Workbook Updated To 2008 Ver

LEAD AUDITOR / AUDITOR COURSE
FOR QUALITY MANAGEMENT

SYSTEM
ISO 9001 : 2008
WORKBOOK / CASE STUDIES
Institute of Quality
Confederation of Indian Industry
IRCA Registration No. : A17392

NABET Registration No. : LQ81 102
CONFEDERATION OF INDIAN INDUSTRY
Institute of Quality
Near Bharat Nagara, II Phase, Magadi Main Road
Vishwaneedam Post, Bangalore – 560091
Tel: 080-23289390 – 91, Fax: 080-23289388
WORKBOOK / CASE STUDIES
No part of this publication may be reproduced, stored in retrieval system or

transmitted 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
CONTENTS
Work Book / Case Studies April 2010 3

EXERCISE E01
INTERPRETING THE
ISO 9001: 2008 CLAUSES

E01: INTERPRETNG THE
ISO 9001: 2008 CLAUSES
INSTRUCTIONS FOR E01
Objective:
Interpreting the ISO 9001: 2008 Clauses, in the context of an Audit.
Method
The following are 12 mutually independent incidents, describing the findings of

the auditors. Identify and relate those incidents that are within the scope of ISO
9001:2008 and mention the appropriate clause and/or sub clause of ISO 9001:
2008. You may relate these to one or more requirements of the Standard.
Format
Please present your responses in the following format .
Sl.No. Whether covered Clause / Sub Clause of ISO 9001: Reasons

in Scope of ISO 2008
9001:2008
Note
 This is a group exercise followed by individual work.

 Nominate a time keeper, presenter.
 All the groups to work on all the incidents.
 Allocation of incidents to groups for presentation will be informed before
the presentation.
 The output of the exercise is part of the formal continuous assessment
and will therefore be marked.
Time allotted: Individual work 30 minutes.

Group work 30 minutes.

EXERCISE E01
1) XYZ Co. has its design center at Singapore and a manufacturing plant at
New Delhi. All products specifications originate at Singapore and the
manufacturing plant only manufacturers, as per the design specifications.
The manufacturing plant has decided to apply for Certification for a QMS,
which excludes Clause 7.3.
2) The MR of a Company says “all our current procedures have been

repeated, replacing the word ‘PROCEDURE FOR………’ to ‘PROCESS
FOR……….; we have not done any other changes, in the documentation”.
3) An Emission from XYZ Company was found to have a pollutant that may
cause adverse impact on health of the employees in the long run.
4) Tiger Toys Ltd., designs and produces toys and play equipment, as per
product codes and regulations. The regulations do not require the QMS to
include design, for the safety class of the products of the Company.
Based on this, Tiger Toys also decides to exclude clause 7.3 from its
QMS.
5) ABC Projects Ltd., designs, develops and produces heavy equipment, but
does not have in house design facility. The design activities are sub
contracted to XYZ Co. Ltd., which is an engineering consultancy
Company. During the audit, the Project Manager says, “we leave the
complete Design Process to them”.
6) Purchasing process does not address the assistance given to suppliers

towards their development.
7) During the audit of a Paint Shop of an auto part, it was found that the
doors and windows of the shop were all left open.

8) A Company providing leasing services of earthmoving equipment to civil
contractors and builders has its Business Operations Divisions at its
headquarters and six repair workshop around the country. The repair
shops provide the service of equipment maintenance to the
headquarters, and have no interactions with the Company’s customers.
One of the workshops is pursing certification to ISO 9001:2008 even
before the parent Company. The workshop management has excluded
the clauses 7.2, 7.3, 7.4 and 7.5.4 from their QMS.
9) Sources of information on customer satisfaction only include customer

complaints and Questionnaire & Surveys but do not include focus groups
reports in various media, sector & industry studies.
10) The Training Manager of a Company says that increasing profits of the
Company amply demonstrates the effectiveness of their training plans
and programmes.
11) Laxmi Bank is implementing ISO 9001: 2008 for the realization of its
various services. The Bank has excluded 7.5.3 & 7.5.4 from its QMS.
12) Corrective Action Procedure of the company does not include results of
Self Assessment.

CASE STUDY – CS1
DOCUMENTATION REVIEW
OF A QUALITY MANUAL

CS1: DOCUMENTATION REVIEW OF
A QUALITY MANUAL
INSTRUCTIONS FOR CS1
Objective
Documentation Review of GECL’s Quality Management System Documentation.
Method
Perform a documentation review or stage one audit of the Quality Manual and
Sample Process Documentation of Materials Department of GECL in order to
assess whether documentation meets ISO 9001: 2008 requirements and to
determine whether adequate arrangements are in place to justify proceeding
with the implementation (onsite) audit.
Format
Please present your responses in the following format on transparency sheet
also identify which of these you would check during the onsite audit.
Clause / Nonconformance Immediate Add to Remarks
Sub-clause clarification Checklist
number required
Yes No Yes No Yes No
Note
 This is a group exercise followed by individual work

 All the groups to work on all the incidents
 Allocation of incidents to groups for presentation will be informed before
the presentation
 The output of the exercised is part of the formal continuous assessment
and will therefore be marked.
Time allotted : Individual Work 90 minutes.

Group Work 30 minutes.

Quality Management System Manual
Goodwill Equipment Company Ltd.,

54-56, Yallers Compound,
New Achievers Road,
Gopal Ram Nager
GEC-QMS-M 1
Copy No.: 10
Issue Date: 22/03/2009
Issued by: MR
Revision No. 2
CASE STUDY – DO NOT MARK ON SCRIPT

INTRODUCTION
Goodwill Equipment Company Limited was founded in 1955 and since 1990
has been owned and managed by the present Managing Director.
GEC Ltd., was a traditional Mechanical Fabrication company, and has

gradually expanded its scope of activity over the years. The Company was
initially supplying to larger firms in the state and in those days the basic
products were fabricated parts and pressure vessels. The Company later
expanded adding a Foundry, Machine shop and Assembly shop.
With the expansion of the Company and with the technical skills available
with the Engineering and Quality Assurance, electrical and electronic
assemblies were also added to the Assemble shop. The Company started its
operation initially from Srirampur Works and later moved into the present
facility at Gopal Ram Nagar. The Srirampur Works has the Foundry, Machine
shop and Heat Treatment facilities. The final assembly of both mechanical
parts and electronic items is carries out at Gopal Ram Nagar Works from
where the management team functions.
Since the two facilities are separated by a distance of about 25 kilometers,

considerable movement of semi finished material takes place between the
two sites. At present, the total employees strength of the Company is above
550 and the product base is changing and expanding, demanding modern
facilities in manufacturing and resources. The Company is therefore putting
its best efforts to change from inspection oriented approach to quality
management system approach, in line with ISO 9000 Family of standards,
with the help of Best Consultants Pvt Ltd.

Our success is based upon a number of factors, not least of which, is our
expertise & willingness to pursue new areas of businesses. We are
particularly fortunate in being able to draw upon a skilled labour force.
Our sub-contractors provide us with specialist expertise in activities such as

non-destructive testing and heat treatment. They complete a team, which
can offer a wide range of services to our customers.
Since 1990, when the present Managing Director took over, the company has
grown to its present strength of 575 employees.

QUALITY POLICY
This manual is for guidance for company quality management system.
All personnel will be guided by the contents of this quality management

system manual & no deviation from the methods described shall be
permitted.
The quality controller is responsible for carrying out the directives in this
manual. He shall have the organizational freedom to identify quality
problems and procedure solutions.
In matters affecting quality, he may not be overturned by any other Director

or Manager with the exception of Managing Director or Manager with the
exception of Managing Director, and then only with client and design
justification approval.
The Quality Policy of the Company states
“We honour Customer requirements and spare no efforts to satisfy

customers by providing quality products on time, at least possible
cost.
GECL Management is committed to continuously improve in their

endeavour to become world class company”

Section AA Issue 1 Rev 1 March 2009 Page 1 of 20
CONTENTS
Title Section No ISO Cl. no
Introduction
Quality Policy
Contents AA -
Record of Revision BB -
Quality Manual Operation CC -
Quality Management System 4.0 4
Management Responsibility 5.0 5
Resource Management 6.0 6
Product Realization 7.0 7
Measurement, Analysis 8.0 8
Improvement
Annexure 1
QMP Diagram –
Internal Audit Process 9.0 8
Annexure 2
Objectives & Process

Measures for Materials Dept. 10.0 7

Section BB Issue 1 Rev 1 March 2009 Page 2 of 20
RECORD OF REVISION
Rev No Date Section Revised Details of Revision
1 March 25, 2009 Original Issue -
2 May 22, 2009 5 Responsibility and

Authority
“ 7 “Production Process
Revised”
“ 8 Details of CAG
added

Section CC Issue 1 Rev 1 March 2009 Page 3 of 20
QUALITY MANUAL OPERATION
This manual is prepared by the MR & approved by Director Quality.
The holder of the controlled copy shall not make further copies of the
manual. If additional copies are required, a requisition is to be sent to MR.
When the holder of controlled copy of the manual ceases to be an authorized
copy holder, all the copies in his possession are to be returned to MR with
due acknowledgement.
The MR will review this Manual periodically with the Departmental Heads to
affirm its adequacy. Changes to the Manual are made by the Departmental
Heads who revise the Manual. All the changes / amendments cancel and
replace any previous copy of the Manual. Authorized copyholders shall
maintain updated copy of the Manual. Departmental Heads maintain the
amended version for reference and use.
Uncontrolled copies of this Manual (with no copy number) may be issued but
these are not subject to updating procedure. Such copies are for information
only. These copies may be identified as ‘Uncontrolled Copy’ on the contents
page of the Manual.
The MR will retain copies of all previous issues / amendments of the Manual.

Section 4.0 Issue 1 Rev 1 March 2009 Page 4 of 20
QUALITY MANAGEMENT SYSTEM
GENERAL
The quality management system of the company is based on the ISO 9000-
2005 and it demonstrates the company’s ability to consistently meet the
customer requirements. It aims to enhance customer satisfaction through
implementation of the system including process for continual improvement.
4.1 General Requirement
The company has established, documented, implemented & maintained a

quality management system and aims to continually improve its effectiveness
in accordance with ISO 9000-2005 standard. The company has:
a) Identified the processes for QMA
b) Determined the interaction & sequences of the process
c) Ensured the effective operation & control of these processes
d) Ensured the availability of resources and information necessary to
support the operation and monitoring of these processes.
e) Established methods to monitor, measure and analyse these
processes.
f) Implemented actions necessary to achieve planned results & continual
improvement of these processes
The processes and their interactions are described in the Departmental

Manuals.

4.2 Documentation
The QMS maintained by the company is documented in the following

documents.
Level – 1 QMS Manual: This addresses the requirements stated in the
ISO9001-2008 Standards as applicable services provided by the
company.
Level – 2 Quality system procedures.

a) As required by the standard and the company
b) As required for smooth functioning of its processes
These procedures describe the activities carried out by different
departments to comply with requirements.
Level – 3 Work Instructions:

These are specific & complete instructions required for execution
of specific tasks
4.3 Control of documents
It is ensured that the documents required by the QMS are controlled and are
available at relevant points of use. Adequate controls are:
a) To approve the document for adequacy

b) To review and update the documents as necessary
c) To ensure that relevant versions of applicable documents are available
at points of use
d) To ensure that documents remain legible and readily identifiable

4.4 Control of records
A documented procedure is established to ensure that the records are

controlled. Records are established to provide evidence of conformity and the
effective operation of the QMS. Records are legible, readily identified and
retrievable. The procedures for control of records (GEC/QSP/01) describe the
identification and retrieval of records. The retention time of records is stated
in the list of records maintained by individual departments.

