Lead Auditor Workbook Updated to 2008 Ver

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    LEAD AUDITOR / AUDITOR COURSE

    FOR QUALITY MANAGEMENT

    SYSTEM

    ISO 9001 : 2008

    Institute ! Qu"#it$

    Cn!e%e&"tin ! In%i"n In%ust&$

     IRCA Registration No. : A17392

     NABET Registration No. : LQ81 102

     

    'OR()OO( / CASE STUDIES

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    CONFEDERATION OF INDIAN INDUSTRY

    Institute ! Qu"#it$ Near Bharat Nagara, II Phase, Magadi Main Road

    Vishwaneedam Post, Bangalore – 560091

    Tel: 00!"#"9#90 – 91, $a%: 00!"#"9#

    No part of this publication may be reproduced, stored in retrieval system ortransmitted in any form or by any means; electronic, mechanical,photocopying, recording or other wise without prior written permission of Head, Institute of Quality, Confederation of Indian Industry

     

    'OR()OO( / CASE STUDIES

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    Work ook ! Case "tudies #pril $%&% #

    CONTENTS

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    Work ook ! Case "tudies #pril $%&% &

    EXERCISE E01

    INTERPRETING THE

    ISO 9001: 2008 CLAUSES

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    E01: INTERPRETNG THE

    ISO 9001: 2008 CLAUSES

    INSTRUCTIONS FOR E01

    Objective:

    Interpreting the I"' (%%&) $%%* Clauses, in the conte+t of an #udit

    Met!"

    -he following are &$ mutually independent incidents, describing the findings of 

    the auditors Identify and relate those incidents that are within the scope of I"'

    (%%&)$%%* and mention the appropriate clause and!or sub clause of I"' (%%&)

    $%%* .ou may relate these to one or more re/uirements of the "tandard

    F!#$%t

    0lease present your responses in the following format

    "lNo

     

    Whether covered

    in "cope of I"'

    (%%&)$%%*

    Clause ! "ub Clause of I"' (%%&)

    $%%*

    1easons

    N!te

    • -his is a group e+ercise followed by individual work

    • Nominate a time keeper, presenter

    • #ll the groups to work on all the incidents

    • #llocation of incidents to groups for presentation will be informed before

    the presentation• -he output of the e+ercise is part of the formal continuous assessment

    and will therefore be marked

    Ti$e %&&!tte": Individual work 2% minutes

    3roup work 2% minutes

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    EXERCISE E01

    &4 5.6 Co has its design center at "ingapore and a manufacturing plant at

    New 7elhi #ll products specifications originate at "ingapore and the

    manufacturing plant only manufacturers, as per the design specifications-he manufacturing plant has decided to apply for Certification for a Q8",

    which e+cludes Clause 92

    $4 -he 81 of a Company says :all our current procedures have been

    repeated, replacing the word 01'C'1???@ to 01'C'1???; we have not done any other changes, in the documentationA

    24 #n

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    *4 # Company providing leasing services of earthmoving e/uipment to civil

    contractors and builders has its usiness 'perations 7ivisions at its

    head/uarters and si+ repair workshop around the country -he repair

    shops provide the service of e/uipment maintenance to the

    head/uarters, and have no interactions with the Company@s customers

    'ne of the workshops is pursing certification to I"' (%%&)$%%* even

    before the parent Company -he workshop management has e+cluded

    the clauses 9$, 92, 9B and 9DB from their Q8"

    (4 "ources of information on customer satisfaction only include customer

    complaints and Questionnaire G "urveys but do not include focus groupsreports in various media, sector G industry studies

    &%4 -he -raining 8anager of a Company says that increasing profits of the

    Company amply demonstrates the effectiveness of their training plans

    and programmes

    &&4 a+mi ank is implementing I"' (%%&) $%%* for the realiation of its

    various services -he ank has e+cluded 9D2 G 9DB from its Q8"

    &$4 Corrective #ction 0rocedure of the company does not include results of 

    "elf #ssessment

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    CASE STU'( ) CS1

    'OCUMENTATION RE*IE+

    OF A ,UALIT( MANUAL

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    CS1: 'OCUMENTATION RE*IE+ OF

    A ,UALIT( MANUAL

    INSTRUCTIONS FOR CS1

    Objective

    7ocumentation 1eview of 3

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    3roup Work 2% minutes

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    ,-%&it. M%/%e$e/t S.te$ M%/-%&

    G!!"i&& E3-i4$e/t C!$4%/. Lt"56

    54-56, Yallers Compound,

    New Achievers Road,

    Gopal Ram Nager 

    3

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     INTRO'UCTION

    3oodwill oundry, 8achine shop and #ssembly shop

    With the e+pansion of the Company and with the technical skills available

    with the oundry, 8achine

    shop and Heat -reatment facilities -he final assembly of both mechanical

    parts and electronic items is carries out at 3opal 1am Nagar Works from

    where the management team functions

    "ince the two facilities are separated by a distance of about $D kilometers,

    considerable movement of semi finished material takes place between the

    two sites #t present, the total employees strength of the Company is above

    DD% and the product base is changing and e+panding, demanding modern

    facilities in manufacturing and resources -he Company is therefore putting

    its best efforts to change from inspection oriented approach to /uality

    management system approach, in line with I"' (%%% >amily of standards,with the help of est Consultants 0vt td

    Work ook ! Case "tudies #pril $%&% 1"

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    'ur success is based upon a number of factors, not least of which, is our

    e+pertise G willingness to pursue new areas of businesses We are

    particularly fortunate in being able to draw upon a skilled labour force

    'ur subJcontractors provide us with specialist e+pertise in activities such as

    nonJdestructive testing and heat treatment -hey complete a team, which

    can offer a wide range of services to our customers

    "ince &((%, when the present 8anaging 7irector took over, the company has

    grown to its present strength of D9D employees

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    ,UALIT( POLIC(

    -his manual is for guidance for company /uality management system

    #ll personnel will be guided by the contents of this /uality management

    system manual G no deviation from the methods described shall be

    permitted

    -he /uality controller is responsible for carrying out the directives in this

    manual He shall have the organiational freedom to identify /uality

    problems and procedure solutions

    In matters affecting /uality, he may not be overturned by any other 7irector

    or 8anager with the e+ception of 8anaging 7irector or 8anager with the

    e+ception of 8anaging 7irector, and then only with client and design

     Eustification approval

    -he Quality 0olicy of the Company states

    7+e !/!-# C-t!$e# #e3-i#e$e/t %/" 4%#e /! e!#t t! %ti.

    c-t!$e# b. 4#!vi"i/ 3-%&it. 4#!"-ct !/ ti$e6 %t &e%t 4!ib&e

    c!t5

    GECL M%/%e$e/t i c!$$itte" t! c!/ti/-!-&. i$4#!ve i/ tei#

    e/"e%v!-# t! bec!$e !#&" c&% c!$4%/. 

    Work ook ! Case "tudies #pril $%&% 1&

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    Secti!/ AA I-e 1 Rev 1 M%#c 2009 P%e 1 ! 20

    CONTENTS

    Tit&e Secti!/ N! ISO C&5 /!

