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

[insect warfare]

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.

I must admit that while reading this thread (after my reply), I did learn a thing or two about this subject, particularly from all of the varied responses from more experienced Covers, and it also made me reflect a little bit more about how I've evaluated this clause in the past as an internal auditor, and as a process owner. I wish more threads could be as energetic as this one.

But this is indeed a strange thread, no? The quizzical part is that I do believe that both sides are technically right for the most part, but for completely different reasons. I think this thread essentially comes down to those who want simply to answer the OP's question of compliance vs. those who feel compelled to tackle it from a consultancy/effectiveness point of view. That is probably why I attached the two quoted posts above (to me these are most representative of both sides).

What I'm definitely taking away from reading this thread is that just answering a question without also providing the risks, benefits or consequences in the proper context may also not be serving the needs of the OP as well as they should be.

Brian

 

[Pcool]

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

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."

you mean the only section I've been focusing on this entire thread? No couldn't be .

How does recording the actual measurement aid in validation?

What you wrote is the equivalent to "How does a part of validation aid in validation?" You can also look it up in 3.8.5 of the QMS fundamentals and vocabulary, it really isn't that complicated.

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.

"Assess" is now "investigate", while these two words are similar they have very different implications. Lets stick with what the standard actually says instead of inserting words that end up not really helping your argument. We are talking about calipers. If you can't see a glaring contradiction in those last few sentences then I don't know what else to say.

Not only is it a better practice to write down the recording at the time of failure, but it's an easier way to meet the requirement. It's not ; if I agreed with you, we would both be wrong.

 

[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?

So just what validation are you referring to here?

 

[Big Jim]

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

What you wrote is the equivalent to "How does a part of validation aid in validation?" You can also look it up in 3.8.5 of the QMS fundamentals and vocabulary, it really isn't that complicated.

Here is 3.8.5 from ISO 9000:

validation
confirmation, through the provision of objective evidence (3.8.1), the the requirements (3.1.2) for a specific intended use or application have been fulfilled

And to be thorough, here is 3.8.1

objective evidence
data supporting the existance or verity of something

Data is not defined in ISO 9000, so a look in the dictionary (Dictionary.com) provides this:

data
individual facts, statistics, or items of information

I suspect that somewhere you fell into a narrower definition of data, leading you to think it has to be numerical. It clearly doesn't.

Once again, I never said that recording "pass/fail" was a good practice. I only said that there is no requirement that kept you from doing so.

This is a little like the public defender that may not agree with his clients comments, but will defend his clients right to express them.

When I entered this, I was standing up against someone that said that it was a requirement, and all I have done is steadfastly pointed out that it isn't.

 

[somashekar]

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

I only said that there is no requirement that kept you from doing so.

I am trying to read this many times ...
The standard uses 'shall determine' and 'shall establish' and 'shall be calibrated' and 'shall be adjusted as necessary' and 'shall be identified' and 'shall be safeguarded from unintended adjustment ' and 'shall be protected'
Are these not requirements ...
The OP asks about mics and caliper. Does that not mandate the measurement requirement...
Does not a measurement requirement mandate a measure and a record requirement of the same in this ...
<<< Records of the result of calibration and verification shall be maintained >>>
We have to DETERMINE everything in a QMS that the organization establishes. This is the REQUIREMENT.

 

[Big Jim]

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

I am trying to read this many times ...
The standard uses 'shall determine' and 'shall establish' and 'shall be calibrated' and 'shall be adjusted as necessary' and 'shall be identified' and 'shall be safeguarded from unintended adjustment ' and 'shall be protected'
Are these not requirements ...
The OP askes about caliper. Does that not mandate the measurement requirement...
Does not a measurement requirement mandate a measure and a record requirement of the same in this ...
<<< Records of the result of calibration and verification shall be maintained >>>
We have to DETERMINE everything in a QMS that the organization establishes. This is the REQUIREMENT.

Pass/fail is results of calibration, and when written down is a record.

So are you thinking that result must be expressed in numbers?

 

[somashekar]

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

Pass/fail is results of calibration, and when written down is a record.

So are you thinking that result must be expressed in numbers?

Dear Jim.
I am not thinking so.
I am certain that the record of the result of calibration for a mic / caliper must have the numbers and the inference.
For me this makes the record of the result of calibration as I determine, and would advise same for a process based QMS and its effective implementation and continual improvement.

 

[Big Jim]

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

Dear Jim.
I am not thinking so.
I am certain that the record of the result of calibration for a mic / caliper must have the numbers and the inference.
For me this makes the record of the result of calibration as I determine, and would advise same for a process based QMS and its effective implementation and continual improvement.

It certainly is a way toward continual improvement. It is even a very good way. That doesn't make it a requirement.

 

[somashekar]

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

It certainly is a way toward continual improvement. It is even a very good way. That doesn't make it a requirement.

Jim.
We know you agree with this and you also say it is a very good way. You are placed high on your depth of knowledge on standard.
I (We) attach this to requirement and anything else to bad way and therefore cannot advise that way as a requirement.
Implementing a standard is not taking a literal meaning from the said words in standard.
If a few CB's permit that, it does not equate to requirement.
Lets see as QMS professionals and not as the attorny defending a court case.

 

[Pcool]

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

Here is 3.8.5 from ISO 9000:

validation
confirmation, through the provision of objective evidence (3.8.1), the the requirements (3.1.2) for a specific intended use or application have been fulfilled

And to be thorough, here is 3.8.1

objective evidence
data supporting the existance or verity of something

Data is not defined in ISO 9000, so a look in the dictionary (Dictionary.com) provides this:

data
individual facts, statistics, or items of information

I suspect that somewhere you fell into a narrower definition of data, leading you to think it has to be numerical. It clearly doesn't.

I never thought data always had to be numerical, but in the case of a caliper(measurement device that uses numerical data) you need the numbers.

look at the objective evidence, and replace "data" with "fail" would lead to "fail supports the existence of failure"... I guess ISO doesn't explicitly forbid circular reasoning though, so good point