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ISO

ISO 9001:2000
9001:2000
QUALITY
QUALITY MANAGEMENT
MANAGEMENT SYSTEM
SYSTEM

INTERNAL
INTERNAL AUDIT
AUDIT

1
What is Quality ??
Fitness for use
Fitness for use
Conformance to requirements
Conformance to requirements
Accuracy
Accuracy
Perfection
Perfection
Zero Defect
Zero Defect
Adequacy
Adequacy
Cost Effectiveness
Cost Effectiveness

“ THETOTALITYOFFEATURESANDCHARACTERISTICSOFAPRODUCTOR

SERVICETHATBEARUPONITSABILITYTOSATISFYSTATEDORIMPLIED

NEEDS“

2
Quality
Customers’ expectations of qualityarenot thesamefor
Customers’ expectations of qualityarenot thesamefor
different classes of products or services.
different classes of products or services.

Best-in-Class Quality
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World-Class Company

Beinga world-class company means that eachof its products and


Beinga world-class company means that eachof its products and
services areconsideredbest-in-class byits customers.
services areconsideredbest-in-class byits customers.

3
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? 5
OBJECTIVES OF ISO 9000:2000 requirements

EXPECTED PLANNED
QUALITY QUALITY
by the Customer by the Company

Measurement of the Measurement of the


Customer’s satisfaction Performance of the Company

PERCEIVED PRODUCED
QUALITY QUALITY
by the Customer by the Company

6
The 8 principles of QMS …

• Customer focus
• Customer focus
• Leadership
• Leadership
• Involvement of people
• Involvement of people
• Process approach
• Process approach
• System approach to management
• System approach to management
• Continual improvement
• Continual improvement
• Decisions based on facts
• Decisions based on facts
• Relationship with suppliers mutually beneficiary
• Relationship with suppliers mutually beneficiary

7
The 8 principles of QMS …

Customer Focus

Organizations Determine
Determine customer
customer needs
needs
&& expectations
expectations
Depends on
Customers .
Requirements
Requirements

Customer
Customer satisfaction
satisfaction
Principle 1
8
The 8 principles of QMS …

Applying the principle of Customer Focus typically leads to


 Researching and understanding customer needs and
expectations
 Ensuring that the objectives of the organization are
linked to customer needs and expectations
 Communicating customer needs and expectations
throughout the organization
 Measuring customer satisfaction and acting on the
results.
 Systematically managing customer relationships.
 Ensuring a balanced approach between satisfying
customers and other interested parties (such as
owners, employees, suppliers, financiers, local
communities and society as a whole).
9
The 8 principles of QMS …

Leadership

Leaders
Leaders must
must set
set the
the direction
direction of
of the
the
organization
organization

Leaders
Leaders must
must create
create and
and maintain
maintain internal
internal
environment
environment that
that encourages
encourages people
people toto
achieve
achieve the
the organization’s
organization’s objectives
objectives

Principle 2
10
The 8 principles of QMS …

Applying the principle of Leadership typically leads to

 Establishing a clear vision of the organization's


future
 Establishing trust and eliminating fear.
 Setting challenging goals and targets.
 Providing people with the required resources,
training and freedom to act with responsibility and
accountability
 Inspiring, encouraging and recognizing people's
contributions.

11
The 8 principles of QMS …

Involvement of people
Must
Must encourage
encourage the
the involvement
involvement of
of people
people at
at
all
all level
level

Must
Must help
help people
people to
to develop
develop and
and use
use their
their
abilities
abilities

Principle 3

12
The 8 principles of QMS …

Applying the principle of Involvement of people


typically leads to

 People understanding the importance of their


contribution and role in the organization.
 People accepting ownership of problems and their
responsibility for solving them.
 People freely sharing knowledge and experience.
 People openly discussing problems and issues.
 People identifying constraints to their performance.

13
The 8 principles of QMS …

Process Approach

Control

Input Activities Output


+
Resources

AA desired
desired result
result is
is more
more efficiently
efficiently achieved
achieved when
when
resources
resources and
and activities
activities are
are managed
managed as as aa process
process

Principle 4
14
The 8 principles of QMS …

Processes – understand interaction

Process A Process C

Process B Process D

Input
Output
Control
15
The 8 principles of QMS …

Applying the principle of Process approach


typically leads to

 Identifying the interfaces of key activities within


and between the functions of the organization.
 Focusing on the factors such as resources,
methods, and materials that will improve key
activities of the organization.
 Systematically defining the activities necessary to
obtain a desired result.
 Establishing clear responsibility and accountability
for managing key activities.

16
The 8 principles of QMS …

System Approach to Management


Identifying,
Identifying, understanding
understanding andand managing
managing
interrelated
interrelated processes
processes as
as aa system
system contributes
contributes
to
to the
the organization's
organization's effectiveness
effectiveness and
and
efficiency
efficiency in
in achieving
achieving its
its objectives.
objectives.

Principle 5

17
The 8 principles of QMS …

Applying the principle of System approach to


management typically leads to
 Structuring a system to achieve the organization's
objectives in the most effective and efficient way.

 Providing a better understanding of the roles and


responsibilities necessary for achieving common
objectives and thereby reducing cross-functional
barriers

 Targeting and defining how specific activities within a


system should operate

 Continually improving the system through


measurement and evaluation

18
The 8 principles of QMS …

Continual Improvement
Customer Focus

Deming’s
Deming’s
wheel
wheel PLAN DO
(P.D.C.A.)
(P.D.C.A.)

CHECK Continual
ACT Improvement
ISO
Principle 6 9000

Continual improvement of the organization's overall performance


should be a permanent objective of the organization.
19
The 8 principles of QMS …

Applying the principle of continual improvement


typically leads to

 Providing people with training in the methods and tools of


continual improvement.
 Making continual improvement of products, processes and
systems an objective for every individual in the organization
 Establishing goals to guide, and measures to track,
continual improvement.
 Establishing goals to guide, and measures to track,
continual improvement.

20
The 8 principles of QMS …

Decision based on facts


Effective
Effectivedecisions
decisionsare
arebased
basedon
onthe
theanalysis
analysisof
ofdata
data
and
andinformation
information

Principle 7

21
The 8 principles of QMS …

Applying the principle of Decision based on the facts


typically leads to

 Ensuring that data and information are sufficiently accurate


and reliable.
 Making data accessible to those who need it.
 Analyzing data and information using valid methods.
 Making decisions and taking action based on factual
analysis, balanced with experience and intuition.

22
The 8 principles of QMS …

Mutually beneficial supplier relationships

An
Anorganization
organizationand
andits
itssuppliers
suppliersare
areinterdependent
interdependentandandaa
mutually
mutuallybeneficial
beneficialrelationship
relationshipenhances
enhancesthe
the ability
ability of of
both
bothtotocreate
createvalue
value

Principle 8

23
The 8 principles of QMS …

Applying the principle of mutually beneficial


relationships typically leads to

 Inspiring, encouraging and recognizing improvements and


achievements by suppliers.
 Clear and open communication.
 Establishing joint development and improvement activities
 Identifying and selecting key suppliers.

