LEAD AUDITOR / AUDITOR COURSE
FOR QUALITY MANAGEMENT
SYSTEM
ISO 9001 : 2008
Institute of Quality
Confederation of Indian Industry
IRCA Registration No. : A17392
NABET Registration No. : LQ81 102
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WORKBOOK / CASE STUDIESCONFEDERATION 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
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
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Work Book / Case Studies April 2010 61
Work Book / Case Studies April 2010 61
E01: INTERPRETNG THE
ISO 9001: 2008 CLAUSES
INSTRUCTIONS FOR E01
Objective:
Interpreting the ISO 9001: 2008 Clauses, in the context of an Audit.
Method
The following are 12 mutually independent incidents, describing the findings of the auditors. Identify and relate those incidents that are within the scope of ISO 9001:2008 and mention the appropriate clause and/or sub clause of ISO 9001: 2008. You may relate these to one or more requirements of the Standard.
Format
Please present your responses in the following format .
Sl.No. / Whether covered in Scope of ISO 9001:2008 / Clause / Sub Clause of ISO 9001: 2008 / ReasonsNote
· 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.
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EXERCISE E01
1) XYZ Co. has its design center at Singapore and a manufacturing plant at New Delhi. All products specifications originate at Singapore and the manufacturing plant only manufacturers, as per the design specifications. The manufacturing plant has decided to apply for Certification for a QMS, which excludes Clause 7.3.
2) The MR of a Company says “all our current procedures have been repeated, replacing the word ‘PROCEDURE FOR………’ to ‘PROCESS FOR……….; we have not done any other changes, in the documentation”.
3) An Emission from XYZ Company was found to have a pollutant that may cause adverse impact on health of the employees in the long run.
4) Tiger Toys Ltd., designs and produces toys and play equipment, as per product codes and regulations. The regulations do not require the QMS to include design, for the safety class of the products of the Company. Based on this, Tiger Toys also decides to exclude clause 7.3 from its QMS.
5) ABC Projects Ltd., designs, develops and produces heavy equipment, but does not have in house design facility. The design activities are sub contracted to XYZ Co. Ltd., which is an engineering consultancy Company. During the audit, the Project Manager says, “we leave the complete Design Process to them”.
6) Purchasing process does not address the assistance given to suppliers towards their development.
7) During the audit of a Paint Shop of an auto part, it was found that the doors and windows of the shop were all left open.
8) A Company providing leasing services of earthmoving equipment to civil contractors and builders has its Business Operations Divisions at its headquarters and six repair workshop around the country. The repair shops provide the service of equipment maintenance to the headquarters, and have no interactions with the Company’s customers. One of the workshops is pursing certification to ISO 9001:2008 even before the parent Company. The workshop management has excluded the clauses 7.2, 7.3, 7.4 and 7.5.4 from their QMS.
9) Sources of information on customer satisfaction only include customer complaints and Questionnaire & Surveys but do not include focus groups reports in various media, sector & industry studies.
10) The Training Manager of a Company says that increasing profits of the Company amply demonstrates the effectiveness of their training plans and programmes.
11) Laxmi Bank is implementing ISO 9001: 2008 for the realization of its various services. The Bank has excluded 7.5.3 & 7.5.4 from its QMS.
12) Corrective Action Procedure of the company does not include results of Self Assessment.
Work Book / Case Studies April 2010 61
Work Book / Case Studies April 2010 61
CS1: DOCUMENTATION REVIEW OF
A QUALITY MANUAL
INSTRUCTIONS FOR CS1
Objective
Documentation Review of GECL’s Quality Management System Documentation.
Method
Perform a documentation review or stage one audit of the Quality Manual and Sample Process Documentation of Materials Department of GECL in order to assess whether documentation meets ISO 9001: 2008 requirements and to determine whether adequate arrangements are in place to justify proceeding with the implementation (onsite) audit.
Format
Please present your responses in the following format on transparency sheet also identify which of these you would check during the onsite audit.
Clause / Sub-clause number / Nonconformance / Immediate clarification required / Add to Checklist / RemarksYes / No / Yes / No / Yes / No
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 exercised is part of the formal continuous assessment and will therefore be marked.
Time allotted : Individual Work 90 minutes.
Group Work 30 minutes.
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Quality Management System Manual
Goodwill Equipment Company Ltd.,
54-56, Yallers Compound,
New Achievers Road,
Gopal Ram Nager
GEC-QMS-M 1
Copy No.: 10
Issue Date: 22/03/2009
Issued by: MR
Revision No. 2
CASE STUDY – DO NOT MARK ON SCRIPT
INTRODUCTION
Goodwill Equipment Company Limited was founded in 1955 and since 1990 has been owned and managed by the present Managing Director.
