PROGRAMME

• ESTABLISH THE OBJECTIVES & EXTENT OF THE AUDIT PROGRAMME

• ESTABLISH RESPONSIBILITIES, PROCEDURES

• ENSURE RESOURCES ARE PROVIDED

• ENSURE IMPLEMENTATION

• MAINTENANCE OF AUDIT PROGRAMME RECORDS

• MONITOR, REVIEW & IMPROVE THE AUDIT PROGRAMME

O

81

Apr 2010 161

AUDIT PROGRAMME RESOURCESAUDIT PROGRAMME RESOURCES

BASED ON :

• FINANCIAL RESOURCES NECESSARY TO DEVELOP, IMPLEMENT, MANAGE & IMPROVE AUDIT ACTIVITIES

• AUDIT TECHNIQUES

• AUDITOR COMPETENCE

• IMPROVEMENT OF AUDITOR PERFORMANCE

• EXTENT OF AUDIT PROGRAMME

• LOGISTICSO

Apr 2010 162

AUDIT PROGRAMME PROCEDURESAUDIT PROGRAMME PROCEDURES

• PLANNING & SCHEDULING AUDITS

• ASSURING COMPETENCE OF AUDITORS & LEAD AUDITORS

• SELECTING APPROPRIATE TEAM & ASSIGN RESPONSIBILITY

• CONDUCT AUDITS

• CONDUCT AUDIT FOLLOW UPS, IF APPLICABLE

• MAINTAIN RECORDS (AUDIT PLANS, REPORTS, NCRS)

• MONITOR PERFORMANCE & EFFECTIVENESS OF THE AUDIT PROGRAM

• REPORTING

O

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Apr 2010 163

AUDIT PROGRAMME MONITORING & REVIEWAUDIT PROGRAMME MONITORING & REVIEW

THE ACTIVITIES INCLUDE :

• MONITOR AT APPROPRIATE INTERVALS

REVIEW TO ASSESS WHETHER AUDIT OBJECTIVES ARE MET

IDENTIFY OPPORTUNITIES OF IMPROVEMENT

REPORT TO TOP MANAGEMENT

O

Contd..

Apr 2010 164

AUDIT PROGRAMME MONITORING & REVIEWAUDIT PROGRAMME MONITORING & REVIEW

PERFORMANCE INDICATORS TO MONITOR CHARACTERISTICS :

• ABILITY OF TEAMS TO IMPLEMENT AUDIT PLAN

• CONFORMITY WITH AUDIT PROGRAMME & SCHEDULE

• FEEDBACK FROM AUDIT CLIENTS, AUDITEES & AUDITORS.

O

83

Apr 2010 165

DEFINING THE AUDIT OBJECTIVES, DEFINING THE AUDIT OBJECTIVES, SCOPE AND CRITERIA (SCOPE AND CRITERIA (ContinuedContinued))

AUDIT SCOPE

EXTENT AND BOUNDARIES

* BY AUDIT CLIENT & LEAD AUDITOR

AUDIT CRITERIA

REFERENCE AGAINST WHICH CONFORMITY IS DETERMINED

* BY AUDIT CLIENT & LEAD AUDITOR

Apr 2010 166

THIRD PARTY

AGREEMENT BETWEEN CERTIFICATION BODY AND AUDITEE

AUDITORS CONFIRM SCOPE WITH BUSINESS BROCHURES / TENDERS

SECOND PARTY

MAY BE COMPANY-WIDE OR CONTRACT-SPECIFIC

MAY BE SCHEDULED OR CIRCUMSTANCE-DRIVEN

FIRST PARTY

COVERAGE OF ALL FUNCTIONS AND PROCESS

TO MEET QMS STANDARD AND DEMONSTRATE COMPLIANCE

OBJECTIVE / SCOPE OF AUDITOBJECTIVE / SCOPE OF AUDIT

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Apr 2010 167

SCHEDULING OF AUDITSSCHEDULING OF AUDITS

THIRD PARTY AUDITSPLANNED WELL IN ADVANCEMUST COVER ALL ASPECTS OF THE QUALITY SYSTEM STANDARDSHALL INCLUDE A 2 STAGE INITIAL AUDITSURVEILLANCE AUDIT IN THE 1ST AND 2ND YEARSRE-CERTIFICATION AUDIT IN THE 3RD YEAR PRIOR TO EXPIRATION OF CERTIFICATION

SECOND PARTY AUDITSREQUIREMENTS OF CURRENT & PENDING CONTRACTSVALUE OF CURRENT & PENDING CONTRACTSDATE OF LAST AUDIT & FINDINGS OF PREVIOUS AUDITAVAILABLE RESOURCES

O

Apr 2010 168

SCHEDULING OF AUDITS (contd.)SCHEDULING OF AUDITS (contd.)

FIRST PARTY AUDITS

PLAN MUST BE AUTHORIZED.

SHOULD COVER ALL THE ACTIVITIES OF QUALITY SYSTEM.

BASED ON THE NEEDS OF THE QUALITY SYSTEM AND OF THE BUSINESS.

O

85

Apr 2010 169

SCHEDULING OF AUDITS (contd.)SCHEDULING OF AUDITS (contd.)

FIRST PARTY AUDIT

‘CALENDAR SCHEDULED’ AUDITS

RESULT OF PREVIOUS AUDITS

FOLLOWING LIKELY CHANGES IN

– MANAGEMENT

– ORGANIZATION

– POLICY

– TECHNIQUES / TECHNOLOGY

– QUALITY SYSTEM

‘EVENT LED’ AUDITS

O

Apr 2010 170

INTERNAL AUDIT SCHEDULE INTERNAL AUDIT SCHEDULE –– YEAR 20XXYEAR 20XX

O

Audit CompletedAudit Performed & Reported

Corrective Action Response Accepted

Follow-up Action Required

Audit Scheduled

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Apr 2010 171

PLANNING OF AUDIT

• Pre-audit contacts

• Documentation Review

• Audit Scope, team competence and selection of team

• On-site Audit Plan

SESSION 3f

Apr 2010 172

PLANNING & PREPARATIONPLANNING & PREPARATION

• APPOINT THE AUDIT TEAM LEADER

• DEFINE AUDIT OBJECTIVES, SCOPE & CRITERIA

• DETERMINE FEASIBILITY OF THE AUDIT

• SELECT AUDIT TEAM

• ESTABLISH INITIAL CONTACT WITH THE AUDITEE

• CONDUCT DOCUMENT REVIEW

• PREPARE AUDIT PLAN (Strategy, sample, timings)

• ASSIGN WORK TO THE AUDIT TEAM

• PREPARE CHECKLIST, SAMPLING PLANS & OTHERS

• AUDIT TEAM BRIEFING

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Apr 2010 173

GATHERING INFORMATIONGATHERING INFORMATION

COMPANY’S PROFILE / MAN POWER LOCATION / GEOGRAPHICAL SPREAD

USE OF TELEPHONE / QUESTIONNAIRE / QUALITY MANUAL

ESTABLISH INITIAL CONTACT WITH THE AUDITEE

PRE-AUDIT VISIT / MEETING (as required)

Apr 2010 174

PURPOSE OF ESTABLISHING INITIAL PURPOSE OF ESTABLISHING INITIAL CONTACT WITH THE AUDITEECONTACT WITH THE AUDITEE

TO ESTABLISH COMMUNICATION CHANNELS WITH THE AUDITEE REPRESENTATIVE

TO CONFIRM AUTHORITY TO CONDUCT THE AUDIT

TO PROVIDE INFORMATION ON TIMING & TEAM COMPOSITION

TO REQUEST ACCESS TO RELEVANT DOCUMENTS & RECORDS

TO DETERMINE THE SITE SAFETY RULES

TO MAKE ARRANGEMENTS FOR THE AUDIT

TO AGREE ON THE OBSERVERS & GUIDES

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Apr 2010 175

PREPRE--AUDIT VISITAUDIT VISIT

WHEN REQUIRED?

