ISO 9001INTERNAL AUDITORS TRAINING- 12th Feb 2010- SNSastry [Compatibility Mode]

TRAINING ON By S N Sas Sastr try y – MR IM IMS S

ISO9001:2008 QUALITY MANAGEMENT SYSTEM Part-I

: Overview of ISO9001:2008 Implementation

Part-II : Orientation Towards Quality Management Part-III PartIII : Details of of ISO9001:2008 ISO9001:2008 Standard Standard Part I

: Over view of Our System

Part V

: Auditors Qualities, Auditing Methodology 1

TRAINING ON ISO9001:2008 QUALITY MANAGEMENT SYSTEM

Part -I

ISO9001:2008 Implementation

2


What is ISO ? ISO stands for …

International Organisation for Standardisation. 

It is an international body, head-quartered in Geneva. .



ISO develops standards and guidelines for the industry.

 There

are thousands of ISO standards on products,

services, and management systems. 

ISO publishes standards, standards, it does not not issue any any certificate. certificate. 3


What is ISO9001:2008 ? ISO9001:2008 is an international standard on Quality Management Systems, released on 15th November 2008. ISO9001:2008 spells out the requirements of a quality management system that need to be complied with. The other two standards in the series, viz., ISO9000: 2005 and ISO9004: 2000 supplement ISO9001:2008. ISO9001:2008 standard replaces the old version, i.e., ISO9001:2000.

4


What are the benefits of ISO9001:2008 implementation ? 

Systems approach to management.



Clarity in definition of authorities and responsibilities.



Better record keeping and documentation.



Better traceability to root causes of quality problems. .



Lesser repetition of errors.



Reduction in the need for multiple assessments.



Use of recognized mark (of certifying agency) on letterheads etc. and advertisements.



Enhanced corporate image and market positioning. 5


Steps involved in ISO9001:2008 Certification: Gap Analysis: Assessment of existing quality management practices visa-vis ISO9001:2008 requirements. Orientation Training: Top / Senior Management orientation on ISO9001:2008 requirements. Documentation: Preparation of quality manuals and formats. mp emen a on: mp emen a on o qua y sys em as per manua s. Company-wide Training: Training on ISO9001 requirements and familiarisation of Quality Manuals & Formats, Statistical Techniques, and Internal Audit. Internal Audits: Periodic assessment of system implementation. Pre-assessment : Initial assessment by Certifying agency. Final Assessment: Detailed assessment by the Certifying agency and recommendation for certification. 6


Who are the ISO9001:2008 Certifying Agencies ? There are over 700 certifying agencies all over the world. Some of the ISO9001Certifying Agencies are...  American Quality Assessors (AQA) 

Bureau of Indian Standards (BIS)



Bureau Veritas ualit International BV I



Det Norske Veritas (DNV)



Indian Register of Quality Systems (IRQS)



International Certifications Limited (ICL)



Lloyds Register of Quality Assurance (LRQA)

 TUV 

India Private Limited (TUV)

Underwriters Laboratories (UL)

7


How long is the ISO9001 certificate valid ? Normally, ISO9001:2008 certificate is issued for a period of three years. However, an ISO9001 certified company needs to perform satisfactorily in the surveillance audits conducted by the certifying body. Surveillance audits can be …. Five half-yearly audits.

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Part -II

Quality Management

9


ISO9001:2008 is all about Quality Management System. Then what is meant by quality ? Quality means different things to different people. The success of an organisation is in understanding and satisfying the customers’ expectations in totality.

Therefore, it is important to understand the meaning of the term QUALITY. 10


THE EQUATION OF QUALITY

Quality = Customer satisfaction = Fitness for use + Conformance to s ecifications + Reliable performance + Value for money. The challenge of every business is to ensure customer satisfaction in every transaction. 11


What Mahatma Gandhi (the father of Indian Nation) said about customer satisfaction ? “Customer is the most important visitor on our premises”. “He is not dependent on us. We are dependent on him.” e s no an n errup on on our wor . e s e purpose o . “He is not an outsider on our business. He is a part of it.” “We are not doing him a favour by serving him. He is doing a favour by giving us an opportunity to do so.” 12


SOME DEFINITIONS 1. QUALITY

Quality is the totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs. (This is the formal definition of Quality as per ISO9000 standard) 2. GRADE It is an indicator of category or rank related to features that cover different sets of needs for products / services intended for the same functional use. Please note that Quality and Grade are Not same. 13


SOME DEFINITIONS 3. QUALITY POLICY It is the overall quality intentions and direction of an organisation regarding quality, as formally expressed by top management. . It is that aspect of overall management function which determines and implements the quality policy.

14


SOME DEFINITIONS 5. QUALITY SYSTEM It is the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. . 6. QUALITY CONTROL It is the operational techniques and activities that are used to fulfil requirements for quality. Inspection / testing of incoming, in-process and final products can be termed as quality control.

15


SOME DEFINITIONS 7. QUALITY ASSURANCE All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality. 8. QUALITY AUDIT A systemic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. 16


QUALITY SYSTEM DOCUMENTATION For any management system to operate effectively, there is a need for documentation of policies, authorities and responsibilities, procedures and guidelines, results of operations etc.

ISO9001:2008 standard requires that certain documentation to be developed, established, and implemented in an organisation. Now let us find out what are these documents ?

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QUALITY SYSTEM DOCUMENTATION PYRAMID

Quality Manual & System

Work Instructions Manual Forms, Quality Records, Product Specifications, Master Lists etc.

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QUALITY SYSTEM DOCUMENTATION 1. QUALITY MANUAL & SYSTEM PROCEDURES Quality manual and system procedures give broad guidelines for implementation of each clause in the specific setup of the company. These procedures have to be followed strictly. Non - compliance of rocedures can result in losin the certificate. Notes : 1. Quality Manual & System Procedures are confidential documents. Ideally, it should not be distributed to any outsiders. Clients / Auditors may be allowed to see the documents for reference purpose only. 2. Quality Manual may be separated from System Procedures and kept in a different folder, and distributed to customers on demand. 19


QUALITY SYSTEM DOCUMENTATION 2. WORK INSTRUCTIONS MANUAL Step-by-step instructions for carrying out production / service / testing activities. Note : Work instructions are company-specific and confidential. .

,

,

,

MASTER LISTS ETC. Quality records shall be maintained in the specified formats. Blank form, when filled-up, becomes a record. Improper record-keeping is a major problem in ISO9001 implementation. Product specifications and master lists are meant for reference. Note : Quality records are company-confidential.

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Part -III

ISO9001:2008 Standard

21


ISO9001:2008 is based on process approach to Quality Management.

Controls

Inputs

QMS Process

Outputs

Feedback Typical QMS processes: Planning, Marketing, Purchasing, R&D, Production, Calibration, Inspection/Testing, Management Review etc. Inter-related processes make the Quality Management System. 22


Continual improvement of Quality Management System

Management Responsibility

Customers

Customers Resource Management

Requirements

Input

Measurement, Analysis

Satisfaction

and Improvement

Product Realization

Product

Output

Value-adding activities Information flow

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Process-based Quality Management System

ISO 9000:2000 Family Annexes A & B for information only

Quality management systems - Fundamentals & vocabulary

Measurement

ISO 9000

Audits

ISO 19011

Guidelines Quality management systems Guidelines for performance improvement

ISO 9004

ISO 9001

Technical Reports

Quality management systems Requirements

ISO 9001:2000 Process Approach PROCESS EFFECTIVENES S

CONTROLS

Extent to w hich planned activities are realized and planned results achieved

PROCESS INPUT

“set of interrelated or interactin activities which transforms inputs into outputs

RESOURCES

OUTPUT

PRODUCT

PROCESS EFFICIENCY Relationship between the result achieved and the resources used

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

ISO 9001:2008 System approach to management Identifying, understanding and managing interrelated processes as a system contributes to the organ za on s effectiveness and efficiency in achieving its objectives

R

I

Process

R

O

I

A

C I I O R C

= = = =

INPUT OUTPUT RESOURCES CONTROLS

B

R

I

C

Process C

C

O

Process

O

I

R

Process D

C

O


ISO9001:2008 Standard is divided into eight sections as below: 1. Scope: Scope and application of the standard. 2. Normative Reference: Reference to ISO9000: 2005. 3. Terms & Definitions: Terms and definitions given in ISO9000 apply. Wherever the term ‘Product’ is used, it can also mean ‘Service’. . ua y anagemen

ys em: ocumen a on requ remen s.

