8.2.6: Monitoring and measurement of product

[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.

Where is the compliance requirement? ie the shall.

 

[Tidge]

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?

If you can assign a unique lot numbers to >100K pieces which are fed through ATE, surely that lot can have the unique identifier of the ATE used attached to it? I think a bigger logistical issue is making measurements of >100K pieces than it is to record the identifier of the equipment making the measurements.

As far as the shall(s)

7.5.1 Control of production and service provision
Production and service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specification. As appropriate, production controls shall include but are not limited to:

c) implementation of monitoring and measurement of process parameters and product characteristics;
d) availability and use of monitoring and measuring equipment;

The organization shall establish and maintain a record (see 4.2.5) for each medical device or batch of medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount manufactured and amount approved for distribution. The record shall be verified and approved.

8.2.6 Monitoring and measurement of product
Evidence of conformity to the acceptance criteria shall be maintained. The identity of the person authorizing release of product shall be recorded (see 4.2.5). As appropriate, records shall identify the test equipment used to perform measurement activities.

 

[Bev D]

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?

In certain industries this research of paper records was required and we called it “climbing the Iron Mountain”. (For the unfamiliar Iron Mountain is a paper record retention and storage company). We hated it but since human life and/or health were at risk it was necessary when a failure or OOT gage or noncompliance before shipping occurred. If you didn’t like the rules you got out of the industry. It did drive a lot of the automation you see now that makes this search way easier.

 

[Bev D]

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?

Of course it matters if you are in aerospace, pharma, medical devices etc. if it is the final inspection gage you are required to perform an OOT investigation. In your scenario it is likely the OOT condition is minor enough to not have accepted non conforming parts but you do have to prove it. You know some industries just have stricter requirements for certain things than others. This is posted in medical devices. What is your argument? That this requirement should not apply to anything? Or that it shouldn’t apply to the specific areas where it has been established?

 

[Golfman25]

Of course it matters if you are in aerospace, pharma, medical devices etc. if it is the final inspection gage you are required to perform an OOT investigation. In your scenario it is likely the OOT condition is minor enough to not have accepted non conforming parts but you do have to prove it. You know some industries just have stricter requirements for certain things than others. This is posted in medical devices. What is your argument? That this requirement should not apply to anything? Or that it shouldn’t apply to the specific areas where it has been established?

I’m not doubting what might be a best practice, and the need for stricter requirements for certain industries. But I don’t yet see such a requirement here. The original post was about the phrase “as appropriate.” I am not convinced that ”as appropriate” means mandatory.

Here is an actual example. Take a single use disposable medical that is injection molded. An adapter for flex tube. An out of tolerance measurement wouldn‘t mean jack squat to its performance. Recording of a measurement device would be unnecessary and imo fall under the “as appropriate“ exception.

 

[Steve Prevette]

This thread has gone all over the place. I'll just say, the two most dangerous words at one work place I was at was "If applicable". We spent a lot of time to get that out of our procedures and say - when was it applicable. I will suggest that in this case "as appropriate" COULD mean - it is appropriate if you used test equipment to make the measurement. If you did not use test equipment, then you don't have to record it.

 

[Bev D]

I’m not doubting what might be a best practice, and the need for stricter requirements for certain industries. But I don’t yet see such a requirement here. The original post was about the phrase “as appropriate.” I am not convinced that ”as appropriate” means mandatory.

Here is an actual example. Take a single use disposable medical that is injection molded. An adapter for flex tube. An out of tolerance measurement wouldn‘t mean jack squat to its performance. Recording of a measurement device would be unnecessary and imo fall under the “as appropriate“ exception.

Thank you. That is a cogent response that clearly states your concern. And echoes the OP,s concern with their finding. We can discuss specifics but only yell past each other with vague generalities.

 

[Tidge]

I’m not doubting what might be a best practice, and the need for stricter requirements for certain industries. But I don’t yet see such a requirement here. The original post was about the phrase “as appropriate.” I am not convinced that ”as appropriate” means mandatory.

If the measurement/test is a part of the DMR, it has been determined to be appropriate. If it isn't appropriate, it wouldn't be part of the DMR. It doesn't matter if it is caliper or a divining rod, if the DMR requires the use of a test/measurement tool it is appropriate to record the tool that is used for each lot/batch/device. The use of the latter will certainly raise eyebrows.

 

[Jim Wynne]

If the measurement/test is a part of the DMR, it has been determined to be appropriate.

This still seems like conjecture to me. Where is the explicit link between the DMR and what's "appropriate" per 8.2.6?

 

[Tidge]

This is NOT conjecture, it is a common standard that has been applied to medical device manufacturers.

(7.1) In planning product realization, the organization shall determine the following, as appropriate:

c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance;

d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.5).

The output of this planning shall be documented in a form suitable for the organization’s method of operations.

7.3.4 Design and development outputs
Design and development outputs shall:

b) provide appropriate information for purchasing, production and service provision;
c) contain or reference product acceptance criteria;

Records of the design and development outputs shall be maintained (see 4.2.5).

The DMR is a design output, so adding the test/measurement criteria to the DMR makes them appropriate.