ASSIGNMENT

DRIVE
PROGRAM
SUBJECT CODE &
NAME
BK ID
CREDITS
MARKS

SPRING 2015
MBA (SEM 4)
QM0015 - ISO/QS 9000 ELEMENTS
B1348
4
60

Note: Answer all questions. Kindly note that answers for 10 marks questions should be
approximately of 400 words. Each question is followed by evaluation scheme.
1) a. Mention the key benefits of all eight principles of Quality management
system.
b. Briefly explain the concept of product tracing with an example.
Answer)
a) Key benefits of Eight Principles of Quality management system
The eight quality management principles are defined in ISO 9000, Quality management
systems Fundamentals and vocabulary, and in ISO 9004, quality management systems
guidelines for performance improvements. Senior managements can use these principles as
a framework to guide their organizations towards improved performance.
Following are the standardized descriptions of the principles as they appear in ISO 9000, with
examples of the benefits obtained from their use and of actions that managers typically take
in applying the principles to improve their organizations performance.
Principle 1: Customer Focus
Customers are the main focus point of all organisations and therefore should understand
current and future customer needs, should meet customer requirements and strive to exceed
customer expectations.
Key benefits:
As result of flexible and rapid responses the organizations will increase revenue and
market share.
Organizations can utilize their resources effectively to enhance customer satisfaction.
Improved customer loyalty leading to repeat business.
Application of this principle leads to:
Organisations to focus on customers primarily. Therefore they research, understand
and communicate with customer to find out about their needs and expectations.
Measuring customer satisfaction and acting on the results.
Effective management of customer relationships.
Balanced approach to satisfy customers and other interested parties such as owners,
employees, suppliers, financiers, local communities and society as a whole.
Principle 2: Leadership
Leaders establish unity in achieving organisations purpose. They are responsible for creating
and maintaining the internal environment in which employees can become fully involved in
achieving the organisation's objectives.
Key benefits:
Employees can easily understand and be motivated towards the organisation's goals
and objectives.
Activities are created and managed in a unified way.
Minimized miscommunication between the various levels of an organisation.
Application of this principle leads to:
Taking into consideration the needs of all interested parties including customers,
owners, employees, suppliers, financiers, local communities and society as a whole.
Setting challenging goals and targets to ensure a clear vision of the organisation's
future.

Creating and sustaining shared values, fairness and following ethical role models at all
levels of the organisation.
Providing a trusty environment and eliminating fear.

Principle 3: Involvement of People

People at all levels are valuable resources of an organisation and their full involvement
enables their abilities to be used for the organisation's benefit.
Key Benefits:
Inspired, committed and involved people within the organisation.
Innovative nature of employees in furthering the organisation's objectives.
Employees are motivated to participate in and contribute to continual improvement
and hence increase their own performance.
Application of this principle leads to:
More responsible employees who can accept the ownership of problems and can solve
those.
An opportunity for employees to enhance their competence, knowledge and
experience.
Sharing of knowledge and experience, openly discussing problems and issues.
Principle 4: Process Approach
Good results are achieved only when activities and related resources are managed as a
process towards achieving the organisation goal.
Key benefits:
Effective usage of resources.
Improved, consistent and predictable results.
Focused and prioritised improvement opportunities.
Application of this principle leads to:
Systematic way of defining the activities necessary to obtain a desired result and clear
responsibility and accountability for managing keyactivities.
Allocation of resources, methods, and materials that will improve key activities of the
organisation.
Principle 5: System Approach to Management
If we manage interrelated processes as a system, it will contribute to the organisation's
effectiveness and efficiency in achieving objective.
Key benefits:
Integration and alignment of the processes that will inspire to achieve the desired
results.
Steps up the confidence level of interested parties as it brings in consistency in the
products, effectiveness in managing and the efficiency of the organisation.
Application of this principle leads to:
Structuring of system to achieve the organisation's objectives in the most effective
and efficient way and structuring of approaches that harmonise and integrate
processes.
Continually evaluating and measuring the system against improvement.
Principle 6: Continual Improvement
Objective of every organisation is to continually improve the overall performance this indeed
would be the permanent objective
Key benefits:
Improved performance.
Distribution of improvement activities at all levels to an organisation's strategic intent.
Application of this principle leads to:
Following a consistent organisation-wide approach to continual improvement of the
organisation's performance.
Establishing a set of goals to guide, and measures to track, continual improvement.

