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INSTITUTE OF QUALITY

Lead Auditor / Auditor Course


For Quality Management Systems
ISO 9001:2008

Apr 2010

INTRODUCTION

Apr 2010 2

1
INTRODUCTION OF PARTICIPANTS
¾ Participants are requested to find a partner each.

¾ You are expected to find out professional information about


your partner in 2 minutes. Also enquire his / her key
expected learning from the programme.

¾ Please record your findings. Write down your name and the
details collected from your partner

¾ Each participant would in turn introduce his partner to the


group and his key expected learning.

¾ Hand over your recorded findings to the tutors.

Duration : 30 Minutes

Apr 2010 3

COURSE FORMAT

¾ FOR A DURATION OF FIVE DAYS

¾ COVERS THE REQUIREMENTS OF IRCA / NABET

¾ ENABLES SUCCESSFUL CANDIDATES TO REGISTER

¾ INCLUDES CLASSROOM SESSIONS, SYNDICATE


WORKSHOPS, ROLE PLAY EXERCISES

¾ EXTENSIVE EXAMPLES AND CASE STUDIES BASED ON


INDUSTRY SITUATIONS

Apr 2010 4

2
COURSE 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 VARIOUS
METHODS 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 5

COURSE PROGRAMME

¾ BLEND OF LECTURES, INTERACTIVE WORKSHOPS AND


PRESENTATIONS

¾ ROLE PLAY ON OPENING AND CLOSING MEETINGS

¾ INCLUDES PRE-COURSE MATERIAL AND


COURSE MATERIAL

¾ CONTINUOUS ASSESSMENT OF PARTICIPANTS

¾ COURSE EXAMINATION

Apr 2010 6

3
DELEGATE RESPONSIBILITIES
¾ COURSE IS INTENSIVE, HENCE FULL ATTENTION AND
DILIGENCE IS REQUIRED

¾ TIME SCHEDULES ARE IMPORTANT

¾ BE ALERT, INTERACTIVE AND CO-OPERATIVE

¾ TAKING NOTES

¾ USE OF MOBILE PHONES PROHIBITED

¾ DELEGATES APPEAL AND COMPLAINT

Apr 2010 7

EVALUATION PROCESS & CRITERIA


• CONTINUOUS ASSESSMENT
• SKILL BASED PRACTICAL WORK
¾ TUTOR MARKED
¾ PRESENTATION / ROLE PLAY
¾ QUIZZES
ƒ DAILY ASSESSMENT
– CONTRIBUTION, QUESTIONING, COMMUNICATION,
REPORTING, PARTICIPATION IN TEAM
– PERSONAL ATTRIBUTES: ATTITUDE,
MANNER,SUITABILITY AS AUDITOR
– ATTENDANCE, PUNCTUALITY AND PARTICIPATION
¾ RESITTING THE EXAMINATION OR THE COURSE
• WRITTEN EXAMINATION
Apr 2010 8

4
ISSUE OF CERTIFICATES
¾ SUCCESSSFUL COMPLETION CERTIFICATE
ƒ WHEN THE DELEGATE HAS PASSSED BOTH THE
WRITTEN EXAMINATION AND CONTINUOUS
ASSESSMENT
¾ ATTENDANCE CERTIFICATE
ƒ WHEN THE DELEGATE HAS NOT PASSSED THE WRITTEN
EXAMINATION BUT SATISFIES THE CONTINUOUS
ASSESSMENT AND ATTENDANCE REQUIREMENT
¾ LETTER OF ATTENDANCE
ƒ WHEN THE DELEGATE IS NOT MEETING ANY OF THE
ABOVE BUT SATISFIES ATTENDANCE REQUIREMENT
ONLY
Apr 2010 9

SECTION – 1
Introduction to QMS

Apr 2010 10

5
Learning 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 11

Certification
and
Streamlining recognition
the systems

Purpose of Benefits
to stake
QMS holders

Improvement
in
performance Enhanced
market
standing

Apr 2010 12

6
BENEFITS OF QUALITY MANAGEMENT
¾ CUSTOMER CONFIDENCE
¾ CONSISTENCY IN QUALITY
¾ REDUCTION IN WASTE AND REWORK
¾ EMPLOYEE PARTICIPATION
¾ REDUCTION IN LIABILITIES
¾ IMPROVEMENT IN PROFIT
¾ CONTINUAL IMPROVEMENT

Apr 2010 13

Activity on understanding QMPs


Group exercise :Relate the following QMPS with
organizations with the attribute most identifiable to them
Process Approach
Factual decision
making
Customer Focus
Continual improvement

Systems Approach
Supplier relationship
Involvement of people

Leadership
Duration = 15 min.

Apr 2010 14

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PRINCIPLES OF QUALITY
MANAGEMENT
¾ TO LEAD AND OPERATE AN ORGANIZATION
SUCCESSFULLY, IT IS NECESSARY TO DIRECT AND
CONTROL IT IN A SYSTEMATIC AND
TRANSPARENT MANNER

¾ MANAGING AN ORGANIZATION ENCOMPASSES


QUALITY MANAGEMENT AMONGST OTHER
MANAGEMENT DISCIPLINES

¾ EIGHT QUALITY MANAGEMENT PRINCIPLES HAVE BEEN


IDENTIFIED AND THEY FORM THE BASIS OF ISO 9001 :
2008 STANDARD
Apr 2010 15

PRINCIPLES OF QUALITY
MANAGEMENT
• QUALITY MANAGEMENT QUALITY MANAGEMENT
PRINCIPLE 1 PRINCIPLE 2
• “CUSTOMER FOCUSED “LEADERSHIP”
ORGANIZATION”
LEADERS ESTABLISH UNITY OF PURPOSE
• ORGANIZATIONS DEPEND ON THEIR
AND DIRECTION OF THE ORGANIZATION.
CUSTOMERS AND THEREFORE
THEY CREATE THE INTERNAL ENVIRONMENT
SHOULD UNDERSTAND CURRENT
IN WHICH PEOPLE CAN BECOME FULLY
AND FUTURE CUSTOMER NEEDS,
INVOLVED IN ACHIEVING THE
MEET CUSTOMER REQUIREMENTS
AND STRIVE TO EXCEED CUSTOMER ORGANIZATION’S OBJECTIVE
EXPECTATIONS.

Apr 2010 16

8
PRINCIPLES OF QUALITY
MANAGEMENT
• QUALITY MANAGEMENT QUALITY MANAGEMENT
PRINCIPLE 3 PRINCIPLE 4

• “INVOLVEMENT OF PEOPLE” “PROCESS APPROACH”

• PEOPLE OF ALL LEVELS ARE THE A DESIRED RESULT IS ACHIEVED MORE


ESSENCE OF AN ORGANIZATION EFFICIENTLY WHEN RELATED
AND THEIR FULL INVOLVEMENT RESOURCES AND ACTIVITIES ARE
ENABLES THEIR ABILITIES TO BE MANAGED AS A PROCESS
USED FOR THE ORGANISATION’S
BENEFIT

Apr 2010 17

PRINCIPLES OF QUALITY
MANAGEMENT
• QUALITY MANAGEMENT QUALITY MANAGEMENT
PRINCIPLE 5 PRINCIPLE 6
• “SYSTEM APPROACH TO “CONTINUAL IMPROVEMENT”
MANAGEMENT”
• IDENTIFYING, UNDERSTANDING CONTINUAL IMPROVEMENT SHOULD BE
AND MANAGING A SYSTEM OF A PERMANENT OBJECTIVE OF THE
INTERRELATED PROCESSES FOR ORGANIZATION
A GIVEN OBJECTIVE IMPROVES
THE EFFECTIVENESS AND
EFFICIENCY OF THE
ORGANIZATION

Apr 2010 18

9
PRINCIPLES OF QUALITY
MANAGEMENT

• QUALITY MANAGEMENT QUALITY MANAGEMENT


PRINCIPLE 7 PRINCIPLE 8
• “FACTUAL APPROACH TO “MUTUALLY BENEFICIAL
DECISION MAKING” SUPPLIER RELATIONSHIP”

• EFFECTIVE DECISIONS ARE AN ORGANISATION AND ITS


BASED ON THE ANALYSIS OF SUPPLIERS ARE INTERDEPENDENT
DATA AND INFORMATION AND A MUTUALLY BENEFICIAL
RELATIONSHIP ENHANCES THE
ABILITY OF BOTH TO CREATE VALUE

Apr 2010 19

PDCA APPROACH

¾ CONCEPT INTRODUCED BY DR.SHEWHART IN


EARLY 40’S

¾ POPULARIZED BY DR. DEMING IN THE 1950’S

¾ BECAME KNOWN AS DEMING CYCLE

¾ PDCA STANDS FOR PLAN, DO, CHECK AND ACT

¾ PDCA CYCLE CAN BE APPLIED AT ALL LEVELS WITHIN


THE ORGANIZATION

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10
PDCA Cycle

PDCA cycle can be applied at all levels within the organization

Apr 2010 21

Activity on PDCA
Group 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.

Apr 2010 22

11
PROCESS

SET OF INTERRELATED OR INTERACTING ACTIVITIES WHICH


TRANSFORM INPUTS INTO OUTPUTS (ISO 9000-2008)

¾ OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTS


INTO OTHER PROCESSES,

¾ PROCESSES MAY BE INTERRELATED OR


INDEPENDENT,

¾ OVERALL AIM IS TO ADD VALUE BY PLANNING AND


CONTROLLING PROCESSES

Apr 2010 23

BASIC PROCESS MODEL


CON TROL / P R OC ED UR ES

MA N AG EM ENT DESIRED
CU STOM ER CU STOM ER

PROCESS ACTIVITIES
SATISFA C TIO N
INP U T
OUTPU TS
EN ABLER S
(RESU LTS)

MO N ITO R ING M EASU REM EN TS

Apr 2010 24

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PRODUCT

¾ THE RESULT OF A PROCESS (ISO 9000-2008)

¾ 4 GENERIC PRODUCT CATEGORIES

ƒ HARDWARE TANGIBLE PRODUCTS

ƒ PROCESSED MATERIAL

ƒ SOFTWARE

ƒ SERVICE

¾ MOST PRODUCTS ARE COMBINATION OF THESE


Apr 2010 25

PROCESS
AN 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

PROCESS APPROACH
THE 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
Apr 2010 26

13
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 27

QMS PROCESSES
QMS TYPICALLY INCLUDES PROCESSES FOR

¾MANAGEMENT ACTIVITIES

¾PROVISION OF RESOURCES

¾PRODUCT REALIZATION

¾MEASUREMENT

Processes are not restricted to production


or service delivery activities only
Apr 2010 28

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PROCUREMENT PROCESS
• Procure material as per
• Actions on vendor related required specs and at
quality problem required date
• Improvement project with • Improve quality of incoming
vendor material
• Improve turn over
• Training needs of dept.
• Optimise inventory
Personnel & vendors
• Cost reduction
P • Timely payment of vendors

A D
• Review of pending payments beyond
agreed time
• Review incoming material go rate C • Vendor selection and
w.r.t. goal (item wise) evaluation
• Chronic vendor problems • Cost reduction project
allotment
• Cost reduction achievement review
• Procure products as per drg
• Status of inventory item wise &
and tech specs.
reduction of prod. Lead Time. (item
wise) • Periodic process audit and
periodic Rating
• Review of matl. With Material
Requirement Planning % (MRP) • Processing of bill/invoice
delivery adherance • Inventory management
• Review inspection cycle time • Disposal of receipt rejection
incoming (itemwise SRV)

Apr 2010 29

EVALUATING A PROCESS WITHIN THE QMS


INCLUDES AUDIT OF :
ƒ PROCESS INPUTS, OUTPUTS & RESULTS
ƒ PROCESS MEASURES, LINKAGE WITH QUALITY OBJECTIVES
& MEASURES FOR CONTINUAL IMPROVEMENT

THROUGH THE 4 BASIC QUESTIONS


ƒ IS THE PROCESS IDENTIFIED & APPROPRIATELY DEFINED ?
ƒ ARE RESPONSIBILITIES ASSIGNED ?
ƒ ARE THE PROCEDURES IMPLEMENTED & MAINTAINED ?
ƒ IS THE PROCESS EFFECTIVE IN ACHIEVING THE REQUIRED
RESULTS?
PROCESSES MAY OR MAY NOT BE DEFINED BY
DOCUMENTATION
Apr 2010 30

15
Activity on understanding and documenting
Process 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 31

Raw
Material
Storage Planning

Procurement Any
other
Process
process

Incoming

Inspection Production

Processes

Apr 2010 32

16
SECTION – 2

Apr 2010 33

Learning Objective

• By the end of the session successful students


will be able to :

¾ Explain the purpose, content & inter-


relationship of ISO 9000, ISO 9001 & ISO 9004

Apr 2010 34

17
Session 2a
Purpose, content & inter – relationship
of ISO 9000 family of Standards

Apr 2010 35

Activity on identifying the Purpose of


ISO 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.