    Introduction

    Quality 0olicy

    Contents ## J

    1ecord of 1evision J

    Quality 8anual 'peration CC J

    Quality 8anagement "ystem B% B

    8anagement 1esponsibility D% D

    1esource 8anagement F% F

    0roduct 1ealiation 9% 9

    8easurement, #nalysis *% *

    Improvement

    #nne+ure &

    Q80 7iagram K

    Internal #udit 0rocess (% *

    #nne+ure $

    'bEectives G 0rocess

    8easures for 8aterials 7ept &%% 9

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    Secti!/ I-e 1 Rev 1 M%#c 2009 P%e 2 ! 20

    RECOR' OF RE*ISION

    1ev No 7ate "ection 1evised 7etails of 1evision

    & 8arch $D, $%%( 'riginal Issue J

    $ 8ay $$, $%%( D 1esponsibility and

      #uthority

     : 9 :0roduction 0rocess

    1evisedA 

     : * 7etails of C#3

    added

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    Secti!/ CC I-e 1 Rev 1 M%#c 2009 P%e ; ! 20

    ,UALIT( MANUAL OPERATION

    -his manual is prepared by the 81 G approved by 7irector Quality

    -he holder of the controlled copy shall not make further copies of the

    manual If additional copies are re/uired, a re/uisition is to be sent to 81

    When the holder of controlled copy of the manual ceases to be an authoried

    copy holder, all the copies in his possession are to be returned to 81 with

    due acknowledgement

    -he 81 will review this 8anual periodically with the 7epartmental Heads to

    affirm its ade/uacy Changes to the 8anual are made by the 7epartmental

    Heads who revise the 8anual #ll the changes ! amendments cancel and

    replace any previous copy of the 8anual #uthoried copyholders shall

    maintain updated copy of the 8anual 7epartmental Heads maintain the

    amended version for reference and use

    =ncontrolled copies of this 8anual with no copy number4 may be issued but

    these are not subEect to updating procedure "uch copies are for information

    only -hese copies may be identified as =ncontrolled Copy@ on the contents

    page of the 8anual

    -he 81 will retain copies of all previous issues ! amendments of the 8anual

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    Secti!/

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    Secti!/ ! 20

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    Secti!/ =50 I-e 1 Rev 1 M%#c 2009 P%e ? ! 20

    =50 MANAGEMENT RESPONSIILIT(

    #4 -he management of the company is committed to the development,

    implementation and continual improvement of the Q8" and has

    a4 Communicated the importance of meeting customer re/uirements and

    statutory re/uirements within the organiation

    b4

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    Secti!/ =50 I-e 1 Rev 1 M%#c 2009 P%e 8 ! 20

    74 1esponsibility and #uthority

    -he responsibility and authorities are known from the structure of the

    organiation chart as shown below -he individual departmental structure

    and their responsibilities are described in the departmental manuals

    -he functional responsibilities are)J

    8anaging 7irector, 8r >ernande) he is responsible for coordinating all

    business and manufacturing activities of the company

    oundry4

    7irector "ales

    7irector Quality

    7irector 8aterials

    7irector >inance

    Q# J >inal

    Q# K In 0rocess

    Calibration ab

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    Secti!/ =50 I-e 1 Rev 1 M%#c 2009 P%e 9 ! 20

    3eneral 8anager 8r "achdeva) He is overall in charge of all matters relating

    to product, process and systems He directly reports to 87 It is his

    responsibility for proper utiliation of men, materials G machines in achieving

    targets He is also responsible to provide training and approve the training

    needs as recommended by individual departments He will support the 87 in

    all the decisions and directives

    7irector "ales, 8r Lapur) He is responsible for obtaining orders for supply of 

    products as also to /uote, negotiate and finalise technical and commercial

    terms of contract, to carry out review of /uotations, contract andamendments to orders He should also ensure timely delivery orders

    7irector Quality, 8r anerEee) He is responsible for all matters relating to

    manufacturing standards He has the responsibility for preparing, maintaining

    and revising the /uality manual in order to reflect changes in manufacturing

    methods, 1eceipt G checking of incoming materials, identification, storage

    arrangements and issue of these materials to manufacturing departments,

    checking final test reports used for presentation to the Customer for

    acceptance prior to issue of materials to dispatch

    7irector 8aterials, 8r Masbir "ingh) He is responsible for all purchase and

    store functions, selection and approval of vendors and sub contractors,

    release of purchase orders, vendor evaluation and advice to vendors and sub

    contractors, receiving and storage of raw materials and identification and

    issue of raw materials and engineering stores

    7irector >inance, 8r 0atel) He is responsible for all matters related to

    finance, accounting, wages, costing etc He supports the 87 in all his

    functions concerning financial matters and any other special task assigned by

    the 87

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    Secti!/ =50 I-e 1 Rev 1 M%#c 2009 P%e 10 ! 20

    -he inJcharge, 8achine "hop, 8r Nair) #ssembly, 8r 7eshpande) Heat

    -reatment, 8r 1eddy have supporting functions in their respective areas to

    the 3eneral 8anager

    -he 7irector Quality is supported by 8r Mabbar #hmed in >inal inspection;

    8r 0arab in InJprocess and 8r Magannath in aboratory -he aboratory inJ

    charge is designated as the 8anagement 1epresentative 814

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    Secti!/ =50 I-e 1 Rev 1 M%#c 2009 P%e 10% ! 20

    ANNEXURE TO SECTION =50

    COMPAN( LE*EL ,UALIT( O@ECTI*ES

    -he Quality 0olicy of the Company has been translated into the following

    Company level Quality 'bEectives)

    &4 Improvement in customer satisfaction inde+

    $4 1eduction in number of customer complaints ! repeat complaints

    24 Improvement in delivery schedule adherence

    B4 1eduction in reEects and reworks

    D4 Cost reduction ! value improvements

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    Secti!/ >50 I-e 1 Rev 1 M%#c 2009 P%e 11 ! 20

    >50 RESOURCE MANAGEMENT

    -he 8anagement of the Company has determined G provides resourcesneededa4 -o implement, maintain and continually improve the Q8"

    b4 -o enhance customer satisfaction

    Human 1esources

    It is ensured that all the personnel engaged in performing work affecting the

    products are competent on the basis of appropriate education, training, skills

    and e+perience

    Competence, #wareness and -raining

    -he company has the following activities to ensure competence, awareness

    and -raining

    a4 7etermination of competence levels for different positions

    b4 0rovision of -raining to ensure that competence levels are achieved

    -hese activities are coordinated through the Company "ecretary

    Infrastructure

    -he company is e/uipped with facilities such as well designed and well

    furnished rooms, dining area, transportation etc which are maintained in

    good condition at all times

    -he company is also e/uipped with facilities G e/uipment to provide

    amenities such as central air conditioning to the offices, stand by power andcommunication, through a team of e+perienced G competent personnel

    Head of

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    Secti!/ ?50 I-e 1 Rev 1 M%#c 2009 P%e 12 ! 20

    ?50 PRO'UCT REALISATION

    #4 0lanning for 0roduct 1ealisation

    -he company plans and develops processes, which are consistent with the

    other processes of the Q8" In planning for product realiation, the /uality

    obEectives and customer re/uirements are considered 8onthly and weekly

    product plans are prepared and issued by 7irector 8aterials -hese plans are

    based on the availability and procurement of materials

    4 Customer related processes

    -he company makes efforts to determine the specified and implied needs of 

    the customer which are necessary for customer satisfaction -he statutory

    and regulatory re/uirements related to the products are compiled by the

    company -he "ales office has the responsibility of identifying needs of the

    customer -he concerned department heads are responsible for the

    compliance of the statutory G regulatory re/uirements applicable to the

    products

    -he customers of the company can be corporate bodies or distribution

    agents -he re/uirements for the product are clearly specified and agreed

    upon -his is based upon the company brochure and e+isting! agreed

    specifications In all cases the re/uirements are reviewed, to ensure that the

    re/uirements are clearly defined, and the company has the ability to meet

    the specified re/uirements If any differences e+ist in the specified

    re/uirements and the proposal, these are resolved at the time of preparationof contract -he record of review is maintained by "ales office

