QUALITY MANAGEMENT SYSTEM QUALITY MANAGEMENT SYSTEM INTERNAL AUDIT INTERNAL AUDIT

ISO 9001:2000 ISO 9001:2000

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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

“ T ET T L T O F A U E A DC A A T RS I SO AP O U TO H O A I Y F E T R S N H R C E I TC F R D C R S R I ET A B A U O I SA I I YT S TS YS A E O I P I D E VC H T E R P N T BL T O A I F T T D R M L E N E S“ ED
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Quality
C s mr ’ e p c a n o q a a en t th s m f r u to e s x e t tio s f u lity r o e a e o C s mr ’ e p c a n o q a a en t th s m f r u to e s x e t tio s f u lity r o e a e o d f re t if e n d f re t if e n c se la s s o p d c o s r ic s f ro u ts r e v e . c se la s s o p d c o s r ic s f ro u ts r e v e .

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ISO

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ISO 9001:2000
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4

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OBJECTIVES OF ISO 9000:2000 requirements

EXPECTED QUALITY by the Customer Measurement of the Customer’s satisfaction PERCEIVED QUALITY by the Customer

PLANNED QUALITY by the Company Measurement of the Performance of the Company PRODUCED QUALITY by the Company

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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

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The 8 principles of QMS …

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

Principle 1

Customer satisfaction Customer satisfaction
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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).
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The 8 principles of QMS …

Leadership
Leaders must set the direction of the Leaders must set the direction of the organization organization Leaders must create and maintain internal Leaders must create and maintain internal environment that encourages people to environment that encourages people to achieve the organization’s objectives achieve the organization’s objectives

Principle 2
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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.

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The 8 principles of QMS …

Involvement of people
Must encourage the involvement of people at Must encourage the involvement of people at all level all level Must help people to develop and use their Must help people to develop and use their abilities abilities

Principle 3
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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.

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The 8 principles of QMS …

Process Approach
Control Input

Activities + Resources

Output

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

Principle 4
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The 8 principles of QMS …

Processes – understand interaction
Process C

Process A

Process B Input Output Control

Process D

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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.

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The 8 principles of QMS …

System Approach to Management
Identifying, understanding and managing Identifying, understanding and managing interrelated processes as a system contributes interrelated processes as a system contributes to the organization's effectiveness and to the organization's effectiveness and efficiency in achieving its objectives. efficiency in achieving its objectives.

Principle 5
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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
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The 8 principles of QMS …

Continual Improvement
Customer Focus
Deming’s Deming’s wheel wheel (P.D.C.A.) (P.D.C.A.)

PLAN

DO

CHECK

Principle 6

ISO 9000

ACT

Continual Improvement

Continual improvement of the organization's overall performance should be a permanent objective of the organization.
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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.

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The 8 principles of QMS …

Decision based on facts
Effective decisions are based on the analysis of data Effective decisions are based on the analysis of data and information and information

Principle 7
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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.

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The 8 principles of QMS …

Mutually beneficial supplier relationships

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

Principle 8
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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.

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ISO 9000:2000 Family
•ISO 9001:2000 – Quality Management Systems: •ISO 9001:2000 – Quality REQUIREMENTS (WHAT ?) 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 – Quality Management Systems: Fundamentals and vocabulary 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.

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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

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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)
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The ISO 9000:2000 requirements Continual improvement of the Quality Management System
Management Responsibility

Satisfaction

CUSTOMERS

CUSTOMERS

Resource Management

Measurement, Analysis and Improvement

Requirements

Input Data

Product / Service Realization

Output Data

Product Service

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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

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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

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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

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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

