posted 12 November 1998 11:09 AM               

Section ¤ 820.181c applies to any equipment that is used to verify or validate a portion or all of the Device Master Record (DMR). For example, if the DMR states that "coating thickness shall not exceed 3 microns" then the DMR should also state how this is verified. A typical paragraph might be:

"After the device has completed the coating process, the coating thickness is verified using an XYZ thickness measurement device, or equivalent, in accordance with Work Instruction xxxxxx. Records of the thickness measurement is maintained in the DHR." DHR is the Device History Record.

Typically, ¤ 820.181c applies to any equipment that generates a record that becomes part of the DHR. The FDA's Small Entity Compliance Guide, Chapter 8, offers this: "The content, style, language, graphics, etc., of device master records should be directed toward the needs of the intended employees and, if the record is a specification or text for labeling, it should be directed toward users. A failure to consider the intended user leads to confusion and means that the company has not achieved the state-of-control intended by the QS regulation. Therefore, applicable records should be directed toward the needs of procurement, processing, and test/inspection personnel, rather than the needs of drafting, technical services, or product development departments. Likewise, installation instructions should be directed to installers." This document, as well as other chapters of the Small Entity Compliance Guide, is available at www.qs9000/pdf_files/fda_files. Chapter 8's name is X08DMR.doc.

The criteria I used were this: If aliens abducted every manufacturing employee in my company, how would I continue to manufacture my product? Consider this question when constructing a DMR. It is also a good idea to consider this question for operations other than manufacturing.

Hope this helps.

posted 13 November 1998 10:07 AM               

Glad it was clear. I have found the Small Entity Compliance Guide (and quite a few other FDA publications) quite useful in these areas. Anything Else, feel free to ask.