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©C P Chandrasekaran Consultant August 2009

2008 Anna University B.E Computer Science MG-1401 TOTAL QUALITY MANAGEMENT
Question paper.

2 MARKS:

1. Define Quality as per Ed. Deming?

Quality is that which is specified by the customer (end user) as according to Deming if the product or
service does not address what was specified by the end user or customer it is worthless and without a
customer there is no need to produce the product.

2. What do you understand by quality statement?

Quality statement is the statement declared by the Top management defining the long term goals and
objectives of the organization with respect to product Quality and customer satisfaction.
This statement is called the Policy and is the source of all activities in QMS of the company.

3. Explain: Empowerment?

Empowerment is the state when employees are able to take decisions in their area of competence
and work and implement their decisions without any need to take permission from their superiors.

4.Explain:Supplier selection?

Supplier selection is employing a criteria of consistency and quality of production and then evaluating
all suppliers to arrive a t a few who are fit to supply the component or material to the organization. this
can be done once or periodically.

5. List out various measurements of dispersion in SPC?

Standard deviation or sigma.


Inter Quartile range.
Range

6. Explain the rules to be followed in sample selection?

Samples should be selected as follows:

1. Sample should represent population.


2. It should be independent of each other.
3. It should be unbiased.
4. It should be from the same process being studied.
5. It should be having sufficient size to draw valid conclusion.
6. It should be analysed in time.

7.List down the pillars of TPM?

1. Autonomous maintenance
2. Equipment and process improvement and Overall Equipment Effectiveness
3. Planned maintenance
4. Early Management of New Equipment
5. Process Quality management
6. TPM in administrative and support departments
7. Education and training
8. Safety and environmental management

8. Explain: Taguchi Quality Loss Function?

L (y) =k (y-m) ² and the definition is as follows


©C P Chandrasekaran Consultant August 2009

Loss which occurs due to poor quality is proportional to the square of the deviation of the
characteristic of the product from the nominal value.

From the above normal curve, the theory of Taguchi can be explained as follows:

1. as you produce the product exactly on the straightline of the curve the target and the characteristic
is same eg weight of the casting is exactly 900 grams. But the process does not produce the output
exactly on the line and produces over the area enclosed by the normal curve as shown by the outline.
As you go away from the target and produces castings of either 500 gm or 1400 gm there is a loss
which is reflected in rework or rejection. Taguchi stated that this will be proportional to the square of
the deviation. Thus producing castings of 1000 gm may be having less impact but the castings of
1400 gm or 400 gm will be creating loss for the customer or supplier.

9. Explain about NCR?


In an internal/external audit , when the auditor finds certain requirements are not followed adequately
or the effectiveness lacking then he records the finding in a report called the NONCONFORMANCE
REPORT. It is signed by the auditor and auditee.
It has three parts.
1. The objective evidence found in the location.
2. The requirement to which it was non conforming.
3. The explanation or conclusion by the auditor with respect to the criticality of the non conformance

Sometimes the NCR is categorized as Major or Minor by the auditor to enable the auditee to take the
corrective action quickly.

10. Explain the need for the quality systems in an organization?

In a situation where one product is manufactured and supplied to one customer and the relationship is
established over a period of time, it is possible that the employees working in the organization in any
function are clear about the requirements. they may be knowing the correct parameter to be employed
, the right tool and the right packing. But, today we have several suppliers all over the world supplying
to many different customers and each has his own requirement. The customer wants his requirements
to be translated into product without errors. Quality systems fulfil the need of speaking on behalf of the
customer to all in the organization and coordinating their activities with one goal ie customer
satisfaction.

16 MARKS (5x16=80)

11. (a).(i) List out the barriers of TPM implementation?[marks 8]

1. Over production
2. Waiting
3. Transportation
4. In appropriate processing
5. Inventory
6. Unnecessary motion
7. producing Defects
©C P Chandrasekaran Consultant August 2009

However, the barriers could also be organizational like

1. Poor planning
2. Bottlenecks in the line
3. Old machinery giving poor quality
4. Poor control on tools.
5. Strict water tight compartments way of working
6. Low knowledge level of workers
7. too many varieties and too few number in a batch.