5.0 MANAGEMENT RESPONSIBILITY
A) The management of the company is committed to the development,

implementation and continual improvement of the QMS and has
a) Communicated the importance of meeting customer requirements and

statutory requirements within the organization.
b) Established the quality policy
c) Conducted periodic management review
d) Ensured the availability of resources.
B) Quality Policy
The quality policy followed by te company is stated in this manual. It is
ensured that the quality policy is communicated and understood within the
organization. The policy is communicated through the available channels of
in-company communication and displays. The understanding of quality policy
is verified during Internal Audits, Operation Reviews and shops floor
briefings. Management Reviews consider the adequacy of the policy for its
continuing suitability.
C) Quality Management System Planning

The QMS is planned to meet requirements of the standard ISO 9001-2008. It
is ensured that the integrity of the QMS is maintained when any changes are
planned and implemented.

D) Responsibility and Authority

The responsibility and authorities are known from the structure of the
organization chart as shown below. The individual departmental structure
and their responsibilities are described in the departmental manuals.
Engineering Director
Machine Shop
Company Secretary
Assembly
General Manager
Heat Treatment
Managing Director (Includes Foundry)
Director Sales
Director Quality QA - Final
Director Materials QA – In Process
Director Finance Calibration Lab
The functional responsibilities are:-

Managing Director, Mr. Fernandez: he is responsible for coordinating all
business and manufacturing activities of the company.
Engineering Director, Mr. Parthasarathy: He reports directly to the M.D and is

responsible for overall engineering design and development. He has the
authority to initiate and implement design changes at any time of
manufacture. He is also responsible for preparation and development of
standard designs and design modifications to meet customer’s requirement.
Company Secretary, Mr. Ashok Mitra: He is responsible for all legal matters
in relation to the company’s. legal and statutory matters & concerning Board
of Directors. He is also responsible for auditing of administrative functions
including documents.

General Manager Mr. Sachdeva: He is overall in charge of all matters relating

to product, process and systems. He directly reports to MD. It is his
responsibility for proper utilization of men, materials & 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 MD in
all the decisions and directives.
Director Sales, Mr. Kapur: He is responsible for obtaining orders for supply of
products as also to quote, negotiate and finalise technical and commercial
terms of contract, to carry out review of quotations, contract and
amendments to orders. He should also ensure timely delivery orders.
Director Quality, Mr. Banerjee: He is responsible for all matters relating to

manufacturing standards. He has the responsibility for preparing, maintaining
and revising the quality manual in order to reflect changes in manufacturing
methods, Receipt & 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.
Director Materials, Mr. Jasbir Singh: 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.
Director Finance, Mr. Patel: He is responsible for all matters related to

finance, accounting, wages, costing etc. He supports the MD in all his
functions concerning financial matters and any other special task assigned by
the MD.

The in-charge, Machine Shop, Mr. Nair: Assembly, Mr. Deshpande: Heat
Treatment, Mr. Reddy have supporting functions in their respective areas to
the General Manager.
The Director Quality is supported by Mr. Jabbar Ahmed in Final inspection;

Mr. Parab in In-process and Mr. Jagannath in Laboratory. The Laboratory in-
charge is designated as the Management Representative (MR)
E) Management Review
The Management Representative of the company carries out review of QMS
once in every quarter. This review is conducted to ensure continuing,
suitability, adequacy and effectiveness of the QMS. Opportunities for
improvement and need for changes are also identified during these meetings.
The meetings are attended by representatives from departments.
After the review, the management representative prepares the minutes and
copies are distributed to the department heads. The MR keeps track of
implementation and the follow up activities. Records of management review
are maintained by all concerned.
Review inputs: - The following issues are considered to form the inputs.
a) Results of internal & external quality audits.
b) Customer feedback & complaints
c) Corrective & preventive actions
d) Follow up actions from previous review.
e) Performance evaluation of suppliers & subcontractors
f) Resources & Training needs (annual)
g) Changes & Recommendations for improvements in QMS
Review output: - The management review outputs are documented in the
form of minutes & issued to the Departmental Heads.

Section 5.0 Issue 1 Rev 1 March 2009 Page 10a of 20
ANNEXURE TO SECTION 5.0
COMPANY LEVEL QUALITY OBJECTIVES
The Quality Policy of the Company has been translated into the following
Company level Quality Objectives:
1) Improvement in customer satisfaction index

2) Reduction in number of customer complaints / repeat complaints
3) Improvement in delivery schedule adherence
4) Reduction in rejects and reworks
5) Cost reduction / value improvements

6.0 RESOURCE MANAGEMENT
The Management of the Company has determined & provides resources

needed
a) To implement, maintain and continually improve the QMS.
b) To enhance customer satisfaction
Human Resources
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 experience.
Competence, Awareness and Training

The company has the following activities to ensure competence, awareness
and Training
a) Determination of competence levels for different positions.
b) Provision of Training to ensure that competence levels are achieved.
These activities are coordinated through the Company Secretary.
Infrastructure
The company is equipped with facilities such as well designed and well
furnished rooms, dining area, transportation etc which are maintained in
good condition at all times.
The company is also equipped with facilities & equipment to provide

amenities such as central air conditioning to the offices, stand by power and
communication, through a team of experienced & competent personnel.
Head of Engineering is responsible for identifying and providing the resource

requirements.

7.0 PRODUCT REALISATION
A) Planning for Product Realisation

The company plans and develops processes, which are consistent with the
other processes of the QMS. In planning for product realization, the quality
objectives and customer requirements are considered. Monthly and weekly
product plans are prepared and issued by Director Materials. These plans are
based on the availability and procurement of materials.
B) Customer related processes

The company makes efforts to determine the specified and implied needs of
the customer which are necessary for customer satisfaction. The statutory
and regulatory requirements related to the products are compiled by the
company. The Sales office has the responsibility of identifying needs of the
customer. The concerned department heads are responsible for the
compliance of the statutory & regulatory requirements applicable to the
products.
The customers of the company can be corporate bodies or distribution

agents. The requirements for the product are clearly specified and agreed
upon. This is based upon the company brochure and existing/ agreed
specifications. In all cases the requirements are reviewed, to ensure that the
requirements are clearly defined, and the company has the ability to meet
the specified requirements. If any differences exist in the specified
requirements and the proposal, these are resolved at the time of preparation
of contract. The record of review is maintained by Sales office.
The company has implemented effective arrangements for communicating

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

enquires, contracts or direct orders and customer feedback including

customer complaints.
C) Design & Development

The products provided by the company are standardized and as such there is
no requirement of designing the products. The Engineering Director
sometimes makes changes to the specifications and has authority to develop
new products. We have not included the design and development in the QMS.
D) Purchasing
The company ensures that purchased product and services conform to
specification requirements. This is carried out through the Materials
department.
The suppliers, sub-contractors are selected on the basis of their past

performance and the rapport / relationship with the management. Purchasing
orders are communicated to supplier and subcontractors wherein the
requirements for the products and services are clearly defined. The products
are varied upon receipt and the services are accessed during the process.
This is made known to the suppliers & sub contractors well in advance.
Normally, purchase orders are issued based on requirements indicated by
users through indents. The Director Materials decides on when and on whom
the purchase orders are released. The purchase orders are reviewed by the
Director Materials.
The company has established inspections and other activities to ensure that
the purchased product meets the specified requirement. The Quality
department carries out these inspections and related activities, which are
product specific, whereas the user departments perform these, are non
product related purchases. These inspections and checks are mentioned in

their respective procedure. Neither the company nor its customers perform
verification at the supplier premises.
E) Production process
1) The company plans and carries out production operation under
controlled conditions. The applicable controlled conditions include:
a) The availability of information at appropriate places. This includes
foundry, heat treatment section, assembly, machine shop etc.
b) Availability of work instructions whenever necessary. Work instructions
are available for all product related activities.
c) The use of suitable equipment in production areas.
d) Use of monitoring and measuring devices in areas related to product
preparation and engineering services.
The above controls are exercised by the respective department heads.
2) Validation of process
There are no processes in the company where the resulting output cannot be
verified. Hence the clause on validation of processes is not applicable.
3) Identification and Traceability

It is ensured that all products and services are identified through out the
process. The products are identified by appropriate label at the time of
manufacturing. The services are identified at different stages such as
customer contact, sales, purchasing, after sales etc. These are related to
different departmental activities. Each department has its own procedures
and work instructions wherein the services and products get identified.
The status of product monitoring / measurement is indicated wherever

appropriate such as receipt, heat – treated items, assembly in progress,
engineering job completion, etc.

4) Customer property
The company exercises utmost care with the customer’s property when the
customer provides any product or information for incorporation into the
products supplied. Utmost care is taken to ensure that the customer does not
lose or suffer damage to his belongings. The overall responsibility rests with
the Manager Personnel & Administration who ensures the security of
customer belongings through a well – organized security force.
5) Preservation of product
The products provided by the company are handled, packed, stored and
preserved as appropriate. Electronic items and small sized products are
packed properly, whereas bigger items are not packed. It is the customer
responsibility for such products.
6) Control of monitoring & measuring devices

The monitoring and measurement devices are provided where appropriate
such as engineering services, machine shop, calibration laboratory etc. The
measuring equipments are:-
a) Calibrated at specified intervals against measurement standards

traceable to National standards.
b) Safeguarded from adjustments
c) Protected from damage and deterioration during handling &
maintenance
The engineering department maintains a list of measuring and monitoring

devices identified for calibration. The calibrations are carried as per
procedures in that department.

8.0 MESUREMENT, ANALYSIS & IMPROVEMENT
A) The company has planned and implemented measurement, analysis and

improvement processes needed to:-
a) Demonstrate conformity of the product
b) Ensure conformity of QMS and
c) Continually improve the effectiveness of the QMS
B) Customer Satisfaction
The management of the company lays a great stress on importance on
satisfying customer needs. This includes customer complaints and evaluation
of customer complaints redressals.
C) Internal Audit
Internal audits are carried out at planned intervals to determine the
effectiveness of the QMS and to verify whether the QMS meets the planned
arrangements, which are in line with the ISO 9001-2008. The management
representative has overall responsibility for organizing internal audit and the
reporting on the findings to the management team. The internal audits are
generally carried out on a quarterly basis to ensure that all activities are
audited in each cycle.
Selected executives of the company are trained to carry out audits and the
selections of auditors for specific audits are made such that the auditors do
not audit their own work. Efforts are made to obtain objectivity & impartiality
of the audit process. The management representative follows a documented
procedure (GEC / QSP / 02) for implementing internal audits.

