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LEAD AUDITOR / AUDITOR COURSE

FOR QUALITY MANAGEMENT

SYSTEM

ISO 9001 : 2008

Institute of QualityConfederation of Indian Industry

IRCA Registration No. : A17392NABET Registration No. : LQ81 102

WORKBOOK / CASE STUDIES

CONFEDERATION OF INDIAN INDUSTRY

Institute of QualityNear Bharat Nagara, II Phase, Magadi Main Road

Vishwaneedam Post, Bangalore – 560091Tel: 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

WORKBOOK / CASE STUDIES

Work Book / Case Studies April 2010 3

CONTENTS


EXERCISE E01

INTERPRETING THEISO 9001: 2008 CLAUSES

E01: INTERPRETNG THEISO 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

Reasons

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 E011) XYZ Co. has its design center at Singapore and a manufacturing plant at

New Delhi. All products specifications originate at Singapore and the manufacturing plant only manufacturers, as per the design specifications. The manufacturing plant has decided to apply for Certification for a QMS, which excludes Clause 7.3.

2) The MR of a Company says “all our current procedures have been repeated, replacing the word ‘PROCEDURE FOR………’ to ‘PROCESS FOR……….; we have not done any other changes, in the documentation”.

3) An Emission from XYZ Company was found to have a pollutant that may cause adverse impact on health of the employees in the long run.

4) Tiger Toys Ltd., designs and produces toys and play equipment, as per product codes and regulations. The regulations do not require the QMS to include design, for the safety class of the products of the Company. Based on this, Tiger Toys also decides to exclude clause 7.3 from its QMS.

5) ABC Projects Ltd., designs, develops and produces heavy equipment, but does not have in house design facility. The design activities are sub contracted to XYZ Co. Ltd., which is an engineering consultancy Company. During the audit, the Project Manager says, “we leave the complete Design Process to them”.

6) Purchasing process does not address the assistance given to suppliers towards their development.

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

8) A Company providing leasing services of earthmoving equipment to civil contractors and builders has its Business Operations Divisions at its


headquarters and six repair workshop around the country. The repair shops provide the service of equipment maintenance to the headquarters, and have no interactions with the Company’s customers. One of the workshops is pursing certification to ISO 9001:2008 even before the parent Company. The workshop management has excluded the clauses 7.2, 7.3, 7.4 and 7.5.4 from their QMS.

9) Sources of information on customer satisfaction only include customer complaints and Questionnaire & Surveys but do not include focus groups reports in various media, sector & industry studies.

10) The Training Manager of a Company says that increasing profits of the Company amply demonstrates the effectiveness of their training plans and programmes.

11) Laxmi Bank is implementing ISO 9001: 2008 for the realization of its various services. The Bank has excluded 7.5.3 & 7.5.4 from its QMS.

12) Corrective Action Procedure of the company does not include results of Self Assessment.



CASE STUDY – CS1

DOCUMENTATION REVIEW OF A QUALITY MANUAL

CS1: DOCUMENTATION REVIEW OF A QUALITY MANUAL

INSTRUCTIONS FOR CS1

ObjectiveDocumentation 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.

FormatPlease 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

Remarks

Yes 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.


Quality Management System Manual

Goodwill Equipment Company Ltd.,54-56, Yallers Compound,

New Achievers Road,Gopal Ram Nager

GEC-QMS-M 1Copy No.: 10

Issue Date: 22/03/2001Issued by: MRRevision No. 2

CASE STUDY – DO NOT MARK ON SCRIPT


INTRODUCTION

Goodwill Equipment Company Limited was founded in 1955 and since 1982 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 1982, 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 2001 Page 1 of 20

CONTENTS

Title Section No ISO Cl. no

IntroductionQuality PolicyContents AA -Record of Revision BB -Quality Manual Operation CC -Quality Management System 4.0 4Management Responsibility 5.0 5Resource Management 6.0 6Product Realization 7.0 7Measurement, Analysis 8.0 8Improvement

