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

[Sidney Vianna]

Can we just log the devices as 'Pass/Fail'? with no record of a reading.

ISO 9001:2008 4.2.4 stipulates

Records established to provide evidence of conformity to requirements shall be controlled.

A calibration process must follow a procedure (documented or otherwise). A procedure has requirements. If the calibration record does not provide evidence of conformity against the calibration procedure, it violates that requirement of the ISO 9001 standard.

Furthermore, ISO 9001:2008 section 7.6 requires that the calibration must be done against measurement standards traceable to international or national measurement standards; bla, bla bla... that is ANOTHER calibration requirement which must be recorded, i.e., the traceability to the standard used to calibrate the device. A simple pass/fail log would fail to comply with that requirement as well.

 

[Jim Wynne]

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.

The relevant part of 7.6:

...the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected.

My emphasis. In order to have a meaningful record of such an event, it will be necessary to record what happened and what was done about it. You are arguing against a contention that no one has made. The question is about the actual results of the calibration, and no matter how much anyone chooses to torture the language into submission to their own misconceptions, "Pass" and "Fail" are valid results.

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.

First of all, a minor technicality: The standard calls for assessment of validity, which is not exactly the same thing as "validation" in the ISO sense. What's being done is an assessment. That bit of pedantry out of the way, I'll point out once again that you're arguing with a strawman because a record must be created. A record that presumably would include the extent of the gage error and its potential or actual effects on previously measured product.

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?

See above.

 

[Jim Wynne]

ISO 9001:2008 4.2.4 stipulates
A calibration process must follow a procedure (documented or otherwise). A procedure has requirements. If the calibration record does not provide evidence of conformity against the calibration procedure, it violates that requirement of the ISO 9001 standard.

If the result of the calibration is "Pass," there is evidence of conformity with the calibration procedure, if that's what the calibration procedure calls for. There is a difference between evidence and proof.

Furthermore, ISO 9001:2008 section 7.6 requires that the calibration must be done against measurement standards traceable to international or national measurement standards; bla, bla bla... that is ANOTHER calibration requirement which must be recorded, i.e., the traceability to the standard used to calibrate the device. A simple pass/fail log would fail to comply with that requirement as well.

I agree that there should be reference to standards used, but that doesn't mean that the actual result can't be pass or fail.

The only thing we can know for sure, given a calibration report, is that the calibration report exists. There might be know way of knowing whether or not calibration was actually even done, so I think we might be giving the records more weight than they deserve when it comes to effectiveness. In the end, the burden is on the auditor to show evidence that the process--whatever it is--is effective or not effective. The null hypothesis going in must be "effective," in other words. We can't be writing NCs against things that have never happened (NC product resulting from out-of-calibration devices, e.g) and without good reason to believe that they will happen.

 

[Pcool]

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

The relevant part of 7.6: My emphasis. In order to have a meaningful record of such an event, it will be necessary to record what happened and what was done about it. You are arguing against a contention that no one has made. The question is about the actual results of the calibration, and no matter how much anyone chooses to torture the language into submission to their own misconceptions, "Pass" and "Fail" are valid results.

Look at the original question once again:

ISO 9001:2008 Section 7.6 Control of monitoring and measuring equipment.
sub-Clause 'a' states 'be calibrated or verified, or both'...

With regard to mics and calipers, the question I have is,

Can we just log the devices as 'Pass/Fail'? with no record of a reading.

Or is there the requirement to record a reading As Found - As Left ?
I do not see this in the standard, but our registrar has told us it is required?

He wants to know if there is anything in the standard that would require the reading of his caliper (side note: I'm not focusing on mics because I'm not as familiar with mics)

First of all, a minor technicality: The standard calls for assessment of validity, which is not exactly the same thing as "validation" in the ISO sense. What's being done is an assessment. That bit of pedantry out of the way, I'll point out once again that you're arguing with a strawman because a record must be created. A record that presumably would include the extent of the gage error and its potential or actual effects on previously measured product.

You can't achieve validity (noun. state of being valid) without validation (noun. from the verb "validate" meaning to make valid). Who am I making a strawman argument for?

See above.

That comment was in response to what Big Jim wrote in posts #12 and #57.

 

[insect warfare]

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

You can't achieve validity (noun. state of being valid) without validation (noun. from the verb "validate" meaning to make valid).

You have seemed to create your own definition of the word "validity" throughout several posts in this thread to make your point, as I have too. However, the fine folks from Technical Committee 176 SC2 (the same SC involved in the creation and revision of ISO 9001) have already defined "validity" for us in this document, which they fully encourage users such as you and I to apply when using ISO 9001 and 9004.

