8.2.6: Monitoring and measurement of product

[Jim Wynne]

Apologies.

Full text from Clause Requirements from the NC report:

Thanks.

First, a disclaimer: I have no experience in medical devices or 13485. Nonetheless, I fail to see anywhere where this NC can be justified. The whole "as appropriate" approach holds no water unless it's actually defined somewhere. In the absence of a normative definition that defines what's appropriate, there's no "there" there. I understand that recording device identification is prudent in many instances.

 

[Sidney Vianna]

And I can assure you all that there are thousands of ISO 13485 certified organizations that DO NOT identify the IMTE in the product inspection records. Having such traceability represents a cost and effort, which, in many cases is not justified nor necessary for the risks involved.

The “AS APPLICABLE” needs to be assessed from a risk based thinking perspective. Otherwise it would not be there.

 

[KiwiWill]

The whole "as appropriate" approach holds no water unless it's actually defined somewhere.

Thanks for the feedback. That's a good question regarding how "as appropriate" is defined, per ISO13485:

When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for: — product to meet requirements; — compliance with applicable regulatory requirements; — the organization to carry out corrective action; — the organization to manage risks

As others have mentioned, this is required for traceability in the event of an issue with the equipment, so the "carry out correct actions" carries a lot of weight here. This is probably a losing battle trying to justify not recoding the equipment used for product acceptance testing.

I am interpreting the 'appropriateness' as deriving from the fact that a DMR required some measurement/test. If the use of a gauge is NOT required, and someone (during manufacture) decided to use one, then that would be IMO a case where there would be not be expected to find a record of the use of that gauge on the DHR.

That does make sense, thank you. So for final product acceptance we'd definitely need to record the equipment ID. For in process inspections that are indicators or repeated on the end product, there might be some ground to justify not including the tool ID?

Any thoughts on Incoming inspection? I guess that depends on the nature of what's being measured, and whether we could show that the measurements are redundant to other inspections we/our suppliers perform.

That might be more work than just recording the tool.

 

[Golfman25]

Thanks for the feedback. That's a good question regarding how "as appropriate" is defined, per ISO13485:



As others have mentioned, this is required for traceability in the event of an issue with the equipment, so the "carry out correct actions" carries a lot of weight here. This is probably a losing battle trying to justify not recoding the equipment used for product acceptance testing.


That does make sense, thank you. So for final product acceptance we'd definitely need to record the equipment ID. For in process inspections that are indicators or repeated on the end product, there might be some ground to justify not including the tool ID?

Any thoughts on Incoming inspection? I guess that depends on the nature of what's being measured, and whether we could show that the measurements are redundant to other inspections we/our suppliers perform.

That might be more work than just recording the tool.

Here is you $64000 question. How are you keeping inspection records. If via paper, it will be all but impossible to back track the gage via its number. if a database, it would need to be setup properly to search for that number. Can you do it?

 

[dwperron]

Here is you $64000 question. How are you keeping inspection records. If via paper, it will be all but impossible to back track the gage via its number. if a database, it would need to be setup properly to search for that number. Can you do it?

Here is the answer.
If he isn't able to track the tool information he needs to come up with a way to do it.
Just because you haven't set up a tracking system doesn't excuse you from needing and having one for compliance purposes.

 

[dwperron]

That does make sense, thank you. So for final product acceptance we'd definitely need to record the equipment ID. For in process inspections that are indicators or repeated on the end product, there might be some ground to justify not including the tool ID?

Any thoughts on Incoming inspection? I guess that depends on the nature of what's being measured, and whether we could show that the measurements are redundant to other inspections we/our suppliers perform.

That might be more work than just recording the tool.

I work in the AS9100 world, where they are also freakishly concerned with product recalls.
We have established ways to track tool use in our factories and in our incoming inspection, anywhere where critical measurements are being made.
Our organization has gone through enough audits and recalls to understand that this is a cost of doing business in our industry.

As for the nature of what's being measured, that gets accounted for in every out of tolerance tool investigation we perform. We are required to be able to show that the OOT condition did not negatively affect our products or processes. Being able to show that the OOT was in a portion of the capability of the tool you do not use is a legitimate response, as is showing that your redundant measurements would have caught the problem.

 

[Tidge]

So for final product acceptance we'd definitely need to record the equipment ID. For in process inspections that are indicators or repeated on the end product, there might be some ground to justify not including the tool ID?

Any thoughts on Incoming inspection? I guess that depends on the nature of what's being measured, and whether we could show that the measurements are redundant to other inspections we/our suppliers perform.

That might be more work than just recording the tool.

Any time your established process calls for the use of a test or measurement tool, the specific/individual tool(s) used should be recorded in the Device History Record. I wouldn't bother trying to justify the use of tools and not recording the unique identifier on a DHR. This is an easy imaginative scenario: If one of your 'indicator' measurements results in a non-conformance or corrective action, those records could be evidence that you did not take effective action in response to the observation. I do believe that there is a spectrum of possible observations, ranging from 'casual' to 'prescribed' but allow me to take a different perspective: Why are you allowing people on the manufacturing floor to wander around making a bunch of measurements that are not required by procedure/DMR using whatever equipment they happen to have on hand? If the measurements are necessary: require and record them. If the measurements are unnecessary: remove wasted time from the process.

Incoming Inspection: The record-keeping of measurements/tests made at incoming inspection are no different than those of in-process or final inspection. The nature of the tests, including sample size considerations, could be different of course. A manufacturer should not be repeating the tests/measurements made at a fully qualified supplier site.

 

[Golfman25]

Here is the answer.
If he isn't able to track the tool information he needs to come up with a way to do it.
Just because you haven't set up a tracking system doesn't excuse you from needing and having one for compliance purposes.

I would suggest a lot will have to do with risks. Not everything is a high risk.

 

[Golfman25]

Any time your established process calls for the use of a test or measurement tool, the specific/individual tool(s) used should be recorded in the Device History Record. I wouldn't bother trying to justify the use of tools and not recording the unique identifier on a DHR. This is an easy imaginative scenario: If one of your 'indicator' measurements results in a non-conformance or corrective action, those records could be evidence that you did not take effective action in response to the observation. I do believe that there is a spectrum of possible observations, ranging from 'casual' to 'prescribed' but allow me to take a different perspective: Why are you allowing people on the manufacturing floor to wander around making a bunch of measurements that are not required by procedure/DMR using whatever equipment they happen to have on hand? If the measurements are necessary: require and record them. If the measurements are unnecessary: remove wasted time from the process.

Incoming Inspection: The record-keeping of measurements/tests made at incoming inspection are no different than those of in-process or final inspection. The nature of the tests, including sample size considerations, could be different of course. A manufacturer should not be repeating the tests/measurements made at a fully qualified supplier site.

Ok, so riddle me this. Here is a process. Production floor sets up job. Measures part using gage #1. It checks good, so they hand it off to QA for confirmation. QA checks part using gage #2, and confirms that it's good. Part is produced, during which time QA takes regular samples and does an inspection (again using gage #2). Production is completed and part goes to a final inspection where it is checked with Gage #3.

Calibration comes around and finds one of the 3 gages out of calibration. Problem or not? Does it matter which gage is out?

 

[Sidney Vianna]

Any time your established process calls for the use of a test or measurement tool, the specific/individual tool(s) used should be recorded in the Device History Record.

What? How do you accomplish this when a device is mass produced (>100,000/day) in multiple production lines and most of the checks are done in automated test equipment?