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Effective Implementation of Quality Management Systems
Effective Implementation of Quality Management Systems
B. Purushothama
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deviations and take preventive actions with the involvement of people and
a committed management. The real implementation actually reduces the
work, as you will be auditing, identifying the non-conformities and taking
corrective and preventive actions, and go on improving your systems on a
continual basis. As the activities are customer-focused, the sale is
guaranteed.
In this book, I have tried to explain the real need for implementing the
systems, the steps in implanting, the roles and responsibilities of
management representative, making effective internal quality audits by
linking exercises, assessing the level of implementation of ISO 9001,
inviting complaints and treating customer as a free consultant, and freely
facing the audits. I hope this book will drive out some of the misconcepts
and help the organizations to become strong and competitive.
B. Purushothama
Sustaining business
1
Sustaining business
. Introduction
In earlier days, normally, the trade was a family business. People used to
stick to their family trade, irrespective of the profitability. They were
respecting what their ancestors did. A carpenter’s son used to become a
carpenter and a soldier’s son used to become a soldier. The community
was recognised by the trade they did, and it was even used as surname.
People were not entering in the trade of others, and an act of doing other’s
trade was even punishable. There was no competition as the productions
were less and the demand was certain.
The increase in demands and the desire to earn more and more led to
development of technology and ultimately to the industrial revolution.
Gradually as the concepts of management was developed, the concepts of
high speed production to reduce the cost of manufacturing pierced in the
minds of the industrialists and technicians. Organized industries started
replacing the earlier cottage industries or craftsmen business. The earlier
craftsmen were compelled to join the organized industries as labourers as
they were not able to compete with the industry by their craftsman skills.
Rapid technological developments and system developments were seen in
20th century as a by-product of the world wars. There were social reforms
also, and the barriers for others in the trade that was being managed by
particular family or community no longer exist. Now a son of a farmer can
become a doctor, and a teacher’s son can become an agriculturist. The
education is open to all and anyone can enter the business. The labourer’s
children no longer wish to work as a labourer as the earnings are much
less compared to other trades. It is now very difficult to get servants to do
petty jobs, where as earlier that was the main job of illiterate poor people.
Now people are able to make their own assessment and try to enter into
that trade where the earnings are more. A number of new industries are
being started because of the financial supports given by governments and
public. This very act led to the competition between units of the same
industry and also between industries.
1
2 Effective implementation of quality management systems
1.2 Recession
As the technology progressed, the speeds of production increased. The
latest high speed machines can produce more than 3–4 times compared to
the machines that were running two decades back. Further, the
developments in engineering aspects assured good quality product even
at the high speed. Therefore, the industries preferred replacing their old
machines with latest state of the art machines to get higher production and
better quality.
Along with the growth of technology, the cost of living also started
increasing. People demanded higher and higher remunerations as the speed
of production increased. As people preferred to work where salaries are
high, a scarcity was developed for skilled human workers, those could
work at a lower wage. The latest technologies, therefore, concentrated on
reducing the human dependency in the activities by automating wherever
possible. The term ‘rationalization of employment’ came to restrict the
component of employee cost in the total cost of manufacture. Voluntary
retirement scheme (VRS) was introduced in the industries as well as service
organizations including government establishments to reduce the number
of employees.
As the technology was developed, old machinery was removed and new
high speed machines were put. The skilled people in a number of industries
opted for VRS and started their own small units by purchasing the old
machines on which they were working earlier as an employee. The
governments supported small scale industries by giving them tax benefits
and soft loans. These small industries became competitors for large
industries because of the cheapness of their products. Also, the eruption
Sustaining business 3
of small industries added to total products available in the market, and the
supply exceeded the demands.
Adapting high speed machines and increasing productions were
preached as an easy way of reducing the contribution of overheads per
unit production and increasing profitability by the costing and management
experts. The calculations were simple. The manufacturing industries started
expanding and increasing their productions in volumes to reduce the cost
of manufacture of unit piece. They were able to achieve this, but
unfortunately were not able to sell their products, as the total demands
remained same or started reducing because of the improved quality products
that were durable.
It is observed that the recession is a cyclic phenomenon. It is repeating
every 10–12 years. As the technology developed, new machineries are
installed and the production is increased. This led to competition and surplus
material in the market leading to recession. The weak performers have to
shut their operations, and even the good performers make loss during the
recessions and reduce their productions. After some time, reduction in
production leads to short of materials and the demand starts. This is called
as a boom period. Recession is cyclic so also the boom period. When the
boom period comes, everyone invests and expands, leading to recession
again (Fig 1.1). Companies with good forward thinking does not simply
expand, but also try to bring innovative products to the markets and will
always be first to introduce new products and capture the market.
Boom period
Performance
Time years
Recession
Recessi
were wild and they could have killed him if he tried to take ivory without
killing them. He stayed in the forests where there were no houses, no luxury,
no facilities and no protection. He had to spend day and night in forests
along with wild animals. The police were after him, so he had to fight
with them and kill the police. He had very good communication systems
in those forest areas that never used mobile phones or satellite services.
He was able to get the information about the movement of police precisely,
where as police were finding very difficult to access he area in spite of
having electronic gadgets, mobile phones, wireless, etc. From the point of
definitions discussed above, i.e. fitness for purpose, working for customer
satisfactions, totality of characteristics of an entity that bear on its ability
to satisfy stated or implied needs of a customer, etc., we must honour him
as the ‘Best Quality Person’. We are not ready to sacrifice our life or family
for the sake of customers, but Veerappan did it. Why are we not recognizing
such quality persons and rewarding them?
Take the examples of terrorists. They plan well and attack. They do
their work right at first time for the sake of their customers, who are looking
after their families and community. Can we call them as quality persons?
Certainly we do not accept smugglers, poachers, thieves, robbers,
terrorists as quality people. Then what is missing in the definition of
‘Quality’?
Take some more examples.
A garment company is producing good quality garments at a very low
price and their customers are very happy. The deliveries are given in time
as agreed in the contracts. They boast themselves as having the lowest
lead time. To achieve this, the employees, who come from poor families,
toil in a bad working condition. They are paid less and kept almost as
‘bonded labour’ much away from their families. The supervisors and
workers work extra hours without getting the overtime wages as per the
rules. The ladies are not looked after well. No facility of crèche is provided
for the babies. The company makes profit, and world’s best brands get
their garments stitched from them. The buyer’s agents who come for doing
compliance audit give a clean chit to that factory, because, if they disqualify
that factory, then they need to pay more and purchase from others. They
shall become uncompetitive. The certifying bodies also give certificates
of ISO 9001, SA 8000, etc, as their business depends on giving more
certificates to the organizations. If they do not give certificate, they will
loose the business and some one will give the certificate. Can you call that
company as a good ‘Quality Company’? They are meeting the requirements
of their customers. The actions taken by the management are fit for the
purpose, i.e. providing the quality goods to the customers at lowest possible
price and at lowest lead time. It meets the definition given by Armand
8 Effective implementation of quality management systems
Customer Requirements
Specified Unspecified
Expectations are clear. Customer has no time to sit and list out
Suppliers are clear. all requirements.
Customers are clear. Customer feels the requirement when a
Process is designed and monitored. problem arises.
Customer feels the requirement when
some one else has got it.
Customer knows the needs but does
not effectively express.
Customer expects the supplier to know.
Once the needs are clear, then we can design the processes to ensure
that the quality is achieved.
How quality is ensured?