D) Monitoring & Measurement of process

The respective department heads monitor the processes under their control
on a day-to-day basis. When the results are below the planned level,
immediate corrections are taken.
E) Monitoring & Measurement of products

For the products provided by the company, there is an elaborate system of
inspection and tests. At all relevant stages of manufacture and additionally,
where specified by the customer, the products are inspected or tested as per
quality plans. Final tests are recorded and the records are maintained by the
respective quality department. Intermediate test records may or may not be
available as many of these tests/inspections are carried out by the
production personnel.
F) Control of nonconforming products

The company takes care to ensure that nonconformities in the products are
reduced or eliminated. It is realized by the company, that the
nonconformities in the products are very much related to human interaction.
Hence it is difficult to identify a non-conformance at the time of occurrence.
The management of the company has however therefore formulated a
“Corrective Action Group” (CAG). The membership of the CAG is decided by
the Engg. Director and is on a rational basis. The role of the CAG is to
monitor the process independently and determine the non conformances, if
any. Product nonconformances, if any, are identified by the QA department
during final testing and informed to the concerned department for
rectification through a defect note. A documented procedure (GEC/QSP/03)
is established for control of non-conforming products and services.

G) Analysis of data
The individual departmental heads collect appropriate data on issues
described earlier for example customer complaints, process and product
conformance, nonconformance, internal audits etc.
This data is analyzed in the respective sections to verify and confirm the
suitability of the QMS and to evaluate areas for continual improvement of the
QMS.
H) Continual improvement
The company strives to continually improve the effectiveness of the QMS
primarily during the management review meetings and other means such as
achievement of quality objectives, audit results, analysis of data, corrective &
preventive actions.
I) Corrective action
The CAG identifies the nonconformities during the processing of product and
delivery. Other opportunities such as internal quality audit, monitoring of
service process etc. are used to identify areas for improvement.
A documented procedure (GEC/QSP/04) is established to determine the

corrective actions to eliminate causes of nonconformities by:-
a) Reviewing non conformities

b) Determining causes of nonconformities
c) Evaluating the action to prevent the recurrence of nonconformities
d) Determining & implementing corrective actions
e) Record the results of actions taken and reviewing the action taken

J) Preventive action
The documented procedure (GEC/QSP/04) covers the action taken to
eliminate causes of potential non-conformities or potential problems.
The procedure includes the requirements for:-

a) Determining potential non conformities & their probable causes
b) Evaluating the action needed to prevent non-conformities.


ANNEXURE – 2
GOODWILL EQUIPMENT COMPANY LIMITED
MATERIALS DEPARTMENT
OBJECTIVES
PROCESS MEASURERS
GEC-MAT-P3
Copy No. : 05
Issue Date : 22/03/2009
Issued By : MR
Revision No. : 0

OBJECTIVES FOR MATERIALS DEPARTMENT
1) Reduction in Lead Time for Procurement
2) Reduction of Rejections of Incoming Materials due to Improper

Communication of Specifications to Suppliers
3) Improvement in Delivery Adherence by Suppliers
4) Reduction in Lead Time of Payment to Suppliers
5) Reduction in Inventory Turns Over time at Receipt Stores
6) Increase in Suppliers with “Direct On Line” Status
7) Cost Reduction / Value Improvement by Key Suppliers

PROCESS AND PRODUCT MEASURES
(LINKED TO OBEJCTIVES)
Sl.No. Process/Product Measure Relation to Objective
01. Reduction of Time from Receipt of 1

indent/purchase Request to issue of PO
02. Reduction of Production Lead Time of Key 1,3,7

Suppliers
03. Reduction of Changeover/Setup Time in 1,3,7

Production Area of Key Suppliers
04. Reduction of Specification Mismatch 2

between indent / Request and Purchasing
Data found during Audit
05. Reduction of “Store Receipt / Inspection 1,4,5

Clearance” Time
06. Improvement in Straight Pass Ratio (OK 2,6

Material / Received material) of Key
Suppliers
07. Monitoring of Item Wise days of 1,5

Inventory (based on Item wise closing
stock and shop consumption pattern)
08. Monitoring of Lead Time of Procurement, 1,3

Supplier wise
09. Reduction of Time of Preparing, Payment 4

Instruction after Material is ok
10. Reduction in Repeat Nature of Rejection 2,6

at Receipt Stage

EXERCISE E02
PREPARATION OF AN
ONSITE AUDIT PLAN

E 02 : PREPARATION OF AN
ONSITE AUDIT PLAN
Objective
Prepare an On-Site Audit Plan after completing the Documentation Review of
GEC Ltd.
Method
Refer to Session 3 f) of your Course Notes for preparing an on-site audit plan
covering points on Audit’s scope, linkage between Policy, Objectives, Targets
monitoring and continual improvements. The plan should consider the core
and support business processes and their interaction reflect the organizations
goals, priorities and all other relevant points. Tutors should clearly steer the
participants away from functional thinking.
Format
Please present your responses in any preferred format and submit your
presentation on paper to the tutors.
Note
 This is a group exercise
 Nominate a time keeper
 The output of the exercise is part of the formal continuous
assessment and will therefore be marked by tutors and feed back
would be given to the participants.
Time allotted: 45 minutes

EXERCISE E03
CHECKLIST FOR AUDITING

A QMS PROCESS

E03 : CHECKLIST FOR AUDITING
A QMS PROCESS
Objective
Prepare two checklists for
1. auditing a Quality Management System Process
2. verifying compliance with the requirements of a clause of ISO9001:
2008
Method
 Read the text of the exercises enclosed.
 Please refer to section 8 of your course notes and prepare
separate checklist for both the exercises
 For exercise No. 1 consider the PDCA principle in terms of
inputs, outputs, result, process measures, linkages with quality
objectives & continual improvement.
Format
Please present you response in any format preferred by you and submit the
same to the tutors.
Note
and will therefore be marked by tutors and feedback would be given to
the participants
Time allotted: 45 minutes

EXERCISES
1. You are conducting an audit of a medium sized manufacturing company.

The document review has raised a concern about how the organization
ensures the competence of staff.
Prepare a checklist that would guide you through a process audit of this
area and state the relevant ISO 9001 clauses.
2. What objective evidence could be available in order to verify compliance

with requirements of Clause 7.2.3 of ISO 9001? In your presentation,
make links to other ISO 9001 clauses as necessary.

EXERCISE E04
OPENING MEETING

E04 : ROLE PLAY ON OPENING MEETING
Objective
To conduct an Opening Meeting in line with what has been covered in the
course notes.
Method
Each team should nominate a team leader who will conduct the role of a Lead
Auditor in the Opening Meeting. This will be a role play and we request all
participants to prepare for it as close as possible to the real life situation.
Individually teams may be assigned the role of an auditor, auditee or an

observer; however preparation is common for all.
Each team should spend about one hour to do the following activities:
 Each team should plan the opening meeting including agenda points in
line with session 9 and the case study.
 The team leader prepares introductory and closing remarks
 The team agrees upon the presentations to be made by each member
and the team leader (roles and responsibilities must be clear including
handling questions).
 Ensure the meeting is complete in 15 minutes.
 No visual aids will be allowed.
 Adhere to a single nomenclature (either NCRs /CARs/ Discrepancies
etc).
 Be brief, clear and crisp.
 The team leader to chair the meeting and be responsible for controlling
and running the meeting to plan.
 As this is a second party audit there is no certificate at stake. Also the
organization is a prestigious one giving you reasonably good products.

 The tutors will allocate the roles to be played by the different teams in
this Opening meeting just before the role play.
Note
 Nominate a time keeper, Team leader and Audit team members.
 This roleplay exercise is part of the formal continuous assessment and
will therefore be marked.
Time allotted
Preparation : 30 minutes
Role Play : 15 minutes
Feedback : 15 minutes

CS2 & CS3
ONSITE (COMPLAINCE) AUDIT

CS2 AND CS3 : ONSITE
(COMPLIANCE) AUDIT
INSTRUCTIONS FOR CS2 AND CS3
Objective
To conduct an Onsite Audit of GEC Limited in a Manufacturing and Service
environment.
Methodology
Case studies CS2 and CS3 are used to highlight a typical description of an
audit teams progress during the compliance audit of GEC Limited. CS2
relates to manufacturing areas while CS3 relates to Service areas. The audit
has been carried out against ISO9001:2008 and the company’s own QMS by
a prestigious customer. Whatever happened in the audit has been recorded
in the different paragraphs which are numbered serially.
The syndicate groups will discuss these paragraphs within their respective
teams, and raise Non Conformance, only when objective evidence of non
compliance either against GEC’s own QMS or against ISO9001:2008 is found.
Some findings would furnish strong clues to objective evidence and could be
proved as NCRs only after further probing. The syndicate groups are
expected to identify such situations and term these findings as Potential Non-
Conformances (PNCR) and write down what further probing may be required
to infer that they are NCRs.

Guidelines for CS2 & CS3 (Presentation)
Please present your responses in the following format on the OHP.
Paragraph NCR/PNCR/ Clause/ Quality Manual
Number Statement Subclause No. Section / Procedure
No.
Guidelines for CS3 (Role Play)

1. The preparatory work of the role play of the auditors & the role of the
observers for all the incidents should make use of the following
guidelines. These guidelines would facilitate the conduct of an audit
interview in a structured and systematic manner
 Use a checklist effectively and follow audit trails
 Gain an understanding of the process, including its purpose,
inputs, outputs, controls and related quality objectives
 Build rapport with the auditee
 Question
 Listen
 Make notes
 Search documents
 Select sufficient and relevant samples
 Provide feedback to the auditee
2. When 1 group plays the role of the auditor, the other groups will
provide feedback.
3. The incidents that would be taken up for the role play would be
communicated to the participants at an appropriate time before the
presentation.
Note

 These are group exercises followed by individual work
 Nominate a time keeper, presenter
 All the groups to work on all the incidents
 Allocation of incidents to groups for presentation will be
informed before the presentation
 Each group presentation would comprise at least one role play
(for CS3 only)
assessment and will therefore be marked.
Time allotted:
CS2 : Individual Work 120 minutes
Group work 45 minutes
CS3 : Individual Work 120 minutes
Group Work for Presentation 45
Group Work for Role Play 30 Minutes

CS2
ONSITE AUDIT IN
MANUFACTURING AREAS

CS2 – IMPLEMENTATION AUDIT
IN A MANUFACTURING AREA
1) After reaching Srirampur Works, the Auditor met the Works Manager
in his office. After brief introduction formalities with the Works
Manager and Shop Incharges of Heat Treatment and machine Shop,
the Auditor enquired about the Quality Policy and Overall Objectives.
The Auditor noted that the replies were in line with the company
documents he had seen earlier.
The Auditor asked the Works Manager how the objectives are
established here, in line with overall objectives. The Works Manager
replied that the objectives are established at the Srirampur Works and
he monitors these objectives closely. The Auditor enquired whether
objectives are also established for the Shops such as machine Shop
and Foundry & Heat Treatment. The Works Manager clarified that
objectives for individual shops are not established since he reports to
the GM on the overall performance of the Works. He added further
that the Shop Incharges of Heat Treatment and Machine Shop only
assist him in achieving these objectives.
2) In the Heat Treatment section, the Auditor noticed a pile of forgings on

the floor. Upon enquiry, he learnt that these are a batch of forgings,
which has completed that Heat Treatment cycle at 1200° C for six
hours and was waiting to be moved over. The Auditor counts 19
pieces and asks for records or instructions. The supervisor says that
records are in his office.
In the office, the area is untidy and several process cards are lying
around. On the wall, the pockets for storage of process cards are
quite empty.