(ii). Discuss about the analysis techniques for the quality cost?[marks 8]

The analysis of Quality cost is done as follows:

1. Cost of internal non conformance this is the cost of rework and rejections happening inside
the organization.
2. Cost of External nonconformance: This is the cost of rejections and replacements in the field
by customers.
3. Cost of Appraisal: this is the cost of inspections and audits carried out to ensure the product is
acceptable to customers.
4. Cost of prevention: this is the cost incurred in activities like training or calibration to prevent
the errors form occurring.

or) (b). (i). Explain the principles of TQM?[marks 8]

1. Achieving Customer satisfaction


2. Ensuring the employee involvement in whatever we do
3. Continuous improvement is all processes.
4. Following PDCA in all improvement activities
5. Safety and interests of Community to be protected.
6. Respect for every individual.
7. A defined way of cascading the goals to employees.
8. Supplier involvement in Quality of product.

(ii) Explain about the strategic planning?[marks 8]

Strategic planning of any company starts with the visioning exercise.


In this exercise, top management deliberates about the company’s future direction and arrives at the
vision statement (and sometimes a mission statement also).
This vision statement serves the purpose of telling every one where the company is determined to go
and carry out its work.

For example, Motorola vision clearly states that “ it intends to be the most trusted integrator of
complex communication and information systems” which means that the company emphasizes on
three things

1. winning the trust of the customers


2. role as an integrator rather than a supplier
3. stay as a company known for the competence in technically complex areas.

Once the mission/vision statements are declared, the SWOT analysis is carried out with the
executives from different functions to know the feasibility of adopting certain strategies. Inputs are
taken from different agencies at this point of time as follows.
1. Market segmentation and changes in the segments
2. Competitor activity
©C P Chandrasekaran Consultant August 2009

3. Global economic indicators


4. Supplier capacity and abilities
5. Human resources
6. Legal scenarios

In the second stage, the goals or strategic objectives are arrived at and released with a time plan or
calendar.
They could be as follows:

1. Entry into small car market in 2010.


2. Become a market leader in Africa by 2012.
3. be the leader in India by 2013

The strategic objectives need to be cascaded to every function and even to dealers and suppliers.
This III stage is enabled by adopting techniques like Policy Deployment or MBO. Some companies
recently have started Balance score Card.

In the IV stage the management needs to review the progress of action plans and modify the plans
due to certain changes happening in the environment.
.

12. (a). Explain the following:

(i). 5S[marks 5]

1. Systemise
2. Sort out
3. Spick and span
4. Standardise
5. Self discipline

(ii) Kaizen[marks 5]

Kaizen means literally “change for the good”. This is a philosophy and as a concept originated in
Japan but it has been adopted all over the world for carrying out small improvements. Normally there
is a team called kaizen team which finds out certain scope for improvement which can be carried out
without much investment. It can be marking entry and exit or putting self glowing signages or even
redesigning trolleys. The team sits down, finds the solution and implements the solution in a weekend.
Kaizen is simple, quick and participative way of getting improvmements.

(iii) Supplier rating and relationship diagram[marks 6]

Supplier rating is the periodic evaluation of suppliers to rate them as A B C or D depending upon
certain pre defined criteria like Quality, delivery, cost and relationship. Many companies do a six
monthly rating and some do it annually. The rating is done as per a system of assigning marks based
on the past six month data. After the rating suppliers who have achieved good rating ( A) are
recognized while the suppliers who got poor rating (D) could be discontinued. Sometimes, an
agreement is done that they will improve within six months. Well known companies like Hyundai
display the ratings in the company where visitors arrive and some treat this as confidential.

Relationship diagram:

It is one of the 7 new QC tools and it indicates the relationships between several entities.

For example, the relationships of individual entities in the transportation are as follows:
©C P Chandrasekaran Consultant August 2009

Driver Wiring
Battery
Console Harness

Switch Temp
indicator
A/C
compressor

Passenger console

Air flow in cabin

(or) (b) Discuss about Maslow's need hierarchy theory and Herzberg's two factor theory for
motivation?[marks 16]

Maslow’s need hierarchy was aimed at explaining the reason for the behaviour of people differently in
situations. Maslow thought of a hierarchy of needs which exist according to which the person behaves
in a particular way which is not clear to others.