SIZE OR COMPLEXITY

GEOGRAPHICAL SPREAD

CONFIRM ‘SCOPE PROPOSED’ IS IN LINE WITH BUSINESS

BENEFITS

TO CLARIFY THE AUDIT PROCESS TO THE AUDITEE

CHECK MATURITY OF QUALITY SYSTEM

ON-SITE DOCUMENTATION REVIEW POSSIBLE

Apr 2010 176

PREPRE--AUDIT VISIT (contd.)AUDIT VISIT (contd.)

TYPICAL AGENDA

UNDERSTANDING THE PROCESSES NEEDED FOR QMS (MAY OR MAY NOT BE DOCUMENTED).EXPLAIN THE AUDIT PROCESSINTRODUCTION WITH KEY PERSONNELCONFIRM SCOPE OF AUDITCONFIRM DATE/DETAILS OF AUDITIDENTIFY NEED FOR SPECIAL KNOWLEDGESHORT VISIT OF SITE TO HAVE A ‘FEEL’ OF THE COMPANYON-SITE DOCUMENTATION REVIEWCLARIFY DOUBTS OF AUDITEE

89

Apr 2010 177

NOMINATE THE AUDIT TEAMNOMINATE THE AUDIT TEAM

INDEPENDENCE OF THE FUNCTION & TO AVOID CONFLICT OF INTEREST

ACCEPTABILITY TO THE AUDITEE

LANGUAGE OF AUDIT & UNDERSTANDING OF AUDITEES SOCIAL AND CULTURAL CHARACTERISTICS

KNOWLEDGE OF BUSINESS

STATUTORY, REGULATORY, CONTRACTUAL & ACCREDITATION / CERTIFICATION REQUIREMENTS, AS APPLICABLE

Apr 2010 178

NOMINATE THE AUDIT TEAM (Contd..)NOMINATE THE AUDIT TEAM (Contd..)

CONSIDERATION TO BE GIVEN TO THE FOLLOWING :

AUDIT OBJECTIVES, SCOPE, CRITERIA & ESTIMATED DURATION OF THE AUDIT

COMPETENCE NEEDED TO ACHIEVE AUDIT OBJECTIVES

WHETHER AUDIT IS JOINT OR COMBINED

TECHNICAL EXPERTISE (FAMILIARITY WITH INDUSTRY SECTOR)

INTERPERSONAL SKILLS

90

Apr 2010 179

PREPARE WORK DOCUMENTSPREPARE WORK DOCUMENTS

CHECKLISTS

AUDIT SAMPLING PLANS

FORMS FOR RECORDING

SUPPORTING EVIDENCE

AUDIT FINDINGS

RECORD OF MEETINGS

[ SAFEGUARD CONFIDENTIAL OR PROPRIETORY INFORMATION AT ALL TIMES]

Apr 2010 180

PREPARING THE AUDIT PLANPREPARING THE AUDIT PLAN

• AUDIT OBJECTIVES

• AUDIT CRITERIA

• AUDIT SCOPE

• DATES & PLACES OF ONSITE AUDIT

• EXPECTED TIME, DURATION INCLUDING MEETINGS WITH AUDITEES MANAGEMENT & AUDIT TEAM MEETINGS

• ROLES & RESPONSIBILITIES OF AUDIT TEAM MEMBERS & TECHNICAL EXPERTS, IF ANY

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Apr 2010 181

PREPARING THE AUDIT PLAN PREPARING THE AUDIT PLAN (continued)(continued)

ALLOCATION OF APPROPRIATE RESOURCES TO CRITICAL AREAS OF AUDIT

OTHER POINTS COULD COVER, AS APPROPRIATE

IDENTIFICATION OF AUDITEES REPRESENTATIVE FOR THE AUDIT

LOGISTICS

MATTERS RELATED TO CONFIDENTIALITY

ANY AUDIT FOLLOW UP ACTIONS

Apr 2010 182

IAF Guidance on the Application of ISO 17021:2006IAF Guidance on the Application of ISO 17021:2006Guide for Process to Determine Auditor Time for Initial Audit Guide for Process to Determine Auditor Time for Initial Audit

(Auditor Time Chart)(Auditor Time Chart)

10276 – 42511426 – 62512626 - 875

9176 – 2758126 – 175786 – 125666 – 85546 – 65426 – 45311 – 2521 – 10

Auditor Time for Initial Audit (auditor days)

Number of Employees

O

216801 – 8500228501 – 10700

Follow Progression above

> 10700

205451 – 6800194351 – 5450183451 – 4350172676 – 3450162026 – 2675151551 – 2025141176 – 155013876 – 1175

Auditor Time for Initial Audit (auditor days)

Number of Employees

1. “Employees” as referenced in the table refers to all individuals whose work activities support the scope of the certification / registration as described by the quality management system

2. Minimum 90% of time shown in Auditor’s time chart should be spent on onsite audit

3. Surveillance time annually should be 1/3rd of the time spent on initial assessment.

4. Re-assessment time should be about 2/3rd of the time spent on initial assessment.

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Apr 2010 183O

AUDIT PLAN OF UCP Ltd. AT GURGAON PLANT Lead Auditor - Mohan P Auditor - Amardeep Scope : The Audit is to the cover the processes of UCP Ltd against ISO 9001 : 2008 Purpose : The purpose of the audit is to assess the Quality Management System against ISO 9001 with eventual registration of the company to the above scope.

Day I

Time Auditors Area / Activities

Coverage Time Auditors Areas / Activities

Coverage

0900 - 0930 hrs.

Lead Auditor + Auditor

Opening Meeting

0930 - 1015 hrs


CEO's office

Management Responsibility including Management Commitment, Resources, Infrastructure, Customer Focus, Quality Policy, objectives and Deployment , QMS Planning, Management Review, Responsibility & Authority, continuous improvement …

1015 - 1115 hrs.

- Do- Interaction with Manage- ment Represen- tative

Internal Communication, Internal Quality Audit, Management Review, Corrective & Preventive Action……

Apr 2010 184O

Continued….. Time Auditors Area /

Activities Coverage Time Auditor

s Areas /

Activities Coverage

1115 - 1300 hrs.

Lead Auditor

MarketingRelated Process

Customer Related processes, process of order procurement, (interactions with mfg.) customer communication processes & customer satisfaction Measurement Processes corrective and preventive action (data, trend & analysis, Root Cause analysis etc.)….

1115 - 1300 hrs.

Auditor Purchasing Processes

Selection, approval of suppliers, verification process at suppliers premises, Inspection plans, Requisition/ Indent making, Interaction Process with Inspection, Mfg. & other related processes….

1300 - 1400 Lunch / liaison meeting

1400 - 1700 hrs.