After searching for quite some time, the Supervisor showed a card and
said, “here, this is it. Part no. 4862516 and job no 04/579”. The
Auditor sees the card and points out that there are 22 pieces in this
job and two of them are to be test pieces.
They go back to the pile of forgings, and the Supervisor recounts

them. Then he remarks that this might have been all they received for
Heat Treatment. 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 Laboratory.
The Auditor requested to have a look at the furnace. He noticed that

the furnace is loaded for the next items but at the back, he noticed an
item similar to the forgings. The Supervisor was quite annoyed but
asked one of the operators to take out the forging. The Auditor
enquired about the controls and interactions of the Heat Treatment
process with the other sections. The Supervisor replied that he had
the process sheet and work instructions in his office.
3) In the Heat Treatment office, the Auditor noticed some

recording instruments and asked the Supervisor which one was for the
furnace just seen. The Supervisor pointed to the no. 3 recorder and
said that out of 4 recorders, two are not functional and so he uses the
two operating ones, as and when required. The Auditor went through
the record and observed that the temperature was held stable only for
5 hours as against the 6 hours required. An 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 –
time graph.
The Auditor asked the Supervisor whether that is the way. The
Supervisor replied that he had no complaints so far from the hardness

machine operators. The Auditor asked the furnace hands whether
they are trained for the job and whether they understand the
importance of the process. The furnace hands were blank and the
Supervisor quipped that they have been in the section for quite a long
time.
4) The Auditor got further interested and enquired the Supervisor

whether any analysis of previous results of the products or process has
been made or any feedback has been given by other departments,
particularly QA. The Supervisor was quite surprised and said that
everyone in the shop are so busy with the production jobs that they
have no time for other work. The Auditor then enquired whether any
Internal Quality Audits have been carried out. The Supervisor said yes
and showed copies of audit reports. The Auditor noticed that the
reports were not available in sequence 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 Auditor was looking for.
5) The Supervisor contacted the General Manager on phone and enquired

whether he was aware of any analysis done earlier. The General
Manager was also not aware and asked what needs to be analysed and
why (he sounded quite irritated). He asked the Supervisor to note
down what the Auditor is looking for so that he can arrange the same
to be done quickly by outside agency.
6) The Auditor asked the Supervisor whether the instruments are

calibrated regularly. The Supervisor replied that an Engineer from the
Engineering Department comes every six months and attends to the
instruments. He was not sure what the Engineer does and generally
he is not around when the instrument is checked. He only calls in the
Engineer when the recorder stops working. The Auditor enquired
whether any furnace survey or any work has been done on the

furnaces. The Supervisor replied that every year the thermocouples
are replaced by the Engineering Department and also when any of
them is not working. Otherwise, for the last 5 years since the
Supervisor was posted in the Heat Treatment shop, there has been no
major work except that two furnaces had to be partially lined two
years back. The Auditor asked for process validation record, to which
the Supervisor replied that the only record he has is the thermocouple
replacement record, which he showed to the Auditor. The Auditor then
thanked the Supervisor and said he had made enough notes on the
Heat Treatment shop and he has to discuss with the Lead Auditor. The
Auditor then left the Heat Treatment shop.
7) After the audit team had a brief meeting where-in the Lead Auditor got
feedback from Audits of Heat Treatment and assembly shops, the Lead
Auditor and one Auditor proceeded to meet the General Manager.
They were greeted by the General Manager who explained the brief
history and background of the Company. He offered to show a video
film on some of the project installations where the Company’s products
were installed. The Lead Auditor asked how long that would take and
upon being informed that it is a little more than 20 minutes, the Lead
Auditor politely declined the offer and said he would prefer to go ahead
with the audit.
The Lead Auditor asked the General Manager to explain the

documentation of the Quality Management System (QMS) of the
Company. To this the General Manager (GM) replied that the Director
Quality and his Deputy, the M.R. have the documents of the QMS. The
GM has only the process documents related to Manufacturing. The
Lead Auditor made a note of this. He then asked for the process
documents. The GM took out a file from a shelf and handed over the
same to the Lead Auditor. After a quick glance through the file the
Lead Auditor handed over the file to the second Auditor to see. The

Lead Auditor asked the GM about the monitoring of processes and
analysis thereon. The GM said that monthly review meetings are held
where the respective shop Supervisors present the details of
performance related to production and process problems, if any.
Regarding the monitoring of process and analysis, he confirmed he has
received a message from the Heat Treatment and assembly shops
when the areas were audited and that the GM would organize a review
in the near future. The Lead Auditor explained that it is not for an
External Body to carryout a one time activity, but it should be an
ongoing activity within the organization. To this the GM had no
answer. He said he would discuss with the other members of the Top
Management and would respond to the Lead Auditor in course of time.
The Lead Auditor and the second Auditor made extensive notes.
8) The Lead Auditor asked how the responsibilities and authorities are
established and made known to the concerned staff. The GM
explained that organization charts have been made and displayed in
each Manufacturing Area Office and individuals have been issued
documents/letters informing them of their responsibilities and
authorities.
Regarding Customer requirements and Statutory / Regulatory

requirements related to the products, the GM explained that these are
included in the production orders issued to the shops from the Sales
Department. Asked whether he had any role in this regard, the GM
shrugged his shoulders and stated that he has almost no role to play
except to oversee that the requirements are met. The Lead Auditor
and second Auditor made notes of these points.
9) The second Auditor prompted the Lead Auditor on the quality

objectives. The Lead Auditor then asked the GM whether quality
objectives have been established in the Manufacturing departments.

The GM explained that production targets are fixed for each area and
reviewed in the monthly production meetings. It is expected that each
department adheres to quality requirements specified by Director
Quality. The GM was not clear on what the Auditors were looking for.
The Lead Auditor explained that quality parameters, in other words,
the specified values of the characteristics of the products need to be
declared and achieved in the departments. Based on these, objectives
and targets for achievements in relation to quality are to be
established and monitored. The GM responded that some such activity
was being carried out in the machine shop and the electronics
assembly shop. The records were called for and upon examination the
Auditors found that in both the shops the achievable targets were
established. These were being monitored also, but no at regular
intervals. The Auditors made notes on the above finding.
10) The Lead Auditor asked the GM as to how the 8 quality management
principles are incorporated in the system, specifically in relation to
involvement of people, process approach and continual improvement.
The GM explained that people at all levels are aware of Customer
specifications and the requirements of quality products. Hence the
Company has succeeded in involving people to a considerable extent.
With respect to process approach, the GM explained that the processes
in each area of Manufacturing are identified with their respective
inputs and outputs. When the Lead Auditor asked about the inter-
relationships and monitoring of processes, the GM replied that there is
no special effort required since the problems are reviewed in the
Monthly Production meetings held in the GM’s office. The Lead Auditor
enquired whether the other Departments such as Sales, Materials and
Engineering also attend these meetings. The GM replied that each
Director conducts his own review meetings at his convenience. When
asked about continual improvement, the GM responded that there are
not many improvements in the recent past. In fact, he stated that it is

quite difficult to maintain the present level of operations. Hence,
improvements have not been considered so far. The Auditors made
extensive notes and said that they would continue the Audits in the
other areas and then come back to GM, at a later time, if required.
Thus saying, the two Auditors departed from GM’s office.
11) The Lead Auditor proceeded to the Purchase Department and the
second Auditor proceeded to the assembly area. The Auditor was
introduced to the Area Supervisor and the Senior Inspector in the
Assembly Area. The Supervisor welcomed the Auditor and informed
him that he has limited time for an hour after which he would leave for
an important meeting. The Auditor made note of the point and
informed the supervisor that he would try to relieve the gentlemen, as
early as possible.
The Auditor asked the Supervisor to explain the processes in the

Electronics Shop. The Supervisor produced a file which identified the
Assembly Processes in the Electronics Area and the identified inputs
and outputs. The Auditor asked whether the process measurable and
process controls had been identified elsewhere. The supervisor was
confused and could not explain these issues. The inspector said that
the Inspection Department controls the process by inspections at
various stages. The Auditor said he would reframe his question and
asked if any objectives have been fixed on the quality parameters. To
this the supervisor looked at the Inspector and the inspector’s said he
has some details in his office. The three persons then proceeded to the
Inspectors Office where he was able to show some objectives on the
performance parameters of the electronic components and assemblies.
The Auditor asked further whether these objectives were being
monitored or measured. The inspector said we have our own methods
of evaluating, but no records are kept.

12) The Auditor asked as to how the job instructions are received by the
assembly section. The Supervisor illustrated by showing copies of
Works Process Cards (WPC) which were originated in the Engineering
Department. These WPCs gave basic technical information on the
jobs. The Auditor noticed that the WPCs made reference to drawings,
process sheets and test procedures as well as parts list. The Planning
Department raised Job Cards based on WPCs and issued them to the
assembly Supervisor with the total instruction package. Work
instructions were supported by the Manufacturing drawings which also
gave reference to some Standards and Parts. In the event of conflicts
in the detailed information available in different documents, the WPCs
took precedence. The Auditor asked for a copy of the Process Map
document of the Department, which was promptly produced. The
Auditor noted that this control was not indicated in the process
document.
13) In the Assembly Shop the Auditor went to an Electrician who was
working on an assembly job. The Job Card was on the Operators
bench together with a drawing. The Auditor asked Electrician if he had
the WPC, to which the operator replied that he gets only the Job
Cards. At this point the Auditor asked the Supervisor whether the
Works Process Cards can be fetched. Upon examination, the Auditor
noted that the Drawing available had revision “C” and that there was
no reference to the revision on the WPC nor in the Job Card, only the
Drawing Number was quoted. The Supervisor said that as a policy
they all followed the latest drawing issue as correct drawings. He
further stated that revision “C” has been issued, this would be the
correct one for use. However, he had not confirmed with the
Engineering Department or with the Quality Department on this point.
The Auditor noted the details of the Drawing in his work book.

The Auditor asked from the Electrician whether he had the online test
procedures. The Electrician replied that it was not a practice to have
the test procedures at the point of use. The work has been set up and
the Electrician operated under the supervision of the supervisor. A
copy of the test procedure was called for and the Auditor noted that it
had revision “B” of an earlier date with respect to the date of drawing.
At this point, the Auditor drew the attention to the revision “C” of the
drawing which called for a change in the test methods. The Auditor
asked which would be correct, to which the inspector replied that the
drawing is correct since it is dated later than the test procedure. The
Auditor made notes of the above.
14) The Auditor asked the Electrician as to how many assemblies were
covered in the Job Card. The Electrician replied that his team is
working on five similar assemblies covered by the same Job Card. The
Auditor enquired whether the assemblies were all available in the Shop
Floor area. The Electrician informed that two of the units have been
moved to the Final Test Bay. The Auditor looked through the Job Card
and asked why there is no mention of the two units moved to the final
test bay. The Electrician replied that all of them knew where the units
are and more over, some times we need to take out some of the
components for assembly checks on the work in progress. This is
because all the parts listed in the parts list for all five units may not be
available at the same time. The Auditor asked as to who keeps track of
these movements to which Electrician showed a piece of paper
inserted in between two components which had some scanty notings.
The Auditor then asked how the units and Sub Assemblies are
identified. The Electrician replied that after final testing the
components and Sub Assemblies are Labeled with aluminum tags. The
Auditor asked how the components are identified during assembly. To
this the Electrician replied “we all know what is what”. The Auditor

looked surprised and made notes. After exchange of few courtesies
the Auditor left the Assembly Area.
15) One of the Guides took one of the Auditors to the Calibration Lab
and introduced to him to the Incharge. The Auditor asked the Lab-
Incharge to explain the functions carried out by the Lab. The Lab-
Incharge explained that the Lab caters to the product testing for
physical and chemical properties. Some of the testing work is given to
a well known Laboratory in the neighborhood. The Lab-Incharge also
explained that the Lab carried out calibration of instruments, gauges
etc. The Auditor asked him whether the Lab sends the Technicians for
on the work spot calibration also. For this the Lab-Incharge mentioned
that at the work spot, calibration is attended to by the Engineering
section. The Auditor asked whether this leads to confusion and
duplication. The Lab-Incharge replied yes, it leads to duplication and
sometimes, some items are left uncalibrated. We are trying to
improve the system but some how neither the Engineering Director
nor Director Quality seem to agree on a common approach”. The Lab-
Incharge explained that under the prevailing circumstances, both the
Laboratory and Engineering Department are doing their best.
16) The Auditor asked whether the Lab Incharge maintains a list of
instruments which need calibration from the Lab. To this the Lab-
Incharge answered that the gauges and instruments are frequently
moved from one section to another, thereby it becomes difficult for
him to maintain an inventory list so that he can call for instrument.
The Auditor asked who ensures that calibration is done as per
schedule. The Lab-Incharge replied that calibration stickers are
provided on the equipment and the Supervisors of the various shops
have to keep track of the instruments/gauges with them. He further
explained that this is quite convenient since the Supervisors and the
GM often send the items for calibration to outside Laboratory also.