5. Management Responsibility: (Top) management’s responsibilities. 6. Resource Management: Requirements of Resources, Personnel, Infrastructure, and Work environment. 7. Product Realization: Requirements for departmental activities. 8. Measurement, Analysis and Improvement: About Customer Satisfaction, Internal Audit, Corrective/Preventive actions etc.

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Clause -1: SCOPE The ISO9001:2008 standard specifies the requirements of a quality management system where an organization … a) needs to demonstrate its ability to consistently provide the products that meets customer and applicable statutory and regulatory requirements. b) aims to enhance customer satisfaction through the effective application of the system and applicable statutory and regulatory requirements.

If a requirement of ISO9001:2008 cannot be applied due to the nature of an organisation/product, it can be excluded (only from clause 7). Note: Statutory and regulatory requirements can be expressed as legal requirements. 28


Clause -2: NORMATIVE REFERENCE The standard “ISO9000: 2005 - Quality Management SystemsFundamentals and vocabulary” to be referred for better understanding of the quality management concepts applied in the ISO9001:2008 standard. e organ za ons mp emen ng : most recent version of ISO9000 standard.

are a v se o re er e

Note: Members of ISO (like the BIS of India) and IEC maintain registers of currently valid International standards, available to public for reference. 29


Clause -3: TERMS AND DEFINITIONS Terms and definitions given in ISO9000 apply for ISO9001 also. Wherever the term ‘Product’ is used, it can also mean ‘Service’.

“ ” implementing ISO9001:2008.

30


Clause - 4: QUALITY MANAGEMENT SYSTEM Sub Clause 4.1: General Requirements The organisation shall establish, document, implement and maintain the QMS and continually improve its effectiveness in accordance with ISO9001:2008 requirements. 1. Determine the processes needed for the QMS and their application. 2. Determine the se uence and interaction of these rocesses. 3. Determine the criteria and methods for effective process operation and control. 4. Ensure the availability of resources & information needed for process operation and monitoring. 5. Monitor, measure where applicable and analyse the performance. 6. Implement action plans for meeting target & continual improvement. 31


Clause - 4: QUALITY MANAGEMENT SYSTEM Sub Clause 4.2: Documentation Requirements QMS documentation must include the following: 1. Statement of Quality Policy and Quality Objectives of the company 2. Quality Manual 3. Documented rocedures and records re uired b ISO9001:2008 4. Documents and records required for effective planning, operation, and control of the company’s processes. Procedures must be established, documented, implemented and maintained. Extent of documentation depends on size of organisation, type & complexity of activities, and the competence of personnel. The documentation can be in any form (text, flow charts, etc.) or any type of 32 medium (paper, computer file, etc.)


Clause Clau se - 4: QUALITY QUALITY MANAG MANAGEMEN EMENT T SYSTEM Sub Clause 4.2.2: Quality Manual

A Quality Manual needs to be prepared, and this manual must include the following: 1. Scope of quality management system (what business activities are covered). 2. Details of and justification for any exclusions (E.g., Design & Development, Process Validation etc). 3. Documented procedures (or reference to such procedures already available in some other manual). 4. A description of the interaction between the QMS processes (E.g., a Process Map). 33


Clause Clau se - 4: QUALITY QUALITY MANAG MANAGEMEN EMENT T SYSTEM Sub Clause 4.2.3: Control of Documents QMS documents shall be controlled controlled.. A documente documentedd procedure to be developed, defining the following controls: 1. Approval of documents for adequacy prior to issue. 2. Review, updating if required, and re-approval of documents. . en ca on o ocumen c anges an curren re rev s on s a us. 4. Ensuring availability of latest documents at points of use. 5. Ensuring that documents remain legible & readily identifiable. 6. Identification and controlled distribution of documents of external origin that are required for planning and operation of the QMS. 7. Prevention of unintended use of obsolete documents, and, proper marking if they are retained for legal purposes, etc.

34


Clause Clau se - 4: QUALITY QUALITY MANAG MANAGEMEN EMENT T SYSTEM Sub Clause 4.2.4: Control of Records QMS records are a special type of document, and shall be controlled. The following requirements apply: 1. Records shall be established and maintained to provide evid ev iden ence ce of … - con orm y o requ remen s e.g., ac ua va ue s spec ca on . - effect effective ive operation of QMS (e.g., internal audit audit results). 2. Records must be legible, readily identifiable and retrievable. 3. A documented procedure procedure must be established, defining defining the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. 35


Clause - 5: MANAGEMENT RESPONSIBILITY The top management of the organisation shall demonstrate their commitment to the development and implementation of QMS by… - ensuring awareness of the importance of meeting requirements. - establishing the quality policy. -

.

- conducting management reviews, and - ensuring the availability of resources. The top management must have customer focus, and ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction. 36


Clause - 5: MANAGEMENT RESPONSIBILITY Sub Clause 5.3: Quality Policy Quality Policy serves as a vision statement of the organisation with respect to customer focus. The top management must ensure that the quality policy... 1. Is appropriate to the purpose of the organisation. 2. Includes a commitment to comply with requirements and continually improve the effectiveness of QMS. 3. Provides a framework for establishing and reviewing quality objectives. 4. Is communicated and understood within the organisation. (May be displayed in local language at office, factory, warehouse etc. ) 5. Is reviewed for continuing suitability.

37


Clause - 5: MANAGEMENT RESPONSIBILITY Sub Clause 5.4: Planning The top management shall establish quality objectives (including those needed to meet product requirements) at relevant functions & levels. Quality objectives shall be measurable and consistent with the quality policy of the organization. The top management must ensure that… - QMS planning is carried out in order to meet the requirements of Clause 4.1of ISO9001:2008 and the company’s quality objectives. - Integrity of the QMS is maintained when changes are planned and implemented. Departmental performance targets may be set every year as part of QMS planning.

38


Clause - 5: MANAGEMENT RESPONSIBILITY Sub Clause 5.5: Responsibility, Authority & Communication Top management shall ensure that responsibilities & authorities are defined and communicated within the organisation. Top management shall appoint a member of the management as the Management Representative (MR) for ISO9001 implementation. Responsibilities & authorities of Management Representative: - Ensure to establish, implement and maintain the QMS processes. - Report QMS performance & improvement needs to Top Management. - Promote company-wide awareness of customer requirements. - Interact with external parties such as ISO9001 certifying agency. Top management shall also ensure that suitable communication processes are established for internal communication. 39


Clause - 5: MANAGEMENT RESPONSIBILITY Sub Clause 5.6: Management Review Top management must review the QMS performance at regular intervals to ensure its continuing suitability, adequacy & effectiveness. Review input (information) shall include the results of audits, customer feedback (including customer complaints), process performance and pro uc con orm y, s a us o preven ve an correc ve ac ons, o owup actions from previous management reviews, changes that could affect the QMS, and recommendations for improvement. Review output shall include decisions and action plans aimed at improvement of product / service related to customer requirements, and effectiveness of QMS. Resource needs also to be identified. Minutes of management reviews must be maintained. 40


Clause - 6: RESOURCE MANAGEMENT Sub Clause 6.1: Provision of Resources Organisation shall determine & provide resources needed for... 1. Implementation and maintenance of the QMS. 2. Continual improvement and effectiveness of the QMS. 3. Enhancement of customer satisfaction by meeting the customer requirements.

