Lets say that we had an ISO 9000 audit and there were gages found on the shop floor that exceeded their calibration date (overdue). What is the severity of this finding?:notme:

Lets say that we had an ISO 9000 audit and there were gages found on the shop floor that exceeded their calibration date (overdue). What is the severity of this finding?:notme:

That depends on:

The impact on the process
The number of gages.
The days overdue
Isolated or systemic event

Stijloor.

Since there were mutiple instances of this is should be classifed as a major finding. Not withstanding that the calibration system is a key element that ensures that part conformance to design requirements is ensured.
:2cents:

Uh... Stijloor gave you the proper, excellent answer.

My opinion? It will not go well. To me, it shows that the management does not care about the calibration process program.:tg:

Minimally, you need to get those past due instruments quarantined. Of course the best is to get a competent lab in there and get them calibrated.

Lets say that we had an ISO 9000 audit and there were gages found on the shop floor that exceeded their calibration date (overdue). What is the severity of this finding?:notme:

Clearly, there's an issue here. In addition to the other posters points, it could be that you've shot yourself in the foot by having too frequent or aggressive a schedule for these gauges. If the auditor had asked to look at your past data, it could be shown that the results show the gauges to be robust and negligible effects between recall periods.

Without some kind of test of this side of the story, grading an NC is meaningless, indeed the whole NC is meaningless...........

To me, it shows that the management does not care about the calibration process program.Come on, Brad. There is no shred of evidence in this thread to support that assertion. Management bashing is too easy. But for the sake of the OP, I think we should stick to the issues at hand.

One thing that is a Major.
1. How many gages.
2. what lines or on the same product line.
3. Was customers notified of this.
4. Qty of product shipped sense experation date.
5. Was product recalled and 100% checked for compliance.
6. Legalities from customer and possible shut at customer.
7. Warranty Issues, etc.


As I would say youre up the creek with out a paddle.

Do not forget that if the gauges labels show out of date conditions and were not identifed by the opperators using them it is an additional problem beyond being out of date.

Why did the recall system not identify the out of date condition? Or if it did what went wrong in the notification/recall process?

A typical question I ask when auditing is to have the calibration folks run the ageing list and show what is done to address the gauges that are identifed as past due.
:2cents:

Wow - I've never read these kind of "Chicken Little" style responses to a simple question. Why does everyone think things are so bad?

I really think everyone's missing the point - as do many auditors when they find such situations. Overdue recall is a symptom and simply writing this up isn't helpful to management.

I've used the oil change analogy before to demonstrate you need more information. Just changing your oil every 6 months wouldn't work for most of us, because there may be very good reasons why - we didn't use the car, we only drove a few miles etc. etc. Similarly, going a day or so past the due date is unlikely to be a big deal in most cases..............

We don't have any data and, as such, all the hypotheses about major and minor etc are just that - hypotheses. Management don't generally care to get excited without data - because they don't know how to react to the size, extent and significance of the issuse. Until that's all present in this post I'd go on with business as usual.......

Wow - I've never read these kind of "Chicken Little" style responses to a simple question. Why does everyone think things are so bad?

I really think everyone's missing the point - as do many auditors when they find such situations. Overdue recall is a symptom and simply writing this up isn't helpful to management.

I've used the oil change analogy before to demonstrate you need more information. Just changing your oil every 6 months wouldn't work for most of us, because there may be very good reasons why - we didn't use the car, we only drove a few miles etc. etc. Similarly, going a day or so past the due date is unlikely to be a big deal in most cases..............

We don't have any data and, as such, all the hypotheses about major and minor etc are just that - hypotheses. Management don't generally care to get excited without data - because they don't know how to react to the size, extent and significance of the issuse. Until that's all present in this post I'd go on with business as usual.......


way to state it Andy!

multiple gages. how many? what % of the entire gage system is this? were they being used while expired? Were they out of calibration? (not just expired but bad...) Has this ever happened before?

lets' start there and get some data before we shut the guy down...

way to state it Andy!

multiple gages. how many? what % of the entire gage system is this? were they being used while expired? Were they out of calibration? (not just expired but bad...) Has this ever happened before?

lets' start there and get some data before we shut the guy down...

I believe that I made that clear in my post.

I believe that I made that clear in my post.

you did. those following you issued a major...

Here the original quote:

Lets say that we had an ISO 9000 audit and there were gages found on the shop floor that exceeded their calibration date (overdue). What is the severity of this finding?:notme:

Come on, Brad. There is no shred of evidence in this thread to support that assertion. Management bashing is too easy. But for the sake of the OP, I think we should stick to the issues at hand.

