How helpful will FDA QSR task checklist derived from the last 10 years of FDA citation data be to u?

  • Very Helpful, Thank you.

    Votes: 0 0.0%
  • Will use it as a reference

    Votes: 0 0.0%
  • Not that Helpful, I have other sources

    Votes: 0 0.0%
  • Couldn't care less

    Votes: 0 0.0%

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#1
Will a Quality Management System (FDA QSR) task checklist derived from the last 10 years of FDA inspection citation data be a handy tool for all you QMS builders in the medical device industry? How helpful will it be to you?

I am planning to make an interactive checklist as part of my project in school, wanted to know if there is a demand out there.

Any opinion will be appreciated. Thanks.
 

yodon

Staff member
Super Moderator
#2
Not completely sure I follow. For example, over the last 10 years, I believe that CAPA has been the front-runner for findings. From things I've read, it seems that a lack of a basic understanding of the process and/or incorporating requirements that aren't in the standards / regulations is a major contributor. Not sure how a task checklist would be helpful if the fundamentals of the processes aren't understood.
 
#3
Not completely sure I follow. For example, over the last 10 years, I believe that CAPA has been the front-runner for findings. From things I've read, it seems that a lack of a basic understanding of the process and/or incorporating requirements that aren't in the standards / regulations is a major contributor. Not sure how a task checklist would be helpful if the fundamentals of the processes aren't understood.
 
#4
Appreciate your response. If I look up MAUDE database citations for 820.100 CAPA, in last 10 years, FDA has given a citation 54 times for not properly analyzing the data source for existing or potential quality problem (820.100a(1)). 53 times they gave a citation for CAPA actions not being verified or validated (820.100a(4)) and 4 times they gave a citation for information related to a quality problem not being disseminated to responsible people.

So based on how many times certain tasks in the regulation has been cited during the last 10 years of FDA inspection in the US, the task checklist would be populated. So for the above example, it would be -

Have you analyzed enough data sources for existing or potential quality problems? # of times occurred in the last 10 years = 54

Have you verified and validated the CAPA you resolved? # of times occurred in the last 10 years = 53

Have you clearly informed all the responsible people about the quality problems opened in CAPA? # of times occurred in the last 10 years = 4


Hope my reply brings some clarity, please let me know what you think.
 

yodon

Staff member
Super Moderator
#5
Have you analyzed enough data sources for existing or potential quality problems? # of times occurred in the last 10 years = 54
I think this is a prime example of the problem I would see. For folks that don't understand the process, of course they'll answer yes! Yet they may have actually done a woeful job.

I'm not saying such a checklist wouldn't be helpful but I think there's more to it than just having a checklist.
 
#6
I think this is a prime example of the problem I would see. For folks that don't understand the process, of course they'll answer yes! Yet they may have actually done a woeful job.

I'm not saying such a checklist wouldn't be helpful but I think there's more to it than just having a checklist.

You are right, a task checklist is not a permanent solution and it won't straighten out a wonky process. However, I would be happy if I could at least spot wonky processes through this checklist.
 


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