According to their guidance, "validity" is defined as "conformity to fact, accuracy or precision". The presence of the word "or" is probably the underlying argument with those who oppose your viewpoint. To "validate" is to "carry out validation" as defined in ISO 9001 paragraph 3.8.5. The definition of "validation" has normative status in ISO 9000, which I'm sure you already know.

FYI only - not here to be argumentative, as I've already made my peace in this thread.

Brian

 

[Sidney Vianna]

If the result of the calibration is "Pass," there is evidence of conformity with the calibration procedure, if that's what the calibration procedure calls for. There is a difference between evidence and proof.

There is a difference between evidence, proof and a record. The latter is the subject of the contention in this thread.

Some believe that there is no requirement for the minimum content of quality records in general and, in this specific case/thread, a calibration record.

I think differently and I believe I pointed out the ISO 9001 requirement which stipulates that a record (including calibration records) must demonstrate that requirements associated with the activity/process/system/product have been complied with.

A calibration process has several requirements in addition to the obvious final result. If we are to allow that records become minimalist in nature, then we could not object to records such as management review records, internal audit records, inspection records, etc... to be summarized with 3 words: It's all good.

Having said that, the adequacy of the calibration record contents could also be affected by the assessment of the calibration process itself: how well defined is it? what is the competence level of the person performing the calibration, etc...

Like you, when it comes to auditing, I believe that we must stick to requirements. But just because section 7.6 of ISO 9001 does not stipulate the minimum contents for a calibration record, it does not mean that the standard does not have a requirement for quality records, in general.

 

[AndyN]

Agreed, Sidney!

We mustn't forget:

4.1 d) and e) as well as 4.2.1 d) and 4.2.4 give a clue too. The danger is always to say "show me the shall" and to look for one clause to state everything needed.

 

[Sidney Vianna]

The danger is always to say "show me the shall" and to look for one clause to state everything needed.

Indeed, Andy. As you pointed out in the early phase of this thread, ISO 9001 has many linkages. The search for the appropriate "shall" should not stop at the immediate vicinity of the subject at hand and it can be contained elsewhere in the standard.

 

[Stijloor]

In an effort to make ISO 9001 more "generic", more confusion is created.

 

[Pcool]

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

You have seemed to create your own definition of the word "validity" throughout several posts in this thread to make your point. However, the fine folks from Technical Committee 176 SC2 (the same SC involved in the creation and revision of ISO 9001) have already defined "validity" for you in this document, which they fully encourage users such as you and I to apply when using ISO 9001 and 9004.

According to their guidance, "validity" is defined as "conformity to fact, accuracy or precision". The presence of the word "or" is probably the underlying argument with those who oppose your viewpoint. To "validate" is to "carry out validation" as defined in ISO 9001 paragraph 3.8.5. The definition of "validation" has normative status in ISO 9000, which I'm sure you already know.

FYI only - not here to be argumentative, as I've already made my peace in this thread.

Brian

That's a fair point (except for the part about me "creating" definitions). I was looking at the English definition of validity, validate, valid. To make my thinking visible to you:

va•lid•i•ty (vəˈlɪd ɪ ti)
n.
1. the state or quality of being valid.
2. legal soundness or force.
[1540–50; < Late Latin]

val•i•date (ˈv?l ɪˌdeɪt)
v.t. -dat•ed, -dat•ing.
1. to make valid; substantiate; confirm.
2. to give legal force to; legalize.
3. to give official sanction, confirmation, or approval to: to validate a passport.

val?id (vld)
adj.
1. Well grounded; just: a valid objection.
2. Producing the desired results; efficacious: valid methods.
3. Having legal force; effective or binding: a valid title.
4. Logic

a. Containing premises from which the conclusion may logically be derived: a valid argument.
b. Correctly inferred or deduced from a premise: a valid conclusion.​

5. Archaic Of sound health; robust.

because I don't have these definitions in my copy of the QMS fundamentals and vocabulary. Thank you for that resource.

Lets use the ISO definition of validity(because it actually gets to my point more quickly than the English definition), you've made a measurement on a product using a caliper. That caliper is now out of tolerance. You are now going to assess (ISO definition: evaluate or estimate the value of) and record (ISO definition: stating results achieved or providing evidence of activities performed) the validity (as you correctly pointed out: conformity to fact, accuracy or precision) of the previous measuring result. The product had an numerical measurement result from that caliper, to prove conformity to that measurement result you have to show another numerical measurement result from the failed caliper.

On top of that, there are other requirements already mentioned by Sidney and others that show you would need to record the reading of a failed caliper.