Apr 2010 36

18
ISO 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 37

IS O 9 0 0 4
ISO 9001 Perspective
Quality of product and customer
satisfaction (effectiveness)
I SO 90 0 1

ISO 9004 Perspective


Wider 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.
Apr 2010 38

19
ISO 9001 & 9004 : Relationship diagram

Apr 2010 O 39

Auditing Standards (Guidelines)

Guideline Standards originally published by ISO


Quality Management

1 1
ISO 10011-1:1990 Guidelines for auditing quality systems -- Part 1: Auditing
• 19 0
ISO 10011-2:1991 Guidelines for auditing quality systems -- Part 2: Qualification criteria for
quality systems auditors
O

y I S
ISO 10011-3:1991 Guidelines for auditing quality systems -- Part 3: Management of audit

db
programmes

s ede
Environmental Management
er
• up
ISO 14010:1996 Guidelines for environmental auditing -- General principles
s

N owmanagement
ISO 14011:1996
environmental
Guidelines for environmental auditing -- Audit procedures -- Auditing of
systems
• ISO 14012:1996 Guidelines for environmental auditing -- Qualification criteria for
environmental auditors

Apr 2010 40

20
ISO 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 41

NATIONAL ISO 9000 SERIES 1987 ISO 9000


STANDARDS 9001 9002 9003 ISO 9004
EN EN 29000
29001 29002 29003 EN 29004

ISO 9000 SERIES 1994 ISO 9000-1, 9000-2


9001 9002 9003 ISO 9004-1, 9004-2, 9004-3

ISO 9001 : 2000 ISO 9004 : 2000

ISO 9000 : 2005


ISO 9001 : 2008
ISO 9004 : 2009
(CONTRACTUAL) (NON-CONTRACTUAL)

Apr 2010 42

21
How is ISO Standard Revised
¾ International organization for standardization (ISO)
is a federation of national standards bodies
¾ ISO works through technical committees.
(TC–176 has the responsibility to issue and update
ISO 9000 standards )
¾ TC – 176 is supported by Sub Committees and
Working Groups (WG)
¾ The standard progresses from Preliminary Working
Draft (PWD) Î Committee Draft (CD) Î Draft
International Standard (DIS) Î Finalized Draft
International Standard (FDIS) Î Published
International Standard
¾ The standard is published only after positive votes
from members

Apr 2010 43

Activity on identifying differences between Auditable


Standard (AS) & Guidance Documents (GD)
Standard AS/ GD Why?

ISO 9000

ISO 9001

ISO 9004

ISO 19011

Identify the auditable standards & the guidance documents from the table

Discuss the rationale for this distinction in your syndicate group


Duration = 20 min.

Apr 2010 44

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Auditable Standards /
Guidance Documents
¾ Auditable standard - ISO 9001:2008
ƒ Requirements for a QMS as specified
ƒ Audits are carried out against the
requirements of ISO 9001. ISO 9001:2008
Requirements
¾ Guidance documents
ƒ ISO 9000 - fundamentals & vocabulary
ƒ ISO 9004 - Managing for Sustained
success of an organization – a quality
management approach
ƒ “Notes” under requirement specified in
ISO 9001 standard
Apr 2010 45

Legal compliance vs conformance to ISO 9001(1)


¾ 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
Examples

– Safety for medical equipments


– Intrinsically safe equipment in gas
dangerous zone
– FDA regulations for food products
& medicines

Apr 2010 46

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Legal compliance vs conformance to ISO 9001(2)

Vendor
Customer driven selection by
corporate

Conformance
to QMS
standard

Voluntary decision Market image


& entry into
new markets

Apr 2010 47

Session 2b
QMS Terminology

Apr 2010 48

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Activity 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 49

Definition Terminology Definition


1. Quality A. Information and its supporting medium
2. Grade B. ………….. increasing the ability to fulfill quality requirements
3. Customer Satisfaction C. ……. who directs and controls an organization, at the highest level
4. Quality Policy D. Document specifying the quality management system of an organization
5. Quality Objectives E. …..inherent characteristics fulfills requirements
6. Top Management F. ……… aimed for, related to quality
7. Quality Management G. Document specifying .. procedure and associated resources …… a specific
project, product, process or contract
8. Quality Control H. Extent to which planned activities are realized and planned results achieved
9. Quality Assurance I. Management system to direct and control an organization ….
10. Quality Planning J. Co-ordinated activities to direct and control an Organization ……
11. Quality Improvement K. The non – fulfillment of a requirement
12. Quality Management L. Document stating results achieved or providing evidence ……
Systems
13. Conformity M. Part of quality management focused on providing confidence …...
14. Non – Conformity N. Overall intentions and direction of an organization…….
15. Defect O. Category or rank given …. having the same functional use
16. Document P. Relationship between the result achieved and resources used
17. Quality Plan Q. Customer’s perception ……customer’s requirements have been fulfilled
18. Quality Manual R. The non – fulfillment of a requirement, related to an intended or specified use
19. Record S. Part of quality management focused on Fulfilling quality requirements
20. Effectiveness T. Part of quality management, focused on setting quality objectives and specifying
necessary operational process and related resources to fulfill the quality objectives
21. Efficiency U. The fulfillment of a requirement

Apr 2010 50

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QUALITY
DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS
FULFILLS REQUIREMENTS

GRADE
CATEGORY OR RANK GIVEN TO DIFFERENT QUALITY
REQUIREMENTS FOR PRODUCTS, PROCESSES OR SYSTEMS HAVING
THE SAME FUNCTIONAL USE

CUSTOMER SATISFACTION
CUSTOMER’S PERCEPTION OF THE DEGREE TO WHICH
THE CUSTOMER’S REQUIREMENTS HAVE BEEN FULFILLED

Apr 2010 51

QUALITY POLICY
OVERALL INTENTIONS AND DIRECTION OF AN ORGANIZATION
RELATED TO QUALITY, AS FORMALLY EXPRESSED BY TOP
MANAGEMENT

QUALITY OBJECTIVES
SOMETHING SOUGHT OR AIMED FOR, RELATED TO QUALITY

Apr 2010 52

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TOP MANAGEMENT

PERSON OR GROUP OF PEOPLE WHO


DIRECTS AND CONTROLS AN ORGANIZATION,
AT THE HIGHEST LEVEL

Apr 2010 53

QUALITY MANAGEMENT
CO-ORDINATED ACTIVITIES TO DIRECT AND CONTROL AN

ORGANIZATION WITH REGARD TO QUALITY

QUALITY CONTROL
PART OF QUALITY MANAGEMENT FOCUSED ON

FULFILLING QUALITY REQUIREMENTS

QUALITY ASSURANCE
PART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING

CONFIDENCE THAT QUALITY REQUIREMENTS WILL BE FULFILLED

Apr 2010 54

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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 55

QUALITY MANAGEMENT SYSTEMS

MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN


ORGANIZATION WITH REGARD TO QUALITY

Apr 2010 56

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CONFORMITY
THE FULFILLMENT OF A REQUIREMENT

NON – CONFORMITY
THE NON – FULFILLMENT OF A REQUIREMENT

DEFECT
THE NON – FULFILLMENT OF A REQUIREMENT, RELATED TO AN
INTENDED OR SPECIFIED USE

Apr 2010 57

DOCUMENT
INFORMATION AND ITS SUPPORTING MEDIUM

QUALITY PLAN
DOCUMENT SPECIFYING WHICH PROCEDURE AND ASSOCIATED
RESOURCES SHALL BE APPLIED BY WHOM AND WHEN TO A
SPECIFIC PROJECT, PRODUCT, PROCESS OR CONTRACT

QUALITY MANUAL
DOCUMENT SPECIFYING THE QUALITY MANAGEMENT SYSTEM OF AN
ORGANIZATION

RECORD
DOCUMENT STATING RESULTS ACHIEVED OR PROVIDING EVIDENCE
OF ACTIVITIES PERFORMED
Apr 2010 58

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EFFECTIVENESS
EXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED AND
PLANNED RESULTS ACHIEVED

EFFICIENCY

RELATIONSHIP BETWEEN THE RESULT ACHIEVED AND RESOURCES


USED

Apr 2010 59

Session 2c
ISO 9001: 2008 QMS Requirements

Apr 2010 60

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Continual improvement of
the quality management system

Management
responsibility

Customers
Measurement,
Resource
Customers management
analysis and Satisfaction
improvement

Output
Input Product Product
Requirements Realization

Value adding activities

Information flow

Apr 2010 61

1. Scope and general


2. Normative references
3. Terms & definitions Clauses
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement

Apr 2010 62

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Scope of ISO 9001
General
¾ This international standard specifies requirements for a quality
management system where an organization
ƒ Needs to demonstrate its ability to consistently provide product
that meets customer and applicable statutory & regulatory
requirements, and
ƒ Aims 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 63

Scope of ISO 9001


Application

¾ 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

¾ 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.

¾ Exclusions are limited to requirements stated in clause 7.

¾ 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
Apr 2010 64

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Justification of Exclusions
¾ When 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.

¾ This must also be clear in any other


publicly available document, such
as certification/registration
document or marketing material

Apr 2010 65

Most Likely Exclusions


¾ Within clause 7 (product realization), the following are the
most likely requirements, though not the only ones.

7.5.4
7.3 Design & Customer
development Most Likely property
Exclusions

7.6 Control
7.5.3 of monitoring
Identification & &
traceability measuring
(traceability may devices.
not be applicable)

Apr 2010 66

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Scope of Audit

• Extent and Boundaries


¾Product
¾Physical location
¾Organizational units
¾Activities/ Processes

Apr 2010 67

Activity on Understanding ISO 9001


Requirements

• 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

Apr 2010 68

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4.0 Quality
Management 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 69

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
Apr 2010 70

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5.0 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 71

6.0 Resource Management

Training
6.1 Provision of Resources

6.2 Human Resources

6.3 Infrastructure

6.4 Work Environment

Work Environment
Apr 2010 72

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7.0 Product Realization

7.1 Planning of Product Realization


7.2 Customer – Related Processes
7.3 Design And Development
7.4 Purchasing
7.5 Production & Service Provision
7.6 Control of Monitoring & Measuring Devices

Apr 2010 73

7.5 Production &


Service 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

Apr 2010 74

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8.0 Measurement, Analysis
& Improvement

8.1 General

8.2 Monitoring & Measurement

8.3 Control of Nonconforming Product

8.4 Analysis of Data

8.5 Improvement

Apr 2010 75

8.2 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

Apr 2010 76

38
Activity on identifying relationship between Quality
Management Principles (QMPs) & 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 77

RELATIONSHIP BETWEEN THE QMPs AND ISO 9001


ISO 9001
P1 P2 P3 P4 P5 P6 P7 P8
Clauses
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
Apr 2010 P3 People Involvement P7 Fact Based Approach 78
P4 Process approach P8 Supplier Relationship

39
Session 2d
Documentation for QMS

Apr 2010 79

Documentation
Requirements

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.

