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Description
This article is one of a continuing series in which representatives of the industry and the regulatory agency have an opportunity to express opinions on current GXP issues.
Thank you for your responses to Questions 12 and 13 which were posed in the last issue of Journal of GXP Compliance. The questions are repeated below; the responses follow. Coincidentally, the response to Question number12 is dependent upon the terminology that is the subject of Question 13 and its response. Therefore, we present the response to Question 13 first.
* Question 13
Q. The terms accountability and responsibility are frequently used in quality standards and guidances, but are not defined by any major document. It is not clear whether these terms are synonyms with no difference in meaning or whether there are significant or subtle differences in meaning. How are these terms to be interpreted or applied within a standard or an internal policy or procedure?
RESPONSE: In addition to being used in quality standards, the terms responsibility and accountability are used often in both management and political circles. Their definitions are, therefore, of wide concern. The problem is that their usage in both professional and everyday language varies.
Dictionaries tend to regard the terms as synonymous. However, both of us (JL & AS) are aware that these words are sometimes used in different contexts and can have graduated shades of meaning as in the use of "directly responsible" versus "indirectly responsible". Accordingly, we surveyed many of our colleagues for their opinions. They provided a wide range of opinion with about half considering the terms... |
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