Clause 7.6 - "Shall have Identification in order to determine its calibration status"

[AndyN]

Re: Clause 7.6 - "Shall have Identification in order to determine its calibration sta

Jim, I think you're not seeing the fallacy of 'the next due' date. Real, effective calibration is based on use, not dates!

I was burned (in the distant past) where a cal. system was run on a time based recall. Trouble was, the gauge usage sky rocketed (how would the gauge lab find out?) and the first 3 turns of a bunch of male thread gauges wore badly (used in stainless steel). Those cal systems I've seen, rarely rely on cal. data (as found, as left) or similar. They are based on some arbitrary, wet finger in the air guestimate (the gauge supplier's answer?) - we read about them here all the time!

An effective cal system takes that data and trends it, keeping in mind use, to determine recall, while still within spec. Real world...Trouble is, most people don't know/want to get into that (it's resource consuming) and external suppliers of cal services don't go that far with their services...

If I was running a shop, I'd be all over an operator being paid to wander around trying to find out if a $50 gauge was calibrated - when I pay someone to know how to calibrate/control it! Double whammy!:mg:

 

[Big Jim]

Re: Clause 7.6 - "Shall have Identification in order to determine its calibration sta

Jim, I think you're not seeing the fallacy of 'the next due' date. Real, effective calibration is based on use, not dates!

I was burned (in the distant past) where a cal. system was run on a time based recall. Trouble was, the gauge usage sky rocketed (how would the gauge lab find out?) and the first 3 turns of a bunch of male thread gauges wore badly (used in stainless steel). Those cal systems I've seen, rarely rely on cal. data (as found, as left) or similar. They are based on some arbitrary, wet finger in the air guestimate (the gauge supplier's answer?) - we read about them here all the time!

An effective cal system takes that data and trends it, keeping in mind use, to determine recall, while still within spec. Real world...Trouble is, most people don't know/want to get into that (it's resource consuming) and external suppliers of cal services don't go that far with their services...

If I was running a shop, I'd be all over an operator being paid to wander around trying to find out if a $50 gauge was calibrated - when I pay someone to know how to calibrate/control it! Double whammy!:mg:

If the company has a system that is able to determine calibration intervals based on usage, not on time (although I've heard of them in theory, I've never seen one) then my comments may not apply.

But I wonder how it would be tracked. If it is by the user maintaining a log, then the user still would be the first to know when the usage limit is nearing or hit.

 

[Jim Wynne]

Re: Identification for 7.6

I can see that I'm standing against two giants in the group, but I still feel that it should be the responsibility of the user to check the status before using a tool. I completely agree that it is the primary duty of management to recall them and get them calibrated, but a back stop is needed for those that may fall through the cracks.

Very frequently on audits I find expired tools that management missed. Sometimes they were missed because they could not find it, and it was recorded as missing.

In a perfect world, that would never happen, but we do not live in a perfect world. A backstop is need for those that fall through the cracks. Saying that no one ever looks is a training issue and a cop-out. They should look.

A label that says that the calibration date for a device has passed doesn't mean that the device isn't accurate. Calibration status should have little to do with labels and a lot to do with what's being measured. If a situation occurs where measurements are falling close enough to specification limits that gage error is likely to cause a problem, the device should be verified (e.g., calibrated against a standard) before decisions are made. Likewise, when measuring things with tight tolerances, devices should be verified, regardless of what a sticker might indicate.

I think due-date labels are more likely to create a false sense of security than they are to help anyone to make accurate measurements.

 

[AndyN]

Re: Identification for 7.6

A label that says that the calibration date for a device has passed doesn't mean that the device isn't accurate. Calibration status should have little to do with labels and a lot to do with what's being measured. If a situation occurs where measurements are falling close enough to specification limits that gage error is likely to cause a problem, the device should be verified (e.g., calibrated against a standard) before decisions are made. Likewise, when measuring things with tight tolerances, devices should be verified, regardless of what a sticker might indicate.

I think due-date labels are more likely to create a false sense of security than they are to help anyone to make accurate measurements.