■ By devising correct work methods,
■ Providing correct materials in time,
■ Engaging competent personnel and training them adequately,
■ Proactively inspecting the machines and maintaining them properly,
■ Checking the material in process and the process itself,
■ Reviewing the systems periodically for their continued suitability,
■ By inspecting the material produced,
■ Checking the documents produced,
■ Getting the services of an external inspection agency,
■ Rejecting the nonconforming materials,
■ Visiting customer place to study the working of our materials and
taking corrective actions and
■ Getting customer feedback and taking measures to correct the situation.
All the points above can be implemented by taking guidance of
International Standards of ISO 9000. One can take more benefits by adapting
the guidelines given in these standards in the daily affairs rather than
concentrating only on getting a certificate. Please remember that a certificate
can impress a customer before starting the real business. Once the business
is started, it is the consistency in the quality of products and services, the
prompt and ethical dealings and your proactive efforts to address the concerns
of the customers help in keeping the business continuous. Therefore, for
surviving in the business, a whole-hearted implementation of quality
management systems is very important rather than getting a certificate.
Sustaining business 13
Getting certified for ISO 9001 is not the end, but it is the starting point.
It gives confidence to the customers that you are on the right track. Unless
you move, you cannot reach the destination.
ISO 9001 explains the minimum requirements that are given as
guidelines for us to design a quality management system and it is not the
end. We need to improve our systems on a continuous basis taking the
help of guidelines given in the standards.
Goal
Organization
ISO 9000
The true implementation of ISO 9000 guidelines does not allow your
company to slip down from what you have already achieved. It shall prevent
you from making mistakes as you shall be following a procedure designed
by you to achieve the results expected by you and you are continuously
monitoring whether you are adhering to your systems and are taking
suitable corrective and preventive actions in time or not.
If you are not adhering to the requirements of the systems and just boast
of having a certificate, you shall be hanged by your customers similar to
as you are hanging your certificate.
IS O 900 1C ertifica te
x xx
2
Understanding and implementation of
ISO 9001:2008
2.1 Introduction
ISO 9000 series of standards, popularly known, as ‘Documented Quality
Management Systems’ were amended and new guidelines for
implementation of Quality Management Systems were released in
November 2008, with slight changes from ISO 9001:2000. All the certified
companies and the companies to be certified a fresh, need to adopt the
amended guidelines. Let us discuss the steps involved in implementing
the new system.
The standards have 8 clauses as follows:
1. Scope
2. Normative reference
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement.
The scope of the standard specifies the requirements of quality
management systems, where an organization needs to demonstrate its
ability to consistently provide the product and services that meets the
customers and applicable statutory, legal and regulatory requirements, and
aims to enhance customer satisfaction through the effective application of
the system. This includes processes for continual improvement and
assurance of conformity to customer and applicable regulatory
requirements. When we talk of the scope of the application for ISO 9000,
we talk about the sections of the organization, which shall be offering
them for third party audits to get themselves certified. When we write the
Quality Manual, it is essential to specify the scope of the application, and
also mention if any sub-clauses from Clause No. 7 are not applicable to
us. This shall depend on the nature of activity. For e.g., Clause No. 7.5.4
viz. Customer Property might not be applicable to a factory or organization
where they are not doing any job work, nor getting any materials from the
"
Understanding and implementation of ISO 9001:2008 15
5. Once we are clear about our mission, vision, policy and objectives,
we can work out the action plan. The plan should consider various
aspects like the processes required, the present situation and the
changes needed, the sequence and interaction of processes, the
authorities and responsibilities, the control points and check points,
the review frequency, skills and knowledge needed by the
organization, resources needed, need for improvements at different
levels, method of improving them, training needed to adopt the
improved process or to experiment the proposed process to achieve
the result, documentation and recording. Inputs for effective and
efficient planning include the strategies of the organization, the
20 Effective implementation of quality management systems
Primary requirements
1. Products of the specified quality
2. Delivery in time
3. Affordable price
4. Prompt after sale service
Secondary requirements
1. Quick response to the enquiries The customer contact person
should always be available to the customer.
2. Quick and prompt resolution of complaints and other issues The
resolution should always be in favour of the customer.
3. Packing should be attractive, but easily removable and disposable It
should help customer to build his reputation in case the products are
directly going to showroom in the name of the customers.
4. Supplier to communicate proactively regarding the despatch
positions, changes if any in product configurations, the developments
in the technology.
5. Supplier to educate the people at customers end on the care to be
taken while using the products and the correct methods of using
them.
6. Supplier should help in maintaining the equipments supplied by them
either freely or with concessional rates.
7. Supplier should maintain the stock of finished materials in his
account, preferably in a warehouse near to customers place, to help
customer to get materials just in time.
8. Supplier should take back the materials and replace with fresh
materials whenever customer expresses dissatisfaction.
9. Supplier should treat well whenever customer visits the suppliers
place and attend to all his needs The senior members from the
suppliers management should attend the customer.
10. Supplier should give evidence of adhering to legal, regulatory and
statutory requirements so that the customers should not be put in
trouble for non-compliance.
11. Supplier should bear with customer in case of any late payment due
to any reason.
12. Supplier should accept the change in product configuration
suggested by customer at any time irrespective of whether
production is started or not.
13. Supplier should hold the deliveries if desired by the customer due to
any reason.
14. Supplier should give some discount either formally or informally
Informal discounts are preferred.
15. The supplier should agree to change the product configurations or
nomenclature in the delivery documents and packages to help
customer getting some tax benefits.
16.
and so on.
Understanding and implementation of ISO 9001:2008 25
the legal and regulatory requirements all the times. Each one should
be aware of the legal and regulatory requirements concerning to the
activities being done and the product being produced. The standards
insist more on implementation of the system rather than on convincing
the auditor and getting certificate. There is a need to educate people
concerned regularly on the legal requirements and the changes if
any, and ensure that they work as per the requirements, rather than
having a separate person to patch up the records to show to the
auditors.
13. The standards requires certain documents to be maintained as
mandatory, which include the quality policy, quality objectives, quality
manual, documented procedures required by the standards, documents
needed by the organisation to ensure effective planning, operation and
control and records required by the standards. If one reads calmly, he
can understand that the scope of documentation covers all the essential
activities of the organization. There is a need to identify and define
the documents and relevant records needed to establish, implement
and maintain the quality management systems, and to support an
effective and efficient operation of the organization’s processes. The
nature and extent of the documentation should satisfy the contractual,
statutory and regulatory requirements, and the needs and expectations
of customers and other interested parties. This also should be
appropriate to the organization. The documents can be in any form or
medium suitable for the needs of the organization. For e.g., written
procedures for implementing regulatory requirements, where as we
can think of a video cassettes for showing the work practices like
material handling systems, assembling and checking the parts,
operating fire extinguishers, etc. We can have sign boards at appropriate
places to give instructions to workmen relating to ‘Do’s and Don’ts’,
or can have online work instructions on each machine for attending to
routine problems. The option is left to the organization, but one should
ensure that the documents are properly controlled. Figure 2.2 illustrates
the documents needed for effective implementation of quality
management systems in any organization.
14. What do we understand by the word document control? It means the
documents are (a) approved by certain authorised and responsible
persons after ensuring its adequacy and relevance to the operations,
(b) are suitably identified to ensure that only the current version are
in use, (c) given only to the concerned users and avoided from going
to unauthorized persons, (d) the obsolete documents are promptly
removed from the place of use, and (e) they are legible and easily
identifiable.
Understanding and implementation of ISO 9001:2008 27
Quality policy
Quality manual
Work procedures
Work instruction
Job descriptions
List of forms
List of records
1 2 3 4 5 6 7 8 9
Department/Section
Subject .
From . To ..
Location .
Responsibility
duplication of work and also help in computing the data for analysis.
It is essential to list all the formats, index them and display so that
people do not create a new format or use a wrong format. It is normal
practice to allocate form numbers to all formats, and give reference
of that format in the procedures, work instructions and job
descriptions.
17. One of the prime functions of any management is to review the
activities to ensure that they are effective and helping to meet the
company objectives. This is called as management review. This
30 Effective implementation of quality management systems
18. The provision of resources is very important part from the top
management commitment point of view. However, there should be a
justification for the resources to be provided. It should help the
management in enhancing customer satisfaction and satisfaction of
other interested parties, i.e. stakeholders, to achieve the company
objectives and fulfil the applicable statutory and regulatory
requirements. Hence, the top management should identify the
resources essential to the deployment of strategy and the achievement
Understanding and implementation of ISO 9001:2008 31
(Contd.)
Understanding and implementation of ISO 9001:2008 33
21. People can work efficiently when they are empowered. This can be
done by suitably defining the organization structure, with clearly
defined authorities and responsibilities. Once a competent man/
woman is allotted the job, and is clear about his/her authorities and
responsibilities, and is aware of the relevance of the work in achieving
the objectives of the section and company, he/she shall be enthused
to do the work and shall work with full potential.
22. The work environment needs to be maintained to get the required
quality and productivity. There are two parts in this: one is physical
environment like required lux level of light, maximum allowable dust
level, maximum tolerable noise level, house keeping, level of
pollution and controls, precautions for maintaining good hygiene,
cleanliness, ergonomics, machinery layout, etc.; where as the second
one is relating to human environment, which include the way in which
the people are treated, the promotion policies, grievance handling
systems, discipline at work, social justice, the welfare measures, etc.,
which all help in building a confidence among the employees that
the top management is concerned about the well being of the
employees and are taking care of them.
23. The other resource, viz, infrastructure includes various items like
plant, working space, tools, equipments, support services, information
and communication technology, transport facilities, etc., which are
all essential for getting the product and service realization to achieve
the company goals. Hence it is essential for the users of the above
infrastructure to justify them as required for improving the systems
and/or enhancing customer satisfaction and/or achieving the company
objectives as per strategic plans. It is also essential to utilize the
infrastructures optimally to keep the cost of operation as low as
possible, while not compromising on the quality.
24. Now let us come to the core activity, i.e. product manufacturing, or
as per ISO 9001:2008, product realization. The first activity in this
area is the planning for product realization. We need to understand
the product requirements before going for manufacturing. We need
to know the customer’s stated needs, implied needs and expectations,
34 Effective implementation of quality management systems
and from that we need to work out the quality objectives of the
product. This explains what is expected out of the product when it
reaches the customer’s end. Let us take some examples:
(a) Textile mill
(i) Ne10s combed hosiery yarn – As the name indicates the
yarn is going for knitting application, and hence the yarn
should be soft twisted and waxed. The yarn is combed
and expected to be free from kitties and neps and
imperfections should be lower. The yarn should have
sufficient strength and elongation to give a trouble free
performance. However, we do not know as to what type
of knitting machine the customer has. Now think of
socks knitting, one for baby socks and the other for
sports socks. For baby socks, the comfort of wear is
more important, where as for sports socks, wear
resistance is very important. Hence for baby socks we
need to give a lower T.M. compared to sports socks.
The short-term variations in yarn looks prominent in
socks as the same yarn shall be coming again and again.
(ii) Same Ne10s combed hosiery for doubling to use in
sweaters – In this case, as the doubling operation is done
at customers end, we have to give un-waxed yarn. The
short-term variations might not be critical as in the case
of socks. Uniformity in shade of yarn is very important,
as the yarns are likely to be dyed and used as an outerwear.
(iii) Ne10s combed soft twist going for candlewicks – In this
case, uniformity in terms of thick and thin places are
very important, and a kitty free yarn is required. The
shade variation is not critical for this end use, and also
the strength of yarn.
(b) Engineering workshop
Customer wants a shaft to be fitted to a drive. The basic
question is: how much load it is supposed to carry. On that
basis the diameter and the material is designed. The second
question is about the speed on which it has to work, on which
the bearing shall be decided. The third question shall be the
atmosphere to which the shaft is exposed, on which the material
to be used for the shaft shall be decided. The functional aspects
are very important in deciding the product objectives.
(c) Cafeteria
Food is to be prepared for 10 people for lunch. We need to be
clear as to whether they need light working lunch or heavy
lunch. The purpose for which the lunch was ordered is very
Understanding and implementation of ISO 9001:2008 35
Product PQR$$##
Previous complaints on similar (1) Short working life although materials have
products required strength.
Product Spindle Top arm Rubber cot Bearing Packing material Brooms
Quality 85 80 60 60 30 30
Delivery 3 3 20 10 40 30
Price 2 2 15 20 20 35
Service 10 15 5 10 10 5
Total 100 100 100 100 100 100
The weightage given can be used for evaluating the vendors as per
the formulae given below.
Reasons
R5
R1
R2
R3
R4
Product Customer
P1 5
P2 2 C1
P3 1
P1 1
P2 4 1 C2
P3 1 1
P1 1 4
P2 1 C3
P3 1
48. The corrective action taken promptly and communicated through out
the organization to prevent it from recurring is a very important step in
achieving improvement. We normally see that the same types of problems
and complaints are repeating, and people happily change the
nomenclature as routine problems. There are a number of books available
on the causes and remedies for routine problems found in an industry.
What is required is to develop Poka-yoke or full proofing the systems
and eliminate those problems once for all. A detailed root cause analysis
for all the deviations and problems is essential and the root of the problem
needs to be attacked to prevent it from surfacing again.
49. We should have a system of identifying the potential problems before
a problem can occur. For example, when a new technology is
implemented, the people on the spot shall not be aware of the
problems they are likely to get. In such cases, a brain-storming session
can help in identifying the potential problems. Similarly changes in
social scenario, political changes, economic changes, competition,
environmental issues, etc., are to be analysed and discussed to identify
the potential problems. It is needed to analyse the problems in detail
to find the root cause, take action, verify the action and if found
suitable standardize.
50. Once we are clear and confident that we are following the system,
we can go for certification. We should understand clearly that a
46 Effective implementation of quality management systems
raised. The auditor shall discuss with management representative and asks
him to amend the manual wherever it is needed. Once the corrections are
made and the quality manual is found okay, the dates for the audits shall
be fixed.
Wherever an organization is not confident, they can request for a trail
audit from the certifying body. The auditors shall go deep in each process
area and try to identify maximum number of deviations and advise the
organization to correct them. Once all the non conformities are attended,
the organization can offer them for final audit. In case the organization is
confident they can directly opt for final audit without going for a trial
audit.
The auditors verify whether the organization is complying with the
minimum requirements of the quality management system or not, and raise
non-conformities whenever deviations are seen. It is the duty of the auditee
to correct them without delay. Certificate cannot be granted if there are
any pending non-conformities. However, by seeing the nature of the non-
conformity, the auditor can recommend for the grant of certificate, while
giving a deadline for correcting the deviations and getting verified by the
auditor.
Even though implementation of QMS is not a one time job and
implemented and monitored on a continuous basis, still we need to prepare
our selves for facing audits. The Chapter 7 explains various fine aspects
of getting ourselves prepared for an audit. Once the audit is started, face
with confidence. Your confidence helps you to win over the auditor.
49
50 Effective implementation of quality management systems
representative. His work is to maintain the records and keeping the manuals
and procedure documents in a safe place. In one such case it was found
that the management representative had not undergone the basic awareness
programme on ISO 9001, but the company was an ISO 9001:2000 certified.