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QUALITY MANAGEMENT SYSTEM

4.2.1 General
Basis of Auditing ( Auditor may look for )
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4 .3 .2 C n l o Dc mn o tro f o u e ts 4 .3 .2 C n l o Dc mn o tro f o u e ts 4 .4 .2 C n l o re o s o tro f c rd 4 .4 .2 C n l o re o s o tro f c rd 8 .2 .2 In rn l A d te a u it 8 .2 .2 In rn l A d te a u it 8 .3 C n l o N n o fo in p d c o tro f o c n rm g ro u ts 8 .3 C n l o N n o fo in p d c o tro f o c n rm g ro u ts 8 .2 .5 C rre tiv Atio o c ec n 8 .2 .5 C rre tiv Atio o c ec n 8 .3 .5 P v n eAtio re e tiv c n 8 .3 .5 P v n eAtio re e tiv c n

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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

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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
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QUALITY MANAGEMENT SYSTEM

4.2.3 Control of Documents
Basis of Auditing (Auditor may look for )
• • • • • • • •
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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 )
e d re o rd l •• Procrocureforforcrecocontrotrol P eu d re rdc n o o f •• Detailsilsretentionperiod d Dta o re n np rio e f te tio e

37

MANAGEMENT RESPONSIBILITY

5 . Management Responsibility
5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning
5.4.1 Quality objectives 5.4.2 QMS planning

5.5 Responsibility , authority and communication
5.5.1 Responsibility , authority 5.5.2 Management representative 5.5.3 Internal communication

5.6 Management review
5.6.1General 5.6.2 Review input 5.6.3 Review output

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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

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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 )
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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 )

•• •• ••

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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 )
a ila q a o je tiv sa re n le lity b c e t t th iz tio a n •• AvAvabilityofofuqualityobjectivesatlevavantvelseofofeorgananization ila ility b re le le ls th o v e rg e h n m th c is fo m ic tio toe p e u a n mlo s •• MMahanismrforecommnunicationtoemyeyees e c th c m eo p lo th S A o je tiv s? R bc e •• ArereerereMMTRTobjectives? A th S A e p mn o je tiv re et c e th c •• Imrovevemntbobjectivelatedtotoeprodudtct Imro e p re te th p u la d e ro
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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

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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 )
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44

MANAGEMENT RESPONSIBILITY

5.5.2 Management Representative
T pmn g mn s a a p in amme o th mn g mn wo, irre p c eo o e o a a e e t h ll p o t e b r f e a a e e t h s e tiv f th r re p n ib , s a h v re p n ib a da th rityth t in lu e s o s ility h ll a e s o s ility n u o a c ds

 EnsuringthatprocessesneededfortheQM areestablished,imlemntedand S p e
min in d a ta e

 Reportingonperformnceof QM includingneedsfor a S

imro e e t p v mn

 Ensuringthepromtionof awrenessof customrneeds&requiremnts o a e e
N te:R s o s ilitymyin lu elia o w e te a p rtie inre tio toQ S o e p n ib a c d is n ith x rn l a s la n M

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 )

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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
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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 )
Aa b o v ila ility f Aa b o v ila ility f e e  Managemntreviewmetingreports Mn g mn re ie me gre o a a e e t v w e tin p rts  e p  Customrcomlaints e p  Customrcomlaints  Processdataanalysis  Processdataanalysis  Productdataanalysis  Productdataanalysis  Evidenceof correctiveandpreventiveaction o  Evidenceof cerrectiveandpreventiveaction  Resourcerequiremntsandapplicationplanning e  Resourcerequiremntsandapplicationplanning e  Objectivesandtargetsachievemnts O je tiv sa dta e a h v mn b c e n rg ts c ie e e ts   Businessplan s  Bueinessplan  Investmntplan e  Investmntplan  HRPlanning  HRPlanning ith e e  Actionplanw responsibilitiesandtim fram ith e e  Actionplanw responsibilitiesandtim fram

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 )

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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 )

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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
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RESOURCE MANAGEMENT

6.2 Human Resources
6.2.2 Competence , awareness and training

Basis of Auditing ( Auditor may look for )
p te en e  ComComceneedndeded p te c e ne ill gapanalysis e  Sk Skill gapanalysis  a of needs  Identificntionatiotraininginingneeds  Ide tific nof tra io o f  Provisronisiotrainingining P v o tra f luationofntrainingeffectiveness Ea v  Evaluationoftrainingeffectiveness   Jobdescriptionstions Jo d s b latedreeocrip R e c  Relatedrdsords c ployee’sarearenessaboutrelevanceandimortanceoftheirwork p  EmEmloyew awrenessaboutrelevanceandimortanceoftheirwork p e a ’s p  ofla turn ors ab  Analyseslysesborlaboroverovertaffstasenteeismism  Ana of turn or ff absentee

