Quality Systems Interview Questions and Answers:

1. What are the three series of ISO 9000 standard?

Ans.

  • ISO 9000 : 2000-Quality Management System-(QMS)-fundamentals and vocabulary
  • ISO 9001 : 2000-(QMS)-requirements
  • ISO 9004 : 2000-(QMS)-guidelines for performance improvement

2. Explain in brief about ISO 9000:2000

Ans. ISO 9000:2000 discusses the fundamental concepts related to QMS and provides the terminology for ISO 9001:2000, ISO 9004:2000

3. What are the eight clauses of ISO 9001 requirements?

Ans.

  • Scope
  • Normative references
  • Definition
  • Quality Management System
  • Management responsibility
  • Product and/or services realization
  • Resource Management
  • Measurement, Analysis and Improvement

4. What is Process approach?

Ans. The application of system of processes within an organization, together with their identification and interactions and managing of these processes is referred to as the process approach.

5. What areas does process approach emphasize?

Ans.

  • Understanding and fulfilling of requirements
  • The need to consider processes in terms of value added
  • Obtaining results of process performance and effectiveness
  • Continual improvement of processes based

6. What are the general requirements of QMS?

Ans.

  • Identify needed processes such as management activities, provision of resources, product realization and measurement
  • Determine the sequence and interaction
  • Determine the criteria and methods for effective operation and control of process
  • Ensure the availability of resources and information necessary to support and monitor these processes
  • Monitor measure and analyze these processes
  • Implement actions to achieve planned results and continual improvement of the processes

7. What are the general materials included in documentation?

Ans.

  • Statements of quality policy and quality objective
  • A quality manual
  • Required documented procedure
  • Needed documents to ensure effective planning, operation and control
  • Required records

8. What are the details furnished in quality manual?

Ans.

  • The scope of the QMS with details and justification for any exclusion
  • The documented procedures or reference to them
  • A description of the interaction among the QMS processes

9. What are the areas of document in which control is needed?

Ans.

  • Approve documents prior to use
  • Review, update and re-approve as necessary
  • Identify current revision status
  • Ensure the current version status
  • Ensure that current versions available at the point of use
  • Ensure that documents are legible and readily identified
  • Identify and distribute documents of external origin
  • Provide for the prompt removal of obsolete documents and suitably identify any that may be retained

10. What are the steps to be followed for implementing QMS?

Ans.

  • Top management commitment
  • Appoint the management representative
  • Awareness
  • Appoint an implementation team
  • Training
  • Time schedule
  • Select element owners
  • Review the present system
  • Write the documents
  • Install the new system
  • Internal audit
  • Management review
  • Pre assessment
  • Registration

11. What are the responsibilities of the management representative of QMS?

Ans.

  • The management representative is responsible for coordinating the implementation and maintenance of the quality system
  • The management representative is the contact person for all parties involved in the process, both internal and external
  • The management representative can be a member of the top management group who is able to ensure that the quality system is effectively implemented, documented and maintained

12. Why is management review conducted?

Ans. The management review is used to determine the effectiveness of the system in achieving the stated quality goals. The system is revised as needed.

13. What are the three parts of registration?

Ans.

  • Choosing a registrar
  • Submitting an application
  • Conducting the registrar’s system audit

14. What are the considerations in choosing a registrar?

Ans.

  • Cost
  • Lead time
  • Customer’s acceptance for the registrar
  • The registrar’s accreditation
  • Familiarity with the industry

15. What are the pitfalls to the successful completion of QMS implementation?

Ans.

  • Using generic documentation program or another organization’s documentation program
  • Over documentation or documentation that is too complex
  • Using external consultants without internal ownership or involvement
  • Limiting documentation to text rather than other type of media
  • Neglecting to obtain top management’s involvement
  • Developing a system that does not represent what actually occurs

16. What is a quality system?

Ans. A quality system is the method used to ensure that the quality level of a product or service is maintained.

17. What are records?

Ans. Records are a way of documenting that the policies, procedures and work instructions have been followed.

18. Draw the documentation pyramid?

Ans.

19. What are the five objectives of an Internal audit?

Ans.

  • Determine that actual performance conforms to the documented QMS
  • Initiate corrective action activities in response to deficiencies.
  • Follow up on noncompliance items from previous audits.
  • Provide continued improvement in the system through feedback to management.
  • Cause the auditee to think about the process, thereby encouraging possible improvements.

20. What kind of training an auditor should possess to audit the quality?

Ans. An Auditor should possess good written and oral communication skills, be a good listener, and be good at taking notes.

21. What are the various skills an auditor should hold?

Ans. The other skills that an auditor should possess are, the ability to concentrate on the task at hand and not be distracted by other activities that are taking place at the same time, be observant and questioning, and be able to separate relevant facts from other information.

22. What are the techniques that an auditor should employ to audit quality?

Ans. The three techniques that an auditor generally employ to audit quality are:

  • Examination of documents.
  • Observation of activities.
  • Interviews.

23. What are the requirements of a document control?

Ans. Document control ensures that

  • Documents are identified with a title, revision date, and responsible owner.
  • Documents are readily available to users.
  • A master list by department or function for procedures, work instructions, and records is appropriately located.
  • There are no obsolete documents at workstations
  • Changes follow a prescribed procedure.

24. State the steps involved in interviewing process.

Ans.

  • Place the auditee in a nonthreatening environment by starting with introductions and an explanation of the purpose of the audit.
  • Spend as much time listening and as little time as possible talking.
  • When and deficiencies in processes and systems are found separate the significant from the trivial.
  • Discuss the major issues informally with the auditee first.
  • Use the appropriate type of question.

25. Mention the types of questions with an example for each.

Ans. The various types of questions are:

  • Open questions
  • Closed questions
  • Clarifying questions
  • Leading questions
  • Aggressive questions
26. State the disadvantage that prevail in each type of question.
Ans. Disadvantages:
  • Open question : The auditor can receive more information than desired.
  • Closed question : The interview can appear to be interrogation.
  • Clarifying question : This gives the impression that the auditor is not Listening or that the auditor is stupid.
  • Leading question : It encourages the auditee to provide a particular answer and will bias the audit findings.
27. List the contents of an audit plan. 
Ans. The contents of an audit plan should identify the activity or department to be audited, list the procedures, documents and
regulatory requirements involved, name the audit team, and list who is to be notified of the audit and who will receive audit
reports.
28. What is an audit schedule? 
Ans. The audit schedule is one which includes audit notification, audit conducted, corrective action required and follow -up.
29. What a checklist should ensure during auditing? 
Ans. It ensures that the audit is efficient and give the auditor control of the process. It can take of the form of questions to ask,
the sequence in which they should be asked, and space for writing the results.
30. Name the three parts of an audit?
Ans. The three parts of an audit are:
  • The preaudit meeting
  • The audit.
  • A closing meeting.
31. What is the purpose of an audit?   
Ans. The purpose of an audit is to determine how well the quality system has been implemented and maintained.

32. What are the contents an audit report should conform?

Ans. The auditor report will :

  • Have a cover sheet that includes the audit date, names of the audit team, areas audited, distribution list, a statement that the audit is only a sample, and a unique reference number, and it will be signed by the lead author.
  • List the nonconformances and copies of all nonconformance reports.
  • Outline procedures for corrective action and subsequent follow-up.