Apr 2010 80

40
Activity 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
¾ A large scale industry
¾ A small scale industry
• What in your opinion are the reasons
for these differences ?
• Tutor lead discussion
Duration 10 mins

Apr 2010 81

Areas of differences
• Degree of Formality
¾ Content
¾ Number
¾ Issue procedures
• Hierarchy of documents
• Document numbering system
• Style of presentation
• Medium
• Distribution of responsibilities
for document approval
Apr 2010 82

41
Typical Quality Management System
Documentation Hierarchy

Source: lS/lSO/TR 10013:2001

Apr 2010 83

A Typical Quality Manual

1. Title and scope


2. Table of contents Quality
l
Manua
3. Review, approval and revision
4. Quality policy and objectives
5. Organization, responsibility and authority
6. References
7. Quality management system description
8. Appendices
Source: lS/lSO/TR 10013:2001

Apr 2010 84

42
Structure of a typical Documented procedure

• Text
• Flow charts,
• Tables
• A combination of the
above,
• Or any other suitable
method

Source: lS/lSO/TR 10013:2001

Apr 2010 85

Content of a typical Documented procedure


• Title
• Purpose
• Scope
• Responsibility and authority •

Xm
mm xmx
xm mx
• Xm xm mx
mx m mx
Xm mm mm

• Description of activities •
• mm mx
X,x
xm xmm
mm m
m
xm mx
m

xm mxm
mm
xm
xm
mx
mx
m
mm mm
mx
xm
m

• Xm m
mx m m x m m mx
Xm m mm m

• Records mx xm xm
m xm m
xm xm
xm xm
xm mm
xm mx
mx m
m

• Appendices
• Review, approval and revision
• Identification of changes
Source: lS/lSO/TR 10013:2001

Apr 2010 86

43
Work 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

Source: lS/lSO/TR 10013:2001

Apr 2010 87

Value of Documentation

¾ Enables communication of intent and consistency of action


¾ Definition of roles for members
¾ Enhancement of understanding
¾ Control and measurement
¾ System becomes auditable
¾ Evaluation of the effectiveness and continuing
suitability of QMS
¾ Information useful for training and competence building
¾ Provides confidence in the QMS
¾ Helps in continual improvement
¾ Provides repeatability and traceability
Apr 2010 88

44
SECTION – 3
Auditing QMS

Apr 2010 89

Section – 3
• LEARNING OBJECTIVES:
• By the end of the section, successful students will be able to
:
¾ Understand the Audit process

¾ Explain the role of auditor to plan, conduct, report and


follow up a QMS audit in accordance with ISO 19011

¾ Understand audit responsibilities

¾ Develop the skills required to plan, prepare, conduct and


report on audits

¾ Understand the certification / registration and


accreditation processes

¾ IRCA / NABET Schemes for Auditor certification

45
Section – 3
Sessions
¾ Accreditation certificate and auditor certification (3 a)
¾ Role of IRCA / NRBPT and Auditor certification (3 b)
¾ Introduction to Auditing (3 c)
¾ Auditor responsibilities (3 d)
¾ Audit Programmes (3 e)
¾ Planning of Audits (3 f)
ƒ Checklists (3 g)
¾ Conducting Audits
ƒ Opening meeting (3 h)
ƒ Onsite auditing and audit skills (3 i)
ƒ Closing meeting (3 j)
¾ Audit reporting (3 k)
¾ Audit follow up (3 l)

Learning Objective – Session 3

• By the end of the session, successful students


will be able to :

¾ Explain the role of an auditor to plan,


conduct, report and follow up a quality
management system audit in accordance with
ISO 19011.

Apr 2010 92

46
SESSION 3a
CERTIFICATION AND
ACCREDITATION
¾ CERTIFICATION

¾ ACCREDITATION

¾ REGISTRATION SCHEME FOR LEAD AUDITORS / AUDITORS

¾ PRINCIPLES OF AUDITING

¾ CONFIDENTIALITY

¾ CONFLICT OF INTEREST

Apr 2010 93

ACCREDITATION
BOARD

APPLICATION FOR AUDIT AND SURVEILLANCE


ACCREDITATION BY ACCREDITATION BOARD

CERTIFICATION BODY (CB)

APPLICATION FOR AUDIT AND


CERTIFICATION SURVEILLANCE BY CB

ORGANIZATION

Apr 2010 94

47
CONFORMITY ASSESSMENT IN UK
DTI

UKAS IRCA/CQI

NAMAS QUALITY MANAGEMENT TRAINING REGISTRATION


LABORATORY SYSTEM CERTIFICATION COURSES
ACCREDITATION BODIES AUDITOR

LEAD AUDITOR

PRINCIPAL
DTI : DEPARTMENT OF TRADE AND INDUSTRY AUDITOR
NAMAS : NATIONAL MEASUREMENT ACCREDITATION SCHEME
PROVISIONAL
UKAS : UNITED KINGDOM ACCREDITATION SERVICES AUDITOR

IRCA : INTERNATIONAL REGISTER OF CERTIFICATED AUDITORS INTERNAL


AUDITOR
CQI : CHARTERED QUALITY INSTITUTE

Apr 2010 95

CONFORMITY ASSESSMENT IN INDIA


Quality Council of India

Secretariat

NABCB NABET NABH NABL


National National National National
Accreditation Accreditation Accreditation Accreditation Board
Board for Board for Board for for Testing &
Certification Education & Hospitals & Health Calibration
Bodies Training services Laboratories

QIES
NBQP
Quality Information &
National Board for
Enquiry Services
Quality Promotion

Apr 2010 96

48
ACCREDITATION

ACCREDITATION OFFERS ASSURANCE TO


THE CERTIFICATION PROCESS

REFERENCE STANDARD FOR ACCREDITATION


EN 45012 / ISO 17021

Apr 2010 97

CERTIFICATION

• CREDIBILITY OF QUALITY SYSTEM


CERTIFICATION DEPENDS ON
) IMPARTIALITY

) WELL DEFINED SCOPE

) MAINTENANCE OF THE CERTIFICATE

) COMPETENCE OF THE AUDITORS

) CONSISTENCY OF APPROACH

Apr 2010 98

49
BENEFITS 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 99

SESSION 3b

ROLE OF IRCA / NABET

AND

AUDITOR CERTIFICATION REQUIREMENTS

Apr 2010 100

50
INTERNATIONAL REGISTRATION SCHEME FOR
AUDITORS 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 101

REGISTRATION AS AUDITOR /
LEAD AUDITOR

DEPENDS UPON

) EDUCATIONAL QUALIFICATION

) WORK EXPERIENCE

) AUDIT EXPERIENCE

) 40 HOURS OF AUDITORS TRAINING

) AUDITOR COMPETENCE

Apr 2010 102

51
COMPETENCE AND EVALUATION
OF AUDITORS

ƒ A COMPETENT AUDITOR
ƒ GENERIC KNOWLEDGE & SKILLS
ƒ SPECIFIC KNOWLEDGE & SKILLS
ƒ EDUCATION, WORK EXPERIENCE, TRAINING
& AUDIT EXPERIENCE
ƒ AUDITOR EVALUATION

Apr 2010 103

A COMPETENT AUDITOR

¾ DEMONSTRATES PERSONAL ATTRIBUTES


¾ DEMONSTRATES ABILITY TO APPLY THE KNOWLEDGE &
SKILLS TO CONDUCT SUCCESSFUL AUDITS & ACHIEVE
THE AUDIT OBJECTIVES
¾ GAINS COMPETENCE THROUGH
ƒ EDUCATION
ƒ WORK EXPERIENCE
ƒ AUDIT TRAINING
ƒ AUDIT EXPERIENCE

Apr 2010 104

52
PERSONAL ATTRIBUTES

¾ ETHICAL
¾ OPEN-MINDED
¾ DIPLOMATIC
¾ OBSERVANT
¾ PERCEPTIVE
¾ VERSATILE
¾ TENACIOUS
¾ DECISIVE
¾ SELF RELIANT
Apr 2010 105

GENERIC KNOWLEDGE & SKILLS


FOR AUDITORS

¾ AUDIT PRINCIPLES, PROCEDURES & TECHNIQUES

¾ MANAGEMENT SYSTEM & REFERENCE DOCUMENTS

¾ ORGANIZATIONAL SITUATIONS

¾ APPLICABLE LAWS, REGULATIONS & OTHER


REQUIREMENTS

Ref : ISO 19011: 2002 Section 7.3.1

Apr 2010 106

53
SPECIFIC KNOWLEDGE & SKILLS
FOR QMS AUDITORS
QUALITY RELATED METHODS AND TECHNIQUES
¾ QUALITY TERMINOLOGY
¾ QUALITY MANAGEMENT PRINCIPLES & THEIR APPLICATION
¾ QUALITY MANAGEMENT TOOLS

PROCESSES AND PRODUCTS INCLUDING SERVICES


¾ SECTOR SPECIFIC TERMINOLOGY
¾ TECHNICAL CHARACTERISTICS OF PROCESSES & PRODUCTS

Ref : ISO 19011: 2002 Section 7.3.3

Apr 2010 107

GENERIC KNOWLEDGE & SKILLS


OF LEAD AUDITORS

ABILITY TO
¾ PLAN THE AUDIT & MAKE EFFECTIVE USE OF RESOURCES
¾ REPRESENT THE AUDIT TEAM
¾ ORGANIZE & DIRECT THE TEAM
¾ DIRECT & GUIDE AUDITORS IN TRAINING
¾ LEAD AUDIT TEAM TO REACH AUDIT CONCLUSIONS
¾ PREVENT / RESOLVE CONFLICTS
¾ PREPARE AUDIT REPORT

Apr 2010 108

54
EDUCATION, WORK EXPERIENCE, TRAINING
AND AUDIT EXPERIENCE OF AUDITORS

¾ EDUCATION TO PROVIDE GENERIC & SPECIFIC


KNOWLEDGE & SKILLS
¾ WORK EXPERIENCE TO CONTRIBUTE TO THE
DEVELOPMENT OF KNOWLEDGE & SKILLS IN
QUALITY MANAGEMENT FIELD
¾ COMPLETION OF AUDITOR TRAINING
¾ AUDIT EXPERIENCE UNDER THE GUIDANCE OF
A COMPETENT LEAD AUDITOR

Apr 2010 109

EDUCATION, WORK EXPERIENCE, TRAINING


AND AUDIT EXPERIENCE OF LEAD AUDITORS

¾ SHOULD HAVE ACQUIRED ADDITIONAL AUDIT


EXPERIENCE TO DEVELOP THE REQUIRED
KNOWLEDGE AND SKILLS

¾ THE ADDITIONAL EXPERIENCE IS FROM ACTING IN


THE ROLE OF AN AUDIT TEAM LEADER UNDER THE
GUIDANCE OF ANOTHER COMPETENT AUDIT TEAM
LEADER

Apr 2010 110

55
LEVELS OF EDUCATION, WORK EXPERIENCE,
AUDITOR TRAINING & AUDIT EXPERIENCE

¾ APPROPRIATE FOR AUDITORS CONDUCTING


CERTIFICATION OR SIMILAR AUDITS.

¾ HIGHER OR LOWER LEVELS ARE APPROPRIATE


DEPENDING ON THE AUDIT PROGRAMME

¾ Ref TABLE 1 of ISO 19011

Apr 2010 111

Table 1 – Example of levels of education, work experience, auditor training


training and
audit experience for auditors conducting certification or similar
similar audits
Auditor in both Audit team
Parameter Auditor
disciplines leader
Education Secondary education Same as for Auditor Same as for Auditor
Total work experience 5 years Same as for Auditor Same as for Auditor
Work experience in At least 2 years of the total 2 years in the second Same as for Auditor
quality or environmental 5 years discipline
management field
Auditor training 40 h. of Audit training 24 h. of training in the 2nd Same as for Auditor
discipline
Audit experience Four complete audits for a Three complete audits for a Three complete audits
total of at least 20 days of total of at least 15 days of for a total of at least 15
audit experience as an audit experience in the 2nd days of audit experience
auditor– in- training under discipline under the direction acting in the role of an
the direction & guidance of & guidance of an auditor audit team leader under
an auditor competent as competent as an audit leader the direction & guidance
an audit team leader in the 2nd discipline . of an auditor competent
The audits should be The audits should be as an audit team leader.
completed within the last 3 completed within the last two
consecutive years consecutive years.
(Contd..)
Apr 2010 O 112

56
MAINTENANCE & IMPROVEMENT OF
COMPETENCE OF AUDITOR

¾ CONTINUAL PROFESSIONAL DEVELOPMENT

¾ MAINTENANCE OF AUDITING ABILITY

Apr 2010 113

AUDITOR COMPETENCE EVALUATION

¾ INITIAL EVALUATION OF AUDITORS WHO WISH


TO BECOME AUDITORS
¾ AS PART OF THE AUDIT TEAM SELECTION
PROCESS
¾ CONTINUAL EVALUATION OF AUDITOR
PERFORMANCE TO IDENTIFY NEEDS FOR
MAINTENANCE & IMPROVEMENT OF
KNOWLEDGE & SKILLS

Apr 2010 O 114

57
RELATIONSHIP BETWEEN THE STAGES OF EVALUATION

Development of Competence
Criteria
not met Continual Evaluation of
Initial Evaluation Performance

Criteria met
Criteria met
Criteria not met
Auditor

Not Selected Maintenance &


Improvement of
Audit Team Selection Competence

Auditing

Apr 2010 O 115

COMPETENCE EVALUATION PROCESS


¾ IDENTIFY PERSONAL ATTRIBUTES, KNOWLEDGE & SKILLS

¾ SET EVALUATION CRITERIA (WORK EXPERIENCE, EDUCATION,


NUMBER OF AUDITS, HOURS OF AUDIT TRAINING)

¾ SELECT APPROPRIATE EVALUATION METHODS (REVIEW OF


RECORDS, FEEDBACK, INTERVIEW, OBSERVATION, TESTING,
POST AUDIT REVIEW)

¾ CONDUCT EVALUATION

Apr 2010 O 116

58
CONFLICT OF INTEREST

¾ AUDITORS SHOULD ENSURE THAT THERE IS NO


CONFLICT OF INTEREST DURING THE AUDIT.

