Beruflich Dokumente
Kultur Dokumente
Institute of Quality
Confederation of Indian Industry
IRCA Registration No. : A17392
NABET Registration No. : LQ81 102
CONTENTS
EXERCISE E01
INTERPRETING THE
ISO 9001: 2008 CLAUSES
Whether covered
in Scope of ISO
2008
Reasons
9001:2008
Note
Time allotted:
EXERCISE E01
1)
XYZ Co. has its design center at Singapore and a manufacturing plant at
New Delhi. All products specifications originate at Singapore and the
manufacturing plant only manufacturers, as per the design specifications.
The manufacturing plant has decided to apply for Certification for a QMS,
which excludes Clause 7.3.
2)
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)
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)
provide
the
service
of
equipment
maintenance
to
the
10)
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)
Nonconformance
Yes
No
Immediate
clarificatio
n required
Yes
No
Add to
Checklist
Yes
Remarks
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
10
GEC-QMS-M 1
Copy No.: 10
Issue Date: 22/03/2009
Issued by: MR
Revision No. 2
11
INTRODUCTION
Goodwill Equipment Company Limited was founded in 1955 and since 1990
has been owned and managed by the present Managing Director.
GEC Ltd., was a traditional Mechanical Fabrication company, and has
gradually expanded its scope of activity over the years. The Company was
initially supplying to larger firms in the state and in those days the basic
products were fabricated parts and pressure vessels. The Company later
expanded adding a Foundry, Machine shop and Assembly shop.
With the expansion of the Company and with the technical skills available
with the Engineering and Quality Assurance, electrical and electronic
assemblies were also added to the Assemble shop. The Company started its
operation initially from Srirampur Works and later moved into the present
facility at Gopal Ram Nagar. The Srirampur Works has the Foundry, Machine
shop and Heat Treatment facilities. The final assembly of both mechanical
parts and electronic items is carries out at Gopal Ram Nagar Works from
where the management team functions.
Since the two facilities are separated by a distance of about 25 kilometers,
considerable movement of semi finished material takes place between the
two sites. At present, the total employees strength of the Company is above
550 and the product base is changing and expanding, demanding modern
facilities in manufacturing and resources. The Company is therefore putting
its best efforts to change from inspection oriented approach to quality
management system approach, in line with ISO 9000 Family of standards,
with the help of Best Consultants Pvt Ltd.
12
Our success is based upon a number of factors, not least of which, is our
expertise & willingness to pursue new areas of businesses. We are
particularly fortunate in being able to draw upon a skilled labour force.
Our sub-contractors provide us with specialist expertise in activities such as
non-destructive testing and heat treatment. They complete a team, which
can offer a wide range of services to our customers.
Since 1990, when the present Managing Director took over, the company has
grown to its present strength of 575 employees.
13
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
14
Section AA
Issue 1
Rev 1
March 2009
Page 1 of 20
CONTENTS
Title
Section No
ISO Cl. no
Introduction
Quality Policy
Contents
AA
Record of Revision
BB
CC
4.0
Management Responsibility
5.0
Resource Management
6.0
Product Realization
7.0
Measurement, Analysis
8.0
9.0
10.0
Improvement
Annexure 1
QMP Diagram
Internal Audit Process
Annexure 2
Objectives & Process
Measures for Materials Dept.
15
Section BB
Issue 1
Rev 1
March 2009
Page 2 of 20
RECORD OF REVISION
Rev No
Date
Section Revised
Details of Revision
Original Issue
Responsibility and
Authority
Production Process
Revised
Details of CAG
added
16
Section CC
Issue 1
Rev 1
March 2009
Page 3 of 20
17
Section 4.0
Issue 1
Rev 1
March 2009
Page 4 of 20
b)
c)
d)
e)
Established
methods
to
monitor,
measure
and
analyse
these
processes.
f)
18
Section 4.0
Issue 1
Rev 1
March 2009
Page 5 of 20
4.2 Documentation
The QMS maintained by the company is documented in the following
documents.
