Documentation - Review and approval process

[Marynel]

In my workplace, we're working on standardization of procedures and forms templates for production related processes. Each department is currently in the process of revising their Standard Operating Procedures (SOPs), Work Instructions (WIs), and forms. However, when it comes to the review and approval stage, the process is to send the documents to all reviewers through email, leading to potential delays in completing a full review cycle. Could you please suggest the most efficient approach to expediting the review and approval process via email? We are solely using the server to establish a common shared folder for centralizing documentaion. And also, How can I explain to the process owner that document signing should be done in PDF format rather than Word? He is insisting on having an e-signature on the Word document copy. Is it correct to sign the signature in word format? Kindly advise. Thank you

 

[Ed Panek]

I used to compare our manual email process to modes of travel. An Uber car will wait for you; A United Airlines flight won't. Top management needs to be invested in promoting the signatures are like an airline flight. Without top management involvement, any system you have in place won't have the teeth it needs. I would have signoff parties over lunch with free pizza in the past to encourage participation and a little pressure.

Word or pdf signature I have no comment on this as I don't know the class of product or risk it possesses. There may be regulatory concerns.

 

[Matt.mv]

That's a great point on Management involvement

I've used programs like Pandadocs to issue electronic signatures through staff email addresses, in additon to this some programs like Adobe allow you to set up workflows for signatures. For example, it'll start with the author, then onto a reviewer, then an approver, who upon signing it allows it to be accessed by all.

In terms of convincing someone it's better to sign it off in PDF than word, can you just go over all the advantages? For example, when in an audit do you want to be scanning through a signed off word copy, or searching for terms in a PDF using crtl-f?

 

[japayson]

What you are doing requires everyone to agree on the methods and everyone then on board to insist on following a system. Not easy to do, hence your question. The one place I worked that had this process set up did so by installing a document control software system. It emailed the users to log in for document review and approval, or rejection with a reason,, etc.. Obviously there is a cost to such a system - the management has to decide how much document (and drawings, too) control is worth.

 

[JimS]

What you are doing requires everyone to agree on the methods and everyone then on board to insist on following a system. Not easy to do, hence your question. The one place I worked that had this process set up did so by installing a document control software system. It emailed the users to log in for document review and approval, or rejection with a reason,, etc.. Obviously there is a cost to such a system - the management has to decide how much document (and drawings, too) control is worth.

Agreed - having a "real" system can take away some of the headaches and standardize approvals. Lots of advantages.

But you still need the users to be invested, which starts with management engagement. An electronic system can send out approvals and reminders, but if users don't act on them, you're still in the same boat for getting approvals done. We still have to manually track certain people down and tell them that they have to do this approval or they can't implement the change in the document, sometimes for weeks.

You have to create a culture of documentation importance (not an easy task).

 

[Xoowoxo]

Had the same problem at my place, it took ages to get everyone signatures and convince that its also important to do it on time. Firstly, I started using docusign tool for the purpose of the signatures, its help to avoid sending documents for signatures per e-mail and individually for each person. But still it was not solved fully a problem. As still some delays in some cases.
To explain this to the process owner, you can emphasize the importance of maintaining document integrity, security, and industry standards. You can mention that PDFs are designed specifically for sharing and signing documents, while Word documents are meant for editing and collaboration. Also, highlight the universal compatibility of PDFs, which makes them more accessible to all stakeholders.

 

[Randy]

It always makes sense to mandate people to sign off on stuff that they have no iota knowledge of because they have a title or position. I see it all the time when non-SME's sign off on garbage that creates more downside that if they hadn't been involved in the 1st place just because it looks good and gives everyone a warm feeling (so does wetting your pants).

Get down and be realistic as to who signs what, and for what reasons other than a fluffy look.

 

[FRA 2 FDA]

I try to limit approvals to two- the SME/process owner and me (quality manager). That helps... the fewer people in the chain, the better. However, some people are just terrible at follow through and/or don't care and without accountability from above, there's not much you can do. Others have said it above and it's a situation I face constantly. Makes me want to punch people! I somehow doubt that would be good advice to give, but I do think it might be at least a little effective

 

[Randy]

Makes me want to punch people!

I used to punch people as part of my former occupation, it saves your fingers and knuckles to pad them a bit