    -he company has implemented effective arrangements for communicating

    with the customers in relation to product information, periodic updates,

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    Secti!/ ?50 I-e 1 Rev 1 M%#c 2009 P%e 1; ! 20

    en/uires, contracts or direct orders and customer feedback including

    customer complaints

    C4 7esign G 7evelopment

    -he products provided by the company are standardied and as such there is

    no re/uirement of designing the products -he

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    Secti!/ ?50 I-e 1 Rev 1 M%#c 2009 P%e 1< ! 20

    their respective procedure Neither the company nor its customers perform

    verification at the supplier premises

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    Secti!/ ?50 I-e 1 Rev 1 M%#c 2009 P%e 1= ! 20

    B4 Customer property

    -he company e+ercises utmost care with the customer@s property when the

    customer provides any product or information for incorporation into the

    products supplied =tmost care is taken to ensure that the customer does not

    lose or suffer damage to his belongings -he overall responsibility rests with

    the 8anager 0ersonnel G #dministration who ensures the security of 

    customer belongings through a well K organied security force

    D4 0reservation of product

    -he products provided by the company are handled, packed, stored andpreserved as appropriate

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    Secti!/ 850 I-e 1 Rev 1 M%#c 2009 P%e 1> ! 20

    850 MESUREMENT6 ANAL(SIS IMPRO*EMENT

    #4 -he company has planned and implemented measurement, analysis and

    improvement processes needed to)J

    a4 7emonstrate conformity of the product

    b4

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     Secti!/ 850 I-e 1 Rev 1 M%#c 2009 P%e 1? ! 20

    74 8onitoring G 8easurement of process

    -he respective department heads monitor the processes under their control

    on a dayJtoJday basis When the results are below the planned level,

    immediate corrections are taken

    or the products provided by the company, there is an elaborate system of 

    inspection and tests #t all relevant stages of manufacture and additionally,

    where specified by the customer, the products are inspected or tested as per

    /uality plans >inal tests are recorded and the records are maintained by therespective /uality department Intermediate test records may or may not be

    available as many of these tests!inspections are carried out by the production

    personnel

    >4 Control of nonconforming products

    -he company takes care to ensure that nonconformities in the products are

    reduced or eliminated It is realied by the company, that the

    nonconformities in the products are very much related to human interaction

    Hence it is difficult to identify a nonJconformance at the time of occurrence

    -he management of the company has however therefore formulated a

     :Corrective #ction 3roupA C#34 -he membership of the C#3 is decided by

    the

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    Secti!/ 850 I-e 1 Rev 1 M%#c 2009 P%e 18 ! 20

    34 #nalysis of data

    -he individual departmental heads collect appropriate data on issues

    described earlier for e+ample customer complaints, process and product

    conformance, nonconformance, internal audits etc

    -his data is analyed in the respective sections to verify and confirm the

    suitability of the Q8" and to evaluate areas for continual improvement of the

    Q8"

    H4 Continual improvement-he company strives to continually improve the effectiveness of the Q8"

    primarily during the management review meetings and other means such as

    achievement of /uality obEectives, audit results, analysis of data, corrective G 

    preventive actions

    I4 Corrective action

    -he C#3 identifies the nonconformities during the processing of product and

    delivery 'ther opportunities such as internal /uality audit, monitoring of 

    service process etc are used to identify areas for improvement

    # documented procedure 3

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    Secti!/ 850 I-e 1 Rev 1 M%#c 2009 P%e 19 ! 20

    M4 0reventive action

    -he documented procedure 3

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    Secti!/ 850 I-e 1 Rev 1 M%#c 2009 P%e 20 ! 20

    Work ook ! Case "tudies #pril $%&% #5

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    ANNEXURE ) 2

    GOO'+ILL E,UIPMENT COMPAN( LIMITE'

    MATERIALS 'EPARTMENT

    O@ECTI*ES

    PROCESS MEASURERS

    GECBMATBP;

    Copy No ) %D

    Issue 7ate ) $$!%2!$%%(

    Issued y ) 81

    1evision No ) %

    Work ook ! Case "tudies #pril $%&% #6

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    O@ECTI*ES FOR MATERIALS 'EPARTMENT

    &4 1eduction in ead -ime for 0rocurement

    $4 1eduction of 1eEections of Incoming 8aterials due to Improper

    Communication of "pecifications to "uppliers

    24 Improvement in 7elivery #dherence by "uppliers

    B4 1eduction in ead -ime of 0ayment to "uppliers

    D4 1eduction in Inventory -urns 'ver time at 1eceipt "tores

    F4 Increase in "uppliers with :7irect 'n ineA "tatus

    94 Cost 1eduction ! alue Improvement by Ley "uppliers

    Work ook ! Case "tudies #pril $%&% #'

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    PROCESS AN' PRO'UCT MEASURES

    LINDE' TO OE@CTI*ES

    "lNo 0rocess!0roduct 8easure 1elation to 'bEective

    %& 1eduction of -ime from 1eceipt ofindent!purchase 1e/uest to issue of 0'

    &

    %$ 1eduction of 0roduction ead -ime of Ley"uppliers

    &,2,9

    %2 1eduction of Changeover!"etup -ime in0roduction #rea of Ley "uppliers

    &,2,9

    %B 1eduction of "pecification 8ismatchbetween indent ! 1e/uest and 0urchasing7ata found during #udit

    $

    %D 1eduction of :"tore 1eceipt ! InspectionClearanceA -ime

    &,B,D

    %F Improvement in "traight 0ass 1atio 'L8aterial ! 1eceived material4 of Ley"uppliers

    $,F

    %9 8onitoring of Item Wise days ofInventory based on Item wise closingstock and shop consumption pattern4

    &,D

    %* 8onitoring of ead -ime of 0rocurement,"upplier wise

    &,2

    %( 1eduction of -ime of 0reparing, 0aymentInstruction after 8aterial is ok

    B

    &% 1eduction in 1epeat Nature of 1eEectionat 1eceipt "tage

    $,F

    Work ook ! Case "tudies #pril $%&% #

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    Work ook ! Case "tudies #pril $%&% #9

    EXERCISE E02

    PREPARATION OF AN

    ONSITE AU'IT PLAN

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    E 02 : PREPARATION OF AN

    ONSITE AU'IT PLAN

    INSTRUCTIONS FOR E02

    Objective

    0repare an 'nJ"ite #udit 0lan after completing the 7ocumentation 1eview of 

    3

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    EXERCISE E0;

    CHECDLIST FOR AU'ITINGA ,MS PROCESS

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    E0; : CHECDLIST FOR AU'ITING

    A ,MS PROCESS

    INSTRUCTIONS FOR E0;

    Objective

    0repare two checklists for

    & auditing a Quality 8anagement "ystem 0rocess

    $ verifying compliance with the re/uirements of a clause of I"'(%%&)

    $%%*

    Met!"

    • 1ead the te+t of the e+ercises enclosed

    • 0lease refer to section * of your course notes and prepare

    separate checklist for both the e+ercises

    • >or e+ercise No & consider the 07C# principle in terms of 

    inputs, outputs, result, process measures, linkages with /uality

    obEectives G continual improvement

    F!#$%t

    0lease present you response in any format preferred by you and submit the

    same to the tutors

    N!te

    • -his is a group e+ercise

    • Nominate a time keeper

    • -he output of the e+ercise is part of the formal continuous assessment

    and will therefore be marked by tutors and feedback would be given to

    the participants

    Ti$e %&&!tte":

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    EXERCISES

    & .ou are conducting an audit of a medium sied manufacturing company

    -he document review has raised a concern about how the organiation

    ensures the competence of staff

    0repare a checklist that would guide you through a process audit of this

    area and state the relevant I"' (%%& clauses

    $ What obEective evidence could be available in order to verify compliance

    with re/uirements of Clause 9$2 of I"' (%%&O In your presentation,make links to other I"' (%%& clauses as necessary

    Work ook ! Case "tudies #pril $%&%

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    Work ook ! Case "tudies #pril $%&% &&

    EXERCISE E0<

    OPENING MEETING

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    E0< : ROLE PLA( ON OPENING MEETING

    INSTRUCTIONS FOR E0<

    Objective

    -o conduct an 'pening 8eeting in line with what has been covered in the

    course notes

    Met!"

