Scope in procedure and content for 7.6 Monitoring and Measuring Equipment

[QAMTY]

Hi all.

I'm in the phase of implementing an ISO 9001:2008 and have some questions in 7.6, please share your ideas. 7.6 require to comply with

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards exist, the basis
used for calibration or verification shall be recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;​

e) be protected from damage and deterioration during handling, maintenance and storage.
and some others...

But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards

 

[drgnrider]

? But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards

Special tests ? no these are not required. You may, however, perform these tests, (or have them performed), to prove a reason for using a calibration interval greater than the manufacturer recommended interval, (typically one year). Neither I, nor my predecessor, ran these tests, but he had enough historical data to make a decent estimate of how the gages are faring using the current intervals.
Personally, I would not mention these tests, other than possibly as a side note 'these are tests that can be used to...'; depending how you word them in your procedures then that is what you must do. If they are not in your procedure, they are options that you can use if, and when, you deem necessary.

Competency ? this can be something as simple as someone with experience deeming you competent after training you. Most calibration is using the tool to measure against a known standard and recording the result.
- Before I started as a machinist I had never used a micrometer, I became proficient using them on the shop floor and now I am only using them on known standards, not parts, and recording my results (aka: calibrating). I added to my skills by seeing what was required of calibration and adjusting our calibration procedures accordingly (they were missing some steps).

As for the standard and your procedure - as long as your procedure addresses all the points of the standard, that is the minimum that is required, anything beyond that up to you... you just have to be doing that.

drgnrider
Calibration & ISO Coordinators

 

[AndyN]

Hi all.

But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards

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If you are going to calibrate something, to do it properly you should know the measurement uncertainty. This why an accredited lab reports this factor. Without it - like checking a caliper against a gauge block - is just verification, NOT calibration. You have to determine whether calibration or verification is needed. It sounds to me that you might need to get some education on calibration before doing much else. To suggest that competency comes from training is putting things around the wrong way - defining competencies comes before taking action - including training - to develop those skills.

So, if YOU don't know if you need to perform any of the analyses such as R & R, linearity, bias, stability etc, then clearly you need to be competent in those things. I'd recommend getting help from someone who IS competent in the subject (some labs also run training)

 

[QAMTY]

Thanks drgnrider and Andyn


Good comments

Even if I'm not going to be a guru in calibration, at least
I have to know the basics of equipment calibration terms and definitions

Thanks again

 

[Big Jim]

Actually, a procedure for calibration isn't required. Gauge R&R isn't required. Measurement uncertainty isn't required.

All are good to do, but is above and beyond ISO 9001.

Any of them could be a customer requirement though.

 

[Johnson]

Hi all.

I'm in the phase of implementing an ISO 9001:2008 and have some questions in 7.6, please share your ideas. 7.6 require to comply with

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards exist, the basis
used for calibration or verification shall be recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;​

e) be protected from damage and deterioration during handling, maintenance and storage.
and some others...

But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards

Firstly the concept and purpose of calibration and Gage R&R should be clarified. To make it simple (but the statement is not accurate enough):

The calibration is to check the correctness and accuracy of a measuring device compared to it's specification. It uses "master" or "reference standard". Normally done by the third party. Your parts are not used.

But Gage R&R is used to check if one selected measuring device is suitable /capable to measure your parts with defined tolerance. It use your parts and the measuring is done by your inspectors or operators. For example, you should not use a caliper （with resolution of 0.01 mm) to measure the parts with tolerance of 10+/-0.020 mm, you may use micrometers (with resolution of 0.001 mm)

Based on above explaination and look at ISO9001 7.6 again. It could be concluded:
A measuring device need to "be calibrated or verified", but R&R is not mentioned. R&R is required in automotive OEM or ISO/TS16949.
I would suggest you use Gage R&R. It is very simple and usefull since you" only have micrometers and rules.".


Hope it helps !

 

[AndyN]

Actually, a procedure for calibration isn't required. Gauge R&R isn't required. Measurement uncertainty isn't required.

All are good to do, but is above and beyond ISO 9001.

Any of them could be a customer requirement though.

"above and beyond" may be your understanding, however, just like many requirements in ISO 9001 - even simple document control, WHAT you do to calibrate equipment to ensure it is "suitable" MAY require an organization to perform these steps. Just be cause ISO/TS 16949 called it out specifically (or by ref. to the MSA manuals etc) may only be because it's not clear enough for those who would "prefer" not to do it.

The control of measuring equipment is often a misunderstood requirement where some most people know a little bit and are too quick to dismiss a number of activities as "not required". Just like many other ISO 9001 requirements don't tell you WHAT has to be done...

 

[Big Jim]

And thus the comment of these activities are above and beyond the requirements of ISO 9001:2008.

Again, as I said before, they still may be desirable, just not a requirement.

 

[AndyN]

And thus the comment of these activities are above and beyond the requirements of ISO 9001:2008.

Again, as I said before, they still may be desirable, just not a requirement.

In all seriousness, could you explain HOW (without reference to any of these established techniques) an organization is going to demonstrate that the equipment they use to measure something - is "suitable"? I'm all ears...

 

[Big Jim]

In all seriousness, could you explain HOW (without reference to any of these established techniques) an organization is going to demonstrate that the equipment they use to measure something - is "suitable"? I'm all ears...

By training the users on how to properly use the equipment and to select the right measureing tool.

Much of selecting the right tool is common sense. You don't use a tape measure to measure something that needs to be within 5 thousands of an inch. You select a tool that has suffecient resolution.

Put the popcorn away. You don't need it here.