24
ISO 9000:2000 Family

•ISO 9001:2000 – Quality Management Systems:


•ISO 9001:2000(WHAT
– Quality
REQUIREMENTS ?) Management Systems:
REQUIREMENTS (WHAT ?)
ISO 9001 oriented effectiveness and certification,
ISO 9001 oriented effectiveness and certification,
•ISO 9004:2000 - Quality Management Systems:
•ISO 9004:2000 - Quality Management Systems:
GUIDELINES FOR PERFORMANCE IMPROVEMENTS
GUIDELINES FOR PERFORMANCE IMPROVEMENTS
(HOW ...?)
(HOW ...?)
•ISO 9000:2000 – Quality Management Systems:
•ISO 9000:2000
and–vocabulary
Quality Management Systems:
Fundamentals
Fundamentals and vocabulary
•ISO 19011:200X – Guidelines for quality and/or
•ISO 19011:200X – Guidelines for quality and/or
environmental management systems auditing.
environmental management systems auditing.

25
ISO 9000:2000 Support Documents

TWO TECHNICAL SUPPORT DOCUMENTS :


TWO TECHNICAL SUPPORT DOCUMENTS :
•ISO 1000x – Technical brochure - Selection & Use
•ISO 1000x – Technical brochure - Selection & Use
•ISO 1000y - Principles and application of quality
•ISO 1000y - Principles and application of quality
management
management

26
The ISO 9000:2000 requirements
Five Operating Elements
4- QUALITY MANAGEMENT SYSTEMS
(QMS, documentation requirements)
5- MANAGEMENT RESPONSIBILITY
(Management commitment, Customer focus, Quality Policy, Planning,
Responsibility, Authority and Communication, Management Review)
6- RESOURCE MANAGEMENT
(Provision of Resources, Human Resources, Infrastructure, Work
Environment)
7- PRODUCT REALIZATION
(Planning, Customer Related Processes, Design and Development),
Purchasing, Service Provision, Control of Measuring Devices)
8- MEASUREMENT, ANALYSIS AND IMPROVEMENT
(Monitoring and Measurement, Control of Non-conforming Product,
Analysis of Data, Improvement)

27
The ISO 9000:2000 requirements

Continual improvement of the


Quality Management System

Management
Responsibility

Satisfaction
CUSTOMERS

CUSTOMERS
Measurement,
Resource
Analysis and
Management
Improvement
Requirements

Product /
Input Output Product
Service
Data Data Service
Realization

28
QUALITY MANAGEMENT SYSTEM

4 Quality management system


4.1 General requirements

Establish , document , implement and maintain a


QMS and continually improve its effectiveness in
accordance with the standard

29
QUALITY MANAGEMENT SYSTEM

4.1 General Requirements


• Identify the processes necessary for QMS
• Determine the sequence and interaction of processes
• Determine criteria & methods to ensure effective
operation & control of the processes
• Ensure availability of resources and information needed
to support the operation & monitoring of the processes
• Measure , monitor and analyze processes
• Implement action necessary to achieve planned results
& continual improvement

30
QUALITY MANAGEMENT SYSTEM

4.1 General Requirements


• Manage the processes in accordance with standard
• Ensure control of outsourced processes affecting product
conformity
• Identify control of outsourced processes within the QMS

Note: Processes needed for QMS include processes for


management activity , provision of resources ,
product realization and measurement

31
QUALITY MANAGEMENT SYSTEM

4.2 Documentation requirements


4.2.1 General

QMS documentation must include


• Quality Policy
• Quality objectives
• Documented procedure required by standard
• Documents required by organization to ensure effective
planning , operation & control processes
• Quality records required by the standard

32
QUALITY MANAGEMENT SYSTEM

4.2.1 General
Basis of Auditing ( Auditor may look for )
Availabilityof
Availabilityof
• StateSm entsof QualityPolicyandObjectives
• tatementsof QualityPolicyandObjectives
• Quality Manual
• lityManual
Q u a
• AvailaAvbailityof DocumentedProcedure
• ilityof DocumentedProcedure
ilab
4.2.3 Control of Documents
4.2.3 Control of Documents
4.2.4 Control of records
4.2.4 Control of records
8.2.2 Internal Audit
8.2.2 Internal Audit
8.3 Control of Nonconformingproducts
8.3 Control of Nonconformingproducts
8.5.2 CorrectiveAction
8.5.2 CorrectiveAction
8.5.3 PreventiveAction
8.5.3 PreventiveAction

33
QUALITY MANAGEMENT SYSTEM

4.2.2 Quality manual


The Organization shall establish and maintain a quality
manual that include as minimum :

• The scope of QMS including details of , and justification


for , and exclusions
• Documented procedures or reference
• Description of the interaction between the processes of
the QMS

34
QUALITY MANAGEMENT SYSTEM

4.2.3 Control of Documents


Documents required by the quality management system
Shall be controlled
Documented procedures to:
• Approve documents prior to issue
• Review , update as necessary and re-approve
documents
• To identify the changes and the current revision status
of documents
• To ensure documents remain legible , readily identifiable
• Ensure relevant versions of applicable documents are
available at points of use
• Ensure that the documents of external origin are
identified and distribution controlled
• Obsolete documents are prevented from unintended use
and identified if kept for any reason
35
QUALITY MANAGEMENT SYSTEM

4.2.3 Control of Documents


Basis of Auditing (Auditor may look for )

• Proceduresfor document approval , document review,reapproval , distributionandcontrol mechanism


• Proceduresfor document approval , document review,reapproval , distributionandcontrol mechanism
• Availabilityof relevantversionof documentsat all pointsof use
• Availabilityof relevantversionof documentsat all pointsof use
• Mechanismforpreservationof obsoletecopiesusage
• Mechanismforpreservationof obsoletecopiesusage
• Systemsforcontrol of useexternal origindocuments
• Systemsforcontrol of useexternal origindocuments

36
QUALITY MANAGEMENT SYSTEM

4.2.4 Control of Records


• Records must be established and maintained
• Records must be legible , readily identifiable and
retrievable
• Documented procedure for control of identification ,
storage , retrieval ,retention time and disposition of
quality records

Basis of Auditing ( Auditor may look for )

•• ProPcroedcuereduforerforercreordcocrdonctro l
ontrol

•• DetaDeilstailsof reofterentetionntiopneriod
period

37
MANAGEMENT RESPONSIBILITY

5 . Management Responsibility
5.1 Management 5.5 Responsibility , authority
commitment and communication
5.5.1 Responsibility , authority
5.2 Customer focus
5.5.2 Management
representative
5.3 Quality policy 5.5.3 Internal communication

5.4 Planning
5.6 Management review
5.4.1 Quality objectives
5.6.1General
5.4.2 QMS planning
5.6.2 Review input
5.6.3 Review output

38
MANAGEMENT RESPONSIBILITY

5.1 Management Commitment


Top Management shall provide evidence of commitment
to the development implementation and improvement
of QMS by:
• Communicating the importance of meeting customer
and statutory and regulatory requirements
• Establishing quality policy & objectives
• Conducting Management review
• Ensuring the availability of resources

39
MANAGEMENT RESPONSIBILITY

5.2 Customer Focus


Top Management shall ensure that customer
requirements are determined and are met with the aim
of enhancing customer satisfaction

Basis of Auditing ( Auditor may look for )