¾ CONFLICT OF INTEREST CAN OCCUR IF AN AUDITOR


IS AN INTERESTED PARTY OF THE ORGANIZATION.

¾ 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 117

WITNESSING OF AUDITORS
) COVERAGE 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

Apr 2010 118

59
SESSION 3c
INTRODUCTION TO AUDITING
¾ WHY AND WHAT OF AUDITS
¾ AUDIT TERMINOLOGY
¾ TYPES OF AUDITS
¾ STAGES OF AUDITS
¾ PROCESS APPROACH TO AUDITS

Apr 2010 119

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


Apr 2010 120

60
PRINCIPLES OF
AUDITING
¾ ETHICAL CONDUCT (TRUST, INTEGRITY, CONFIDENTIALITY,
DISCRETION)
¾ FAIR PRESENTATION (TRUTHFUL & ACCURATE REPORTING)
¾ DUE PROFESSIONAL CARE (DILIGENCE & JUDGMENT IN
AUDITING)
¾ INDEPENDENCE (INDEPENDENT, FREE FORM BIAS & CONFLICT
OF INTEREST OBJECTIVES)
¾ EVIDENCE BASED APPROACH (RELIABLE & REPRODUCIBLE
AUDIT CONCLUSIONS BASED ON VERIFIABLE EVIDENCE &
APPROPRIATE SAMPLING)
Apr 2010 121

AUDIT TERMINOLOGY
AUDIT
SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR
OBTAINING AUDIT EVIDENCE AND EVALUATING IT
OBJECTIVELY TO DETERMINE THE EXTENT TO WHICH AUDIT
CRITERIA ARE FULFILLED

AUDIT EVIDENCE
RECORDS, STATEMENTS OF FACT OR
OTHER INFORMATION WHICH ARE RELEVANT TO
THE AUDIT CRITERIA AND VERIFIABLE.

AUDIT CRITERIA
SET OF POLICIES, PROCEDURES OR REQUIREMENTS,
USED AS REFERENCE
Apr 2010 122

61
AUDIT FINDINGS

RESULTS OF THE EVALUATION OF COLLECTED


AUDIT EVIDENCE AGAINST AUDIT CRITERIA

AUDIT CONCLUSION
OUTCOME OF AN AUDIT PROVIDED BY THE AUDIT
TEAM AFTER CONSIDERATION OF THE AUDIT
OBJECTIVES & ALL AUDIT FINDINGS

Apr 2010 123

AUDIT PROGRAMME
SET OF ONE OR MORE AUDIT PLANNED FOR A
SPECIFIC TIME FRAME & DIRECTED TOWARDS A
SPECIFIC PURPOSE

AUDIT PLAN
DESCRIPTION OF THE ACTIVITIES &
ARRANGEMENTS FOR AN AUDIT

AUDIT SCOPE
EXTENT & BOUNDARIES OF AN AUDIT
Apr 2010 124

62
TYPES OF AUDIT
• INTERNAL AUDITS
FIRST PARTY AUDIT
AN AUDIT PERFORMED WITHIN AN ORGANIZATION BY THE
ORGANIZATION’S OWN AUDITING RESOURCES.

• EXTERNAL AUDIT
SECOND 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 AUDIT


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

Apr 2010 125

First, Second and Third party audits


Auditor roles
• Common
¾ To conduct audit in a professional and unbaised manner
¾ Finding evidence against defined criteria
¾ Determining effectiveness of processes and systems
• Varying
¾ First party –to determine opportunities for improvements
ƒ Can give suggestions in the reports
¾ Second party –to determine capability of auditee’s systems to supply
products / services
ƒ Can mutually agree on improvements specific to contract
¾ Third Party –to determine capability to meet and enhance satisfaction of
all customers
Apr 2010 O 126

63
First, Second and Third party audits
Auditee roles
• Common
¾ To provide for time and resources for the audit to be conducted
• Varying Objectives
¾ First party
ƒ To develop internal audit criteria and ensure its implementation
ƒ To plan and schedule audits based on importance of activities
ƒ To provide competent and independent internal auditors
ƒ To take follow up actions on internal audit reports and review
findings in management review
¾ Second and third party
ƒ To agree on audit dates, audit plans and auditors
ƒ To provide guides during audits
ƒ To agree on improvement actions if non conformances are raised
ƒ To take follow up actions and report to audit client
Apr 2010 O 127

First, Second and Third party audits


Audit Client role
Common
¾ To establish and inform to auditee and auditors
ƒ Audit criteria which may include statutory / regulatory requirements
ƒ Expectations from audits
ƒ Audit procedure and manner of reporting
• Varying
¾ First party – Top Management is Audit Client
ƒ To review audit findings during management review and take decisions for improvements
¾ Second party
ƒ To inform auditee of any contract specific audit criteria
ƒ To receive a specific evaluation report from the audit team in respect of the terms of
contract and / or regulatory requirements
ƒ To base business decisions on the report findings
¾ Third Party –
ƒ To receive a report from the audit team with recommendations
ƒ To inform decisions on certification or approval as relevant

Apr 2010 O 128

64
STAGES OF AUDIT
INITIATING THE AUDIT

STAGE 1 AUDIT

STAGE 2 AUDIT

ONSITE AUDIT ACTIVITIES

REPORTING ON THE AUDIT

AUDIT COMPLETION

AUDIT FOLLOW UP

Apr 2010 129

STAGE 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.

Apr 2010 130

65
STAGE 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 131

TYPICAL STAGES OF AUDIT


I. DOCUMENTATION REVIEW
ƒ REVIEW OF RELEVANT MANAGEMENT SYSTEM
STAGE DOCUMENTS AND RECORDS, IF REQUIRED, AND
1 DETERMINATION OF THEIR ADEQUACY
II. VERIFICATION OF PREPAREDENESS OF AUDITEE (OFF SITE +
ON SITE)

III. ON-SITE AUDIT


ƒ CONDUCTING OPENING MEETING
ƒ COLLECTING AND VERIFYING INFORMATION
(COLLECTING AUDIT EVIDENCE)
ƒ IDENTIFYING AUDIT FINDINGS STAGE
2
ƒ COMMUNICATION DURING THE AUDIT
ƒ AUDIT CONCLUSIONS
ƒ PREPARATION FOR CLOSING MEETING
ƒ CONDUCTING CLOSING MEETING
Apr 2010 132

66
AUDITING QMS DOCUMENTATION

¾ USE CHECK LIST / MATRIX.

¾ CAN BE DONE OFF-SITE BUT ON-SITE REVIEW PREFERRED.

¾ SHOULD COVER ALL THE LEVELS OF QUALITY SYSTEM


DOCUMENTS; MAY BE RESTRICTED TO QUALITY MANUAL,
INITIALLY, IN THIRD PARTY AUDITS FOR CONFIDENTIALITY
REASONS.

¾ LOOK FOR CLARITY IN UNDERSTANDING AND


INTERACTION OF THE PROCESSES ALSO.

¾ RAISE NON-CONFORMANCE REPORTS, WHERE REQUIRED

Apr 2010 133

PURPOSE 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

Apr 2010 134

67
D OCUM EN TATI ON REV I EW M ATRI X

I SO 9001 REQUI REM EN TS D OCUM EN TATI ON TH AT AD D RESSES TH I S


RQUI REM EN T

QUAI TY M AN UAL PROCED URE OTH ERS


5.1 M AN AGEM EN T
COM M I TM EN T
5.2 CUSTOM ER FOCUS
5.3 QUALI TY POLI CY
5.4 PLAN N I N G
5.5 RESPON SI BI LI TY,
AUTH ORI TY AN D
COM M UN I CATI ON

Apr 2010 135


O

PROCESS APPROACH TO AUDITING


AUDIT 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.
Apr 2010 O 136

68
PROCESS 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 local
quality 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 are
identified.
• evidence of continual improvement is available
• needs of internal and external customers are clear.

Apr 2010 O 137

SESSION 3d

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


Apr 2010 138

69
WHO ARE INVOLVED IN AN AUDIT

• AUDITOR : A PERSON WITH THE


COMPETENCE TO CONDUCT
AN AUDIT

• AUDITEE : ORGANIZATION BEING


AUDITED

• AUDIT CLIENT : ORGANIZATION OR PERSON


REQUESTING AN AUDIT

Apr 2010 139

WHO ARE INVOLVED IN AN AUDIT (Continued)

• 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

Apr 2010 140

70
WHO ARE INVOLVED IN AN AUDIT (Continued)

¾ AUDIT TEAM : ONE OR MORE AUDITORS


CONDUCTING AN AUDIT
SUPPORTED IF NEEDED BY
TECHNICAL EXPERTS

¾ TECHNICAL EXPERT : A PERSON WHO PROVIDES


SPECIFIC KNOWLEDGE OR
EXPERTISE TO THE AUDIT
TEAM: Does not act as auditor

Apr 2010 141

ROLE 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

Apr 2010 142

71
MANAGEMENT RESPONSIBILITIES OF
LEAD AUDITOR
¾ NEGOTIATE THE AUDIT SCOPE
¾ SELECTION OF AUDIT TEAM
¾ DIRECT THE AUDIT TEAM MEMBERS
¾ PLANNING THE AUDIT & MAKE EFFECTIVE USE OF
RESOURCES
¾ REPRESENTING THE AUDIT TEAM
¾ MANAGING THE AUDIT
¾ REVIEW OF AUDIT TEAM’S WORK
¾ PREVENT & RESOLVE CONFLICTS
¾ TO LEAD THE AUDIT TEAM TO REACH AUDIT
CONCLUSIONS
¾ PREPARATION OF THE REPORT
¾ CONTROL OF THE OPENING AND CLOSING
MEETINGS
¾ SUBMISSION OF THE REPORT
Apr 2010 143

ROLE OF AUDITOR

¾ COMMUNICATING AUDIT REQUIREMENTS TO THE AUDITEE


¾ CONDUCTING AUDIT
¾ DOCUMENTING OBSERVATIONS WITH EVIDENCE
¾ VERIFYING THE EFFECTIVENESS OF THE QUALITY SYSTEM
¾ REPORTING RESULTS TO THE LEAD AUDITOR
¾ CO-OPERATING WITH AND ASSISTING LEAD AUDITOR

Apr 2010 144

72
ROLE OF AUDITEE

• PRE - AUDIT

• DURING THE AUDIT

• POST AUDIT

Apr 2010 145

ROLE OF AUDITEE

• PRE - AUDIT
1. 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
Apr 2010 146
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ROLE OF AUDITEE
• DURING THE AUDIT
1. 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 147

ROLE OF AUDITEE

• 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

Apr 2010 O 148

74
ROLES & RESPONSIBILITIES OF GUIDES
¾ SHOULD ASSIST THE AUDIT TEAM
¾ SHOULD ACT ON REQUEST OF THE LEAD AUDITOR

OTHER RESPONSIBILITIES :
¾ ESTABLISH CONTACTS &TIMINGS FOR INTERVIEWS
¾ ARRANGE VISITS TO SPECIFIC SITES
¾ ENSURE RULES CONCERNING SAFETY ARE FOLLOWED BY
AUDITORS
¾ WITNESS THE AUDIT ON BEHALF OF AUDITEE IF REQUIRED
¾ PROVIDE CLARIFICATION OR ASSIST IN COLLECTING
INFORMATION

GUIDES & OBSERVERS MAY ACCOMPANY THE


AUDIT TEAM BUT ARE NOT PART OF IT

Apr 2010 149

GUIDE TO THE GUIDE


¾ MUST HAVE GOOD KNOWLEDGE ON THE STANDARD
¾ MUST HAVE GOOD KNOWLEDGE OF QMS, IN THE AREA OF AUDIT
¾ MUST HAVE OVERALL UNDERSTANDING OF QMS OF THE COMPANY
¾ MUST BE TACTFUL AND COURTEOUS
¾ ACKNOWLEDGE NOT KNOWING AN ANSWER
¾ MUST BUILD RAPPORT WITH AUDITOR
¾ WITNESS TO THE OBSERVATION
¾ MUST BE BRIEF AND PRECISE
¾ SHOULD HELP THE AUDITOR IN FACILITIES
¾ NOT TO ARGUE WITH THE AUDITOR
¾ NOT TO VOLUNTEER OPINIONS
• AUDITORS SHOULD FIND THE NON-CONFORMANCES; IT IS NOT FOR
THE GUIDES TO PROVIDE THEM
Apr 2010 150

75
COMMUNICATION 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 151

CONFIDENTIALITY
¾ AUDITORS 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.