Lead Auditor

Production related processes in the Machining & Welding operations

Production related processes including Production Planning, Quality objectives & requirement of product, provision of resources specific to the product, verification, validation, monitoring etc., control of nonconforming product, corrective and preventive action……

1400 - 1700 hrs.

Auditor Production related processes in the Heat treatment operations

Verification, validation, monitoring etc., control of NC, work environment, resource provision, quality objectives, targets….

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Apr 2010 185O

Continued….. Day II

Time Auditors Area / Activities Coverage Time Auditors Areas / Activities

Coverage

1000 - 1200 hrs.

Lead Auditor

Calibration Process (Laboratory Instrument)

Control of Monitoring & Measuring Devices though External Calibration…

1000 - 1300 hrs.

Auditor Processes related to maintenance

Infrastructure, linkage with production related processes, qualification of personnel, effectiveness of the maintenance process

1200 - 1300 hrs

Lead Auditor

Production processes related to Presentation of Products

Purchase Process on Incoming material, process of storage, Preservation, Packaging, Interaction with Produc-tion, Mfg, Quality objectives, targets…

1300 - 1400 hrs.

Lunch / Liaison Meeting

1400 - 1550 hrs

Lead Auditor

Processes related to Monitoring and measuring devices and processes related to Measure-ment

Monitoring & Measuring Devices; Calibration done inter-nally (Engg.), Interaction Processes with Engg., Monitoring & Measurement of processes

1400 – 1550 hrs.

Auditor Processes related to training and competence building

Human Resources, Competence, Awareness & Training, Effectiveness of Training…

1530 - 1630 hrs.


Preparation for Closing Meeting

1630 - 1730 hrs.

Closing Meeting

Apr 2010 186

EXERCISE E:02EXERCISE E:02

Learning Objective : How to prepare On-Site Audit Plan

Method : Refer 6.4 of ISO 19011 & the Quality Manual to prepare Audit Plan

Time : 45 minutes for team work : Prepare Audit Plan (team wise)

Feedback by Tutors after evaluation, followed by common discussion

94

Apr 2010 187

Case Study CSCase Study CS--11

Learning Objective : How to conduct Documentation Review

Method : Conduct Documentation Review of a Quality Manual against ISO 9001:2008 requirements

Time : 45 minutes for individual review

30 minutes for consensus among teams

90 minutes for team presentation on flip charts

Apr 2010 188

CHECKLISTS

CHECKLISTS – PREPARATION

CHECKLISTS – USE, BENEFITS & LIMITATIONS

SESSION 3g

95

Apr 2010 189

CHECKLISTS CHECKLISTS -- PREPARATIONPREPARATION

ACTIVITY

After this training programme, your company management has asked you to conduct the audit of a Supplier of your company. During the initial contact with the supplier, you realize that there are no documented procedures for the QMS of the supplier.

WHAT CONSIDERATIONS WILL YOU GIVE WHILE PLANNING THIS AUDIT? HOW WILL YOU PROCEED WITH THE PLANNING OF THIS AUDIT?

Each team to reflect for 15 minutes followed by open house discussion (15 minutes)

Apr 2010 190

CHECKLISTS CHECKLISTS -- PREPARATIONPREPARATION

PREPARED DURING AUDIT PLANNING AND DOCUMENTATION REVIEW

SHOULD BE IN LINE WITH OBJECTIVE / SCOPE OF THE AUDIT

SEPARATE CHECK LIST FOR PROCESSES COVERINGDIFFERENT WORK-AREA TO BE AUDITED

TIME TO BE PROVIDED FOR AN AUDIT IN ACCORDANCE WITH NUMBER OF ITEMS IN THE CHECK LIST.

MAY BE LIST OF QUESTIONS OR LIST OF HEADINGS (HEADINGS PREFERRED)

96

Apr 2010 191

CHECKLISTS CHECKLISTS -- PREPARATION PREPARATION (Continued)(Continued)

• BASIS OF PREPARATIONQUALITY POLICY AND QUALITY OBJECTIVES (FUNCTION AND LEVELS)ISO 9001 STANDARDQMS DOCUMENTATION INCLUDING QMS PROCESS DOCUMENTATIONMEASUREMENT, ANALYSIS AND IMPROVEMENTCONTINUAL IMPROVEMENT (P - D - C - A)STATUTORY AND REGULATORY REQUIREMENTS APPLICABLEUSE OF PERSONAL EXPERIENCE

• CHECKLIST MUST ENABLE THE AUDITOR TO PURSUEAN EFFECTIVE AND PURPOSEFUL AUDIT TRAIL

Apr 2010 192

CHECKLISTS CHECKLISTS -- BENEFITSBENEFITS

HELPS TO ENSURE COVERAGE OF ENTIRE SCOPE IN TIME

HELPS TO BALANCE AUDIT SAMPLE

TOOL FOR PREPARATION OF AUDITOR

CONTROLS THE ‘PACE’ OF AUDIT

HELPS TO PRIORITISE CHECK POINTS

RECORD OF ACTIVITIES EXAMINED

BECOMES A BASE FOR IMPROVEMENT

97

Apr 2010 193

CHECKLISTS CHECKLISTS -- LIMITATIONSLIMITATIONS

MAY RESTRICT ENQUIRY BY AUDITOR

(Auditor should not become a slave or victim of the Checklist)

Apr 2010 194O 08 - 04

Sample Audit Checklist Related to the Purchasing Process (The PDCA Approach to a Process Audit)

Sl. No.

Checklist ISO Clause

Remarks Time

1. Ask for the overview of the Purchasing Process 7.4.1 2. Are there planned results identified in line with established objectives (from the Quality Policy) for

the Purchasing function 5.4.1 / 7.1

3. Understand the overall Process Sequence 4.1a 4. What are the processes identified in the Dept. / function to achieve planned results ( e.g. Selection

of Suppliers, Evaluation of Performance of Suppliers, Release of Purchase Orders, Testing Requirements by Suppliers etc. ) 4a. What procedures / work instructions are available

4.1a 4.1c/d

5 Check for sequencing of these processes 5a. Check for process owners

4.1b 4.1 f/d

6. Check for interaction of processes with inter or intra-functional processes ( e.s. - Check for testing by suppliers before dispatch - Check approval of Transporters for RM etc.)

4.1b

7. Check whether input & output & process performance measures are identified for the processes 4.1c 8. Check how processes are monitored & measured 4.1e 9. Are there targets to monitor

9a. Analyse characteristics & trends of processes 9b. Review process performance 9c. Identify NC ( if any )

4.1c 8.4 8.2.3

10. What is the "Corrective Action" and /or preventive action mechanism 8.5 11. What records / evidence are there to show that product characteristics (if any) are in conformity

with acceptance criteria 8.2.4 , 8.3

12. How is continual improvement of these process planned & implemented 8.5

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Apr 2010 195


Learning Objective : How to prepare a Checklist

Method : Prepare Checklists for the two situations in the Case Study / Workbook individually.

Time : 30 minutes : Individual work15 minutes : Self Evaluation 15 minutes : Discussion

Self Evaluation by the participants in line with the Marking Guidelines, followed by common discussion.

