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

[Jim Wynne]

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

What Kees means (I'm sure) is that it's required "to run an effective calibration system which prevents problems occurring"...

"Pass/fail" doesn't employ one of the basic Quality Management Principles - that is "Use of Data". Since no actual measurements are taken, no-one can determine the next suitable recall, and, as been mentioned, there can be no evaluation of the effects of the out of spec. situation on product.

It's all very well chanting the mantra "show me the shall", but the effectiveness of such a system is what's at stake here...

Who said that "no actual measurements are taken"?

 

[AndyN]

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

If measurements are taken, I fail to see why - if you want to run an effective calibration system - recording pass/fail is going to help. Why not record the measurements. Variables data always trumps attribute in this situation!

You cannot predict - the very heart of an effective cal system - the trends if you use pass/fail...

 

[Jim Wynne]

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

If measurements are taken, I fail to see why - if you want to run an effective calibration system - recording pass/fail is going to help. Why not record the measurements. Variables data always trumps attribute in this situation!

You cannot predict - the very heart of an effective cal system - the trends if you use pass/fail...

The question wasn't about whether or not it's prudent to record measurement data, it was about whether recording the data is required by the standard. It isn't.

 

[Jim Wynne]

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

having a log that only has "pass" or "fail" without any other parameters might make it difficult to assess the validity of previous measuring results. Don't you agree?

What that part of 7.6 means is that when a device is found out of tolerance, you're supposed to try to determine whether any previous measurement of product might have been affected. We must assume, even though the actual measurement data isn't recorded for posterity, that at the time an out-of-tolerance condition is identified, the extent of the error is known and it's possible to determine whether the nonconformity might have affected prior measurements.

 

[AndyN]

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

The question wasn't about whether or not it's prudent to record measurement data, it was about whether recording the data is required by the standard. It isn't.

If you read 7.6 alone, Jim, that's true. As you well know, the failing is in reading one requirement in isolation of the others! We know there's no "shall", as there isn't for many other requirements - read in isolation.

If anyone wishes to run an effective system, the use of actual recorded information must be used to determine what to do next - planning. You cannot effectively plan for the recall of a device if you only record pass/fail, let alone go back when a problem occurs.

For anyone to simply state "where's the shall?" is doing a dis-service to those who seek to implement an effective system - and strikes at the very heart of why so much bad is written about the standard, IMHO...

 

[Pcool]

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

shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.

Lets break this down:

Shall means required.

Validity of a previous measuring result - For an argument to be valid the conclusion has to be logically entailed by its premises - "pass" or "fail" results are conclusions and have no premises by themselves. Because this "Shall" must record the validity, you have to show the premises that allowed you to reach a pass or fail conclusion.

Equipment because it says equipment.

 

[Jim Wynne]

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

You have ignored the "assess" part of the requirement. It says "assess and record the results..." which means you must record the results of the assessment--you must have a record of having determined the possible outcome(s) of the device being used to measure product.

 

[Pcool]

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

Without ignoring "assess"(which I already mentioned in a previous comment) the sentence still reads "shall assess and record the validity of the previous measuring results"... it does not say "assess, and record the results"
The subject being validity of the results, not just the results. "Pass" or "Fail" are not valid alone, they need conditions(premises) that make them valid conclusions.
For that reason, StevePenney must show more than just pass/fail.

 

[Jim Wynne]

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

I think you may be confused about what "measurement results" means in this context, and you might reading something into it that isn't there. Let me explain:

1. I calibrate a caliper, and find that it's out of tolerance. I know the exact amount of the error.
2. The result of the calibration is "fail."
3. I review the records to determine what product might have been measured with that caliper (previous measurement results) and take action accordingly.
4. I create a record of the actions taken. This record might include reference to the amount of error found in calibration and could be separate from the calibration record itself.
5. I am in compliance with 7.6.

 

[Pcool]

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

There is no confusion on "measuring results"
Yes, in this example you would be compliant because you know the exact amount of the error.
To build upon your example:

1. A caliper is out of tolerance by 5 mm, we allow +- 2 mm of tolerance for a 15 mm space between the components of the product in our process.
2. The result of the calibration is Fail
3. I review the records(I have to asses and record the validity of previous measurement results). I see one of the products was recorded as having 14mm of space between components. If it just said "Fail" I would not be able to validate that this product is bad. I have to be able to see the amount the caliper failed by and then take action based on that amount.
4. I create a record of the actions taken. This record will(Validity is a requirement) include reference to the amount of error found in calibration and could be separate from the calibration record itself.
5. And then you are in compliance with 7.6