Level 1
Level 2
b)
Work Instructions:
These are specific & complete instructions required for execution
of specific tasks
b)
c)
d)
19
Section 4.0
Issue 1
Rev 1
March 2009
Page 6 of 20
20
Section 5.0
Issue 1
Rev 1
March 2009
Page 7 of 20
B)
Quality Policy
21
Section 5.0
D)
Issue 1
Rev 1
March 2009
Page 8 of 20
The responsibility and authorities are known from the structure of the
organization chart as shown below. The individual departmental structure
and their responsibilities are described in the departmental manuals.
Engineering Director
Company Secretary
General Manager
Machine Shop
Assembly
Heat Treatment
(Includes Foundry)
Managing Director
Director Sales
Director Quality
QA - Final
Director Materials
QA In Process
Director Finance
Calibration Lab
The functional responsibilities are:Managing Director, Mr. Fernandez: he is responsible for coordinating all
business and manufacturing activities of the company.
Engineering Director, Mr. Parthasarathy: He reports directly to the M.D and is
responsible for overall engineering design and development. He has the
authority to initiate and implement design changes at any time of
manufacture. He is also responsible for preparation and development of
standard designs and design modifications to meet customers requirement.
Company Secretary, Mr. Ashok Mitra: He is responsible for all legal matters in
relation to the companys. legal and statutory matters & concerning Board of
Directors. He is also responsible for auditing of administrative functions
including documents.
Work Book / Case Studies April 2010
22
Section 5.0
Issue 1
Rev 1
March 2009
Page 9 of 20
23
Section 5.0
Issue 1
Rev 1
March 2009
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 incharge is designated as the Management Representative (MR)
E)
Management Review
b)
c)
d)
e)
f)
g)
24
Section 5.0
Issue 1
Rev 1
March 2009
Page 10a of 20
2)
3)
4)
5)
25
Section 6.0
Issue 1
Rev 1
March 2009
Page 11 of 20
Human Resources
It is ensured that all the personnel engaged in performing work affecting the
products are competent on the basis of appropriate education, training, skills
and experience.
Competence, Awareness and Training
The company has the following activities to ensure competence, awareness
and Training
a)
b)
26
Section 7.0
Issue 1
Rev 1
March 2009
Page 12 of 20
The company plans and develops processes, which are consistent with the
other processes of the QMS. In planning for product realization, the quality
objectives and customer requirements are considered. Monthly and weekly
product plans are prepared and issued by Director Materials. These plans are
based on the availability and procurement of materials.
B)
The company makes efforts to determine the specified and implied needs of
the customer which are necessary for customer satisfaction. The statutory
and regulatory requirements related to the products are compiled by the
company. The Sales office has the responsibility of identifying needs of the
customer. The
concerned
department
heads
are
responsible
for
the
27
Section 7.0
Issue 1
Rev 1
March 2009
Page 13 of 20
The products provided by the company are standardized and as such there is
no requirement of
Engineering Director
Purchasing
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
Work Book / Case Studies April 2010
28
Section 7.0
Issue 1
Rev 1
March 2009
Page 14 of 20
their respective procedure. Neither the company nor its customers perform
verification at the supplier premises.
E)
Production process
1)
operation under
b)
c)
d)
Validation of process
There are no processes in the company where the resulting output cannot be
verified. Hence the clause on validation of processes is not applicable.
3)
It is ensured that all products and services are identified through out the
process. The products are identified by appropriate label at the time of
manufacturing. The services are identified at different stages such as
customer contact, sales, purchasing, after sales etc. These are related to
different departmental activities. Each department has its own procedures
and work instructions wherein the services and products get identified.
The status of product monitoring / measurement is indicated wherever
appropriate such as receipt, heat treated items, assembly in progress,
engineering job completion, etc.
Work Book / Case Studies April 2010
29
Section 7.0
4)
Issue 1
Rev 1
March 2009
Page 15 of 20
Customer property
The company exercises utmost care with the customers property when the
customer provides any product or information for incorporation into the
products supplied. Utmost care is taken to ensure that the customer does not
lose or suffer damage to his belongings. The overall responsibility rests with
the Manager Personnel & Administration who ensures the security of
customer belongings through a well organized security force.
5)
Preservation of product
The products provided by the company are handled, packed, stored and
preserved as appropriate. Electronic items and small sized products are
packed properly, whereas bigger items are not packed. It is the customer
responsibility for such products.
