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

[AndyN]

[FONT=&quot]Wow, I never would have thought there would be such an involved discussion on this thread, and with such polarized opinions. In my reading of the standard, I can see where recording the result may be implied, but not required. Our registrar has interpreted things this way also. Since it is just a little more work to write down a number, why not do it as additional informative information? Since it is our Quality Manager who decides how the calibration results are recoded, I will let him argue this one at our next re-certification. Honestly, I still am not sure what the standard actually requires. [/FONT]

I think you and your quality manager may be looking at this somewhat from the wrong perspective. For example, you have to do internal audits. It doesn't say anywhere that you "shall" plan the individual audit by creating a checklist or similar. But try doing an audit without this level of detail. It won't be effective. I'd suggest you take a look at what's being said here - what has to be recorded to run an effective cal system for what it's worth, not counting "shalls". I'd strongly suggest that because a cal. lab under ISO/IEC 17025 would have to do this, it's appropriate for you - for precisely the same reasons. Or, stop calling it calibration and just do "verification" instead...

 

[Big Jim]

I think you and your quality manager may be looking at this somewhat from the wrong perspective. For example, you have to do internal audits. It doesn't say anywhere that you "shall" plan the individual audit by creating a checklist or similar. But try doing an audit without this level of detail. It won't be effective. I'd suggest you take a look at what's being said here - what has to be recorded to run an effective cal system for what it's worth, not counting "shalls". I'd strongly suggest that because a cal. lab under ISO/IEC 17025 would have to do this, it's appropriate for you - for precisely the same reasons. Or, stop calling it calibration and just do "verification" instead...

Again, there isn't a requirement under ISO 9001:2008 to do so. ISO 9001:2008 does not require an organization to follow ISO 17025.

And why could you not do an effective intenal audit without it?

 

[Pcool]

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

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.

How do you show validation? The reason why validation is required is because the products created by that measuring equipment might not be defective even though the equipment was measured out of tolerance.

You can't just say this equipment is slightly out of tolerance, therefore all products made using it are bad because some products might still be within an acceptable range.

Imagine you have 100 components that were made with a caliper that was found to be out of tolerance by 1 mm, the standard for each component is 10 mm +/- 2 mm. 50 components have measurements of 8 mm, 25 of 9 mm, and 25 of 10 mm. You would rework all 100 components even though 50 are still in the allowable range? That is madness.

The only way to know why an affected product is defective is with objective evidence, which is in the ISO definition of validation.

And it what world is a single employee doing all of these tasks, and having them write down an exact measurement for equipment too much work/information?

 

[Big Jim]

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

How do you show validation? The reason why validation is required is because the products created by that measuring equipment might not be defective even though the equipment was measured out of tolerance.

You can't just say this equipment is slightly out of tolerance, therefore all products made using it are bad because some products might still be within an acceptable range.

Imagine you have 100 components that were made with a caliper that was found to be out of tolerance by 1 mm, the standard for each component is 10 mm +/- 2 mm. 50 components have measurements of 8 mm, 25 of 9 mm, and 25 of 10 mm. You would rework all 100 components even though 50 are still in the allowable range? That is madness.

The only way to know why an affected product is defective is with objective evidence, which is in the ISO definition of validation.

And it what world is a single employee doing all of these tasks, and having them write down an exact measurement for equipment too much work/information?

I'm sure you are referring to the paragraph immediately following the letters in element 7.6

"In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements."

How does recording the actual measurement aid in validation? It is the results of the INVESTIGATION that helps to determine the validity of previous results. The investigation may go down several paths depending on the circumstances, the actual reading at the time of failure being only one of them. There is no reason that such data could not become part of the investigation, and can be taken when the need is discovered. That certainly doesn't mean that it is a requirement to take it all of the rest of the time.

 

[Jen Kirley]

Simply because it wasn't there.

Negative: it is simply because you choose to define results in a manner that makes you feel comfortable, and you choose to look at one element's focus on one activity instead of considering the system.

 

[Jen Kirley]

[FONT=&quot]Wow, I never would have thought there would be such an involved discussion on this thread, and with such polarized opinions. In my reading of the standard, I can see where recording the result may be implied, but not required. Our registrar has interpreted things this way also. Since it is just a little more work to write down a number, why not do it as additional informative information? Since it is our Quality Manager who decides how the calibration results are recoded, I will let him argue this one at our next re-certification. Honestly, I still am not sure what the standard actually requires. [/FONT]

This is rare, but it happens sometimes. The Cove has a lot of very knowledgeable people with a broad spectrum of experience, and while we sometimes disagree the spectacle is usually courteous. It is true there are at least two distinctly different ways to look at this question. The benefit of this energetic discussion has been to show you the different viewpoints and the rationales behind them. As always, the system is yours, not ours; you and your people own it and whatever comes from your decisions.

Be well!

 

[Big Jim]

[FONT=&quot]Wow, I never would have thought there would be such an involved discussion on this thread, and with such polarized opinions. In my reading of the standard, I can see where recording the result may be implied, but not required. Our registrar has interpreted things this way also. Since it is just a little more work to write down a number, why not do it as additional informative information? Since it is our Quality Manager who decides how the calibration results are recoded, I will let him argue this one at our next re-certification. Honestly, I still am not sure what the standard actually requires. [/FONT]

This should really be the end of it. The OP's organization took it to the registrar and the registrar says it isn't required.

And this should not be a surprise. There are no hidden or ocluded shalls. Every single response claiming there is a shall here did their best to twist and spin to make one out of it, but it just isn't there.

The saddest part of this whole thread is that there are so many that want to cling on to their ideas without looking for the obvious. Think how irritated auditees get when an auditor creates a nonconformance where there isn't one. This is the exact sort of thing that gives the program a bad name.

 

[Kevin Mader]

An answer without the proper context lacks validity which is a point that's been made by several here. I'm in agreement with these folks. The notion that giving a "Pass/Fail" response without the proper context as being meaningful is a broad...and unsafe...assumption (IMHO).

A minimalists approach coupled with a narrow interpretation of a requirement is going to draw criticism. And while one can decide to challenge an auditor in a battle of wit (and vanity??) that might yield a single point victory, the fallout later might be far worse. The choice is yours.

 

[Jen Kirley]

This should really be the end of it. The OP's organization took it to the registrar and the registrar says it isn't required.

And this should not be a surprise. There are no hidden or ocluded shalls. Every single response claiming there is a shall here did their best to twist and spin to make one out of it, but it just isn't there.

The saddest part of this whole thread is that there are so many that want to cling on to their ideas without looking for the obvious. Think how irritated auditees get when an auditor creates a nonconformance where there isn't one. This is the exact sort of thing that gives the program a bad name.

I regret you wrote that.

 

[Big Jim]

An answer without the proper context lacks validity which is a point that's been made by several here. I'm in agreement with these folks. The notion that giving a "Pass/Fail" response without the proper context as being meaningful is a broad...and unsafe...assumption (IMHO).

A minimalists approach coupled with a narrow interpretation of a requirement is going to draw criticism. And while one can decide to challenge an auditor in a battle of wit (and vanity??) that might yield a single point victory, the fallout later might be far worse. The choice is yours.

Something that just isn't getting through here is that I never said it was a good practice. It just isn't a requirement of ISO 9001:2008, and that was the original question.

Are you saying there is a shall here? It doesn't look like you are. You are saying it is not a good practice, and I have no argument there.