How to respond to 483 validation finding we disagree with?

[mrsrobinson1110]

The FDA inspector stated that "A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures. Specifically your firm failed to validate CNC swiss turn, laser marking, lathe, and milling processes used to manufacture devices that cannot be fully verified by subsequent inspection and tests."

I'm at a loss as to how to respond to this.....with all of our machining processes we do first piece inspection, first article inspection, in-process inspection, and final inspection. I would consider that "fully verified". There are no results that cannot be verified (due to destructive testing, etc), so I'm failing to see why the extensive inspection and subsequent results are not sufficient.

With the laser marking, everything is verified visually 100%, must survive passivation and copper sulfate testing. I would say this is fully verified.....am I just looking at this all wrong?

 

[shimonv]

There is something unjust about process validation...
The thing is, realistically speaking, you cannot verify every measurement for each manufactured unit. I think you are better off doing process validation and subsequently shortening your production time.
What you already have is good, but you will need to scale it up to process validation.
Arguing with FDA inspector is tough since they are both the judge and jury.

-Shimon

 

[Zero_yield]

I mean, they're pretty much just quoting 21 CFR 820 at you. Do you have procedures and documentation of all of these verifications?

Sec. 820.75 Process validation.

(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

 

[Sidney Vianna]

that cannot be fully verified by subsequent inspection and tests."

Did you argue that the outputs of such processes can be fully verified with the FDA inspector? If so, what was his/her response?

I am not familiar with FDA’s appeal process, but they must have one, for sure. This finding DEFINITELY needs to be voided.

Good luck.

 

[yodon]

Kind of piggy-backing off the response @shimonv provided, it sounds like you don't have documented evidence that the process is validated. Bear in mind that validation should be commensurate with the risk and so between what the original risk is and the detection controls you have in place, validation is likely going to be fairly simple.

This finding DEFINITELY needs to be voided.

Given what the OP described, I would disagree - sounds like the inspector identified a valid NC.

 

[Sidney Vianna]

Given what the OP described, I would disagree - sounds like the inspector identified a valid NC.

so you machine a shaft and you can easily measure the diameter and the length of the shaft. In your view that machining process needs to be validated? If so, how?

 

[yodon]

so you machine a shaft and you can easily measure the diameter and the length of the shaft. In your view that machining process needs to be validated? If so, how?

The regulations state that if the output of processes are not 100% verified then the process needs to be validated. IF they DO measure the diameter and length then that's 100% verification and the process would not need to be validated. If they don't measure 100% then, by regulation, it should be validated.

The OP said that they do first part, in-process, and final; not 100%.

 

[Sidney Vianna]

The regulations state that if the output of processes are not 100% verified then the process needs to be validated. IF they DO measure the diameter and length then that's 100% verification and the process would not need to be validated. If they don't measure 100% then, by regulation, it should be validated.

the regulation does not say that, in my assessment. The regulation basically refers to what used to be called special processes where the output cannot always be verified short of destructive testing and, thus, must be validated. Typical examples of special processes include welding, brazing, painting, coating, etc…. I do not interpret the regulation as you do, and, in my estimation, the FDA inspector is misinterpreting the requirements as well.

 

[mrsrobinson1110]

I mean, they're pretty much just quoting 21 CFR 820 at you. Do you have procedures and documentation of all of these verifications?

The regulations state that if the output of processes are not 100% verified then the process needs to be validated. IF they DO measure the diameter and length then that's 100% verification and the process would not need to be validated. If they don't measure 100% then, by regulation, it should be validated.

The OP said that they do first part, in-process, and final; not 100%.

We also do first piece and first article on every job. Every first piece is inspected 100% as is every first article. We don't 100% inspect all dimensions on every single part, but we do inspect pieces from every job 100% We have records of these for each job.

 

[mrsrobinson1110]

I mean, they're pretty much just quoting 21 CFR 820 at you. Do you have procedures and documentation of all of these verifications?

Yes, we have all procedures documented, every single inspection report for every single job that are traceable. I just don't see how this doesn't equate to fully verified according to the FDA