6)
Calibrated
at
specified
intervals
against
measurement
standards
c)
Protected
from
damage
and
deterioration
during
handling
&
maintenance
The engineering department maintains a list of measuring and monitoring
devices identified for calibration. The calibrations are carried as per
procedures in that department.
30
Section 8.0
Issue 1
Rev 1
March 2009
Page 16 of 20
B)
a)
b)
c)
Customer Satisfaction
Internal Audit
31
Section 8.0
D)
Issue 1
Rev 1
March 2009
Page 17 of 20
The respective department heads monitor the processes under their control
on a day-to-day basis.
The company takes care to ensure that nonconformities in the products are
reduced
or
eliminated.
It
is
realized
by
the
company,
that
the
final
testing
and
informed
to
the
concerned
department
for
32
Section 8.0
G)
Issue 1
Rev 1
March 2009
Page 18 of 20
Analysis of data
Continual improvement
Corrective action
The CAG identifies the nonconformities during the processing of product and
delivery.
b)
c)
d)
e)
Record the results of actions taken and reviewing the action taken
33
Section 8.0
J)
Issue 1
Rev 1
March 2009
Page 19 of 20
Preventive action
b)
34
Section 8.0
Issue 1
Rev 1
35
March 2009
Page 20 of 20
ANNEXURE 2
MATERIALS DEPARTMENT
OBJECTIVES
PROCESS MEASURERS
GEC-MAT-P3
Copy No.
05
Issue Date
22/03/2009
Issued By
MR
Revision No.
36
1)
2)
3)
4)
5)
6)
7)
37
Process/Product Measure
01.
02.
1,3,7
03.
1,3,7
04.
05.
1,4,5
06.
2,6
07.
1,5
08.
1,3
09.
10.
2,6
Relation to Objective
38
EXERCISE E02
PREPARATION OF AN
ONSITE AUDIT PLAN
39
E 02 : PREPARATION OF AN
ONSITE AUDIT PLAN
INSTRUCTIONS FOR E02
Objective
Prepare an On-Site Audit Plan after completing the Documentation Review of
GEC Ltd.
Method
Refer to Session 3 f) of your Course Notes for preparing an on-site audit plan
covering points on Audits scope, linkage between Policy, Objectives, Targets
monitoring and continual improvements. The plan should consider the core
and support business processes and their interaction reflect the organizations
goals, priorities and all other relevant points. Tutors should clearly steer the
participants away from functional thinking.
Format
Please present your responses in any preferred format and submit your
presentation on paper to the tutors.
Note
40
EXERCISE E03
CHECKLIST FOR AUDITING
A QMS PROCESS
41
2.
Method
Format
Please present you response in any format preferred by you and submit the
same to the tutors.
Note
42
EXERCISES
1.
2.
43
EXERCISE E04
OPENING MEETING
44
Each team should plan the opening meeting including agenda points in
line with session 9 and the case study.
The team leader to chair the meeting and be responsible for controlling
and running the meeting to plan.
45
The tutors will allocate the roles to be played by the different teams in
this Opening meeting just before the role play.
Note
Time allotted
Preparation
30 minutes
Role Play
15 minutes
Feedback
15 minutes
46
47
CS2
relates to manufacturing areas while CS3 relates to Service areas. The audit
has been carried out against ISO9001:2008 and the companys 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 GECs 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.
expected to identify such situations and term these findings as Potential NonConformances (PNCR) and write down what further probing may be required
to infer that they are NCRs.
48
NCR/PNCR/
Clause/
Quality Manual
Number
Statement
Subclause No.
Section / Procedure
No.
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.
2.
Question
Listen
Make notes
Search documents
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.
49
Note
Time allotted:
CS2
CS3
50
CS2
ONSITE AUDIT IN
MANUFACTURING AREAS
51
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.
objectives are also established for the Shops such as machine Shop
and Foundry & Heat Treatment.
He added further
that the Shop Incharges of Heat Treatment and Machine Shop only
assist him in achieving these objectives.
2)
quite empty.
Work Book / Case Studies April 2010
52
After searching for quite some time, the Supervisor showed a card and
said, here, this is it.
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.
The Auditor
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 recorders temperature
time graph.
