Copyright ©1999, Datachem Software Inc., Westborough, MA
Question #: 1
Subject Area: Audit Reporting
A key difference between "compliance" and "conformance" is:
A) The state of meeting the requirements
B) Relevant specifications are involved
C) Supplier vs. product or service
D) Contracts and regulations
The correct answer is: C
"Compliance" involves the "supplier" of a product or service meeting specified requirements while "conformance" is related to the "product or service" itself meeting the specified requirements. This is according to ANSI/ASQ A3 - Quality Systems Terminology.
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| TopQuestion #: 2
Subject Area: Audit Reporting
The auditee received conditional nonapproval after the completed audit. This means:
A) The system requires major redesign and development.
B) With significant corrective actions the system will become acceptable.
C) Minor improvements are needed to make the system acceptable.
D) The auditors must reverify certain points found during the audit.
The correct answer is: B
When significant corrective actions take
place the system will become acceptable. According to Charles A. Mills in "The
Quality Audit" there are four possibilities at the conclusion of an audit. These
include:
1. Unconditional approval
2. Conditional approval
3. Conditional nonapproval
4. Unconditional nonapproval
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Subject Area: Corrective Action, Followup and
Closure
A comprehensive quality internal audit
reporting system failure analysis and corrective action feedback loop must determine:
I. What failed
II. How it failed
III. Why it failed
IV. Who caused the failure
A) I and II
B) I and IV
C) I, II and III
D) I, II, III and IV
The correct answer is: C
Who caused the failure is not thought of as being part of the corrective action feedback loop. Later followup however, demands that training be given to the person(s) who made the error.
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Subject Area: Corrective Action, Followup and
Closure
If a nonconformance is found during the
audit, the following should be reported:
I. What the requirement was.
II. At what location did the nonconformance occur.
III. Who caused the nonconformance.
IV. What evidence was found.
V. What was the nature of the nonconformance.
A) I, II, IV, and V
B) I, IV, and V
C) I, II, and III
D) I, II, III, IV and V
The correct answer is: A
It is not proper to state the specific name of a person who caused the nonconformance. The pupose of the audit is not to hunt down those responsible for problems. The purpose is to discover whether the quality system meets the requirements.
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Subject Area: Ethics, Professional Conduct,
Liability
John is a member of ASQ. He became aware that the widget his friend purchased is potentially dangerous to children. According to the ASQ Code of Ethics, which of the following would be the most appropriate response?
A) Do nothing - he used to work for the company that made the product.
B) Do nothing until he sells the stock he owns in the company.
C) Contact the manufacturer to tell them of his concerns as well as tell his friend to do the same.
D) None of the above.
The correct answer is: C
Many places in the Code of Ethics requires the member to assist the public and help make products safe. If this was a former employer, loyalty would also dictate the response in C).
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| TopQuestion #: 6
Subject Area: Ethics, Professional Conduct,
Liability
You have been assigned by your firm, an independent auditing firm, to audit the cooking system of QuickBurger, a locally owned fast food chain. You own a substantial amount of stock in the company. You should:
A) Request that you be given an alternate assignment due to conflict of interest.
B) Keep this information to yourself and proceed.
C) Call in sick.
D) Inform your supervisor of the situation but assure him that, being a CQA, you can be relied upon to be impartial and
request to be allowed to proceed.
The correct answer is: A
It is not just a question of your ability
to be impartial, which would be difficult in this situation. You must maintain the
appearance of impartiality to be effective as an auditor.
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Subject Area: General Knowledge
CPU is defined as:
A) Allowable upper spread / 6 sigma
B) Allowable upper spread / actual lower spread
C) Actual upper spread / allowable lower spread
D) Allowable upper spread / actual upper spread
The correct answer is: D
This is the basic definition of CPU. CPU is usually = (the upper specification limit - the process mean) divided by 3 sigma, ie. (USL - mu)/3 sigma.
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| TopQuestion #: 8
Subject Area: General Knowledge
*Shewhart X-bar control charts are designed with which one of the following objectives?
