Job Aids for administrative staff in GLP environment

#1
I've always worked in GMP environments. However last year, I began working as a GLP archivist. It turns out that the archiving staff never created job aids or left even notes about how the job was done. I'm literally starting from scratch. I've asked the director about creating job aids for my role. What seems reasonable to me isn't for him. He's discouraged creating and has gone to great length to explain why they're okay for GMP but not for GLP. I need a second opinion because job aids can be updated. These job aids would focus on how to use the archive databases, a task that's not reflected in the SOPs. Thanks!
 
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JJ_FDA

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#3
What do you mean by job aids? Your SOPs should describe how materials are indexed in, stored in, and retrieved from the archives; how access to the archives is controlled; how the materials are protected from loss / degradation; what and for how long materials are stored; and what happens to the materials if your business has to close. So you should be theoretically be able to piece together how the archivist job was done for GLP.
 
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#4
What do you mean by job aids? Your SOPs should describe how materials are indexed in, stored in, and retrieved from the archives; how access to the archives is controlled; how the materials are protected from loss / degradation; what and for how long materials are stored; and what happens to the materials if your business has to close. So you should be theoretically be able to piece together how the archivist job was done for GLP.
Yes the SOPs describe most of those things. However, nothing goes into to detail about how to use those databases.
 
#5
What is his explanation for why they are not okay for GLP?
I think his fear is that job aids won't be updated like SOPs and he thinks at the time of an audit or inspection this could lead to serious problems. In my past jobs, job aids that accompany an SOPs were always updated and, of course, reviewed by and SME or management.
 

JimS

Starting to get Involved
#6
I think his fear is that job aids won't be updated like SOPs and he thinks at the time of an audit or inspection this could lead to serious problems.
So, he doesn't want to have the job aids because they might not get updated. And he thinks it's better to have uncontrolled documents hanging around? Or to have nothing at all?

It sounds like you have SOP's only and nothing that gives more detail than that. Yes, in my opinion you definitely need some work instructions. Or job aids, visual aids or whatever term you want to use for them. But something to give more detail. There's no reason they can't be maintained and updated as required. You should also implement some sort of review cycle that enforces revisiting them annually, or whatever time frame works for you, to ensure they are up to date.
 
#7
Thanks for understanding my point. Because of the position's turnover, we're starting from scratch. The SOP is fine, but I don't think he understands that in administrative roles, job aids are needed. SOPs go through annual or biannual review. I'll reach out to him again and work on putting a process in place. Thanks again!
 
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