ISO 9001:2008 Sec 7.6 - Can we just log measurement devices as 'Pass/Fail'?

[Big Jim]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Mathematic is the difference between the standard's value and the measured value.

Would you allow a practice like using a micrometer to calibrate pin gages? The 10:1 rule isn't in the standard.

The act of calibration in dimensional tools is mathematical comparison between a known value and an assessed value. Its result is a number. If the number exceeds the allowed limit or not, a decision is made. But that is what is derived from the measured value; the value is the result.

I never mentioned the 10:1 rule. You have brought it up as a defense, and it just doesn't fit the scenerio.

Actually, the 10:1 rule isn't always appropriate. From earlier posts here from those that mainly deal with 17025, sometimes (and if I remember correctly mor often than not) it is 4:1.

The real point is that the 10:1 (or 4:1) rule has no bearing on this topic.

You have moved into requirement creep, imagining that there is more to it that what is in the written word.

How long are you going to try to keep this spinning?

 

[Pcool]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

I never mentioned the 10:1 rule. You have brought it up as a defense, and it just doesn't fit the scenerio.

Actually, the 10:1 rule isn't always appropriate. From earlier posts here from those that mainly deal with 17025, sometimes (and if I remember correctly mor often than not) it is 4:1.

The real point is that the 10:1 (or 4:1) rule has no bearing on this topic.

You have moved into requirement creep, imagining that there is more to it that what is in the written word.

How long are you going to try to keep this spinning?

Wow this thread is going off on tangents... Lets bring this back to just 7.6, no spinning is necessary to see the requirement.
Here is a scenario: You have been using calipers to measure components for products. The next morning, a caliper is tested and found to be out of tolerance. You know that a few products have been measured using that caliper before it was found to be out of tolerance by another employee. What are you going to write when you assess and record the validity of previous measuring results from that equipment on the affected products? All you have is a log that says the caliper failed.
What are you going to write down so other people know why the equipment caused a defective product?

 

[BradM]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Pass/fail is data.

Yes. About as good as "day-time"/ "night-time" is to asking what time it is.

 

[BradM]

It would appear that you conveniently left part of my post off in your quote here:

That, in a nutshell, describes what has happened to this thread.

How many angels can dance on the head of a pin?

So here is the entire post:

You cannot legislate morality. And you cannot ( and do not) want to try to have an international standard that mandates every jot and tittle.

There is too much to gain by writing down the actual raw data when performing calibrations. Write the data down.

BTW... four angels can "fit" on the head of a needle.

Without seeing the actual write-up and the auditors observations, there may be solid evidence for the findings as a by-product of some of the other required standards.

It's also possible the auditor was referring to other standards besides ISO 9001.

If I paid somebody for a calibration and all they could produce is a pass/fail evaluation, I ask for my money back. That to me, is not a calibration.

Back to the OP's question, I would be interested to find out more as to what the findings was surrounding, what was cited, etc. At this point, it appears to be nothing more than speculation.

But instead of arguing that it is not a requirement, given that paper and pens are pretty cheap, it takes no additional resources to record it and much is gained by recording it, I would thank the auditor for the chance to improve the process, implement, and start gaining from the benefits.

 

[BradM]

I don't think anyone here, with the possible exception of the OP, thinks limiting the record to pass/fail is a good idea. You also don't want auditors making up their own requirements, though.

I agree Jim. Being privy to the write-up, what was observed, etc. would help.

Generally I don't like any knee-jerk responses. Many times they lead to silly patches for things that aren't broken in the first place. But anytime any recommendation is made to record data, I would say it's a good thing.

 

[Jim Wynne]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Have you ever told anyone about the 10:1 "rule"? Would you allow the practice of calibrating a pin gage measuring to millionths using a micrometer measuring to ten thousandths? It's not in the standard.

There is no universally applicable 10:1 "rule" or 4:1 for that matter either. It might become a rule if I make it one, for my system, but otherwise it's only a guideline.

What is being recorded: the measurement when comparing the instrument against the standard, or the decision to accept/not accept? Both of which are included in good practice calibration documentation, with accept/not accept recorded as pass/fail for as found condition.

You're being very selective in your definitions. How about, as a definition of "result," A consequence, effect or outcome of something? Is "Pass" not an outcome?

7.6 requires a record to be kept of the results of calibration and verification. The FreeOnlineictionary defines results as Saying merely "pass/fail" is record of a decision, not the value.

This last makes no sense, I'm afraid. There is nothing anywhere (except in the tortured interpretations of some in this thread) that says that numeric values must be recorded.

 

[Big Jim]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Wow this thread is going off on tangents... Lets bring this back to just 7.6, no spinning is necessary to see the requirement.
Here is a scenario: You have been using calipers to measure components for products. The next morning, a caliper is tested and found to be out of tolerance. You know that a few products have been measured using that caliper before it was found to be out of tolerance by another employee. What are you going to write when you assess and record the validity of previous measuring results from that equipment on the affected products? All you have is a log that says the caliper failed.
What are you going to write down so other people know why the equipment caused a defective product?

What more would you know if you did have the actual measurements? NOTHING. You know it failed. You know when you found it to be out of specification. You know the last time it was checked. So everything measured in the interval from the last time it passed until it failed becomes suspect. How is that changed because you recorded the actual measurements? It hasn't.

 

[Big Jim]

Re: ISO 9001:2008 Sec 7.6 - Can we just log the devices as 'Pass/Fail'?

Yes. About as good as "day-time"/ "night-time" is to asking what time it is.

That is not a good analogy, but since you brought it up, sometimes "day time"/"night time" is enough.

 

[Big Jim]

It would appear that you conveniently left part of my post off in your quote here:



So here is the entire post:




BTW... four angels can "fit" on the head of a needle.

Without seeing the actual write-up and the auditors observations, there may be solid evidence for the findings as a by-product of some of the other required standards.

It's also possible the auditor was referring to other standards besides ISO 9001.

If I paid somebody for a calibration and all they could produce is a pass/fail evaluation, I ask for my money back. That to me, is not a calibration.

Back to the OP's question, I would be interested to find out more as to what the findings was surrounding, what was cited, etc. At this point, it appears to be nothing more than speculation.

But instead of arguing that it is not a requirement, given that paper and pens are pretty cheap, it takes no additional resources to record it and much is gained by recording it, I would thank the auditor for the chance to improve the process, implement, and start gaining from the benefits.

And you know for a surity that four angels can fit on the head of a needle? Why not thousands? Why not one would cover many needles? This falls into the realm of the unknowable.

I would agree that it is a good practice to write down the readings, after all, they had to be at least mentally noted in the process of determining pass/fail. But that isn't the question here. The question is really very simple. Is it a requirement. No matter how much you would like it to be, it simply is not.

 

[Big Jim]

I agree Jim. Being privy to the write-up, what was observed, etc. would help.

Generally I don't like any knee-jerk responses. Many times they lead to silly patches for things that aren't broken in the first place. But anytime any recommendation is made to record data, I would say it's a good thing.

I have no arguement that it is a good thing. It just isn't a requirement.