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 )

 Plantstsandprodtiotioncilities s  Planandproducucnfafacilitie  CoCorrectiveandPreventiveaintenanaece  rrectiveandPreventivemmintencn a  Trendndsofaintenanaece  Tresof mmintencn a  EqEquipmntePerformece et ac  uipmneP rformnan

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 •Light • Noise • Pollution • Vibration • Air flow • Cleanliness •Hygiene

Basis of Auditing ( Auditor may look for )

 EvEvideeceofstructiotionincupupationaafetyty  idencnof ininstrucninococcational sl safe  EvEvideeceofesatistisfactionoftatutoryryandgugulatoryququiremntsor e ts  idencnof ththesafactionof s statutoandrerelatoryrereiremne or
c n itio s od n c n itio s od n

 WWrkplacevevtigtigations orkplaceininsesations o

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 )

 Customminququiries e  Custoreriniries  Ordersrs  Orde  ReRordsonondisssionwithithstommrs e  cecords discucussionwcucustors e
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 )

 EvEvideeceofonontractvieww  idencnof c ctractrerevie  Docummntationofmmndmnts e ta e d e ts  Docunetionof a anemne  Orderernonformtioncords s a  Ordcocformtionrerecord a
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 )

 Custommr’srodudtctpepificatiotion e  Custor’sp procus scecifican e  CoContracts  ntracts  AcAnknowledgemntfofrderer et  kcowledgemneo o ord  Custommreququtstsrforahanges e  Custorerreesesfo chcnges

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 )
na e tp n n la  DesigDesndDevelopmlopmntplan ig a dDv n n ee e ile sand c inplan  M stonestonessaheduleeduleinplan ile sh  Ml prov ndincD&D  Approvaprovalisionsisionsinplanplan rawAp prov D&D g  D inrawing D ualityPlans  Q QualityPlans  ninputreco  DesigDesigninputrdscords  ie ordre s  D&DrevDwrecwrecords D re ie & v  re c  D&Dverificationatioordscords D Dv & estrecordserific nre  T Test records  re c  D&Dvalidationatioordscords D Dv lid nre & a  approval  Validationationapproval lid  Vachan re n  DesigDesigngeanquestsuests  vis ch gereq  Newreewionstatustatus N istoryofrevisions H c ags hn e   Historyof changes

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 reevaluation 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 )
es c a n ific tio  Purchashaspespecification  Purc e eo u p re lu tio lie v a n  Evidencencfesofpsupplieraevaluation  Evid p rs lie  ListLoftapprovedvsupsuppliers  is of appro ed lu tio C ria a n rite  EvaEvaluationCriteria  eo c in so o mrc l f e ic l a  Purchashasrder–rlarityritytermrmcofmom iarcandtechnchnical e  Purc eorde –cla inte s c m ial andte as s a e  Qualitylityurancencgreementsnts e  Qua assura eagre m du o m  Orderapprovalvalcdocentsnts e  Orderappro um

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 )

 VeVerificationplan  rificationplan  AcAcpeptaececriteria  cectancncriteria  TeTtstcordsofofupupprsrs  sererecords s splielie  Incom ginspectionof mterials in a
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 )
a sh c  Mintenancenceeduledule a  Mintena sche c  ServiceContrants cts  ServiceCo tra p rtsm a a et n  Sparearepartsnagememnt a  Sp mnag e o S l p es f p ro s  Identificationtionofeciaecialcprocess Id n a e tific S p  ov f s e tio p  Availabilityilityalidationtioncificaificntion Aa b o v lid s e a v ila f a a pc 

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 )