1. Need for self actualization


2. needs for self esteem
3. need for belongingness
4. needs for safety
5. needs for physiological protection

1 is the highest level and 5 is the lowest. He also stated two conditions in this hierarchy.
1. Once a lower level need is satisfied it loses its potency as a motivator.
2. The individual moves up one level at a time.

For example once the physical needs are satisfied by salary, this is not a motivating force for better
working but the higher need could ,for example belonging to a team, be motivating.
The criticism of Maslow theory is it is not proven by experiments. Secondly, the later experiences of
Dr Maslow seemed to bring in certain pre conditions which are required for this hierarchy to operate.
Around the same time when Maslow cam up with is throry (1960) Dr Frederick Herzberg founded the
two factor theory. Herzberg said that it is important to find what makes people happy and satisified on
their jobs or what makes them unhappy and dissatisfied. He isolated two needs which happened to be
isolated from each other. The findings on unhappiness and dissatisfaction were clubbed into hygiene
factor and those with happiness and satisfaction were clubbed into motivation factor. Herzberg said
that the hygiene factors like pay or canteen are required to keep the people at work in the sense they
are like basic hygiene for the body but beyond a point they do not create happiness at work.
Opportunities to learn, the team work and the recognition may be the motivating factors which could
bring in better productivity and better contribution. The criticism of Herzberg theory is that many times
the productivity cannot be predicted by this theory. Some believed that money has a power beyond
the theory to motivate people even to innovate or work in teams. Later papers did not find that
hygiene and motivation can be separated and they can be put in a grid to proceed in both ( J W
McLean-Productivity Grid).
©C P Chandrasekaran Consultant August 2009

13. (a). Explain in detail: (i). Process capability[marks 8]

Process capability

Process capability is the extent to which the variation in process is within the acceptable limits or
tolerances of the customer/internal customer. This is stated by the Process capability indices Cp and
Cpk.
Cp is Process capability index and is calculated as follows.

Upper spec limit-Lower spec limit/ Upper Control limit-Lower control limit.

Upper spec and lower spec limit are given by cutomers. Eg 2 hours to 4 hours response time.

Control limits are derived from the data (after checking normality of the distribution). Eg 1 hour to 5
hours response time.

Cp= 2/4 =0.5.

For a capable process Cp >1, it should be preferably 1.3. Here we note that Cp is 0.5 and hence the
process is stated to have poor capability. Cpk is Process performance. This takes into account the
fact whether the process is centred or it is off centre. It is supposed to be more precise than Cp.

Cpu= Upper spec limit-Target /Upper control limit-Mean


Cpl= Target-Lower spec limit/Mean-Lower control limit.
Cpk is the minimum of the above two.

Eg in the above numerical illustration Cpu= 4-3 /5-3 =0.5; Cpl= 3-2/3-1=0.5 Cpk=0.5
In this case Cpk and Cp are same but in many cases when the process is off centre Cpk tends to be
lower than Cp.
This is explained by the figure given below.

We can observe theat the Control limits are wider than the Specification limits and hence quite a fe
occasions (as per the area of the normal curve) fall outside the acceptance limits. These are
defectives and could dissatisfy those customers who receive such services /products.
For the customer satisfaction, the process control limits should be well within the spec limits and the
mean of the data should coincide with the target value.
In TS standars it is required that the process capability should be as follows:
Cp=1.33 and Cpk=1.67 to allow for the process drift.
LCL LSLμ USLμ UCLμ
USL
L Target
μ

(ii). Six sigma[marks 8]

Six sigma derives its origin from the greek letter sigma meaning standard deviation. (σ). Six sigma is
also a measure of the process as in normal distribution, 99.3 % of the data is estimated to fall within
the linmits of 3 sigma on one side of the mean and 3 sigma on the other side of the mean. Since
©C P Chandrasekaran Consultant August 2009

99.7% is a very close figure to 100% and due to the curve of normal distribution not touching the x
axis, this is taken as the figure to indicate the capability of the process.

