I had a discussion last week with a consultant about what information a process flow chart describing a manufacturing process should contain. Is it enough to just display the single process steps together with the responsibilties for each step or is more information required / recommended, such as CQA, Input/Output, CPP, Documents, Equipment, etc ?
In my opinion a process flow chart should only contain a brief overview of the steps + responsibilities and should be supplemented by a detailed written description for each process step, containing all the infos about the process step.
I am also wondering what regulatory bodies expect to see in a process flow chart. Please share your advice and experiences on that topic.
You’re correct. A process flow chart only contains minimal information. It’s a place for an investigator to start asking questions.
In my experience regulatory bodies can’t demand that information is presented in a particular way or format. The only requirements they can give you is that the information is accessible, and that it follows Good Documentation Practices. How your company decides to present it is up to you.
What ever you do, don’t put redundant information in multiple places. This makes document lifecycle difficult and potentially a source of discrepancy - because if the information is in two places, you now have 2x the updates to make if the process changes at all down the road. Also, if you update the process and fail to update one of the 2 documents, you now have competing information which could cause your activity to be done incorrectly (following the old method that wasn’t updated). So having the information in two places is both a business risk, and a GMP risk (so avoid doing it).
Instead, make reference to the document which does contain the instruction. So the information is quick to find, if the auditor or end user ever does ask for it.
Thank you both for your replies.
@JaredCroft: I see your point, it sounds rational and I understand the concern about having information spread over many places for one and the same thing. I am wondering though how one can achieve a good process overview both internally and also for an external viewer without having a short visual overview combined with a detailed description containing all the “deep” information. I have seen many flow charts containing some of the information needed to gain some overview but not enough to really understand the process.
In my view there should be some sort of document which allows to get a full overview of the process, its products, CPPs, CQAs, documents, equipment, etc which helps to understand the process and therefore serves as a good basis for risk management / analysis.
Would it be a suitable approach for both, good process overview and minimising redundancy, to just combine the two documents into one ?
So for example first few pages containing the flow chart overview followed by detailed description of each step.
The absolute most elegant solution, is to create a process flow diagram, with hyperlinks to additional information as needed. Some hyperlinks would be validations, drawings, filings, SOPs, batch records, etc.
Compiling all the information into one place is both noble and time consuming. Make sure you have a good path forward. Do thinks like change controls also be included in the process flow diagram? What would you include, and what wouldn’t you include?
Again, I think additional information is best left out of the PDF, but references made to where the information can be found if wanted. But this is my suggestion, and of course there are a millions ways to “skin a cat”.