17) The Auditor looked a little disappointed with the arrangement and
made notes. He further asked whether he could see some of the
reports from the outside Laboratory. The Lab-Incharge promptly
produced a file which had many certificates, nearly filed with
separators, which had the identification of the instruments. The
Auditor 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. The
Auditor asked whether the accuracy of the instrument is acceptable.
The Lab-Incharge replied that it is for the External Labs to indicate
whether the accuracy is acceptable. The Auditor further noticed that
there was no remark from the External Laboratory in this regard. The
Auditor made notes and continued to look through the file.
18) The Auditor picked up another Test Report from another External
lab which referred to an electronic instrument. He asked the Lab
Incharge whether the External Lab indicates their instruments against
which the Company’s instrument was checked. The Lab-Incharge
looked for a long time through the report and finally showed the
Auditor an instrument number at the end of the second page. The
Auditor asked whether the Lab-Incharge would know if that instrument
belonging to the External Lab is calibrated. The lab Incharge replied
that this External lab is an approved Lab by the GM and he assumed
that their instruments would be certainly calibrated. The Auditor
explained that he was looking for traceability of calibration to National
or International Standards. Since the certificate makes no mention of
the calibration of the instrument owned by the External lab, he is
unable to conclude on traceability. The Lab-Incharge responded that
one of his relative works there and he knows that this Lab has foreign
collaboration also. The Auditor made notes and proceeded with the
audit.

19) The Auditor asked the Lab-Incharge as to how many such External
Laboratories are engaged by the Company. To this the Lab-Incharge
replied that there are quite a few Laboratories and since the Company
has a variety of Equipments for monitoring and measurement, it is not
possible to restrict to one or two External Laboratories. The Auditor
asked as to who would have the list of Laboratories and whether there
was any approval procedure. The Lab-Incharge replied that the GM
and the Engineering Director both have Director of Calibration
Laboratories and they select the Laboratory from the Directory.
Auditor asked whether a copy of Directory is available in the
Calibration Lab, since all the certificates are filed in the Calibration
Lab. The Lab-Incharge said that he does not have the Directory and it
was decided recently that an additional copy for the Lab would not be
required, firstly, since it is expensive and secondly, the GM goes
through all the calibration reports before passing on to the Lab-
Incharge for filing.
20) The Auditor asked whether the Lab-Incharge has carried out any
survey of the measurement uncertainty of the available
instrumentation or any analysis of the performance of the instruments
during its validity of calibration. To this the Lab-Incharge looked
puzzled and wondered in what way it would help if such an exercise
was carried out. The Auditor said that he would refer to the MR who
might have read and understood the ISO 9001 and ISO 9004
standards. To this the Lab-Incharge replied that he himself is the MR.
The Auditor politely smiled and said he would come back to audit the
MR function in the afternoon. The Auditors then proceeded from the
Calibration lab.

CS3
ONSITE AUDIT IN
SERVICE AREAS

CS3: IMPLEMENTATION AUDIT
IN SERVICE AREA
1) The Lead Auditor was taken to the Director – Sales. After the brief
introduction and formalities, the Director Sales excused 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
project sites of the Customers. In the mean time, tea and snacks
were served to the Lead Auditor. After full 20 minutes, the Lead
Auditor asked the Guide whether he could arrange for the second
person in the Department to arrive with an organization structure of
the Department. The Sales Manager for Standards Products soon
responded and anxiously presented the Departmental Organization
Chart which also had the roles and responsibilities of different
Executives. The Organization Chart showed Sales Offices at two
metros. The Auditor asked what role these Offices had in the Sales
function. The Manager (Standards Products) explained that these
Offices are mainly liaison Offices for Customer contacts and sometimes
for follow up of imported items. The Lead Auditor asked as to how the
Officers in these Metro Offices interact with Customers. The Manger
explained that these Offices are provided with product Catalogues and
information on new development and new supplies. The Lead Auditor
asked whether the Manager is aware of what Catalogues and
information is available at these Offices. The Manager said that there
is no formal method of updating the Catalogues or information
available with them. The Lead Auditor asked whether the Manager is
aware of the latest Catalogues and information issued to them. The
Manager replied that he was not aware and may be the Director is
aware, but no records are available.

2) The Lead Auditor asked as to how the enquiries and quotations are
handled. The Sales Manager replied that the first task is to enter into
a log book and complete the relevant details. The Lead Auditor asked
whether he could see the log book, the Manager offered to lead into
the Sales Office where the other staff are working. The Lead Auditor
and the Manager went to the adjoining Office and the Manager started
to look around for the log book. He went over to a desk where one of
the Sales engineer was working. After a long time and after
discussions, the Manager brought the log book. The Auditor could see
that many of the entries had just numbers and the Manger was in the
meantime explaining that the young Engineer had a problem with the
enquiry he was handling. The Lead Auditor asked why many of the
entries were missing and how would the Manager know as to who was
handling a particular enquiry. The Manager said it is not difficult and
he would shout across the hall to find out who has that particular file.
The Lead Auditor asked whether all the Sales Engineers work on a
similar methodology and whether enquiry handling is identified as a
process. The Director Sales had just joined in and wanted to know
what the issue was. The Lead Auditor again expressed his question to
which the Director Sales replied that the process starts with receipt of
enquiry and ends with issue of Job work Order to Engineering
Department who in turn issue the work Process Card to the Planning
Section. The Lead Auditor asked to see a particular enquiry bearing
number P448. The Manager went around the Office and after some
time came back to say that the particular enquiry and its
corresponding quotation were not in the file. The director Sales
immediately remembered that he had taken some enquiries and
quotations to his home since he had to meet the Customer at dinner.
The Lead Auditor asked as to what is the present status of this
enquiry. To this, the Director replied that Customer had already
confirmed that order one week ago. The Lead Auditor asked whether
any notings of the negotiations and meetings are made. The Manger

produced two more log books, one for quotation and one for order.
The Auditor could not identify any co-relation between the three log
books. He reiterated that there is no follow up of information in a
sequence and that the process is not uniformly followed. The
Manager, who was quite embarrassed, stated that he would look into
the matter.
3) The Lead Auditor asked whether the inputs, outputs and interactions
for the sales order processing have been identified. To this the
Director Sales replied “we all know our Customers requirements well
and also any additional requirements such as the recent order L-41,
wherein special types of process Instrumentation was called for”. The
Lead Auditor asked as to what was the action taken. The Manager
replied that clarification was sought from Engineering Department on
this specification. The Lead Auditor asked whether this order has
progressed. He called for the file and on going through the file, he
indicated that there were some comments from materials Department
regarding procurement and hence the job could not progress. The
Director Sales replied that there were problems faced by materials and
Quality Assurance regarding that type of instrumentation.
The Lead Auditor explained that if the process and interactions had
been identified, such problems could have been avoided or foreseen.
The director Sales appeared to agree to the Lead Auditor’s point and
the Manager added. “We do not yet know what the Manufacturing and
Assembly would come up with”.
4) The Lead Auditor pointed out that there is a requirement of monitoring

Customer Satisfaction and monitoring information regarding the
Customer perception of the products and supporting services. The
Sales director replied that installation teams are sent to Customer sites
and if there are any problems, they are immediately attended. In the

case of product supply only, defects are informed to us and then
rectified by our staff.
The Lead Auditor explained that the ISO 9001 Standard requires the
organization to be pro-active, rather than passive. It expects the
organization to look for Customer Satisfaction as well as
dissatisfaction. The Director Sales replied that the company has done
whatever possible towards customer Satisfaction. 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 quite satisfied. Still he said he will look into
the matter and do something.
5) The Lead Auditor asked how the Customers requirements are reviewed
before acceptance of the order. The Director Sales replied that all the
Sales Engineers who prepare the quotations are aware of the
requirements and any changes during the negotiation. The Lead
Auditor asked if any notes are being maintained by the Sales
engineers when they attend the negotiation meetings. To this, the
Director Sales replied that most of the negotiation meetings are
attended by him and the Sales Engineers accompany him. The Lead
Auditor looked through the register of orders and asked for the file on
supply order S-481 which was finalized during the last month. He
compared the quotations and the final order and saw that there were
some differences in delivery requirements and some changes in the
material for fabrication. He asked whether the production order has
been released. The concerned Sales Engineer was called to reply. The
Sales engineer said that he has been very busy on a new project and
he is not sure whether the formal production order has been released.
He however said that he has informed the supervisor of the Fabrication
Shop about the order and procurement is already arranged. There

were no records of negotiation meetings and the Engineer was not
aware of the changes in the specification.
6) The Lead Auditor further looked through the order S-481 and said that
there were some Aluminium parts to be incorporated. He enquired
from the Sales director whether the fabrication facilities for Aluminium
working are available. To this the Sales Director looked surprised and
said “I was not informed about this”. There was also a structure of 25
meters to be fabricated in one piece. The Sales Director was aware of
this but he said “at present we do not have equipment to handle this
size of job”. He said that he was considering different alternatives,
one was to take up with the Customer to fabricate the job in two units
and the second alternative was to take up with the Managing Director
for putting up a long fabrication bench. The Lead Auditor asked as to
when the resource and infrastructure facilities are reviewed. The Sales
Director replied that as and when problems come, they are solved.
The Lead Auditor concluded the audit, thanked the Director and
Manager and requested the Guide to escort him to the Purchase
Section.
7) The Lead Auditor commenced auditing the Materials Department and

he asked the Director – Materials whether planned results have been
identified in line with the established objectives of the Materials
Department. (At this point, it is worthwhile for the participants to
refer to the process documents of materials Department describing
objectives and process measures, in CS1). The Auditor questioned
regarding the processes identified in this department to achieve
planned results. The Director promptly responded that there are
various processes such as selection of suppliers, evaluation of
performance of suppliers, release of purchase orders, etc. The Auditor
continued regarding the sequencing of processes. To this, the Director

replied that there are Section Heads who keep the detailed process
diagrams for their respective areas of work, whereas the Director
maintains overall process diagram for the department. While
responding to the interactions of processes, asked for by the Auditor,
the Director stated that the process interactions within the department
are identified in the overall process diagram. The Auditor then
enquired about interactions with the processes of other departments.
To this, the Director replied that purchasing is an independent function
and therefore no interactions need to be determined with the
processes of other departments. The Auditor took notes of this. The
Auditor asked as to how the processes in the Materials Department are
being monitored. The Director – Materials replied that this is carried
out by the individual Section Heads and he sets targets for them. The
Auditor then asked Director – Materials whether he has any plans for
improvement. The Director stated that he increases the target by
10% every year.
8) The Lead Auditor proceeded to the Purchase Section and asked the
Manager Purchase as to how the Suppliers are selected. The Manager
Purchase said that the decision is with the Director Materials. We
maintain a list of suppliers but expressed that it is not always possible
to adhere to this list. The Lead Auditor asked whether the selection of
Suppliers has been identified as a part of purchasing process. To this,
the Manager replied that it is identified as a process and the inputs and
outputs are clearly identified. The Lead Auditor asked if there are any
interactions identified with other Departments or processes. The
Manager said that the selection of Suppliers is a prerogative of the
Purchase Department alone. The Lead Auditor asked whether any
controls and monitoring are identified. The Manager replied that the
Director Materials decides on the supplier and hence he exercises
control.