When the six sigma limits are closer and less than the spec limits the process is considered to be
good as at any time the products are going to conform to requirements.

The six sigma is also a methodology to ensure that the variation comes down and the six sigma
continuously shows that the process variation is less than the tolerance limits. The lesser it is the
better is the Quality and more is the customer satisfaction.

Six sigma methodology was introduced by Motorola in 1988 and became the flag ship improvement
process in the company. Six sigma now is adopted all over the world and the improvement projects
save millions of rupees every day.
The projects are taken through the five phases as follows:

1. Define
2. Measure
3. Analyse
4. Improve
5. Control

The teams normally take up different projects and complete the projects in six months. The goal is
normally specified in the units of sigma meaning the process was earlier in 2 sigma and the goal is 4
sigma. It is not mandatory for all processes to be in six sigma but closer it is the better.

(or) (b) Discuss the need, construction and applications of control charts for variables.[marks
16]

The need of control charts:

From days of the early industrial revolution till 1920s the only way to control quality was to inspect. Lot
of man hours were spent in inspection at all stages and an army of inspectors thronged the
workplaces. However, it hardly improved the quality. Inspectors did mistakes and managers over
reacted to variations as per their own judgement. W A Schewart created the control charts to let the
managers to avoid employing large number of inspectors but still have control on the output.

The control charts are needed to

1. avoid spending on inspection


2. know when to intervene and correct the process.
3. find whether the process is stable or not.
4. empower the operator to act if required.
5. save time in waiting for inspection to pass the lot.
6. transparent as far as the process is concerned with customers.

Construction of control chart:

Control charts are constructed as follows:

A process which is to be put under statistical control is selected.

The items produced are taken from routine production every hour in groups of 4 or 5 and the
characteristic say weight is measured. This is called sub group. These 4 or 5 sample have a mean X
bar and a standard deviation sigma. Similarly, it is possible to continue collecting about 30 readings
continuously.
©C P Chandrasekaran Consultant August 2009

Now, we have enough data to construct a control chart. Before we do it, some checks are required to
be done.

1. If there are outliers meaning some point which is totally irrelevant and could be error they
should be removed as they will affect the calculation.
2. All data should be independent meaning one point should not affect the other.
3. There should not be trend time wise.
4. Distribution of data should be normal.

After carrying out these checks. The mean of sample means is calculated ( average of sample
averages) this is called X bar bar.
The control limits are calculated as follows.

LCL = X bar bar – 3 times sigma or standard deviation (Xbarbar- A2 R bar )


UCL= X bar bar + 3 times the sigma ie standard deviation (X bar bar + A2 R bar)

The control chart looks like this :

UCL
Summary Statistics = T

CL

LCL
Time

Similarly the range values in each sub group are plotted as a range chart.

The centre line of the chart being R bar (mean of ranges). The contol limit for ranges Rbar+ D4 Rbar
and R bar-D3 R bar where value of D3 and D4 are taken from the statistical tables for the sub group
size.

Control charts for variables:

For subgroup based data Xbar R chart is the most suitable one. Typical applications are from any
manufacturing industry. For instance in injection moulding four plastic bottles are produced in every
stroke. Here, the weight of the bottle is critical. So, a control chart can be constructed where every
hour, 4 bottles are taken and the readings taken.

The contol chart read at the end of the day shows the variation in the weight of bottles from hour to
hour. As far as the variation in weight is within the control limits, the process is stable and is behaving
within the statistical control, In case any data point has gone out of the control limit, the process has
deviated at that time due to an assignable cause and this needs to be acted upon by stopping the
process and investigating.
The range chart is to be studied for within group variation. Incase any point has go ne out of the
control limit then the inter group (one of the four moulds) is the cause for creating instabiulity.
©C P Chandrasekaran Consultant August 2009

For manufacturing situations where the subgroup is not possible because the events are taking place
one at a time, individual x readings are plotted and it is called I –MR or individual and moving range
chart.

These two charts are used for variables which are continuous.