Principle 7: Factual Approach to Decision Making

Effective decisions can be taken with a proper analysis of data and information.
Key benefits:
Informed decisions.
More opportunities to demonstrate the effectiveness of past decisions through
reference to factual records.
Increased opportunities to review, challenge and change opinions and decisions.
Application of this principle leads to:
Reliable, accurate data and information.This makes this data accessible to those who need
it.
Analyzing data and making decisions based on factual analysis, balanced with
experience and intuition.
Principle 8: Mutually Beneficial Supplier Relationships
An organisation and its suppliers are interrelated and a mutually beneficial relationship
enhances the ability of both to create value.
Key benefits:
Creating value for both parties.
Immediate responses to changing market or customer needs and expectations.
Application of this principle leads to:
Establishing balanced relationships between short-term and long-term considerations.

Establishing joint development and improvement activities.

Inspiring, motivating and recognising improvements and achievements by suppliers.

Organisations can apply quality management principles in many different ways.

Implementation of these principles depends on the nature of the organisation and the specific
challenges it faces. It is beneficial for organisations to set up quality management systems
based on these principles.
b) Concept of Product Tracing
The process of Product Traceability maintains records of all products and parts from
purchasing to finished goods. Traceability ensures product tracking thereby satisfying
customer that they get the right product in time. Traceability improves product control since it
has the capability to identify and track a product or a component to its roots. Traceability
provides a means of identifying the units for recall. Some products (e.g. aircraft components,
fresh product, meat) require complete traceability.
The supplier establishes and maintains documented procedures for unique identification of
each and individual product or batches and records the identification made. Traceability is
basic for establishing and eliminating the root cause of nonconforming product. Hence
traceability should be mandatory in view of the requirements for Corrective Action. Providing
traceability can be a difficult task. In some applications or situations, products need to be
traced back to the original ingot from which they were produced. For example, safety or
national security is a situation where it is necessary to identify product in such a manner that
if a product is used in a critical application and consequently found defective, it becomes a
must to track down all other products of the same batch and eliminate them before there is a
disaster. Such situation is called as product recall situations. Continuous product identification
and traceability is a must in any industry where human life may be at risk (Example: Medicines
and medical equipment) due to a defective product being in circulation.
Traceability is also important to control processes. You may need to know which products have
been through which processes and on what date, if a problem is found some time later.
Scope of Product Identification and Traceability in the industry.

Product identification extends to identifying manufacturing order number, process

order number, lot number, and inspection order number in all stages of
manufacturing. It links each component element, whether material, process,
measuring gauge or personnel to any related activities for final output or traceability.

Product identification also deals with applicable drawings, specifications, revisions and
quality records.
Traceability includes measuring and calibrated instruments like gages and tools that
are used during the production process
Identification extends to human resources also. For example those performing
traceability personnel performing quality activities.

Some common benefits of Traceability include the following:

It enables real time monitoring of shipments. One could also find out about the arrival
time.
If an organisation wishes to provide warranty service verification, traceability can help
with tracking the customers file
In the Accounting processes of organisation Traceability can measure the costs
incurred.
In the Security industry, it helps to identify counterfeit and illegal items
Traceability makes it easier to find the effects of product changes and even enable the
organisation to come up with customised products and services.
Traceability provides logs that help in being evidence for product liability claim.

