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

[somashekar]

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

It could turn out to be both and more ..
Standard is so general in its saying that any method of identification could work for the organization managing a calibration system. This also has got to do in the maturity and knowledge level of the user of the instrument. With nothing done, the unique Sl. # of the instrument can be the identification of its calibration status, if this Sl. # is captured into the calibration system.
There are situations where some model of instruments do not have Sl. # and you could be using many of them. There could be situations where the instrument is so mounted that it is not easy to access and see the Sl. # of the instruments perhaps on its rear panel. These are situations when the organization plan to identify by some numbering method (label / sticker) and across the board apply to all instruments. We had an other thread about POST-IT note being used to mark identification.
So coming back to the OP's point, he is OK in using his expensive s/w package and its issued label for identification.

 

[howste]

Re: Identification for 7.6

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...

I'm going to have to disagree with you on this one. If the organization specified the calibration/verification intervals based on risk then there's a good reason to write a nonconformity if the gages aren't recalled by their due date. It's exceeded the organization's own risk criteria. The organization determined that to go beyond that date was a risk they were unwilling to accept.

Now if the organization specified the intervals based on nonsensical reasons, then it's not the auditor's fault that there's no value in the finding. You suggest that the auditor's job is to identify the risks to the organization. I say that it's the organization's responsibility to identify their risks. If there's no value, the responsibility rests squarely on the organization.

 

[somashekar]

Re: Identification for 7.6

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...

Perhaps audit purpose gets diverted to analysis, investigation and advisory...leading to consultancy.

 

[harry]

Re: Identification for 7.6

............... The question you should want to find out is, what's best for the employees and your system? I personally prefer to have something to reference on the equipment itself, such as a label, so that I know it's in cycle before I use it. Not everyone has that preference though.

I thought howste sums it up very nicely in this post with regards to 'label' - it is individual preference. Not having one doesn't improve the situation of having one.

What should had been mentioned (and for the benefit of those who are new) is that the calibration process had to be actively managed just like any other processes. You start from the risk angle. The people who calibrate your equipments often do not know how you use it. They just affix a date of calibration and a date for next calibration - commonly and arbitrarily fixed as 1 year. The person who managed the calibration program should assess whether this 1 year period is acceptable from the risk angle. If not, they should fix a date/period and monitor it by some means. At other times, you may find that you can extend this 1 year period - for which you will need all the justification and then document monitor and recall the equipment when the date is due.

The same applies to situations where you choose not to affix a sticker - the argument of whether an affixed sticker causes confusion is ongoing. My is that in an industrially less matured country like my, having a sticker is more common.

 

[Big Jim]

Re: Identification for 7.6

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.

I apologize Jim. I made a bad assumption that the two of you were standing together.

I agree that there are other ways to meet the requirement for 7.6c other than using labels. It is up to the organization involved to determine what is effective for them.

I like the idea of using stickers or tags, and if it isn't practical to apply a sticker or tag on the instrument itself, to apply it to the storage container and keep the container in close proximity. I like it, because it can be an easy way to provide a back stop for watching for expiration. I also believe it makes it easier for management to keep track of them too.

 

[Big Jim]

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

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?

I don't know what it means for you. Only you can tell. Maybe it means you have forgotten to read the requirement. No interpretation needed. It is very clear.

 

[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:

Where's the "double whammy?

How is a user "running around trying to find out if a $50 gauge was calibrated" if all he needs to do is look at the sticker when he uses the tool.

If you wanted the user to be the back stop and there were no stickers, then, yes, he could be wandering around, but that was not my suggestion was it?

 

[Mr.Happy]

Re: Identification for 7.6

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.

How do you explain that you can find "missed equipment" when they are with a sticker? That means that the users do not look at all to the expired date on it!
Me myself choose to not sticker any measuring equipment except maybe those that are calibrated on location by a external lab e.a. CMM.
Try to sticker an M2 Gage
Our calibration due times are central controlled by our self made Excel file and except from the Excel program from MS it is far from expensive
Cheers
Mr.Happy

 

[Big Jim]

Re: Identification for 7.6

How do you explain that you can find "missed equipment" when they are with a sticker? That means that the users do not look at all to the expired date on it!
Me myself choose to not sticker any measuring equipment except maybe those that are calibrated on location by a external lab e.a. CMM.
Try to sticker an M2 Gage
Our calibration due times are central controlled by our self made Excel file and except from the Excel program from MS it is far from expensive
Cheers
Mr.Happy

Management could not find it and users provided no insight as to where it was so management figured that the tool had grown legs. As an auditor, I found it in use with an expired sticker. The records also showed that the calibration update had not been performed.

It's not up the the auditor to determine why it was missed. Auditors write nonconformances based on what they find. It's up to the organization to figure out what happened and apply a cure. The nonconformance response on one of those occasions found that an employee had taken the tool home so it was missing when it was due for recall and didn't tell anyone when it was returned to use.

I'm sure there are other things that happen to cause the same situation, such as the tool being put away where it isn't expected, such as leaving with a bin of tooling for a particular project.

Your system sounds appropriate.

 

[BradM]

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

Wow! This popped up to be an interesting discussion.

I guess for me I have seen and heard the calibration sticker debate, and see merit on both sides and such. I guess overall I find it easier to have the calibration stickers with:

• ID number
• Calibration date
• Due Date
• Name doing the calibration
• Use range/limits/ etc.

Now... some questions come to mind about the overall process, including

• Size of instrument program
• Accessibility of information in calibration program
• Overall training of individuals
• Level of management concern in the instrument program
• General control of the instruments (are they "hid"; do they end up in drawers; etc.)

It really doesn't matter what system you develop, if people are too lazy or don't care enough to assess the current status, nothing will fix that. Too, if your calibration status database/program takes a while to access, requires special passwords, not basic in its operation, etc., the chances of people checking it are slim.

Overall... I have found that calibration stickers work out best, as it gives an 'in the field' assessment of a piece of equipment. The odds of getting people to "assess" the equipment they are using is a bit slim anyway. But tends to be slightly better if there is an indicator on the instrument.