The Lead Auditor asked for the list of approved Suppliers 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.
The Lead Auditor asked as to what these Suppliers are approved to
supply. The Manager replied that the Suppliers are mostly
components and raw materials Suppliers. The Lead Auditor asked the
Manager whether there is a frequent transport of material between the
units of the company; and between the company and its job work sub
contractors. The Manager 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 handling
and transport”. The Lead Auditor asked whether such transporters
and job work sub contractors are listed in the approved list. The
Manager said that may be one or two are listed, but you will have to
search for it. The Lead Auditor asked whether the Manager knows as
to how many times the orders are placed on non listed Suppliers. The
Manager was not sure, but he said that majority of orders are placed
on the listed Suppliers.
9) The Lead Auditor was going through some Purchase Orders and
noticed that there was a section on certain electronic items which
needed testing by the supplier before dispatch. He asked the Manager
Purchase whether anybody from the Company visits this Supplier for
seeing or witnessing the tests as there was a mention of testing prior
to dispatch. To this, the Manager replied that in some cases, an
Engineer from the Engineering Division is sent to carry out these types
of tests. The Lead Auditor asked whether this activity is included in
the process diagram. The manger Purchase replied that the overall
Process diagram is kept with the Director Materials. The Lead Auditor
and the Manager Purchase moved into the Director’s Office. The
Director arranged for tea and biscuits and then they got down to

serious discussions. The Lead Auditor clarified that what he was
looking for. The Director took out a neatly preserved folder which
appeared to be very fresh and not opened. He handed over the folder
to the Lead Auditor and remarked. “The Management Representative
gave this to me last week and I am afraid I have not made really much
of it”. The Lead Auditor re-confirmed that he was looking for some
specific interaction concerning testing at Suppliers works, prior to
dispatch. When he looked through the process map, there was no
interaction regarding inspection. The Lead Auditor asked as to who
decides on inspection at Suppliers works. The Director Material said
that it depends on the item or the sub assembly and may be the
Engineering or the QA decide. Once they decide, the Director said that
they inform him to arrange for it. The Lead Auditor asked as to who
decides on the types of tests, methods for tests, acceptance, etc. To
this, the Director appeared to be indifferent and remarked that it does
not really concern the Purchase section and the testing is left to
individuals.
10) The Lead Auditor asked the Director Materials as to the process
followed in selecting Suppliers for placement of orders. The Director
said that he has to keep everyone happy and so he decides the
supplier, on case to case basis. The Lead Auditor mentioned that he
had seen a number of purchase orders being placed on Suppliers who
are not listed as approved. The Director said, “oh, I keep meeting a
lot of young and bright entrepreneurs at many social meetings and
clubs etc”. When they give an introduction and if I feel comfortable, I
try them out for Supplies. If they are found reliable, they become our
regular Suppliers. The Lead Auditor asked how long that would take.
To this, the Director said that in some cases may take a few years.
The Lead Auditor asked whether he keeps track of the performance
and does he analyse such data. To this, the Director produced a folder
containing details of Suppliers and the performance details. Each

supplier was entered in a new page and data of analysis was available
with some remarks by the Director.
11) The Engineering. Department was being Audited by another Auditor.

He was with the Assistant Manager (Engineering) and enquired
whether anybody is sent to Customers project site, since high value
and specialized equipment are involved. The Assistant Manager replied
that all the Engineers in his Department are frequently deputed to
Customer's project site. The Auditor asked whether any problems are
faced and reported in such situations. The Assistant Manager said that
there are no problems and if there is anything they always call back on
phone and other means of communication. The Auditor asked whether
he could look at any typical piping layout plan for a project. One such
plan was shown to him and he saw a number of hands written entries
on the pipe numbering and some remarks which said that "wall had to
be broken". The Auditor asked what these remarks are for. The
Assistant Manager said that in many instances, the pipes and some of
the equipment are not tagged and the Engineer has to find out by trial
and error. The Auditor asked for some more layout plans and saw that
in a few cases the machine alignment was not proper. In one case
primary machine had to be rotated through 90 degrees for installation.
The Auditor made notes of these points.
12) The Auditor asked one of the Engineers to be called in. He asked the
Engineer which are all the sites he has been deputed for. The Engineer
rattled out a number of names, out of which one of them was of
interest to the Auditor. The Auditor asked the Engineer, if he could
explain what the equipment he had handled was. The Engineer stated
that there were lot of welding jobs, structural fabrication and pressure
vessels. There were also lot of Instrumentation and electronic controls
for which another Engineer was working. The Auditor asked him to
explain his background of education and training. The Engineer

mentioned that he had a Mechanical Engineering background and had
worked in a sheet metal industry before joining this company. The
Auditor asked him whether he has undergone any training after joining
this company. He replied that he has been too busy to attend any
training programme. The Auditor thanked the Engineer for his
participation in the audit and permitted him to leave. The Auditor then
asked the Assistant Manager whether any competence requirements
have been established for the Engineers who are deputed to such jobs.
The Assistant Manager replied that the Engineers are well experienced
and he knows that they are quite competent.
13) The Auditor requested for meeting another Engineer present in the
Department. The Auditor went to his table and after exchange of a few
formalities; he wanted to start the Audit. The Engineer was quite
nervous and. the Auditor had to calm him down. The Auditor asked
him that he has seen that there are a number of situations wherein the
parts do not match properly at site or there are mistakes in
instructions. In such cases, the Auditor wanted to know what would
be the Engineer's role. The Engineer expressed his helplessness at the
situation and said that at the project site the Engineer has to complete
the job somehow. Otherwise he gets a bad remark from his seniors.
The Auditor asked him whether such problems are communicated back
to the works. The Engineer said that even if they write, he gets no
response and no action is taken.
14) The Auditor proceeded to the Office of the Director of Engineering to

continue the Audit. The Auditor asked the Director Engineering
whether the activities of attending to Customer sites have been
identified as a process. The Director Engineering looked for some time
through his files and said that this matter was discussed by MR a few
days back and he has made some notes. However, the process was
not yet documented or mapped. The Auditor asked him whether he

could see the draft notes prepared. The Director took out some sheets
of paper and showed it to the Auditor. Each sheet had different
headings such as inputs, outputs, process, details of trials, daily
reports of. progress, maintenance of expenditure account, methods of
communication etc. The Auditor asked whether any interactions with
other processes are listed. The Director said, "that's all have".
15) The Auditor pointed out to the Director Engineering that there is a
procedure established in the QMS, which relates to the product and
process non conformities. He further asked whether the problems
faced by the Engineers at the Customers project site can be
considered for inclusion in this procedure. The Director said "we never
thought so and I don't think these points can be considered for
inclusion since nothing can be done".
16) The Auditor asked the Director Engineering as to when was the last
Management Review meeting held. The Director Engineering replied
that a meeting was held last week. The Auditor asks for the copy of
the meeting minutes. The Director Engineering took out his copy and
presented it to the Auditor. The Auditor saw that the report was
running into number of pages. Though many of the important issues,
as required, were discussed, the topics presented were not structured
to facilitate understanding. The Auditor looked up for results of internal
audits which appeared in a number of places in the minutes. He picked
up a few internal audit findings which needed immediate action. There
were incidents of inadequate identification, process documentation and
quality policy display. Though there were lengthy discussions on these
topics, there was no plan of action or responsibility assigned.
17) The Auditor informed Director Engineering, that he has gone through a
few of the Departments, particularly the Heat Treatment shop. In this
shop, many of the operators were not aware that the company has

established a quality policy. He also expressed that the operators were
not aware of the importance of their activities with regard to the
quality of the products. In this context, the Auditor wanted to know as
to how such information is communicated. The Director Engineering
said that the manufacturing shops are looked after by the General
Manager and may be the Auditor should ask the GM. The Auditor
expressed that as a part of Top Management, may be, the Director
Engineering would be aware of the methodology. The Director felt
elated and tried to explain at length that they have training programs,
videos, shop floor briefings, etc. Then the Auditor asked whether these
are effectively utilized. The Director Engineering replied, "well, I guess
we do".
18) One of the Auditors was with the General Manager during the audit and
asked whether a list of process equipment and machinery is available.
The General Manager produced a list which was dated 3 years back.
The Auditor asked him whether this list is reviewed at all. The GM said
that the list is updated only when some new additions are made. The
Auditor asked the General Manager whether the adequacy of
equipment and machinery in relation to the Customer contracts being
negotiated is reviewed. The General Manager replied that the Sales
people are aware of our existing equipment and quote accordingly. The
Auditor said that in the Sales Department he came across a contract
already in progress which requires fabricating a structure of 25mts in
length in one piece. The General Manager expressed surprise and
exclaimed "nobody ever told me".
19) During the audit with the General Manager, the Auditor expressed that
in the Foundry, Heat Treatment and a few other shops, there are too
many fumes and no proper exhaust ventilation. The General Manager
said that the company has been in existence for a long time and have
been adding equipment and machines whenever the need arises. May

be in this process, some areas have been over looked and he assured
the Auditor that he would immediately arrange for exhaust fans. The
Auditor asked whether any other factors are considered from the point
of working. The General Manager said "what else do you think?".
20) The Auditor asked the General Manager whether the company has
strategic decisions taken towards improvement. The General Manager
said, the company has been growing continuously by the grace of God.
As you might have seen from the Quality Manual and the company
brochures, we have been growing in size and expanding into a new
business. The Auditor wanted to know if any improvement in the
systems and particularly quality management system is being
perceived. The General Manager said that "as management, we are
happy with the growth of the company and now we have implemented
the systems as per ISO 9001 Standards."