..
2) Explain the importance of identification of the non-conformance products.
Discuss the ways in which disposition of products can happen.
Answer:
Importance of identification of the Non-Conformed Products
The identification of the product differentiates the non conformed product from the conformed
equipment in a clear and explicit manner. The process of identification includes the physical
separation, also called segregation from the conformed products. There must be a specific or
special area marked for non conformed products. The most important requirement for the non
conforming product in ISO/QS 9000 is that, the non conforming product must be distinguished
from conforming product units. In identification procedure, the organisation identifies those
products that do not confirm to the specifications. ISO/QS 9000 standards do not have specify
the methods to identify the non conforming product. The organisation can have its own
methods to identify it. Some of them are:

Tags or stickers affixed to the product

Labelled bins, bags and boxes
Directions written on the product
Ribbon enfolded around the product
Coded markings on the product
Electronic detections such as bar codes attached to the product
Storing the product in specially marked areas

The organisation can have their choices of deciding the ways of identification which is suitable
for their method of operations. There are no universal conventions exist for non conforming
identification. An interview with the employees will be effective to indicate if the identification
system isperforming well.
Disposition of Nonconforming Products
The disposition of the nonconforming products is an important evaluation process as per the
ISO/QS 9000 standards. The process of disposition includes the decision taken for handling the
non conforming product. As per the standards of ISO 9000, there are three different ways of
dispositions. One of the methods is to take adequate action to reduce the detected non
conformity. In this process, the identity of the product will be maintained, but the nonconformity characteristics will be got rid of. This can happen in several ways such as

Repairing: This include the actions which make the product functional though it does
not comply itself to the specifications of the product. Such a product will not have the
same warranty as the original quality.

Reworking: This comprise the actions which make the product comply with the
original specifications. In customers view point, the product will be as same as the
first quality non conforming product. The product follows the same operations cycle,
often with a drawing. Repaired and reworked products are subjected to original
inspection criteria and are verified thoroughly before being accepted.

Reprocessing: The product is sent back through the process of transformation. The
product could also be regarded to be used for alternative applications.

By authorising its use, release or acceptance: The product is accepted with or

without concession, which suggests that the product is nonconforming as per the
specifications of the organisation, but acceptable as per the clients specifications, a
concession can be issued by the organisation. Though nothing is done to reduce the
non-conformity or to change the products quality and performance, it is still accepted
by the customer. It is important to know that the concession can come only from the
client.

Rejecting the non-conforming product. Such scrap products which have no other
means of disposition are sent to the original supplier or customer or separated from
the other products and labeled to avoid nonuse.

.
3) Explain the audit criteria and audit process. Differentiate between
Internal and External auditors.
Answer
1) Audit Criteria
Audit criteria refer to the set of policies, procedures and requirements used as a reference.
The part of preparation for Audit actually deals with developing Audit criteria. The Audit
criteria should establish the area of audit, specifically the procedures and any other industry
specific regulations or any other contractual requirements. A checklist is a valuable source
which helps in explaining the audit criteria requirements. They need to be developed to
provide assistance to the audit process. This will help the auditor to concentrate on the salient
items of the audit and also not miss the content. The checklist enables the auditor to
determine in advance the skill or expertise needed to audit and also that would be needed to
evaluate the response by the concerned department and also place the right methods of
evaluation. Audit criteria help to structure the audit analysis which forms the basis for their
findings (audit report).
Audit criteria checklists are organisation specific. The Audit criteria should use common
methods to judge but should achieve consistent findings by restricting the interviews with a
set of predetermined questions. The preliminary task when preparing the Audit criteria
checklist includes viewing the four basic sources:
a.
b.
c.
d.

ISO/QS 9000 Standards which spell the requirements

Customer specifications which are spelled out in the contract review
Internal documents and procedures
The Statutory or regulatory requirements (legal aspects)

Audit criteria have to be revised from time to time and should focus more to bring effectiveness
to the system. Internal auditors focus more on process performance and will not just test for
simple compliance.
2) Audit process
a) Preparing for an Audit
Internal audit is a process of self-introspection and hence the organisation should maintain a
systematic audit procedure which should define the audit process. The process of internal
auditing is a monitoring and measurement tool of the organisation. Management is expected to
answer and satisfy that QMS is implemented totally which can be reflected through the following
questions. These questions are related to not only the QMS but also the product realization.
1. Does the organisation plan their internal audits?
2. Does the organisation conduct their internal audits at regular intervals?
3. Are the audit programmers planned in advance?