 Produdtctenentification  Procuididtification  RoRoutingg g  utingtata  segegregationss s  sregationsliplip
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 )

 Inveventoryt t  Inntorylislis  Dispapatcmmodods  Distchhethths e  regugulationonpking,gs,toragegepreservatiotionanddeeryry  relationonpacackin stora, ,preservananddelivlive
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 )

 IdenentificationofqEquipmnts e ts  Idtificationof E uipmne  CaCalibtiotionsndndasanandeRords s  libraranstataardrdsdRcecord  AcAcpeptaecCriteriaria  cectancneCrite  CaCalibtiotionstructiotion  libraranininstrucn

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 )

 IdenentificationofqEquipmnts e ts  Idtificationof E uipmne  CaCalibtiotionsndndasanandeRords s  libraranstataardrdsdRcecord  AcAcpeptaecCriteriaria  cectancneCrite  CaCalibtiotionstructiotion  libraranininstrucn

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 )

 AvAvabilityofofffeffectivestemmofustommsratistisctiotioneaeusuremnts e s e ts  ailailabilitye ectivesysysteof c custore safafacnmmaremne  Custommsrtistisctiotionanalysis e  Custoreasafafacnanalysis

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 )
rn l a a  InteInternuditingprocedureure  al auditingproced it p a ds h la n c  AudAuditnslansandedulesules  p sched it re p  AudAuditortsorts  rep it n te os o tiv e id n e e v ec  AudAuditno/proofrofofverifiedobjecbjectiveevidence te /p o v rifie o s fe d  c n rm re o fo ity  NonNonconformportport ityre  us s io a re inM s R  DiscDiscunsofnudituditultsultsinMRM  s io of a res M ito q a u c rtific te e as  AudAuritorlificationtioncertificates  d qualifica c ea tio tiv c  Correorrectiveans ns C c tio 

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 )

 Processssapammrsrs e  Procep raratete e  StatististicaleThnhniques  Statical T ceciques  KPKPIPePerformecindicatorsrs ac  I/ /rformnaneindicato  ArereeKPKPIinlineithfunctiotionalbobjectives  AththeIinlineww funcnal o jectives ith

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 forfor inspectionQuality plan andand test plan  Procedure inspection . . Quality plan test plan  Person approving thethe check and release thethe product shall be identified  Person approving check and release of of product shall be identified  Inspection reports  Inspection reports  Deviation accepted by by customer or approved by designated authorities  Deviation accepted 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 reverified 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 )
A a s th t p v ein rmtio o n ly is a ro id fo a n n A a s th t p v ein rmtio o n ly is a ro id fo a n n C s mrs tis c n u to e a fa tio C s mrs tis c n u to e a fa tio C n rm top d c re u mn o fo ity ro u t q ire e ts C n rm top d c re u mn o fo ity ro u t q ire e ts C a c ris sa dtre do p c s e a dp d c h ra te tic n n f ro e s s n ro u t C a c ris sa dtre do p c s e a dp d c h ra te tic n n f ro e s s n ro u t S p lie u p rs S p lie u p rs

-

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 )
c n ityre o  NonNonformrmcordsrds  confo ityreco c tio toc c a tio tiv c  Instrustrunsrelatedtedorreorreetiveantion  In ctionsrela toc c c p in a is la  Comomtsinnalysalysis C p tsa la n  m a toid e ro c o  Systeystepproachachtontifytifytroauseuse  S mappro iden otca itie s tos e u  Avoidingnonconformrmduedueamacaeseuse  Avoidingnonconfo ities tos m ca o d ta n s toid f a a is e p te tia on  UseUseof datalynalysistontifytifypotelncausesses a a id n e tia c u la  wo tre d to s p te tia c mlia a on op n n p re a tio c  Revieeviefwofntrendsidentifytifypotelnnonnoncomcencenecessaryaryventivetiveantion toid n e tia l p lia a n c s p v n c n e e s re e  R