GEC Ltd., was a traditional Mechanical Fabrication company, and has gradually expanded its scope of activity over the years. The Company was initially supplying to larger firms in the state and in those days the basic products were fabricated parts and pressure vessels. The Company later expanded adding a Foundry, Machine shop and Assembly shop.
With the expansion of the Company and with the technical skills available with the Engineering and Quality Assurance, electrical and electronic assemblies were also added to the Assemble shop. The Company started its operation initially from Srirampur Works and later moved into the present facility at Gopal Ram Nagar. The Srirampur Works has the Foundry, Machine shop and Heat Treatment facilities. The final assembly of both mechanical parts and electronic items is carries out at Gopal Ram Nagar Works from where the management team functions.
Since the two facilities are separated by a distance of about 25 kilometers, considerable movement of semi finished material takes place between the two sites. At present, the total employees strength of the Company is above 550 and the product base is changing and expanding, demanding modern facilities in manufacturing and resources. The Company is therefore putting its best efforts to change from inspection oriented approach to quality management system approach, in line with ISO 9000 Family of standards, with the help of Best Consultants Pvt Ltd.
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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.
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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”
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Section AA Issue 1 Rev 1 March 2009 Page 1 of 20
CONTENTS
Title Section No ISO Cl. no
Introduction
Quality Policy
Contents AA -
Record of Revision BB -
Quality Manual Operation CC -
Quality Management System 4.0 4
Management Responsibility 5.0 5
Resource Management 6.0 6
Product Realization 7.0 7
Measurement, Analysis 8.0 8
Improvement
Annexure 1
QMP Diagram –
Internal Audit Process 9.0 8
Annexure 2
Objectives & Process
Measures for Materials Dept. 10.0 7
Section BB Issue 1 Rev 1 March 2009 Page 2 of 20
RECORD OF REVISION
Rev No Date Section Revised Details of Revision
1 March 25, 2009 Original Issue -
2 May 22, 2009 5 Responsibility and
Authority
“ 7 “Production Process
Revised”
“ 8 Details of CAG
added
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Section CC Issue 1 Rev 1 March 2009 Page 3 of 20
QUALITY MANUAL OPERATION
This manual is prepared by the MR & approved by Director Quality.
The holder of the controlled copy shall not make further copies of the manual. If additional copies are required, a requisition is to be sent to MR. When the holder of controlled copy of the manual ceases to be an authorized copy holder, all the copies in his possession are to be returned to MR with due acknowledgement.
The MR will review this Manual periodically with the Departmental Heads to affirm its adequacy. Changes to the Manual are made by the Departmental Heads who revise the Manual. All the changes / amendments cancel and replace any previous copy of the Manual. Authorized copyholders shall maintain updated copy of the Manual. Departmental Heads maintain the amended version for reference and use.
Uncontrolled copies of this Manual (with no copy number) may be issued but these are not subject to updating procedure. Such copies are for information only. These copies may be identified as ‘Uncontrolled Copy’ on the contents page of the Manual.
The MR will retain copies of all previous issues / amendments of the Manual.
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Section 4.0 Issue 1 Rev 1 March 2009 Page 4 of 20
QUALITY MANAGEMENT SYSTEM
GENERAL
The quality management system of the company is based on the ISO 9000-2005 and it demonstrates the company’s ability to consistently meet the customer requirements. It aims to enhance customer satisfaction through implementation of the system including process for continual improvement.
4.1 General Requirement
The company has established, documented, implemented & maintained a quality management system and aims to continually improve its effectiveness in accordance with ISO 9000-2005 standard. The company has:
a) Identified the processes for QMA
b) Determined the interaction & sequences of the process
c) Ensured the effective operation & control of these processes
d) Ensured the availability of resources and information necessary to support the operation and monitoring of these processes.
e) Established methods to monitor, measure and analyse these processes.
f) Implemented actions necessary to achieve planned results & continual improvement of these processes
The processes and their interactions are described in the Departmental Manuals.
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Section 4.0 Issue 1 Rev 1 March 2009 Page 5 of 20
4.2 Documentation
The QMS maintained by the company is documented in the following documents.
Level – 1 QMS Manual: This addresses the requirements stated in the ISO9001-2008 Standards as applicable services provided by the company.
Level – 2 Quality system procedures.
a) As required by the standard and the company
b) As required for smooth functioning of its processes
These procedures describe the activities carried out by different departments to comply with requirements.
Level – 3 Work Instructions:
These are specific & complete instructions required for execution of specific tasks
4.3 Control of documents
It is ensured that the documents required by the QMS are controlled and are available at relevant points of use. Adequate controls are:
a) To approve the document for adequacy
b) To review and update the documents as necessary
c) To ensure that relevant versions of applicable documents are available at points of use
d) To ensure that documents remain legible and readily identifiable
Section 4.0 Issue 1 Rev 1 March 2009 Page 6 of 20
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.