Apr 2010 196

OPENING MEETING

OPENING MEETING

PURPOSE OF OPENING MEETING

OPENING MEETING – AGENDA

SESSION 3h

99

Apr 2010 197

OPENING MEETINGOPENING MEETING

FORMAL START OF THE ON-SITE AUDIT

CHAIRED BY LEAD AUDITOR

CONDUCTED AT AUDITEE ORGANIZATION’S PREMISES

PROVIDES GENERAL RULES FOR CONDUCT OF AUDIT

ENSURE AUDITEE MANAGEMENT TEAM PRESENT

LANGUAGE AND CULTURE AND TIMING TO SUIT (ISO 19011)

SHOULD BE SHORT

Apr 2010 198

PURPOSE OF OPENING MEETINGPURPOSE OF OPENING MEETING

TO CONFIRM THE AUDIT PLAN

TO CLARIFY HOW THE AUDIT ACTIVITIES WILL BE UNDERTAKEN

TO ESTABLISH COMMUNICATIONS WITH THE AUDITEE MANAGEMENT.

TO PROVIDE OPPORTUNITY TO THE AUDITEE TO SEEK CLARIFICATION

100

Apr 2010 199

OPENING MEETING OPENING MEETING -- AGENDAAGENDA

INTRODUCTION OF PARTICIPANTS

AUDIT OBJECTIVES, SCOPE & CRITERIA

TIMETABLE

CLOSING MEETING - TIME, INTERIM MEETING & OTHER LATE CHANGES

AUDIT BY SAMPLING

EXPLAIN AUDIT PROCEDURE & DISCLAIMER

AUDIT RESPONSIBILITIES

FORMAL COMMUNICATION CHANNELS BETWEEN AUDITOR & AUDITEE

Apr 2010 200

OPENING MEETING OPENING MEETING -- AGENDA (contd.)AGENDA (contd.)

LANGUAGECONFIRMATION TO KEEP AUDITEE INFORMED OF AUDIT PROGRESSRESOURCES & FACILITIES REQUIREMENT CONFIDENTIALITYRELEVANT WORK SAFETY, SECURITY PROCEDURESINTRODUCTION TO GUIDESREPORTING METHODS (NCRS, GRADINGS)TERMINATION OF AUDITAPPEAL SYSTEM ON THE CONDUCT OR CONCLUSIONS OF THE AUDIT CLARIFY AUDITEES DOUBTS

101

Apr 2010 201

EXERCISE E:04EXERCISE E:04Learning Objective : How to conduct Opening Meeting

Method :

Refer 6.5.1 of ISO 19011

Role Play across two teams each playing role of Audit team and management team and two teams play the role of observer

Time : 30 minutes for team work : Preparation by all teams for respective roles

15 minutes for role play

15 minutes for Feedback

Apr 2010 202

ON-SITE AUDITING & AUDIT SKILLS

AUDITING

COLLECTING INFORMATION FOR REACHING AUDIT CONCLUSION

COMMUNICATIONS DURING AUDIT

PROCESS APPROACH TO AUDIT

AUDIT OF MANAGEMENT COMMITMENT

AUDITING SKILLS

SESSION 3i

102

Apr 2010 203

TASKS FOR 3TASKS FOR 3RDRD PARTY PARTY CERTIFICATION AUDITCERTIFICATION AUDIT

EXAMINE AND VERIFY THE STRUCTURE, POLICIES, PROCESSES, PROCEDURES, RECORDS AND RELATED DOCUMENTS OF THE CLIENT RELEVANT TO THE MANAGEMENT SYSTEM

MEET REQUIREMENTS RELEVANT TO THE SCOPE OF CERTIFICATION

DETERMINE PROCESSES ARE ESTABLISHED, IMPLEMENTED AND MAINTAINED EFFECTIVELY TO PROVIDE A BASIS FOR CONFIDENCE IN THE CLIENT’S MANAGEMENT SYSTEM

COMMUNICATE TO THE CLIENT ANY INCONSISTENCIES BETWEEN CLIENT’S POLICIES, OBJECTIVES AND TARGETS AND THE RESULTS

O

Apr 2010 204

AUDITINGAUDITINGEXISTENCE OF QUALITY MANAGEMENT SYSTEM

• CLEARLY DEFINED RESPONSIBILITIES AND AUTHORITIES

• ADEQUACY OF SYSTEM COMPONENTS/ELEMENTS

OPERATION OF QUALITY SYSTEM

• UNDERSTANDING OF PROCESSES AND THEIR INTERACTIONS

• PROVISION OF ADEQUATE RESOURCES

EFFECTIVENESS OF QUALITY SYSTEM

• ACHIEVEMENT OF DECLARED OBJECTIVES

• CORRECTIVE ACTION / CONTINUAL IMPROVEMENT

103

Apr 2010 205

AUDITINGAUDITING

COVERAGE OF ENTIRE SCOPE

NON-CONFORMANCE REPORTS (NCR)

OBJECTIVITY OF NCRs AND WITNESSING BY AUDITEE

IMMEDIATE INFORMATION TO COMPANY FOR MAJOR NCRs

HOLDING OF REGULAR REVIEW MEETING WITH TEAM MEMBERS

HOLDING OF REGULAR LIAISON MEETING WITH AUDITEE REPRESENTATIVE

TO INFORM ALL AUDIT OBSERVATIONS TO THE AUDITEE

Apr 2010 206

PROCESS OF COLLECTING INFORMATION PROCESS OF COLLECTING INFORMATION FOR REACHING AUDIT CONCLUSIONSFOR REACHING AUDIT CONCLUSIONS

Audit conclusions

- Interviews- Observation of activities- Review of Documents/Records

Review audit findings

Source of information

Collect by appropriate sampling & verifying

Audit Evidence

Evaluate audit evidence against audit criteria

Audit findings

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Apr 2010 207

SOURCE OF INFORMATIONSOURCE OF INFORMATION

• INTERVIEWS WITH EMPLOYEES & OTHERS

• OBSERVATION OF ACTIVITIES

• DOCUMENTS (POLICY, OBJECTIVES, PLANS, PROCEDURES, STANDARDS, INSTRUCTIONS ETC.)

• RECORDS

• ANALYSIS OF DATA

• CUSTOMER FEEDBACK

• SUPPLIER RATINGS

Apr 2010 208

COMMUNICATION DURING AUDITCOMMUNICATION DURING AUDIT

EXCHANGE INFORMATION

ASSESS AUDIT PROGRESS

IF NEEDED REASSIGN WORK BETWEEN AUDIT TEAM MEMBERS

2. WITH THE AUDITEE

1. WITHIN AN AUDIT TEAM

ANY CONCERNS TO THE AUDITEE (& CLIENT)

PROGRESS OF THE AUDIT

ANY SIGNIFICANT RISKS (SAFETY, ENVIRONMENT, QUALITY) TO BE REPORTED IMMEDIATELY TO AUDITEE (& CLIENT)

105

Apr 2010 209


ANY CONCERN ABOUT AN ISSUE OUTSIDE THE AUDIT SCOPE SHOULD BE NOTED AND REPORTED TO LEAD AUDITOR (FOR POSSIBLE COMMUNICATION TO AUDITEE / CLIENT)

