Please move this post if I'm in the wrong forum.

The company I work for is fairly new and we sometimes get into arguments over things that I think we shouldn't. The latest is due to a switch in some procedures to become ISO 13485 compliant. Some in the company want to go ahead and release the upper level procedures now, then correct the lower level procedures when we get the chance. Some of the problems are fairly minor (like an incorrect procedure referenced) but some are going to take major amounts of work, like reorganizing a technical file.

I'm arguing that you shouldn't release a procedure that you know you're not currently following, you should make the changes you need at the same time, so you are never out of compliance. For example release both procedures at the same time to fix the reference, or get the technical file organized before you release that document. On the slim chance someone else (FDA) were to come audit before we made the changes, I assume they wouldn't be happy. Technically I guess we could release the procedure and I could follow up with a CAPA a few days later, but I'm trying not to get people angry.

Is there a good reason to sign off on a document that you know you're not following?

Thank you.

Is there a good reason to sign off on a document that you know you're not following?

None that I known… why you need to sign it off on the first place without approving it or even concessions that you are going to follow it? It is strange, is it? :confused: And I don’t see any significant reason behind it…

…in most cases, releasing a procedure “you are not following before” emphasize one thing – “you have to follow that procedure!”… this happens when you are implementing something new, that you are not doing before but because the standard requires it, you have to implement it anyway – by hook or by crook… :whip:

…and hey, don’t get upset because your company is fairly new and you are having arguments :argue: from time-to-time… it happens even in most long-time established companies… it simply part of the system…

Thank you, I think the motivation for releasing a procedure that we are not following is so that we can say we got something "done".

...something done?… :rolleyes: hmm...

...OK, :agree1: expand that “something done” and include the necessity of following that procedure…

You mentioned the FDA,

820.40 (a) require that obsolete documents shall be removed "promptly" to prevent unintended use.

I am taking it that your lower level documents will be obsolete by the introduction of your higher level, the question I would be asking is how will you ensure that these lower level documents will not be used? and simply removing them will leave a void and how will you show what should be be followed in the absence of these lower levels?

Perhaps a compliance plan that provides the route your company will be taking with timescales and concessions required until in compliance, that is approved by QA will provide some evidence that you are aware of the situation but are in control of it.

Subpart D--Document Controls Sec. 820.40 Document controls.
Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

ISO13485:2003 requires the same 4.2.3 Control of Documents (g)

to prevent the unitended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose