In this third post in our series "Getting started with a QMS from scratch", we focus a bit more on the review and approval of documents, processes, work instructions...anything really within your QMS.
One of the biggest frustrations when having to get something reviewed and approved is the "hunt for signatures".
A typical scenario in the life of a QA manager (supposing this is the lucky one that needs to get something approved):
- Write a document and send it out to collect feedback
- Send out a few reminders and collect feedback
- Finalize the document and print it
- Give it to the first person to have it signed.
- Wait... (yes, this can take days or weeks)
- Contact that person to check if he/she already had the time to look at the document. Answer: "Which document? I don't have it!"
- Print the document again
- Give it again to the first person, who by now found back the initial printout
- Get comments on the document
- Go back to change the content once more
- Print and bring it to the first person who signs
- Go to the next person, who unfortunately is on business trip for the next two weeks
- and so on, and so on
We're not saying it's like this everywhere, but we're sure quite a few people will recognize the situation.
Why bother collecting signatures?
This is a valid question. Do we need signatures on each and every document?
However, when it comes to procedures and work instructions, you do need a way to document the review and approval.
There is one basic rule for this: you should not review and approve your own work.
With this being said, you should think about every document on who should review and/or approve them.
It also doesn't need to be 10 people every time. The content and purpose of the document will define who needs to review/approve the document.
Does this mean that we need signatures (with a blue pen preferably ;) by every reviewer and for every approval?
Let's look at what FDA is saying about document approval: "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."
It's not needed that every reviewer signs a document on paper although it is recommended to document the review activity as well (in some way). Of course the last final approval needs to ensure that the right reviewers reviewed the document and it can be approved according to their feedback.
How can an electronic QMS help to speed up the process?
A system, like MatrixQMS, provides the possibility to electronically document your reviews and approvals.
There are some major advantages of using an electronic system:
- No need to print any documents and have them travel from one desk to another, which might save considerable amount of time
- Multiple people can review and document their comments in parallel
- Clear indication of when the review has been finalized
- Electronic signatures can be entered from anywhere, no need to physically be present at the office
Looking back at our previous post, it becomes immediately clear that working with smaller processes e.g. also saves time during the review process.
Next up will be a closer look on releasing processes and training people on processes.