A) Reduce sample size.
B) Fix risk of accepting poor product.
C) Decide when to hunt for causes of variation.
D) Establish an acceptable quality level.
The correct answer is: C
After control limits are calculated, it's possible, using Shewhart's chart, to distinguish between common cause and special cause variation. With points falling outside the control limits or the presence of abnormal, unnatural patterns within the control limits, special cause variation is indicated. At this point, in most cases, the assignable cause is determined and an appropriate adjustment is made.
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| TopQuestion #: 9
Subject Area: Audit Program Management
If there is a hierarchy of quality system audits and evaluations in terms of comprehensiveness they may be ranked as follows from highest to lowest:
A) System, product, process, survey
B) System, survey, product, process
C) Survey, system, process, product
D) Product, process, system, survey
The correct answer is: C
The survey is the most comprehensive of the four types of audits or evaluations listed. A survey goes beyond the quality system audit and may include an evaluation of the entire organization and its long term prospects including but not limited to economics, evaluation of personel, etc.
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| TopQuestion #: 10
Subject Area: Audit Program Management
When planning a total quality system, one key objective is to provide a means of guaranteeing "the maintenance of product integrity." Which of the following quality system provisions is designed to most directly provide such a guarantee?
A) Drawing and print control
B) Special process control
C) Calibration and maintenance of test equipment
D) Identification and segregation of nonconforming material
The correct answer is: D
The key word is "guarantee." Despite all the preventative tools the company has in place, the process could produce a number of nonconforming products and they could find their way to the customer if we don't have an effective system for properly identifying and segregating nonconforming material. This is a key element in the ongoing efforts made to maintain product integrity.
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| TopQuestion #: 11
Subject Area: Audit Performance
Your company has consistently received products from Company A that meet your quality requirements. This has been established by the COAs received from Company A, your company's testing of the products, and the testing that your company has had completed by an independent laboratory. You are auditing Company A and discover that they have a quality manual but there is no documentation, as their manual calls for specifically, of the performance of any of the procedures. You conclude:
A) That there is no quality program
B) There is a quality program, but it is not fully implemented
C) The COAs must be a hoax
D) Nothing
The correct answer is: B
The fact that a quality manual exists is evidence that there is a quality program. Since the manual calls for specific documentation which does not exist, the program cannot be fully implemented. You can conclude that the quality program is partially implemented because the COAs, your testing and independent testing all say the same thing, that Company A has an acceptable level of quality. As an auditor you should make sure you adequately investigate this area to determine the extent of the implementation for your final report.
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Subject Area: Audit Performance
At the end of the audit day, assuming the
audit is more than one day, a team meeting should be conducted. The purpose is:
I. Verify facts and observations
II. Replan the next day's schedule if required
III. Discuss issues that may be unclear
IV. Review status of the audit with the auditee if needed
A) I and II
B) I, II, III and IV
C) II and III
D) III and IV
The correct answer is: B
All of these may be activities conducted at the end of the day audit team meeting. It may not be necessary to review the status of the audit with the auditee on a daily basis, however, certainly members of the auditee's organization would appreciate some type of update.
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| TopQuestion #: 13
Subject Area: Audit Preparation
One important thing an audit checklist should address is:
A) Procedures that deal with special non-standard operating conditions.
B) The names of all quality personel.
C) The audit scope and its relationship to the auditee.
D) The timing of the audit.
The correct answer is: A
It is possible that the auditee's procedures adequately cover normal operationg conditions. But are there procedures that cover special situations or conditions that may cause panic to reign in the organization? Are standard procedures ignored during times of stress? What happens during abnormal situations?
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| TopQuestion #: 14
Subject Area: Audit Preparation
Which of the following is the American National Standard for a Quality System that includes design?
A) ISO 9001
B) QS 9000
C) Q-9001
D) Q-9002
The correct answer is: C
Q-9001 is the American National Standard equivalent of ISO 9001. For a copy of this standard or more information contact the ASQ at 1-800-248-1946.
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