Risk Assessments, Packaging Qualification and Equipment Modifications

R

rina120

#1
Where do I Begin???
I just took on a new position.
I manage the validation of both the secondary packaging lines (non sterile) and manufacturing.
Currently, i feel that we over qualify and over document which bogs everyone down and we can't focus on real compliance issues.

Examples: Risk Assessments are written for everything. If a new sensor is to be installed onto a line, a Risk Assessment is done. Risk Assessments are included for all equipment. If we are introducing a new process, there is an equipment modification risk assessment, a cleaning risk assessment for each process train, a process risk assessment....

So my question is this: how much do you all use Risk Assessments for qualifying everyday equipment? Or for making modification to every day equipment? There is really no QRM implemented at my company, it's more just make sure you write all these risk assessments.

I've been looking for specific examples of Risk Assessments, but I have not been able to find any on this level.

Any links, attachments, advice, etc will be greatly appreciated!!!
 
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R

rina120

#3
well...
not exactly. Does it have to be? I found this site originally for medical devices, but i saw another post or two that didnt seem to be directly related.
If its not appropriate, then I can delete. It just seems like everyone here are so knowledgable on links, etc that I thought I would give it a go.

Packaging lines are packaging lines though...all have sensors for rejects, and vision systems to ensure correct lot numbers, etc...
And cleaning is cleaning as well...
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
Not a problem - It's not my field, but I wanted to clarify for readers and potential helpers. That's the only reason I asked.
 
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