AUDIT EVIDENCE TO SUPPORT THAT AUDIT OBJECTIVES ARE UNATTAINABLE

ANY REASONS FOR MODIFICATION OF AUDIT PLAN, OBJECTIVES, SCOPE OR TERMINATION OF AUDIT

[ ANY NEED FOR CHANGE IN AUDIT SCOPE DURING AUDIT SHOULD BE REVIEWED WITH & APPROVED BY AUDIT CLIENT & / AUDITEE

Apr 2010 210


OBJECTIVE AND SCOPE OF THE AUDIT

AUDIT PROGRAMME AND ASSIGNMENT OF RESPONSIBILITIES

REVIEW OF CHECKLIST, WITHIN THE AUDIT TEAM

REVIEW OF OBSERVATIONS

CROSS FLOW OF INFORMATION TO AUDIT TEAM MEMBERS

ADDITIONAL DOCUMENTS / REFERENCES IF REQUIRED

ANY CORRECTIONS TO AUDIT PROGRAM

STATUS OF AUDIT & ANY CONCERN AREA TO THE AUDITEE

WHEN THE AUDIT OBJECTIVES ARE UNATTAINABLE, REPORT THE REASON TO AUDITEE & DETERMINE APPROPRIATE ACTION

106

Apr 2010 211

AUDIT TRAILSAUDIT TRAILS

POLICY AND COMPANY LEVEL OBJECTIVESDEPLOYED OBJECTIVESPROCESS DOCUMENTATIONPROCESS INPUTSRESOURCESOPERATION OF PROCESSCONTROL OF PROCESSMONITORING AND MEASUREMENTOUTPUTSPERFORMANCE INDICATORSDATA ANALYSISUSE OF DATA FOR IMPROVEMENT

Apr 2010 212

PROCESS APPROACH TO AUDITPROCESS APPROACH TO AUDIT

UNDERSTAND THE PROCESS TO BE AUDITED (MAY OR MAY NOT BE DOCUMENTED)

SCOPE AND RESPONSIBILITIES

CHECK THAT PROCESS INPUTS & OUTPUTS ARE PROPERLY IDENTIFIED AND SUIT THE PURPOSE

INTERACTION WITH OTHER PROCESSES

CHECK THE RESULT AND OUTCOMES

VERIFY THE PROCESS MEASURABLES

EVALUATE IF THE OBJECTIVES ARE ADDRESSED AND ACHIEVED

ARE THE MEASURABLES LEADING TOWARDS CONTINUAL IMPROVEMENT

107

Apr 2010 213

INTERVIEWSINTERVIEWS

HELD WITH PERSONS FROM DIFFERENT LEVELS /FUNCTIONS (ESPECIALLY WITHIN THE SCOPE OF AUDIT)

SHOULD BE CONDUCTED DURING NORMAL WORK HOURS AND NORMAL WORK PLACE

PUT THE INTERVIEWED PERSON AT EASE PRIOR TO THE INTERVIEW

REASON FOR INTERVIEW AND NOTE TAKING EXPLAINED

INITIATE BY ASKING DESCRIPTION OF THEIR WORK

RESULTS SUMMARISED AND REVIEWED WITH THE PERSON

QUESTIONS LEADING TO BIAS TO BE AVOIDED

THANK FOR PARTICIPATION AND CO-OPERATION

Apr 2010 214

AUDIT OF MANAGEMENT COMMITMENTAUDIT OF MANAGEMENT COMMITMENT

• AUDITOR LOOKS FOR EVIDENCE OF TOP MANAGEMENT COMMITMENT IN:

ESTABLISHMENT OF QUALITY POLICY.

ENSURING THAT THE OBJECTIVES ARE ESTABLISHED.

COMMUNICATING WITHIN THE ORGANIZATION THE IMPORTANCE OF MEETING CUSTOMER AND STATUTORY / REGULATORY REQUIREMENTS.

ENSURING AVAILABILITY OF RESOURCES.

CONDUCTING MANAGEMENT REVIEW.

108

Apr 2010 215

AUDIT OF MANAGEMENT COMMITMENTAUDIT OF MANAGEMENT COMMITMENT (Continued)(Continued)

IDENTIFICATION OF TOP MANAGEMENT PERSONNEL

DETAILED INTERVIEWS OF TOP MANAGEMENT PERSONNEL

NOT A ONE PERSON AUDIT

NOT A ONE PLACE AUDIT

RECORDS MAY NOT BE SUFFICIENT EVIDENCE

AUDITORS TO GIVE FEEDBACK TO LEAD AUDITOR

LEAD AUDITOR TO CONCLUDE DURING CLOSING MEETING

SHOULD FIND A PLACE IN THE AUDIT REPORT

TO CONCLUDE ON LACK OF TOP MANAGEMENT COMMITMENT, COMPREHENSIVE AND HIGHER ORDER EVIDENCE IS REQUIRED.

Apr 2010 216

AUDITING SKILLSAUDITING SKILLS

TIME MANAGEMENT

FACT FINDING

REPORTING

109

Apr 2010 217

TIME MANAGEMENTTIME MANAGEMENTPLANNING AND PREPARATION

BE PUNCTUAL

AVOID TIME WASTERSINTRODUCTION / PRESENTATION

WALK ROUND THE PLANT

LUNCH / TEA / COFFEE

FALSE TRAILS

UNIMPORTANT ISSUES

FRIENDLY TALKS

TOP BRASS

Apr 2010 218

FACT FINDINGFACT FINDING

PURPOSE OF AN AUDIT IS TO FIND FACTS SUPPORTED BY OBJECTIVE EVIDENCE, WHICH MAY BE:

DOCUMENTS (Eg. POLICY, OBJECTIVES, PLANS, PROCEDURES ETC.)

RECORDS (MANY EXAMPLES POSSIBLE)

DATA SUMMARIES, ANALYSIS, METRICS AND PERFORMANCE INDICATORS

REPORTS FROM OTHER SOURCES (Eg. CUSTOMER FEEDBACK, VENDOR RATINGS ETC.)

OBSERVATIONS OF ACTIVITIES

OBSERVATION OF SURROUNDING WORK ENVIRONMENT AND CONDITIONS

SOMETIMES, EVEN STATEMENTS OF INFORMED PERSONS

110

Apr 2010 219

FACT FINDING METHODSFACT FINDING METHODS

READING

COMMUNICATIONS

INTERVIEWING

LISTENING

FIRST QUESTION

USE OF CHECK LIST

TAKE NOTES

SPOT CHECK DOCUMENTS

RECORDS/SAMPLES

• OBSERVATION

• BODY LANGUAGE

• QUESTIONING

• USE OF THOUGHT SPEED

• UNASKED QUESTIONS

• TO-AND- FRO CHECKING

• SELECT SAMPLE YOURSELF

Apr 2010 220

COMMUNICATING WITH THE AUDITEECOMMUNICATING WITH THE AUDITEE

MESSAGE TO BE IN LINE WITH− PURPOSE− AUDIENCE− SITUATION

USE OF SIMPLE LANGUAGE

STRUCTURED / ORGANIZED MESSAGE

IMPACT OF A MESSAGE IS − 7 % VERBAL− 38% VOCAL− 55% BODY LANGUAGE

111

Apr 2010 221

QUESTIONINGQUESTIONINGLEADING QUESTIONS LIKE

DO YOU?…………DON’T YOU ?

CLOSED QUESTIONS LIKEDO YOU……….. ?CAN YOU ……… ?WILL YOU ………. ?

OPEN QUESTIONS LIKE THOSEWHAT, WHEN, WHERE, WHO, WHY, HOW AND “SHOW ME”

ONE QUESTION AT A TIME

QUESTIONS RELEVANT TO THE ACTIVITY BEING AUDITED.