41


Clause - 6: RESOURCE MANAGEMENT Sub Clause 6.2: Human Resources Personnel whose work affect product / service quality shall be competent with respect to the necessary education, training, skills and experience. Organisation shall... . e erm ne e compe ence requ remen

or recru men promo on .

2. Provide training to or re-assign the existing personnel or recruit new people to satisfy competence requirement. 3. Evaluate the effectiveness of training/re-assigning/recruitment). 4. Ensure that the personnel are aware of the importance of their activities and how they contribute to achievement of quality objectives. 5. Maintain the records of education, training, skills & experience.

42


Clause - 6: RESOURCE MANAGEMENT Sub Clauses 6.3 & 6.4: Infrastructure & Work Environment The infrastructure needed to achieve product conformity requirements shall be determined, provided and maintained. Infrastructure typically includes the following: -

,

.

- Process equipment (both hardware and software). - Supporting services such as transport, communication or information systems. Organisation shall also determine and manage the work environment necessary to achieve conformity to product requirements. Infrastructure and work environment are the Top Management’s responsibilities, in general.

43


Clause -7: PRODUCT REALIZATION Sub Clause 7.1: Planning of product realization A detailed plan (known as Quality Plan) for product / service realization needs to be prepared. Quality plans shall determine (describe) the following: 1. Quality objectives and requirements of the product / service. 2. Processes, documents, and resources re uired for makin the product / rendering the service. 3. Verification, validation, monitoring, inspection / testing for the product / service and the product / service acceptance criteria. 4. Quality records to be maintained at various stages of production / service provision. Many customers (like auto majors, railways, etc.) demand their suppliers to implement customer / contract-specific Quality Plans. 44


Clause -7: PRODUCT REALIZATION Sub Clause 7.2: Customer-related processes (Marketing and Sales) Effective system needs to be established for communication with customers (marketing, enquiry & order, feedback, and complaints) When an enquiry is received, Sales Personnel shall determine... 1. Customer’s requirements for the product, delivery & after-sales support. 2. Requirements not stated by the customer but necessary for specified or intended use, where known. 3. Statutory & regulatory requirements related to the product. 4. Any additional requirements determined by own organisation.

Order review shall be conducted before acceptance to ensure that the organisation has the capability to execute the order. Order amendments must be communicated to the persons concerned. Records of order review & amendments to be kept.

45


Clause -7: PRODUCT REALIZATION Sub Clause 7.3: Design and Development (D&D) D&D planning shall determine the activities, milestones, review stages, and the authorities and responsibilities. D&D inputs shall cover the requirements for functionality, performance, statutory/regulatory compliance, etc. Inputs must be reviewed. , materials, state the product acceptance criteria, and the product characteristics. Stage-wise reviews shall be conducted and records maintained. D&D verification and validation shall be carried out and the records shall be maintained. Design changes shall be controlled and recorded. Most organisations can exclude this clause, if not applicable.

46


Clause -7: PRODUCT REALIZATION Sub Clause 7.4: Purchasing Suppliers shall be selected on the basis of their ability to supply product in accordance with the organisation’s requirements. Criteria for selection, evaluation & re-evaluation to be established. from the evaluation shall be maintained. Purchased product must conform to specified requirements. Organisation must establish & implement receiving inspection or other activities (like third-party certification) necessary for ensuring that purchased product meets specified purchase requirements. Records of incoming inspection must be maintained.

47


Clause -7: PRODUCT REALIZATION Sub Clause 7.5.1 : Control of Production & Service Provision Production & service provision must be planned and carried out under controlled conditions. Controlled conditions shall include ... 1. Availability of information on product / service characteristics. 2. Availability of work instructions (preferably in local language). 3. Use of suitable equipment (with desired process capability). 4. Availability and use of monitoring and measuring equipment. 5. Implementation of monitoring and measurement schemes. 6. Implementation of release, delivery & post-delivery activities. 48


Clause -7: PRODUCT REALIZATION Sub Clause 7.5.2 : Validation of Processes for Production & Service Provision

Special processes like welding (where quality of output cannot be verified by subsequent monitoring and measurement) shall be validated. ... 1. Defining criteria for process review & approval, and doing it. 2. Approval of equipment and qualification of personnel. 3. Use of specific methods and procedures. 4. Maintaining records of monitoring process parameters. 5. Revalidation.

49


Clause -7: PRODUCT REALIZATION Sub Clauses 7.5.3 : Identification & Traceability 7.5.4 : Customer Property 7.5.5 : Preservation of Product

Products need to be identified by suitable means (lot numbering, tagging, etc.) throughout the manufacturing process. Product status OK, on-hold, re ected, etc. needs to be established at various stages of manufacturing. Where traceability is a requirement, a unique identification (like serial number) of the product needs to be maintained. Customer property (including intellectual property and personal data) shall be identified, verified, protected and safeguarded. Defects and losses to be reported to the customer. Appropriate methods shall be employed for handling, storage, packaging 50 and protection of the product (preservation) at various stages.


Clause -7: PRODUCT REALIZATION Sub Clause 7.6 : Control of Monitoring & Measuring Equipment Monitoring and Measuring Equipment shall be selected on the basis of measurement requirement. As a thumb rule, Least count (LC) of the measuring instrument should be less than 10% of Tolerance band. 1. Calibration / verification against measurement standards traceable to International / National measurement standards. 2. Adjustment / re-adjustment as necessary (under control). 3. Affixing a calibration status sticker on the equipment. 4. Safeguarding from un-authorised adjustments. 5. Protecting from damage/deterioration during handling/cleaning/storage. Calibration records must be maintained.

51


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.1: General requirements The organisation shall plan and implement the monitoring, measurement, analysis and improvement processes needed... 1. To demonstrate conformity of the product. . o ensure con orm y o

e qua y managemen sys em an

3. To continually improve the effectiveness of the QMS. This shall include determination of applicable methods, including statistical techniques and the extent of their use.

52


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.2.1: Customer satisfaction Organisation shall monitor the information relating to customer perception (not just satisfaction) as to whether the organisation has met customer requirements. Methods for obtaining and using the customer perception data s a e e erm ne . pproac ng a cus omer every now an en for feedback can result in dissatisfaction) Analysis of customer perception data is one of the most important activities in ISO9001:2008 implementation. Customer perception analysis (satisfaction survey, complaints, lost business analysis, compliments, opinion surveys, etc.) MUST be reviewed in the subsequent Management Review meeting, and suitable 53 corrective & preventive actions need to be initiated.


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.2.2: Internal audit The organisation shall use a documented procedure and conduct internal audits at planned intervals to determine whether the QMS... 1. Conforms to the requirements of ISO9001:2008 standard and to the QMS requirements established by the organisation, and 2. Is effectivel im lemented and maintained. Internal audits shall be planned, considering the status and importance of processes being audited. Audit criteria, scope, frequency and methods shall be defined. Internal auditors must be qualified (through formal training), and they should be independent of the area being audited. Internal audit findings to be discussed in Management Review. Internal audit records must be maintained.