Annexure 1

QMP Diagram – Internal Audit Process 9.0 8

Annexure 2

Objectives & ProcessMeasures for Materials Dept. 10.0 7


Section BB Issue 1 Rev 1 March 2001 Page 2 of 20

RECORD OF REVISION

Rev No Date Section Revised Details of Revision

1 March 25, 2001 Original Issue -

2 May 22, 2001 5 Responsibility and Authority

“ 7 “Production ProcessRevised”

“ 8 Details of CAG added


Section CC Issue 1 Rev 1 March 2001 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 2001 Page 4 of 20

QUALITY MANAGEMENT SYSTEM

GENERAL

The quality management system of the company is based on the ISO 9000-2008 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 9000-2008 standard. The company has:a) Identified the processes for QMAb) Determined the interaction & sequences of the processc) Ensured the effective operation & control of these processesd) Ensured the availability of resources and information necessary to

support the operation and monitoring of these processes. e) Established methods to monitor, measure and analyse these

processes. f) Implemented actions necessary to achieve planned results & continual

improvement of these processes

The processes and their interactions are described in the Departmental Manuals.



4.2 Documentation

The QMS maintained by the company is documented in the following documents.Level – 1 QMS Manual: This addresses the requirements stated in the

ISO9001-2008 Standards as applicable services provided by the company.

Level – 2 Quality system procedures.a) As required by the standard and the companyb) As required for smooth functioning of its processesThese 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 adequacyb) To review and update the documents as necessaryc) To ensure that relevant versions of applicable documents are available

at points of used) 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 policyc) Conducted periodic management reviewd) Ensured the availability of resources.

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



D) Responsibility and AuthorityThe 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.

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. Section 5.0 Issue 1 Rev 1 March 2001 Page 9 of 20


Managing Director

Engineering Director

Company Secretary

General Manager

Machine Shop

Assembly

Heat Treatment(Includes Foundry)

Director Sales

Director Quality

Director Materials

Director Finance

QA - Final

QA – In Process

Calibration Lab

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. Section 5.0 Issue 1 Rev 1 March 2001 Page 10 of 20


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 ReviewThe 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 & complaintsc) Corrective & preventive actionsd) Follow up actions from previous review.e) Performance evaluation of suppliers & subcontractorsf) Resources & Training needs (annual)g) Changes & Recommendations for improvements in QMSReview 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 2001 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 index2) Reduction in number of customer complaints / repeat complaints3) Improvement in delivery schedule adherence4) Reduction in rejects and reworks5) Cost reduction / value improvements



6.0 RESOURCE MANAGEMENT

The Management of the Company has determined & provides resources neededa) 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 TrainingThe company has the following activities to ensure competence, awareness and Traininga) Determination of competence levels for different positions.b) Provision of Training to ensure that competence levels are achieved.These activities are coordinated through the Company Secretary.

Infrastructure The company is equipped with facilities such as well designed and well furnished rooms, dining area, transportation etc which are maintained in good condition at all times.

The company is also equipped with facilities & equipment to provide amenities such as central air conditioning to the offices, stand by power and communication, through a team of experienced & competent personnel.

Head of Engineering is responsible for identifying and providing the resource requirements.



7.0 PRODUCT REALISATION

A) Planning for Product RealisationThe 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 processesThe 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 & DevelopmentThe 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) PurchasingThe 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 Section 7.0 Issue 1 Rev 1 March 2001 Page 14 of 20


their respective procedure. Neither the company nor its customers perform verification at the supplier premises.

E) Production process1) 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 processThere 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 TraceabilityIt 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.Section 7.0 Issue 1 Rev 1 March 2001 Page 15 of 20

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 productThe 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 devicesThe 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 adjustmentsc) Protected from damage and deterioration during handling &

maintenance

The engineering department maintains a list of measuring and monitoring devices identified for calibration. The calibrations are carried as per procedures in that department.