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    • #s this is a second party audit there is no certificate at stake #lso the

    organiation is a prestigious one giving you reasonably good products

    • -he tutors will allocate the roles to be played by the different teams in

    this 'pening meeting Eust before the role play

    N!te

    • -his is a group e+ercise

    • Nominate a time keeper, -eam leader and #udit team members

    • -his roleplay e+ercise is part of the formal continuous assessment and

    will therefore be marked

    Ti$e %&&!tte"

    0reparation ) 2% minutes

    1ole 0lay ) &D minutes

    >eedback ) &D minutes

    Work ook ! Case "tudies #pril $%&% &6

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    Work ook ! Case "tudies #pril $%&% &'

    CS2 CS;

    ONSITE COMPLAINCE AU'IT

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    CS2 AN' CS; : ONSITE

    COMPLIANCE AU'IT

    INSTRUCTIONS FOR CS2 AN' CS;

    Objective

    -o conduct an 'nsite #udit of 3

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    G-i"e&i/e !# CS2 CS; P#ee/t%ti!/

    0lease present your responses in the following format on the 'H0

    0aragraph

    Number

    NC1!0NC1!

    "tatement

    Clause!

    "ubclause No

    Quality 8anual

    "ection ! 0rocedure

    No

    G-i"e&i/e !# CS; R!&e P&%.

    & -he preparatory work of the role play of the auditors G the role of the

    observers for all the incidents should make use of the following

    guidelines -hese guidelines would facilitate the conduct of an audit

    interview in a structured and systematic manner

    ⇒ =se a checklist effectively and follow audit trails

    ⇒ 3ain an understanding of the process, including its purpose,

    inputs, outputs, controls and related /uality obEectives

    ⇒ uild rapport with the auditee

    ⇒ Question

    ⇒ isten

    ⇒ 8ake notes

    ⇒ "earch documents

    ⇒ "elect sufficient and relevant samples

    ⇒ 0rovide feedback to the auditee

    $ When & group plays the role of the auditor, the other groups will

    provide feedback

    2 -he incidents that would be taken up for the role play would be

    communicated to the participants at an appropriate time before the

    presentation

    Work ook ! Case "tudies #pril $%&% &9

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    N!te

    • -hese are group e+ercises followed by individual work

    • Nominate a time keeper, presenter

    • #ll the groups to work on all the incidents

    • #llocation of incidents to groups for presentation will be

    informed before the presentation

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    Work ook ! Case "tudies #pril $%&% 51

    CS2

    ONSITE AU'IT IN

    MANUFACTURING AREAS

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    CS2 ) IMPLEMENTATION AU'IT

    IN A MANUFACTURING AREA

    &4 #fter reaching "rirampur Works, the #uditor met the Works 8anager in

    his office #fter brief introduction formalities with the Works 8anager

    and "hop Incharges of Heat -reatment and machine "hop, the #uditor

    en/uired about the Quality 0olicy and 'verall 'bEectives -he #uditor

    noted that the replies were in line with the company documents he

    had seen earlier

    -he #uditor asked the Works 8anager how the obEectives are

    established here, in line with overall obEectives -he Works 8anager

    replied that the obEectives are established at the "rirampur Works and

    he monitors these obEectives closely -he #uditor en/uired whether

    obEectives are also established for the "hops such as machine "hop

    and >oundry G Heat -reatment -he Works 8anager clarified that

    obEectives for individual shops are not established since he reports to

    the 38 on the overall performance of the Works He added further

    that the "hop Incharges of Heat -reatment and 8achine "hop onlyassist him in achieving these obEectives

    $4 In the Heat -reatment section, the #uditor noticed a pile of forgings on

    the floor =pon en/uiry, he learnt that these are a batch of forgings,

    which has completed that Heat -reatment cycle at &$%%P C for si+

    hours and was waiting to be moved over -he #uditor counts &( pieces

    and asks for records or instructions -he supervisor says that records

    are in his office

    In the office, the area is untidy and several process cards are lying

    around 'n the wall, the pockets for storage of process cards are

    /uite empty

    Work ook ! Case "tudies #pril $%&% 5"

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    #fter searching for /uite some time, the "upervisor showed a card and

    said, :here, this is it 0art no B*F$D&F and Eob no %B!D9(A -he

    #uditor sees the card and points out that there are $$ pieces in this

     Eob and two of them are to be test pieces

    -hey go back to the pile of forgings, and the "upervisor recounts

    them -hen he remarks that this might have been all they received for

    Heat -reatment He says he would ask someone in the section to look

    for the other pieces He was not sure whether the test pieces had

    been sent to the aboratory

    -he #uditor re/uested to have a look at the furnace He noticed thatthe furnace is loaded for the ne+t items but at the back, he noticed an

    item similar to the forgings -he "upervisor was /uite annoyed but

    asked one of the operators to take out the forging -he #uditor

    en/uired about the controls and interactions of the Heat -reatment

    process with the other sections -he "upervisor replied that he had

    the process sheet and work instructions in his office

    24 In the Heat -reatment office, the #uditor noticed some

    recording instruments and asked the "upervisor which one was for the

    furnace Eust seen -he "upervisor pointed to the no 2 recorder and

    said that out of B recorders, two are not functional and so he uses the

    two operating ones, as and when re/uired -he #uditor went through

    the record and observed that the temperature was held stable only for

    D hours as against the F hours re/uired #n operator was called in and

    he clarified that the time is counted by all operators from the start of 

    the curve and upto return of the curve on the recorder@s temperature K

    time graph

    -he #uditor asked the "upervisor whether that is the way -he

    "upervisor replied that he had no complaints so far from the hardness

    Work ook ! Case "tudies #pril $%&% 5#

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    machine operators -he #uditor asked the furnace hands whether they

    are trained for the Eob and whether they understand the importance of 

    the process -he furnace hands were blank and the "upervisor

    /uipped that they have been in the section for /uite a long time

    B4 -he #uditor got further interested and en/uired the "upervisor

    whether any analysis of previous results of the products or process has

    been made or any feedback has been given by other departments,

    particularly Q# -he "upervisor was /uite surprised and said that

    everyone in the shop are so busy with the production Eobs that they

    have no time for other work -he #uditor then en/uired whether any

    Internal Quality #udits have been carried out -he "upervisor said yesand showed copies of audit reports -he #uditor noticed that the

    reports were not available in se/uence and it was not possible to find

    out the dates of previous audits None of the available reports made a

    reference to the points which the #uditor was looking for

    D4 -he "upervisor contacted the 3eneral 8anager on phone and en/uired

    whether he was aware of any analysis done earlier -he 3eneral

    8anager was also not aware and asked what needs to be analysed and

    why he sounded /uite irritated4 He asked the "upervisor to note

    down what the #uditor is looking for so that he can arrange the same

    to be done /uickly by outside agency

    F4 -he #uditor asked the "upervisor whether the instruments are

    calibrated regularly -he "upervisor replied that an

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    are replaced by the

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    analysis thereon -he 38 said that monthly review meetings are held

    where the respective shop "upervisors present the details of 

    performance related to production and process problems, if any

    1egarding the monitoring of process and analysis, he confirmed he has

    received a message from the Heat -reatment and assembly shops

    when the areas were audited and that the 38 would organie a review

    in the near future -he ead #uditor e+plained that it is not for an

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    reviewed in the monthly production meetings It is e+pected that each

    department adheres to /uality re/uirements specified by 7irector

    Quality -he 38 was not clear on what the #uditors were looking for

    -he ead #uditor e+plained that /uality parameters, in other words,

    the specified values of the characteristics of the products need to be

    declared and achieved in the departments ased on these, obEectives

    and targets for achievements in relation to /uality are to be

    established and monitored -he 38 responded that some such activity

    was being carried out in the machine shop and the electronics

    assembly shop -he records were called for and upon e+amination the

    #uditors found that in both the shops the achievable targets were

    established -hese were being monitored also, but no at regularintervals -he #uditors made notes on the above finding