Apr 2010 222

LISTENINGLISTENING

• BARRIERS TO LISTENINGDECIDING IN ADVANCE THAT THE SUBJECT IS NOT INTERESTING

EVALUATING THE SPEAKER

BECOMING EMOTIONALLY INVOLVED

LISTENING FOR FACTS, NOT IDEAS

TAKING COPIOUS NOTES

FAKING ATTENTION

GETTING DISTRACTED

AVOIDS DIFFICULT LISTENING

FAILING TO CAPITALIZE ON “THOUGHT SPEED”

112

Apr 2010 223

THOUGHT SPEEDTHOUGHT SPEED

•AVERAGE PERSON SPEAKS ABOUT 120 WORDS PER MINUTE WHILE BRAIN CAN PROCESS 450-500 WORDS PER MINUTE

A GOOD LISTENER USES THIS EXCESS CAPACITY TO:

ANTICIPATE WHAT THE PERSON IS GOING TO SAY

ANALYZE WHAT HE IS SAYING

SUMMARISE WHAT HAS BEEN SAID

MENTALLY FRAME THE NEXT QUESTION

UNDERSTAND ANY EMPHASIS BEING MADE

UNDERSTAND BODY LANGUAGE

Apr 2010 224

BODY LANGUAGEBODY LANGUAGE

EYE CONTACT

CLENCHED FISTS

CROSSED ARMS AND LEGS

HAND SHAKE

EYE MOVEMENT

DIRECTION OF FEET AND LEGS

CARE ABOUT PERSONAL SPACE

SILENCE AT THE END OF A QUESTION

113

Apr 2010 225

AUDIT REPORTING

NON CONFORMANCE REPORTS (NCR)

NCR GRADING AND IMPLICATIONS

OPPORTUNITY FOR IMPROVEMENT & AUDIT CONCLUSION

REPORTING

SUMMARY STATEMENT

SESSION 3j

Apr 2010 226

OBJECTIVE EVIDENCE OBJECTIVE EVIDENCE DATA SUPPORTING THE EXISTENCE OR

VERIFIABILITY OF AN ENTITY NOTE.

OBJECTIVE EVIDENCE MAY BE OBTAINED THROUGH OBSERVATION, MEASUREMENT,

TEST OR OTHER MEANS.

VERIFICATIONCONFIRMATION, THROUGH THE PROVISION OF

OBJECTIVE EVIDENCE, THAT SPECIFIED REQUIREMENTS HAVE BEEN FULFILLED.

114

Apr 2010 227

SUBJECTIVE / OBJECTIVE OBSERVATION SUBJECTIVE / OBJECTIVE OBSERVATION (EXAMPLES)(EXAMPLES)

SUBJECTIVE OBSERVATION

• THE TESTING OF WELDERS IS THE RESPONSIBILITY OF THE PRODUCTION MANAGER WHEREAS IT WOULD BE MORE SENSIBLE IF IT WERE THE RESPONSIBILITY OF THE WELDING ENGINEER.

OBJECTIVE OBSERVATION

• AN UNQUALIFIED WELDER MR. A IS WORKING ON A CONTRACT FOR WORK ORDER 0201 WHICH CALLS FOR A WELDER TO BE QUALIFIED TO BS 4871.

Apr 2010 228

NON NON –– CONFORMANCE REPORT (NCR)CONFORMANCE REPORT (NCR)OROR

CORRECTIVE ACTION REQUEST (CAR)CORRECTIVE ACTION REQUEST (CAR)

• OBSERVATION

• ATTRIBUTION

• EXPLANATION

• CORRECTIVE ACTION PROPOSAL

• FOLLOW UP ACTIVITIES

115

Apr 2010 229

QMS AUDIT Incident Number NONCONFORMITY REPORT

Company under Audit : Note Number Area under review: ISO 9001: 2008 Clause Number Category MAJOR / MINOR (DELETE ONE)

Observation : Attribution Explanation Auditor : Acknowledged by : Date : Date : Comments / Agreed Action Target Date : Signature : Date : Actions Taken Signature : Date : NCR Closed Sample Audit OK Signature : Date

Apr 2010 230

QMS AUDIT Incident Number

NONCONFORMITY REPORT Company under Audit : UCP Ltd Note Number 1 / 12

Area under review : Clause Number 8.2.3 of ISO 9001:2008

Materials Section

Category MAJOR / MINOR (DELETE ONE)

Observation : Stocks of a fast moving item (Headlight Rims), Part No. 05/1234 are not monitored daily.

Attribution NCR against Clause 8.2.3 ISO 9001 : 2000 and Company Document No. QSP/ PUR / 7.4

Explanation

• Clause 8.2.3, ISO 9001 : 2000 requires the organization to apply suitable methods to monitor the processes for its Quality Management Systems.

• Company Document No. QSP / PUR / 7.4 requires stocks of all fast moving items to be monitored daily

Auditor : Y K Nayar Acknowledged by : Rajkumar

Date : 10th June, 2001 Date : 10th June, 2009

Comments / Agreed Action Target Date : 30, June 2001

• A daily Run Chart indicating the stock position of Headlight Rims is introduced

• Monitoring method for all fast moving items to be reviewed

• Materials Staff to be trained on revised procedures.

Signature : Rajkumar

Date : 12th June, 2009

Actions Taken

• Materials Staff trained on the revised methods of monitoring of fast moving items on 29 June, 2001

• Procedures now implemented. Signature : Rajkumar

Date : 30th June, 2009

NCR Closed Sample Audit O.K. Signature : Y K Nayar

Date 6th July, 2001

116

Apr 2010 231

NCR GRADINGNCR GRADINGMAJOR NC

COMPLETE ABSENCE OF A STATEMENT OR PROCEDURE TO MEET A REQUIREMENT OF THE STANDARD.

BREAKDOWN OR NON OBSERVANCE OF A SPECIFIED REQUIREMENT.

MINOR NCSINGLE OBSERVED LAPSE IN THE USE OF A DEFINED PROCEDURE OR REQUIREMENT.

A NUMBER OF MINOR (NUMBER NOT SPECIFIED) NCs AGAINST ONE PROCEDURE OR REQUIREMENT, AROUND THE ORGANIZATION OR IN A SINGLE DEPARTMENT, PROVING A BREAKDOWN, CAN BECOME A MAJOR NC.

Apr 2010 232

IMPLICATIONS OF NCR GRADINGIMPLICATIONS OF NCR GRADINGMAJOR NC

RECOMMENDATION CANNOT BE MADE

CORRECTIVE ACTION GENERALLY REVIEWED BY AUDITEE MANAGEMENT

CLOSURE OF NCR THROUGH FOLLOW UP VISIT

MINOR NCRECOMMENDATION CANNOT BE MADE IF NON CONFORMITY PERTAINS TO REQUIREMENT OF STANDARD

RECOMMENDATION CAN BE MADE AFTER CORRECTION AND VERIFICATION

CLOSURE OF NCR IS POSSIBLE THROUGH DOCUMENTARY EVIDENCE / FOLLOW UP VISIT / SURVEILLANCE AUDIT

117

Apr 2010 233

OPPORTUNITY FOR IMPROVEMENTOPPORTUNITY FOR IMPROVEMENT

THE AUDIT TEAM MAY IDENTIFY OPPORTUNITIES FOR IMPROVEMENT BUT SHALL NOT RECOMMEND SPECIFIC SOLUTIONS

Apr 2010 234

AUDIT CONCLUSIONSAUDIT CONCLUSIONS

EXTENT OF CONFORMITY OF THE MANAGEMENT SYSTEM WITH THE AUDIT CRITERIA

EFFECTIVE IMPLEMENTATION, MAINTENANCE & IMPROVEMENT OF THE MANAGEMENT SYSTEM

CAPABILITY OF THE MANAGEMENT REVIEW PROCESS TO ENSURE THE CONTINUING SUITABILITY, ADEQUACY, EFFECTIVENESS & IMPROVEMENT OF THE MANAGEMENT SYSTEM

118

Apr 2010 235

EXERCISE E:05EXERCISE E:05Learning Objective : How to write Non Conformance Reports

Method : Use the three incidents in the Case Study/ Workbook to identify possible Non Conformances in relation to ISO 9001 requirements, individually.See instructions in Workbook.