8.0 MESUREMENT, ANALYSIS & IMPROVEMENT

A) The company has planned and implemented measurement, analysis and improvement processes needed to:-

a) Demonstrate conformity of the productb) Ensure conformity of QMS and c) Continually improve the effectiveness of the QMS

B) Customer SatisfactionThe 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 AuditInternal 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 processThe 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 productsFor 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 productsThe 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 dataThe individual departmental heads collect appropriate data on issues described earlier for example customer complaints, process and product conformance, nonconformance, internal audits etc.

This data is analyzed in the respective sections to verify and confirm the suitability of the QMS and to evaluate areas for continual improvement of the QMS.

H) Continual improvementThe company strives to continually improve the effectiveness of the QMS primarily during the management review meetings and other means such as achievement of quality objectives, audit results, analysis of data, corrective & preventive actions.

I) Corrective actionThe 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 conformitiesb) Determining causes of nonconformitiesc) Evaluating the action to prevent the recurrence of nonconformitiesd) Determining & implementing corrective actionse) Record the results of actions taken and reviewing the action taken



J) Preventive actionThe 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 causesb) Evaluating the action needed to prevent non-conformities.


ANNEXURE – 2

GOODWILL EQUIPMENT COMPANY LIMITED

MATERIALS DEPARTMENT

OBJECTIVES

PROCESS MEASURERS

GEC-MAT-P3

Copy No. : 05Issue Date : 22/03/2001Issued By : MRRevision No. : 0


OBJECTIVES FOR MATERIALS DEPARTMENT

1) Reduction in Lead Time for Procurement

2) Reduction of Rejections of Incoming Materials due to Improper Communication of Specifications to Suppliers

3) Improvement in Delivery Adherence by Suppliers

4) Reduction in Lead Time of Payment to Suppliers

5) Reduction in Inventory Turns Over time at Receipt Stores

6) Increase in Suppliers with “Direct On Line” Status

7) Cost Reduction / Value Improvement by Key Suppliers


PROCESS AND PRODUCT MEASURES

(LINKED TO OBEJCTIVES)

Sl.No. Process/Product Measure Relation to Objective

01. Reduction of Time from Receipt of indent/purchase Request to issue of PO

1

02. Reduction of Production Lead Time of Key Suppliers

1,3,7

03. Reduction of Changeover/Setup Time in Production Area of Key Suppliers

1,3,7

04. Reduction of Specification Mismatch between indent / Request and Purchasing Data found during Audit

2

05. Reduction of “Store Receipt / Inspection Clearance” Time

1,4,5

06. Improvement in Straight Pass Ratio (OK Material / Received material) of Key Suppliers

2,6

07. Monitoring of Item Wise days of Inventory (based on Item wise closing stock and shop consumption pattern)

1,5

08. Monitoring of Lead Time of Procurement, Supplier wise

1,3

09. Reduction of Time of Preparing, Payment Instruction after Material is ok

4

10. Reduction in Repeat Nature of Rejection at Receipt Stage

2,6



EXERCISE E02

PREPARATION OF ANONSITE 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.

MethodRefer to Session 6 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.

FormatPlease 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 AUDITINGA QMS PROCESS


Objective Prepare two checklists for1. auditing a Quality Management System Process2. 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.

FormatPlease present you response in any format preferred by you and submit the same 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 feedback would be given to the participants

Time allotted: 45 minutes

EXERCISESWork Book / Case Studies April 2010 41

1. You are conducting an audit of a medium sized manufacturing company. The document review has raised a concern about how the organization ensures the competence of staff.

Prepare a checklist that would guide you through a process audit of this area and state the relevant ISO 9001 clauses.

2. What objective evidence could be available in order to verify compliance with requirements of Clause 7.2.3 of ISO 9001? In your presentation, make links to other ISO 9001 clauses as necessary.



EXERCISE E04

OPENING MEETING

E04 : ROLE PLAY ON OPENING MEETING


Objective To conduct an Opening Meeting in line with what has been covered in the course notes.