54


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.2.3: Monitoring and measurement of processes The organisation shall apply suitable methods for monitoring and where applicable measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken as appropriate to ensure conformity of the product.

55


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.2.4: Monitoring & measurement of product The organisation shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements. v ence o con orm y w e accep ance cr er a s a e ma n a ne . Records shall indicate the person(s) authorizing release of product. Product release and service delivery shall not proceed until the planned arrangements (inspection / testing etc.) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable, by the customer. 56


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.3 : Control of non-conforming product The organisation shall ensure that product which does not conform to product requirements is identified & controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with . The organisation shall deal with non-conforming product by... 1. Taking action to eliminate the detected non-conformity. 2. Authorizing its use, release or acceptance under concession by a relevant authority and where applicable by the customer. 3. Taking action to preclude its original intended use or application. Records of non-conforming product disposal must be maintained.

57


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.4: Analysis of data Appropriate data should be collected & analyzed to demonstrate the stability and effectiveness of the QMS and to evaluate where continual improvement can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to... 1. Customer satisfaction 2. Conformity to product requirements 3. Characteristics and trends of processes and products (including opportunities for preventive action) and 4. Suppliers. 58


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.5.1: Continual improvement The organisation shall continually improve the effectiveness of the quality management system through the use of… 1. Quality policy 2. Quality objectives 3. Audit results 4. Analysis of data 5. Corrective and preventive actions, and 6. Management review.

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Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.5.2: Corrective action Corrective actions must be taken to eliminate the cause of non-conformities in order to prevent recurrence. Needs a documented procedure defining the requirements for ... .

-

.

2. Determining the causes of non-conformities. 3. Evaluating the need for actions to ensure non-recurrence. 4. Determining and implementing actions needed. 5. Records of the results of actions taken. 6. Reviewing the corrective actions taken. 60


Clause - 8: MEASUREMENT, ANALYSIS & IMPROVEMENT Sub Clause 8.5.3: Preventive action The organisation shall determine action to eliminate the cause of potential non-conformities in order to prevent their occurrence. Needs a documented procedure defining the requirements for ... .

-

.

2. Evaluating the need for preventive action. 3. Determining and implementing actions needed. 4. Records for results of actions taken. 5. Reviewing preventive actions taken. 61


Part -IV

62

What is IMS at GRCD – ISO 9001- QMS – ISO 14001-EMS – OHSAS 18001-SMS – SA 8000-SAS

Document status – APEX MANUAL – GCD-M-04 – PROCEDURES – WORK INSTRUCTION & FORMATS

CONTENTS OF APEX MANUAL 1. Introduction 2. References 3. Term Terms, s, Def Defin init itio ion n & Abbre Abbrevi viat atio ions ns .

equ remen s

emen s

5. Mana Manage geme ment nt Resp Respon onsi sibi bili lity ty 6. Res Resourc urce Manage nagem ment 7. Product duct Reali aliza zattion 8. Meas Measur ureme ement nt,, Analy Analysi siss & Impr Improve ovemen mentt 9. Ethical Gove Goverrnanc ance

STATUS OF PROCEDURES S.NO.

NAME OF DEPTT.

REFERENCES

TOTAL NO. OF PROCEDURES

1

SYSTEM PROCEDURES

SYS –P - 01 TO SYS- P - 25

25

2

PRODUCTION [MCU-I&II ( Cell,Brine, Cl2, HCl, Hypo, CSF,SBP, PAC, CSA & HB )

PRD – P – 01 TO PRD – P- 10

10

3.

PROCESS & QUALITY CONTROL

QCD – P – 01 TO QCD – P - 09

09

4.

MECHANICAL

MMD – P- 01 TO MMD MMD MMD – P -03 -03 & DRG – P - 01

04

5.

ELECTRICAL

EMD – P -01 TO EMD – P - 03

03

6.

INSTRUMENT

INT – P -01 TO INT – P- 04

04

7.

CIVIL

CMD – P – 01 TO CMD – P- 02

02

8.

HR AND P&A

HRD – P- 01

01

9.

MARKETING

MKT – P- 01 TO MKT – P- 05

05

10.

STORES

STR –P- 01 TO STR – P- 02

02

11.

PURCHASE

PUR –PPUR –P- 01 TO PUR PUR – P- 03 & ITD ITD –P–P01

04

12.

SAFETY

SFT –P – 01 TO SFT – P- 02

02

STATUS OF WORK INSTRUCTIONS S.NO.

NAME OF DEPTT.

REFERENCES

TOTAL NO. OF WI

1

SYSTEM PROCEDURES

2


PRD – W – 01 TO PRD – W- 10

10

3.

PROCESS & QUALITY CONTROL

QCD – W – 01 TO QCD –W- 09

09

4.

MECHANICAL

MMD –W–W- 01 TO TO MMD –W-24 –W-24 & DRG DR G –W–W- 01

25

5.

ELECTRICAL

EMD –W-01 TO EMD –W- 12

12

6.

INSTRUMENT

INT –W-01 TO INT –W- 08

08

7.

CIVIL

CMD –W– 01 TO CMD –W- 04

04

8.

HR AND P&A

PER –W–W- 01 TO PER –W- 03

01

9.

MARKETING

MKT – W- 01 TO MKT – W- 08

08

10.

STORES

STR –W- 01 TO STR – W- 09

09

11.

PURCHASE

-

-

12.

SAFETY

-

-

-

-

STATUS OF FORMATS & LOG SHEETS S.NO.

NAME OF DEPTT.

REFERENCES – FORMATS

REFERENCES –LOG SHEETS

TOTAL NO OF FORMATS & LOGSHEETS

1

SYSTEM PROCEDURES

SYS - F – 01 TO SYS –F- 34

-

34

2


PRD – F – 01 TO PRD – F- 10

3.

PROCESS & QUALITY

-

4.

MECHANICAL

MMD –F- 01TO MMD –F-14

5.

ELECTRICAL

EMD –F-01 TO EMD –F- 27

6.

INSTRUMENT

INT –F-01 TO INT –F- 08

7.

CIVIL

8.

HR AND P&A

9.

MARKETING

MKT – F- 01 TO MKT – F- 28

-

10.

STORES

STR –F- 01 TO STR – F- 09

-

11.

PURCHASE

PUR –F- 01 TO PUR –F- 15

-

12.

SAFETY

PRD – L – 01 TO PRD – L- 31

-

-

EMD –L-01 TO EMD –L- 05 -

-

-

41

-

Table of Contents

Section No.

Title

ISO 9001: 2008 Cl.

ISO 14001: 2004 Cl.

OHSAS 18001: 2007 Cl.

SA 8000: 2008 Cl.

0.0

Introduction

-

-

-

-

1.0

Foreword

-

-

-

-

2.0

Structure of manual

-

-

-

-

3.0

Manual Issue Procedure

-

-

-

-

4.0

Manual Revision, Updation & Amendment Procedure

-

-

-

-

5.0

Com an Profile

-

-

-

-

6.0

Distribution List

-

-

-

-

1.0

Scope

1

1

1

I

1.1

-General

1.1

-

-

-

1.2

-Application

1.2

-

-

-

1.2.1

Exclusions under ISO 9001

7.3, 7.5.2

-

-

-

1.2.2

Exclusions under SA 8000

-

-

-

9.10

2.0

References

2

2

2

II

2.1

List of Standards, Manuals, Procedures, Regulatory requirements,

2

2

2

II

No. of Pages 08

02

06

3.0

Terms & Definition, Abbreviations

3

3

3

III

3.1

Terms

3

3

3

III

3.2

Definitions

3

3

3

III

3.3

Abbreviations

3

3

3

III

4.0

Requirements &Elements.

4

4

4

IV

.

