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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Reporting Errors in Methodology Operations

Subject:
Reporting Errors in Methodology Operations
Area:
Operations Management
Date Revised:
September, 6 1994

 

 

PURPOSE

To provide field scientists with a formal mechanism for reporting printed errors in analytical methodology, in such a manner that all laboratories may be quickly informed and the methods can be kept correct and current.

BACKGROUND

Historically, field scientists encountering printing errors in the methodology of various manuals, compendia, etc., have used different methods to communicate these errors to management. Because there was no formal system to make management aware of these errors, some interested parties were not informed in a timely manner. Also, there have been delays in having the errors corrected in the appropriate manuals and compendia, etc.

Analytical methods which are used for regulatory purposes and which contain factual errors must be corrected as soon as possible. This FMD is issued to describe a formal mechanism by which field scientists may recommend corrections in published methods. In almost all cases, the factual error, when pointed out, can be concurred on immediately by the Division of Field Science (DFS) and the involved Center. After headquarters approval, these corrections will be promptly disseminated to all interested parties for use and for correction in pertinent publications. Errors as defined in this FMD cover only factual errors and obvious ambiguities and do not involve any language interpretation or procedures which are merely perceived to be in need of improvement.

PROCEDURE

1. When an error is encountered in an analytical method, the analyst will inform his supervisor.

2. The supervisor will draft a memo to the Division of Field Science, HFC-140.

a. The subject of the memo should be "FMD-118..." followed by a brief description of the method; e.g., "FMD-118, AOAC, Metals in Infant Formula."

b. The memo should be in the following format:

Method Reference -
Error Noted -
Change Suggested -
Name and phone number of party to contact for further information -

3. The supervisor will submit the draft to the Laboratory Director.

4. If the Lab Director concurs, he will send the memo (via fax or other means) to DFS for approval and issuance.

5. DFS will obtain agreement, if necessary, for the proposed change from the involved Center(s).

All districts and involved Center(s) will then be notified of the subject error in the published analytical method, and will be instructed to conform to the issued changes. DFS and, if appropriate, the involved Center(s) will communicate with the publishers/authors of the methodology to seek necessary corrections.

Methodology sources covered by this directive include official compendia such as the Official Methods of Analysis of the AOAC and United States Pharmacopeia; Analytical Manuals such as the Pesticide Analytical Manual and Bacteriological Analytical Manual; other methodology sources such as Journals, Laboratory Information Bulletins, and other compilations of methods used by FDA scientists.