4. Is this planning done taking into consideration the status and importance of the process and
the areas to be audited?
5. Are the results of previous audits also taken into account during the planning of the audit?.
6. Are the audit criteria, scope, frequency and methods of internal audit properly defined?
7. Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the
audit process?
8. Is it ensured that auditors do not audit their own work?
9. Does the organisation have documentary procedure for internal audit?
For proper Auditing, the Management needs to have positive answers for all the above
mentioned Questions. Auditors need a clear view of the linkage of processes in an organisation
since the process approach would be the commonly followed management strategy. Processes
are unified because the output from one process becomes the input for another. In broad, there
are three basic types of inputs/outputs: products, services, and information.
b) Planning Audits
The scope of your audit process should be defined and documented by the organisation and
must spell out the following: Auditing process is a planned programme and audit schedules spell
out the details of the time and frequency. The management and all employees should be aware
that the audit is a part of organisations quality management process. It has to be risk based and
the planning should also focus on maximising the resources. The plan-do-check act management
model would be the right way to approach the internal audit. The internal audit programme
would be planned and implemented as per the schedule. The efficiency of the programme is
periodically reviewed for the programme improved.
c) Conducting Audits
Audits are conducted on the basis of the following;
Product quality: Whether the intended product has been performing according to
the quality plan. This is tested through the process of sampling.
ISO/ QS 9000 requirements. The requirements as stated in the standard and
encompasses the entire organisation in the product realization life cycle which
includes the customer complaints, purchasing information, Corrective preventive
action (CAPA) requirements, training.
Quality Procedures and processes: This kind of audit involves evaluating the
efficiency of processes and correlating to find out if the quality objectives are met.
There has to be special attention to processes that has a high risk of failure on process
capability, non compliance with the statutory and regulatory requirements.
Previous audit results: The non-conforming product that has been identified has to
be audited and verified for conformance.
d) Reporting Results
The results of the internal audits serve as the feedback to the management review and hence
have greater significance in the management review process. It should present to you a
balanced view opinion and should discuss conformance and non-conformance issues. It should
also include observations and improvements. Non conformance relates to the failure of the
system to fulfil its objective. Non conformance could relate to a process which does not fulfil
the quality objective. The observation of the auditor is also an important issue which deals
with opinion. This is very vital in a non-conformance scenario as the auditor could present
some vital facts to the management.
The process of audit can be explained as follows:
1. The Department is identified for audit. The Audit team prepares the Audit plan and
procedure and performs the Audit.
2. The Department responds to the Audit requirements. The final Audit findings are tabulated.
3. It is reviewed by the Audit team and the management.
4. The internal audit process is repeated within a small schedule if there is any non
conformity.

3) Difference between Internal and External Auditor

Internal and external auditors are qualified professionals who follow specialised standards of
auditing. Their complementary skills, areas of proficiency, and perceptions help the
organisation to prepare the
organisation to reduce redundancies and bring in solid operational performance.

Internal auditors:
Internal auditors are trained personnel who are an important part of the organisation. The
objectives to internal auditing are set by the management board of the organisation.

The internal auditor serves the organisation by helping it achieve its quality objectives by
qualitatively auditing the processes. They audit both for adequacy and compliancy.
Internal auditors are concerned with all aspects of the organisation - both financial and
nonfinancial.
Internal auditors help the management to set their focus on future action based on their
audit report. They try to track down any inconsistencies with the process, help to avoid
deception and help to prevent frauds in any form.
Internal auditors function primarily to recognise risks and guarantee a proper internal
control of the organisation. Their work adds value to each and every department of the
organisation.
There is a special category of trained internal auditor called the Lead Auditor.
These internal auditors are part of the organisation who not only audit the organisation for
ISO/ QS 9000 compliance but also perform second and third party audits (audit both
suppliers and their facilities).
An Internal auditor is selected by the Management Committee of the company. Internal
auditor reports directly to the Board of Director of the organisation.

External auditors

External auditors are not the integral part of the organisation.

