William,
Thank you very much for your question.
We have analyzed FDA 483 citations (>> 6000 for devices and >> 4000 for pharmaceuticals) for the past seven years and ranked them to help the industry while preparing for an FDA inspection.
For device firms, quality plan was ranked #321 in our list (113 times of citations in 483s for quality plan).
I treat Quality Plan, analogous to Regulatory Plan in RA.
In our consulting practice, I go through my "own gut checking time" at the beginning of reviewing documents just to see whether Quality Plan has been implemented as I see "Quality Plan" sort of as a roadmap.
If I don't see it, I recommend it. As for Quality Plan, people seem to get defensive.
Usually, firms like to have their audit scope for the 200 items so I go with it.
If firms want me to assess all possible aspects of quality management systems, then I go through 325 items in my list (we call it as "Bullet Proof List").
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President and Principal
http://www.regulatorydoctor.com Riner VA
United States
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Original Message:
Sent: 07-31-2013 06:34
From: William White
Subject: Quality Plans
Thank you for these comments. They will be useful to some. However, my question is whether anyone has had experience of FDA investigators' or other 3rd party auditors' having done a really active pursuit of the question. At the moment, the silence on that question seems to be in itself a kind of answer.
Bill
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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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Original Message:
Sent: 07-31-2013 02:12
From: Gadi Shtepel
Subject: Quality Plans
The basic quality plan is actually detailed in you Quality System Manual where the detailed SOPs are also referenced. Special quality plans are needed for specific activities that can impact the QMS and products such as moving a clean room from one location to the other.
Additional quality plans are needed for introduction of new products and for this you can find good guidance in ISO 10005 titled : Quality management systems - Guidelines for quality plans/
Regards
Gadi
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Gadi Shtepel
Gadi Shtepel Ltd.
Sgula
Israel
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Original Message:
Sent: 07-30-2013 09:12
From: William White
Subject: Quality Plans
21 CFR 820.20(d) requires manufacturers to have "a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured." There is even an international standard for this purpose, ISO 10005, "Quality management systems - Guidelines for quality plans." The very first question in the QSIT manual states "Verify that a ...quality plan and .... have been defined and documented."
At the same time, most use of quality plans that I have observed has been for the purpose of making improvements to quality management systems while ensuring the ongoing effectiveness of those systems.
Has anyone had experience with FDA investigators (or other external auditors) making issues about the use of quality plans in connection with products? If so, how have you addressed those issues?
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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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