¾ THIS IS ESSENTIAL SINCE CONFIDENTIAL AND


SENSITIVE INFORMATION MAY BECOME
ACCESSIBLE TO THE AUDITORS DURING THE
AUDIT

Apr 2010 152

76
IRCA CODE OF CONDUCT
All 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 auditee
organization
• 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 153

SESSION 3e

AUDIT PROGRAMME

SET OF ONE OR MORE AUDITS

PLANNED FOR A SPECIFIC TIME FRAME &

DIRECTED TOWARDS A SPECIFIC PURPOSE

Apr 2010 154

77
PROCESS FLOW FOR MANAGEMENT OF AN AUDIT
PROGRAMME
Authority for the audit
programme

Establishing the Audit Programme Plan


• Objectives
• Responsibilities
• Resources
• Procedures
Improving the Competence
Act Audit Implementing the Audit Programme
• Scheduling audits & Evaluation Do
Programme of auditors
• Evaluating Auditors
• Selecting audit team
• Directing audit activities Audit
Audit Activities
Activities
• Maintaining records

Monitoring & Reviewing Audit Programme


• Monitoring & reviewing Check
• Identifying needs for Corrective & Preventive action
• Identifying opportunities for implement

Apr 2010 155

AUDIT 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

Apr 2010 156


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78
EXTENT OF AN AUDIT PROGRAMME
GOVERNED 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

Apr 2010 157


O

DEFINING THE AUDIT OBJECTIVES,


SCOPE 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
¾ DETERMINING EXTENT OF CONFORMITY OF THE AUDITEES
MANAGEMENT SYSTEM
¾ EVALUATING THE CAPABILITY OF MANAGEMENT SYSTEM TO
ENSURE COMPLIANCE TO STATUTORY, REGULATORY &
CONTRACTUAL REQUIREMENTS
¾ EVALUATING EFFECTIVENESS OF MANAGEMENT SYSTEM IN
MEETING ITS SPECIFIED OBJECTIVES
¾ IDENTIFICATION OF AIMS FOR POTENTIAL IMPROVEMENT OF THE
MANAGEMENT SYSTEM, BY AUDIT CLIENT
Apr 2010 158
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FEASIBILITY OF THE AUDIT

• ADEQUATE INFORMATION FOR PLANNING THE AUDIT

• ADEQUATE CO-OPERATION FROM THE AUDITEE

• AVAILABILITY OF TIME AND ADEQUATE RESOURCES

Apr 2010 159


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RESPONSIBILITIES FOR MANAGING


THE 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

Apr 2010 160


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80
AUDIT 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
• LOGISTICS
Apr 2010 161
O

AUDIT 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

Apr 2010 162


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81
AUDIT PROGRAMME MONITORING & REVIEW

THE ACTIVITIES INCLUDE :


• MONITOR AT APPROPRIATE
INTERVALS

¾ REVIEW TO ASSESS WHETHER


AUDIT OBJECTIVES ARE MET

¾ IDENTIFY OPPORTUNITIES OF
IMPROVEMENT

¾ REPORT TO TOP MANAGEMENT

Contd..
Apr 2010 163
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AUDIT 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.

Apr 2010 164


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DEFINING THE AUDIT OBJECTIVES,
SCOPE AND CRITERIA (Continued)
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 165

OBJECTIVE / SCOPE OF AUDIT


¾ THIRD PARTY
ƒ AGREEMENT BETWEEN CERTIFICATION BODY AND AUDITEE
ƒ AUDITORS CONFIRM SCOPE WITH BUSINESS BROCHURES /
TENDERS

¾ SECOND PARTY
ƒ MAY BE COMPANY-WIDE OR CONTRACT-SPECIFIC
ƒ MAY BE SCHEDULED OR CIRCUMSTANCE-DRIVEN

¾ FIRST PARTY
ƒ COVERAGE OF ALL FUNCTIONS AND PROCESS
ƒ TO MEET QMS STANDARD AND DEMONSTRATE COMPLIANCE

Apr 2010 166

83
SCHEDULING OF AUDITS
¾THIRD PARTY AUDITS
ƒ PLANNED WELL IN ADVANCE
ƒ MUST COVER ALL ASPECTS OF THE QUALITY SYSTEM STANDARD
ƒ SHALL INCLUDE A 2 STAGE INITIAL AUDIT
ƒ SURVEILLANCE AUDIT IN THE 1ST AND 2ND YEARS
ƒ RE-CERTIFICATION AUDIT IN THE 3RD YEAR PRIOR TO
EXPIRATION OF CERTIFICATION

¾SECOND PARTY AUDITS


ƒ REQUIREMENTS OF CURRENT & PENDING CONTRACTS
ƒ VALUE OF CURRENT & PENDING CONTRACTS
ƒ DATE OF LAST AUDIT & FINDINGS OF PREVIOUS AUDIT
ƒ AVAILABLE RESOURCES
Apr 2010 167
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SCHEDULING OF AUDITS (contd.)

¾ FIRST PARTY AUDITS

ƒ PLAN MUST BE AUTHORIZED.

ƒ SHOULD COVER ALL THE ACTIVITIES OF QUALITY


SYSTEM.

ƒ BASED ON THE NEEDS OF THE QUALITY SYSTEM


AND OF THE BUSINESS.

Apr 2010 168


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84
SCHEDULING OF AUDITS (contd.)

¾ FIRST PARTY AUDIT


ƒ ‘CALENDAR SCHEDULED’ AUDITS
ƒ RESULT OF PREVIOUS AUDITS
ƒ FOLLOWING LIKELY CHANGES IN
– MANAGEMENT
– ORGANIZATION
– POLICY
– TECHNIQUES / TECHNOLOGY
– QUALITY SYSTEM

ƒ ‘EVENT LED’ AUDITS

Apr 2010 169


O

INTERNAL AUDIT SCHEDULE – YEAR 20XX

Audit Scheduled Corrective Action Response Accepted

Audit Performed & Reported Follow-up Action Required Audit Completed

Apr 2010 170


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85
SESSION 3f

PLANNING OF AUDIT

• Pre-audit contacts
• Documentation Review
• Audit Scope, team competence and
selection of team
• On-site Audit Plan

Apr 2010 171

PLANNING & 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
Apr 2010 172

86
GATHERING INFORMATION

¾ COMPANY’S PROFILE / MAN POWER


LOCATION / GEOGRAPHICAL SPREAD

¾ USE OF TELEPHONE / QUESTIONNAIRE /


QUALITY MANUAL

¾ ESTABLISH INITIAL CONTACT WITH THE


AUDITEE

¾ PRE-AUDIT VISIT / MEETING (as required)

Apr 2010 173

PURPOSE OF ESTABLISHING INITIAL


CONTACT WITH THE AUDITEE
¾ TO ESTABLISH COMMUNICATION CHANNELS WITH THE
AUDITEE REPRESENTATIVE
¾ TO CONFIRM AUTHORITY TO CONDUCT THE AUDIT
¾ TO PROVIDE INFORMATION ON TIMING & TEAM
COMPOSITION
¾ TO REQUEST ACCESS TO RELEVANT DOCUMENTS &
RECORDS
¾ TO DETERMINE THE SITE SAFETY RULES
¾ TO MAKE ARRANGEMENTS FOR THE AUDIT
¾ TO AGREE ON THE OBSERVERS & GUIDES

Apr 2010 174

87
PRE-AUDIT VISIT

¾ WHEN REQUIRED?
ƒ SIZE OR COMPLEXITY
ƒ GEOGRAPHICAL SPREAD
ƒ CONFIRM ‘SCOPE PROPOSED’ IS IN LINE WITH BUSINESS

¾ BENEFITS
ƒ TO CLARIFY THE AUDIT PROCESS TO THE AUDITEE
ƒ CHECK MATURITY OF QUALITY SYSTEM
ƒ ON-SITE DOCUMENTATION REVIEW POSSIBLE

Apr 2010 175

PRE-AUDIT VISIT (contd.)

¾ TYPICAL AGENDA
ƒ UNDERSTANDING THE PROCESSES NEEDED FOR QMS
(MAY OR MAY NOT BE DOCUMENTED).
ƒ EXPLAIN THE AUDIT PROCESS
ƒ INTRODUCTION WITH KEY PERSONNEL
ƒ CONFIRM SCOPE OF AUDIT
ƒ CONFIRM DATE/DETAILS OF AUDIT
ƒ IDENTIFY NEED FOR SPECIAL KNOWLEDGE
ƒ SHORT VISIT OF SITE TO HAVE A ‘FEEL’ OF THE COMPANY
ƒ ON-SITE DOCUMENTATION REVIEW
ƒ CLARIFY DOUBTS OF AUDITEE
Apr 2010 176

88
NOMINATE THE AUDIT TEAM

¾ INDEPENDENCE OF THE FUNCTION & TO AVOID


CONFLICT OF INTEREST

¾ ACCEPTABILITY TO THE AUDITEE

¾ LANGUAGE OF AUDIT & UNDERSTANDING OF AUDITEES


SOCIAL AND CULTURAL CHARACTERISTICS

¾ KNOWLEDGE OF BUSINESS

¾ STATUTORY, REGULATORY, CONTRACTUAL &


ACCREDITATION / CERTIFICATION REQUIREMENTS, AS
APPLICABLE

Apr 2010 177

NOMINATE THE AUDIT TEAM (Contd..)