••EvaEluvaalutioantioonf coufsctousmtoem
rssurvey
erssurvey

••MaMrkaerktaentaalynasislysis
••Com plaint documentation /analyses
Complaint documentation /analyses

••CusCtousmtoem
rsatisfactionanalyses
ersatisfactionanalyses

40
MANAGEMENT RESPONSIBILITY

5.3 Quality policy


Top management shall ensure that the quality
policy
a) is appropriate to the purpose of the organization
b) commitment to comply with requirements &
continually improve the effectiveness of the QMS
c) framework for establishing and understood within the
organization
d) is reviewed for continuing suitability
Basis of Auditing ( Auditor may look for )
•• Documentationof qualitypolicy
Documentationof qualitypolicy

•• Abletogiveframe-worktoestablishobjectives
Abletogiveframe-worktoestablishobjectives

•• Mechanismforcommunicationof thequalitypolicy totheemployees


Mechanismforcommunicationof thequalitypolicy totheemployees
–Trainingscheduleandevidence
–Trainingscheduleandevidence 41
MANAGEMENT RESPONSIBILITY

5.4.1 Quality Objectives


• Establish quality objectives at relevant functions and
level
• Objectives must be measurable & consistent with the
quality policy
• Include those needed to meet requirements for product
{ see 7.1 (a)}
• Documented {see 4.2.1 (a)}
Basis of Auditing ( Auditor may look for )
•• AvAavilaabilaility of qualityobjectivesat relevant levelsof theorganization
bilityof qualityobjectivesat relevant levelsof theorganization

•• MeMcheachnaisnmism forthecommunicationtoemployees
forthecommunicationtoemployees

•• AreArethethreereSMSAMRATRoTbojebcjetivctiv
es?
es?

•• ImIm
provement objectiverelatedtotheproduct
provement objectiverelatedtotheproduct
42
MANAGEMENT RESPONSIBILITY

5.4.2 Quality planning


Top management shall ensure that
• Planning of the QMS is carried out in order to meet
requirements given in 4.1 , as well as the quality
objectives
• the integrity of the QMS integrity must be maintained
when changes are planned and implemented

43
MANAGEMENT RESPONSIBILITY

5.5 Responsibility ,authority and communication

5.5.1 Responsibility and authority


Top management shall ensure that the responsibilities
and authorities are defined and and communicated
within the organization

Basis of Auditing ( Auditor may look for )

••RoRleo,lefu,nfuctio nandresponsibilitymatrices
nctionandresponsibilitymatrices

••OrgOargnizanaiztioatio
nal chart
nal chart

••AuAthuothritiesshall beclearlyknowntoemployeesalongwithresponsibilities
oritiesshall beclearlyknowntoemployeesalongwithresponsibilities

44
MANAGEMENT RESPONSIBILITY

5.5.2 Management Representative


Topmanagement shall appoint amemberof themanagement who, irrespectiveof other

responsibility, shall haveresponsibilityandauthoritythat includes

 EnsuringthatprocessesneededfortheQMSareestablished,implementedand
maintained

 Reportingonperformanceof QMSincludingneedsfor improvement

 Ensuringthepromotionof awarenessof customerneeds&requirements

Note:Responsibilitymayincludeliaisonwithexternal partiesinrelationtoQMS

45
MANAGEMENT RESPONSIBILITY

5.5.3 Internal communication


Top management shall ensure that appropriate communication processes are established within the organization , and that communication takes place

regarding the effectiveness of the QMS

Basis of Auditing ( Auditor may look for )


MinMuinteusteasnadnredpreoprtsortsofomfemeetinetin
g
g

NoNticotic
eboards, internal magazinesandcircularletter
eboards, internal magazinesandcircularletter

AuAduiod-viois-vuisaul aalnadnedleecletroctro
nicmedia
nicmedia

EmEpmlopyloeyeeseugsuggegstio nsystem
estionsystem

46
MANAGEMENT RESPONSIBILITY

5.6 Management Review


5.6.1 General
Review of the QMS by top management at planned intervals to:

 Ensure QMS suitability , adequacy &


effectiveness
 Assess opportunities for improvement
 Evaluate the need for changes to QMS including
policy & objectives

47
MANAGEMENT RESPONSIBILITY

5.6 Management Review


5.6.2 Review input
Review performance and improvement opportunities
related to :

 Audit results
 Customer feedback
 Process performance & product conformity
 Status of preventive and corrective actions
 Follow up actions from earlier reviews
 Changes that could affect the QMS
 Recommendation for improvement

48
MANAGEMENT RESPONSIBILITY

5.6 Management Review


5.6.3 Review output
Output to include actions related to :

 Improvement of the effectiveness of the QMS and


its processes
 Improvement of product related to customer
requirements
 resource needs

Result of management review must be recorded

49
QUALITY MANAGEMENT SYSTEM

5.6 Management Review


Basis of Auditing ( Auditor may look for )
Availabilityof
Availabilityof
 Managementreviewmeetingreports
 Managementreviewmeetingreports
 Customercomplaints
 Customercomplaints
 Processdataanalysis
 Processdataanalysis
 Productdataanalysis
 Productdataanalysis
 Evidenceof correctiveandpreventiveaction
 Evidenceof correctiveandpreventiveaction
 Resourcerequirementsandapplicationplanning
 Resourcerequirementsandapplicationplanning
 Objectivesandtargetsachievements
 Objectivesandtargetsachievements
 Businessplan
 Businessplan
 Investmentplan
 Investmentplan
 HRPlanning
 HRPlanning
 Actionplanwithresponsibilitiesandtimeframe
 Actionplanwithresponsibilitiesandtimeframe

50
RESOURCE MANAGEMENT

6. RESOURCE MANAGEMENT
6.1 Provision of resource
6.2 Human resource
6.2.1 General
6.2.2 Competence , awareness and training
6.3 Infrastructure
6.4 Work environment

51
RESOURCE MANAGEMENT

6.1 Provision of Resources


The organization shall determine and provide the resources
needed to :
 Implement , maintain the QMS and continually
improve its effectiveness
 Enhance customer satisfaction by meeting
customer requirements

Basis of Auditing ( Auditor may look for )


InvInevstment planningrelatedtohumanresource
estment planningrelatedtohumanresource

StaSffin gschedules
taffingschedules

OthOethretarrgtaergtebtubdugdegtsets/E/qEuqipumipemnetnetnehnahnacenm ent program


cement program

52
RESOURCE MANAGEMENT

6.2 Human Resources


6.2.1 General
Personnel performing work affecting product quality
must be competent on the basis of appropriate
education , training , skills and experience

Basis of Auditing ( Auditor may look for )

JobJo/bfu/nfuctio nprofiles–competencyrequirementsat variouslevels


nctionprofiles–competencyrequirementsat variouslevels

CoCmopmepteentecyncmyampappinpgin–gm–inmim umrequirementsv/sactual available


inimumrequirementsv/sactual available

53
RESOURCE MANAGEMENT

6.2 Human Resources


6.2.2 Competence , awareness and training
The organization shall
Determine the necessary competence for
personnel performing work affecting product
quality
Provide training or take other actions to satisfy
these needs
Evaluate the effectiveness of the actions taken
Ensure that its personnel are aware of the
relevance and importance of their activities and
how contribute to the quality objectives
Maintain appropriate records of education ,
training , skills and experience
54
RESOURCE MANAGEMENT