MethodEach 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 This is a group exercise Nominate a time keeper, Team leader and Audit team members. This roleplay exercise is part of the formal continuous assessment and

will therefore be marked.

Time allottedPreparation : 30 minutesRole Play : 15 minutesFeedback : 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.

MethodologyCase 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

Number

NCR/PNCR/

Statement

Clause/

Subclause No.

Quality Manual Section

/ Procedure No.

Guidelines for CS3 (Role Play)1. The preparatory work of the role play of the auditors & the role of the

observers for all the incidents should make use of the following guidelines. These guidelines would facilitate the conduct of an audit interview in a structured and systematic manner Use a checklist effectively and follow audit trails Gain an understanding of the process, including its purpose,

inputs, outputs, controls and related quality objectives Build rapport with the auditee Question Listen Make notes Search documents Select sufficient and relevant samples Provide feedback to the auditee

2. When 1 group plays the role of the auditor, the other groups will provide feedback.

3. The incidents that would be taken up for the role play would be communicated to the participants at an appropriate time before the presentation.

Note These are group exercises followed by individual work


Nominate a time keeper, presenter All the groups to work on all the incidents Allocation of incidents to groups for presentation will be

informed before the presentation Each group presentation would comprise at least one role play

(for CS3 only) 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 AUDITIN 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 INSERVICE 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. Nominate a time keeper, presenter. The output of the exercise is part of the formal continuous

assessment and will therefore be marked.

Time allotted : 45 minutes


EXERCISES

Incident Number 1 During an audit of management review activities you notice from the minutes of management review meetings that the meetings are not attended by any of the top management team. When you query this, the management representative tells you that management review has evolved into a two tier process, as it was proving so difficult to get all of the departmental and top managers available at the same time. The process is now that departmental managers meet and conduct the first level of management review. The management representative prepares a summary report including actions and recommendations. This is passed round each of the top management team for comment, and the Managing Director finally agrees the action plan.

Incident Number 2 During an audit of internal audits you are shown internal audit reports from the last audit. These include a non conformity report stating that 3 people in the purchasing department had not been trained in the use of the approved supplier list. The corrective action taken was to train the 3 members of staff. The audit report has been closed. The management representative tells you that no further investigation was made as the corrective action was obvious. The internal auditor had checked the training records of the staff concerned before closing the reports.

Incident Number 3 In the Purchasing Department the auditor asks how the new subcontractor for TMX 101 items was selected. The purchasing clerk explains was placed with a subcontractor which they had never used before, only because the price quoted was extremely low. The clerk states that no other evaluation was conducted.


QMS AUDIT Incident Number………………

NON CONFORMITY REPORT

Company under Audit: GEC Ltd., Note Number………………………

Area under review: ISO 9001: 2008 Clause Number

……………………………………… ……………………………………………

Category MAJOR* MINOR* * delete one

Deficiency

Auditor Date:

If you do not think that there is sufficient evidence of non-conformity, state the reasons for your decision and state also what further actions the auditor should take._____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________



EXERCISE E06

AUDIT SUMMARY REPORT

E06: AUDIT SUMMARY REPORT


Objective To prepare an accurate, meaningful, Audit Summary Report.

Method Now that the audit at GEC Ltd. is completed, prepare an Audit

Summary Report, using the learning of session 11. The report should cover among other items, scope and

objectives of the audit, positive audit findings, opportunities for improvement and recommendations.

Format Please prepare your Audit Summary in the Annexed format and submit on paper to the Tutors.

Note 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 feedback would be given to the participants

Time allotted : 45 minutes



AUDIT SUMMARY REPORT

External Audit of …………………………… Report No:

On behalf of ………………………………….

Audit Dates …………………………………..

Audit Team …………………………………………………………………………..

……………………………………………………………………………

……………………………………………………………………………

Scope

Objectives

Audit Criteria 1.2.3.