External auditors are individuals outside the organisation and they objectively assess the
effectiveness of the quality system.
External auditors are registered personnel of ISO / QS 9000 and their findings and report
recommend the organisation for certification.
The regular assessment by External auditors that is carried out periodically is called
Surveillance Audit.
.
4)

a. Explain in-process inspection and testing.

b. Discuss Measurement System Analysis(MSA) in QS 9000

Answer:
In-process Inspection and Testing
In-process inspection and testing are performed to validate the features and characteristics
during the assembly or processing of products. The objective hence is to verify and document
specifications and requirements that pertain to final product and that it is stable and can
continue to meet the specifications and requirements throughout the product run. The product
is put into inspection and test as per the quality plan or the other procedures of
documentation. The main objective behind this is to identify the changes at various levels of
production, especially the context where the characteristics of the products are exposed to
measurement. This also makes sure that non-conforming products are not released before it
gets conformed.
Among various levels of production (in-process), the inspection of the product takes place by
collecting samples from the line without disrupting the line production. It is also require a
product release procedure when the results indicate the acceptance of the product. In-process
inspection concludes with an approval to continue manufacturing parts. The report will
indicate that all contract requirements are met and are satisfied. Failure in in-process
inspection might enable us to find the flaws at that stage, and they are sent for re-starting the
manufacturing process after repair or are rejected (Also called as disposition). If such defects
are detected at the last stage, the operating costs of expenses of removing the product are
very high.

For example, let us take the example of a manufacturing unit. If the flaws in the product
identified in the in-process inspection stage, it can be corrected. However, if the flaws
identified in the last stage, it
increases the cost of the product. Once the manufacturing process is approved and
production sample is collected, the inspection takes place. If the product is conformed as
the product requirements, it is accepted and the manufacturing process continues. If
product is rejected because of non-conformance it is either disposed or corrected as per
requirements. The disposed product is returned for additional processing.

are
are
the
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the
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During inspection, you must verify the measurements which are made and the exactness
required to express the conformance of the product to the specifications. You should choose
the suitable inspection, measuring and test equipment, which is accurate and precise enough
to reveal them conformance of products to the requirements. They must perform some
important steps, which are essential in testing.

The organisation has to create, calibrate and regulate all the inspection, testing and
measuring equipments, which can make an impact on product quality.
The organisation has to calibrate all tools at specified intervals and against specified
equipment that possesses more recognised standards at the national and international
level.
The organisation has to define the procedures employed for calibration of inspection,
measurement and test equipment.

Explanation of Measurement System Analysis(MSA) in QS 9000

As per the standards of ISO 9000, the Measurement system analysis (MSA) is a mathematical
and experimental method to determine the extent of variations within the measurement
process that contributes to the overall process variability. There are five parameters to
examine in Measuring System Analysis: bias,
linearity, constancy, repeatability and reproducibility.

A general rule for measurement system acceptability is it accepts only 10 percent error.
If the percentage of error is between10 percent to 30 percent, it indicates that the
system is acceptable based on the importance of application, cost of measurement
devise and expense of repair and other elements.
If the percentage of error is over 30 percent, it is regarded as unacceptable and the
measurement system should be improved.

In addition to percent fault and the number of diverse categories, the firm should also review
the graphical analysis to decide the suitability of a measurement system. Based on known
requirements and organisational demands such as ISO 9000, MSA enables you to control,
inspect, maintain and calibrate the complete inventory gauges and measurement tools. Errors
in measurements will result in decisional errors.
The main objective behind Measurement System Analysis is to qualify a measurement system
for usage by counting its accurateness, exactitude, and constancy. The characteristics or
features of a measurement system are described in five different ways:

Stability: This refers to the capability of a measurement system to create the same
values over time when calculating the same sample. As with statistical process control
charts, constancy means the lack of special cause variation.
Bias: This refers to Accuracy and is a measurement of the average value of the
calculations and the actual and the true value of the sample.
Linearity: This is a calculation of the constancy of Bias over the range of the
measurement equipment.
Repeatability: This gauge whether the same appraiser can calculate the same sample
with the same measurement apparatus and obtain the same value.
Reproducibility: This calculates whether diverse appraisers can calculate the same
part/sample with the same measurement device and get the same value.