.

.

.

4.2

-

-

1.2, 1.3 9.1(d), 9.12

. 4.2

Documentation requirements

4.2.1

General

4.2.1

4.4.4

4.4.4

-

4.2.2

IMS Manual

4.2.2

-

-

-

4.2.3

Control of documents

4.2.3

4.4.5

4.4.5

-

4.2.4

Control of records

4.2.4

4.5.4

4.5.3

9.14

07

04

5.0

Management responsibility

5

-

-

IV - 9

5.1

Management commitment

5.1

4.2,4.4.1

4.2,4.4.1

9.1

5.2

Customer focus

5.2

4.3.1, 4.3.2

4.3.1, 4.3.2, 4.6

-

5.3

Company Policy

5.3

4.2

4.2

9.1

5.4

Planning

5.4

4.3

4.3

9.5

5.4.1

GRCD Objectives

5.4.1

4.3.3

4.3.3

9.5

5.4.2

GRCD Planning

5.4.2

4.3.3

4.3.4

9.5

5.5

4.1

4.1

3.2, 9.5

5.5

Responsibility, Authority &Communication

5.5.1

Responsibility & Authority.

5.5.1

4.4.1

4.4.1

3.2, 9.5(a)

5.5.2

Management representative & Management Appointee.

5.5.2

4.4.1

4.4.1

3.2,9.3, 9.4

5.5.3

Communication

5.5.3

4.4.3

4.4.3

9.12

5.6

4.6

4.6

9.2

5.6

Mana ement reviews

5.6.1

General

5.6.1

4.6

4.6

9.2

5.6.2

Review input

5.6.2

4.6

4.6

9.2

5.6.3

Review out put

5.6.3

4.6

4.6

9.2

6

4.4.1

4.4.1

-

6.0

Resource management

6.1

Provision of resources

6.1

4.4.1

4.4.1

9.11

6.2

Human resource

6.2

4.4.1

4.4.1

-

6.2.1

General

6.2.1

4.4.2

4.4.1

-

6.2.2

Training, Awareness & Competency.

6.2.2

4.4.2

4.4.2

3.3, 9.5(b), 9.5(c)

6.3

Infrastructure

6.3

4.4.1

4.4.1

3.5, 3.6

6.4

Work Environment and Occupational Health and Safety

6.4

4.4.1, 4.4.7

4.4.1, 4.4.7

3.1, 3.4, IV-3

7.0

Product realization

7

4.4, 4.4.6

4.4, 4.4.6

9.5

7.1

Planning of product realization

7.1

4.4.6

4.4.6

9.5

7.2

Customer related processes

7.2

4.4.6

4.4.6

-

7.2.1

Determination of requirements related to Product

7.2.1

4.3.1,4.3.2,4. 4.6

4.3.1,4.3.2, 4.4.6

II, 3.1, 9.1(b)

7.2.2

Review of requirement related to Product

7.2.2

4.3.1,4.4.6

4.3.1,4.4.6

3.1

7.2.3

Customer Communication

7.2.3

4.4.3

4.4.3

9.10, 9.12

.

-

-

-

. 7.3.1

Planning

7.3.1

-

-

-

7.3.2

Inputs

7.3.2

-

-

-

7.3.3

Outputs

7.3.3

-

-

-

7.3.4

Review

7.3.4

-

-

-

7.3.5

Verification

7.3.5

-

-

-

7.3.6

Validation

7.3.6

-

-

-

7.3.7 7.4

Changes Purchasing

7.3.7

-

-

-

7.4

4.4.6

4.4.6

9.6, 9.7, 9.8

7.4.1

Purchasing process

7.4.1

4.4.6

4.4.6

9.6

7.4.2

Purchasing information

7.4.2

4.4.6

4.4.6

9.7, 9.8

7.4.3

Verification of purchased product and Access for verification

7.4.3

4.4.6

4.4.6

9.13

7.5

4.4.6

4.4.6

-

7.5

Production & Service provision

7.5.1

Control of Prodn. & Service provision

7.5.1

4.4.6

4.4.6

-

7.5.2

Validation of processes for Prodn. & service provision@

7.5.2

4.4.6

4.4.6

-

7.5.3

Identification & traceability

7.5.3

4.4.6

4.4.6

-

7.5.4

Customer property

7.5.4

4.4.6

4.4.6

-

7.5.5

Preservation of Product

7.5.5

4.4.6

4.4.6

-

7.6

4.5.1

4.5.1

9.5(d)

7.6

Control of monitoring & Measuring Devices

8.0

Measurement, Analysis & Improvement

8

4.5

4.5

9.5

8.1

General

8.1

4.5.1

4.5.1

9.5(d)

8.2

Monitoring & measurement

8.2

4.5.1

4.5.1

9.5(d)

8.2.1

Customer Satisfaction

8.2.1

4.5.1

4.5.1

9.10

8.2.2

Internal Audit

8.2.2

4.5.5

4.5.4

9.5(d)

8.2.3

Monitoring & measurement of process

8.2.3

4.5.1, 4.5.2

4.5.1

9.5(d)

. .

. . , . .

. .

-

-

4.5.3

-

. . 8.2.5

Incident Investigation

.

8.3

Control of non conforming product / Activities

8.3

4.4.7,4.5.3

4.4.7,4.5.2

9.5(d), 9.10

8.4

Analysis of data

8.4

4.5.1

4.5.1

9.5(d), 9.10

8.5

Improvement

8.5

4.2

4.2

-

8.5.1

Continual improvement

8.5.1

4.3.3, 4.2, 4.6

4.3.4

9.1(c )

8.5.2

Corrective action

8.5.2

4.5.3

4.5.2

9.10, 9.11

9.0

Ethical Governance

-

-

-

IV

9.1

Child Labour

-

-

-

IV-1

9.2

Forced & Compulsory Labour

-

-

-

IV-2

9.3

Freedom of Association & Right to collective Bargaining

-

-

-

IV-4

9.4

Discrimination

-

-

-

IV-5

9.5

Disciplinary Practices

-

-

-

IV-6

9.6

Working Hours

-

-

-

IV-7

9.7

Remuneration

-

-

-

IV-8

04


Part -V

, Methodology

76

TRAINING ON MANAGEMENT SYSTEM (QMS / EMS) AUDITS

What is audit ? Most of us are familiar with the term ‘audit’. Typically, ‘audit’ is considered to be associated with financial matters such as accounts, costing, taxation etc. As a result, the very mention of ‘audit’ evokes fear, not comfort. However mana ement s stem audits are totall different in nature whether on Quality Management Systems (ISO9001:2008) or Environment Management Systems (ISO14001:2004). The International Organization for Standardization (ISO) has even published a standard (ISO19011:2002) to provide guidance on how to conduct quality / environment management system audits.

77


Definition of Audit Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Scope of Audit: It may include the examination of System Adequacy and/or Compliance, and identification of Improvement Opportunities.

Types of Audit: 1. Internal Audit 2. External Audit 3. Combined Audit 4. Joint Audit

78


1. Internal Audit (First Party Audit) It is conducted by or on behalf of the organization itself for management review and other internal purposes. Internal audit may form the basis for an organization’s self declaration of conformity. Independence can be demonstrated by deploying internal auditors who are not responsible for the activity being audited.

2. External Audit 2nd / 3rd Part Audit Second party audits are conducted by parties having an interest in the organization, such as customer or by other persons on their behalf. Third party audits are conducted by external independent auditing organizations such as those providing registration / certification of conformity to the requirements of ISO9001 or ISO14001. 79


3. Combined Audit When a quality management system and an environmental management system are audited together, this is termed a combined audit. 4. Joint Audit When two or more auditing organizations co-operated to audit a single auditee, this is termed a joint audit.

