Validation of existing equipment - I have been asked to write a quality assessment for equipment

duff999

Involved In Discussions
#1
I have been asked to write a quality assessment for equipment that has already been installed to be used as an assessment against no IQ performed, Also I have asked to perform an assessment of the PQ that has not been performed, any good advice on where to start. This is for an existing very small manufacturer who is in the process of getting ISO 13485 accreditation.
 
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yodon

Staff member
Super Moderator
#2
I personally would start by ensuring that everyone knew that being a small company doesn't earn them any exemptions. :)

Seriously, I would start with a master validation plan and establish a risk-based approach. I personally wouldn't buy into the "just because we haven't seed anything bad so it must all be good" approach. Maybe you can leverage data collected to date to help scope / frame a validation but not as a substitute.

You can then compile an inventory of equipment and use, apply your risk-based criteria, and develop your plans. FMEAs can be helpful in understanding risk.

If you've been producing product with unqualified equipment / processes that should have been validated but weren't, I'd recommend you start building the case (documented) why the product released under those conditions don't pose a safety threat and meet all efficacy claims.
 

Bob Jenkins

Starting to get Involved
#3
For reference information on IQ, OQ and PQ I included an FDA presentation and what appears to still be regarded as the "go to" reference for IQ, OQ, PQ validation (even 15 years later).

Having a Master Validation Plan written out is the best first step.

Bob Jenkins
MedAccred Certified Pre-assessment SME/Auditor/ ISO 13485 Lead Auditor
 

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duff999

Involved In Discussions
#4
How would I determine WHAT equipment requires validation. Is it safe to say any piece in the production/manufacturing process needs to be validated. What if the piece of equipment does not affect any workflow, production, etc

Thanks
 

yodon

Staff member
Super Moderator
#5
This is why I endorse a a master plan with risk-based criteria for decision-making coupled with an inventory list of equipment with the risk criteria applied. That enables you to document decisions based on a solid foundation.

(Maybe semantics but equipment is qualified and processes are validated.)

Using reasonable risk-based criteria, equipment not used in workflow or production would not require any qualification (no risk of failure).

Processes are a bit different. Any process whose output is not 100% verified is subject to validation. Again, use risk-based criteria to justify the level of validation (or lack of validation).
 

duff999

Involved In Discussions
#6
Thank you, that is good information. I will incorporate those thoughts into the master validation plan. I am struggling because the equipment is already installed but we are now wanting to get ISO 13485 certified so I am trying to come up with justification on why there is no need to validate based on our 100% inspection that is in place for products produced. If I dont have to worry about the equipment that is not used in production that makes it somewht easier to figure out, the process validation is for another time. Any more tips are appreciated.
 

yodon

Staff member
Super Moderator
#7
A good tip: stay active here in the Cove! :) Good luck. Do post questions if you hit any potholes along the way.
 

duff999

Involved In Discussions
#8
Thanks, I think I just need that push at the start and I can go from there, searching for examples how to get started
 

duff999

Involved In Discussions
#9
Could you give me a risk based approach example. For example, we have a number of equipment that was just calibrated, I would assign a low risk to these because they were just calibrated are in working order. For larger pieces equipment, such as a 3D printer that is used for the main production, it has not been validated but we do have 100% inspection on the final product through QC, what type of risk assesment do you assign to this and what is the rationale?

Thank you
 

yodon

Staff member
Super Moderator
#10
Calibration is just calibration - either calibrated or not - so there's no need for a risk-based approach.

You only need to validate if the outputs aren't 100% verified so you could argue that the 3D printing process need not be validated. On the flip side of that, though, is that you're only verifying dimensional aspects, I expect. Are there any requirements that can't be verified like hardness, strength, etc?

You would still likely want to qualify the equipment to ensure it's properly installed, proper PM is defined, etc.

Risk, per 13485, "pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements" so your risk classifications would be (worst case) death then go down from there. So if a process could introduce something that would cause harm, that gets the higher levels of validation. Sterilization is a good example of a process that requires the most vigorous validation. A misprinted label may not result in harm (maybe!!) but would certainly be a regulatory nonconformity. You have to determine, based on the risk, where that failure would fall on the risk scale.
 
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