Well, while I might have been a bit stringent, I can't muster the opinion that there is no shred of evidence of management disregard. There is no reason why there needs to be multiple past due gauges sitting out on the shop floor. If the time period is too short, change it. Whatever.

So... when management does a walk-through, is past due equipment something to be noticed? Do they not review whatever past-due tracking system they have? Do they not make any preparation for an audit?

NOTE: I did not classify in any way; I don't have enough evidence. I simply stated than I can't imagine the outcome being good.

Wow - I've never read these kind of "Chicken Little" style responses to a simple question. Why does everyone think things are so bad?

I really think everyone's missing the point - as do many auditors when they find such situations. Overdue recall is a symptom and simply writing this up isn't helpful to management.

I've used the oil change analogy before to demonstrate you need more information. Just changing your oil every 6 months wouldn't work for most of us, because there may be very good reasons why - we didn't use the car, we only drove a few miles etc. etc. Similarly, going a day or so past the due date is unlikely to be a big deal in most cases..............

We don't have any data and, as such, all the hypotheses about major and minor etc are just that - hypotheses. Management don't generally care to get excited without data - because they don't know how to react to the size, extent and significance of the issuse. Until that's all present in this post I'd go on with business as usual.......

Very well stated, Andy. Another way to view this: the OP asks a question if this is an issue. My answer is: Yes. If they have procedural methods to utilize past due equipment, then my answer becomes a maybe.

It is a bit juvenile (in my opinion) to assume everyone audits like you guys. I've been through their work; they're not worthy to pour your coffee.:yes: However, they exist and are doing audits, and calibration/ past due instruments are such low-lying fruit. Whether their findings are "valid" are not, they still become something to be reckoned with.

I can't muster the opinion that there is no shred of evidence of management disregard. There is no reason why there needs to be multiple past due gauges sitting out on the shop floor. If the time period is too short, change it. Whatever.

So... when management does a walk-through, is past due equipment something to be noticed? Do they not review whatever past-due tracking system they have? Do they not make any preparation for an audit?If you follow that logic, ANY non-conformity in the system, no matter how small, should be followed by a conclusion that management does not care. Management is not omnipresent. A system exists so management does not have to do everything.

In addition to what Stijlor and Andy mentioned on this specific subject, two more items I would consider, before reaching a conclusion about the severity of the finding are:

the criticality of the product in question. I.e, are we dealing with nuclear, aerospace, medical or other highly critical product? Or just non-critical commercial items. This information has an impact on the risk assessment of the situation.
Is this a recurring issue? Chronic, recurring problems could be escalated to major findings, in order to grab's the organization's attention to the need of effective root cause analysis and true corrective action.

I agree with your sentiments, Brad. I guess after over 16 years of dealing with this kind of situation, I'd (foolishly) expected a different result from auditors. I suppose it just goes to prove my conviction that auditor training hasn't improved in that time frame.

Auditors techniques aside, it seems that this calibration system was poorly designed in the first place. I rarely worry about how much the operators understand about recall and labelling. Their job is principally to use what they've got, in the same way as anything else - tooling, work instructions etc. I wouldn't want my production workers to be wandering around asking about document control, calibration periods etc. What has to be put in place is a well designed, and therefore implementable, process. Once established the owners/implementors of the system should be using the data to drive adjustment of recalls etc. The idea of auditors not interogating the symptom in depth to reveal what the real problem is, is just layering problems.

One thing that is a Major.
1. How many gages.
2. what lines or on the same product line.
3. Was customers notified of this.
4. Qty of product shipped sense experation date.
5. Was product recalled and 100% checked for compliance.
6. Legalities from customer and possible shut at customer.
7. Warranty Issues, etc.


As I would say youre up the creek with out a paddle.

Before you address 1-7 you might need to check. Is the gage bad?

The question was: "Lets say that we had an ISO 9000 audit and there were gages found on the shop floor that exceeded their calibration date (overdue). What is the severity of this finding?"

I agree that it is a Major finding, but going off half cocked on what might be a perfectly fine gage is a little premature. You need to access whether there is damage before going into damage control.

Briz

What criteria are you using for your scale? How are you defining a major? What classification categories do you have? A major according to my procedures may be minor in yours.

I agree that this situation is something that needs to be looked at in greater depth. What is the rest of the story? Hopefully I won't bore anyone to death, but let me share an example...