6.2 Human Resources


6.2.2 Competence , awareness and training

Basis of Auditing ( Auditor may look for )

 CompCeotemnpceetenneceednedeeded

 Skill Sgakillpagnaaplyasnisalysis
 ationof trainingneeds
 Identific
 Identificatioinninogf trainingneeds
 ProvisProionvisoiof tra
 nof training
 Evaluatiotra
Eva lu a tio n o f iningeffectiveness
 tions ftrainingeffectiveness
n o
 JobdJoesbcrip
 descriptions
 Relatecdordrescords
Rela te d re
 yee’sawarenessaboutrelevanceandimportanceoftheirwork
 EmploEm
 ployee’sawarenessaboutrelevanceandimportanceoftheirwork
 AnalyAsneaslyosfelasboofrlatubornrotuvernroovresrtaoffrsatabsffenatebseeisnm
 teeism

55
RESOURCE MANAGEMENT

6.3 Infrastructure
The organization shall Identify ,provide & maintain the infrastructure needed to achieve
product conformity .
Infrastructure includes as applicable

 Building ,workspace & associated utilities


 Process equipments (hardware & software )
 Supporting services ( Transport , communication )

Basis of Auditing ( Auditor may look for )


PlaPnlatsntsanadnpdropdroudctionfacilities
uctionfacilities

CoCrreorre
ctiveandPreventivemaintenance
ctiveandPreventivemaintenance

TreTnrednsdosfomfaminateinnteannacence
EqEuqipumipemnetnPtePrfoerfo
rmance
rmance 56
RESOURCE MANAGEMENT

6.4 Work Environment


The organization shall determine and manage the work environment needed
to achieve conformity to product requirements

Physical factors
• Heat • Noise • Vibration • Cleanliness
•Light • Pollution • Air flow •Hygiene

Basis of Auditing ( Auditor may look for )

EvEidveidnecencoefoinfsintrustru
ctioninoccupational safety
ctioninoccupational safety

EvEidveidnecencoefothfethseatis factionof statutoryandregulatoryrequirementsor


satisfactionof statutoryandregulatoryrequirementsor
conditions
conditions

WoWrkorkplapclaecinevinevstigations
estigations
57
PRODUCT REALIZATION

7 Product Realization

7.1 Planning of product realization


7.2 Customer related processes
7.3 Design & development

7.4 Purchasing

7.5 Production & service operation

7.6 Control of measuring & monitoring devices

58
PRODUCT REALIZATION

7.1 Planning of product realization


The organization shall plan and develop the processes needed
for product realization .

Planning must determine as appropriate :


 Quality objectives and requirements for the product
 the need for processes , documentation , resources specific to the product
 verification and validation activities & acceptance criteria for product acceptance
 Records
The output of this planning shall be in a form suitable for the organization’s methods
of operations.

Examples
Production Control plan
Project Plan
59
PRODUCT REALIZATION

7.2 Customer related process


7.2.1 Determination of requirements related to the products
The organization shall determine

 Requirements specified by the customer , including the


requirements for delivery and post delivery activities
 Requirements not stated by the customers but
necessary for specified or intended use
 Statutory and regulatory requirements related to the
products
 Any additional requirements determined by the
organization
Basis of Auditing ( Auditor may look for )
CuCstousm erinquiries
tomerinquiries

OrdOerdrsers
ReRcoerdcosrdosnodnisdcisuscsuiossniownithwithcusctousm ers
tomers
60
PRODUCT REALIZATION

7.2 Customer related process


7.2.2 Review of requirements related to the products
The organization shall review the requirements related to the product.
This review shall be conducted prior to the organization’s commitment to supply a product to the customer and shall ensure that

 Product requirements are defined


 Contract or order requirements differing from those
previously expressed are resolved
 The organization has the ability to meet the defined
requirements
Basis of Auditing ( Auditor may look for )
EvEidveidnecencoefocfoncotrantra
ct review
ct review

DoDcuom entationof amendments


cumentationof amendments

OrdOerdrecroncofonrm ationrecords
formationrecords
61
PRODUCT REALIZATION

7.2 Customer related process


7.2.3 Customer Communication
The organization shall determine and implement effective arrangements for
communication with customers in relation to

 Product information
 Enquiries , contracts or order handling , including
amendments
 Customer feedback , including customer complaints

Basis of Auditing ( Auditor may look for )


CuCstousm er’sproduct specification
tomer’sproduct specification

CoCnotrantra
cts
cts

AcAknckonwolewdlegdegmeemnetnotfoofrdoerdrer
CuCstousm errequestsforchanges
tomerrequestsforchanges 62
PRODUCT REALIZATION

7.3 Design and Development


7.3.1 Design & development planning

7.3.2 Design & development input

7.3.3 Design & development output

7.3.4 Design & development review

7.3.5 Design & development verification


7.3.6 Design & development validation

7.3.7 Control of design & development changes

63
PRODUCT REALIZATION

7.3 Design and Development


7.3.1 Design & development planning
The organization shall plan and control the design and
development of product
During the planning to include :
* D&D stages
* required review , verification and validation activities
* responsibilities & authorities for D&D
 Interfaces between groups must be managed
 Planning output shall be updated as the D&D progresses

64
PRODUCT REALIZATION

7.3 Design and Development


7.3.2 Design & development input
 Determine & record product requirements including
* functional & performance requirements
* applicable statutory and regulatory requirements
* information from previous similar designs
* any other essential requirements
 Review input for adequacy

65
PRODUCT REALIZATION

7.3 Design and Development


7.3.3 Design & development outputs
 D&D output must
* meet the input requirements
* provide information for purchasing ,production or
service provision
* contain or reference acceptance criteria
* define characteristics essential for proper & safe
use
 Approve output prior to release

66
PRODUCT REALIZATION

7.3 Design and Development


7.3.4 Design & development review
 At suitable stages systematic reviews of D&D to
* evaluate the ability to fulfill requirements
* identify problems and propose follow up
 Involve all functions concerned
 Record the results and any necessary actions

67
PRODUCT REALIZATION

7.3 Design and Development


7.3.5 Design & development verification

 Verify D&D to ensure that output meets the input


requirements
 Record the results of verification and necessary actions

68
PRODUCT REALIZATION

7.3 Design and Development


7.3.6 Design & development validation
 Perform D&D validation to confirm that product is
capable of meeting the requirements for the specified or
known intended use
 Whenever applicable to be completed prior to delivery
 Results of validation and necessary action must be
recorded

69
PRODUCT REALIZATION

7.3 Design and Development


7.3.7 Control of design and development changes
 Design and development changes must be identified and
records maintained
 Changes must be reviewed , verified and validated as
appropriate and approved before implementation
 Record results of review of changes and any necessary
actions

70
PRODUCT REALIZATION

7.3 Design and Development


Basis of Auditing ( Auditor may look for )
 DesigDneasnigdnDaenvdeloDpem v
ent plan
elopment plan