80


Audit Scope: Adequacy Vs Compliance Adequacy audit (also known as “system” or “management” audit) aims to establish the extent which the entire documented system meets the requirements of the applicable standard. It is a desktop exercise, based on System Documentation such as manual, procedures, work instructions etc. Sometimes, it involve sample check on System . contradictions within the documented system itself.

Compliance Audit seeks to establish the extent to which the documented system is implemented and observed by the workforce. i.e., “Are the people complying with the system?”

81


Principles of Auditing Audit can be an effective support tool for management by checking the implementation status of policies & procedures, and providing information that can help improving the process performance. In order to ensure that the audit conclusions are relevant, and circumstances, the ISO has spelt out some pre-requisites/guidelines for the auditors and the audit process itself. These are known as the “Principles of Auditing”.

82


Principles of Auditing (For Auditors) 1. Ethical conduct (the foundation of professionalism) - Trust, integrity, confidentiality and discretion are essential to auditing.

2. Fair presentation (obligation to report truthfully and accurately) - Audit findings, audit conclusions and audit reports must reflect truthfully and accurately about the audited activities. Significant obstacles encountered and the auditee are reported.

3. Due professional care (diligence and judgement in auditing) - Auditors must exercise care in accordance with the importance of the task they perform and the confidence placed in them by audit clients and other interested parties. Possessing the necessary competence is also an important factor.

83


Principles of Auditing (For Audit Process) 1. Independence (impartiality and objectivity of audit conclusions) - Auditors are independent of the activity being audited and are free from bias and conflict of interest. Auditors maintain an objective state of mind throughout the audit process to ensure that the audit findings and conclusions will be based only on the audit evidence.

2. Evidence-based a roach the rational method for reachin reliable and reproducible audit conclusions in a systematic audit process) - Audit evidence is verifiable. It is based on samples of the information available, since an audit is conducted during a finite period of time and with finite resources. The appropriate use of sampling is closely related to the confidence that can be placed in the audit conclusions.

84


Definition of some useful terms: 1. Audit Criteria: The set of policies, procedures or requirements that apply to the management system being audited. 2. Audit Evidence: Verifiable records, statement of fact or other audit criteria. 3. Audit Findings: The results of evaluation of the collected audit evidence against audit criteria which indicates conformity / non-conformity / opportunity for improvement.

85


Definition of some useful terms: 4. Audit Conclusion: It is the outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings. 5. Audit Client: It is the organization or person requesting an audit

6. Auditee: It is the organization being audited. 7. Auditor: He / she is a person who possesses the required competence to conduct an audit.

86

TRAINING ON MANAGEMENT SYSTEM (QMS / EMS) AUDITS Definition of some useful terms: 8. Competence: It is the demonstrated personal attributes and ability to apply knowledge and skills. 9. Audit Team: It is a team of one or more auditors (may include some auditors-in-training) conducting an audit, supported (if needed) by technical experts. One auditor of the audit team is appointed as the audit team leader. 10. Technical Expert: He / she is a person who provides specific knowledge or expertise (related to the organization / process / activity to be audited, or language / culture) to the audit team. A technical expert does not act as an auditor.

87


Definition of some useful terms: 11. Audit Program: It is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. 12. Audit Scope: It is the extent and limits of an audit, which generally units activities and processes as well as the time period covered.

88


Audit Management

89


Planning for Audit The following questions should be asked while planning an audit: 1. WHO should be audited ? 2. WHY should be audited ? 3. WHAT type of audit to be conducted ? 4. WHAT should be the depth and scope of audits ? 5. WHEN should the audit take place ? 6. WHO will perform the audit ? 7. IS the audit schedule prepared ?

90


Stages of an Audit Every management system audit has the following stages: 1. Audit Initiation 2. Document Review 3. Preparing for on-site audit .

-

5. Preparing, approving and distributing the audit report 6. Audit Completion 7. Audit Follow-up

91


Stages of an Audit : 1. Audit Initiation a) Appoint the audit team leader Audit Manager (usually the MR of the QMS / EMS) should appoint an audit team leader for the specific audit.

b) Define audit objectives, scope and criteria Any audit should be based on documented objectives, scope and audit criteria.

c) Determine the feasibility of the audit Availability of sufficient information for audit planning, cooperation from the auditee, and adequate time and resources to be considered. If the audit is not feasible, an alternative should be proposed to the audit client in consultation with the auditee.

d) Select the audit team Audit team should be selected on the basis of the competence needed to achieve the audit objectives. Technical experts and trainee auditors may be included in the team. If there is only one auditor, he / she should perform all duties of an audit team leader. Auditors should be INDEPENDENT of the area of audit.

e) Establish initial contact (formal / informal) with the auditee Initial contact should be made by the audit manager or the audit team leader. The purpose is to establish communication channels with the auditee’s representative, to confirm the authority to conduct the audit, to tell about the proposed timing and audit team composition, to request access to relevant documents including records, to determine applicable site safety rules, to make arrangements for the audit, and, to agree on the presence of observers and the need for guides for the audit team.

92


Stages of an Audit : 2. Document Review Auditee’s documentation should be reviewed (prior to on-site audit) in order to determine the conformity of the system (as documented) with the audit criteria. The documents under review may include management system documents & records, and previous audit reports. (The size, nature, and complexity of the organization also matters.) , doesn’t affect the effectiveness of the audit. In some cases, a preliminary site visit may be conducted for on-the-spot information gathering. If the documentation is found to be inadequate, the audit team leader should inform the audit client, audit manager, and the auditee. Also, it needs to be decided whether to continue OR suspend the audit until the inadequacies in the documentation are corrected.

93


Stages of an Audit : 3. Preparing for on-site audit . ... a) Prepare the audit plan The audit team leader should prepare an audit plan covering the following: - audit objectives, audit criteria and any reference documents - audit scope (including the identification of the organizational & functional processes) - dates and places where the on site audit activities are to be conducted - expected time & duration of on site audit activities - roles and responsibilities of the audit team members and accompanying persons - allocation of appropriate resources to critical areas of the audit - identification of the auditee’s representative for the audit - working & reporting language of the audit, report topics, and confidentiality issues. - logistic arrangements (travel, on site facilities etc) - any audit follow up actions The plan must be reviewed and accepted by the audit client and presented to the auditee prior to commencement of on-site audit activities. Any objections by the auditee should be resolved between the audit team leader, the auditee and the audit client. Any revised audit plan should be agreed among the parties concerned before continuing the audit. 94


Stages of an Audit : 3. Preparing for on-site audit .. ... b) Assign work to the audit team The audit team leader should assign responsibility to each team member for auditing specific processes, functions, site areas, or activities. It should be done in consultation with the audit team, also taking into account … - the independence and competence of auditors - the effective use of resources - roles & responsibilities of auditors, auditor-in-training, and technical experts. Changes to the work assignments may be made as the audit progresses to ensure the achievement of the audit objectives.

95


Stages of an Audit : 3. Preparing for on-site audit … ... c) Preparing work documents The audit team members should prepare the necessary work documents in advance for reference and for recording audit proceedings. Work documents may include... - checklists and audit sampling plans - forms for recording information such as audit findings and records of meetings Use of standard checklists and forms should not restrict the audit process. Auditors may change the extent of audit activities on the basis of the information collected during the audit. Work documents should be retained at least until the audit completion. Documents containing confidential / proprietary information should be suitably safeguarded at all times by the audit team members.

