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Simulation 1: Faulty Quality System

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(@srg36)
Posts: 117
Estimable Member
Topic starter
 

In the first simulation this week, we are requesting changes to documents in the Quality System hierarchy. The hierarchy laid out in this simulation is the Quality Manual on the top, followed by Quality System Procedures (QSP), followed by Work Instructions (WI), followed by the Specification on the lowest level. Many of these documents reference documents at different levels of the hierarchy. For example, the WI may reference the Spec. I want to pose the question, when these documents are referenced in another document, such as the example given, is it necessary to include the revision of the document? What are you thoughts?

My thoughts are that it is not necessary, because then when one document is updated to a new revision, it can create a cascading effect where all the documents that reference the updated document need to be revised as well so that they are not referencing an outdated document.

 
Posted : 15/02/2018 7:58 am
(@hm243)
Posts: 85
Trusted Member
 

It does seem a bit tedious to repeatedly update the document when a new revision is made because then multiple documents will have to be updated as well. However, I do feel that it is very important and necessary that this process is done. If the revised document is not recorded, then the current documents will not be suitable for the revision. For example, when the SPEC document was revised, it is important that the work instructions are revised to reference the new revised document. If not, the work instructions will not be fitting for the new document and cannot be used properly. As you mentioned, if the documents are not updated, then they will become outdated, which puts the company at more risk for their product. As repetitive as it may seem, this plays a huge role in ensuring the correct protocols are met.

 
Posted : 17/02/2018 4:01 pm
(@alexandrabuga)
Posts: 149
Estimable Member
 

I agree with @hm243 that although it would be time consuming to update the document every time a new revision is made, it would be necessary to update all the relevant documents. So as @hm243 mentions that if the Work Instructions reference a SPEC document and you revise the SPEC document you would need to update the Work Instructions where it references that SPEC. I think its necessary to do this so that documents are up to date and if you're audited or hire new team members, all the documents are accurate and up-to-date. I haven't had a role where I've needed to work with device documentation at this level, so I'm not sure how realistic it is to do this or that its done especially for small med device companies, but I personally believe that it should be done.

 
Posted : 17/02/2018 4:34 pm
(@dipanpatel)
Posts: 71
Trusted Member
 

I may be misunderstanding your question, but revised documents should always be updated. If any other document references the changed document, then that document should also be checked for any necessary changes. No document should be outdated, especially in a heavy FDA regulated industry. Outdated documentation can lead to safety issues and problems during a future audit. However, if you are speaking about an automated system that updates all preceding documents then that can be a time saver. However, these documents should also be check for accuracy and any other necessary changes.

 
Posted : 17/02/2018 4:36 pm
(@bb254)
Posts: 113
Estimable Member
 

While completing this week’s simulation I realized that all references to a specific document also references the revision level of that document. This does create traceability however it ends up creating a lot more work in the long run. Just to update one document, multiple other documents must be updated to state the new revision of the document. Good manufacturing practices requires the need to make these edits, but it takes away a lot of time. The edit seems to be minute but from this weeks simulations one will realize how many documents need to be updated due to a revision change. Its better to omit the revision of the document when references a procedure or specification.

Reference:
https://www.ispe.org/initiatives/regulatory-resources/gmp

 
Posted : 18/02/2018 6:27 am
(@thuytienlecao)
Posts: 72
Trusted Member
 

I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it's needed to have all the docs updated once a revision is made. I also agree that it's a lot of work and sometimes tedious to chase these related docs. An automated updating system can be a huge help. I found this Medical Device Document Control Software Systems called MasterControl Documents (by MasterControl TM). It has the ability to store all documents, revision, approval and prevent using the old/outdated version of the docs. If it works as good as it advertised, I think I could save a lot of time and efforts in organizing and keeping docs up-to-date.

 
Posted : 18/02/2018 1:18 pm
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