Some consultants were managing to get the certificate. By taking certificate
in this manner, the company cannot get any benefit as the systems are not
improved. They will have a certificate hanging, without realizing that the
company’s future itself is hanging.
In some of the companies, it is seen that management representative
is a separate man from the regular activities of the organization and is
not assigned any regular responsibilities. This man will concentrate
only of documentation, conducting audits and liaising for management
reviews and audits. The reason given is “The activities are too many
and the documentation is difficult. A separate man as MR can
concentrate on documentation, and shall be able to explain to auditors
so that the certificate is got”. Here the basic purpose of implementing
ISO 9000 is lost. The organizations should realize that ISO is not a
separate activity, but a part of the activities that are being carried out
in order to meet the objectives of the company. There is no need for
doing an activity that is not contributing for meeting the objectives of
the company. By keeping MR as a separate entity, without any regular
assignments, the management gives a message to all that ISO 9000
activities are additional activities, and is not a part of regular activities.
By this the MR shall have resistance from the co-employees, who get
a feeling the ISO 9000 activities are a burden. A management
representative should be a role model, who can demonstrate to the
people by implementing the concepts of quality management system in
his routine works. The management representative should be a senior
manager with regular responsibilities, and should be able to implement
the systems while doing his regular activities. Then only he can
command others to implement the systems as a part of their regular
activities. If he is a separate man, he shall never get recognition.
It is a normal practice in majority of the companies that the chief of
quality control becomes the management representative, because they are
implementing quality management systems. It is a wrong understanding.
The quality control activities are normally concentrated on product quality,
and it is a technical job. The ISO 9001 is concentrating on the quality of
the management system and not only on the quality of the products. If the
management system is good, the quality shall be good at all places.
Therefore, a senior manager having command on all the sections and
departments is the best person to become a management representative
and he should be dedicated.
Roles and responsibilities of management representative 51
modify them to reduce the number of forms and make them more
effective and user friendly.
13. Maintaining the master list of all documents, records and forms, and
the distribution charts is one of the prime responsibilities of the
management representative.
14. It is normally seen that numbers of records are maintained in any
organization. There might be duplication of records, and some vital
information might not have documented at any place. It is the
responsibility of management representative to help the HODs in
identifying the records to be maintained considering the company/
department/section and individual activities, goals and targets.
15. Interpreting the customer requirements and communicating down the
line is an important activity in any organization. The management
representative is expected to help the concerned HODs in preparing
the specifications and guidelines for meeting the requirements.
16. As the technology advances and the company adopts new technology
and systems, there is a need to amend the procedures and the
documents. Arranging for adequacy audits in case of any changes in
system, process or the people is one of the main tasks of a management
representative.
17. Preparing the procedures, instructions, manuals and documenting
them is not the end of implementation. Everyone needs to read them,
understand and implement in their routine works. Training the people
to adapt to the systems is very important. The management
representative is expected to arrange for training of users for the use
of documents and records.
18. We need a team of internal quality auditors to periodically audit the
systems through out the organization. Identifying the potential internal
quality auditors and arranging for their training is one of the
responsibilities of the management representative.
19. Internal quality audits should be effective and all auditors and auditee
should follow the requirements meticulously. Developing procedures
for internal quality audits and training the users for the
implementation is the responsibility of management representative.
20. Internal audits needs to be planned in advance and communicated to
the users for the effective implementation of the systems. It cannot
be a surprise audit as a quality control man does. Planning internal
quality audits and arranging for the audits is one of the prime
responsibilities of the management representative.
21. Closing the non-conformities without undue delay is the responsibility
of the auditee. However, it is seen in a number of cases that unless
the management representative is after the auditee and auditor, the
non-conformities are not attended and closed. Hence, following up
54 Effective implementation of quality management systems
with the auditors and auditee for the timely closing of non-conformity
has become the responsibility of the management representative.
22. Due to various reasons, the auditee might not accept the non-
conformity raised by an auditor (especially in the internal quality
audits). Sorting out the difference of opinions between auditors and
auditee relating to the non-conformities and the observations during
audits by referring to the standards is one of the responsibilities of
the management representative.
23. It is seen in a number of cases that the auditors fail to write the non-
conformity notes precisely explaining the nature of the non-
conformity and its potential effects and linking the observed non-
conformity to the clauses of ISO 9001. Guiding the auditors in writing
the non-conformity notes and linking them to the guidelines given in
the standards has become one of the responsibilities of the
management representative.
24. Conducting periodic review of the activities is the responsibility of
the top management. However, due to their varied nature of activities
and the changing priorities, they do not proactively conduct the
reviews. They expect that discussing with the top management and
arranging for periodic review as the responsibility of management
representative. Therefore, this activity becomes one of his regular
tasks.
25. Similar to internal quality audits, the external audits also are to be
done periodically. Liaising with the certifying body and top
management and getting audits done is the responsibility of
management representative.
26. Normally the auditee, although capable, expects the management
representative to guide him in closing the non-conformity raised
during external audits. Following up for closing of non-conformities
in time becomes the responsibility of the management representative.
27. After the audits, getting the certificate and audit reports is very
essential. Following up with the certifying body in getting certificate
is one of the responsibilities of the management representative.
28. Educating all concerned in the organization regarding the certificate
and ensuring proper display of the same at prominent points also is
the responsibility of the management representative.
29. The responsibilities of the management representative include
maintaining the records of internal quality audits, management
review, external audits, auditor’s attendance and performance,
auditor’s training, trends in performance, follow up for the actions
decided in the management review and the correspondences relating
to the implementation of quality management systems.
Roles and responsibilities of management representative 55
4
Internal quality audits:
A strong tool for quality management
56
Internal quality audits 57
questions the basis of the procedure adopted, and modifies them. An auditor
being an outsider cannot suggest any improvement, but can only say that
a deviation is found. He doesn’t know whether the deviation found was
advantageous or disadvantageous. Table 4.1 gives few differences among
quality control, review by top man and internal quality auditing.
Table 4.1 Few differences among quality control, review by top man and internal
quality auditing.
the process as being followed. Our final aim is to achieve the results as a
result of following a judicious system and not getting a result by chance,
or in other words, by grace of someone like God. So the auditor shall
instigate the auditee to think and take the real corrective action for the
deviation found, and not just changing the documents to close the non-
conformity rose.
The auditor is a friend and not an enemy. He comes to show the
deviations made by us so that we correct ourselves. Auditor is not supposed
to suggest corrective actions. However, in case of process management
relating to production operations done by a senior technical person of the
same organization, the advantage can be taken to improve the system.
The auditor finds the deviation as a deviation from the system and not
as a mistake done. A deviation in system can be due to improper
communication, improper understanding of the process or by some new
developments done recently for improvement that was not documented.
The auditor shall not target any person for highlighting the deviations.
He shall highlight the events where deviations were found, and can give
the name of the person as an example.
The auditor should verify the compliance by asking for evidences, like
production records, test results, demonstration of calibration, demonstration
of an activity, personally checking the speeds, setting, etc., visiting the
spot of actions being taken and the process going on, questioning the people
on the spot to understand the extent of understanding of the objectives,
targets, procedures and systems by the people working on the spot, the
display boards put in the department for giving various instructions, etc.
The auditor is not supposed to assume any thing, and he should record
only what he has verified.
The auditor should go with a proper checklist prepared after carefully
going through the procedures, work instructions, job descriptions, process
parameters, etc. He should identify the links between the processes and
procedures and verify the effects of non-compliance. This is called a linking
exercise. A change done at one place might affect the performance of other
section, and auditor is the person who can highlight that.
