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Need guidance on project

#1
Hello all,

I have a QA case study that I was given on Monday and is due on Tuesday. I have only worked in food industry and I am more familiar with those processes. However, this involves ISO 13485:2016 Exam/Medical Business & Industrial/Non-Medical products. I have been having a hard time researching and figuring out how to tackle the project. It is vague so any guidance helps.

I wasn't sure where else to find good resources or people to talk to about this. I also apologize if this is also posted on the wrong thread.

Thank you all for your time.
 

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#2
So maybe ignore the business sector process details. Allegedly, the medical device sector has processes that reduces complaints (ostensibly by improving quality and not that the patients are no longer able to complain :notme:). You'll want to adopt those good practices throughout the other business divisions. You'd need to investigate what the changes to the QMS system were and try to correlate what changes had the positive effects.

The CAPA question sounds like just investigating why CAPAs bog down, mostly. There's an aspect of effectiveness so maybe that's also something to investigate. Sounds like there may be internal assessment processes from the industrial sector may have practices to adopt.

Indeed, the request is vague but that's not uncommon in industry. Management knows some things work well and some don't but they need the data to make decisions on where to apply resources to effect improvement.
 
#3
So maybe ignore the business sector process details. Allegedly, the medical device sector has processes that reduces complaints (ostensibly by improving quality and not that the patients are no longer able to complain :notme:). You'll want to adopt those good practices throughout the other business divisions. You'd need to investigate what the changes to the QMS system were and try to correlate what changes had the positive effects.

The CAPA question sounds like just investigating why CAPAs bog down, mostly. There's an aspect of effectiveness so maybe that's also something to investigate. Sounds like there may be internal assessment processes from the industrial sector may have practices to adopt.

Indeed, the request is vague but that's not uncommon in industry. Management knows some things work well and some don't but they need the data to make decisions on where to apply resources to effect improvement.
Thank you very much for your reply. I will keep this in mind to help me complete the project :)
 
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