QUALITY SYSTEMS -UNIT-V

QUALITY SYSTEMS-UNIT-V

PART A (2 MARKS):

 1.  Give the ISO 9000 Series of Standards?

i. ISO 9000, “Quality Management and Quality Assurance Standards Guidelines

for Selection and Use”.

ii. ISO 9001, “Quality Systems – Model for Quality Assurance in Design,

Development, Production, Installation & Servicing”.

iii. ISO 9002, “Quality Systems – “Model for Quality Assurance in Production,

Installation & Servicing”.

iv. ISO 9003, “Quality Systems – “Model for Quality Assurance in Final

Inspection and Test”.

v. ISO 9004-1, “Quality Management and Quality System Elements –

Guidelines”.

2. What is the need for ISO 9000?

ISO 9000 is needed to unify the quality terms and definitions used by

industrialized nations and use terms to demonstrate a supplier’s capability of

controlling its processes.

3. Give some other quality systems?

The quality systems are

i. QS-9000

i. QS-9000

ii. TE-9000

iii. AS9000

4. Enumerate the steps necessary to implement the Quality Management

System?

The steps necessary to implement the Quality Management System are

i.   Senior management commitment

ii. Appoint the management representative

iii. Awareness

iv. Appoint an implementation team

v. Training

vi. Time schedule

vii. Select element owners

viii. Review the present system

ix. Write the documents

x. Install the new system

xi. Internal audit

xii. Management review

xiii. Pre assessment

xiv. Registration.

5.What are the three sections of QS-9000?

The three sections of QS-9000 are

i. Common requirements, which include the exact text of ISO 9001 and the addition

of automotive/heavy trucking requirements.

ii. Additional requirements covering production part approval process, continuous

improvement and manufacturing capabilities.

iii. Customer-specific requirements.

6. Give the objectives of the internal audit?

The objectives of the internal audit

a) Determine the actual performance conforms to the documented quality

systems.

b) Initiate corrective action activities in response to deficiencies.

c) Follow up on noncompliance items of previous audits.

d) Provide continued improvement in the system through feedback to

management.

e) Cause the auditee to think about the process, thereby creating possible

improvements.

7. What are the requirements of ISO 14001?

The requirements of ISO 14001 are

i. General requirements

ii. Environmental policy

iii. Planning

iv. Implementation and operation

v. Checking and corrective action

vi. Management review

8. What are the benefits of ISO 14000?

The benefits of ISO 14000 are

a. Global

i. Facilitate trade and remove trade barriers

ii. Improve environmental performance of planet earth

iii. Build consensus that there is a need for environment management and a

common terminology for EMS.

b. Organizational

9. What are the four elements for the checking & corrective action of ISO

14001?

a) Monitoring and measuring

b) Nonconformance and corrective and preventative action

c) Records

d) EMS audit

10. What are the seven elements for the implementation & operations of ISO

14001?

a) Structure and responsibility

b) Training, awareness and competency

c) Communication

d) EMS documentation

e) Documentation control

f) Operational control

g) Emergency preparedness and response

11. What are the four elements for the planning of ISO 14001?

a) Environmental aspects

b) Legal and other requirements

c) Objectives and targets

d) Environmental Management Programs

12. Give the types of Organizational Evaluation Standards?

i. Environmental Management System

ii. Environmental Auditing

iii. Environmental Performance Evaluation

13. Give the types of Product Evaluation Standards?

i. Environmental Aspects in Product Standards

ii. Environmental Labeling

iii. Life-Cycle Assessment

14. Define Quality Audits?

Quality Audits examine the elements of a quality management system in order to

evaluate how well these elements comply with quality system requirements.

15. Give the usage of an effective recognition and reward system?

ı_Serves as a continual reminder that the organization regards quality and

productivity as important.

ı_Offers the organization a visible technique to thank high achievers for outstanding

performance.

ı_Provides employees a specific goal to work toward. It motivates them to improve

the process.

ı_Boosts morale in the work environment by creating a healthy sense of competition

among individuals and teams seeking recognition.

16. What are the typical measurements frequently asked by managers and

teams?

ı_Human Resource

ı_Customers

ı_Production

ı_Research & Development

ı_Suppliers

ı_Marketing/Sales

ı_Administration

17.Explain the ISO/QS 9000 elements?

i. Management responsibility

ii.The Quality system

iii.Contract review

iv. Design control

v.Document and data control

vi. Purchasing

vii.Control of customer-supplied product

viii. Product identification and traceability

ix. Process control

x.Inspection and testing

xi. Control of inspection, measuring and test equipment

xii.Inspection and test status

18.What are the benefits of ISO?

ı_Fewer on-site audit by customers.

ı_Increased market share.

ı_Improved quality, both internally and externally.

ı_Improve product and service quality levels from suppliers.

ı_Greater awareness of quality by employees.

ı_A documented formal systems.

ı_Reduced operating costs.

19. Give the ISO 9001 requirements?

ı_Scope

ı_Normative Reference

ı_Terms and Definitions

ı_Quality Management System

ı_Management Responsibility

ı_Resource Management

ı_Product Realizatio20

20. What are the methods of actual audit?

i. Examination of documents

ii. Observation of activities

iii. Interviews

21. Analyze TQM?

Total  = Made up of the whole.

