Suitability and Capability of Measurement Equipment

[TonyCA]

We recently had an customer audit and received a nonconformance for not having records for section A of 21CFR820.72-Control of inspection, measuring, and test equipment. What proof is needed to determine if equipment is suitable for its intended purpose and is capable of producing valid results?

Thanks for your imput

-Tony

[GStough]

In Reply to Parent Post by TonyCA

We recently had an customer audit and received a nonconformance for not having records for section A of 21CFR820.72-Control of inspection, measuring, and test equipment. What proof is needed to determine if equipment is suitable for its intended purpose and is capable of producing valid results?

Thanks for your imput

-Tony

Hi TonyCA and welcome to the Cove!

What about preventive maintenance, calibration, equipment inspection, etc. records to demonstrate that the equipment is suitable for its intended purpose?

Product inspection and/or testing results might also demonstrate that the equipment is capable of producing valid results.

Hope this helps.

[justncredible]

Anything used to measure needs to be controled and calibrated, so a scale used to weigh a part has to be calibrated and has to have a way to prove it is correct and some set of rules saying when and what action will be taken to make sure it is working and is under control.

[David DeLong]

In Reply to Parent Post by TonyCA

We recently had an customer audit and received a nonconformance for not having records for section A of 21CFR820.72-Control of inspection, measuring, and test equipment. What proof is needed to determine if equipment is suitable for its intended purpose and is capable of producing valid results?

Thanks for your imput

-Tony

Tony:

I would always suggest that you select a measuring instrument that can read down to at least 1/10th the part tolerance. That is considered suitable. Make sure that your calibration sheet for this instrument indicates where it can be used.

I always remember a grinding machine Operator trying to use a .001 micrometer on a tolerance range of .0007". It sure didn't work out well. He should have used a digital micrometer that could read in tenths (still not quite the 10%) and the company eventually purchased this measuring instrument for him.

As far a capability, the R & R study is great. There are quite a few excel files shown in this forum that could be used. The automotive companies state that a measuring instrument should not use any more than 30% of the process but if you were not in the automotive game, make it no more than 30% of the tolerance (or state of the art).

Hope these thoughts help out.

[BradM]

Hello, Tony! Welcome to the discussion board!

In Reply to Parent Post by TonyCA

We recently had an customer audit and received a nonconformance for not having records for section A of 21CFR820.72-Control of inspection, measuring, and test equipment. What proof is needed to determine if equipment is suitable for its intended purpose and is capable of producing valid results?

Thanks for your input

-Tony

A nonconformance, huh? Let me ask you this... instead of focusing on what you don't have, what do you have? Do you perform calibrations? Do you have records? Do you perform any level of validation/ verification of the equipment?

Of the equipment you don't have calibrated, is there a cross-functional way to verify the operation of equipment, either by it's output, or comparison to an industry standard/specification?

[justncredible]

"resoution to be at most 1/10 of total process six sigma devation instead of the traditional rule"

page 46 of msa 3rd ed.


just dun ask me what that means........... a stable process and then look where it runs and 1/10th of that........OMG!


and to think I was getting quotes for a redesign of my companys gages, just got the first @ $20,000, I will have to rethink it. I just read the MSA this last week.

[db]

Tony, Welcome to the Cove

What GMP is trying to do is ensure you can trust your equipment. So the question is how can you have faith in your devices? The answer needs to be 1) valid, and 2) documented. Now, there may be some room for argument about #2. Calibration records 820.72 (b) (2), relate to calibration (they are a subset of 820.72 (b) (2), not 820.72 (b) (1). However, at the bottom of 820.72 (b) (1), there is the language "These activities shall be documented." This requires answer to the question of how you ensure your equipment is suitable, and can produce valid results be documented.

As Dave mentioned, a Gauge R&R is one way of showing capability (and one I too, would recommend), but it is not required.

[TonyCA]

Brad,

We do have records of calibration, validations, and inspection results. Calibration is outsourced. We do a loose validation of the manufacturing equipment. I think what they were after was how do you know if that particular measuring device is right for that measurement application.