EXERCISE E05
NCR WRITING

E05 : NCR WRITING
Objective
Write and grade Non Conformance Reports (NCRs)
Method
Please write and grade NCRs for the given incidences. If you do not think that
there is sufficient objective evidence of nonconformity then you should state
your reasons in the space below the report. You should also state what the
auditor should do next.
Format
Please present your responses in the given format, on OHP/ flip chart.
Note
 This is a group exercise.
assessment and will therefore be marked.
Time allotted : 45 minutes

EXERCISES
Incident Number 1
During an audit of management review activities you notice from the minutes
of management review meetings that the meetings are not attended by any
of the top management team. When you query 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. The process is now that departmental
managers meet and conduct the first level of management review. The
management representative prepares a summary report including actions
and recommendations. This is passed round each of the top management
team for comment, and the Managing Director finally agrees the action plan.
Incident Number 2
During an audit of internal audits you are shown internal audit reports from
the last audit. These include a non conformity report stating that 3 people in
the purchasing department had not been trained in the use of the approved
supplier list. The corrective action taken was to train the 3 members of staff.
The audit report has been closed. The management representative tells you
that no further investigation was made as the corrective action was obvious.
The internal auditor had checked the training records of the staff concerned
before closing the reports.
Incident Number 3
In the Purchasing Department the auditor asks how the new subcontractor
for TMX 101 items was selected. The purchasing clerk explains was placed
with a subcontractor which they had never used before, only because the
price quoted was extremely low. The clerk states that no other evaluation
was conducted.

QMS AUDIT Incident Number………………
NON CONFORMITY REPORT
Company under Audit: GEC Ltd., Note Number………………………
Area under review: ISO 9001: 2008 Clause Number
……………………………………… ……………………………………………
Category MAJOR* MINOR* * delete one
Deficiency
Auditor Date:
If you do not think that there is sufficient evidence of non-conformity, state

the reasons for your decision and state also what further actions the auditor
should take.
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________

EXERCISE E06
AUDIT SUMMARY REPORT

E06: AUDIT SUMMARY REPORT
Objective
To prepare an accurate, meaningful, Audit Summary Report.
Method
 Now that the audit at GEC Ltd. is completed, prepare an Audit
Summary Report, using the learning of session 11.
 The report should cover among other items, scope and
objectives of the audit, positive audit findings, opportunities for
improvement and recommendations.
Format
Please prepare your Audit Summary in the Annexed format and submit on
paper to the Tutors.
Note
assessment and will therefore be marked by tutors and feedback
would be given to the participants
Time allotted : 45 minutes

AUDIT SUMMARY REPORT
External Audit of …………………………… Report No:
On behalf of ………………………………….
Audit Dates …………………………………..
Audit Team …………………………………………………………………………..
……………………………………………………………………………
……………………………………………………………………………
Scope
Objectives
Audit Criteria 1.
2.
3.
SUMMARY STATEMENT – Enclosed
Recommendations / Conclusions
Enclosures
1. Summary Statement
2.
3.


Signed by: (Lead Auditor) Date
Note
1. This audit is based on limited samples and other non-conformances
may exist.
2. This report and its contents should be treated as confidential

EXERCISE E07
ROLE PLAY ON CLOSING

MEETING

E07 : ROLE PLAY ON CLOSING MEETING
Objective
To conduct a Closing Meeting in line with what has been covered in the course
notes.
Method
Each team should nominate a team leader who will conduct the role of a Lead
Auditor in the Closing Meeting. This will be a role play and we request all
participants to prepare for it as close as possible to the real life situation.
Individually teams may be assigned the role of an auditor, auditee or an

observer; however preparation is common for all
Each team should spend about one hour to do the following activities:
 Each team should select NCRs(3) from the case study which was
presented on the previous days from CS1, CS2 & CS3. NCRs should have
been adequately supported with objective evidence, attribution and
explanation.
 The team leader prepares introductory and closing remarks.
 The team agrees upon the presentations to be made by each member and
the team leader(roles and responsibilities must be clear including handling
questions).
 Ensure the meeting is complete in 30 minutes. Decision on selection of
nos of NCRs should be based on the time frame.
 No visual aids will be allowed.
 Adhere to a single nomenclature (either NCRs / CARs/ Discrepancies etc).
 Be brief, clear and crisp.
 Do not rattle of Clause, sub-clause from the standards. Top management
do not necessarily know them well.

 The team leader to chair the meeting and be responsible for controlling
and running the meeting to plan.
 As this is a second party audit there is no certificate at stake. Also the
organization is a prestigious one giving you reasonably good products.
 The tutors will allocate the roles to be played by the different teams in
this closing meeting just before the role play.
Note
 Nominate a time keeper, Team leader and Audit team members.
 This roleplay exercise is part of the formal continuous assessment and will
therefore be marked.
Time allotted
Preparation : 30 minutes
Role Play : 30 minutes
Feedback : 30 minutes

EXERCISE E08
EVALUATING PROPOSALS
FOR EFFECTIVENESS OF
CORRECTIVE ACTION

E08 : EVALUATING PROPOSALS FOR
EFFECTIVENESS OF CORRECTIVE ACTION
Objective
Evaluation of effectiveness of corrective action.
Method
For the Non Conformance reports (NCR) raised, enclosed please find some
proposals on corrective actions. Consider the two incidents and evaluate the
proposals with respect to effectiveness of corrective action.
Your evaluations should address:
1. Whether actions taken by Company are correction or corrective action?
2. If it is corrective action, is there enough information in the proposal on
what they are going to do?
3. By reading the proposal, do you think they have done a root cause
analysis?
4. What is your judgment on the effectiveness of the proposal?
Format
Please present your response in any format preferred by you and submit the
same to the tutors.
Note
 Nominate a time keeper.
and will therefore be marked by tutors and feed back would be given
to the participants
Time allotted : 30 minutes.

PROPOSALS FOR CORRECTIVE ACTION - E08
Incident 2
NC: The 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. A review of the actions taken failed to identify that
action had not been taken to prevent recurrence of the problem. (8.5.2)
Proposed action
a) Internal auditors will be trained to distinguish between correction and
corrective action.
b) NCR format is modified. The internal auditors need to put their
comments on the effectiveness of the corrective action taken before
closing the NCRs
Incident 3
NC: A subcontractor of TMX101 item was selected on the basis of price and
no further evaluation 6f the supplier was made. (7.4.1)
Proposed corrective action

Director Materials along with Director Quality shall review the requirements
with TMX101 items. Suppliers, those participated in the bid shall be
evaluated with the identified requirements. The selection of the supplier shall
take place based on the ability to supply TMX 101 items as per requirements.

SPECIMEN EXAMINATION
PAPER

Examination for Auditors of Quality Management Systems
INTERNATIONAL REGISTER
OF CERTIFICATED AUDITORS
QMS AUDITOR EXAMINATION PAPER QMS 5 – SPECIMEN PAPER

FOR USE ON THE
ISO 9000:2008 SERIES AUDITOR/LEAD AUDITOR TRAINING COURSE
(IRCA /2245)
CONFIDENTIAL TO IRCA APPROVED TRAINING ORGANIZATION
Please write your name in the space: Course No.
Date:
THESE SPACES ARE THE OFFICIAL USE ONLY

Section Marker 1 Market 2 Pass mark Maximum
Check
mark/arithmetic
check
Delete as
applicable
1 4 10
2 8 20
3 8 20
4 12 30
Total 56 80
Name of marker Verified
Result
IRCA/146 QMS 5/08/1, November 2008

IRCA examination paper QMS 5 Specimen Paper, amended for use on certified course Axx operated by TO
Page 1 of 12
Information for candidates
This examination paper is in four sections. Please attempt all sections.
The time allowed is two hours. There is no additional time allowed for reading the question
paper. There are a maximum of 80 marks available; the pass mark is 70% (56 marks) and
you must also achieve at least 40% in each of the four sections.
Your answers must be written on the sheets that are supplied. Additional loose sheets will not
be accepted.
The phrase "ISO 9001" and “standard” always refer to ISO 9001:2008.
The word "clause" refers to a paragraph or section of ISO 9001 that is identified by a
number such as 5.4.1 or a number and letter such as 7.1b.
This examination is open book.
Section 1 is worth 10 marks
Comprises questions which require you either to place a circle around the letter (a, b, c, d or e)
to indicate which you judge to be the best answer. You must only give one answer for each
question. If it is not clear which option you have selected, you will be awarded zero marks.
Comprises questions that require a brief written answer in the space provided.
Comprises questions that require a detailed written answer that will normally fill the space
provided.
Comprises a number of audit situations for which a nonconformity report (NCR) may be
required.

Page 2 of 12
Section 1 worth 10 marks

Each question is worth 1 mark.
1.01 Quality system audits are used to verify
a. the number of persons working on a contract.

b. the extent to which audit criteria are fulfilled.
c. that all suppliers to the organization have ISO 9001 certification.
d. all of the above.
e. none of the above.
1.02 A third party audit is
a. an internal audit.
b. an audit by the customer or client.
c. an audit by an independent organization.
1.03 ISO 9001 includes:
a. health and safety requirements.

b. quality planning.
c. quality costing.
1.04 Which of the following activities must be carried out by someone who does not perform
the activity being evaluated?
a. a contract review.
b. an inspection of product.
c. a quality system audit.
1.05 A system based on the requirements of ISO 9001 aims to
a. achieve customer satisfaction.

b. demonstrate an organization’s ability to consistently supply conforming product.
c. prevent non conformity.

Page 3 of 12
1.6 Data supporting the existence or verity of something is called:
a. objective evidence.
b. a deficiency.
c. a nonconformity report.
1.07 What information is being sought during a third party audit of a quality system?
a. a list of non-conformities to ISO 9001.

b. objective evidence of conformity with ISO 9001.
c. a management commitment to quality assurance.
1.08 To act as an auditor of a quality system a person has to
a. be registered as a certificated auditor.

b. have a detailed knowledge of the product or service of the organization to be audited.
c. have been a quality systems manager.
1.09 The process approach to a quality management system seeks to help organizations:
a. manage numerous linked activities.

b. understand and fulfil requirements .
c. continually improve processes.
1.10 The extent of documentation of the quality system should be determined by:
a. the complexity of processes and their interactions.

b. the expectations of auditees.
c. the culture of the quality department.

Page 4 of 12

Each question is worth 5 marks
2.1 There are three types of quality system audit based on a first, second and third
party involvement. Explain the specific features that distinguish each of them. (5
marks)
2.2 What is the objective of quality management system documentation? (2 marks)

Give six examples of the benefits that can arise from effective documentation. (3
marks)

Page 5 of 12
2.3 ISO 9000 identifies a “process approach” as one of the 8 quality principles that
support the achievement of quality objectives.
a. Explain your understanding of what is meant by “a process approach” (1 mark).

b. Identify at least 4 ISO 9001 clauses that support such an approach (4 marks).
2.4 An auditor is conducting a third party audit. The guide, who has been appointed to
accompany the auditor around the various departments, is called away by a senior
manager. After five minutes the guide has not returned.
What should the auditor do? (3 marks)

What should the auditor not do? (2 marks)

Section 3 maximum20 marks
3.1 You are planning a process audit of an organization that consists of the following
departments:
- sales and marketing
- purchasing
- warehouse
- packing and despatch
- support services
The top management team consists of the Managing Director and departmental
managers from each of the above areas.
a) What would be your two main considerations in deciding the sequence of
activities for the audit? (4 marks)
b) How would you approach the audit of continual improvement in this

organization? (6 marks)

Page 7 of 12
3.02 You are conducting an audit of a medium sized organization. During the
document review you have raised a concern about the organisation’s system for
ensuring the competence staff.
Prepare a checklist that would guide you through a process audit of competence of
staff and state the relevant ISO 9001 clauses. (10 marks)

Page 8 of 12

Three incidents that occur during a third party audit of a supplier are described below. They
contain situations for which nonconformity reports may be required. Examine each incident
carefully then take one of the following actions:
a) If you think that there is sufficient objective evidence of nonconformity, you should
complete a nonconformity report and categorise it as major or minor.
b) If you do not think that there is sufficient objective evidence of nonconformity, you
should:
 state why you think there is insufficient evidence of nonconformity
 make a list of things you would look for as evidence that the situation is under
control
The answer to each incident is worth 10 marks.