Excellent point, Jim W! I had had the same thought, but forgot to mention the point about accuracy after the specified date, in my last post.

It's always been a bone of contention for me that auditors would write up an nc; "Gauges X, Y and Z were not recalled after the date". They can be perfectly accurate the day after, and possibly for months later, under normal usage. But the auditor didn't probe into the calibration data/trends to see what the risk is! So, a wild goose chase ensues, equipment purged only to discover the 'as found' conditions indicate it is still accurate for use! Value of audit finding? 20% of what it SHOULD be...

Big, Jim - it's a sad indictment of calibration system that such a comment is true - rarely are recalls etc based on use, so they tend to be the default of a very basic calendar which is fairly arbitrarily selected, what's more.

 

[Big Jim]

Re: Identification for 7.6

Excellent point, Jim W! I had had the same thought, but forgot to mention the point about accuracy after the specified date, in my last post.

It's always been a bone of contention for me that auditors would write up an nc; "Gauges X, Y and Z were not recalled after the date". They can be perfectly accurate the day after, and possibly for months later, under normal usage. But the auditor didn't probe into the calibration data/trends to see what the risk is! So, a wild goose chase ensues, equipment purged only to discover the 'as found' conditions indicate it is still accurate for use! Value of audit finding? 20% of what it SHOULD be...

Big, Jim - it's a sad indictment of calibration system that such a comment is true - rarely are recalls etc based on use, so they tend to be the default of a very basic calendar which is fairly arbitrarily selected, what's more.

Both of you are forgetting the requirements of the standard. Don't ding your auditor for doing what he should.

7.6 a speaks specifically to what you both are ignoring.

"Where necessary to ensure valid results, measuring equipment shall . . . be calibrated or verified, or both, AT SPECIFIED INTERVALS . . . "

Emphasis added.

If the specified interval is time with a defined due date, IT DOESN'T MATTER IF THE TOOL IS STILL ACCURATE. If it is still accurate then you can avoid grief over the paragraph after the letters in 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. The organization shall take appropriate action on the equipment and any product affected."

Maybe you guys are using a different standard.

 

[AndyN]

Re: Clause 7.6 - "Shall have Identification in order to determine its calibration sta

No Jim, not ignoring, not using a different standard - just looking at it from another perspective, not the conventional 'wisdom'...

 

[Big Jim]

Re: Clause 7.6 - "Shall have Identification in order to determine its calibration sta

No Jim, not ignoring, not using a different standard - just looking at it from another perspective, not the conventional 'wisdom'...

Ya Sure.

 

[Jim Wynne]

Re: Identification for 7.6

Both of you are forgetting the requirements of the standard. Don't ding your auditor for doing what he should.

7.6 a speaks specifically to what you both are ignoring.

"Where necessary to ensure valid results, measuring equipment shall . . . be calibrated or verified, or both, AT SPECIFIED INTERVALS . . . "

Emphasis added.

If the specified interval is time with a defined due date, IT DOESN'T MATTER IF THE TOOL IS STILL ACCURATE. If it is still accurate then you can avoid grief over the paragraph after the letters in 7.6. I don't know who "both of you" refers to; I didn't say anything about specified intervals not being required.

"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. The organization shall take appropriate action on the equipment and any product affected."

Maybe you guys are using a different standard.

I don't know who "both of you" and "you guys" refers to. I haven't ignored anything and haven't said anything about "specified intervals" not being required. It has nothing to do with the subject at hand, which is whether labels are required. They're not required, and the argument can and has been made that labels might not even be useful or prudent. If one does find them useful, they should be used, but I think they're used mainly because people think they have to use them.

 

[AndyN]

Re: Identification for 7.6

I don't know who "both of you" and "you guys" refers to.

I think Big Jim is referring to us, JW...

 

[AndyN]

Re: Clause 7.6 - "Shall have Identification in order to determine its calibration sta

Ya Sure.

So by implication, then, you have the only correct interpretation and the position Jim W and I take is, therefore, incorrect? Is that what you mean, Big Jim?