5) a. Describe the procedural requirements that the organisation must

follow while documenting the quality records.
b. Discuss the importance of packaging labels.

Answer:
Purpose of quality record keeping system
There are three main purpose of the quality record keeping system:
1) The records prove that products meet requirements
2) They serve as objective evidences for the quality system implemented
3) They also highlight the corrective action against non-conformities
An organisation must maintain quality records at every stage of the product. To name a few,
there must be quality records on inspection reports, analytical results, calibration and
corrective action reports. The records which the firm should maintain are:

The quality record keeping system must be protected from all kinds of unauthorised
usage.
The records can be paper based or electronic as they document the performance of the
products.
The organisation must determine the length of time the records have to be kept.

There are three primary factors that influence this - the contractual obligations and the
regulatory requirements, the presence of the product (life) in market and contractual records.
The quality records must be maintained for the following processes such as;
Management Review Quality Planning Contract Review Design Output Design
Review Design verification Subcontractors (Approved list) Control of Customer
supplied Product Product Traceability Process Control Production Release (urgent)
Final Inspection and Testing Inspection and Test Records Control Procedure
Nonconforming product (Review and disposition) Corrective and Preventive action
Results of Nonconforming work Internal Quality Audits Training
Procedural requirements
According to the ISO/ QS 9000 the organisation shall maintain the documented procedures to
identify collect, index, access, fill, store, maintain and dispose the quality records. There are
eight procedural requirements that must be addressed in the element control of quality
records. They are;
1) Identification of quality records: Quality records exist for each department of the
organisation which details the 20 elements of the standard. Each procedure would contain
forms, reports, lists, charts and other kind of quality records. These records exist in an
organisation department wise.
2) Collection of Quality Records: The record describing a procedure should contain
information of the person responsible for the verification of the specification. This includes
the person to whom the records passes on and the submitting person. The collection of
data is a simple step if you make use of a computer network.
3) Indexing of Quality Records: This attribute makes sure that all records are identified and
are not missed. There are plenty of methods of indexing such as checklists, colour coding
and sequential numbering systems.
4) Access to Quality Records: This requirement addresses the capability to retrieve a quality
record and its security. To safeguard the integrity of the files, your organisations should
provide the access to those individuals who are authorised only. The organisation must
define additional security like locking of the rooms, cabinets and the usage of sign-in and
sign-out logs.
5) Filing quality records: Indexing and filing are requirements that are closely linked with each
other. Files are identified with a matrix. The way the filing is done can be different for the
departments of your organisation. The record matrix identifies those storage locations
which authorised persons to retrieve the record as required.
6) Storage of quality records: The identification of the storage location is done by matrix
described by the department. The storage includes the actual place where files are stored,
environmental conditions (heat, light and air) and the measures taken by the organisation
for safe upkeep for future reference. For electronic records, the details regarding the way a
back up of the data is taken must be included.

7) Maintenance of quality records: Maintenance includes issues related to filing, collection

and storage. This also means maintaining the files in an up-to date manner in a proper
location, by not allowing the changes to the completed records and preserving them in a
easily retrievable manner.
8) Disposition of the quality Records: This refers to the disposal of the quality records. The
records retention matrix recognises the extent of the time records that are to be
maintained. This is closely associated with the length of a contract, product life, legal
requirements and the audit cycle. In case of confidential records, the organisation must
be clear regarding the way they intend to destroy the records.
Importance of packaging labels
The organisation must have a specific procedure to control packing, preservation and other
marking processes. This is to make sure that product complies with all the specifications. The
product shall be identified, preserved and segregated from the time of receipt till its handed
over to the customer. The organisation must develop packaging and marking methods to
protect the control the quality of the products and materials. The packing procedures and
methods must make sure that the products are protected from loss, damage and
deterioration. The packaging methods must ensure that there are:
Properly labelled packages
Suitable packing materials are used
Safely stored and transported
Regularly monitored
The organisation can use forms to give a clear description of the contents as specified in the
contract. There must also be clearly defined provisions to check the effectiveness of
packaging. The quality of the labels is an essential part in the labelling requirements. Some
organisations use bar codes to reduce error. The print quality of the bar codes must clear the
government guidelines verification. The organisation must include the additional information
regarding the quality on shipping identification labels.
Packaging Labels: Packaging labels should be made with the following considerations. They
are:

Physical protection: The objects that are enclosed in the packet might require
protection from physical impacts like shock, vibration, temperature and shock

Barrier Protection: The products need to be protected from all the barriers such as
oxygen, dust and water vapour. The primary function of the organisation must be to
keep the products clean, safe and fresh.