The Auditor asked the Supervisor whether that is the way.
The
53
machine operators. The Auditor asked the furnace hands whether they
are trained for the job and whether they understand the importance of
the process.
quipped that they have been in the section for quite a long time.
4)
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.
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 General
Manager was also not aware and asked what needs to be analysed and
why (he sounded quite irritated).
down what the Auditor is looking for so that he can arrange the same
to be done quickly by outside agency.
6)
whether any furnace survey or any work has been done on the
furnaces.
54
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 Companys 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
The
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
Work Book / Case Studies April 2010
55
analysis thereon. The GM said that monthly review meetings are held
where
the
respective
shop
Supervisors
present
the
details
of
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
informing
them
of
their
responsibilities
and
authorities.
Regarding
Customer
requirements
and
Statutory
Regulatory
shrugged his shoulders and stated that he has almost no role to play
except to oversee that the requirements are met.
56
Hence the
57
Hence,
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 GMs office.
11)
him that he has limited time for an hour after which he would leave for
an important meeting.
confused and could not explain these issues. The inspector said that
the Inspection Department controls the process by inspections at
various stages.
The Auditor asked as to how the job instructions are received by the
assembly section.
58
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
The
Auditor noted that this control was not indicated in the process
document.
13)
He
further stated that revision C has been issued, this would be the
correct one for use.
59
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)
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.
looked surprised and made notes.
the Auditor left the Assembly Area.
60
The Auditor
15)
One of the Guides took one of the Auditors to the Calibration Lab
and introduced to him to the Incharge.
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.
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 LabIncharge explained that under the prevailing circumstances, both the
Laboratory and Engineering Department are doing their best.
16)
61
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 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
The Auditor
audit.
19)
62
The Auditor asked whether the Lab-Incharge has carried out any
survey
of
the
measurement
uncertainty
of
the
available
63
CS3
ONSITE AUDIT IN
SERVICE AREAS
64
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 Auditor asked what role these Offices had in the Sales
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.
65
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.
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.
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.
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.
time
came
back
to
say
that
the
particular
enquiry
and
its
confirmed that order one week ago. The Lead Auditor asked whether
any notings of the negotiations and meetings are made. The Manger
Work Book / Case Studies April 2010
66
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.
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
The Manager
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 Auditors point and
the Manager added. We do not yet know what the Manufacturing and
Assembly would come up with.
4)
The
Sales director replied that installation teams are sent to Customer sites
and if there are any problems, they are immediately attended. In the
67
to
look
for
Customer
Satisfaction
It expects the
as
well
as
dissatisfaction. The Director Sales replied that the company has done
whatever possible towards customer Satisfaction.
He said for
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.
released.
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.
Work Book / Case Studies April 2010
68
There
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.
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)
69
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
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
controls and monitoring are identified. The Manager replied that the
Director Materials decides on the supplier and hence he exercises
control.
70
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.
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
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.
Engineer from the Engineering Division is sent to carry out these types
of tests.
Process diagram is kept with the Director Materials. The Lead Auditor
and the Manager Purchase moved into the Directors Office.
The
Director arranged for tea and biscuits and then they got down to
Work Book / Case Studies April 2010
71
serious discussions.
looking for.
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.
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)
72
supplier was entered in a new page and data of analysis was available
with some remarks by the Director.
11)
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
73
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)
14)
74
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
16)
The Auditor asked the Director Engineering as to when was the last
Management Review meeting held.
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)
75
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
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.
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
76
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
perceived.
particularly
quality
management
system
is
being
happy with the growth of the company and now we have implemented
the systems as per ISO 9001 Standards."
77
EXERCISE E05
NCR WRITING
78
Time allotted
45 minutes
79
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.
80
QMS AUDIT
Incident Number
Note Number
Category
MAJOR*
MINOR*
* delete one
Deficiency
Auditor
Date:
81
EXERCISE E06
AUDIT SUMMARY REPORT
82
Format
Please prepare your Audit Summary in the Annexed format and submit on
paper to the Tutors.
Note
Time allotted
45 minutes
83
Report No:
On behalf of .
Audit Dates ..
Audit Team ..
Scope
Objectives
Audit Criteria
1.
2.
3.
Enclosures
1. Summary Statement
2.