At a previous employer, we had more than 1500 pieces of M&TE. Each month work orders were sent to each functional area (~ 10 departments) notifying them to collect gages for calibration. One month in particular, 2 pieces came up missing. An exhaustive search by the department resulted in a lost (stolen) gage. The issue was documented and the gage inactivated in the recall system. Management agreeded that this was the appropriate method for handling the situation as we could not shut down production until the missing gage was located.

Several months later, the gages turned up (during an audit). They were not being actively used, but they were found in the dark deep recesses of a storage shelf.

Would this be a major non-conformance? I think not. Does this show poor commitment by management? I also think not. The original post does not provide insight to the surrounding situation. As auditors, one must consider all of the data before jumping to conclusions.

:2cents:

This is a great thread because it illustrates an important point about auditing. Always make sure you have enough information before making a judgment.

The hardest part of training auditors is teaching them to withhold judgment until they know enough about the situation, IMO.

That depends on:

The impact on the process
The number of gages.
The days overdue
Isolated or systemic eventStijloor.

I would give the same list, Stijloor, but add one item.

An overdue gage is not necessarily giving incorrect readings. If the readings are accurate, it might still be a minor. If the readings were inaccurate, and bad product got shipped, it probably meets the automatic definition of a major.

I would give the same list, Stijloor, but add one item.

An overdue gage is not necessarily giving incorrect readings. If the readings are accurate, it might still be a minor. If the readings were inaccurate, and bad product got shipped, it probably meets the automatic definition of a major.

I agree.. however, if at the time of auditing, how are you supposed to know if the readings are accurate/inaccurate? You probably won't, and neither do the process owners.

There are an infinite amount of auditing scenarios that can play out from this one situation. And each of you with your experience/ background may come up with thoroughly.

The thread title has been changed. The original question is:

Lets say that we had an ISO 9000 audit and there were gages found on the shop floor that exceeded their calibration date (overdue). What is the severity of this finding?:notme:

And I still say-it's not a good thing. :tg:

I agree.. however, if at the time of auditing, how are you supposed to know if the readings are accurate/inaccurate? You probably won't, and neither do the process owners.

There are an infinite amount of auditing scenarios that can play out from this one situation. And each of you with your experience/ background may come up with thoroughly.

The thread title has been changed. The original question is:



And I still say-it's not a good thing. :tg:


No, of course it is not a good thing. It would definitely be a finding, the severity of which would determine the level of NC.

To your question, in most cases, my clients would immediately cross check/verify these gages to determine if the readings were accurate, or if nonconforming product was shipped. That is an automatic requirement in these situations.

I agree.. however, if at the time of auditing, how are you supposed to know if the readings are accurate/inaccurate? You probably won't, and neither do the process owners.

There are an infinite amount of auditing scenarios that can play out from this one situation. And each of you with your experience/ background may come up with thoroughly.


Brad! What a great point - and IMHO one of those which goes to illustrate what I believe is fundamentally important to establish:- Why were the auditors auditing when they found this?

Now, for an external auditor, it was a 'gotcha' finding and you're correct in saying that there's little or no time to evaluate the condition of the gauges. Write an NC and let the client get on with determining the reason.

But what about the internal auditor? - they should pursue the situation. However, I don't believe such a gross finding would have been s'tumbled' over. In any system, it's likely to have been on management's plate in one form or another - one mgr would have made an issue of insufficient resources, another would have complained about the cal. lab folks not getting to process the gauges etc. etc. These all become triggers for going and doing an internal audit and, therefore, following up on the reason for the symptom.

Only when internal audits a) are scheduled based on including the hot buttons of the day (aka 'status and importance') and b) stop reporting simple symptoms - will internal audit programs - and the people involved with them - ever be taken seriously!

To your question, in most cases, my clients would immediately cross check/verify these gages to determine if the readings were accurate, or if nonconforming product was shipped. That is an automatic requirement in these situations.

As always, I learn so much from you folks. Thank you. :yes:Now the above is a point of interest. Are you suggesting that most/some/none/all auditors would see the calibration of gauges while they wait? Most auditors I have been in contact with, write-it up and move one.

Again, no disagreement or negativity implied.:yes: I am truly wanting to learn.

As always, I learn so much from you folks. Thank you. :yes:Now the above is a point of interest. Are you suggesting that most/some/none/all auditors would see the calibration of gauges while they wait? Most auditors I have been in contact with, write-it up and move one.

Again, no disagreement or negativity implied.:yes: I am truly wanting to learn.