CONSIDERATION TO BE GIVEN TO THE FOLLOWING :

¾ AUDIT OBJECTIVES, SCOPE, CRITERIA & ESTIMATED


DURATION OF THE AUDIT

¾ COMPETENCE NEEDED TO ACHIEVE AUDIT


OBJECTIVES

¾ WHETHER AUDIT IS JOINT OR COMBINED

¾ TECHNICAL EXPERTISE
(FAMILIARITY WITH INDUSTRY SECTOR)

¾ INTERPERSONAL SKILLS
Apr 2010 178

89
PREPARE WORK DOCUMENTS

¾ CHECKLISTS
¾ AUDIT SAMPLING PLANS
¾ FORMS FOR RECORDING
ƒSUPPORTING EVIDENCE
ƒAUDIT FINDINGS
ƒRECORD OF MEETINGS
[ SAFEGUARD CONFIDENTIAL OR
PROPRIETORY INFORMATION AT ALL TIMES]

Apr 2010 179

PREPARING 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
Apr 2010 180

90
PREPARING THE AUDIT PLAN (continued)
¾ ALLOCATION OF APPROPRIATE RESOURCES
TO CRITICAL AREAS OF AUDIT
¾ OTHER POINTS COULD COVER, AS
APPROPRIATE
ƒ IDENTIFICATION OF AUDITEES
REPRESENTATIVE FOR THE AUDIT
ƒ LOGISTICS
ƒ MATTERS RELATED TO CONFIDENTIALITY
ƒ ANY AUDIT FOLLOW UP ACTIONS

Apr 2010 181

IAF Guidance on the Application of ISO 17021:2006


Guide for Process to Determine Auditor Time for Initial Audit
(Auditor Time Chart)

Number of Employees Auditor Time for Initial Number of Employees Auditor Time for Initial
Audit (auditor days) Audit (auditor days)
1 – 10 2 876 – 1175 13
11 – 25 3 1176 – 1550 14
26 – 45 4 1551 – 2025 15
46 – 65 5 2026 – 2675 16
66 – 85 6 2676 – 3450 17
86 – 125 7 3451 – 4350 18
126 – 175 8 4351 – 5450 19
176 – 275 9 5451 – 6800 20
276 – 425 10 6801 – 8500 21
426 – 625 11 8501 – 10700 22
626 - 875 12 > 10700 Follow Progression
above
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.
Apr 2010 182
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91
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 / Coverage Time Auditors Areas / Coverage
Activities Activities
0900 - Lead Opening
0930 Auditor + Meeting
hrs. Auditor
0930 - Lead CEO's Management Responsibility
1015 Auditor + office including Management
hrs Auditor Commitment, Resources,
Infrastructure, Customer
Focus, Quality Policy,
objectives and Deployment ,
QMS Planning, Management
Review, Responsibility &
Authority, continuous
improvement …
1015 - - Do- Interaction Internal Communication,
1115 with Internal Quality Audit,
hrs. Manage- Management Review,
ment Corrective & Preventive
Represen- Action……
tative

Apr 2010 183


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Continued…..
Time Auditors Area / Coverage Time Auditor Areas / Coverage
Activities s Activities

1115 - Lead Marketing Customer Related processes, 1115 - Auditor Purchasing Selection, approval of suppliers,
1300 Auditor Related process of order procurement, 1300 Processes verification process at suppliers
hrs. Process (interactions with mfg.) hrs. premises, Inspection plans,
customer communication Requisition/ Indent making,
processes & customer Interaction Process with
satisfaction Measurement Inspection, Mfg. & other related
Processes corrective and processes….
preventive action (data, trend &
analysis, Root Cause analysis
etc.)….

1300 - 1400 Lunch / liaison meeting

1400 - Lead Productio Production related processes 1400 - Auditor Production Verification, validation,
1700 Auditor n related including Production Planning, 1700 related monitoring etc., control of NC,
hrs. processes Quality objectives & hrs. processes in work environment, resource
in the requirement of product, the Heat provision, quality objectives,
Machining provision of resources specific to treatment targets….
& the product, verification, operations
Welding validation, monitoring etc.,
operations control of nonconforming
product, corrective and
preventive action……

Apr 2010 184


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92
Continued…..
Day II
Time Auditors Area / Activities Coverage Time Auditors Areas / Coverage
Activities
1000 - Lead Calibration Process Control of Monitoring & 1000 - Auditor Processes Infrastructure, linkage
1200 hrs. Auditor (Laboratory Measuring Devices though 1300 related to with production related
Instrument) External Calibration… hrs. maintenance processes, qualification
of personnel,
effectiveness of the
maintenance process
1200 - Lead Production processes Purchase Process on
1300 hrs Auditor related to Presentation Incoming material, process
of Products of storage, Preservation,
Packaging, Interaction
with Produc-tion, Mfg,
Quality objectives,
targets…
1300 - Lunch / Liaison
1400 hrs. Meeting
1400 - Lead Processes related to Monitoring & Measuring 1400 – Auditor Processes Human Resources,
1550 hrs Auditor Monitoring and Devices; Calibration done 1550 related to Competence,
measuring devices and inter-nally (Engg.), hrs. training and Awareness & Training,
processes related to Interaction Processes with competence Effectiveness of
Measure-ment Engg., Monitoring & building Training…
Measurement of processes
1530 - Lead Preparation for
1630 hrs. Auditor + Closing Meeting
Auditor
1630 - Closing Meeting
1730 hrs.

Apr 2010 185


O

EXERCISE 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

Apr 2010 186

93
Case Study CS-1

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 187

SESSION 3g

CHECKLISTS

¾ CHECKLISTS – PREPARATION

¾ CHECKLISTS – USE, BENEFITS & LIMITATIONS

Apr 2010 188

94
CHECKLISTS - PREPARATION

ACTIVITY
¾ 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.

¾ WHAT CONSIDERATIONS WILL YOU GIVE WHILE


PLANNING THIS AUDIT? HOW WILL YOU PROCEED WITH
THE PLANNING OF THIS AUDIT?
¾ Each team to reflect for 15 minutes followed by open
house discussion (15 minutes)

Apr 2010 189

CHECKLISTS - PREPARATION

¾ PREPARED DURING AUDIT PLANNING AND


DOCUMENTATION REVIEW

¾ SHOULD BE IN LINE WITH OBJECTIVE / SCOPE OF THE


AUDIT

¾ SEPARATE CHECK LIST FOR PROCESSES COVERING


DIFFERENT WORK-AREA TO BE AUDITED

¾ TIME TO BE PROVIDED FOR AN AUDIT IN ACCORDANCE


WITH NUMBER OF ITEMS IN THE CHECK LIST.

¾ MAY BE LIST OF QUESTIONS OR LIST OF HEADINGS


(HEADINGS PREFERRED)

Apr 2010 190

95
CHECKLISTS - PREPARATION (Continued)
• BASIS OF PREPARATION
ƒ QUALITY POLICY AND QUALITY OBJECTIVES (FUNCTION AND
LEVELS)
ƒ ISO 9001 STANDARD
ƒ QMS DOCUMENTATION INCLUDING QMS PROCESS
DOCUMENTATION
ƒ MEASUREMENT, ANALYSIS AND IMPROVEMENT
ƒ CONTINUAL IMPROVEMENT (P - D - C - A)
ƒ STATUTORY AND REGULATORY REQUIREMENTS APPLICABLE
ƒ USE OF PERSONAL EXPERIENCE

• CHECKLIST MUST ENABLE THE AUDITOR TO PURSUE


AN EFFECTIVE AND PURPOSEFUL AUDIT TRAIL

Apr 2010 191

CHECKLISTS - BENEFITS

¾ HELPS TO ENSURE COVERAGE OF ENTIRE SCOPE IN TIME

¾ HELPS TO BALANCE AUDIT SAMPLE

¾ TOOL FOR PREPARATION OF AUDITOR

¾ CONTROLS THE ‘PACE’ OF AUDIT

¾ HELPS TO PRIORITISE CHECK POINTS

¾ RECORD OF ACTIVITIES EXAMINED

¾ BECOMES A BASE FOR IMPROVEMENT

Apr 2010 192

96
CHECKLISTS - LIMITATIONS

¾ MAY RESTRICT ENQUIRY BY AUDITOR

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

Apr 2010 193

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

Sl. Checklist ISO Remarks Time


No. Clause
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 5.4.1 /
the Purchasing function 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 4.1a
of Suppliers, Evaluation of Performance of Suppliers, Release of Purchase Orders, Testing
Requirements by Suppliers etc. )
4a. What procedures / work instructions are available

4.1c/d
5 Check for sequencing of these processes 4.1b
5a. Check for process owners 4.1 f/d
6. Check for interaction of processes with inter or intra-functional processes ( e.s. - Check for testing 4.1b
by suppliers before dispatch
- Check approval of Transporters for RM etc.)
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 4.1c

9a. Analyse characteristics & trends of processes 8.4


9b. Review process performance
9c. Identify NC ( if any ) 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 8.2.4 ,
with acceptance criteria 8.3
12. How is continual improvement of these process planned & implemented 8.5

Apr 2010 194


O 08 - 04

97
EXERCISE E:03

Learning Objective : How to prepare a Checklist


Method : Prepare Checklists for the two situations in the
Case Study / Workbook individually.
Time : 30 minutes : Individual work
15 minutes : Self Evaluation
15 minutes : Discussion
Self Evaluation by the participants in line with the
Marking Guidelines, followed by common discussion.

Apr 2010 195

SESSION 3h

OPENING MEETING

¾ OPENING MEETING

¾ PURPOSE OF OPENING MEETING

¾ OPENING MEETING – AGENDA

Apr 2010 196

98
OPENING MEETING

¾ FORMAL START OF THE ON-SITE AUDIT

¾ CHAIRED BY LEAD AUDITOR

¾ CONDUCTED AT AUDITEE ORGANIZATION’S PREMISES

¾ PROVIDES GENERAL RULES FOR CONDUCT OF AUDIT

¾ ENSURE AUDITEE MANAGEMENT TEAM PRESENT

¾ LANGUAGE AND CULTURE AND TIMING TO SUIT (ISO 19011)

¾ SHOULD BE SHORT

Apr 2010 197

PURPOSE OF OPENING MEETING

¾ TO CONFIRM THE AUDIT PLAN

¾ TO CLARIFY HOW THE AUDIT ACTIVITIES


WILL BE UNDERTAKEN

¾ TO ESTABLISH COMMUNICATIONS WITH


THE AUDITEE MANAGEMENT.

¾ TO PROVIDE OPPORTUNITY TO THE


AUDITEE TO SEEK CLARIFICATION

Apr 2010 198

99
OPENING MEETING - AGENDA

¾ INTRODUCTION OF PARTICIPANTS
¾ AUDIT OBJECTIVES, SCOPE & CRITERIA
¾ TIMETABLE
¾ CLOSING MEETING - TIME, INTERIM MEETING & OTHER
LATE CHANGES
¾ AUDIT BY SAMPLING
¾ EXPLAIN AUDIT PROCEDURE & DISCLAIMER
¾ AUDIT RESPONSIBILITIES
¾ FORMAL COMMUNICATION CHANNELS BETWEEN
AUDITOR & AUDITEE

Apr 2010 199

OPENING MEETING - AGENDA (contd.)


¾ LANGUAGE
¾ CONFIRMATION TO KEEP AUDITEE INFORMED OF AUDIT
PROGRESS
¾ RESOURCES & FACILITIES REQUIREMENT
¾ CONFIDENTIALITY
¾ RELEVANT WORK SAFETY, SECURITY PROCEDURES
¾ INTRODUCTION TO GUIDES
¾ REPORTING METHODS (NCRS, GRADINGS)
¾ TERMINATION OF AUDIT
¾ APPEAL SYSTEM ON THE CONDUCT OR CONCLUSIONS OF
THE AUDIT
¾ CLARIFY AUDITEES DOUBTS
Apr 2010 200

100
EXERCISE E:04
Learning 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 201

SESSION 3i

ON-SITE AUDITING & AUDIT SKILLS

¾ AUDITING
¾ COLLECTING INFORMATION FOR REACHING AUDIT
CONCLUSION
¾ COMMUNICATIONS DURING AUDIT
¾ PROCESS APPROACH TO AUDIT
¾ AUDIT OF MANAGEMENT COMMITMENT
¾ AUDITING SKILLS
Apr 2010 202

101
TASKS FOR 3RD PARTY
CERTIFICATION AUDIT
¾ EXAMINE AND VERIFY THE STRUCTURE, POLICIES,
PROCESSES, PROCEDURES, RECORDS AND RELATED
DOCUMENTS OF THE CLIENT RELEVANT TO THE
MANAGEMENT SYSTEM
¾ MEET REQUIREMENTS RELEVANT TO THE SCOPE OF
CERTIFICATION
¾ DETERMINE PROCESSES ARE ESTABLISHED,
IMPLEMENTED AND MAINTAINED EFFECTIVELY TO
PROVIDE A BASIS FOR CONFIDENCE IN THE CLIENT’S
MANAGEMENT SYSTEM
¾ COMMUNICATE TO THE CLIENT ANY INCONSISTENCIES
BETWEEN CLIENT’S POLICIES, OBJECTIVES AND
TARGETS AND THE RESULTS
Apr 2010 O 203

AUDITING
¾ EXISTENCE OF QUALITY MANAGEMENT SYSTEM
• CLEARLY DEFINED RESPONSIBILITIES AND AUTHORITIES
• ADEQUACY OF SYSTEM COMPONENTS/ELEMENTS