For discrete/ attribute type data.

P charts for proportions and np charts for non conforming items are used.

For low numbers like defects or complaints

C charts or u charts are used.

14. (a). Discuss the objectives, process, outcome and benefits of FMEA?[marks 16]

Objectives of FMEA

1. To identify failure modes and the corresponding risks.


2. To quantify the risks of failures.
3. To prioritise the risks.
4. to take countermeasures for the prioritized risks.

Process of Design FMEA;

1. The CFT is formed for performing the design FMEA.


2. The individual items are listed and the function of each item is listed.
3. The failure mode by which the item will not perform its function is identified. Say a tube will
leak This is a failure mode of the tube.
4. the failure mode is extended to its consequence eg the leak will cause damage to the
machine then the severity of such an occurrence is rated in a scale of 1-10.
5. the potential causes for such a failure mode are identified eg a leak is caused because of
impurities in the liquid.
6. The probability of this cause ocurring is rated in a scale of 1-10 I being rare and 10 being the
number for very often occurring cause.
7. The Severity and Probability determine the risk however it is modified by detection
mechanisms if something is available to detect the impurities in time.
8. Ths the risk priority number RPN is the product of Severity* probability* detection.

Item Potential Potential S C Potential O Current Current D R. Recommended Responsi- Action results
effect(s) e l cause(s) c Design Design e P. action(s) bility & Actions S O D R.
failure of failure V a /mechanism(s) c controls Controls t N. target taken E C E P.
mode s of failure u Prevention Detection e completion V C T N.
F S R C date
unction
Tube Leak Damage 8 Impurity in oil 6 Nil Nil 10 480 Install warning B S Shah 24th Sep
in machine

Process of process FMEA:


©C P Chandrasekaran Consultant August 2009

1. CFT is formed.
2. List all the operations one by one.
3. Write the purpose of each operation. Eg cuttting
4. Write the failure mode for each operation eg cut to wrong length
5. Identify the consequence of such a failure mode eg batch rejected.
6. Write the severity of the failure eg 8
7. Identify the potential causes for such a failure eg wrong tool.
8. Write the probability of such a cause occurring in na scale of 1-10 (1 rare 10 very often).
9. Severity and Probability together constitute the risk but it is modified by the detection.
10. Depending on the process control/ error proofing the detection score is given.
11. Then RPN is calculated as Severity * probability* detection.

Operation Potential Potential S C Potential O Current Current D R. Recommended Responsi- Action results
effect(s) e l cause(s) c Process Process e P. action(s) bility & Actions S O D R.
failure of failure V a /mechanism(s) c controls Controls t N. target taken E C E P.
mode s of failure u Prevention Detection e completion V C T N.
S R C date
Cutting Wrong Rejection 8 Mistake in tooll 6 Nil Nil 10 480 Install checking B S Sanjay 24th Sep
length for tool

(or) (b). Explain about the following:

(i). QFD process[marks 8]

The Quality Function Deployment is tool to translate the customer requirements to product
characteristics as done by a CFT. First the customer requirements are gathered and written as
follows:
Example A bicycle for young students

No Customer wants Importance Competitive status


1 Attractive styling 4 At par
2 Choice of colours 4 Inferior
3 Works well on all roads 5 Inferior
4 Carries a lot 2 At par
5 Fast 3 Superior
5 Theft resistant 5 Inferior

Let us then speak to Designers and get the technical characteristics of the bicycle

No Technical characteristics
1 Pedal Force
2 Weight of cycle
3 Paint thickness
4 Gearing ratio
5 Wheel rim width
5 Lock design
©C P Chandrasekaran Consultant August 2009

Now w e construct a house of Quality called Quality Function Table.

weight
Force

Score
lock design
No Customer wants vs

Pedal

Paint

Gearing
technical
characteristics

1 Attractive styling 0 0 0 0 0 0
2 Choice of colours 0 0 6 0 0 6
3 Works well on all roads 9 9 3 9 0 30
4 Carries a lot 6 6 0 6 0 18
5 Fast 9 9 0 9 0 27
5 Theft resistant 0 0 0 0 9 9
Tech comparisons medium medium equal poor poor
Target value X kgf Y kg 100 dft 3 speed nil