Page 9 of 12
Incident Number 1
During an audit of management review process, the auditor notices from the
records of the management review meetings that the meetings are not
attended by any of the top management team. When the auditor queries this,
the management representative explains that management review has evolved
into a two tier process, as it was proving so difficult for all of the departmental
and top managers to be available at the same time. The process is now that
departmental managers meet and conduct the first tier of management review.
The management representative prepares a summary report including actions
and recommendations. This is passed round each of the top management team
for comment, and the Managing Director finally agrees the action plan.
If you think there is evidence of a nonconformity, complete this report:
IRCA QMS AUDIT – NONCONFORMITY REPORT

Company under Audit: XYZ plc Nonconformity Number:
Area under review: ISO 9001 Clause Number:
Nonconformity:
Auditor:
Or, if you do not think that there is sufficient evidence of nonconformity, state the reasons
for your decision and state also what further actions the auditor should take

IRCA/146 QMS 5/08/1, November 2008 Page 10 of 12
Page 10 of 12
Incident number 2
During an audit of internal audits the auditor is shown internal audit reports from
the last audit. These include a nonconformity report stating that 3 people in the
purchasing department had not been trained in the use of the approved supplier list.
The corrective action taken was to train the 3 members of staff. The audit report has
been closed. The management representative tells you that no further investigation
was made as the corrective action was obvious. The internal auditor had checked
the training records of the staff concerned before closing the reports.

Nonconformity:
Auditor:
Or, if you do not think that there is sufficient evidence of nonconformity, state the reasons for
your decision and state also what further actions the auditor should take.

Incident Number 3

Page 11 of 12

Page 11 of 12
In the Purchasing Department the auditor asks how the new supplier for TMX101
items was selected. The purchasing clerk explains that the regular supplier could
not meet the delivery date and the order was placed with a supplier that they had
never used before, only because the price quoted was extremely low. The clerk
states that no other evaluation was carried out.

Nonconformity:
Auditor:
Or, if you do not think that there is sufficient evidence of nonconformity, state the reasons for
your decision and state also what further actions the auditor should take.
End of examination

Page 12 of 12

GUIDELINES ON LODGING
COMPLAINTS

ADD TO WORKBOOK / CASE STUDIES + Q MANUAL
Reference Title
WI/81 Guidelines On How To Make Complaints
Issue No. Revision No. Issue Date Approved By Page

1 of 2
2 3 01-10-06
1.0 Purpose
1.1 The purpose of this guideline is to inform delegates on the appeal procedure.
2.0 Scope
2.1 This work instruction covers all the complaints relating to administration,
conduct and management of certificated courses.
3.0 Responsibility
3.1 Delegates are responsible for raising complaints. Management of CII is
responsible for resolving them. IRCA / NRBPT has an adjudicating note in
this `appeal’ procedure.
4.0 Complaints
4.1 Complaints could be raised for any of the following reasons:
- Integrity, impartiality of personnel involved as tutors or in the
course administration & management of certificated courses
- Non-responsiveness of administration and/or tutor to reasonable
requests
- Delays in receipts of certificates/confirmation information/
acknowledgment of receipt of payment
- Others
4.2 Within a maximum of two working days there would be an immediate

response on receipt of complaints by a call or letter. If the problem can be
resolved immediately, it will be done so, otherwise complainant will be
informed of actions taken.
Reference Quality Manual : Section 2 Procedure : CII/QMP/81

ADD TO WORKBOOK / CASE STUDIES + Q MANUAL
Reference Title
WI/81 Guidelines On How To Make Complaints
Issue No. Revision No. Issue Date Approved By Page
1 of 2
2 3 01-10-06
4.3 In case complainant is not satisfied with CII’s actions, , they have the right
to appeal to IRCA and/or NABET at the following address :
Training Manager Director

Course No. : A5633 National Registration Board
IRCA, P.O. Box : 25120 for Education and Training
12 Grosvenor Crescent
London, SW IX 7ZL Institute of Engineers Building, 2nd
Floor, Bahadur Shah Marg
Tel. : +44(O) 20 7245 6833 New Delhi 110002
Fax : +44(O) 20 7245 6844
E-mail: irca@irca.org Tel. : +91 11 2337 0567
Fax : +91 11 2337 9621
e-mail : nrbpt@qcin.org
5.0 Records
Record of complaints file
6.0 References
6.1 Forms
Forms 17 : Record of Complaints
Reference Quality Manual : Section 2 Procedure : CII/QMP/81

Work Book / Case Studies 94
DELEGATE FEEDBACK FORM

Form Title : DELEGATE FEEDBACK FORM
IRCA Criteria Number : IRCA/2245/2001/2002/2003/2004
(tick the appropriate number)

Course Title :
Name :
(Please write your name very clearly as you would like to see on your certificate)
Organization:
Designation :
Objective for attending the course:
COURSE
(Please indicate your opinion in each section by marking the appropriate number. If you grade
any feature 1 please state your reasons in the “COMMENTS” area (on page 3 of 3))
PARAMETERS Excellent Good Fair Poor

Relevant
1. OVERALL RATING
a) Considering the general objective of 4 3 2 1

the course, how did you rate it
overall?
b) Considering the learning objectives of

the course how did you rate the
following:
i) The purpose of a quality 4 3 2 1

management system and the 8
principles of quality management.
1 of 3
Form 6/Oct 2006/01
ii) The purpose, content and 4 3 2 1
interrelationship of ISO 9000, ISO
9001, ISO 9004 and ISO 19011.
iii) Interpreting requirements of ISO 4 3 2 1

9001 in the context of an audit
iv) The roles and responsibilities of 4 3 2 1

auditors and lead auditors.
v) Plan and conduct and audit in 4 3 2 1

accordance with ISO 19011.
vi) Reporting the audit, including 4 3 2 1

writing valid, factual and value-
adding non-conformity reports.
1
vii) Undertaking audit follow-up 4 3 2
activities, including evaluating the
effectiveness of corrective action.
2. AIMS Fully Fairly well Not very Not at all
satisfied satisfied well satisfied
satisfied
a) How well did the course meet its
4 3 2 1
aims, as you understood them?
b) How well were your specific needs
met? 4 3 2 1
PARAMETERS Excellent Good Fair Poor
Relevant
3. COURSE DESIGN &
DELIVERY
How satisfied were you with the
4 3 2 1
a) Visual aids 4 3 2 1
b) Course notes 4 3 2 1
c) Case studies & exercises 4 3 2 1
d) Syndicate Work & Role play 4 3 2 1
e) Course Structure

4. TUTOR SKILLS* T1 T2 T1 T2 T1 T2 T1 T2
How do you rate the following skills:
a) Clarity
b) Time Management 4 4 3 3 2 2 1 1
c) Coverage 4 4 3 3 2 2 1 1
d) Response 4 4 3 3 2 2 1 1
e) Presentation 4 4 3 3 2 2 1 1
4 4 3 3 2 2 1 1
PARAMETERS Fully Fairly well Not very Not at all

satisfied satisfied well 2 of 3
satisfied
Form 6/Oct 2006/01
5. ADMINISTRATION
How satisfied you were with the :
a. Registration and response 4 3 2 1

time 4 3 2 1
b. Planning? 4 3 2 1
c. Environment (comfort,
audibility) 4 3 2 1
d. Catering 4 3 2 1
e. Information & Feedback
6. CONTENT
a) Was the subject level (pl. tick) Too About right Too
advanced elementary
b) Were the subjects (pl. tick) Partly
Very relevant Not at all
relevant relevant
COMMENTS : To assist us in our objective of continuous improvement, please

specify what the high and low points of the course were in your
opinion. Identify specific dissatisfaction and indicate any serious
omissions.
RIGHTS Every delegate has the right to complain to CII in case they are
dissatisfied with any aspect in the course. In case unsatisfactory
action is taken by CII, you may also directly write to IRCA / NABET.
Refer WI/81. On `How’ to do so.
* 1. T1 refers to the Lead Tutor where more than one Tutor is conducting the course.

2. T2 refers to the Tutor supporting the Lead Tutor
3. Where only one Tutor is conducting use column for T1
3 of 3
Form 6/Oct 2006/01
2 of 4
Form 6/Oct 2006/01
4 of 4
Form 6/Oct 2006/01

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LEAD AUDITOR / AUDITOR COURSE

FOR QUALITY MANAGEMENT

WORKBOOK / CASE STUDIES

IRCA Registration No. : A17392

WORKBOOK / CASE STUDIES

No part of this publication may be reproduced, stored in retrieval system or

Work Book / Case Studies April 2010 3

Work Book / Case Studies April 2010 4

INSTRUCTIONS FOR E01

Interpreting the ISO 9001: 2008 Clauses, in the context of an Audit.

The following are 12 mutually independent incidents, describing the findings of

Please present your responses in the following format .

Sl.No. Whether covered Clause / Sub Clause of ISO 9001: Reasons

 This is a group exercise followed by individual work.

Time allotted: Individual work 30 minutes.

Work Book / Case Studies April 2010 5

2) The MR of a Company says “all our current procedures have been

6) Purchasing process does not address the assistance given to suppliers

Work Book / Case Studies April 2010 6

9) Sources of information on customer satisfaction only include customer

Work Book / Case Studies April 2010 7

Work Book / Case Studies April 2010 8

INSTRUCTIONS FOR CS1

 This is a group exercise followed by individual work

Time allotted : Individual Work 90 minutes.

Work Book / Case Studies April 2010 9

Goodwill Equipment Company Ltd.,

CASE STUDY – DO NOT MARK ON SCRIPT

Work Book / Case Studies April 2010 10

GEC Ltd., was a traditional Mechanical Fabrication company, and has

Since the two facilities are separated by a distance of about 25 kilometers,

Work Book / Case Studies April 2010 11

Our sub-contractors provide us with specialist expertise in activities such as

Work Book / Case Studies April 2010 12

This manual is for guidance for company quality management system.

All personnel will be guided by the contents of this quality management

In matters affecting quality, he may not be overturned by any other Director

The Quality Policy of the Company states

“We honour Customer requirements and spare no efforts to satisfy

GECL Management is committed to continuously improve in their

Work Book / Case Studies April 2010 13

Title Section No ISO Cl. no

Objectives & Process

Work Book / Case Studies April 2010 14

Rev No Date Section Revised Details of Revision

1 March 25, 2009 Original Issue -

2 May 22, 2009 5 Responsibility and

Work Book / Case Studies April 2010 15

QUALITY MANUAL OPERATION

This manual is prepared by the MR & approved by Director Quality.

Work Book / Case Studies April 2010 16

QUALITY MANAGEMENT SYSTEM

4.1 General Requirement

The company has established, documented, implemented & maintained a

The processes and their interactions are described in the Departmental

Work Book / Case Studies April 2010 17

The QMS maintained by the company is documented in the following

Level – 2 Quality system procedures.

Level – 3 Work Instructions:

4.3 Control of documents

a) To approve the document for adequacy

Work Book / Case Studies April 2010 18

4.4 Control of records