The auditor should be friendly with people and has no authority to fire
any of the auditee members, even though he is a junior person. His job is
to convince the other man regarding the deviation observed comparing to
what was planned.
The auditor is not a trouble shooting man, going with a mission of
identifying a root cause for a problem and implementing corrective actions.
His job ends only in identifying the deviations. If required, the company
can ask the auditor, after the audits are over, to become a member of trouble
shooting team to solve the problems found during audit, as a normal process
64 Effective implementation of quality management systems
Question Status
4.8.1 General
1. Understand the activities carried out in the auditee section, and link
it to the main process of the company.
2. Find out the importance of the activity in achieving the company
goals.
3. Verify whether any targets are set for the goals.
4. Find out how the auditee is monitoring the activity.
5. Check for the evidence for monitoring.
6. Find out whether the procedure for doing and monitoring the activities
are documented.
7. Verify how the objectives stated in the procedures have been linked
to the targets set.
8. Verify whether the objectives specified for each procedure are
measurable or not.
9. Enquire how the procedure written is helping in achieving the targets
set.
10. Verify whether the people performing the job have understood the
procedures documented.
11. Check whether the resources required are adequately documented.
12. Verify the process of getting the resources for performing the job.
13. Verify whether the applicable legal, regulatory and statutory
requirements are identified and documented.
14. Verify the legal and regulatory requirements section wise that are to
be fulfilled.
15. Check whether the people performing are clear about the legal and
regulatory aspects that they need to fulfil.
16. Verify the records identified by the section.
17. Verify whether the records cover all the activities of the section or not.
18. Verify how the records are used in taking decisions.
19. Whether the records identified cover all the objectives spelled out?
20. Whether the records are maintained properly to have easy retrieval?
21. Verify whether the records are controlled and protected from getting
damaged.
22. Verify whether the life and disposal of records are determined and
followed.
23. Verify whether the people are aware of their authorities and
responsibilities.
66 Effective implementation of quality management systems
4.8.3 Production
1. Verify the system of planning the processes needed for product
realization.
2. Verify the linkage of the system of planning for product realization
to the adopted quality management system.
3. Verify whether quality plans are available for all the products being
manufactured.
4. Verify whether quality objectives are defined for each product being
worked.
5. Verify whether the customer requirements are clear to the people in
production line.
68 Effective implementation of quality management systems
26. Verify whether the design out put meet the design input requirements
or not.
27. Whether the design changes are properly recorded?
28. Verify whether the designs of the products are controlled effectively
or not.
29. Verify the process parameters adopted and compare with those derived
by the design process.
30. Whether any special processes exist in the production line, where
the results can be known only after the work is complete?
31. Whether the special processes are identified or not?
32. In case of special processes, whether the process is validated to ensure
the requirements are met?
33. Does the validation demonstrate the ability of these processes to
achieve planned results?
34. Whether any control points and check points are prepared for the
process being followed?
35. Verify whether the working conditions like temperature, humidity,
noise level, light, dust level, etc., are maintained as appropriate to
the process.
36. Verify whether the men employed are having adequate knowledge
and skills required for the job.
37. Verify the safety precautions that are followed in relation to the safety
requirements.
38. Verify the system adopted for identification and traceability of
materials in relation to the systems documented.
39. Verify whether the status of the product is displayed based on
monitoring and measurement requirements.
40. Look for the monitoring systems available on the production
equipments, and their utilization in process monitoring.
41. Is the monitoring and measuring device that has been devised and
implemented are capable of providing evidence of conformity of
product to determined requirements?
42. Does the monitoring and measuring are in a manner that is consistent
with the monitoring and measuring equipment?
43. Check whether the validity of results measured previously are
revalidated when equipment is found non-conforming to the
requirements.
44. Check the material handling systems adopted and their suitability
for the materials being handled.
45. Inspect the material storage place and verify in relation to norms
considering the safety and quality.
46. Verify the maintenance systems adopted and compare with
documented system.
70 Effective implementation of quality management systems
4.8.6 Marketing
1. Verify the process of getting the customer requirements and
communicating to production and service operations.
Internal quality audits 73
2. Verify the system of segmenting the markets and products, and for
targeting the customers before approaching them for offering the
products.
3. Verify whether any requirement is given by the production/service
department as minimum information to be collected from customer
while deciding on the customer requirements.
4. What is the system adopted to determine the customer requirements
when the customer has not given documented requirements?
5. Whether the product requirements worked out by the mills are
communicated to customers and their approval taken prior to
acceptance of order?
6. Verify the communication systems for dealing with customer.
7. Verify whether the communication systems followed with customers
cover the product information, enquires, contracts or order handling,
amendments to contracts, customer feed backs and customer
complaints.
8. Verify the training needs identified for the customer contact
personnel.
9. Verify whether the training is imparted effectively.
10. Verify whether the contracts or orders differing from those previously
expressed and accepted are resolved.
11. Whether records are maintained for the reviews done for each contract
and their results?
12. Verify whether the contracts entered have been reviewed to ensure
taking care of company capability for supplying the product.
13. Verify how the customer perception as to whether the product and
services met their requirements is gathered.
14. How the customer’s perception data and feedback are analysed to
take suitable action to enhance customer satisfaction?
15. Verify whether all the requirements of customers are documented in
the contracts or not.
16. Verify the method of ensuring that all the requirements of the
customers are covered in the contract.
17. Verify whether the legal requirements relating to products and trade
applicable are identified and communicated to the personnel
responsible to fulfill.
18. Verify the system of communicating the customer requirements,
including the amendments in time to concerned personnel at
production area, viz, production planning, manufacturing and quality
assurance, packing of final products, despatch, costing and training
sections.
19. Verify the system of following up to ensure that the customers get
the materials and services as specified by them.
74 Effective implementation of quality management systems
20. Whether any defined procedure is there to collect the dues from
customer in time for the materials supplied to them?
21. Verify the system of getting customer feedback/complaints, and
communicating the information to concerned production personnel
and back to customers.
22. Verify the system of deciding on the prices and other terms and
conditions of marketing while entering a contract.
23. Verify the system of reviewing marketing performance.
24. Verify whether the system adopted to review marketing performance
has helped in achieving continuous improvements.
16. Verify the system of issuing materials to users while ensuring only
approved materials are issued.
17. Verify the methods adopted for effective traceability of supplies and
suppliers.
18. Verify whether any system exists for visiting suppliers for inspection
evaluation. In such cases whether the suppliers are informed suitably
the purpose of visit.
19. Whether any material is given to suppliers for conversion or
incorporation in the product being procured. In such cases, what
system is followed to ensure that the same materials are being used
and accounted properly?
20. Verify the system of covering the risk while materials are in transit
or in stores.
21. Verify the system of ensuring that the materials in stock maintain the
properties similar to that of while receiving.
22. In case of materials likely to lose their salient features over a period
of time, verify how the shelf-life is determined and the deliveries
monitored.
23. Verify the system of informing accounts section relating to the
materials received and approved.
24. Verify the system of informing the users relating to the delivery
positions of the materials ordered.
25. Verify the system of monitoring the stock levels of regular moving
items in order to have smooth working.
26. Verify the system of actions taken for non-moving items and rejected
items.
27. Verify the system of stocktaking and their valuation.
4.8.8 Despatches
1. Verify the system of receiving and storing the materials at warehouse
ready for despatch.
2. Verify whether applicable regulatory requirements are identified and
listed and system exists for proactive monitoring.
3. Verify the system of identifying the materials in warehouse.
4. Verify the storage system adopted to ensure that the materials are
prevented from damages.
5. Verify the system of storage of flammable and/or hazardous items
like chemicals, petrol, diesel, etc., before despatch.