Quality = Degree of excellence a product or service provides. Management = Act, art or manner of handling, controlling, directing etc.

22. What is the purpose of Quality audit?

Ø  To establish the adequacy of the system.

Ø  To determine the effectiveness of the system.

Ø  To afford opportunities for system analysis.

Ø  To help in problem solving.

Ø  To make decision making easier etc.

23. List the types of audit.

1. First – Party Audit.
2. Second – Party Audit.
3. Third – Party Audit

24. Classify the Quality audit.

Ø  System Audit.

Ø  Process Audit.

Ø  Product Audit.

Ø  Adequacy Audit.

Ø  Compliance Audit

25. What is EMS?

The overall aim of the Environmental Management systems is to provide protection to the environment and to prevent pollution.

26. What are the evaluation standards in EMS?

1. Organization Evaluation Standards
2. Product Evaluation Standards

27. What are the global benefits of EMS?

Ø  Facilitate trade & remove trade barrier

Ø  Improve environmental performance of planet earth

Ø  Build consensus that there is a need for environmental management and a common terminology for EMS

28. What are the organisational benefits of EMS?

Ø  Assuring customers of a commitment to environmental management

Ø  Meeting customer requirement

Ø  Improve public relation

Ø  Increase investor satisfaction

Ø  Market share increase

Ø  Conserving input material & energy

Ø  Better industry/government relation

Ø  Low cost insurance, easy attainment of permits & authorization

29. What is ISO 14000?

                        ISO 14000 standards are set of norms for Environment Management System either at organization and process level or product level.

30. Give notes on NCR. (Nov/Dec ‘08)

 During ISO certification the things which do not comply the ISO requirements are reported in the format known as Non Conformance Report.

31. What is the third party audit? (Nov/Dec ‘10)

 It refers to the audit by an independent organization on a supplier for accreditation assessment purposes.

32. Mention any two organizational benefits of QS 9000? (Nov/Dec ‘08)

1. QS 9000 enhances quality systems for suppliers.

2. QS 9000 eliminates redundant requirements and reduces costs.

33. What is the need for documentation? (Nov/Dec ‘09)

1. Documentation regularizes the method of performing the day-to-day activities.

2. It provides formats for standardizing practices.

3. It provides reference for assessing degree of enforcement in practice.

4. It facilitates troubleshooting for tracking back on the process.

5. It demonstrates the ISO quality system certification.

34. What is the equivalent Indian standard for ISO: 8402? (Apr/May’05)

The equivalent Indian standard for ISO: 8402 is ISO:13999

35. What is ISO 9000:2000? (Nov/Dec ‘05)

The ISO 9000 standards are a collection of formal international standards, technical reports, handbooks and web based documents on quality management and quality assurance.

36. What are the elements of quality systems? (Apr/May’09)

Clause 4. Quality management system

Clause 5. Management responsibility

Clause 6. Resource management

Clause 7. Product realization

Clause 8. Measurement, analysis and improvement

37. What is an environment objective? (Nov/Dec ‘06)

Environment objective is an overall environment goal arising from the policy statement that an organization sets for itself,

38. Differentiate between TS 16949 and ISO 4001 standards. (Nov/Dec ‘07)

ISO 4001 standards are standards for environmental management, whereas TS 16949 standards are standards for automotive quality management systems.

39. What is the purpose of EMS audit?

The purpose of EMS audit is to ensure that the EMS conforms to plans.

40. Contrast environmental objective and environmental target.

Environment objective is an overall environment goal arising from the policy statement that an organization sets for itself

Environmental target is a detailed performance requirement and should be quantified when practical.

41. Define environmental aspect and environmental impact.

Environmental aspect is defined as an element of organization’s activities or services that can interact with the environment.

42. Define environmental impact.

Environmental impact is defined as any change whether adverse or beneficial wholly or partially resulting from an organization’s activities or services.

43. How ISO 14000 differs from ISO 9000 series of standards?

ISO 4001 standards are standards for environmental management, whereas ISO 9000 standards are standards for quality management systems

44. What is QS 9000?

QS 9000 is a set of quality system requirements to help automotive suppliers to ensure that they are meeting customer requirements.

45. What is ISO/TS 16949?

ISO/TS 16949 is an ISO technical specification which aligns existing American, German, French and Italian automotive quality system standards within  the global automotive industry with the aim of eliminating the need for multiple certifications to satisfy multiple customer requirements.

46. What does the term quality system mean?

The quality system is an organizational structure, responsibilities, procedures, processes and resources for implementing quality management.

47. Differentiate between ISO 9001 and ISO 9004 standards.

ISO 9001 is the only standard in the family of ISO 9000 standards that can be used for registration and certification. ISO 9004 is a guide standards and are not meant for certification.

PART B (16 Marks)

1.Explain the steps to be followed in implementing quality system ISO 9001:2000

2. What are the requirements of ISO 14000? Explain them briefly.

3. Define quality system and explain the evaluation of ISO 9000.

4. Explain ISO 14000 with an Industrial application.

5. Explain the steps followed to get ISO 9000 certification for an educational institute.

6. What are the elements of ISO 9000:2000 quality system?

7. Explain in detail about the quality auditing with its different types.

8. Discuss in briefly about the documentation of quality system.

9. Discuss in detail about the EMS system.