The table shows Quality ie what customer wants on one side and Function ie what our designers
provide on the other side. By making a matrix let us study both and see how they are matching.
9 shows the maximum correlation of characteristic to the want.
6 shows medium correlation.
3 shows minimum correlation.
0 shows no correlation.
The table is interpreted as follows:
Among customer wants “works well on all roads” is addressed by our designers comprehensively but
still we are inferior to the competitor. Since arrow marks indicate the efforts going on, we will take
credit for the efforts and accelerate them. Least score is for attractive styling (0) no technical feature is
addressing this and we are at par as per the comparison. We can be overtaken soon as we are not
putting any efforts. Customer has given the second highest importance score to attractive styling and
so we may lose out. We need to put in efforts in this direction and designers need to correct their
development models to offer more attractive styling. As far as the technical characteristics are
concerned except locking all are high but locking is of maximum importance. We are not clear that the
company is serious about this. So Designers should come out with not only good lock but theft free
design. (not duplicated or not repeated or double locking system)

This is how QFD helps us. There could be contradictions as we improve attractive styling it may
become less fast due to air drag or weight. This is called technical contradiction in QFD. This has to
be resolved by innovation only.

(ii). Benchmarking process[marks 8]

The benchmarking process works as follows:

1. what are the strategic needs of the company?


2. what are the key processes which are crucial for improvement/breakthrough?
3. what are the characteristics /measures which we can observe in the process for efficiency or
effectiveness?
4. Do we see the gap in them with respect to others/
5. Do a primary study and locate partners with whom we can benchmark the process. Note: the
partners need not be in the same industry.
6. Select a team to go and study the partner’s process and share your process with them.
7. Limit your study to agreed areas and do not go beyond the scope.
8. Record the findings and adopt the findings to improve the process.
9. Record the learnings.

15.(a). (i). Explain about quality system auditing?[marks 8]

Quality system auditing can be as follows


©C P Chandrasekaran Consultant August 2009

1. Internal audits
2. External audits

In external audits system auditing is carried out by people not belonging to the same organization and
when it is conducted by customers it is called second party audits and when it conducted by
certification agencies or independent registrars it is called Third party audits.

The system auditing is either done for qualifying a supplier or is done for improvement of the existing
system.

Normally, the Quality system auditing is done as per the international standard ISO 9001 but it is
possible to do the auditing as per a customer’ requirements also. For example in the automotive
industry the standard TS 16949 requires the system auditing to take note of the requirements of the
customers.

There is an international standard for system auditing and it is called ISO 19001:2002 . It covers audit
planning, competences of auditors, audit management and the communication of results.

Unlike product audits, system auditing does not have any fixed sample size to audit. The auditors
have knowledge of the quality systems and they pick up trails of a particular order or a requirement
and find whether the system is complied with by all the prople. If the requires are not found to be
complied, eg a wrong machine is used or a test is missed out then th auditors raise Non
conformance note called NCR .

This is not a note telling the auditee what to do or complaining against any one but it is an objective
record of an event being found that a particular requirement is not followed.. it has three parts,
1. Evidence
2. Attribution of the finding to a requirement
3. Explanation about the need to comply.

The NCRs are signed both by the auditor and the auditee and given to management also for follow
up. Many companies have affixed time period within which the NCRs are to be closed and actions
taken verified by the auditor.

It is usual to upgrade the competences of auditors periodically as the job calls for high degree of
knowledge and familaiarity with the Quality systems being audited. Many take the feedback form the
auditee to monitor the fairness of the audit process.

(ii) Discuss the implementation of ISO:9000:2000 quality systems?[marks 8]

The ISO 9001:2000 (now revised to 2008) needs be implemented in a planned way. For a big
company this exercise may take about six to eight months and for a small company it may take 3 to 5
months time depending on the efforts put in continuously.
The activities are detailed as follows.

