QM0015 – ISO/QS 9000 ELEMENTS

 

 

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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.

Q1. Explain the following

a) Advanced Product Quality Planning (APQP)

b) Failure Mode and Effects Analysis (FMEA)

c) Production Part Approval Process (PPAP)

Answer:

Advanced Product Quality Planning (APQP)

APQP is developed in the late 1980s by a commission of experts gathered from the big three US automobile manufacturers: Ford, GM and Chrysler. It is a framework of procedures and techniques used to develop products in

industry, particularly the automotive industry. It serves as a guide, a standard way to share results between suppliers and automotive companies.

According to the Automotive Industry Action Group (AIAG), the objective of APQP is “to produce a product quality plan which will support development of a product or service to satisfy customers”. APQP specify three phases: Development, Industrialization and Product Launch. Through these phases some main topics will be monitored. These main topics will be all

 

 

Q2. Discuss the different tiers of documentation in ISO/QS 9000. Describe document control procedures for internal and external documents. [Different tiers of documentation, Document control procedures (internal & external documents) ] 5, 5

Answer:

Different tiers of documentation

Documentation of ISO/ QS9000 may use the concept of a pyramid model 2with a five tiered documentation. This is a generic approach which has evolved over years and has been followed by ISO/QS 9000 certified companies’ world over.

Tier 1 – Quality Assurance Manual: This is a roadmap to the system, outlining the policies and objectives that relate to specific aspects of the system. It defines quality objective and approach that are not subjective.

Tier 2 – Policies and procedures: These provide process descriptions and flowcharts of activities. They give more detail of what, who, where, why, and when an activity is carried out.

Tier 3 – Work instructions: These describe step by step how to carry out a task. They are often called standard operating procedures (SOP) or standard job practices (SW) or operating guides. Work instructions must be revised and integrated into the overall documentation system.

Tier4 – Forms and records. Forms are often used to collect information and record the completion of required quality activities. Sufficient records must be kept to provide objective evidence that the quality activities are being carried out.

 

 

 

 

Q3. Explain preservation, protection and maintenance of customer supplied products. (Preservation of Customer supplied products, Protection of Customer supplied products, Maintenance of Customer supplied products) 4, 3, 3

Answer.

Preservation of Customer Supplied Product

• Organization should ensure that the conformity of the product is preserved during internal processing and delivery up to the intended destination. The organization is expected to preserve the product with safe handling, packaging, storing and protection in order to ensure that the requirement for processing is met and taken care of up to the delivery of the property to the destination. The purpose of this requirement is to prevent damage or deterioration to the conforming product that may happen when it contacts other products or when it is being harmed due to environmental factors.

 

 

Q4. Explain Preventive maintenance, Risk management and the importance of Environmental regulations. (Explanation of Preventive maintenance, Explanation of Risk management in ISO 9000, Importance of Environmental regulations) 3, 3, 4

Answer.

Preventive Maintenance

In ISO 9000, maintenance is an important aspect of quality. People responsible for implementing quality programs should make sure that the maintenance function is addressed in a proper manner. In order to remain competitive and successful, quality should become an input, not a measurement of output. Most of the firms spend lot of money and time on productivity and quality, but less on maintenance. Preventive maintenance4 is a list of pre planned maintenance actions.

 

 

Q5. Differentiate between Internal and External auditors. Explain the audit process. (Difference between Internal and External Auditor, Audit Process – Preparing for an Audit) 4, 6

Answer.

Difference between Internal and External Auditor

Internal and external auditors are qualified professionals who follow specialized standards of auditing. Their complementary skills, areas of proficiency, and perceptions help the organization to prepare the organization to reduce redundancies and bring in solid operational performance. Internal auditors are trained personnel who are an important part of the organization. The objectives to internal auditing are set by the management board of the organization. The internal auditor serves the organization 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

 

 

Q6. Explain Data Analysis Performance Assessment and Defect Analysis. (Explanation of Data Analysis Performance Assessment, Explanation of Defect Analysis) 5, 5

Answer.

Data Analysis Performance Assessment

Data analysis and Performance assessment is one of the most important aspects of QS 9000.

The process of analysis begins with an understanding of the process. In the first step, the weakness in whole process and the problem needing correction is clarified. Flowcharts, theme selection matrix and Cause and effect diagram are used as a tool in this process.

In the second step, data is gathered and is examined. The data is gathered specifically to concentrate on frequently occurring problems. The next step is the implementation of the plan with statistical techniques that help to analyze the problem and develop solution that prevents the root cause from occurring again.

An important fourth step is to evaluate the effectiveness of the solution. The effects of the implemented solution are evaluated to ensure that the solution has

 

 

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