workbook_updated_to_2008_ver (1).doc Lead Auditor case studies

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
EXERCISE E01
INTERPRETING THE
ISO 9001: 2015 CLAUSES
E01: INTERPRETNG THE
ISO 9001: 2015 CLAUSES
INSTRUCTIONS FOR E01
Objective:
Interpreting the ISO 9001: 2015 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 9001:2015
and mention the appropriate clause and/or sub clause of ISO 9001: 2015. 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 2015
9001:2015
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
8.3.
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 8.3 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: 2015 for the realization of its various
services. The Bank has excluded 8.5.3 & 8.5.4 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: 2015 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
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: 22/03/2019
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 2019 Page 1 of 20
CONTENTS
Title Section No ISO Cl. no
Introduction
Quality Policy
Contents AA -
Record of Revision BB -
Quality Manual Operation CC -
Context of the organization 4.0 4
Management Responsibility 5.0 5
Planning 6.0 6
Support 7.0 7
Operations 8.0 8
Performance Evaluation 9.0
Improvement 10
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 2019 Page 2 of 20
RECORD OF REVISION
Rev No Date Section Revised Details of Revision
1 March 25, 2019 Original Issue -
2 May 22, 2019 5 Responsibility and

Authority
“ 7 “Production Process
Revised”
“ 8 Details of CAG
added
Section CC Issue 1 Rev 1 March 2019 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 2019 Page 4 of 20
QUALITY MANAGEMENT SYSTEM
GENERAL
The quality management system of the company is based on the ISO 9001-2015 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 9001-2015 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 ISO9001-2015
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 9001-2015. 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 2019 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.
8.0 Operations
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.
9.0 PERFORMANCE EVALUATION
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.
10. 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.
H) 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
I) 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 : 22/03/2019
Issued By : MR
Revision No. : 0
OBJECTIVES FOR MATERIALS DEPARTMENT
a. Reduction in Lead Time for Procurement
b. Reduction of Rejections of Incoming Materials due to Improper Communication

of Specifications to Suppliers
c. Improvement in Delivery Adherence by Suppliers
d. Reduction in Lead Time of Payment to Suppliers
e. Reduction in Inventory Turns Over time at Receipt Stores
f. Increase in Suppliers with “Direct On Line” Status
g. 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 Inventory 1,5

(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 at 2,6

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
therefore be marked by tutors and feedback would be given to the participants
Time allotted: 45 minutes
EXERCISES
i. 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.
ii. 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
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 Section /
Number Statement Subclause No. 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)
 The output of the exercise is part of the formal continuous 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.
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: 2015 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
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. EXERCISE E07

2.
3.
SUMMARY STATEMENT – EnclosedROLE PLAY ON CLOSING

Recommendations / Conclusions MEETING
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
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
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.
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
1.06 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
2.01 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)
2.02 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)
2.03 ISO 9000 identifies a “process approach” as one of the 8 quality principles that
support the achievement of quality objectives.
a. QMS
IRCA/146 Explain your
5/08/1, understanding
November 2008 of what is meant by “a process approach” (1
IRCA examination
mark).paper QMS 5 Specimen Paper, amended for use on certified course Axx operated by TO
Page 5 of
b. Identify at least 4 ISO 9001 clauses 12support such an approach (4 marks).
that
2.04 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)

Page 6 of 12
Section 3 maximum20 marks
3.01 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)
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.
Page 7 of 12
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 re-
cords 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 pro-
cess, 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 repres-
entative 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:
Category MAJOR* MINOR* *

delete one
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
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.
IRCA QMS AUDIT – NONCONFORMITY REPORT

delete one
Nonconformity:
Auditor:
Incident Number 3
In the Purchasing Department the auditor asks how the new supplier for TMX101
items was
IRCA/146 QMSselected. The purchasing
5/08/1, November 2008 clerk explains that the regular supplier could
not meet
IRCA the delivery
examination paper QMS date and Paper,
5 Specimen the order was
amended placed
for use withcourse
on certified a supplier thatbythey
Axx operated TO had
never used before, only because the Page 11 ofquoted
price 12 was extremely low. The clerk
states that no other evaluation was carried out.

IRCA
IRCA examination paper QMS 5QMS AUDIT
Specimen Paper, – NONCONFORMITY
amended REPORT
for use on certified course Axx operated by TO
Page 11 of 12

delete one
Nonconformity:
Auditor:
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
Work Book / Case Studies 92

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 93

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

management system and the 8 4 3 2 1
principles of quality management.
ii) The purpose, content and

interrelationship of ISO 9000, ISO 4 3 2 1 of 3 1
9001, ISO 9004 and ISO 19011. Form 6/Oct 2006/01
iii) Interpreting requirements of ISO
9001 in the context of an audit 4 3 2 1
iv) The roles and responsibilities of

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

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

valid, factual and value-adding non- 4 3 2 1
conformity reports.
vii) Undertaking audit follow-up 1

activities, including evaluating the 4 3 2
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 2 of 1
3
1
4 4 3 3 2 Form26/Oct 12006/01
1
PARAMETERS Fully Fairly well Not very Not at all
satisfied satisfied well
satisfied
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

INSTRUCTIONS FOR E01

Interpreting the ISO 9001: 2015 Clauses, in the context of an Audit.

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.

9) Sources of information on customer satisfaction only include customer

INSTRUCTIONS FOR CS1

 This is a group exercise followed by individual work

Time allotted : Individual Work 90 minutes.

Goodwill Equipment Company Ltd.,

CASE STUDY – DO NOT MARK ON SCRIPT

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

This manual is for guidance for company quality management system.

The Quality Policy of the Company states

“We honour Customer requirements and spare no efforts to satisfy customers by

GECL Management is committed to continuously improve in their endeavour to

Title Section No ISO Cl. no

Objectives & Process

Rev No Date Section Revised Details of Revision

1 March 25, 2019 Original Issue -

2 May 22, 2019 5 Responsibility and

QUALITY MANUAL OPERATION

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

QUALITY MANAGEMENT SYSTEM

4.1 General Requirement

The company has established, documented, implemented & maintained a quality

The QMS maintained by the company is documented in the following documents.

Level – 2 Quality system procedures.

Level – 3 Work Instructions:

4.3 Control of documents

a) To approve the document for adequacy

Section 4.0 Issue 1 Rev 1 March 2019 Page 6 of 20

A documented procedure is established to ensure that the records are controlled.

5.0 MANAGEMENT RESPONSIBILITY

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

a) Communicated the importance of meeting customer requirements and statutory

C) Quality Management System Planning

D) Responsibility and Authority

Director Quality QA - Final

Director Materials QA – In Process

Director Finance Calibration Lab

The functional responsibilities are:-

Engineering Director, Mr. Parthasarathy: He reports directly to the M.D and is

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

Director Quality, Mr. Banerjee: He is responsible for all matters relating to

ANNEXURE TO SECTION 5.0

1) Improvement in customer satisfaction index

6.0 RESOURCE MANAGEMENT

Competence, Awareness and Training

Head of Engineering is responsible for identifying and providing the resource

A) Planning for Product Realisation

B) Customer related processes