Help I'm Being Audited by the FDA

Article

Marash, I. Robert   (1987, ASQC)   STAT-A-MATRIX, Edison, NJ

41st Annual Quality Congress, May 1987, Minneapolis, MN    Vol. 41    No. 0
QICID: 3292    May 1987    pp. 169-173
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Article Abstract

For many years we have seen dozens of papers presented on audit techniques, how to develop audit plans, how to use a check list, and other similar techniques to assist a person in developing and implementing an Audit System. However, little if anything has been presented in "How to Be Audited."This paper will focus on the auditee not the auditor. It will look at the problems the auditee faces when confronted by different types of auditors: the regulatory agencies, the corporate auditors and the internal department auditors.The paper will address the results of:What questions should the auditee respond to? How should you respond? How should you handle questions on subjects outside the scope of the audit? How should you prepare to be audited? Is the best defense an offense? How do you respond to significant audit finding? How do you handle harassment by the auditor? What is your responsibility to your company? What is your responsibility to yourself?We will explore the auditees perception of (1) The situation "How do I perceive the importance of this situation to me?" (2) Ones self "How confident do I feel in the situation?" (3) To others "Is this person friendly, hostile, detached....?"Persons reading this paper will gain a better insight into how they react an dhow they should react in an audit situation.In addition to identifying the problems that the auditee faces, the paper will give real life solutions to many of the problems and assist the listener in developing and implementing a strategy on "How to survive an audit."

Keywords

Biomedical


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