96


Stages of an Audit : 4. Conducting on-site audit a) Opening meeting An opening meeting should be held with the auditee’s management or those responsible for the functions / processes to be audited. The purpose of an opening meeting is - to confirm the audit plan - to provide a short summary of how the audit activities will be undertaken - to confirm the communication channels, and - to provide an opportunity for the auditee to ask questions. 97


Stages of an Audit : 4. Conducting on-site audit b) Communication during the audit The audit team should meet periodically to exchange information assess audit progress and to reassign work between the audit team members as needed. During the audit, audit team leader should periodically communicate the audit progress and any concerns to the auditee and audit client as appropriate. Evidence collected during the audit that suggests an immediate and significant risk (e.g , . If the available audit evidence indicates that the audit objectives are unattainable, the audit team leader should report the reason to the audit client and the auditee to determine appropriate action. Any need for changes to the audit scope which may become apparent with the progress of on-site auditing activities should be reviewed with and approved by the audit client and the auditee.

98


Stages of an Audit : 4. Conducting on-site audit c) Roles and responsibilities of guides and observers Guides and observers may accompany the audit team, but are not a part of it. They should not influence or interfere with the conduct of the audit. When guides are appointed by the auditee, they should assist the audit team and act on the request of the audit team leader. Their responsibilities may include the following … - establishing contact and timing for interviews - arranging visits to specific parts of the site or organization - ensuring that rules concerning site safety and security procedures are known and respected by the audit team members - witnessing the audit on behalf of the auditee - providing clarification or assisting in collecting information

99


Stages of an Audit : 4. Conducting on-site audit d) Collecting and verifying information During the audit, information relevant to the audit objectives scope and criteria including the information relating to interfaces between functions activities and processes should be collected by appropriate sampling and should be verified. Only those information that are verifiable may be treated as audit evidence. Audit evidence should be recorded. The audit evidence is based on samples of the available information. Therefore there is an element of uncertainty in auditing and those acting upon the audit conclusions should be aware of this uncertainty. 100


Stages of an Audit : 4. Conducting on-site audit e) Generating audit findings Audit evidence should be evaluated against the audit criteria to generate the audit findings indicating conformity / nonconformity with audit criteria. When specified by the audit objectives, audit findings can identify an opportunity for improvement. The audit team should review the audit findings at appropriate stages of audit. Conformity with audit criteria shou d be summarized (usua y, in a chec ist to indicate location, functions or processes that were audited. Non-conformities and the supporting audit evidence should be categorized, recorded, and reviewed with the auditee (to obtain acknowledgement that the audit evidence is accurate and that the non-conformities are understood). Diverging opinion about the audit evidence and/or findings needs to be resolved. Unresolved points should be recorded.

101


Stages of an Audit : 4. Conducting on-site audit f) Preparing audit conclusion The audit team should confer prior to the closing meeting … - to review the audit audit finding finding and any other appropr appropriate iate inform information ation collected during the audit against the audit objectives - to agree on on the audit conclusi conclusion on taking taking into account account the uncertainty inherent in the audit process - to prepare prepare recommend recommendations ations if specified specified by by the audit objectives objectives and 102

- to discuss discuss audit audit follow up up if included included in the the audit plan. plan.


Stages of an Audit : 4. Conducting on-site audit g) Conducting the closing meeting A closing meeting chaired by the audit team leader and attended by the auditors and auditees should be held to present the audit finding and conclusion so that they are understood and acknowledged by the auditee. Participants in the closing meeting may also include the audit client and other parties. In case of internal audits in a small organization, the audit team leader may just . For other audit situations, a formal f ormal closing meeting should be held, and the minutes (including the records of attendance) should be kept. If specified by the audit objectives, recommendation recommendation for improvement should be presented. It should be emphasized that recommendation are not binding.

103


Stages of an Audit : 5. Audit Reporting . .. a) Preparing the audit report Audit team leader is responsible for the preparation and contents of audit report. The audit report should provide prov ide a complete, accurate, concise, and clear record of the audit and should include or refer to the following … - audit objectives objectives,, audit scope, identific identification ation of the audit client client - ident identifica ification tion of audit team team leader and member memberss - the dates and places where where the on site audit activities activities were were conducted - audit criteria criteria,, audit findings, findings, and audit conclusio conclusion n The audit report may also include or refer to the following as required ... - audit plan, list list of auditee representatives, summary of the audit process & obstacles encountered - confirmation of accomplishment of audit objectives within audit scope and as per audit plan - any left-out areas specified in the audit scope, any unresolved diverging opinion - recommendati recommendation on for improvement, improvement, agreed follow up action plans plans - a statement of the confidential nature of the contents, and the report distribution list.

104


Stages of an Audit : 5. Audit Reporting .. .. b) Approving and distributing the audit report The audit report should be issued within the agreed time period. If this is not possible, the reasons for the delay should be communicated to the audit client and a new issue date should be agreed upon. The audit report should be dated, reviewed, and approved in accordance with audit procedures given in the management system manuals. The approved audit report should then be distributed to recipients designated by the audit client. The audit report is the property of the audit client. The audit team members and all report recipients should respect and maintain the confidentiality of the report.

105


Stages of an Audit : 6. Audit Completion Audit is completed when all activities described in the audit plan have been carried out and all approved audit reports have been distributed. Documents pertaining to the audit should be retained or destroyed by agreement between the participating parties and in accordance with audit procedures and applicable statutory / regulatory and contractual requirements. Unless re uired b law the audit team and those res onsible for mana in the audit program should not disclose the audit report or any information obtained during the audit to any other party without the explicit approval of the audit client. If disclosure of the contents of an audit document is required, the audit client and auditee should be informed as soon as possible.

106


Stages of an Audit : 7. Audit Follow-up The conclusion of the audit may indicate the need for corrective preventive or improvement action as applicable. Such actions are usually decided and undertaken by the auditee within an agreed timeframe and are not considered to be part of the audit. The auditee should keep the audit client informed of the status of these action. The completion and effectiveness of corrective action should be verified. This verification may be part of a subsequent audit. The audit program may specify follow up by members of the audit team which add value by using their expertise. In such cases, care should be taken to maintain independence in subsequent audit activities. 107


Competence and Evaluation of Auditors

108


Competence and Evaluation of Auditors Confidence in the audit depends on the competence of the auditors. Competence is based on the demonstration of personal attributes and the ability to apply the knowledge and skills gained through the education, work experience, auditor training, and audit experience. Auditors should develo , maintain, and im rove their com etence through continual professional development and regular participation in audit. Let us now look at the following aspects in detail... 1. Personal attributes 2. Knowledge and skill 3. Education & work experience, audit training & experience 4. Maintenance and improvement of competence 5. Auditor evaluation

109


Auditors > 1. Personal attributes Every auditor should possess the following personal attributes: a) Ethical : i.e., is fair, truthful, sincere, honest and discreet b) Open minded : i.e., willing to consider alternative ideas or points of view c) Diplomatic : i.e., tactful in dealing with people servan : .e., ac ve y aware o p ys ca surroun ng an s ua on e) Perceptive : i.e., instinctively aware of and able to understand situation f) Versatile : i.e., adjusts readily to different situation g) Tenacious : i.e., persistent, focussed on achieving objectives h) Decisive : i.e., reaches timely conclusion based on logical reasoning / analysis i) Self reliant : i.e., acts independently but interacts effectively with others

110


Auditors > 2. Knowledge and skill QMS / EMS auditors need to possess generic and specific knowledge & skills. Generic knowledge and skill: a) An auditor should be able to ... - apply audit principles, procedures, and techniques - plan and organize the work effectively and within the agreed time schedule - prioritize and focus on matter of significance, choose appropriate samples - collect information through effective interviewing, listening, observing and reviewing documents records / data, and verify the accuracy of information - confirm the sufficiency and appropriateness of audit evidence to support audit finding and conclusion - assess the factors that can affect the reliability of audit finding and conclusion - use work document to record audit activities, prepare the audit report - maintain the confidentiality and security of information, and - communicate effectively using linguistic skill or through an interpreter

111


Auditors > 2. Knowledge and skill Generic knowledge and skill: b) An auditor should be able comprehend the system documentation and apply the audit criteria. The knowledge and skill requirements are… - the application of management systems to different organizations - interaction between the components of the management system - ualit / environmental mana ement s stem standards a

licable

procedures and other management system documents used as audit criteria - recognizing differences between and priority of the reference documents - application of the reference documents to different audit situations, and - information system and technology for authorization security distribution and control of document, data, and record.