6. Whether any system exists to ensure that the material in stock has
not deteriorated during storing for a long time?
76 Effective implementation of quality management systems
13. Verify the system of handling cash and assuring security for the
persons handling cash.
4.8.13 Security
1. Verify the system of checking the incoming vehicles and the materials.
2. Verify the method of checking the incoming men and their belongings.
3. Verify the system of checking the out going vehicles, men and
materials.
4. Verify the system of checking the documents and signatures on
documents and gate passes.
5. Verify the system followed for security in final packing area.
6. Verify the system of security patrols.
7. Verify the training provided for the security personnel.
8. Verify the method of selecting security service providers and the
security personnel.
9. Verify the system of monitoring the fire extinguishers, fire hoses
and the condition of fire fighting equipments.
10. Verify the system of maintenance of weapons and security tools.
● Relation diagram
● Tree diagram
● Matrix data analysis
● Matrix diagram
● Process decision programme chart (PDPC)
● Arrow diagram
Affinity diagram – This collects large amount of disorganized and
confused verbal data and groups based on natural relationship. It is a
creative process and not a logical process. Affinity diagram is used where
participants have no past experience, situation is complex, need to find a
pattern among thoughts and when there is a need to arrive at a consensus
and no unity exists.
We can use affinity diagram to link working by identifying the group to
which the activity belongs. Next we need to identify similar activities
supporting this and then verify the linkage between activities. The
differences in the style of performing the activity are then verified and
also the reasons for having different styles. By this we can verify the likely
effect of the action taken at one place.
Relations diagram – This is a tool for finding solution to problems that
have complex casual relationships. It helps to untangle and find the logical
relations among the intertwined causes and effects and allows for multi-
directional thinking rather than linear thinking. This can be used to identify
the relation between documents and systems (Fig. 4.1).
Company Departmental
Customer Policies and
Expectations Policies and
Objectives Objectives
Departmental
Statutory, Procedures
Legal and regulatory
Requirements
Company Manual
and
General Procedures
Organization
Structure Work Instructions
Records
Arrow diagram or PERT chart (Fig. 4.4), which helps in project planning,
scheduling and monitoring is a network technique using nodes for events
and arrows for activities. It is a very useful tool when we want to plan the
activities of a known but complex task. Process mapping can be in the
form of an arrow diagram also.
After mapping the process, it becomes easy to find the links.
● Documents may have reference of other documents. This can be
verified by writing down a matrix.
● Organization can follow a system which has a link to another system
or document.
● Different documents may use different words or terms may be used
for the same activity or material.
● Some records are identified and referred in the procedures, but some
other are in practice.
● Certain objectives are defined by the company and something else is
defined for the departments.
● Organization has developed data collection check sheets.
A matrix can be used to analyse the links between processes, procedures,
standards, instructions and other documents (Fig. 4.5).
88 Effective implementation of quality management systems
Result
work is
not done
Job description of
HOD does not
mention
Work procedure says
HOD is responsible
Quality manual says HOD is
responsible for the activity
The matrix can also be used to identify the links between the company
objectives, the departmental objectives, the targets and action plans.
Table 4.3 is an illustration for the same.
Process design programme chart – This is a useful and powerful method
to overcome problems when a goal is to be achieved by mapping out all
the conceivable events or contingencies that can occur in the
implementation stage. A PDPC chart is constructed by the following steps.
● Identify existing situation.
● Draw a normal flow chart assuming that no problem will be
encountered.
● Discuss the constraints.
● Write the activities that are to be done in case of constraints.
● Prepare a list showing the possible problems and the contingency plan.
● Review for any missing information.
● Prepare final drawing and implement.
● Watch the progress and darken the line where activities are completed.
● Study deviations and re-plan.
Internal quality audits 89
Start
Activity 1 Support 1
Check 1 Activity 2
Support 2
Support 1
Activity 3 Check 2
Support 3
Check 3 Activity 4 Activity 2
Activity 7 Activity 8
Arrow Diagram
6
5
2
3 5 days
1
Start 4 days 3
1 2 5 End
6 7
3
= Objective 5 =
= Objective 4 =
= Objective 3 =
= Objective 2 = =
= Objective 1 =
Sectional objectives
Departmental objectives
Action plans
Objective 1
Objective 2
Objective 4
Objective 3
Plan 1
Plan 4
Plan 3
Plan 2
Quality Policy
Company objectives
= Objective - 1 =
= Objective - 2 = =
= Objective - 3 = =
= Objective - 4 =
= Objective - 5 =
Example 1
Procedure says “Supervisor shall give an indent for…..”
● Verify the job description and find out whether supervisor is
authorized to give that indent.
92 Effective implementation of quality management systems
● Verify the list of format, and see whether that indent format is
controlled.
● Ask for the record where the copies of indent are filed.
● Check the list of records, whether that record is controlled.
● Check to whom this indent is given. Verify the procedure at the
receiving end, whether the acceptance of this indent is documented.
● Verify whether any work instruction is written for writing this indent.
● Verify the procedure for deciding on writing the indent.
● Verify whether all the criteria were fulfilled for a completed indent.
Example 2
Verification of the linkage between procedure and departmental objectives.
Note down the points in the procedure that has a link with the objectives.
,AFartment ABC
Department objectives
XXX-WP-03 Point 2
XXX-WP-06
Example 3
Verification of links between job description and the departmental objectives.
Following is an example of linking job descriptions to objectives.
Internal quality audits 93
Department objectives
XXX-JD-03 Point 2
XXX-JD-04 Point 7
XXX-JD-05 Point 3
XXX-JD-06 Point 6
Example 4
Verification of the minimum competency levels specified and comparing
with the hierarchy for the mismatches. The competency expectations must
be of higher level for seniors in the hierarchy compared to those at junior
level. Following is an example of mismatch.
Example 5
Verify the records of stoppages and the reasons documented. Link it to the
efficiency or productivity achieved. Say, the production department has
recorded 4 hours stoppage of a machine for breakdown, where as the
maintenance department has recorded 3 hours stoppage. When the
production is verified, they have achieved 60% of their normal production
in that shift indicating a loss of 3 hours and 12 minutes. It means the
machine was started 12 minutes late after it was handed over by the
maintenance, but additional stoppage was shown to project a better
efficiency.
Example 6
Verify the objectives and targets specified for a section and between
sections of an organization. See whether they are complementary or
contradictory.
Example 7
For each target check the proposed action plan. Each target should be
supported by an action plan in order to achieve it. The method of
implementation of the action plans must be specified in the work
procedures, or else it is not possible to implement. There should be the
responsibilities defined and the records identified. Auditor needs to check
whether the documents explain the method of taking action, where the
records are kept and who is responsible.
Linking exercises can be a very powerful tool for an auditor. It helps in
identifying the real pits and helps the management to take necessary
corrective actions. The seven management tools can be suitably made use
for linking exercises.
Linking exercise helps to integrate different activities of an organization.
It helps effective implementation of systems organization wide.
Measuring maturity in QMS implementation 95
5
Measuring maturity in QMS implementation
95
96 Effective implementation of quality management systems
a number of cases, it is found that auditors are closing their eyes even
when a major non-conformance is noticed.
ISO 9001 guidelines give basic requirements for a good quality
management system, which are practical and simple. In the initial stages,
people were considering the certification of ISO 9000 as a great
achievement, but now due to innumerable number of certificate holders, it
is no more considered as an achievement. It has become the basic or
fundamental requirement for any organization to survive. If one is not
following a QMS, he is likely to collapse shortly.
