Severity of Finding for "Past Due Gage" found on the shop floor

[jdyaker]

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?

 

[Stijloor]

Re: Finding for out of calibration gage

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?

That depends on:

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

Stijloor.

 

[andygr]

Re: Finding for out of calibration gage

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.

 

[BradM]

Re: Finding for out of calibration gage

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.

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.

 

[AndyN]

Re: Finding for out of calibration gage

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?

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...........

 

[Sidney Vianna]

Re: Finding for out of calibration gage

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.

 

[world quality]

Re: Finding for out of calibration gage

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.

 

[andygr]

Re: Finding for out of calibration gage

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.

 

[AndyN]

Re: Finding for out of calibration gage

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.......

 

[Bev D]

Re: Finding for out of calibration gage

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...