 MilestoMnileesstoannedssachneddsucleheinduplelainnplan

 ApproAvpaplroprovavlispioronvsisinionDs&inDpDla&nDplan

 DrawinDragwing

 QualityQuPalalitynsPlans

 DesigDneinsigpuntinrepcuotrdrescords

 D&DreD&vDiewrereviecwordrescords

 D&DvDe&rific ationrecords
TestrecoDrdvserificationrecords

 Test records
 D&DvDa&lidDavtioalidnaretioconrdrescords

 ValidaVtioalidnaatio
pproval
napproval

 DesigDnecshiganngceharenqgueerestsquests

 NewreNevwisiorenvsistaiotunsstatus

 HistoryHisotof cryhaonfgcehsanges

71
PRODUCT REALIZATION

7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of Purchased product

72
PRODUCT REALIZATION

7.4 Purchasing
7.4.1 Purchasing process
 Ensure that purchased product meets requirements
 Evaluate and selects suppliers based on their ability to
supply conforming product
 Establish criteria for selection , evaluation and re-
evaluation of suppliers
 Results of evaluation and any necessary actions must be
recorded

73
PRODUCT REALIZATION

7.4 Purchasing
7.4.2 Purchasing information
Purchasing information must describe the product to be
purchased including where appropriate :
* requirements for approval of product , procedures
processes and equipment
* requirements for qualification of personnel
* quality management system requirements

Ensure adequacy of specified purchase requirements


prior to their communication to supplier

74
PRODUCT REALIZATION

7.4 Purchasing
Basis of Auditing ( Auditor may look for )

PurcPhuarcsheasspeescpificecaifictioantion
EvidEevnidceenocfesoufpspuliepprlieevraeluvaation
luation
ListLoisftaopfparopvperodvseudpspuliepprsliers
EvaEluvaatio nCriteria
luationCriteria
PurcPhuarcsheaosrdeeorrd–ercla–rity intermsof commercial andtechnical
clarityintermsof commercial andtechnical
QuaQlity assuranceagreements
ualityassuranceagreements
OrdOerrdaeprparopvparolvdaolcduomceunmtsents

75
PRODUCT REALIZATION

7.4 Purchasing
7.4.3 Verification of Purchased product
Establish & implement inspection or other activities
needed to ensure purchased product conformity

Where organization or its customer propose verification


at supplier’s premises , organization must specify in
purchasing information :
* verification arrangements
* method of product release
Basis of Auditing ( Auditor may look for )
VeVrific ationplan
erificationplan

AcAcecpcetapntacencceritecrite
ria
ria

TeTstesretcreordcosrdosfosfupsupplieprsliers
 Incominginspectionof materials 76
PRODUCT REALIZATION

7.5 Product and service provision

7.5.1 Control of production and service provision


7.5.2 Validation of processes for production and service
provision
7.5.3 Identification & traceability

7.5.4 Customer property

7.5.5 Preservation of products

77
PRODUCT REALIZATION

7.5 Product and service provision


7.5.1 Control of production and service provision

The organization shall plan and carry out production & service
provision under controlled conditions . Controlled conditions
include as applicable:

 availability of information describing product


characteristics
 availability of work instruction
 the use of suitable equipment
 availability & use of measuring & monitoring devices
 implementation of monitoring and measurement
 the implementation of release , delivery and post
delivery activities

78
PRODUCT REALIZATION

7.5 Product and service provision


7.5.2 Validation of processes
Processes where outcome is not verified and / or
where deficiencies may become apparent after delivery
must be validated to demonstrate ability to achieve
planned results
Arrangements must be established for these
processes including , as applicable :
 criteria for review and approval of the process
 approval of equipment
 qualification of personnel
 use of defined methods & procedures
 requirements for records
 re-validation
79
PRODUCT REALIZATION

7.5 Product and service provision


Basis of Auditing ( Auditor may look for )

 MainMteaninatencneansccehesdcuhleedule

 ServSiceervCicoentra cts
 Contracts
 SpareSpapreartspamrtsanmagaenm ent
 agement
 IdenIdtificenatific
tionof Special process
 ationof Special process
 AvailaAvbaility of validationspecification
 ila b ility of validationspecification

80
PRODUCT REALIZATION

7.5 Product and service provision


7.5.3 identification & traceability
 Where appropriate identify product by suitable means
throughout realization
 Identify status with respect to measurement &
monitoring requirements
 Where traceability is required control & record unique
identification of product

Basis of Auditing ( Auditor may look for )


ProPdroudctucidteidnetification
ntification

RoRuotinutin
gtag
gtag

segsereggreagtioatio
nslips
nslips

81
PRODUCT REALIZATION

7.5 Product and service provision


7.5.4 Customer Property
 Care for customer’s property while it is under
organization’s control or being used by organization
 Identification , verification , protection & safeguarding
customer property provided for use or incorporation
 Any customer property that is lost , damaged or found
unsuitable must recorded & reported to customer

Note: Customer property includes intellectual property

82
PRODUCT REALIZATION

7.5 Product and service provision


7.5.5 Preservation of product
 Preserve conformity of product during internal
processing and final delivery to intended destination
 Include identification , handling , packaging , storage
and protection
 This applies to constituent parts of a product

Basis of Auditing ( Auditor may look for )

InvInevnetonrytorylistlist
DisDpisaptcahtcm ethods
hmethods

regreuglautiolatio
nonpacking, storage, preservationanddelivery
nonpacking, storage, preservationanddelivery

83
PRODUCT REALIZATION

7.6 Control of measuring & monitoring devices


 Determine monitoring and measurement to be made &
measurement & monitoring devices needed to provide
evidence of conformity of product
 Ensure measuring and monitoring is carried out
consistently with monitoring and measurement
requirements
 Suitability of measuring / monitoring software must be
confirmed prior to use
Basis of Auditing ( Auditor may look for )

IdeIdnetificationof Equipments
ntificationof Equipments

CaClibalib
rationstandardsandRecords
rationstandardsandRecords

AcAcecpcetapntacencCeriteria
Criteria

CaClibalib
rationinstruction
rationinstruction
84
PRODUCT REALIZATION

7.6 Control of measuring & monitoring devices


 Calibrate or verify measuring and monitoring devices
(MMD)at specified intervals
 Adjust or re-adjust as necessary
 Identify to enable the determination of calibration status
 Safeguard MMD from adjustments invalidating calibration
 Protect MMD from damage or deterioration during
handling , maintenance & storage
 Record results of calibration

Basis of Auditing ( Auditor may look for )


IdeIdnetificationof Equipments
ntificationof Equipments

CaClibalib
rationstandardsandRecords
rationstandardsandRecords

AcAcecpcetapntacencCeriteria
Criteria

CaClibalib
rationinstruction
rationinstruction
85
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.1 General
8.2 Monitoring / measurement
8.2.1 Customer satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring & measurement of processes
8.2.4 Monitoring & measurement of product

8.3 Control of nonconforming product


8.4 Analysis of data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective action
8.5.3 Preventive action
86
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.1 General
Plan & implement measurement , monitoring analysis
and improvement processes needed to :
> demonstrate conformity of the product
> ensure conformity of QMS
> continually improve the effectiveness of the QMS

This includes determination of applicable methods


including statistical techniques and extend of their
use

87
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.2.1 Customer satisfaction