1. Management should declare the intention to go for ISO standard QMS and nominate a team
which will implement the standard.
2. The team meets and deliberates about the present status and decides the time required.
3. Management to declare the Quality Policy and objectives to all the people.
4. management will inform the functional Heads to study the requirements and understand the
need to have processes which are cutting across the functions.
5. The team defines the key processes in the company they may be 5 to 10 depending on the
complexity of the company’s operations.
6. The process maps are prepared and verified by all the managers.
7. thius constitutes the main implementation document.
8. The Quality manual is written with the process maps as guiding document.
9. The II level procedures are written by the dept heads with the assistance of all the employees.
©C P Chandrasekaran Consultant August 2009

10. The documentation is completed for all activities and the documents are released for all the
employees.
11. the Internal auditors are trained for conducting the audits on all aspects of the company and
its operations.
12. The internal audits are conducted and the flaws in the system are reported.
13. The management reviews the audit findings and takes the corrective actions.
14. After getting convinced that the system is stable, the management requests the certification
agency to come and do an external audit.
15. The selected agency sends its team of auditors who come and do the audit and submit the
report to the management.
16. In case there are no major discrepancies or non conformances the certificate is awarded to
the company’s Quality management system which is valid for 3 years subject to an annual
surveillance audit.

(or) (b).(i). Explain about the documentation process in ISO 9000:2000 system?[marks 8]

Quality Manual

Process maps

Procedures and
Work Instructions

Data and records

The documentation has several tiers but many companies follow a 4 tier documentation process.

I tier is the Quality Manual. A Quality manual is the apex document of the company and is also called
the apex manual. This manual is the only document which defines the scope of the Quality
management system and addresses all the requirements of the standard briefly.

It is not only useful to employees but also useful to customers and external agencies as they can read
and understand about the company’s Quality management system.
The exceptions are stated in the manual eg no servicing is included in the scope.
The manual is signed by the CEO and no one can revise it except the CEO.

II level is the Process maps. Since ISO has adopted the process approach the companies need to
introduce the process way of working which cuts across the depts. Activities. The process maps are
the property of the company and so they are common for many depts..

III level procedures are functional documents. HR or Purchase or Shipping may have their own
procedure manuals detailing the activities in their scope. In production, work instructions are common
and they are displayed in the shop floor.
©C P Chandrasekaran Consultant August 2009

In the last level, we have data and records. All the activities carried out generate records. Eg
inspection reports. These are stored either in paper or in digital media. Many times the records are in
the form of data and these are also to be stored safely so that they can be retrieved if required.
Management Representative is the person who is authorized to carryout revisions in any document
and is also responsible to distribute them to all concerned persons.

(ii) Discuss ISO 14000 requirements and its benefits?[marks 8]

ISO 14000 is an Environ management standard and is aimed at reducing the environment impact and
pollution due to the processes.

Its requirements are as flows:

Clause no 4
4.1 General requirements
4.2 4.2 Environmental policy: This defines the need for having a policy for environment
management system.
4.3 Planning :

This clause calls for having an assessment of environment impacts around the company. It has also
called for the organization to collect the legal requirements. With the legal limits and the impacts
created by the processes around the company (or to the users of products), objectives are defined
these are quantifiable and time bound. In nplanning each and every process is studied for the
environment aspects for example the painting process has an aspect regarding the air pollution. The
aspect register is compiled with all processes and related aspects. This forms the foundation of
implementing the EMS.

4.4 Here the management needs to plan for resources to implement the environment
management system. It also calls for the training of people and upgrading the competences of
all employees. In this clause operational control is defined. The routine operations need to be
controlled so that eh environmental aspects are monitored and kept within the limits.
Emergency preparedness is an important part of operational control wherein the emergency
situations are defined and the procedures are written for dealing with the situations. Mock
drills are a part of emergency preparedness.
4.5 In this clause, the requirements are listed for monitoring and measurement, audits and
evaluation of compliance. The non conformities noted either during routine monitoring or
through audits need to be acted upon in a timely manner.

Other clauses which enable the administration of Environment management systems are

a) document control
b) record keepInternal audit
c) management review
d) Internal audit
e) Communication

They are not unique to ISO 14000 and are common with many other management standards.

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