First Article Inspection Criteria for Medical Device Manufacturers

L

Lbrager

#1
From a regulatory standpoint, is a medical device manufacturer required to verify every dimension/specification on a drawing as part of first article inspection for a new part? Can the manufacturer take a risk based approach if it is not feasible to verify every dimension? The alternative would be to verify every critical to quality specification and to rely on the supplier's FAI results for the remaining verifications.

For the aerospace industry AS9102 requires that anything noted on the drawing be verified, however I am uncertain if a similar requirement exists for the medical device industry.

-Laurie
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
From a regulatory standpoint, is a medical device manufacturer required to verify every dimension/specification on a drawing as part of first article inspection for a new part? Can the manufacturer take a risk based approach if it is not feasible to verify every dimension? The alternative would be to verify every critical to quality specification and to rely on the supplier's FAI results for the remaining verifications.

For the aerospace industry AS9102 requires that anything noted on the drawing be verified, however I am uncertain if a similar requirement exists for the medical device industry.

-Laurie
Hello and welcome to the cove :bigwave:

I'm not aware of a similar requirement to verify everything on the drawing, in a medical device regulation or international standard.

Risk-based approach is common with medical devices, and if you have reasonable justifications documented (and readily accessible) you should be all right in most cases.

I'm not 100% sure I understand what stage you refer to by "as part of first article inspection for a new part", though. Do you refer to the beginning of every batch / lot production run, or to the first lot ever produced? If you refer to the first case, then I would say yes, it makes a lot of sense to verify critical requirements and handle all the rest with less rigour (it is up to you to decide how - e.g. rely on your supplier FAI - and document your justifications); If the latter then I would recommend everything is verified and documented at least once as part of a proper design and development process.

Please also note that requirements validated as part of process validation do not formally require verification on a regular basis, though you might like to monitor the process performance at some level, as a safety measure.

Cheers,
Ronen.
 
Q

Quality Practitioner

#3
I would agree with Ronen.

There is no regulatory standpoint that I am aware of that requires every dimension to be inspected?

I work for a subcontract medical device manufacturer.

The first time we manufacture a new device we perform a FAI on all dimension/features on the drawing. We will identify with our customers the CTQ's and run validations to prove capability depending on the feature and validation outcome we may continue to 100% inspect routinely or go to a sampling plan. Generally for CTQ's we 100% inspect and on other features use an appropriate sampling plan. Our Customer may also dictate that we 100% inspect all features/dimensions, but this is rare and most are satisfied with a acceptable process capability

Cheers
Chris
 
Q

Quality Practitioner

#4
I would agree with Ronen.

There is no regulatory standpoint that I am aware of that requires every dimension to be inspected?

I work for a subcontract medical device manufacturer.

The first time we manufacture a new device we perform a FAI on all dimension/features on the drawing. We will identify with our customers the CTQ's and run validations to prove capability depending on the feature and validation outcome we may continue to 100% inspect routinely or go to a sampling plan. Generally for CTQ's we 100% inspect and on other features use an appropriate sampling plan. Our Customer may also dictate that we 100% inspect all features/dimensions, but this is rare and most are satisfied with a acceptable process capability

Cheers
Chris
 
S

shethprati

#6
If I am getting First Article Inspection performed by external Lab, does that lab need to be ISO 17025 certified?

I know a company who got a finding from notified body for not performing calibration from ISO 17025 lab?

What about First Article Inspection since ISO 17025 includes test and calibration?
 
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