Control: There are some objects which are grouped together in one packet for reasons
of efficiency. For example, a single box of 1000 pencils might need lesser physical
handling methods than 1000 single pencils. Even materials like liquids, powders and
granular ones might need containment.

Information Transmission: The packages and labels should explain the ways
products can be opened, used, transported, disposed and recycled.

Marketing tool: Packaging and labels persuade potential buyers to buy the product.
Package graphic design and physical design should be constantly evolved.

Security: Packaging play a crucial role in eliminating the security risks involved in
shipment. Some of the packages will have authentication seals and make use of
security printing to indicate that the packages and contents are not counterfeit.
Packages will also include anti-theft devices and electronic article surveillance tags.

Convenience: Some of the packages have some features that add convenience to
distribution, handling, stacking and display.

.
6) a. Explain any two Statistical process control tools.
b. What are the different activities an organization should undertake while
training the employees?

Answer
a) Explanation of any two Statistical process control tools
Manufacturing units face acceptance decisions about subcontractor products, including the
raw material lots, in-process products and finished product lots. Acceptance Sampling helps to
arrive at decisions on whether to accept or reject product that has already been produced. A
product sample is used to determine acceptability. An Acceptance Sampling Plan is used to
define how many samples must be taken to verify the batch and the acceptance and rejection
criteria. Acceptance Sampling includes Attribute Sampling, which makes accept /reject
decisions based on the number of defects within a lot and Variable Sampling, which is based
on measurement values. There are three factors determining a sampling plan.
Batch size
Sample size
The least number of defects that are allowed before rejection.
Many methods are available for acceptance testing, but Acceptance Sampling plans accounts
the Acceptable Quality Level and Lot Tolerance Percent Defective which are considered to be
the most statistically valid.
Statistical Process Control (SPC)
Statistical Process Control is a collection of statistical techniques used to monitor critical
parameters and also reduce variations. This is often used to attain process stability and also
improves the quality of output of a manufacturing process. Managers can directly analyse
product performance using SPC practices. Their key processes and performance variables
enable the organisation to know about key performance indicators that causes attention about
these processes and variables. SPC information then evaluates the data, sends feedback and
makes way for corrective actions. SPC communicates what the process is doing and
guarantees a specific quality level essential for the customers.
SPC Tools
SPC is centered around statistical tools that enable continuous process improvement. The
section explains the different tools used. The advantage of SPC is that sampling is done
regularly, which increases the chance of finding a process problem in its early stages. Frequent
data collection enables production to be stopped as soon as a problem is detected, so that
minimum resources are wasted. There are different types of SPC tools like Flowcharts, Pareto
Charts, Run Charts, Control Charts, Taguchi Method etc
Pareto Charts:
Pareto charts are graphical representation of occurrences, with the most often occurring event
appearing on the left side and lesser common occurrences to the right. Pareto charts are
named after Vilfredo Pareto, an Italian economist who coined the (80-20 rule).Through Pareto
chart, managers can determine the most prevalent problems in their organisations.

Taguchi Method:
Taguchi was renowned for developing processes to enhance quality of developed products and
to decrease prices. This method was known as Taguchis method, which was used as a
process for assessing and
enhancing improvements in the required features of products. Taguchis methods include the
methodologies of both Statistical Process Control (SPC), as well as the statistical features of
the method, procedure, strength, and the quality enhancement processes.
Robust Design method, also called Taguchi Method, significantly improves engineering
efficiency by, considering the noise factors and the cost of failure, to assure customers
fulfilment. It considers the noise factors i.e. differences in the environment during the
treatment of products, variation in manufacturing, aging of products, and the cost of failure.