 Organization shall monitor information related to


customer perception as to whether the organization
has fulfilled customer requirements
 The methods for obtaining and using this information
must be determined

Basis of Auditing ( Auditor may look for )

AvAavilaabilaility of effectivesystemof customersatisfactionmeasurements


bilityof effectivesystemof customersatisfactionmeasurements

CuCstousm ersatisfactionanalysis
tomersatisfactionanalysis

88
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.2.2 Internal Audit
Conduct internal audits as planned intervals to determine if
 QMS conform to the planned arrangements,
requirements of the standard and organization’s
requirements
 QMS is effectively implemented & maintained

Plan the audit programme considering :


 Status and importance of the processes and the areas
 Results of previous audits
Define audit criteria ,scope ,frequency & methodologies
Auditor must not audit own work

89
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.2.2 Internal Audit
Basis of Auditing ( Auditor may look for )

 InteInrntealrnauadlitin gprocedure
 a ud itingprocedure
 AudAitupdlaitnpslaannsdasncdhesdcuhleedsules

 AudAitureditporertsports

 AudAitundoittenso/tepsro/opfroofofveorifie dobjectiveevidence
 f v e rifiedobjectiveevidence
 NonNcoonnfocorm ityreport
 n fo rmityreport
 DiscDuisssciounssoiofnauodfitaureditsureltssuinltsMinRMMRM

 AudAitourdito
qualificationcertificates
 rqualificationcertificates
 CorreCocrre
tiveactions
 ctiveactions

90
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.2.3 Monitoring and measurement of processes
Apply suitable methods for monitoring and , where
applicable , measurement of QMS processes
 These methods shall demonstrate the ability of the
processes to achieve planned results
 Where planned results are not achieved corrections
and corrective actions must be taken to ensure
conformity of the product
Basis of Auditing ( Auditor may look for )
ProPcroescsespsapraam eters
rameters

StaStistatis
tical Techniques
tical Techniques

KPKIP/IP/ePrfoerfo
rmanceindicators
rmanceindicators

AreArethethKePKIPinIinlinlin
ewithfunctional objectives
ewithfunctional objectives 91
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.2.4 Monitoring and measurement of product
 The organization shall monitor & measure characteristics of
the product requirements have been met.This shall be
carried out at appropriate stages of realization processes in
accordance with planned arrangements
 Evidence of conformity with the acceptance criteria must be
maintained . Records must indicate the person(s)
authorizing release of the product
 Product release or delivery must not processed until all the
planned arrangements have been satisfactorily completed ,
unless otherwise approved by a relevant authority , and
where applicable by the customer

92
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.2.4 Monitoring and measurement of product
Basis of Auditing ( Auditor may look for )

Procedure for inspection . Quality plan and test plan


Procedure for inspection . Quality plan and test plan
Person approving the check and release of the product shall be identified
Person approving the check and release of the product shall be identified
Inspection reports
Inspection reports
Deviation accepted by customer or approved by designated authorities
Deviation accepted by customer or approved by designated authorities

93
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.3 Control of nonconforming product
 Nonconforming product must be identified and controlled to
prevent unintended use or delivery
 Documented procedure to define controls , responsibility and
authority
 When nonconformance detected after delivery take
appropriate action
 Organization must deal with nonconforming product by one or
more of the following ways
>action to eliminate detected nonconformity
> concession

 When the nonconforming product is corrected it must be re-


verified to demonstrate conformity
 Records of the nature of nonconformity and any subsequent
action including concessions must be maintained

94
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.3 Control of nonconforming product
Basis of Auditing ( Auditor may look for )

What options an organization has selected when a non conforming product is detected
What options an organization has selected when a non conforming product is detected
- Reworking the product to make it confirm to specification
- Reworking the product to make it confirm to specification
- Negotiating with the customers to accept the product as it or after repair
- Negotiating with the customers to accept the product as it or after repair
- Scrapping the product
- Scrapping the product

95
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.4 Analysis of data
 Determine ,collect & analyze appropriate data to
demonstrate the suitability and effectiveness of QMS
and to evaluate where continual improvement of the
QMS can be made
 Data from measurement & monitoring & other relevant
sources
 Analyze data to provide info on:
 Customer satisfaction
 Conformance to product requirements
 Process , product characteristics and their trends
including opportunities for preventive action
 Suppliers

96
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.4 Analysis of data
Basis of Auditing ( Auditor may look for )

Analysisthat provideinformationon
Analysisthat provideinformationon
- Customersatisfaction
- Customersatisfaction
- Conformitytoproduct requirements
- Conformitytoproduct requirements
- Characteristicsandtrendof processesandproduct
- Characteristicsandtrendof processesandproduct
- Suppliers
- Suppliers

97
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.5 Improvement
8.5.1 Continual improvement
Organization shall continually improve the
effectiveness of the QMS through use of :
 Quality policy
 Quality objectives
 Audit results
 Analysis of data
 Corrective action
 Preventive action
 Management review

98
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , Analysis and Improvement


Continual Improvement

SPC
Benchmarking

Quality Circles
Risk Assessment
Teamwork for Quali
Quality Function Deployme

99
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


Continual Improvement

Problem Solving Techniques


 Cause & effect diagram
 Pareto analysis
 Flowcharting
 Brain storming

100
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.5.2 Corrective action

Organization shall take action to eliminate the causes


of nonconformities to prevent recurrence .
Corrective actions appropriate to the impact of the
problem
Documented procedure shall define requirements
for :
 Reviewing nonconformities (including customer
complaints)
 Evaluating the causes of nonconformities
 Determining & implementing action needed
 Recording results of action taken
 Reviewing corrective action taken

101
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.5.3 Preventive action
Organization shall take action to eliminate the
causes of potential nonconformities to prevent
recurrence .
Actions appropriate to the impact of the potential
problem
Documented procedure shall define requirements
for :
 Determining potential nonconformance &their
causes
 Evaluating the need for preventive action
 Determining & implementing action needed
 Recording results of action taken
 Reviewing corrective action taken

102
MEASUREMENT , ANALYSIS AND IMPROVEMENT

8 Measurement , analysis and improvement


8.5.2 ,8.5.3 – Corrective action , Preventive action

Basis of Auditing ( Auditor may look for )

 NonNcoonnfocorm ityrecords
 nformityrecords
 Instru ctionsrelatedtocorrectiveaction
 Instructionsrelatedtocorrectiveaction
 ComCpolaminptslainantsalyansaislysis

 SysteSymsteapmproapapcrohatochidtoenidtifyentify
root cause
 root cause
 AvoidAvinogidninogncnoonnfocorm itiesduetosamecause
 nformitiesduetosamecause
 UseUosfedoaftadaatanalyansaislytosisidtoenidtifyentify
potential causes
 potential causes
 RevieRewvieofwtreofntre
dstoidentifypotential noncomplianceannecessarypreventiveaction
 ndstoidentifypotential noncomplianceannecessarypreventiveaction

103
QMS DOCUMENTATION

Quality System Documentation


QMS Documentation shall include :
 Documentation statement of Quality Policy and
Objectives
 A Quality Manual
 Documented Procedures required by Standard
 Documentation needed by the organization to
ensure effective planning , operation and control
of its processes
 Records required by the standard
 Records required by the organization