Time : 45 minutes : Individual work 20 minutes : Self Evaluation 25 minutes : Discussion

Self Evaluation by the participants in line with the Marking Guidelines, followed by common discussion.

Apr 2010 236

Case Study CSCase Study CS--22Learning Objective : How to conduct audit of

manufacturing functions

Method : Sequel to Case Study 1

Identify Non-conformances and Potential non conformances in the 20 scenarios of the Case Study.

Time : 45 minutes for Individual work

30 minutes for consensus among teams

90 minutes for team presentation on flip charts

119

Apr 2010 237

SUMMARY REPORT SUMMARY REPORT -- CONTENTCONTENT

THE SUMMARY REPORT SHOULD INCLUDE OR REFER TO THE FOLLOWING :

THE AUDIT OBJECTIVESTHE AUDIT SCOPE (ORGANIZATIONAL & FUNCTIONAL UNITS OR PROCESSES AUDITED AND THE TIME PERIOD COVERED)AUDIT TEAM LEADERS & MEMBERSDATES & PLACES OF ONSITE AUDITAUDIT CRITERIATHE AUDIT FINDINGSTHE AUDIT CONCLUSIONS

Apr 2010 238

SUMMARY REPORT SUMMARY REPORT –– CONTENT CONTENT (Continued)(Continued)

THE REPORT SHOULD INCLUDE OR REFER TO THE FOLLOWING, AS APPROPRIATE

THE AUDIT PLANLIST OF AUDITEE REPRESENTATIVESA SUMMARY OF THE AUDIT PROCESSDISCLAIMER ANY AREAS NOT COVERED ALTHOUGH WITHIN THE AUDIT SCOPEANY UNSOLVED DIVERGING OPINIONS BETWEEN AUDIT TEAM & AUDITEERECOMMENDATIONS FOR IMPROVEMENT, IF SPECIFIED IN AUDIT OBJECTIVESAGREED FOLLOW UP ACTION PLANA STATEMENT OF THE CONFIDENTIAL NATURE OF THE CONTENTSDISTRIBUTION LIST FOR THE AUDIT REPORT

120

Apr 2010 239

REPORTINGREPORTINGTHE METHOD AND CONTENT OF REPORTING DEPENDS ON THE TYPE OF AUDIT

IN FIRST PARTY (INTERNAL) AUDITS, SUMMARY STATEMENTS AND NCR WILL SUFFICE

IN A SECOND PARTY (EXTERNAL) AUDIT, A FORMAL REPORT STATING THE PURPOSE, SCOPE, CONTRACT, AUDIT TEAM, LOCATION AUDITED, DOCUMENTS REFERRED, FINDINGS, CONCLUSIONS AND POSSIBLE FOLLOW-UP ACTIONS ARE REQUIRED

IN A THIRD PARTY OR CERTIFICATION AUDIT, A FORMAL REPORT AS PER SECOND PARTY & FURTHER STATING THE CONCLUSIONS REACHED BY THE AUDIT TEAM, IN TERMS OF RECOMMENDATION, ARE REQUIRED.

Apr 2010 240

SUMMARY STATEMENTSUMMARY STATEMENT(Audit Report)(Audit Report)

This Company has a quality system which is well documented and generally in compliance with the requirements of ISO 9001. However, the systems and procedures have not been fully implemented in the contract, planning and product shipment areas. The audit found 33 deficiencies• Particular concern is felt for :

(a) interaction of processes between laboratory & engineering section regarding control of monitoring & measuring devices.

(B) lack of quality awareness on the part of project and senior management personnel.(C) although there are systems of collecting data in production & customer related processes, the analysis and

utilizations of these data towards continual improvement is not evident.(D) quality objectives for some important sections/functions i.e. Heat treatment section and Machine shop have

not been established.• No significant problems were found in systems for design & purchasing processes.• There is a need for more frequent review of the quality management systems and related process documents.• It will therefore be necessary for the company to undertake corrective action on the deficiencies raised and for a further audit to be carried out to verify that it had been taken before the company can be awarded a certificate. Corrective action should be effected within three months from today.

121

Apr 2010 241

Case Study CSCase Study CS--33Learning Objective : How to conduct audit of Service functions

Method : Identify Non conformances, potential non conformances and Statement against 20 scenarios related to Quality Manual

Time : 45 minutes for individual review45 minutes for consensus among teams 45 minutes for team presentation on flip charts 30 minutes for preparation for Role play 45 minutes for Role Play 15 minutes for Feedback on Role Play

Apr 2010 242


Learning Objective : How to write Summary Audit Reports

Method : Refer 6.6 of ISO 19011. Use Audit findings of CS-1, CS-2 and CS-3 for writing an Audit Summary Report

Time : 45 minutes for preparing the Summary Report, team-wise

30 minutes for evaluation and feedback

122

Apr 2010 243

CLOSING MEETING

PURPOSE OF CLOSING MEETING

CLOSING MEETING –PREPARATION

CLOSING MEETING –AGENDA

SESSION 3k

Apr 2010 244

CLOSING MEETINGCLOSING MEETING

FORMAL END OF THE ON-SITE AUDIT


CONDUCTED AT AUDITEE ORGANIZATION PREMISES

SENIOR MANAGEMENT OF AUDITEE ORGANIZATION PRESENT

123

Apr 2010 245

PURPOSE OF CLOSING MEETING PURPOSE OF CLOSING MEETING

A CLOSING MEETING IS HELD TO PRESENT AUDIT FINDINGS AND CONCLUSIONS

IT IS TO BE ENSURED THAT THE AUDIT FINDINGS ARE UNDERSTOOD AND ACKNOWLEDGED BY THE AUDITEE

A CORRECTIVE ACTION PLAN IS TO BE AGREED UPON, IF APPROPRIATE

TO CLARIFY AUDITEE’S DOUBTS

DISCUSS AND RESOLVE ANY DIVERGING OPINIONS. IF NOT, RECORD IT

Apr 2010 246

CLOSING MEETING CLOSING MEETING -- PREPARATIONPREPARATION

AUDIT TEAM MEETS BEFORE CLOSING MEETING TO:

REVIEW ALL THE NON – CONFORMANCES

CATEGORISE NCRs AS MAJOR/MINOR, IF APPLICABLE

PREPARE A SUMMARY REPORT

PREPARE AGENDA FOR THE CLOSING MEETING

124

Apr 2010 247

EXERCISE E:07EXERCISE E:07Learning Objective : How to conduct Closing Meeting

Method : Sequel to Case Study 3 : Role Play across two teams, playing role of the Audit team and the Management team respectively

