Work Instructions/Job Aids in the Quality System

P

pmags

#1
Hi everyone,

This is my first time posting here. I am in doc control at a biologics company in Pennsylvania and am having some documentation questions. We are held to 21 CFR 210 and 211, 21 CFR 600, 601 and 610 and 21 CFR 1271. Currently I'm in a pickle over work instructions or job aids and their documentation in the quality system.
We currently have them tacked up in our offices and cleanroom as unregulated posters/signage. In an outside audit, the auditor spoke of the need for QA to control this documentation. I was wondering if anyone who has been in a similar situation could point me in the right direction regarding their move into the quality system. Specifically I was wondering:

1) Do these documents have to be incorporated into the Quality system with their own document class (e.g. WI-01-001) subject to the normal change control process?

OR

2) Will setting them up with simply a signature for Quality Assurance to approve them (and treat them more as forms or records) be enough to fulfill FDA requirements?

OR

3) Is there some sort of in between that would satisfy FDA regs? Any advice on the subject would be greatly appreciated. Thank you.
 
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BradM

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#2
Welcome to the Cove! We are glad that you dropped by!:bigwave:

First, let us clarify that these type of documents can be called by any name: procedure, work instructions, guidance document, etc. The name is your choice, and has less importance than its position in the quality document system.

I would suggest the primary area of importance is document control and training. Say you have all these documents posted on the wall. How do you know which is the current version? Is there a later version?

Saying, I would pick whatever system you need to assure that only the current revision of the document is being utilized. While having them posted on the wall is awfully convenient, it becomes very problematic keeping up with them, and changing them out where there is a revision. Personally, I like having a designation like you suggested (WI 001 and such), where there is a clear/objective reference to it.

Second, make sure you keep training records on all these documents. Make sure that you can demonstrate people are trained.

As far as the signatures, that's up to you. Some have QA/ supervisor; supervisor/engineering; validation, supervisor; etc. I would just make the people who really need to know a change is being made, and that the change is supported by management. My suggestion is have the person changing it, QA and the area supervisor sign the documents.
 
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