SUMMARY STATEMENT – Enclosed

Recommendations / Conclusions

Enclosures

1. Summary Statement2.3.

Signed by: (Lead Auditor) Date

Note1. This audit is based on limited samples and other non-conformances

may exist.2. This report and its contents should be treated as confidential


EXERCISE E07

ROLE PLAY ON CLOSING MEETING

E07 : ROLE PLAY ON CLOSING MEETING


ObjectiveTo conduct a Closing Meeting in line with what has been covered in the course notes.

MethodEach 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 This is a group exercise Nominate a time keeper, Team leader and Audit team members. This roleplay exercise is part of the formal continuous assessment and will

therefore be marked.

Time allotted

Preparation : 30 minutes

Role Play : 30 minutes

Feedback : 30 minutes



EXERCISE E08

EVALUATING PROPOSALSFOR EFFECTIVENESS OF

CORRECTIVE ACTION

E08 : EVALUATING PROPOSALS FOR EFFECTIVENESS OF CORRECTIVE ACTION


ObjectiveEvaluation of effectiveness of corrective action.

MethodFor 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?

FormatPlease present your response in any format preferred by you and submit the same 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 : 30 minutes.


PROPOSALS FOR CORRECTIVE ACTION - E08

Incident 2NC: 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 actiona) 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 actionDirector 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

INTERNATIONAL REGISTEROF 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 ONLYSection Marker 1 Market 2

Check mark/arithmetic

checkDelete as applicable

Pass mark Maximum

1 4 102 8 203 8 204 12 30

Total 56 80Name of marker VerifiedResult

Examination for Auditors of Quality Management Systems

IRCA/146 QMS 5/08/1, November 2008IRCA 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 marksEach 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.d. all of the above.e. none of the above.

1.03 ISO 9001 includes:

a. health and safety requirements.b. quality planning.c. quality costing.d. all of the above.e. none of the above.

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.d. all of the above.e. none of the above.

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.d. all of the above.e. none of the above.



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.d. all of the above.e. none of the above.

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.d. all of the above.e. none of the above.

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.d. all of the above.e. none of the above.

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.d. all of the above.e. none of the above.

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.d. all of the above.e. none of the above.

Work Book / Case Studies April 2010 93IRCA/146 QMS 5/08/1, November 2008IRCA examination paper QMS 5 Specimen Paper, amended for use on certified course Axx operated by TO

Page 4 of 12

Section 2 worth 20 marksEach 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)



Page 5 of 12

2.03 ISO 9000 identifies a “process approach” as one of the 8 quality principles that support the achievement of quality objectives.

a. Explain your understanding of what is meant by “a process approach” (1 mark).b. Identify at least 4 ISO 9001 clauses that support such an approach (4 marks).

2.04 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)

Work Book / Case Studies April 2010 95 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 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 servicesThe 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.

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 7 of 12



Page 8 of 12

Section 4 worth 30 marks

Three incidents that occur during a third party audit of a supplier are described below. They contain situations for which nonconformity reports may be required. Examine each incident carefully then take one of the following actions:

a) If you think that there is sufficient objective evidence of nonconformity, you should complete a nonconformity report and categorise it as major or minor.

b) If you do not think that there is sufficient objective evidence of nonconformity, you should: state why you think there is insufficient evidence of nonconformity make a list of things you would look for as evidence that the situation is under

control

The answer to each incident is worth 10 marks.



Page 9 of 12

Incident Number 1

During an audit of management review process, the auditor notices from the records of the management review meetings that the meetings are not atten-ded by any of the top management team. When the auditor queries this, the management representative explains that management review has evolved into a two tier process, as it was proving so difficult for all of the departmental and top managers to be available at the same time. The process is now that departmental managers meet and conduct the first tier of management review. The management representative prepares a summary report including actions and recommendations. This is passed round each of the top management team for comment, and the Managing Director finally agrees the action plan.