3.
Date
Note
1. This audit is based on limited samples and other non-conformances
may exist.
2. This report and its contents should be treated as confidential
Work Book / Case Studies April 2010
84
EXERCISE E07
ROLE PLAY ON CLOSING
MEETING
85
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 agrees upon the presentations to be made by each member and
the team leader(roles and responsibilities must be clear including handling
questions).
86
The team leader to chair the meeting and be responsible for controlling
and running the meeting to plan.
The tutors will allocate the roles to be played by the different teams in
this closing meeting just before the role play.
Note
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
87
EXERCISE E08
EVALUATING PROPOSALS
FOR EFFECTIVENESS OF
CORRECTIVE ACTION
88
2.
3.
By reading the proposal, do you think they have done a root cause
analysis?
4.
Format
Please present your response in any format preferred by you and submit the
same to the tutors.
Note
89
Time allotted
30 minutes.
b)
Incident 3
NC: A subcontractor of TMX101 item was selected on the basis of price and
no further evaluation 6f the supplier was made. (7.4.1)
Proposed corrective action
Director Materials along with Director Quality shall review the requirements
with TMX101 items. Suppliers, those participated in the bid shall be
evaluated with the identified requirements. The selection of the supplier shall
take place based on the ability to supply TMX 101 items as per requirements.
90
SPECIMEN EXAMINATION
PAPER
91
INTERNATIONAL REGISTER
OF CERTIFICATED AUDITORS
Course No.
Date:
Marker 1
Market 2
Check
mark/arithmetic
check
Delete as
applicable
Pass mark
Maximum
1
2
3
4
4
8
8
12
10
20
20
30
Total
56
80
Name of marker
Verified
Result
Page 1 of 12
Page 2 of 12
Page 3 of 12
1.6
1.07
a.
b.
c.
d.
e.
1.08
a.
b.
c.
d.
e.
1.09
a.
b.
c.
d.
e.
1.10
a.
b.
c.
d.
e.
objective evidence.
a deficiency.
a nonconformity report.
all of the above.
none of the above.
What information is being sought during a third party audit of a quality system?
a list of non-conformities to ISO 9001.
objective evidence of conformity with ISO 9001.
a management commitment to quality assurance.
all of the above.
none of the above.
To act as an auditor of a quality system a person has to
be registered as a certificated auditor.
have a detailed knowledge of the product or service of the organization to be audited.
have been a quality systems manager.
all of the above.
none of the above.
The process approach to a quality management system seeks to help organizations:
manage numerous linked activities.
understand and fulfil requirements .
continually improve processes.
all of the above.
none of the above.
The extent of documentation of the quality system should be determined by:
the complexity of processes and their interactions.
the expectations of auditees.
the culture of the quality department.
all of the above.
none of the above.
95
Page 4 of 12
There are three types of quality system audit based on a first, second and third
party involvement. Explain the specific features that distinguish each of them. (5
marks)
2.2
Page 5 of 12
2.3
ISO 9000 identifies a process approach as one of the 8 quality principles that
support the achievement of quality objectives.
a. Explain your understanding of what is meant by a process approach (1 mark).
b. Identify at least 4 ISO 9001 clauses that support such an approach (4 marks).
2.4
An auditor is conducting a third party audit. The guide, who has been appointed to
accompany the auditor around the various departments, is called away by a senior
manager. After five minutes the guide has not returned.
What should the auditor do? (3 marks)
What should the auditor not do? (2 marks)
97
98
You are planning a process audit of an organization that consists of the following
departments:
- sales and marketing
- purchasing
- warehouse
- packing and despatch
- support services
The top management team consists of the Managing Director and departmental
managers from each of the above areas.
Page 7 of 12
100
Page 8 of 12
101
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:
Page 9 of 12
Nonconformity Number:
Category
MAJOR*
MINOR*
* delete one
Nonconformity:
Auditor:
Or, if you do not think that there is sufficient evidence of nonconformity, state the reasons
for your decision and state also what further actions the auditor should take
Page 10 of 12
Nonconformity Number:
Category
MAJOR*
MINOR*
* delete one
Nonconformity:
Auditor:
Or, if you do not think that there is sufficient evidence of nonconformity, state the reasons for
your decision and state also what further actions the auditor should take.