    &%4 -he ead #uditor asked the 38 as to how the * /uality management

    principles are incorporated in the system, specifically in relation to

    involvement of people, process approach and continual improvement

    -he 38 e+plained that people at all levels are aware of Customer

    specifications and the re/uirements of /uality products Hence the

    Company has succeeded in involving people to a considerable e+tent

    With respect to process approach, the 38 e+plained that the processes

    in each area of 8anufacturing are identified with their respective

    inputs and outputs When the ead #uditor asked about the interJ

    relationships and monitoring of processes, the 38 replied that there is

    no special effort re/uired since the problems are reviewed in the

    8onthly 0roduction meetings held in the 38@s office -he ead #uditor

    en/uired whether the other 7epartments such as "ales, 8aterials and

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    improvements have not been considered so far -he #uditors made

    e+tensive notes and said that they would continue the #udits in the

    other areas and then come back to 38, at a later time, if re/uired

    -hus saying, the two #uditors departed from 38@s office

    &&4 -he ead #uditor proceeded to the 0urchase 7epartment and the

    second #uditor proceeded to the assembly area -he #uditor was

    introduced to the #rea "upervisor and the "enior Inspector in the

    #ssembly #rea -he "upervisor welcomed the #uditor and informed

    him that he has limited time for an hour after which he would leave for

    an important meeting -he #uditor made note of the point and

    informed the supervisor that he would try to relieve the gentlemen, asearly as possible

    -he #uditor asked the "upervisor to e+plain the processes in the

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    Works 0rocess Cards W0C4 which were originated in the

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    the

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    &D4 'ne of the 3uides took one of the #uditors to the Calibration ab

    and introduced to him to the Incharge -he #uditor asked the abJ

    Incharge to e+plain the functions carried out by the ab -he abJ

    Incharge e+plained that the ab caters to the product testing for

    physical and chemical properties "ome of the testing work is given to

    a well known aboratory in the neighborhood -he abJIncharge also

    e+plained that the ab carried out calibration of instruments, gauges

    etc -he #uditor asked him whether the ab sends the -echnicians for

    on the work spot calibration also >or this the abJIncharge mentioned

    that at the work spot, calibration is attended to by the

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    reports from the outside aboratory -he abJIncharge promptly

    produced a file which had many certificates, nearly filed with

    separators, which had the identification of the instruments -he

    #uditor leafed through the file and picked up a report which had a

    number of temperature reading He noticed that there were deviations

    in the instrument reading with respect to the actual setting -he

    #uditor asked whether the accuracy of the instrument is acceptable

    -he abJIncharge replied that it is for the

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    has a variety of

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    Work ook ! Case "tudies #pril $%&% 6&

    CS;

    ONSITE AU'IT IN

    SER*ICE AREAS

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    CS;: IMPLEMENTATION AU'IT

    IN SER*ICE AREA

    &4 -he ead #uditor was taken to the 7irector K "ales #fter the brief 

    introduction and formalities, the 7irector "ales e+cused himself for a

    few minutes stating that he has an important and urgent message in

    the communication room, where hot lines have been established to

    proEect sites of the Customers In the mean time, tea and snacks

    were served to the ead #uditor #fter full $% minutes, the ead

    #uditor asked the 3uide whether he could arrange for the second

    person in the 7epartment to arrive with an organiation structure of 

    the 7epartment -he "ales 8anager for "tandards 0roducts soon

    responded and an+iously presented the 7epartmental 'rganiation

    Chart which also had the roles and responsibilities of different

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    $4 -he ead #uditor asked as to how the en/uiries and /uotations are

    handled -he "ales 8anager replied that the first task is to enter into

    a log book and complete the relevant details -he ead #uditor asked

    whether he could see the log book, the 8anager offered to lead into

    the "ales 'ffice where the other staff are working -he ead #uditor

    and the 8anager went to the adEoining 'ffice and the 8anager started

    to look around for the log book He went over to a desk where one of 

    the "ales engineer was working #fter a long time and after

    discussions, the 8anager brought the log book -he #uditor could see

    that many of the entries had Eust numbers and the 8anger was in the

    meantime e+plaining that the young

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    produced two more log books, one for /uotation and one for order

    -he #uditor could not identify any coJrelation between the three log

    books He reiterated that there is no follow up of information in a

    se/uence and that the process is not uniformly followed -he 8anager,

    who was /uite embarrassed, stated that he would look into the matter

    24 -he ead #uditor asked whether the inputs, outputs and interactions

    for the sales order processing have been identified -o this the

    7irector "ales replied :we all know our Customers re/uirements well

    and also any additional re/uirements such as the recent order JB&,

    wherein special types of process Instrumentation was called forA -he

    ead #uditor asked as to what was the action taken -he 8anagerreplied that clarification was sought from

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    case of product supply only, defects are informed to us and then

    rectified by our staff

    -he ead #uditor e+plained that the I"' (%%& "tandard re/uires the

    organiation to be proJactive, rather than passive It e+pects the

    organiation to look for Customer "atisfaction as well as

    dissatisfaction -he 7irector "ales replied that the company has done

    whatever possible towards customer "atisfaction He said for

    Corporate and bigger Customer there is a proper communication

    whereas for smaller Customers and for product supply contracts there

    is no definite way of obtaining feed back He said that many of such

    Customers appear to be /uite satisfied "till he said he will look intothe matter and do something

    D4 -he ead #uditor asked how the Customers re/uirements are reviewed

    before acceptance of the order -he 7irector "ales replied that all the

    "ales abrication

    "hop about the order and procurement is already arranged -here

    Work ook ! Case "tudies #pril $%&% 6

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    were no records of negotiation meetings and the

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    replied that there are "ection Heads who keep the detailed process

    diagrams for their respective areas of work, whereas the 7irector

    maintains overall process diagram for the department While

    responding to the interactions of processes, asked for by the #uditor,

    the 7irector stated that the process interactions within the department

    are identified in the overall process diagram -he #uditor then

    en/uired about interactions with the processes of other departments

    -o this, the 7irector replied that purchasing is an independent function

    and therefore no interactions need to be determined with the

    processes of other departments -he #uditor took notes of this -he

    #uditor asked as to how the processes in the 8aterials 7epartment are

    being monitored -he 7irector K 8aterials replied that this is carriedout by the individual "ection Heads and he sets targets for them -he

    #uditor then asked 7irector K 8aterials whether he has any plans for

    improvement -he 7irector stated that he increases the target by

    &% every year

    *4 -he ead #uditor proceeded to the 0urchase "ection and asked the

    8anager 0urchase as to how the "uppliers are selected -he 8anager

    0urchase said that the decision is with the 7irector 8aterials We

    maintain a list of suppliers but e+pressed that it is not always possible

    to adhere to this list -he ead #uditor asked whether the selection of 

    "uppliers has been identified as a part of purchasing process -o this,

    the 8anager replied that it is identified as a process and the inputs

    and outputs are clearly identified -he ead #uditor asked if there are

    any interactions identified with other 7epartments or processes -he

    8anager said that the selection of "uppliers is a prerogative of the

    0urchase 7epartment alone -he ead #uditor asked whether any

    controls and monitoring are identified -he 8anager replied that the

    7irector 8aterials decides on the supplier and hence he e+ercises

    control

    Work ook ! Case "tudies #pril $%&% '0

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    -he ead #uditor asked for the list of approved "uppliers and the list

    was promptly produced He noticed that the list was a running list of 

    addresses, with names of contact persons and telephone numbers

    -he ead #uditor asked as to what these "uppliers are approved to

    supply -he 8anager replied that the "uppliers are mostly

    components and raw materials "uppliers -he ead #uditor asked the

    8anager whether there is a fre/uent transport of material between the

    units of the company; and between the company and its Eob work sub

    contractors -he 8anager replied :yes we have lot of movement of 

    materials and we try to restrict the transport vehicles to a few

    identified transport contractors We take lot of care of our products

    and semi finished goods and we are very particular about the handlingand transportA -he ead #uditor asked whether such transporters and