Time : 45 minutes for team work : Preparation by all 4 teams for their respective roles (Refer 6.5.7 of ISO 19011)

30 minutes for Role play

30 minutes for Feedback

Apr 2010 248

CLOSING MEETING CLOSING MEETING –– AGENDAAGENDA


INTRODUCTION

THANKS FOR ASSISTANCE AND HOSPITALITY

RE-STATE OBJECTIVE AND SCOPE OF THE AUDIT

DISCLAIMER FOR SAMPLE AUDIT

EMPHASIS ON NEGATIVE REPORTING

PRESENT THE FINDINGS

EXPLAIN THE CONCLUSION/RECOMMENDATIONS

EXPLAIN THE SURVEILLANCE

125

Apr 2010 249

CLOSING MEETING CLOSING MEETING –– AGENDA AGENDA (Continued)(Continued)

RECONFIRM CONFIDENTIALITY

DIVERGING OPINIONS

CLARIFY AUDITEE’S DOUBTS

HAND OVER COPY OF THE REPORT

ASK FOR CORRECTIVE ACTION PLAN / COMMITMENT

RECORD ATTENDANCE AND PROCEEDINGS

IF SPECIFIED BY AUDIT OBJECTIVES, MAKE RECOMMENDATIONS FOR IMPROVEMENT BUT EMPHASISE THAT RECOMMENDATIONS ARE NOT BINDING

Apr 2010 250

AUDIT FOLLOW-UP

PURPOSE FOR CORRECTIVE ACTION

EVALUATION OF CORRECTIVE AND PREVENTIVE ACTION

SURVELLIANCE AUDIT

SESSION 3L

126

Apr 2010 251

AUDIT FOLLOWAUDIT FOLLOW--UPUP(Ref. ISO 9000 : 2005)(Ref. ISO 9000 : 2005)

CORRECTION

ACTION TO ELIMINATE A DETECTED NON-CONFORMITY

CORRECTIVE ACTION

ACTION TO ELIMINATE THE CAUSE OF A DETECTED NON-CONFORMITY OR OTHER UNDESIRABLE SITUATION

PREVENTIVE ACTION

ACTION TO ELIMINATE THE CAUSE OF A POTENTIAL NON-CONFORMITY OR OTHER UNDESIRABLE POTENTIAL SITUATION

Apr 2010 252

STEPS TAKEN BY AN AUDITEE TO CARRYOUT OUT CORRECTIVE ACTIONS

EXTERNAL AUDIT (2ND / 3RD PARTY)

RESPONSIBILITY AUDITOR

AUDITOR

GUIDE / AUDITEE

AUDITOR / LEAD AUDITOR

AUDITEE

M.R. / INTERNAL AUDITORS

OBSERVATION WITNESSED

NCR FORMAT FILLED

NCR CATEGORISED

TARGET DATE COMMITTED

IMPLEMENT ACTION

INTERNAL QUALITY AUDIT

NCR IDENTIFIED

INFORM EXTERNAL BODY ON COMPLETION OF ACTION

IS STATUS OK ?

NCR PRESENTED IN CLOSING MEETING

CAUSE IDENTIFICATION AND DETAILED PLAN OF ACTION

INFORM COMPLETION OF CORRECTIVE ACTION TO M.R.

AUDITOR / LEAD AUDITOR

AUDITEE

AUDITEE

AUDITEE

M.R. / INTERNAL AUDITORS YES

NO

M.R

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Apr 2010 253

EXERCISE E:08EXERCISE E:08Learning Objective : Understanding effectiveness of

Corrective action proposal

Method : Read two scenarios and evaluate the effectiveness of the corrective action proposal

Time : Discuss in pairs. Arrive at consensus. Record findings on Flip Charts

15 minutes for discussion

15 minutes for presentations

Apr 2010 254

VERIFICATION OF CORRECTIVE ACTIONVERIFICATION OF CORRECTIVE ACTION

REGULAR SCHEDULED AUDITSPECIAL FOLLOW–UP AUDITS / FOLLOW-UP ACTIVITIES

AS PER CONTRACTUAL REQUIREMENT OR AS DECIDED IN THE CLOSING MEETING

WRITING TO CERTIFICATION BODY AND/OR SUBMISSION OF DOCUMENTARY EVIDENCESPECIFIC FOLLOW – UP AUDITDURING REGULAR SURVEILLANCE

FIRST PARTY

SECOND PARTY

THIRD PARTY

128

Apr 2010 255

NCR / CORRECTIVE ACTION STATUS LOGNCR / CORRECTIVE ACTION STATUS LOG

N CR N O.

D ate Issued

Initiator Subject of

N CR

D ate of Response

Approval of

Response

V erified by (N ame) (D ate)

Closed (D ate)

O

Apr 2010 256

EVALUATION OF CORRECTIVE & EVALUATION OF CORRECTIVE & PREVENTIVE ACTIONPREVENTIVE ACTION

WHETHER THE ACTION HAS BEEN COMPLETED WITHIN THE TARGETED TIME.THE METHODOLOGY OF INTERNAL REVIEW FOR EFFECTIVENESS DOES THE REVIEW FOR EFFECTIVENESS COVER THE FOLLOWING AS APPLICABLE

NEED FOR CHANGE IN QMS PROCEDURESNEED FOR ADDITIONAL TRAININGNEED FOR APPLICATION OF MISTAKE PROOFING TOOLS.

NOTE : IF ANY OF THE THREE ACTIVITIES DETAILED ABOVE HAS NOT BEEN CONSIDERED, THERE ARE CHANCES OF PROBLEM RECURRENCE

129

Apr 2010 257

SURVEILLANCE AUDITSURVEILLANCE AUDIT

• PERIODIC AUDITS ON A CERTIFIED

ORGANISATION FOR DETERMINING THE

CONTINUING AND EFFECTIVE

IMPLEMENTATION OF THE QUALITY

MANAGEMENT SYSTEM

Apr 2010 258

SURVEILLANCE AUDITSURVEILLANCE AUDIT

ANNOUNCED

− GENERAL PRACTICE

− ENSURES AVAILABILITY OF KEY PERSONNEL

− UNLIKELY TO BE ABORTED

130

Apr 2010 259

SURVEILLANCE AUDIT ACTIVITIESSURVEILLANCE AUDIT ACTIVITIES

AUDIT OF LIMITED SECTION / AREA

HOWEVER THE FOLLOWING MUST BE AUDITEDinternal audits and management review,a review of actions taken on nonconformities identified during the previous audit,treatment of complaints,effectiveness of the management system with regard to achieving the certified client's objectives,progress of planned activities aimed at continual improvement,continuing operational control,review of any changes, anduse of marks and/or any other reference to certification.

Apr 2010 260

OTHER SURVEILLANCE OTHER SURVEILLANCE ACTIVITIESACTIVITIES

Other surveillance activities may include

• enquiries from the certification body to the certified client on aspects of certification,

• reviewing any client's statements with respect to its operations (e.g. promotional material, website),

• requests to the client to provide documents and records (on paper or electronic media), and

• other means of monitoring the certified client's performance.

131

Apr 2010 261

SPECIAL AUDITSSPECIAL AUDITS

Extensions to scope

• Can be combined with a surveillance audit

To investigate complaints, review changes or follow up on suspensions

• additional care in selecting audit team because lack of opportunity for client to object

O

Apr 2010 262

132

Apr 2010 263