THE QUALITY AUDITOR SOLUTIONS TEXT



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Transcription:

THE QUALITY AUDITOR SOLUTIONS TEXT 2012 by Bill Wortman - All rights reserved

2.1. An audit for registration to ISO 9001 would be an example of what type of audit? a. Second party audit b. Third party audit c. First party audit d. Procedural audit Solution: An ISO audit for registration is one of the best examples of a third party audit. References: CQA Primer, Section II - 19. Arter, D.R.,(1994), Quality Audits for Improved Performance (page 4). 2.2. Various aspects of a business such as facilities, resources, economic stability, technical capability, personnel, production capabilities, and past performance, as well as the entire quality system is called: a. An ISO 9001 audit b. An internal assessment c. A first party audit d. A quality assessment Solution: A quality assessment such as that performed on a prospective supplier would include the review of the supplier's continued viability as a business, their capabilities to produce the desired product or service and so forth that are beyond the supplier's quality system. Answer d is correct. Reference: CQA Primer, Section II - 20/22. 2.3. Auditor independence is demonstrated by: a. The corrective action taken by the auditee b. The quality and objectivity of the audit report c. The number of findings reported d. Their placement in the organizational chart Solution: Auditors must be independent of that which they audit. The audit report contains statements of findings and observations. The audit statements are unbiased, verifiable, and supported by facts. a. False. The corrective action taken by the auditee may or may not be appropriate, regardless of the independence of the audit. b. True. The auditor's independence (or lack of it) is demonstrated in the audit report. c. False. The quantity of findings does not express auditor independence. d. False. Organizational placement (within reason) is a distracter choice Reference: CQA Primer, Section II - 6 and 50/51 (and other locations). CQAS 2012 1 QUALITY COUNCIL OF INDIANA

2.4. Audits are often conducted using a standard to ensure: a. Objectivity in the evaluation of performance b. A timely execution of the audit c. A maximum number of observations d. Uniformity in both process and product observations Solution: Answer b could refer to the benefit from checklist usage. Answers c and d are distracter choices. Reference: CQA Primer, Section II - 27/34 (and logic). 2.5. The act of quality audit planning is best described as: a. Preparation of detailed operating procedures b. Predetermination of quality audit related actions c. Early identification of mandatory inspection points d. Preliminary assignment of audit responsibilities Solution: The best definition (among the choices) of quality audit planning is the predetermination of quality related actions. Quality planning begins with what action is to be accomplished. Answers c and d may be part of a quality audit plan but they occur at the procedural or instructional levels. The preparation of detailed operating procedures is important but this activity may be done by manufacturing management or process engineering. Reference: CQA Primer, Sections II - 9 (plus numerous other locations). 2.6. The purpose of a quality auditing program is to: a. Provide management with objective feedback b. Establish commercial intentions c. Establish written procedures d, Prevent all unfit products from reaching the customer Solution: The audit program is the management defined structure of objectives and methods for the organizational audit system. The quality audit report is necessary to keep management informed. Problems may be evident from noncompliance or discovery of a quality system need. Early detection helps to prevent problems from developing or escalating. However, commercial intentions are established by management. Audits verify that required procedures are actually in use. Normally, written procedures are established by other means. Quality audits aid in uncovering system/process failures, and may initiate improvement to prevent noncompliance. They do not prevent all unfit products from reaching the customer. Reference: CQA Primer, Section II - 12/13. CQAS 2012 2 QUALITY COUNCIL OF INDIANA

2.7. Which of the following is an advantage that an internal auditor would typically have over an external auditor? a. A known level of knowledge and professional care b. A greater ability to find deficiencies c. An understanding of internal politics d. A greater knowledge of employees, thus reducing audit stress Solution: An internal auditor would usually be more familiar with both formal and informal processes, people, etc. A danger or disadvantage is that an internal auditor may become less objective if close working relationships and personal friendships develop with personnel in the areas being audited. References: CQA Primer - Section II - 18. Hutchins, G., (1992), Standard Manual of Quality Auditing (page 45). 2.8. If an audit team were to prepare for a key supplier audit of an aerospace firm, which of the following authoritative documents would be most appropriate for review? a. ISO 9000 and ISO 9001 b. The contract and AS 9100 c. JCAHO and AS 9000 d. ISO/TS 16949 and 10 CFR Part 50, Appendix B Solution: The key question phrase is "most appropriate." Answers c, and d are quickly eliminated. JCAHO is a health care document, 10 CFR Part 50, Appendix B relates to the nuclear industry and ISO/TS 16949 is an automotive standard. ISO 9000 and ISO 9001 may or may not apply. However, the contract and AS 9100 are most applicable. Reference: CQA Primer, Section II - 20 and 27/33. 2.9. Being sympathetic to an auditee's plight will: a. Encourage the auditee's management to correct deficiencies b. Uphold the client's best interest c. Demonstrate professionalism d. Often be detrimental to the outcome of the audit Solution: Sympathy is almost never helpful to the best interests of the auditee or the client. Sympathy could result in nondisclosure of findings and observations; excusing poor performance. Answer d is correct. Reference: CQA Primer, Section II - 43. CQAS 2012 3 QUALITY COUNCIL OF INDIANA

2.10. In order to evaluate the internal effectiveness of the customer order planning function, which of the following audits is most appropriate? a. Product audit b. Process audit c. Management audit d. System audit Solution: Management and systems audits both seem too broad for the scope of the question. A product audit is an inappropriate answer since this term is generally reserved for the final product instead of the paperwork to achieve the product. A process audit is indicated by the question content. Reference: CQA Primer, Section II - 14. 2.11. The limits that define the conformance boundaries for an individual manufacturing unit or service operation are the: a. Three sigma limits b. Specification limits c. Variance control points d. Process capability limits Solution: The specification limits - usually Upper and Lower - are the conformance boundaries. This is often expressed as a nominal parameter with an upper tolerance, lower tolerance or both. A unit or service operation parameter measured outside these limits constitutes a non-conformance. Reference: CQA Primer, Section II - 10 (plus several other locations in Section VII). 2.12. Any audit evidence can best be described as: a. The same as a finding b. Any deficiency discovered by the auditor c. Any item of objective evidence d. Any suggestion made by the client Solution: This question is requesting the best definition for an audit observation. a. False. A finding is more serious than an observation. b. False. This answer can imply a finding as well. c. True. Audit evidence is an item of objective evidence. d. False. This answer is what it implies, a suggestion. Answer c is correct. Reference: CQA Primer, Section II - 6/7. CQAS 2012 4 QUALITY COUNCIL OF INDIANA