     Eob work sub contractors are listed in the approved list -he 8anager

    said that may be one or two are listed, but you will have to search for

    it -he ead #uditor asked whether the 8anager knows as to how

    many times the orders are placed on non listed "uppliers -he

    8anager was not sure, but he said that maEority of orders are placed

    on the listed "uppliers

    (4 -he ead #uditor was going through some 0urchase 'rders and

    noticed that there was a section on certain electronic items which

    needed testing by the supplier before dispatch He asked the 8anager

    0urchase whether anybody from the Company visits this "upplier for

    seeing or witnessing the tests as there was a mention of testing prior

    to dispatch -o this, the 8anager replied that in some cases, an

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    serious discussions -he ead #uditor clarified that what he was

    looking for -he 7irector took out a neatly preserved folder which

    appeared to be very fresh and not opened He handed over the folder

    to the ead #uditor and remarked :-he 8anagement 1epresentative

    gave this to me last week and I am afraid I have not made really much

    of itA -he ead #uditor reJconfirmed that he was looking for some

    specific interaction concerning testing at "uppliers works, prior to

    dispatch When he looked through the process map, there was no

    interaction regarding inspection -he ead #uditor asked as to who

    decides on inspection at "uppliers works -he 7irector 8aterial said

    that it depends on the item or the sub assembly and may be the

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    supplier was entered in a new page and data of analysis was available

    with some remarks by the 7irector

    &&4 -he

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    mentioned that he had a 8echanical

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    see the draft notes prepared -he 7irector took out some sheets of 

    paper and showed it to the #uditor

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    established a /uality policy He also e+pressed that the operators were

    not aware of the importance of their activities with regard to the

    /uality of the products In this conte+t, the #uditor wanted to know as

    to how such information is communicated -he 7irector

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    be in this process, some areas have been over looked and he assured

    the #uditor that he would immediately arrange for e+haust fans -he

    #uditor asked whether any other factors are considered from the point

    of working -he 3eneral 8anager said Swhat else do you thinkOS

    $%4 -he #uditor asked the 3eneral 8anager whether the company has

    strategic decisions taken towards improvement -he 3eneral 8anager

    said, the company has been growing continuously by the grace of 3od

    #s you might have seen from the Quality 8anual and the company

    brochures, we have been growing in sie and e+panding into a new

    business -he #uditor wanted to know if any improvement in the

    systems and particularly /uality management system is beingperceived -he 3eneral 8anager said that Sas management, we are

    happy with the growth of the company and now we have implemented

    the systems as per I"' (%%& "tandardsS

    Work ook ! Case "tudies #pril $%&% ''

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    Work ook ! Case "tudies #pril $%&% '

    EXERCISE E0=

    NCR +RITING

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    E0= : NCR +RITING

    INSTRUCTIONS FOR E0=

    Objective

    Write and grade Non Conformance 1eports NC1s4

    Met!"

    0lease write and grade NC1s for the given incidences If you do not think that

    there is sufficient obEective evidence of nonconformity then you should state

    your reasons in the space below the report .ou should also state what the

    auditor should do ne+t

    F!#$%t

    0lease present your responses in the given format, on 'H0! flip chart

    N!te

    • -his is a group e+ercise

    • Nominate a time keeper, presenter

    • -he output of the e+ercise is part of the formal continuous

    assessment and will therefore be marked

    Ti$e %&&!tte" : BD minutes

    Work ook ! Case "tudies #pril $%&% '9

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    EXERCISES

    I/ci"e/t N-$be# 1

    7uring an audit of management review activities you notice from the minutesof management review meetings that the meetings are not attended by any

    of the top management team When you /uery this, the management

    representative tells you that management review has evolved into a two tier

    process, as it was proving so difficult to get all of the departmental and top

    managers available at the same time -he process is now that departmental

    managers meet and conduct the first level of management review -he

    management representative prepares a summary report including actions

    and recommendations -his is passed round each of the top management

    team for comment, and the 8anaging 7irector finally agrees the action plan

    I/ci"e/t N-$be# 2

    7uring an audit of internal audits you are shown internal audit reports from

    the last audit -hese include a non conformity report stating that 2 people in

    the purchasing department had not been trained in the use of the approved

    supplier list -he corrective action taken was to train the 2 members of staff-he audit report has been closed -he management representative tells you

    that no further investigation was made as the corrective action was obvious

    -he internal auditor had checked the training records of the staff concerned

    before closing the reports

    I/ci"e/t N-$be# ;

    In the 0urchasing 7epartment the auditor asks how the new subcontractor

    for -85 &%& items was selected -he purchasing clerk e+plains was placed

    with a subcontractor which they had never used before, only because the

    price /uoted was e+tremely low -he clerk states that no other evaluation

    was conducted

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    Q8" #=7I- Incident Number??????

    NON CONFORMIT( REPORT

    Company under #udit) 3

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    Work ook ! Case "tudies #pril $%&% "

    EXERCISE E0>

    AU'IT SUMMAR( REPORT

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    E0>: AU'IT SUMMAR( REPORT

    INSTRUCTIONS FOR E0>

    Objective

    -o prepare an accurate, meaningful, #udit "ummary 1eport

    Met!"

    • Now that the audit at 3

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    Work ook ! Case "tudies #pril $%&% &

    AU'IT SUMMAR( REPORT

    Ete#/%& A-"it ! Re4!#t N!:

    O/ be%& ! 5

    A-"it '%te 55

    A-"it Te%$ 55

       

     

    Sc!4e

    Objective

    A-"it C#ite#i% 15

    25

    ;5

    SUMMAR( STATEMENT ) E/c&!e"

    Rec!$$e/"%ti!/ C!/c&-i!/

    E/c&!-#e

    15 S-$$%#. St%te$e/t

    25;5 

    Si/e" b.: Le%" A-"it!# '%te

    N!te

    & -his audit is based on limited samples and other nonJconformancesmay e+ist

    $ -his report and its contents should be treated as confidential

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    Work ook ! Case "tudies #pril $%&% 5

    EXERCISE E0?

    ROLE PLA( ON CLOSINGMEETING

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    E0? : ROLE PLA( ON CLOSING MEETING

    INSTRUCTIONS FOR E0?

    Objective

    -o conduct a Closing 8eeting in line with what has been covered in the course

    notes

    Met!"