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 - Procedure - Specification - Drawing - Standard Medium Paper Electronic Photographic 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 guidelines  Documents are  Documents are dynamic and can be dynamic and can be revised revised Examples - Procedure for production planning - Drawing - Part Quality Standard - Work Instruction for Printing  It provides evidence of  It provides evidence of work done work done  Records cannot be  Records cannot be changed changed Examples - Production Report - Inspection Results

107

QMS DOCUMENTATION

WHY Stated Once

Policy , Manual

Define WHAT will be done

WHO WHEN WHERE

Procedures
HOW

Work Instructions Or Practices Records Or

Evidence

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 Fact
Finding Exercise

AUDIT is a

111

INTERNAL AUDIT

Audit :

Audit Definition

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

Auditee : Auditor :

Definitions

Organization to be audited

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 Effectiveness Opportunity Compliance wrt wrt wrt wrt Requirements Objectives Improvements 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

119

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
120

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

121

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

122

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

123

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

124

INTERNAL AUDIT

Fact Finding
Collecting Evidence is one important auditing skill – Done through - Observations - Reading - Communication - Interviews - Listening - Use of check lists
125

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

126

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

127

INTERNAL AUDIT

Factors affecting communication
 Physical Factors  Environment Factors  Intellectual Factors  Emotional Factors

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INTERNAL AUDIT

Factors affecting communication
Emotional Factors - Ego - Confidence - Fear Physical Factors - Hunger - Thirst - Rest - Pain Intellectual Factors - Concepts - Terminology - Language Environment Factors - Ventilation - Lighting - Temperature - 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 them

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

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INTERNAL AUDIT

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

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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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Reporting and audit conclusion
Definition
Requirements

INTERNAL AUDIT

- 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 Implementation Effectiveness a requirement has not been addresses practice differs from the defined system 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 : Audite e : Nature of NonC onformity : C a te gory of Nonconrma nce : ISO C lause R e f NC R No: Date :
Adequacy Minor Non-Conformity Major

Ae ra

C te oy a gr O je tiv bc e E id n e v ec

: Document R e:f De ta il of Non - conformity Nature of Non - C onformity

Signature of Audite e Signa ture of Auditor Agre ed corre ctive a ction R e sponsibility

T a rge t Da te:

Signa ture of Audite e Proposed P re ve ntive Action

N nc n r a c o o fomn e D ta e ils C r e tiv a tio or c e c n d ta e ils Pe e tiv a tio r vn e c n d ta e ils

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

Signature of Audite e Ve rifie d C orre ctive Actions is NC R C lose d

Signa ture of Auditor( follow up a udit) E ffe ctive / Not E ffective Y es / No Signa ture

T o be discusse d in ma na ge ment re view es / No Y

V r a nA d eific tio u it D ta e ils R p r S tu e ot ta s

148

INTERNAL AUDIT

Situation 1
T ea d re te th mn fa tu ga a&id n slo o fille p ly e eb g k p h u ito n rs e a u c rin re e tifie ts f d o th n a s e t.

Ad r u ito

:Wa isth rein id th s b g ? h t e s e ee a s

Ad e u ite

: T e ea mu e ite s wic wre h s re o ld d m h h e isd n in llywiled v lo in n wp d c . o e itia h e e p g e ro u ts

mn fa tu dd rin s mle a u c re u g a p

p d c nwic ro u tio h h

Ad r u ito

: Wa w y ud w th ? h t ill o o ith is

Ad e u ite

: W s p k e th m e imly e p e .

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INTERNAL AUDIT

Situation 2
Wilea d gth p rc a ed p rtmn a d rfin s h u itin e u h s e a e t, u ito d th t aP . fo ap rtic la ra mte l isg e toa a .O r a u r w a ria iv n n ws u e e o rc .

Ad r u ito

:Wyisth n ws u eb in id n d h is e o rc e g e tifie ?

Ad e u ite

: T e e is g s u e d e n t me th re u d h x tin o rc o s o e t e q ire

s e ific tio o th mte ls fo wic w a fa in mn p c a n f e a ria , r h h e re c g a y q a p b m fo th p s o e o th u lity ro le s r e a t n -mn .

150

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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