104
QMS DOCUMENTATION

Quality Manual
Quality Manual: Document specifying the QMS of an
organization

Documented Procedure
Documented Procedure : Specified way to carry out an activity
or process

Record
Record : Document stating result achieved or providing
evidence of activities performance

105
QMS DOCUMENTATION

Document
Document : Information and its supporting medium
Documentation can be in any format or medium
Document provides guidelines

Information Medium
- Procedure Paper
- Specification Electronic
- Drawing Photographic
- Standard Magnetic

Document may be established in any form or type of medium


- Flow chart
- Text
- Drawing Sketches
- Audio or video tapes
106
QMS DOCUMENTATION

Difference between documents & records


Document Record
It provides guidelines It provides evidence of
It provides guidelines It provides evidence of
work
workdone
Documents are
Documents are done
dynamic Records cannot be
dynamicandandcan
canbe
be Records cannot be
revised changed
revised changed

Examples Examples
- Procedure for production - Production Report
planning - Inspection Results
- Drawing
- Part Quality Standard
- Work Instruction for
Printing
107
QMS DOCUMENTATION

WHY
Define WHAT will be
Stated Once done
Policy ,
Manual
WHO
WHEN
Procedures
WHERE
HOW Work Instructions
Or
Practices
Evidence
Records
Or
Proof

Documentation Pyramid
108
INTERNAL AUDIT

INTERNAL AUDIT

109
INTERNAL AUDIT

INTERNAL AUDIT

• Audit Definition and criteria


• Audit objectives
• Types and stages of Auditing
• Auditing Process
• Audit and Assessment

110
INTERNAL AUDIT

What is Audit

AUDIT is a Fault Finding Exercise


AUDIT is a Fact Finding Exercise

111
INTERNAL AUDIT

Audit Definition
Audit :
Systematic , documented verification process
of objectively obtaining and evaluating
evidence to determine whether specified
activities , events , conditions , management
systems or information about these matters
conform with audit criteria , and
communicating these results of this process
to the client
Audit Evidence :
A statement of facts or other information relevant
to audit criteria
- based on actual observation
- uninfluenced by emotion
- stated or documented
- verifiable 112
INTERNAL AUDIT

Definitions
Auditee :
Organization to be audited

Auditor :
A person qualified to perform audits

Lead Auditor :
A person qualified to manage and perform audits

Audit Scope :
Audit scope provides the extend and boundaries of
the audit

113
INTERNAL AUDIT

Audit criteria
Audit Criteria :
Policies , practices , procedures or requirements
against which the auditor compares the collected
evidence about the subject matter

Requirements may include but are not limited to


- Customer requirements
- ISO 9001:2000 system requirements
- Organization QMS requirements
- Statutory and regulatory requirements

114
INTERNAL AUDIT

Audit Objectives
Objectives of the audit are

- Conformity wrt Requirements


- Effectiveness wrt Objectives
- Opportunity wrt Improvements
- Compliance wrt regulatory requirements

115
INTERNAL AUDIT

Type and stages of audit


Types of Audit
- First party audit
Self Audit , by an organization on itself for
their own purposes – Internal audit

- Second party audit


By an interested organization in another
organization

- Third party audit


By an independent organization
- Certification audit

116
INTERNAL AUDIT

Type and stages of audit


Type of Audit - System wise:
a) Quality System Audit
Done to verify whether the quality systems are meeting the standard's
requirements and whether they are being followed or not.
b) Process Quality Audit
Done to verify whether a particular production procedure is followed or
now to meet the product specification.
c) Inspection Audit
Done on the product itself to verify whether it meet the specifications or
not. It is simply an inspection activity to identify whether the product is
conforming or non-conforming.
d) Service Quality Audit
Done to verify whether the services rendered meet the procedure laid
down in the quality manual. (Service to customer satisfaction must be the
motto to be established by audit).

117
INTERNAL AUDIT

Type and stages of audit


Stages of audit
- Adequacy audit / Document review audit
An exercise to determine the extend to
which the documented quality system
represented by the quality manual and the
associated procedures.
- Compliance audit
An audit to establish the extent to which the
documented system is implemented

118
INTERNAL AUDIT

Audit Process
Audits are expensive
Audits must be well managed
Audits must not be carried out by surprise
Always agree mutually convenient dates well in
advance

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INTERNAL AUDIT

Audit Process
Audit Plan Preparation

Audit Schedule Preparation

Audit schedule Communication

Conduct Audit

Briefing the findings to auditee

Report preparation

Hand over Report to MR

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INTERNAL AUDIT

Audit Checklist
 Audit checklists are used during the audit to collect the
information / evidence / notes

Benefits
 To assist memory
 Maintains continuity during the audit
 To ensure depth & continuity of the audit
 Help in time management
 Part of audit report

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INTERNAL AUDIT

Auditing skills and approach


Skills required to conduct the effective audit :

 Time Management
 Fact Finding
 Audit Reporting

Relations between AUDITORS and AUDITEES are critical


for successful audit and the approach of the audit should
ensure that audit is conducted in a POSITIVE
ENVIRONMENT

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INTERNAL AUDIT

Time Management

 Time is always short – avoid wasting time


 Plan well – use check list
 Do not allow your audit to get side tracked
 Remember an audit is a sampling activity
 Do not waste time on over friendly chatting
 Do not focus on trivial issues

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INTERNAL AUDIT

Fact Finding

Collect Evidence

 Sufficient to determine conformance to the


audit criteria
 Through
- Interviews
- Examination of documents and records
- Observation of activities and conditions

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INTERNAL AUDIT

Fact Finding

Collecting Evidence is one


important auditing skill –
Done through

- Observations
- Reading
- Communication
- Interviews
- Listening
- Use of check lists

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INTERNAL AUDIT

Communication ( Important for Fact Finding)


 Know your auditee – could range from top
management to lowest level
 Keep the message simple – avoid complex
phrases and words
 Ensure the communication meets the objectives
 Consider the location and timing factor
 Use of most effective medium – could also be
usage of local language

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INTERNAL AUDIT

Communication Skills
How do we communicate ?
- Verbal
- Using Body Language
- Through Facial Expressions
- Using different styles and sounds

Impact of communication is maximum


through body language

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INTERNAL AUDIT

Factors affecting communication

 Physical Factors
 Environment Factors
 Intellectual Factors
 Emotional Factors

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INTERNAL AUDIT

Factors affecting communication

Emotional Factors Intellectual Factors


- Ego - Concepts
- Confidence - Terminology
- Fear - Language

Physical Factors Environment Factors


- Hunger - Ventilation
- Thirst - Lighting
- Rest - Temperature
- Pain - Quality of print

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INTERNAL AUDIT

Communication barriers

 Bad word choice


 Mumbling
 Outside distractions
 Poor listening or reading skills
 Lack of interest

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INTERNAL AUDIT

Communication - Interviewing
 Hold interviews only during normal working
hours
 Put the auditee at ease
 Communicate the objective of the interview
 Show an interest in what THEY do
 Always start with open ended questions
 Verify the facts and records is as finding
 Avoid arguments
 Explain your observations
 Thank the auditee for participation and
opportunity for auditing
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INTERNAL AUDIT