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    do not necessarily know them well

    • -he team leader to chair the meeting and be responsible for controlling

    and running the meeting to plan

    • #s this is a second party audit there is no certificate at stake #lso the

    organiation is a prestigious one giving you reasonably good products

    • -he tutors will allocate the roles to be played by the different teams in

    this closing meeting Eust before the role play

    N!te

    • -his is a group e+ercise

    • Nominate a time keeper, -eam leader and #udit team members

    • -his roleplay e+ercise is part of the formal continuous assessment and will

    therefore be marked

    Ti$e %&&!tte"

    0reparation ) 2% minutes

    1ole 0lay ) 2% minutes

    >eedback ) 2% minutes

    Work ook ! Case "tudies #pril $%&% '

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    Work ook ! Case "tudies #pril $%&%

    EXERCISE E08

    E*ALUATING PROPOSALSFOR EFFECTI*ENESS OF

    CORRECTI*E ACTION

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    E08 : E*ALUATING PROPOSALS FOR

    EFFECTI*ENESS OF CORRECTI*E ACTION

    INSTRUCTIONS FOR E08

    Objective

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    Ti$e %&&!tte" : 2% minutes

    PROPOSALS FOR CORRECTI*E ACTION B E08

    I/ci"e/t 2

    NC) -he internal audit resulted in correction, but there is no evidence that

    the cause of the non conformity was determined, or that action was taken to

    prevent its recurrence # review of the actions taken failed to identify that

    action had not been taken to prevent recurrence of the problem *D$4

    P#!4!e" %cti!/

    a4 Internal auditors will be trained to distinguish between correction and

    corrective action

    b4 NC1 format is modified -he internal auditors need to put their

    comments on the effectiveness of the corrective action taken before

    closing the NC1s

    I/ci"e/t ;

    NC) # subcontractor of -85&%& item was selected on the basis of price and

    no further evaluation Ff the supplier was made 9B&4

    P#!4!e" c!##ective %cti!/

    7irector 8aterials along with 7irector Quality shall review the re/uirements

    with -85&%& items "uppliers, those participated in the bid shall be

    evaluated with the identified re/uirements -he selection of the supplier shall

    take place based on the ability to supply -85 &%& items as per re/uirements

    Work ook ! Case "tudies #pril $%&% 90

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    Work ook ! Case "tudies #pril $%&% 91

    SPECIMEN EXAMINATION

    PAPER 

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    INTERNATIONAL REGISTER 

    OF CERTIFICATE' AU'ITORS

    ,MS AU'ITOR EXAMINATION PAPER ,MS = ) SPECIMEN PAPER

    FOR USE ON THE

    ISO 9000:2008 SERIES AU'ITORLEA' AU'ITOR TRAINING COURSE

    IRCA 22

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    I/!#$%ti!/ !# c%/"i"%te

    -his e+amination paper is in four sections 0lease attempt all sections

    -he time allowed is two hours -here is no additional time allowed for reading the /uestionpaper -here are a ma+imum of *% marks available; the pass mark is 9% DF marks4 andyou must also achieve at least B% in each of the four sections

    .our answers must be written on the sheets that are supplied #dditional loose sheets will notbe accepted

    -he phrase SI"' (%%&S and :standardA always refer to I"' (%%&)$%%*-he word SclauseS refers to a paragraph or section of I"' (%%& that is identified by anumber such as DB& or a number and letter such as 9&b

    -his e+amination is open book

    Secti!/ 1 i !#t 10 $%#J

    Comprises /uestions which re/uire you either to place a circle around the letter a, b, c, d or e4to indicate which you Eudge to be the best answer .ou must only give one answer for each/uestion If it is not clear which option you have selected, you will be awarded ero marks

    Secti!/ 2 i !#t 20 $%#J

    Comprises /uestions that re/uire a brief written answer in the space provided

    Secti!/ ; i !#t 20 $%#J

    Comprises /uestions that re/uire a detailed written answer that will normally fill the spaceprovided

    Secti!/ < i !#t ;0 $%#J

    Comprises a number of audit situations for which a nonconformity report NC14 may bere/uired

     

    E%$i/%ti!/ !# A-"it!# ! ,-%&it. M%/%e$e/t S.te$

    I1C#!&BF Q8" D!%*!&, November $%%*I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T

    0age $ of &$

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    Secti!/ 1 !#t 10 $%#J

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    &F 7ata supporting the e+istence or verity of something is called)

    a obEective evidenceb a deficiencyc a nonconformity report

    d all of the abovee none of the above

    &%9 What information is being sought during a third party audit of a /uality systemO

    a a list of nonJconformities to I"' (%%&b obEective evidence of conformity with I"' (%%&c a management commitment to /uality assuranced all of the abovee none of the above

    &%* -o act as an auditor of a /uality system a person has to

    a be registered as a certificated auditorb have a detailed knowledge of the product or service of the organiation to be auditedc have been a /uality systems managerd all of the abovee none of the above

    &%( -he process approach to a /uality management system seeks to help organiations)

    a manage numerous linked activitiesb understand and fulfil re/uirements c continually improve processesd all of the above

    e none of the above

    &&% -he e+tent of documentation of the /uality system should be determined by)

    a the comple+ity of processes and their interactionsb the e+pectations of auditeesc the culture of the /uality departmentd all of the abovee none of the above

    Work ook ! Case "tudies #pril $%&% 95I1C#!&BF Q8" D!%*!&, November $%%*I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T

    0age B of &$

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    Secti!/ 2 !#t 20 $%#J

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    $2 I"' (%%% identifies a :process approachA as one of the * /uality principles thatsupport the achievement of /uality obEectives

    a

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    Work ook ! Case "tudies #pril $%&% 9

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    Secti!/ ; $%i$-$20 $%#J

    2& .ou are planning a process audit of an organiation that consists of the followingdepartments)

    B sales and marketingB purchasing

    B warehouseB packing and despatchB support services

    -he top management team consists of the 8anaging 7irector and departmentalmanagers from each of the above areas

    a4 What would be your two main considerations in deciding the se/uence of

    activities for the auditO B marks4

    b4 How would you approach the audit of continual improvement in this

    organiationO F marks4

     

    E%$i/%ti!/ !# A-"it!# ! ,-%&it. M%/%e$e/t S.te$

    I1C#!&BF Q8" D!%*!&, November $%%*I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T

    0age 9 of &$

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    2%$ .ou are conducting an audit of a medium sied organiation 7uring thedocument review you have raised a concern about the organisation@s system forensuring the competence staff

    0repare a checklist that would guide you through a process audit of competence of staff and state the relevant I"' (%%& clauses &% marks4

    Work ook ! Case "tudies #pril $%&% 100

    E%$i/%ti!/ !# A-"it!# ! ,-%&it. M%/%e$e/t S.te$

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    Work ook ! Case "tudies #pril $%&% 101

    I1C#!&BF Q8" D!%*!&, November $%%*I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T

    0age * of &$

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    Secti!/ < !#t ;0 $%#J

    -hree incidents that occur during a third party audit of a supplier are described below -heycontain situations for which nonconformity reports may be re/uired

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    I/ci"e/t N-$be# 1

    '-#i/ %/ %-"it ! $%/%e$e/t #evie 4#!ce6 te %-"it!# /!tice #!$ te

    #ec!#" ! te $%/%e$e/t #evie $eeti/ t%t te $eeti/ %#e /!t%tte/"e" b. %/. ! te t!4 $%/%e$e/t te%$5 +e/ te %-"it!# 3-e#ie ti6

    te $%/%e$e/t #e4#ee/t%tive e4&%i/ t%t $%/%e$e/t #evie % ev!&ve"i/t! % t! tie# 4#!ce6 % it % 4#!vi/ ! "iic-&t !# %&& ! te "e4%#t$e/t%&%/" t!4 $%/%e# t! be %v%i&%b&e %t te %$e ti$e5 Te 4#!ce i /! t%t"e4%#t$e/t%& $%/%e# $eet %/" c!/"-ct te i#t tie# ! $%/%e$e/t #evie5Te $%/%e$e/t #e4#ee/t%tive 4#e4%#e % -$$%#. #e4!#t i/c&-"i/ %cti!/%/" #ec!$$e/"%ti!/5 Ti i 4%e" #!-/" e%c ! te t!4 $%/%e$e/t te%$!# c!$$e/t6 %/" te M%/%i/ 'i#ect!# i/%&&. %#ee te %cti!/ 4&%/5

    If you think there is evidence of a nonconformity, complete this report)

    IRCA ,MS AU'IT ) NONCONFORMIT( REPORT

    Company under #udit) 5.6 plc Nonconformity Number)