Page 11 of 12
Page 11 of 12
In the Purchasing Department the auditor asks how the new supplier for TMX101
items was selected. The purchasing clerk explains that the regular supplier could
not meet the delivery date and the order was placed with a supplier that they had
never used before, only because the price quoted was extremely low. The clerk
states that no other evaluation was carried out.
If you think there is evidence of a nonconformity, complete this report:
IRCA QMS AUDIT NONCONFORMITY REPORT
Company under Audit: XYZ plc
Nonconformity Number:
Category
MAJOR*
MINOR*
* delete one
Nonconformity:
Auditor:
Or, if you do not think that there is sufficient evidence of nonconformity, state the reasons for
your decision and state also what further actions the auditor should take.
End of examination
Page 12 of 12
Work Book / Case Studies April 2010
105
GUIDELINES ON LODGING
COMPLAINTS
91
Title
Guidelines On How To Make Complaints
Issue No.
Revision No.
Issue Date
01-10-06
Approved By
Page
1 of 2
1.0
1.1
Purpose
The purpose of this guideline is to inform delegates on the appeal procedure.
2.0
2.1
Scope
This work instruction covers all the complaints relating to administration,
conduct and management of certificated courses.
3.0
3.1
Responsibility
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
4.1
Complaints
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
response
resolved
informed
Reference
Procedure : CII/QMP/81
Title
WI/81
Issue No.
Revision No.
4.3
Issue Date
Page
1 of 2
01-10-06
In case complainant is not satisfied with CIIs actions, , they have the right
to appeal to IRCA and/or NABET at the following address :
Training Manager
Course No. : A5633
IRCA, P.O. Box : 25120
12 Grosvenor Crescent
London, SW IX 7ZL
Tel. : +44(O) 20 7245 6833
Fax : +44(O) 20 7245 6844
E-mail: irca@irca.org
5.0
Approved By
Records
Record of complaints file
6.0
References
6.1
Forms
Forms 17 : Record of Complaints
Director
National Registration Board
for Education and Training
Institute of Engineers Building, 2nd
Floor, Bahadur Shah Marg
New Delhi 110002
Tel. : +91 11 2337 0567
Fax : +91 11 2337 9621
e-mail : nrbpt@qcin.org
Reference
Procedure : CII/QMP/81
94
94
95
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.
1 of 3
Form 6/Oct 2006/01
ii)
The
purpose,
content
and
interrelationship of ISO 9000, ISO
9001, ISO 9004 and ISO 19011.
iii)
iv)
v)
vi)
vii) Undertaking
audit
follow-up
activities, including evaluating the
effectiveness of corrective action.
1
4
Fully
satisfied
Fairly well
satisfied
Not very
well
satisfied
Not at all
satisfied
2.
AIMS
3.
COURSE
DESIGN
DELIVERY
How satisfied were you with the
a)
b)
c)
d)
e)
Fair
Poor
3
3
3
3
3
2
2
2
2
2
1
1
1
1
1
&
4
4
4
4
4
Visual aids
Course notes
Case studies & exercises
Syndicate Work & Role play
Course Structure
Good
Relevant
97
4.
TUTOR SKILLS*
T1
T2
T1
T2
T1
T2
T1
T2
4
4
4
4
4
4
4
4
4
4
3
3
3
3
3
3
3
3
3
3
2
2
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
Clarity
Time Management
Coverage
Response
Presentation
PARAMETERS
5.
Fully
satisfied
Fairly well
satisfied
4
4
4
3
3
3
2
2
2
1
1
1
4
4
3
3
2
2
1
1
Too
advanced
About right
Too
elementary
ADMINISTRATION
Registration
and
response
time
b.
c.
Planning?
Environment
audibility)
d.
Catering
e. Information & Feedback
(comfort,
6.
CONTENT
a) Was the subject level (pl. tick)
b) Were the subjects (pl. tick)
Very
relevant
Partly
relevant
Not at all
relevant
COMMENTS :
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.
98
3 of 3
Form 6/Oct 2006/01
99
2 of 4
Form 6/Oct 2006/01
100
4 of 4
Form 6/Oct 2006/01
101