Communication – Interviewing Open end question

 Open end question can increase the amount of


information offered – start with them
 This shall ensure that the responder HAS to give
the information
-Can you please tell me what to do ?
-What are the aspects in your area
 Open questions are auditor friends
 Ask WHO , WHAT , WHERE , WHEN and HOW
questions

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INTERNAL AUDIT

Communication – Interviewing Closed end question

 Avoid Closed Questions


 Closed questions yields only a simple YES / No
-Are you responsible for report preparation
-Have the objectives targets decided for the year?
 Instead of Ask
- Who is responsible for report preparation?
- What are the objectives and targets for the year ?
 Closed questing are limiting and reduce the amount
of information offered

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INTERNAL AUDIT

Communication – Clarifying Questions

Intended to clarify , retrieve full information and


prevent misunderstanding , allowing to grasp full
picture
- can you show me another example please , I
think I am beginning to understand ?
- Sorry , I do not get you , could you please
explain that again please
Disadvantages :
If used too often may create impression that
you were not listening
Are time consuming
If you are prepared to listen in full don’t ask
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INTERNAL AUDIT

Successful approach to audit

 Establish suitable climate


 Put Auditee at ease
 Use proper questioning techniques
 Use open questions and avoid closed
questions
 Be friendly and diplomatic

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INTERNAL AUDIT

Positive Characteristics of Auditor

 Polite  Open Minded


 Friendly  Diplomatic
 Helpful  Honest
 Informative  Mature
 Judicious  Tactful
 Trained  Self disciplined

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INTERNAL AUDIT

Negative Characteristics of Auditor

Argumentative Inflexible
Opinionated Lazy
Over conclusive Impractical
Inconsistent Know it all
Inconsiderate Indecisive
Untrained Uncommunicative
Accepts things at Unprofessional
face value

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INTERNAL AUDIT

Auditor’s Qualities
 Auditor must be a good listener . Listen and Listen
with full attention
 Listen without your own judgment and conclusion
 Do not start teaching
 Active listening always assist auditee to give more
information
 Generate questions from what auditee says – this
possible only when auditor listens carefully
 Auditors should be situation manager

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INTERNAL AUDIT

Sampling
No time to check everything
Select representative sample
No sampling calculation
Sample should represent all activities
Should be on random basis
Spot checking
Take permission before asking / taking samples

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INTERNAL AUDIT

Observations
Keep observing the physical evidence

Example –Equipment in Production Area


-What is used for ?
-Need it to be calibrated ?
-Was it calibrated ?
-Is there a record ?
-What is the reading ?
-Is the reading within the acceptable range ?
-Identification ?
-Status with respect to measurement ?
-Storage location and condition
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INTERNAL AUDIT
Reporting and audit conclusion
Definition
Requirements
- Need or expectation that is stated , generally implied
or obligatory
Conformity
- Fulfillments of a requirement
Non Conformity
- Non fulfillment of a requirement
Defect
- No fulfillment of a requirement related to intended use
Corrective Action
- Action to eliminate the cause of a detected non
conformity
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INTERNAL AUDIT

Non conformity

Non Conformity
- Non fulfillment of a requirement

Non Conformity is established by


OBJECTIVE EVIDENCE
Intent a requirement has not been addresses
Implementation practice differs from the defined system
Effectiveness the practice is not effective

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INTERNAL AUDIT

Categorizing Non Conformities


Major Non Conformity
- The absence or complete non fulfillment or
breakdown of the standard’s stated requirements
- A failure to achieve legal or statutory
requirements
Minor Non Conformity
- An isolated or sporadic lapse in the content or
implementation or procedures or records which could
reasonable lead to failure of the system , if not corrected

- isolated examples of measuring instrument


out of calibration date

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INTERNAL AUDIT

Non Conformity Report Writing


 State the fact with the objective evidence
 Statement should be clear , unambiguous
 Refer the clause number and audit criteria against
which non conformity is established
 It should be trace up to verifiable status of facts
 Grade the non conformity as major or minor if it is
practiced in the organization
 It should be agreed , accepted and signed by the
auditee
 Other relevant details like location , auditee , date etc
should be mentioned.

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INTERNAL AUDIT

Quality characteristics of a report


 Informative
 Factual
 Complete
 Accurate
 Precise
 Legibility
 Transparency
 Clarity

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INTERNAL AUDIT

Timely Reporting
 Report without delay
 Don’t leave writing report till late
 Time never becomes available
 Prepare NCR’s on the spot
 Timely reporting adds value

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INTERNAL AUDIT

Non Conformance Report


 Location / Area
 Category
 Objective Evidence
 Details of Nonconformance
 Details of corrective actions
 Details of preventive actions
 Follow up audit status
 Report Status

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G.M.Pens Inte rna tiona l Pvt Ltd

NON - CONFORM A NC E REPORT


( INT E R NAL AUDIT )

Depa rtme nt : NC R No:


Audite e : Date :

Nature of NonC onformity : Adequacy Non-Conformity


Area C a te gory of Nonconrma nce
: Minor Major

ISO C lause R e f : Document R e:f


De ta il of Non - conformity
Nature of Non - C onformity
Category

Objective Signature of Audite e Signa ture of Auditor


Agre ed corre ctive a ction R e sponsibility

Evidence
T a rge t Da te: Signa ture of Audite e
Proposed P re ve ntive Action

Nonconformance
R esponsibility T a rge t Da te
Verifica tion of C orre ctive Action ( Follow up Audit)

Details
Correctiveaction Signature of Audite e Signa ture of Auditor( follow up a udit)
Ve rifie d C orre ctive Actions is E ffe ctive / Not E ffective
NC R C lose d Y es / No
details T o be discusse d in ma na ge ment re viewY es / No
Signa ture
Preventiveaction

details

VerificationAudit

Details

ReportStatus
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INTERNAL AUDIT

Situation 1

Theauditorentersthemanufacturingarea&identifieslotsof filledpolythenebagskept.

Auditor :What isthereinsidethesebags?

Auditee : Thesearemouldeditems whichwere manufacturedduringsample

productionwhich isdoneinitiallywhiledevelopingnewproducts.

Auditor : What will youdowiththis?

Auditee : Wesimplykeepthem.

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INTERNAL AUDIT

Situation 2

Whileauditingthepurchasedepartment, auditorfinds

that aP.O. foraparticularrawmaterial isgiventoa

newsource.

Auditor :Whyisthisnewsourcebeingidentified?

Auditee : The existing source does not meet the required


specificationof thematerials, for whichwearefacingmany
qualityproblemsforthepast one-month.

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INTERNAL AUDIT

Situation 3

The Auditor while going through the Training records observed that an employee attended an External Training

Programme conducted in May 2006. When enquired about the measurement of effectiveness, Training manager

says “ I maintain only record of training. You have to ask the trainee for effectiveness.”

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INTERNAL AUDIT

Situation 4

Auditor found some packed boxes laying in a corner of the stores without having any identification.

When asked, the stores in-charge said that these are meant for transport to godowns. Personnel doing

routine truck loading and all the stores personnel are aware of this.

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INTERNAL AUDIT

Thank You

if any body wants more details pl mail me I will reply u

sivasankaran2001@yahoo.com

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