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

[Jim Wynne]

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.

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.

 

[Jim Wynne]

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

....If our OP wants to contest the NC he might succeed in getting it reversed. But if he wants a robust system he might consider going past the reactive measures listed in the shalls.


Win the battle....lose the war.

Which part of 7.6 is reactive?

 

[Big Jim]

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

:

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

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

 

[Jim Wynne]

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

<snip>I think this sort of thing comes down to why we have a QMS. If it is to meet the shalls and maintain a certificate, then we can do the minimum specified in 7.6. If we want our calibration system support our competitive market position by truthfully measuring critical characteristics in a reliable manner, we can ask for more than reactive measures (recalibrating an out-of-tolerance instrument). We don't need to do a full-blown MSA study like automotive does, but we can pay attention to instruments' performance over time and maintain confidence in them.

This is not responsive to the question, which is whether the OP's method meets the requirements of 7.6. In 30+ years of dealing with these things, I can't recall a single instance where a signifanct NC occurred in mechanical inspection due to a device being out of calibration. Not one. If we're concerned about our measurement systems' ability to be "truthfully" accurate, we always double-check our measurements when something seems amiss.

Whether a given process is effective or not can only be judged by the consistency of its output in achieving the objectives. "Objective" evidence is obtained, by definition, by observation. I'm all for evaluation of effectiveness, but the criteria for effectiveness may not be the same in my process as they are in someone else's. In the end, economincally responsible delivery of conforming output is the prime criterion for any process, and there could be more than one way of getting there. If an auditor projects personal beliefs as to what is "truthful" onto auditees, especially with regard to potential effectiveness, the whole system of objective auditing goes down the tubes.

 

[Jen Kirley]

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

This is not responsive to the question, which is whether the OP's method meets the requirements of 7.6. In 30+ years of dealing with these things, I can't recall a single instance where a signifanct NC occurred in mechanical inspection due to a device being out of calibration. Not one. If we're concerned about our measurement systems' ability to be "truthfully" accurate, we always double-check our measurements when something seems amiss.

Whether a given process is effective or not can only be judged by the consistency of its output in achieving the objectives. "Objective" evidence is obtained, by definition, by observation. I'm all for evaluation of effectiveness, but the criteria for effectiveness may not be the same in my process as they are in someone else's. In the end, economincally responsible delivery of conforming output is the prime criterion for any process, and there could be more than one way of getting there. If an auditor projects personal beliefs as to what is "truthful" onto auditees, especially with regard to potential effectiveness, the whole system of objective auditing goes down the tubes.

When a clause asks for a record of the calibration event, what is being recorded? A measurement or a decision? The OP wants to record the decision but the auditor is asking him to record the measurement results during the instruments' verification process (calibration). Such nuances can be overlooked when just trying to meet the shalls.

Not having seen the writeup it's hard to go further without truly guessing. I have seen such a writeup from a registrar before, but it was done after a discussion of what the objectives were that the calibration program was trying to achieve. No one was making anything up then either. I disagree that it was based on personal belief; these are calibration good practices, along with the 10:1 "rule" that ISO 9001 doesn't refer to in any way but we advise all the time.

I have also seen such data used to justify extending a calibration cycle, and also to shorten it. It's valuable information and takes very little effort to keep. It's about product, but it's also about the system.

 

[Big Jim]

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

When a clause asks for a record of the calibration event, what is being recorded? A measurement or a decision? The OP wants to record the decision but the auditor is asking him to record the measurement results during the instruments' verification process (calibration). Such nuances can be overlooked when just trying to meet the shalls.

Not having seen the writeup it's hard to go further without truly guessing. I have seen such a writeup from a registrar before, but it was done after a discussion of what the objectives were that the calibration program was trying to achieve. No one was making anything up then either. I disagree that it was based on personal belief; these are calibration good practices, along with the 10:1 "rule" that ISO 9001 doesn't refer to in any way but we advise all the time.

I have also seen such data used to justify extending a calibration cycle, and also to shorten it. It's valuable information and takes very little effort to keep. It's about product, but it's also about the system.

The question here is about the requirement of the standard, not what would be a best practice. It is not a requirement, and no amount of twisting can make it a requirement.

Like so many other things in the standard, it only becomes a requirement when the organization makes it one. That is NOT making it a requirement of the standard.

 

[Jen Kirley]

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

The question here is about the requirement of the standard, not what would be a best practice. It is not a requirement, and no amount of twisting can make it a requirement.

Like so many other things in the standard, it only becomes a requirement when the organization makes it one. That is NOT making it a requirement of the standard.

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.

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.

7.6 requires a record to be kept of the results of calibration and verification. The FreeOnlineictionary defines results as

2. (Mathematics) a number, quantity, or value obtained by solving a mathematical problem

Saying merely "pass/fail" is record of a decision, not the value.

 

[Big Jim]

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.

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.

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.

The standard requires "records of the results of calibration".

I can't find "mathematic" in there. Can you?

Pass/fail IS results.

The on-line Merriam Webster Dictionary defines results as:

"to proceed or arise as a consequence, effect, or conclusion"

 

[Jen Kirley]

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

The standard requires "records of the results of calibration".

I can't find "mathematic" in there. Can you?

Pass/fail IS results.

The on-line Merriam Webster Dictionary defines results as:

"to proceed or arise as a consequence, effect, or conclusion"

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.

 

[AndyN]

Absolutely correct, Jennifer!

The decision is to "pass or fail", not the result. The decision is based on the result(s) of the calibration, that is to "pass" the equipment and use it or to "fail" it and determine a course of action.

No amount of justification will replace the practical reality of not being able to "do" anything in the measurement world - which is what calibration is - without data. It is exactly why to run an effective calibration control system, you must actually evaluate the whole spectrum of linearity, bias and stability (as applicable) and hence to measurement uncertainty.

It is no different to QC checks on product. You perform a measurement (or go/not go check) and a decision is made: Pass or Fail.

There is little point in recording the decision. What's required is the results of the activity (calibration or inspection) which justifies the decision.