¾ OPERATION OF QUALITY SYSTEM


• UNDERSTANDING OF PROCESSES AND THEIR INTERACTIONS
• PROVISION OF ADEQUATE RESOURCES

¾ EFFECTIVENESS OF QUALITY SYSTEM


• ACHIEVEMENT OF DECLARED OBJECTIVES
• CORRECTIVE ACTION / CONTINUAL IMPROVEMENT

Apr 2010 204

102
AUDITING

¾ COVERAGE OF ENTIRE SCOPE


¾ NON-CONFORMANCE REPORTS (NCR)
¾ OBJECTIVITY OF NCRs AND WITNESSING BY AUDITEE
¾ IMMEDIATE INFORMATION TO COMPANY FOR MAJOR NCRs
¾ HOLDING OF REGULAR REVIEW MEETING WITH
TEAM MEMBERS
¾ HOLDING OF REGULAR LIAISON MEETING WITH AUDITEE
REPRESENTATIVE
¾ TO INFORM ALL AUDIT OBSERVATIONS TO THE AUDITEE

Apr 2010 205

PROCESS OF COLLECTING INFORMATION


FOR REACHING AUDIT CONCLUSIONS
- Interviews
Source of information - Observation of activities
- Review of Documents/Records

Collect by appropriate
sampling & verifying
Audit Evidence
Evaluate audit evidence
against audit criteria
Audit findings

Review audit findings

Audit conclusions
Apr 2010 206

103
SOURCE 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 207

COMMUNICATION DURING AUDIT


1. WITHIN AN AUDIT TEAM

¾ EXCHANGE INFORMATION
¾ ASSESS AUDIT PROGRESS
¾ IF NEEDED REASSIGN WORK BETWEEN AUDIT TEAM
MEMBERS

2. WITH THE AUDITEE


¾ ANY CONCERNS TO THE AUDITEE (& CLIENT)
¾ PROGRESS OF THE AUDIT
¾ ANY SIGNIFICANT RISKS (SAFETY, ENVIRONMENT,
QUALITY) TO BE REPORTED IMMEDIATELY TO AUDITEE
(& CLIENT)
Apr 2010 208

104
COMMUNICATION DURING AUDIT
¾ ANY CONCERN ABOUT AN ISSUE OUTSIDE THE AUDIT
SCOPE SHOULD BE NOTED AND REPORTED TO LEAD
AUDITOR (FOR POSSIBLE COMMUNICATION TO
AUDITEE / CLIENT)
¾ AUDIT EVIDENCE TO SUPPORT THAT AUDIT
OBJECTIVES ARE UNATTAINABLE
¾ 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 209

COMMUNICATION DURING AUDIT

¾ OBJECTIVE AND SCOPE OF THE AUDIT


¾ AUDIT PROGRAMME AND ASSIGNMENT OF RESPONSIBILITIES
¾ REVIEW OF CHECKLIST, WITHIN THE AUDIT TEAM
¾ REVIEW OF OBSERVATIONS
¾ CROSS FLOW OF INFORMATION TO AUDIT TEAM MEMBERS
¾ ADDITIONAL DOCUMENTS / REFERENCES IF REQUIRED
¾ ANY CORRECTIONS TO AUDIT PROGRAM
¾ STATUS OF AUDIT & ANY CONCERN AREA TO THE AUDITEE
¾ WHEN THE AUDIT OBJECTIVES ARE UNATTAINABLE, REPORT THE
REASON TO AUDITEE & DETERMINE APPROPRIATE ACTION

Apr 2010 210

105
AUDIT TRAILS
ƒ POLICY AND COMPANY LEVEL OBJECTIVES
ƒ DEPLOYED OBJECTIVES
ƒ PROCESS DOCUMENTATION
ƒ PROCESS INPUTS
ƒ RESOURCES
ƒ OPERATION OF PROCESS
ƒ CONTROL OF PROCESS
ƒ MONITORING AND MEASUREMENT
ƒ OUTPUTS
ƒ PERFORMANCE INDICATORS
ƒ DATA ANALYSIS
ƒ USE OF DATA FOR IMPROVEMENT

Apr 2010 211

PROCESS APPROACH TO AUDIT

¾ UNDERSTAND THE PROCESS TO BE AUDITED


(MAY OR MAY NOT BE DOCUMENTED)
¾ SCOPE AND RESPONSIBILITIES
¾ CHECK THAT PROCESS INPUTS & OUTPUTS ARE PROPERLY
IDENTIFIED AND SUIT THE PURPOSE
¾ INTERACTION WITH OTHER PROCESSES
¾ CHECK THE RESULT AND OUTCOMES
¾ VERIFY THE PROCESS MEASURABLES
¾ EVALUATE IF THE OBJECTIVES ARE ADDRESSED AND ACHIEVED
¾ ARE THE MEASURABLES LEADING TOWARDS CONTINUAL
IMPROVEMENT

Apr 2010 212

106
INTERVIEWS
¾ HELD WITH PERSONS FROM DIFFERENT LEVELS /FUNCTIONS
(ESPECIALLY WITHIN THE SCOPE OF AUDIT)
¾ SHOULD BE CONDUCTED DURING NORMAL WORK HOURS
AND NORMAL WORK PLACE
¾ PUT THE INTERVIEWED PERSON AT EASE PRIOR TO THE
INTERVIEW
¾ REASON FOR INTERVIEW AND NOTE TAKING EXPLAINED
¾ INITIATE BY ASKING DESCRIPTION OF THEIR WORK
¾ RESULTS SUMMARISED AND REVIEWED WITH THE PERSON
¾ QUESTIONS LEADING TO BIAS TO BE AVOIDED
¾ THANK FOR PARTICIPATION AND CO-OPERATION

Apr 2010 213

AUDIT OF MANAGEMENT COMMITMENT

• AUDITOR LOOKS FOR EVIDENCE OF TOP MANAGEMENT


COMMITMENT IN:

¾ ESTABLISHMENT OF QUALITY POLICY.

¾ ENSURING THAT THE OBJECTIVES ARE ESTABLISHED.

¾ COMMUNICATING WITHIN THE ORGANIZATION THE


IMPORTANCE OF MEETING CUSTOMER AND
STATUTORY / REGULATORY REQUIREMENTS.

¾ ENSURING AVAILABILITY OF RESOURCES.

¾ CONDUCTING MANAGEMENT REVIEW.

Apr 2010 214

107
AUDIT OF MANAGEMENT COMMITMENT (Continued)

¾ IDENTIFICATION OF TOP MANAGEMENT PERSONNEL


¾ DETAILED INTERVIEWS OF TOP MANAGEMENT PERSONNEL
¾ NOT A ONE PERSON AUDIT
¾ NOT A ONE PLACE AUDIT
¾ RECORDS MAY NOT BE SUFFICIENT EVIDENCE
¾ AUDITORS TO GIVE FEEDBACK TO LEAD AUDITOR
¾ LEAD AUDITOR TO CONCLUDE DURING CLOSING MEETING
¾ 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 215

AUDITING SKILLS

¾TIME MANAGEMENT

¾FACT FINDING

¾REPORTING

Apr 2010 216

108
TIME MANAGEMENT
¾ PLANNING AND PREPARATION
¾ BE PUNCTUAL
¾ AVOID TIME WASTERS
ƒ INTRODUCTION / PRESENTATION
ƒ WALK ROUND THE PLANT
ƒ LUNCH / TEA / COFFEE
ƒ FALSE TRAILS
ƒ UNIMPORTANT ISSUES
ƒ FRIENDLY TALKS
ƒ TOP BRASS
Apr 2010 217

FACT FINDING
PURPOSE OF AN AUDIT IS TO FIND FACTS SUPPORTED
BY OBJECTIVE EVIDENCE, WHICH MAY BE:
¾ DOCUMENTS (Eg. POLICY, OBJECTIVES, PLANS, PROCEDURES
ETC.)
¾ RECORDS (MANY EXAMPLES POSSIBLE)
¾ DATA SUMMARIES, ANALYSIS, METRICS AND PERFORMANCE
INDICATORS
¾ REPORTS FROM OTHER SOURCES (Eg. CUSTOMER FEEDBACK,
VENDOR RATINGS ETC.)
¾ OBSERVATIONS OF ACTIVITIES
¾ OBSERVATION OF SURROUNDING WORK ENVIRONMENT AND
CONDITIONS
¾ SOMETIMES, EVEN STATEMENTS OF INFORMED PERSONS
Apr 2010 218

109
FACT FINDING METHODS
¾ READING • OBSERVATION
¾ COMMUNICATIONS • BODY LANGUAGE
¾ INTERVIEWING • QUESTIONING
¾ LISTENING • USE OF THOUGHT SPEED
¾ FIRST QUESTION • UNASKED QUESTIONS
¾ USE OF CHECK LIST • TO-AND- FRO CHECKING
¾ TAKE NOTES • SELECT SAMPLE YOURSELF
¾ SPOT CHECK DOCUMENTS
¾ RECORDS/SAMPLES

Apr 2010 219

COMMUNICATING WITH THE AUDITEE

¾ MESSAGE TO BE IN LINE WITH


− PURPOSE
− AUDIENCE
− SITUATION
¾ USE OF SIMPLE LANGUAGE
¾ STRUCTURED / ORGANIZED MESSAGE
¾ IMPACT OF A MESSAGE IS
− 7 % VERBAL
− 38% VOCAL
− 55% BODY LANGUAGE
Apr 2010 220

110
QUESTIONING
¾ LEADING QUESTIONS LIKE
DO YOU?…………DON’T YOU ?
¾ CLOSED QUESTIONS LIKE
DO YOU……….. ?
CAN YOU ……… ?
WILL YOU ………. ?
¾ OPEN QUESTIONS LIKE THOSE
WHAT, WHEN, WHERE, WHO, WHY, HOW AND “SHOW
ME”
¾ ONE QUESTION AT A TIME
¾ QUESTIONS RELEVANT TO THE ACTIVITY BEING AUDITED.

Apr 2010 221

LISTENING

• BARRIERS TO LISTENING
¾ DECIDING IN ADVANCE THAT THE SUBJECT IS NOT INTERESTING
¾ EVALUATING THE SPEAKER
¾ BECOMING EMOTIONALLY INVOLVED
¾ LISTENING FOR FACTS, NOT IDEAS
¾ TAKING COPIOUS NOTES
¾ FAKING ATTENTION
¾ GETTING DISTRACTED
¾ AVOIDS DIFFICULT LISTENING
¾ FAILING TO CAPITALIZE ON “THOUGHT SPEED”

Apr 2010 222

111
THOUGHT 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:

¾ ANTICIPATE WHAT THE PERSON IS GOING TO SAY

¾ ANALYZE WHAT HE IS SAYING

¾ SUMMARISE WHAT HAS BEEN SAID

¾ MENTALLY FRAME THE NEXT QUESTION

¾ UNDERSTAND ANY EMPHASIS BEING MADE

¾ UNDERSTAND BODY LANGUAGE

Apr 2010 223

BODY LANGUAGE
¾EYE CONTACT
¾CLENCHED FISTS
¾CROSSED ARMS AND LEGS
¾HAND SHAKE
¾EYE MOVEMENT
¾DIRECTION OF FEET AND LEGS
¾CARE ABOUT PERSONAL SPACE
¾SILENCE AT THE END OF A QUESTION
Apr 2010 224

112
SESSION 3j

AUDIT REPORTING

¾ NON CONFORMANCE REPORTS (NCR)

¾ NCR GRADING AND IMPLICATIONS

¾ OPPORTUNITY FOR IMPROVEMENT & AUDIT CONCLUSION

¾ REPORTING

¾ SUMMARY STATEMENT

Apr 2010 225

OBJECTIVE EVIDENCE
DATA SUPPORTING THE EXISTENCE OR
VERIFIABILITY OF AN ENTITY NOTE.
OBJECTIVE EVIDENCE MAY BE OBTAINED
THROUGH OBSERVATION, MEASUREMENT,
TEST OR OTHER MEANS.

VERIFICATION
CONFIRMATION, THROUGH THE PROVISION OF
OBJECTIVE EVIDENCE, THAT SPECIFIED
REQUIREMENTS HAVE BEEN FULFILLED.