Robust Design concentrates on improving the basic function of the product or method. As a
result, it helps in assisting flexible designs and synchronised engineering. In fact, it is the most
influential technique existing to decrease product rate, develop quality, and at the same time
reduce intervals in the developmental stages.
Taguchi suggested that one must look at the design stage itself, from where the quality
begins. Various theories and concepts of Taguchi that have enhanced the product quality and
efficiency are:
Experimental Design
The Loss function
Robust design
Philosophy of Off-line quality control
The following are the results of experiments obtained from different phases:
Phase-1: Recognise the purpose, consequences, nature of malfunction.
Phase-2: Categorise noise factors, test circumstances, quality features.
Phase-3: Discover the function to be enhanced.
Phase-4 Recognise control factors and their stages.
Phase-5: Choose the orthogonal array matrix test.
Phase-6: Carry out the matrix experiment.
Phase-7: Evaluate, calculate the most favourable stages and performance.
Phase-8: Execute the confirmation experiment and plan for upcoming achievements
b) Activities an organization should undertake while training the employees
Traditionally, the purpose of training and development is to ensure that employees can
effectively complete their work. Today, organisations have intense pressure to stay have a
competitive advantage through innovation and reinvention. Organisations must foster the
trend of continuous learning as a social responsibility to ensure they are competitive in the
global marketplace. By definition, training and development refers to the process to attain or
relocate knowledge, skills and abilities needed to complete a particular task. For an effective
training, it should include the following:
Training in quality management, including cost of quality and internal auditing.
Education regarding the organization's quality policy and concepts of customer
satisfaction.
A quality-awareness program with periodic effective refreshers.
Training in process control, metrics and corrective action, team relationships and
communications.
Procedures that record the staff training and its effectiveness based upon individual and
team performance evaluation.
Activities to examine training efficiency
Organisations should consider the different preparatory or actual evaluation activities the
before, during and after training to determine the training effects.
Training needs analysis includes:
Collecting and combining the training requests from the trainees and the manager.
Identifying necessary knowledge, skills and attitudes including of human factors.
Reviewing whether the training objectives prescribed by the regulatory authorities are
incorporated into the training programs.
Consulting work group SMEs to verify that the training material accurately reflect the
scope of the job and confirm the training needs.
Identifying specific training goals and evaluation of trainees initial level by his/her
direct supervisor.
Making decisions on the most appropriate training modes and settings.
Individualisation of training programs (in particular, using a computerised system
accumulating data on the trainee career development, trainee performance and
instructor comments) and ensuring that training objectives associated with the skills
are measurable and their achievement is observable.
During the job analysis verification, the incumbent participants evaluate each task that they
have been trained on, and provide feedback on their continuing training needs for those tasks
selected for retraining.
Activities performed during training
Following are the activities performed during training:

Assessment of trainee knowledge, skills and attitudes by means of written and oral
tests, and practical exercises/operating tests.
Achievement of training objectives is associated with the skills that should be checked.
Not accomplished objectives are identified and necessary measures are taken
accordingly.
Competencies of the trainees should be continuously evaluated against prescribed
criteria during training period.
Evaluation of instructor performance and continuous feedback from the trainees.
During the implementation phase evaluative information is gained through immediate
verbal feedback.

Generally at the end of the training program the trainees complete course critiques on the
training material content and delivery. During the delivery, supervisors occasionally assess
instructor performance and provide constructive criticism on instructional methods. Using the
results of the end of course written exams, instructors are able to enhance the training quality
in the further sessions.
Activities Performed After Training
Following are the activities performed after training:
Yearly confirmation of employee competence is done by assessment of individual work
results conducting written, oral and operating tests/examinations as well as on-job
evaluation.
Organizing surveys and questionnaires to assess the effects of training.
Conducting interviews with trainees, trainees managers and customers of trainees.
Final evaluation of trainee performance by means of a computerized parameter event
data logging system using data from simulator exercises.
Development of evaluation reports by the instructors or by training program
coordinators, and presentation of these reports to the training managers for improving
the course content and the further training techniques and methods.
Evaluation of total costs associated with the training.