DRIVE SPRING 2015PROGRAM MBA (SEM 4) SUBJECT CODE & NAME QM0015 - ISO/QS 9000 ELEMENTSBK ID B1348CREDITS 4MARKS 60

ASSIGNMENT

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) K e y b e n e fits of Eight Pr i n c ip l e s of Q u a l i t y man a g e ment s y stem

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 organisation’s 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) Con ce pt of P r odu c t Tr ac i ng

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 customer‟s 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.

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2) Explain the importance of identification of the non-conformance products. Discuss the ways in which disposition of products can happen.

Answer:

I mpor t a n c e o f identifi ca t i on of the N on - Confo r m e d P rodu c t s

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 productLabelled bins, bags and boxes Directions written on the product Ribbon enfolded around the productCoded markings on the productElectronic 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 non-conformity 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 customer’s 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 client’s specifications, a concession can be issued by the organisation. Though nothing is done to reduce the non-conformity or to change the product’s 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.

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3) Explain the audit criteria and audit process. Differentiate between Internal and External auditors.

Answer

1) Audit CriteriaAudit 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. ISO/QS 9000 Standards which spell the requirementsb. Customer specifications which are spelled out in the contract reviewc. Internal documents and procedures d. 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 pro ce ss

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 organisation’s 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 ResultsThe 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 theorganisation 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 are identified in the in-process inspection stage, it can be corrected. However, if the flaws are identified in the last stage, itincreases the cost of the product. Once the manufacturing process is approved and the production sample is collected, the inspection takes place. If the product is conformed as per the product requirements, it is accepted and the manufacturing process continues. If the product is rejected because of non-conformance it is either disposed or corrected as per the requirements. The disposed product is returned for additional processing. 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.

E x plan a t i on of Me a sur e ment 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.

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5) a. Describe the procedural requirements that the organisation must follow while documenting the quality records.

b. Discuss the importance of packaging labels.

Answer:P u r pose of qu a l i t y r e c o rd k ee pi n g s y s t e m

There are three main purpose of the quality record keeping system: 1) The records prove that products meet requirements2) They serve as objective evidences for the quality system implemented3) 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

P ro c e dur a l r e quir e m e nts

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.

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

Answera) 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 ToolsSPC 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 „Taguchi‟s method‟, which was used as a process for assessing andenhancing improvements in the required features of products. Taguchi‟s 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 customer‟s 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 employeesTraditionally, 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 efficiencyOrganisations 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 trainee‟s 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 trainingFollowing 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 TrainingFollowing 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.