With over one million ISO 9000 certified companies world over, the
significance of the certificate is getting lost. Almost everyone is ISO
certified. The customers, who were recognising their suppliers because of
their accreditation to QMS, are now in confusion. They are finding
difficulty in identifying good suppliers those are matured in understanding
the requirements, could proactively respond and have quality management
systems implemented effectively company wide and following religiously.
There is no method of assessing the effectiveness of implementation,
although some companies have developed their own systems to measure
their performance. There is a need for scientific/logical measurement of
the maturity of implementation of quality management in an organization.
9. Process evolution
1 Processes being followed in the company are listed down.
2 Processes mandatory for the implementation of QMS are
identified and listed.
3 Processes required for achieving the company objectives while
moving in the path defined by quality policy are identified.
4 Processes required to enhance QMS to achieve continual
improvements are identified.
5 Processes required to achieve the results at par with benchmarks
are identified and implemented.
proposed date of action, but has not identified the root cause.
3 The clause number is correct, but the non-conformity is in a
suggestion mode or dictation mode. The root cause analysis is
not made by the auditee. The MR has written the root cause.
4 The root cause analysis is made by the auditee for all the non-
conformities and actions taken.
5 Trend analysis is made for identifying the repeated type of non-
conformities and taking preventive actions. The MR is tracking
the progress.
2 Some of the auditors could not attend in time, but have informed
the MR in advance. No alternative arrangement is made.
3 Auditors are conducting the audits on specified date or on
mutually agreed date in consultation with the management
representative. Some reports are delayed.
4 Analysis of auditor’s punctuality shows a positive trend and
continuous improvement. Some audit reports are submitted late.
5 All auditors are attending the audit as per schedule, and
submitting the report in time.
3 The HOD gets the trend charts prepared of the data and analyses
on a monthly basis.
4 The cause-wise trends are prepared and analysis is made on
monthly basis, season wise, product wise and submitted to top
management.
5 The trends of improvement or deterioration are compared with
similar industry, and also with the best in the class. The reasons
for deviations are identified.
99. Leadership
1 People respect the CEO. Whenever he visits, complete premises
shall be kept clean and senior officers shall be present during
his rounds.
2 Whatever the CEO says is the ultimate and everyone follows it
with out any grumbling.
3 CEO discusses the plans and problems with senior managers,
and reviews during his next visit.
4 CEO demonstrates his commitment to the system by personally
following it all the time.
5 CEO discusses his plans even with senior workmen and union
leaders while planning for future, and implements the plan as
discussed.
6
Welcome the complaints
133
134 Effective implementation of quality management systems
at some other café, and not go to same place where your experience
was not good.
● You feel something as unethical and you are not doing it. Some one,
whom you do not know is doing that unethical work, are you going
to advise him? The answer is “No. It is not my business”. If the same
is done by your brother or a close friend, you are advising.
● In your office, your boss is not good in language. He makes mistakes
in using appropriate words, and hence it might mean different. Are
you going to tell your boss to correct his language? The answer is
“No”. If the same mistake is done by your younger brother or sister,
you would like to correct them and explain as to why that was wrong.
Some times you might make a skit by imitating the language and
style of your boss on a happy occasion with your friends.
People travel daily in crowded city busses or local train. The buses or
trains might come late or the commuters might not get a seat to sit
comfortably. But they never complain either for the train or bus coming
late or for not getting a seat for sitting comfortably, although they have
paid money for ticket. They can sue the railways or bus service for not
providing a seat and making them standing or virtually hanging in a bus or
train, or not for maintaining the time as per the published time table. It is
the duty of railways or road transport corporations to provide seat to all
their passengers, or charge less for the passengers standing. The bus or
train services should compensate for loses incurred by the commuters for
delays. But it never happens. By seeing the plight of their employees, if a
company introduces free bus service, then people complain of not coming
in time. Normally, seat is provided for all on all the days; however, on a
particular day, due to some emergency, if one or two passengers are taken
extra, the people make complaint.
The customers want consistency in quality and supplies and not very
good quality at some times. If you are consistently providing a poor quality
and service, your customers get adjusted to it. They will be coming to you
till they find another alternative that is better than you. They will not make
any complaint. However, if you start improving your quality of products
and services, the customers shall be happy and they will stick to you. The
expectations of customer will increase as your quality of product and
services improve. They will now have a different tolerance for the same
products and services, based on the best services you provided. They will
show their displeasure if you slip down from your achieved levels.
Therefore, you should always have a system of reinforcing the systems
and sustaining the performance at improved levels.
7
Face the audits
138
Face the audits 139
Some times it is seen that the system documented is outdated and the
people have adopted an improved method for their works. In such cases,
the audits indicate that the procedures need to be documented properly as
per the changed working systems. If the documentation is not changed,
there are chances of some people following the old system and some with
new, finally resulting in the variations and poor quality. It is a known fact
that one cannot identify some of his/her mistakes or deviations, where as
an outsider with an open mind can identify them. Therefore, getting the
self-audited by an outsider at periodic intervals is suggested.
● Audit is a process to ensure conformity to the systems.
● Ensure that actions are taken in time for the points raised in
Management Review Meeting. [Note: Any delay or non-taking action
shall be taken seriously by external auditors as they reflect badly on
top management commitment].
● Make market complaint analysis party wise, reason wise, and product
wise and show the trends for at least one year.
● Keep the records of vendor analysis ready.
● Keep the proof of letter written to suppliers for rejections, and low
rating in vendor evaluation.
● Keep the records of training need identified and training given as
per the training need identified.
can make out what is real. He shall be linking your statement to some
other area for verification.
● Do not become nervous. Remember that auditor is our friend who
shall show the area where we need improvement.
● Auditor has seen different industries and has a fair idea of what is
practicable and what is not. Although auditor is not supposed to
suggest, shall give a hint while asking questions. Observe him
carefully and note down his reactions or observations.
● Show the actions taken on the observations and nonconformities to
the auditor before the closing meeting. It shall impress the auditor
and shall demonstrate our enthusiasm for improvement.
● Everyone who attended the opening meeting must be present in the
closing meeting, along with representatives of the area audited.
● Maintain timings of the audit and the meetings.
Appendix 1
Departmental objectives and expectations
1. Training
Objectives
1. To provide required training to the employees to meet the product
requirements and to achieve company objectives while adhering to
legal and regulatory requirements.
2. To enhance the skill of employees to help them improve productivity
and quality while reducing the wastes.
3. To build confidence in the employees regarding their ability to
perform and to achieve.
4. To build the feeling of oneness among the employees.
Performance indicators
1. Reduction in market complaints relating to worker controllable errors.
2. Improvement in worker efficiency.
3. Reduction in wastes relating to worker errors.
4. Clarity about the job content, the responsibility and authorities among
the employees.
5. Clarity about the product requirement among the employees.
6. No loss of production due to shortage of required skills.
146
Appendix 147
Procedures
1. Planning the training activities and training resources.
2. Preparing training calendar.
3. Evaluation of trainers; both in-house and external faculty.
4. Evaluation of trainees.
5. Evaluation of training activities.
6. Preparation and evaluation of training syllabus.
Records
1. The persons trained subject wise, section wise.
2. The training hours per employee.
3. Training evaluation report.
4. Evaluation report of training faculty.
5. Evaluation report of the training aids; machines, equipments, slides
and other presentation materials, books and manuals, slogans and
displays etc.
Reference documents
1. Operating instructions
2. Standard work practices
3. Work norms
4. Product safety requirements
5. Company standing orders
6. Job descriptions
Performance indicators
1. No loss of production or delay in activities due to short of human
resource.
2. Reduction or no complaints relating to non-compliance of regulatory
norms.