    #rea under review) I"' (%%& Clause Number)

    Category 8#M'1T 8IN'1T T delete one

    Nonconformity)

    #uditor)

    'r, if you "! /!t think that there is sufficient evidence of nonconformity, state the reasonsfor your decision and state also what further actions the auditor should take

    E%$i/%ti!/ !# A-"it!# ! ,-%&it. M%/%e$e/t S.te$

    I1C#!&BF Q8" D!%*!&, November $%%*I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T

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    I/ci"e/t /-$be# 2

    '-#i/ %/ %-"it ! i/te#/%& %-"it te %-"it!# i !/ i/te#/%& %-"it #e4!#t #!$te &%t %-"it5 Tee i/c&-"e % /!/c!/!#$it. #e4!#t t%ti/ t%t ; 4e!4&e i/ te

    4-#c%i/ "e4%#t$e/t %" /!t bee/ t#%i/e" i/ te -e ! te %44#!ve" -44&ie# &it5Te c!##ective %cti!/ t%Je/ % t! t#%i/ te ; $e$be# ! t%5 Te %-"it #e4!#t %

    bee/ c&!e"5 Te $%/%e$e/t #e4#ee/t%tive te&& .!- t%t /! -#te# i/veti%ti!/% $%"e % te c!##ective %cti!/ % !bvi!-5 Te i/te#/%& %-"it!# %" cecJe"te t#%i/i/ #ec!#" ! te t% c!/ce#/e" be!#e c&!i/ te #e4!#t5

    If you think there is evidence of a nonconformity, complete this report)

    IRCA ,MS AU'IT ) NONCONFORMIT( REPORT

    Company under #udit) 5.6 plc Nonconformity Number)

    #rea under review) I"' (%%& Clause Number)

    Category 8#M'1T 8IN'1T T delete one

    Nonconformity)

    #uditor)

    'r, if you "! /!t think that there is sufficient evidence of nonconformity, state the reasons foryour decision and state also what further actions the auditor should take

    I/ci"e/t N-$be# ;

     I1C#!&BF Q8" D!%*!&, November $%%*

    I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T0age && of &$

    I1C#!&BF Q8" D!%*!&, November $%%*I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T

    0age && of &$

    E%$i/%ti!/ !# A-"it!# ! ,-%&it. M%/%e$e/t S.te$

    E%$i/%ti!/ !# A-"it!# ! ,-%&it. M%/%e$e/t S.te$

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    I/ te P-#c%i/ 'e4%#t$e/t te %-"it!# %J ! te /e -44&ie# !# TMX101ite$ % e&ecte"5 Te 4-#c%i/ c&e#J e4&%i/ t%t te #e-&%# -44&ie# c!-&"

    /!t $eet te "e&ive#. "%te %/" te !#"e# % 4&%ce" it % -44&ie# t%t te. %"/eve# -e" be!#e6 !/&. bec%-e te 4#ice 3-!te" % et#e$e&. &!5 Te c&e#J

    t%te t%t /! !te# ev%&-%ti!/ % c%##ie" !-t5

    If you think there is evidence of a nonconformity, complete this report)

    IRCA ,MS AU'IT ) NONCONFORMIT( REPORT

    Company under #udit) 5.6 plc Nonconformity Number)

    #rea under review) I"' (%%& Clause Number)

    Category 8#M'1T 8IN'1T T delete one

    Nonconformity)

    #uditor)

    'r, if you "! /!t think that there is sufficient evidence of nonconformity, state the reasons foryour decision and state also what further actions the auditor should take

    E/" ! e%$i/%ti!/

    Work ook ! Case "tudies #pril $%&% 105

    I1C#!&BF Q8" D!%*!&, November $%%*I1C# e+amination paper Q8" D "pecimen 0aper, amended for use on certified course Axx operated by T

    0age &$ of &$

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    Work ook ! Case "tudies #pril $%&% 91

    GUI'ELINES ON LO'GING

    COMPLAINTS

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     ADD TO WORKBOOK / CASE STUDIES + Q MANUAL

    1eference Ti!le

    WI!*& G-i"e&i/e O/ H! T! M%Je C!$4&%i/t

    Issue No 1evision No Issue 7ate #pproved y 0age

    $ 2 %&J&%J%F& of $

    150 P-#4!e

    && -he purpose of this guideline is to inform delegates on the appeal procedure

    250 Sc!4e

    $& -his work instruction covers all the complaints relating to administration,conduct and management of certificated courses

    ;50 Re4!/ibi&it.

    2& 7elegates are responsible for raising complaints 8anagement of CII isresponsible for resolving them I1C# ! N10- has an adEudicating note inthis Vappeal@ procedure

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     ADD TO WORKBOOK / CASE STUDIES + Q MANUAL

    1eference Ti!le

    WI!*& G-i"e&i/e O/ H! T! M%Je C!$4&%i/t

    Issue No 1evision No Issue 7ate #pproved y 0age

    $ 2 %&J&%J%F& of $

    B2 In case complainant is not satisfied with CII@s actions, , they have the rightto appeal to I1C# and!or N#a+ ) BB'4 $% 9$BD F*BBa+ ) (& && $229 (F$&eJmail ) nrbptX/cinorg

    D% Rec!#"

    1ecord of complaints file

    >50 Ree#e/ce

    F& >orms

    >orms &9 ) 1ecord of Complaints

     

    mailto:[email protected]:[email protected]:[email protected]:[email protected]

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    Work ook ! Case "tudies #pril $%&% 9&

    Re"erence #uali!$ %anual & Section 2 'rocedure & CII/QMP/81

    'ELEGATE FEE'ACD FORM

     Work ook ! Case "tudies   9&

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    Work ook ! Case "tudies #pril $%&% 95

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    F!#$ Tit&e : 'ELEGATE FEE'ACD FORM

    IRCA C#ite#i% N-$be# : IRCA22orm F!'ct $%

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    ii4 -he purpose, content andinterrelationship of I"' (%%%, I"'(%%&, I"' (%%B and I"' &(%&&

    iii4 Interpreting re/uirements of I"'

    (%%& in the conte+t of an audit

    iv4 -he roles and responsibilities of auditors and lead auditors

    v4 0lan and conduct and audit inaccordance with I"' &(%&&

    vi4 1eporting the audit, includingwriting valid, factual and valueJadding nonJconformity reports

    vii4 =ndertaking audit followJupactivities, including evaluating theeffectiveness of corrective action

    B

    B

    B

    B

    B

    B

    2

    2

    2

    2

    2

    2

    $

    $

    $

    $

    $

    $

    &

    &

    &

    &

    &

    &

    25 AIMS F-&&.

    %tiie"

    F%i#&. e&&

    %tiie"

    N!t ve#.

    e&&

    %tiie"

    N!t %

    %ti

    a4 How well did the course meet itsaims, as you understood themO

    b4 How well were your specific needsmetO

    B

    B

    2

    2

    $

    $

    &

    &

    PARAMETERS Ece&&e/t G!!"

    Re&ev%/t

    F%i# P!!#

    ;5 COURSE 'ESIGN  

    'ELI*ER(

    How satisfied were you with the

    a4 isual aidsb4 Course notesc4 Case studies G e+ercisesd4 "yndicate Work G 1ole playe4 Course "tructure

    BBBBB

    22222

    $$$$$

    &&&&&

    Work ook ! Case "tudies #pril $%&% 9'

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    orm F!'ct $%%F!%&

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      9 T9 re"ers !o !he Tu!or suppor!ing !he 8ead Tu!or   : 1here onl$ one Tu!or is conduc!ing use column "or T3

    Work ook ! Case "tudies #pril $%&% 99

      $ of B>orm F!'ct $%%F!%&

      2 of 2>orm F!'ct $%%F!

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    Work ook ! Case "tudies #pril $%&% 100

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