Apr 2010 226

113
SUBJECTIVE / OBJECTIVE OBSERVATION
(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 227

NON – CONFORMANCE REPORT (NCR)


OR
CORRECTIVE ACTION REQUEST (CAR)

• OBSERVATION
• ATTRIBUTION
• EXPLANATION
• CORRECTIVE ACTION PROPOSAL
• FOLLOW UP ACTIVITIES

Apr 2010 228

114
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 229

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

Apr 2010 230

115
NCR GRADING
MAJOR NC
ƒ COMPLETE ABSENCE OF A STATEMENT OR PROCEDURE
TO MEET A REQUIREMENT OF THE STANDARD.
ƒ BREAKDOWN OR NON OBSERVANCE OF A SPECIFIED
REQUIREMENT.

MINOR NC
ƒ SINGLE OBSERVED LAPSE IN THE USE OF A DEFINED
PROCEDURE OR REQUIREMENT.
ƒ 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 231

IMPLICATIONS OF NCR GRADING


MAJOR NC
ƒ RECOMMENDATION CANNOT BE MADE
ƒ CORRECTIVE ACTION GENERALLY REVIEWED BY AUDITEE
MANAGEMENT
ƒ CLOSURE OF NCR THROUGH FOLLOW UP VISIT

MINOR NC
ƒ RECOMMENDATION CANNOT BE MADE IF NON
CONFORMITY PERTAINS TO REQUIREMENT OF STANDARD
ƒ RECOMMENDATION CAN BE MADE AFTER CORRECTION
AND VERIFICATION
ƒ CLOSURE OF NCR IS POSSIBLE THROUGH DOCUMENTARY
EVIDENCE / FOLLOW UP VISIT / SURVEILLANCE AUDIT
Apr 2010 232

116
OPPORTUNITY FOR IMPROVEMENT

THE AUDIT TEAM MAY IDENTIFY


OPPORTUNITIES FOR IMPROVEMENT BUT
SHALL NOT RECOMMEND SPECIFIC
SOLUTIONS

Apr 2010 233

AUDIT CONCLUSIONS
¾ EXTENT OF CONFORMITY OF THE
MANAGEMENT SYSTEM WITH THE AUDIT
CRITERIA
¾ EFFECTIVE IMPLEMENTATION, MAINTENANCE
& IMPROVEMENT OF THE MANAGEMENT
SYSTEM
¾ CAPABILITY OF THE MANAGEMENT REVIEW
PROCESS TO ENSURE THE CONTINUING
SUITABILITY, ADEQUACY, EFFECTIVENESS &
IMPROVEMENT OF THE MANAGEMENT
SYSTEM

Apr 2010 234

117
EXERCISE E:05
Learning 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 235

Case Study CS-2


Learning 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

Apr 2010 236

118
SUMMARY REPORT - CONTENT
THE SUMMARY REPORT SHOULD INCLUDE OR
REFER TO THE FOLLOWING :

¾ THE AUDIT OBJECTIVES


¾ THE AUDIT SCOPE (ORGANIZATIONAL & FUNCTIONAL
UNITS OR PROCESSES AUDITED AND THE TIME
PERIOD COVERED)
¾ AUDIT TEAM LEADERS & MEMBERS
¾ DATES & PLACES OF ONSITE AUDIT
¾ AUDIT CRITERIA
¾ THE AUDIT FINDINGS
¾ THE AUDIT CONCLUSIONS

Apr 2010 237

SUMMARY REPORT – CONTENT (Continued)


THE REPORT SHOULD INCLUDE OR REFER TO THE
FOLLOWING, AS APPROPRIATE
¾ THE AUDIT PLAN
¾ LIST OF AUDITEE REPRESENTATIVES
¾ A SUMMARY OF THE AUDIT PROCESS
¾ DISCLAIMER ANY AREAS NOT COVERED ALTHOUGH WITHIN
THE AUDIT SCOPE
¾ ANY UNSOLVED DIVERGING OPINIONS BETWEEN AUDIT TEAM
& AUDITEE
¾ RECOMMENDATIONS FOR IMPROVEMENT, IF SPECIFIED IN
AUDIT OBJECTIVES
¾ AGREED FOLLOW UP ACTION PLAN
¾ A STATEMENT OF THE CONFIDENTIAL NATURE OF THE
CONTENTS
¾ DISTRIBUTION LIST FOR THE AUDIT REPORT

Apr 2010 238

119
REPORTING
THE METHOD AND CONTENT OF REPORTING DEPENDS
ON THE TYPE OF AUDIT
¾ IN FIRST PARTY (INTERNAL) AUDITS, SUMMARY STATEMENTS
AND NCR WILL SUFFICE

¾ 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

¾ 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 239

SUMMARY STATEMENT
(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.

Apr 2010 240

120
Case Study CS-3
Learning 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 review
45 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 241

EXERCISE E:06

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

Apr 2010 242

121
SESSION 3k

CLOSING MEETING

¾ PURPOSE OF CLOSING
MEETING

¾ CLOSING MEETING –
PREPARATION

¾ CLOSING MEETING –
AGENDA
Apr 2010 243

CLOSING MEETING

¾ FORMAL END OF THE ON-SITE AUDIT

¾ CHAIRED BY LEAD AUDITOR

¾ CONDUCTED AT AUDITEE ORGANIZATION


PREMISES

¾ SENIOR MANAGEMENT OF AUDITEE


ORGANIZATION PRESENT
Apr 2010 244

122
PURPOSE OF CLOSING MEETING

¾ A CLOSING MEETING IS HELD TO PRESENT AUDIT


FINDINGS AND CONCLUSIONS

¾ IT IS TO BE ENSURED THAT THE AUDIT FINDINGS ARE


UNDERSTOOD AND ACKNOWLEDGED BY THE AUDITEE

¾ A CORRECTIVE ACTION PLAN IS TO BE AGREED UPON,


IF APPROPRIATE

¾ TO CLARIFY AUDITEE’S DOUBTS

¾ DISCUSS AND RESOLVE ANY DIVERGING OPINIONS. IF


NOT, RECORD IT
Apr 2010 245

CLOSING MEETING - PREPARATION

AUDIT TEAM MEETS BEFORE CLOSING MEETING


TO:

¾ REVIEW ALL THE NON – CONFORMANCES

¾ CATEGORISE NCRs AS MAJOR/MINOR, IF APPLICABLE

¾ PREPARE A SUMMARY REPORT

¾ PREPARE AGENDA FOR THE CLOSING MEETING

Apr 2010 246

123
EXERCISE E:07
Learning 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 247

CLOSING MEETING – AGENDA


¾ CHAIRED BY LEAD AUDITOR
¾ INTRODUCTION
¾ THANKS FOR ASSISTANCE AND HOSPITALITY
¾ RE-STATE OBJECTIVE AND SCOPE OF THE AUDIT
¾ DISCLAIMER FOR SAMPLE AUDIT
¾ EMPHASIS ON NEGATIVE REPORTING
¾ PRESENT THE FINDINGS
¾ EXPLAIN THE CONCLUSION/RECOMMENDATIONS
¾ EXPLAIN THE SURVEILLANCE

Apr 2010 248

124
CLOSING MEETING – AGENDA (Continued)

¾ RECONFIRM CONFIDENTIALITY
¾ DIVERGING OPINIONS
¾ CLARIFY AUDITEE’S DOUBTS
¾ HAND OVER COPY OF THE REPORT
¾ ASK FOR CORRECTIVE ACTION PLAN / COMMITMENT
¾ RECORD ATTENDANCE AND PROCEEDINGS
¾ IF SPECIFIED BY AUDIT OBJECTIVES, MAKE
RECOMMENDATIONS FOR IMPROVEMENT BUT
EMPHASISE THAT RECOMMENDATIONS ARE NOT
BINDING

Apr 2010 249

SESSION 3L

AUDIT FOLLOW-UP

¾ PURPOSE FOR CORRECTIVE ACTION

¾ EVALUATION OF CORRECTIVE AND


PREVENTIVE ACTION

¾ SURVELLIANCE AUDIT

Apr 2010 250

125
AUDIT FOLLOW-UP
(Ref. ISO 9000 : 2005)
¾ CORRECTION
ACTION TO ELIMINATE A DETECTED NON-CONFORMITY

¾ CORRECTIVE ACTION
ACTION TO ELIMINATE THE CAUSE OF A DETECTED
NON-CONFORMITY OR OTHER UNDESIRABLE SITUATION

¾ PREVENTIVE ACTION
ACTION TO ELIMINATE THE CAUSE OF A POTENTIAL
NON-CONFORMITY OR OTHER UNDESIRABLE POTENTIAL
SITUATION
Apr 2010 251

STEPS TAKEN BY AN AUDITEE TO CARRYOUT OUT CORRECTIVE ACTIONS

EXTERNAL AUDIT (2ND / 3RD PARTY)


RESPONSIBILITY
NCR IDENTIFIED AUDITOR

OBSERVATION WITNESSED GUIDE / AUDITEE

NCR FORMAT FILLED AUDITOR

NCR CATEGORISED AUDITOR / LEAD AUDITOR

NCR PRESENTED IN CLOSING AUDITOR / LEAD AUDITOR


MEETING

TARGET DATE COMMITTED AUDITEE

CAUSE IDENTIFICATION AND AUDITEE


DETAILED PLAN OF ACTION

IMPLEMENT ACTION AUDITEE

INFORM COMPLETION OF
CORRECTIVE ACTION TO M.R. AUDITEE

INTERNAL QUALITY AUDIT M.R. / INTERNAL AUDITORS

NO
IS STATUS OK ? M.R. / INTERNAL AUDITORS
YES

INFORM EXTERNAL BODY ON


COMPLETION OF ACTION M.R

Apr 2010 252

126
EXERCISE E:08
Learning 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 253

VERIFICATION OF CORRECTIVE ACTION


) FIRST PARTY
ƒ REGULAR SCHEDULED AUDIT
ƒ SPECIAL FOLLOW–UP AUDITS / FOLLOW-UP
ACTIVITIES

) SECOND PARTY
ƒ AS PER CONTRACTUAL REQUIREMENT OR AS
DECIDED IN THE CLOSING MEETING

) THIRD PARTY
ƒ WRITING TO CERTIFICATION BODY AND/OR
SUBMISSION OF DOCUMENTARY EVIDENCE
ƒ SPECIFIC FOLLOW – UP AUDIT
ƒ DURING REGULAR SURVEILLANCE
Apr 2010 254

127
NCR / CORRECTIVE ACTION STATUS LOG

N CR D ate I nitiator Subject D ate of Approval V erified by Closed


N O. I ssued of Response of (N ame) (D ate)
N CR Response (D ate)

Apr 2010 O 255

EVALUATION OF CORRECTIVE &


PREVENTIVE ACTION
¾ WHETHER THE ACTION HAS BEEN COMPLETED WITHIN
THE TARGETED TIME.
¾ THE METHODOLOGY OF INTERNAL REVIEW FOR
EFFECTIVENESS
¾ DOES THE REVIEW FOR EFFECTIVENESS COVER THE
FOLLOWING AS APPLICABLE
ƒ NEED FOR CHANGE IN QMS PROCEDURES
ƒ NEED FOR ADDITIONAL TRAINING
ƒ NEED 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
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SURVEILLANCE AUDIT

• PERIODIC AUDITS ON A CERTIFIED

ORGANISATION FOR DETERMINING THE

CONTINUING AND EFFECTIVE

IMPLEMENTATION OF THE QUALITY

MANAGEMENT SYSTEM

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SURVEILLANCE AUDIT

¾ANNOUNCED
− GENERAL PRACTICE
− ENSURES AVAILABILITY OF KEY
PERSONNEL
− UNLIKELY TO BE ABORTED

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SURVEILLANCE AUDIT ACTIVITIES
AUDIT OF LIMITED SECTION / AREA

HOWEVER THE FOLLOWING MUST BE AUDITED


¾ internal audits and management review,
¾ a review of actions taken on nonconformities identified during
the previous audit,
¾ treatment of complaints,
¾ effectiveness of the management system with regard to
achieving the certified client's objectives,
¾ progress of planned activities aimed at continual improvement,
¾ continuing operational control,
¾ review of any changes, and
¾ use of marks and/or any other reference to certification.

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OTHER SURVEILLANCE
ACTIVITIES
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.

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SPECIAL 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

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131
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132