Usually, I will identify that we have an issue. Someone will confiscate the gage, take it to the lab, and have a qualified person verify it. In the meantime, I usually move on, in the interest of time. Sometime in the next hour or so, they will let me know what the results are. No later than the end of the day. Sometimes, if I have my dounbts as to someone's integrity, or if we happen to find it in the lab, I may stay and watch the verification. Most of my clients stay on this stuff, and this is not a frequent situation anymore.

Note: I still write the finding, regardless, this just helps determine the level of significance.


PS: And, Andy, this is not a "gotcha!" for us...sheesh. Just when ya think you're starting to know somebody...:D It's jus' doin' my job, mate...

Lets not overcomplicate things here. I wanted what I thought was a fairly simple answer to a simple question. We have a number of overdue gages that I have noticed on the shop floor as being overdue for calibration. If we were to be audited by and ISO auditor -for lets say recertification, I was wondering what the severity of the finding would be if he happened to during his factory walk, randomly pick up a gage and find that the calibration sticker indicated that the gage was overdue. That's all- nothing more. If he decided to make it a "finding", would this be considered a minor-major or something other?? Thanks- jdyaker:biglaugh:

Lets not overcomplicate things here. I wanted what I thought was a fairly simple answer to a simple question. We have a number of overdue gages that I have noticed on the shop floor as being overdue for calibration. If we were to be audited by and ISO auditor -for lets say recertification, I was wondering what the severity of the finding would be if he happened to during his factory walk, randomly pick up a gage and find that the calibration sticker indicated that the gage was overdue. That's all- nothing more. If he decided to make it a "finding", would this be considered a minor-major or something other?? Thanks- jdyaker:biglaugh:


Unless you are willing/able to provide us with more specifics regarding this nonconformity, none of us will be able to rate it either as a minor or major nonconformity.

Now, having said this, to me it does not matter if I have a small leak or big hole in my tire; I am going to fix the darn thing...:D

Stijloor.

Lets not overcomplicate things here. I wanted what I thought was a fairly simple answer to a simple question. We have a number of overdue gages that I have noticed on the shop floor as being overdue for calibration. If we were to be audited by and ISO auditor -for lets say recertification, I was wondering what the severity of the finding would be if he happened to during his factory walk, randomly pick up a gage and find that the calibration sticker indicated that the gage was overdue. That's all- nothing more. If he decided to make it a "finding", would this be considered a minor-major or something other?? Thanks- jdyaker:biglaugh:

Oh! you wanted a simple answer..............:lol::lmao:

Firstly, thanks for posting this question to give us the chance to show that even a relatively simple issue found by an auditor could end up as either a minor or a major. So the simple answer is - either! It really is dependant on the skills and knowledge of the auditor and perhaps the policies of the CB.

But realistically, what has played out in this thread is what should be demonstrated, in part, by auditors who want to report more than a symptom.

These are the specifics to my fictional scenario:
[LIST]
We have some overdue gages on the shop floor
[LIST]
An auditor picked up a gage and noticed it was past due to the stickers due date
How severe of a situation is it?

These are the specifics to my fictional scenario:
[LIST]
We have some overdue gages on the shop floor
[LIST]
An auditor picked up a gage and noticed it was past due to the stickers due date
How severe of a situation is it?

Impossible to answer.

"Some overdue gages." Two or ten?
"Auditor picked up a gage." Type and impact of gage?

See post #2.

Stijloor.

If it's the only gauge used to verify outgoing product quality - potentially you're in big do-do. As previously stated, it depends on the robustness of the gauge, from historical data, how much over due it is, when it was used last etc, etc. Unfortunately, you've not provided that detail.

If it's one of hundreds or thousands, it's only a day or to overdue and (for example) it's a solid gauge with negligible wear characteristics (i.e it's robust) and the auditor has an appreciation for this kind of thing - it might get a 'RE' rating (Raised Eyebrow):lol:

Lets not overcomplicate things here. I wanted what I thought was a fairly simple answer to a simple question. We have a number of overdue gages that I have noticed on the shop floor as being overdue for calibration. If we were to be audited by and ISO auditor -for lets say recertification, I was wondering what the severity of the finding would be if he happened to during his factory walk, randomly pick up a gage and find that the calibration sticker indicated that the gage was overdue. That's all- nothing more. If he decided to make it a "finding", would this be considered a minor-major or something other?? Thanks- jdyaker:biglaugh:

I would not say it's complicated, but it's not a simple answer. If you will take a gander at your thread, most every single post is relevant to your initial query. Most of the posters have had quality posts. Many posting here are auditors, doing the audits. They are letting you know-it depends on several factors.:)

Auditing is not a perfected Science; a black box that you input, and get outputs. Good auditors are smart, well-trained, and use that brain in between their shoulders. But they need to know many, many factors to make a sound decision.