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

IRCA QMS AUDIT – NONCONFORMITY REPORT

Company under Audit: XYZ plc Nonconformity Number:

Area under review: ISO 9001 Clause Number:


Nonconformity:

Auditor:

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



Page 10 of 12


Page 10 of 12

Incident number 2

During an audit of internal audits the auditor is shown internal audit reports from the last audit. These include a nonconformity report stating that 3 people in the purchasing department had not been trained in the use of the approved supplier list. The corrective action taken was to train the 3 members of staff. The audit report has been closed. The management representative tells you that no further investigation was made as the corrective action was obvious. The internal auditor had checked the training records of the staff concerned before closing the reports.






Nonconformity:

Auditor:

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


Incident Number 3

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






Nonconformity:

Auditor:

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



Page 11 of 12


Page 11 of 12


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 Page2 3 01-10-06 1 of 2

1.0 Purpose1.1 The purpose of this guideline is to inform delegates on the appeal procedure.

2.0 Scope2.1 This work instruction covers all the complaints relating to administration,

conduct and management of certificated courses.

3.0 Responsibility3.1 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 Complaints4.1 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

2 3 01-10-06 1 of 2

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 DirectorCourse No. : A5633 National Registration BoardIRCA, P.O. Box : 25120 for Education and Training12 Grosvenor CrescentLondon, SW IX 7ZL Institute of Engineers Building, 2nd

Floor, Bahadur Shah MargTel. : +44(O) 20 7245 6833 New Delhi 110002Fax : +44(O) 20 7245 6844E-mail: [email protected] Tel. : +91 11 2337 0567

Fax : +91 11 2337 9621e-mail : [email protected]

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

mailto:[email protected]

mailto:[email protected]


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 Relevant

Fair Poor

1. OVERALL RATING

a) Considering the general objective of 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 principles of quality management.

ii) The purpose, content and interrelationship of ISO 9000, ISO 9001, ISO 9004 and ISO 19011.

iii) Interpreting requirements of ISO 9001 in the context of an audit

4

4

4

4

3

3

3

3

2

2

2

2

1

1

1

1

1 of 3Form 6/Oct 2006/01

iv) The roles and responsibilities of auditors and lead auditors.

v) Plan and conduct and audit in accordance with ISO 19011.

vi) Reporting the audit, including writing valid, factual and value-adding non-conformity reports.

vii) Undertaking audit follow-up activities, including evaluating the effectiveness of corrective action.

4

4

4

4

3

3

3

3

2

2

2

2

1

1

1

1

2. AIMS Fully satisfied

Fairly well satisfied

Not very well

satisfied

Not at all satisfied

a) How well did the course meet its aims, as you understood them?

b) How well were your specific needs met?

4

4

3

3

2

2

1

1PARAMETERS Excellent Good

RelevantFair Poor

3. COURSE DESIGN & DELIVERYHow satisfied were you with the

a) Visual aidsb) Course notesc) Case studies & exercisesd) Syndicate Work & Role playe) Course Structure

44444

33333

22222

11111

4. TUTOR SKILLS*

How do you rate the following skills:

a) Clarityb) Time Managementc) Coveraged) Responsee) Presentation

T1

44444

T2

44444

T1

33333

T2

33333

T1

22222

T2

22222

T1

11111

T2

11111

PARAMETERS Fully satisfied

Fairly well satisfied

Not very well

Not at all


2 of 3Form 6/Oct 2006/01

satisfied5. ADMINISTRATION

How satisfied you were with the :

a. Registration and response time

b. Planning?c. Environment (comfort,

audibility)d. Cateringe. Information & Feedback

444

44

333

33

222

22

111

11

6. CONTENTa) Was the subject level (pl. tick)

b) Were the subjects (pl. tick)

Too advanced

Very relevant

About right

Partly relevant

Too elementary

Not at all 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


2 of 4Form 6/Oct 2006/01

3 of 3Form 6/Oct 2006/01


4 of 4Form 6/Oct 2006/01

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