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'?

How would I know whether if the device failed if I didn't also know the extent of the failure? Why would I not know "the amount the caliper failed by"?

 

[Pcool]

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

You would "know" the extent of a failure, but a person's memory is not a record of validation.
I thought that you recorded it in your first example when you wrote "I know the exact amount of the error."

 

[insect warfare]

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.

"Validity" of an assessment is the degree to which it measures what it is supposed to measure. This is not the same as "reliability", which is the extent to which a measurement gives results that are consistent.

Also, the word "valid" is derived from the Latin word "validus", meaning "strong". When applied to 7.6, the organization need only assess and record the strength (or degree) of those previous measuring results. Thus, "pass" or "fail" can be as valid of results as you need them to be. Would "pass" or "fail" suffice in an industry that relies heavily on variable data for its assessments? Probably not, but there is nothing out there that says attribute data is totally worthless either, when utilized in the appropriate manner.

Brian

 

[Pcool]

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

"Validity" of an assessment is the degree to which it measures what it is supposed to measure. This is not the same as "reliability", which is the extent to which a measurement gives results that are consistent.

Also, the word "valid" is derived from the Latin word "validus", meaning "strong". When applied to 7.6, the organization need only assess and record the strength (or degree) of those previous measuring results. Thus, "pass" or "fail" can be as valid of results as you need them to be. Would "pass" or "fail" suffice in an industry that relies heavily on variable data for its assessments? Probably not, but there is nothing out there that says attribute data is totally worthless either, when utilized in the appropriate manner.

Brian

No, you have to say why it failed or why it passed.
We are looking at the ISO definitions of Validation and the English definition of Validity, not the Latin word "validus" ...

Under the Quality Management Systems Fundamentals and Vocabulary

3.8.5 Validation - confirmation, through the provisions of objective evidence (3.8.1), that the requirements for a specific intended use or application have been fulfilled.

3.8.1 Objective evidence - Data supporting the existence or verity of something.

 

[Billy M]

In regards to the calibration or verification, it is acceptable to verify that the device is still in calibration by checking against a calibrated standard with regular frequency (daily, weekly, monthly) and recording on a log or form that it passed. That log or form could be a checklist showing the current status. The problem with calibration frequencies on some devices is that when it is re-calibrated, you must verify the as-received or as-found condition. If it is found out of calibration then you must assess the validity of any previous measuring results. If you are verifying on a regular basis, then the time frame for the device going out of calibration can be narrowed down to a time period within the last verification cycle. But the verification has to be documented. I have used this method for many years with no issues from auditors or certification bodies. As a note, I always put a small procedural content on the bottom of the form that described the process of verification and made sure whomever was doing the verification was trained to do so.

 

[Jen Kirley]

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

Yes, it is required.

A good auditor would ask: How did you determine it passed the calibration? If it failed, how far was it out? If it failed you would want to know how far it was out and take appropriate action. Without the actual data, you cannot answer that question.

I agree with this because the standard starts by laying out requirements for us to design and maintain an effective QMS:

4.1c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes...

Only after that does the standard break out specifics into sections like 7.6, which give more details but don't tell us to step in march right-foot-left-foot and to breathe-in, breathe-out. It is the difference between auditing compliance and auditing for effectiveness. If we were to only audit to the "shalls" the 4.1 section would have been left out I think.

 

[Jim Wynne]

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

Yes, it is required.

A good auditor would ask: How did you determine it passed the calibration? If it failed, how far was it out? If it failed you would want to know how far it was out and take appropriate action. Without the actual data, you cannot answer that question.

I agree with this because the standard starts by laying out requirements for us to design and maintain an effective QMS:

4.1c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes...

Only after that does the standard break out specifics into sections like 7.6, which give more details but don't tell us to step in march right-foot-left-foot and to breathe-in, breathe-out. It is the difference between auditing compliance and auditing for effectiveness. If we were to only audit to the "shalls" the 4.1 section would have been left out I think.

Madness this way lies. I can't imagine that you believe it's a good idea for auditors to be able to invent their own criteria for effectiveness or their own "shalls."

 

[Jen Kirley]

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

Madness this way lies. I can't imagine that you believe it's a good idea for auditors to be able to invent their own criteria for effectiveness or their own "shalls."

I don't invent the criteria for effectiveness, I discuss the subject with my client and explore with him what his calibration system is trying to achieve. I'm not Judge Judy, I do not write NCs without the client fully understanding the nature, context and reason for them - and I make sure to receive their agreement to the NC before the closing meeting. I make sure we are aligned that the audit is not to simply confirm the shalls are met; it is to verify effectiveness, definition of which we arrive together to ensure there's no wasted effort in asking for a system improvement.

The monitoring and measurement system, of which calibration is a small part, is meant to help make sure the organization's goals are met through valid, reliable measurements. Those two terms don't mean the same thing; asking for an understanding of the instruments' performance is, I agree more than asking for an out-of-tolerance tool to get calibrated.

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.

On the flip side [of what we Navy folks used to call "nuking it" because of the extreme measures the nuclear engineers wold take on their process controls], this kind of analysis can sometimes justify lengthening calibration cycles and saving calibration costs.

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.

 

[BradM]

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.

 

[Kevin Mader]

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.