...
But realistically, what has played out in this thread is what should be demonstrated, in part, by auditors who want to report more than a symptom.

Actually, this has been a great thread, with several good gems in it. At some point in the future, I would enjoy extending the conversation Sidney and I had on management commitment/ responsibility/ etc., and the amount/quantity/quality etc. of findings.

These are the specifics to my fictional scenario:
[list]
We have some overdue gages on the shop floor
[list]
An auditor picked up a gage and noticed it was past due to the stickers due date
How severe of a situation is it?

...a generic answer to a generic question - with no guarantees...

Mostly, this situation results in a minor, unless there are too many, or there was a risk of NC product being shipped...

...a generic answer to a generic question - with no guarantees...

Mostly, this situation results in a minor, unless there are too many, or there was a risk of NC product being shipped...

Helmut and my Fellow Covers,

The OP is very persistent in trying to obtain a definite answer from us.
Maybe the OP is trying to address an internal issue.....or to make a point perhaps?

I believe that all of us provided decent responses. :agree1:

No need to continue this thing (beating a dead horse) unless we get some more specifics.

What you y'all think? ;)

Stijloor.

The OP is very persistent in trying to obtain a definite answer from us.
Maybe the OP is trying to address an internal issue.....or to make a point perhaps? Or his organization has been written up by an external auditor, as a major NC, and he is trying to gather "support" to have this classified as a minor. I believe that all of us provided decent responses.Not really. Some rushed to judgment. No need to continue this thing (beating a dead horse) unless we get some more specifics. Agreed. What you y'all think?If the OP insists on a categorization, with no further contextual information, dismissing all of the good thoughts contained herein, he should accept whatever categorization he was given by the auditor and carry on.

Or his organization has been written up by an external auditor, as a major NC, and he is trying to gather "support" to have this classified as a minor.

Sidney,

I don't think so because the OP stated: (highlight in red is mine)

These are the specifics to my fictional scenario:

We have some overdue gages on the shop floor
An auditor picked up a gage and noticed it was past due to the stickers due date

How severe of a situation is it?

Stijloor.

I would give the same list, Stijloor, but add one item.

An overdue gage is not necessarily giving incorrect readings. If the readings are accurate, it might still be a minor. If the readings were inaccurate, and bad product got shipped, it probably meets the automatic definition of a major.

this my have already been posted - I am just catching up to this thread - but I would also add: are the gages in question used for FINAL acceptance of Product? often companies opt to calibrate everything to avoid having to justify not calibrating reference gages...

Helmut and my Fellow Covers,

The OP is very persistent in trying to obtain a definite answer from us.
Maybe the OP is trying to address an internal issue.....or to make a point perhaps?

I believe that all of us provided decent responses. :agree1:

No need to continue this thing (beating a dead horse) unless we get some more specifics.

What you y'all think? ;)

Stijloor.

I agree - the OP needs to read the responses we've given. reminds me of the thread on raising a NC for effectiveness. I really don't know waht the OP is looking for anymore.

I agree - the OP needs to read the responses we've given. reminds me of the thread on raising a NC for effectiveness. I really don't know waht the OP is looking for anymore.

Hallelujah! :applause:

Stijloor.

This thread is not only great,but is haute.We have recieved the most professional advice from the real experts,and if one reads through the posts with concentration,he may gain more insight into auditing.

IMO,the OP is just looking for a simple answer,may be to second his already formed opinion,else he would have given 'specifics' as asked for by the experts;to help him out.

Just my:2cents:

As Einstein said: things should be made as simple as possible but no simpler.

as a generic summary to the question of the level of a finding of gages that are beyond their calibration period: It depends on the exact circumstances of the event and the state of mind & skill level of the auditor who makes the finding. It may range from an OFI to a Major to a revocation of registration.

But of more importance is that the question itself is irrelevant to the OP if they truly care about their QMS. It is a great question for those who audit and a useful question for those who need to write procedures and reaction plans concernign calibration. But taking the OP literally (including his choice of smilie) the real answer is: you know something is wrong; fix it! the severity of the finding has - or should have - no bearing on whether or not he fixes the immediate problem and the system that put him in that place. If the severity of the finding actually matters in whether or nto action is taken the OP has a far larger problem than the severity of the finding.

Of course, the answers given do provide useful context for immediate and long term corective actions to the discovery, but they did not answer his question as to teh severity of the finding...