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Auditors > 2. Knowledge and skill Generic knowledge and skill: ... c) Auditor should have the ability to comprehend the organization’s operational context, such as ... - organizational size, structure, functions, and relationship - general business processes and related terminology, and - cultural and social customs of the auditee d) Auditor should have the awareness about the applicable laws, regulations, and other requirements that apply to the organization being audited, such as ... - local regional and national codes laws and regulation - contract and agreement - international treaties and convention and - other requirement to which the organization subscribes.

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Auditors > 2. Knowledge and skill Generic knowledge and skill requirements of Audit Team Leaders: Audit team leaders should have additional knowledge and skill in audit leadership to facilitate the efficient and effective conduct of an audit. Audit team leader should be able to … - plan the audit and make effective use of resources during the audit - represent t e au t team n commun cat on w t t e au t c ent an au tee - organize and direct audit team members - provide direction and guidance to auditors in training - lead the audit team to reach the audit conclusion - to prevent and resolve conflicts, and - to prepare and complete the audit report

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Auditors > 2. Knowledge and skill Specific knowledge and skill requirements of QMS auditors: Persons auditing a Quality Management System (based on ISO9001:2008 or other QMS standard) must have the following skills/knowledge. a) Knowledge of quality related method and techniques such as ... - quality terminology - qua ity management princip es and their app ication, and - quality management tools and their application b) Knowledge of processes and products (including services), such as … - sector-specific terminology - technical characteristic of processes and products including services, and - sector-specific processes and practices

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Auditors > 2. Knowledge and skill Specific knowledge and skill requirements of EMS auditors: Persons auditing an Environment Management System (based on ISO14001 or other EMS standard) must have the following skills / knowledge. a) Knowledge of environmental management methods and techniques such as ... - environmental terminology - environmental management principles and their application, and b) Environmental science and technology related issues such as ... - the impact of human activities on the environment - interaction of ecosystem - environmental media - management of natural resources - general methods of environmental protection

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Auditors > 2. Knowledge and skill Specific knowledge and skill requirements of EMS auditors: ... c) Technical and environmental aspects of operations, such as … - sector specific terminology - environmental aspects and impacts - methods for evaluating the significance of environmental aspects - critical characteristic of operational processes products and services - monitoring and measurement technique, and - technologies for the prevention of pollution

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Auditors > 3. Education, Work experience, Auditor training, Audit experience a) Requirements for Auditors: Education: They should have completed an education sufficient to acquire the knowledge and skill required to become auditors. Work Experience: They should have work experience that contributes to the development of the knowledge and skill. This work experience should be in technical managerial or professional position involving the exercise or judgement problem solving and communication with other managerial or professional personnel peers customers and/or . activities undertaken contribute to the development of knowledge and skill in… - the quality management field for quality management system auditors and - the environmental management field for environmental management system auditors. Auditor Training: They should have completed auditor training that contributes to the development of the knowledge and skill, which may be provided by the person’s own organization or by an external organization. Audit Experience: Must have audit experience gained under the direction and guidance of an auditor who is competent as an audit team leader in the same discipline. 118


Auditors > 3. Education, Work experience, Auditor training, Audit experience b) Requirements for Audit Team Leaders: Basic Requirements: Education: Same as prescribed for Auditors Work Experience: Same as prescribed for Auditors Auditor Training: Same as prescribed for Auditors

Additional Requirements: An audit team leader should have acquired additional audit experience gained while acting in the role of an audit team leader under the direction and guidance of another auditor who is competent as an audit team leader.

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Auditors > 3. Education, Work experience, Auditor training, Audit experience c) Requirements for Auditors who perform both QMS and EMS audit: Basic Requirements: Education: Same as prescribed for Auditors Work Experience: Same as prescribed for Auditors Auditor Training: Same as prescribed for Auditors Audit Experience: Same as prescribed for Auditors

Additional Requirements: Auditors who perform both Quality Management System and Environmental Management System audit should have ... - the training and work experience needed to acquire the knowledge & skill for both the disciplines and - conducted audit covering the QMS / EMS under the direction and guidance of an auditors who is competent as an audit team leader in that discipline.

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Auditors > 4. Maintenance and Improvement of Competence Continual professional development - Auditors must maintain and improve their knowledge, skill, and personal attributes continually. This can be achieved through additional work experience, training, private study, coaching, seminars and conferences etc. - Changes in the needs of the individual and the organization, the practice of auditing, standards, and other requirements should also be taken into account. - Auditors should demonstrate their continual professional development. Maintenance of auditing ability - Auditors need to maintain and demonstrate their auditing ability through regular participation in audits of quality and/or environmental management system.

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Auditors > 5. Auditor Evaluation The evaluation of auditors and audit team leaders should be planned, implemented, and recorded in accordance with audit system procedures. Evaluation process must provide some objective, consistent, fair, and reliable outcome; and should identify the training and other skill enhancement needs. In general, the auditor evaluation takes place at the following stages: - Initial evaluation of person who wish to become auditor - Evaluation of the auditor as part of the audit team selection process, and - Continual evaluation of auditor performance to identify needs for maintenance and improvement of knowledge and skill. Now, let us look at the four-step evaluation process suggested in the ISO19011:2002 standard.

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Auditors > 5. Auditor Evaluation > The Evaluation Process Step 1 of 4: Identify the personal attributes, knowledge & skill requirements - Consider the nature and complexity of the management system to be audited - Keep in view, the extent of audit program and certification requirement (if any) - Consider the level of confidence required in the program Step 2 of 4: Set the evaluation criteria - It may be quantitative (such as the number of audit conducted, hours of audit training) or ualitative (such as the erformance of skill in the training sessions) Step 3 of 4: Select the appropriate evaluation method - Evaluation should be undertaken by a person or a panel using one or more of the method selected from those given in the table (see the next slide) Step 4 of 4: Conduct the evaluation activity - Here we compare the information collected about the person (to be evaluated) against the evaluation criteria set in Step - 2.

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Auditors > 5. Auditor Evaluation > Methods Some of the auditor evaluation methods suggested in the ISO19011 standard: Method

Objective

Typical Activities

Review of records:

To verify the auditor’s background

Analysis of records of education, training, employment, audit experience

Feedback (+ve / ve):

To find the perception about the auditor’s performance

Questionnaires, testimonials, complaints, performance evaluation, peer review

Interview:

To evaluate skills, personal Face to face and telephone interview attributes, knowledge etc.

Observation:

To evaluate the ability to Role playing, witnessed audits, on-theapply knowledge and skill job performance

Testing:

To evaluate knowledge & skill

Oral & written test, psychometric testing

Review of audit reports and discussion Post-audit review: To provide information where with the audit client, auditee, colleagues direct observation may not be and with the auditor. possible or appropriate

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ISO 9001INTERNAL AUDITORS TRAINING- 12th Feb 2010- SNSastry [Compatibility Mode]

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