3. Reduction in legal expenses.
4. Reduction in absenteeism.
5. Reduction in strikes and disputes.
6. Reduction in employee turnover.
7. Reduction in employee expenses as a percent of sales turnover.
8. Availability of complete information in the personal records regarding
the employees.
Procedures
1. Planning the human resource requirement.
2. Calling the applications, conducting interviews, selecting the
candidates by referring to minimum competency requirements.
3. Providing induction to new recruits and explaining Standing orders
of the company and the legal requirements.
4. Maintaining attendance and providing data to accounts section for
salary and bonus payments.
5. Preparation and maintenance of personal records.
6. Preparation of statutory returns and submitting.
7. Monitoring the compliance to statutory, legal and regulatory
requirements.
8. Taking disciplinary actions for wilful violations of laid out laws and
systems.
9. Taking actions on absenteeism.
10. Taking action on negligence.
11. Monitoring overtime.
12. Counselling and handling grievances.
13. Encouraging employee involvement in activities of the company.
14. Receiving suggestions, processing them and taking necessary actions.
15. Transferring of employees.
16. Promoting employees.
17. Fixing salary for each job category.
18. Evaluating the job contents and fixing work loads.
19. Negotiating with trade unions and community leaders.
20. Planning welfare activities and implementing them.
Records
1. Personal files of each employee including those of retired, left and
dead.
2. Applications received for jobs.
3. Selection formalities like written tests, interviews and offers.
4. Attendance records.
5. Leave records.
6. Provident fund records.
7. ESI records.
8. Records of welfare activities.
9. Suggestions received and actions taken.
10. Records of grievances received and handled.
11. Minutes of meetings and negotiations.
12. Correspondence with factory inspector and other government offices.
13. Records of legal proceedings.
150 Effective implementation of quality management systems
Reference documents
1. Applicable Factory Acts
(a) Minimum wages
(b) ESI
(c) PF
(d) Safety
(e) Working hours
(f) Settlement of disputes etc.
2. Applicable legislations – Copy of gazettes
3. Reference of dispute settlements (Court judgments)
4. Standing orders
3. Stores
Objectives
1. To receive the materials and store them in identified location.
2. To get the approval of materials received by the concerned user
department.
3. To issue the approved materials to the users as per requirements.
4. To send the bills of approved materials for passing to accounts section.
5. To ensure safe storage of material .
6. To educate management regarding non-moving items from time-to-
time .
7. To maintain accounts of materials received, issued and materials in
stock and provide information for taking decisions on purchases.
8. To dispose rejected, damaged and non-moving items.
9. To send materials out on returnable or non-returnable basis depending
on the situation.
Performance indicators
1. Reduction in complaints relating to non-traceability of materials in-
time.
2. Time taken for preparing the goods receipt notes (GRN) and getting
the materials approved.
3. Zero difference in stock shown and the actual stocks in stores.
4. Reduction in wastes and damages due to handling/storing at stores.
5. Clarity about the shelf-life of materials, storing them accordingly
and issuing by referring to expiry date.
6. Clarity about the materials requirement for different sections of the
organization.
7. No loss of production due to shortage of required materials in stores.
Appendix 151
Procedures
1. Receiving, storing and issuing of materials.
2. Preparation of goods receipt notes and sending to user department.
3. Sending the bills of approved materials for passing.
4. Perpetual and periodic stock taking.
5. Identification and traceability of materials in stores.
6. Storing of hazardous materials.
7. Disposal of rejected, damaged and non-moving items.
8. Sending materials out on returnable and non-returnable basis.
Records
1. The materials received
2. The materials issued
3. The materials waiting for inspection
4. Materials rejected
5. Rejected materials in stock
6. Evaluation report of stocks
7. Material sent out on returnable basis
Reference documents
1. Material safety data of the materials received
2. Shelf-life information of the materials in stores
3. Insurance guidelines for materials stored
4. Directory of transporters and material handling crew
152 Effective implementation of quality management systems
4. Accounts department
Objectives
1. To maintain accounts of all monetary transactions.
2. To verify and approve the spending with respect to budget.
3. To pass the bill of approved materials and making payments.
4. Verifying the legal aspects and ensuring adherence to legal
requirements in money transactions.
5. To prepare the returns of monetary transactions as per statutory
requirements and filing them in time.
6. To prepare the statement of accounts like income and expenditure,
profit and loss, current assets and liabilities, balance sheets, etc., as
needed by the top management and submitting in time.
7. Advise the management in case of unwanted or excess expenses,
transactions violating the statutory and legal norms.
Performance indicators
1. Speed of giving the accurate information relating to monetary
position.
2. Time taken for preparing the accounts statements like Income and
Expenditure statements, Profit and Loss accounts, Balance sheet, etc.
3. Zero difference in accounts shown and the actual money in hand.
4. Reduction in wastes and losses due to improper accounting and non-
fulfilment of statutory and legal requirements.
5. Clarity about the accounts, and appropriate allocations.
6. Clarity about the money requirement for different activities of the
organization.
7. No loss to the company due to mistakes or delays in accounts sections.
8. Following up activities relating to money to be recovered.
Procedures
1. Classification of income and expenditure and entering in records.
2. Preparation of accounts statements and submitting to management.
Appendix 153
Records
1. The money received and spent party wise, section wise, reason wise.
2. The statutory returns filed.
3. The tax deducted and paid to government and taxes to be deducted.
4. Cash flow analysis and cash in-hand.
5. Audited statement of accounts and balance sheet.
Reference documents
1. Tax regulations – latest.
2. Bank and other financial institution regulations.
3. Statutory regulations.
5. Production department
Objectives
1. To produce the required quality materials in time of the required
quantity.
2. To maintain the efficiency and utilization at optimum level to have
the lowest cost and get the required quality.
3. To maintain health and safety conditions for the employees as well
as for the products and equipments.
Performance indicators
1. Production achieved product wise
2. Quality levels of the products
3. Reduction in rejections
4. Utilization of men and machinery
5. Production efficiency
6. Reduction in wastes
154 Effective implementation of quality management systems
Procedures
1. Production procedures for different products.
2. Production planning.
3. Work instructions for each activity of workmen.
4. Allocation of men as per product requirement.
5. Arriving at process parameters for each product.
6. Identification and traceability of materials.
7. Maintaining the production records.
8. Disposal of obsolete records.
9. Following for maintenance and attending of breakdowns.
Records
1. Production records
2. Rejection records
3. Analysis of rejections and action taken
4. Analysis of breakdowns and actions taken
5. Analysis of accidents and actions taken
6. Action taken records for other non-conformities
Appendix 155
Reference documents
1. Customer requirements (specifications and purchase order details)
2. Industry norms of production, quality and work allocations
6. Maintenance department
Objectives
1. To maintain the machines to produce the required quality materials
in time of the required quantity.
2. To maintain breakdown free performance of the machines.
3. To maintain health and safety conditions of the machines and
equipments.
4. To maintain machines at lowest possible cost.
Performance indicators
1. Breakdown free performance
2. Quality levels of the products and rejections
3. Utilization of machinery
4. Production efficiency
5. Cost of maintenance per unit
6. Accident free performance
Procedures
1. Procedures for periodic preventive maintenance.
156 Effective implementation of quality management systems
Records
1. Machine-wise maintenance records
2. Machine history
3. Analysis of breakdowns and actions
4. Action taken records for rejections and other non-conformities
5. Spares and other materials received and consumed
6. Calibration records
Reference documents
1. Machinery catalogues and manuals.
2. Catalogues and manuals of lubricants, bearings, belts, etc., required
in the company.
References 157
References
References
158
Index 159