Here is the scenario, crimping machine is found to over crimp caps on a pressure vessel. New parts are necessary to remedy the problem, but there is a 6 – 8 week lead time on delivery. The applications engineer determines that the product quality is not compromised and approves continued use of crimper until parts are delivered. What are the proper steps to take to ensure calibrations and approve usage of machine by operators when the calibration sticker shows the device out of date?
I would love to hear some expert’s comments on this

Digitalfemale,

1. you are talking about changing caps Lt 6-8wks, then you jump to
operator noting out of calibration for crimper. Is this correct.

2. First thwere has to be a deviation approved by there customer for a certain period of time.

3. If which I have done before in hose cripping, is to get a certified load cell
with ring and do a 10-20 piece study and all with tolerance this can be added to the deviation to allow shipment to customer, that is if customer has signed off on it.

Here is the scenario, crimping machine is found to over crimp caps on a pressure vessel. New parts are necessary to remedy the problem, but there is a 6 – 8 week lead time on delivery. The applications engineer determines that the product quality is not compromised and approves continued use of crimper until parts are delivered. What are the proper steps to take to ensure calibrations and approve usage of machine by operators when the calibration sticker shows the device out of date?
I would love to hear some expert’s comments on this

A few questions:

Is your company the OEM for the pressure vessel, or are you supplying it to another company?
If the "defect" is such that "product quality is not compromised," why is it a problem?
Do you mean that new parts are need for the crimper? Is the crimper broken, or just out of calibration?
You seem to have a process in place to deal with things like this--the applications engineer makes the call--but is it documented? Is authority for this sort of thing defined in writing?

Good questions raised. In particular, Jim's question was the first that came to mind. What is really important here, IMO, is to find out what procedures you have to continue. Do you have specific provisions that allow using an instrument beyond calibration?

Do you really procedurally have the ability for the engineer to override two checks (crimp specification and instrument past calibration date)? That's fine if you do, but seems a little out of the ordinary. Most times, QA signs/approves such moves.

Anyway, like the others, just trying to pull a little more information from you.:)

Here is the scenario, crimping machine is found to over crimp caps on a pressure vessel. New parts are necessary to remedy the problem, but there is a 6 – 8 week lead time on delivery. The applications engineer determines that the product quality is not compromised and approves continued use of crimper until parts are delivered. What are the proper steps to take to ensure calibrations and approve usage of machine by operators when the calibration sticker shows the device out of date?
I would love to hear some expert’s comments on this

Here is more information, and Thanks for your input.
We are the supplier OEM of the pressure vessel.
The defect is not compromising the quality of the product, but the applications engineering approves the deviation only until the replacement die set is installed.
The crimper is out of calibration.
And for dcumentation, it was done verbally and not documented.
Additionally we are not AS9100 certified, but are in the process of getting there.
One things that happened here is that it shows we certainly have a deficency in our system.

If the crimper is continued to be used, what steps should be taken to show the operator that it is okay to use the machine until fixed?

1. You have a real problem.

2. No written deviation to customer and or from customer, you are subject to recall of all product and replace plus any monotary value that will be place on you company, from your customer.

There is no way I would let anything out of that plant unless the owner or plant manager agreed to sign off in writing.

He does not have authority to do so and if the Quality Manager lets him get by with it, then let the chips fall.

Like I said before there is ways of certifing the crimper until new caps and
you can get your crimper re calibrated.

Good Luck

Are you really using the correct terminology? Is the crimper 'calibrated'? Since it's a production machine, is there some kind of gauge or measuring device which indicates a process performance measurement that needs calibrating? If so, calibration is the right word.

However, if you are simply using the word to describe that the crimper is working properly, - capably - then it's best not to use 'calibration' terminology, since many readers here will associate it with a measuring device and the effects can be far reaching........

Can you clarify for us?

Are you really using the correct terminology? Is the crimper 'calibrated'? Since it's a production machine, is there some kind of gauge or measuring device which indicates a process performance measurement that needs calibrating? If so, calibration is the right word.

However, if you are simply using the word to describe that the crimper is working properly, - capably - then it's best not to use 'calibration' terminology, since many readers here will associate it with a measuring device and the effects can be far reaching........

Can you clarify for us?

Nice point, Andy:yes:

DigitalFemale, forgive us if we seem to be asking more questions than answers. But, as Andy and World Quality have alluded to, this appears on the surface to be concerning. It's important to understand if this is a "calibrated" device or not.

Here is more information, and Thanks for your input.
We are the supplier OEM of the pressure vessel.
The defect is not compromising the quality of the product, but the applications engineering approves the deviation only until the replacement die set is installed.
The crimper is out of calibration.
And for dcumentation, it was done verbally and not documented.
Additionally we are not AS9100 certified, but are in the process of getting there.
One things that happened here is that it shows we certainly have a deficency in our system.

If the crimper is continued to be used, what steps should be taken to show the operator that it is okay to use the machine until fixed?

There is a difference between a gage being beyond calibration date, and a machine that is "Over-crimping" something. Over-crimping sounds like a failure to meet requirements. Thus, there has to be a valid basis or reason for why the decision is made to continue. When in doubt, the customer has to be consulted and brought into the decision.

I will clarify the information I am given is not based on your situation but what I do if an item needs calibration extended. Not having all the details or your process I cannot give you a direct answer to your problem just what I do.

1. Whether an item is out of calibration and needs repair parts or an item needs a calibration extension due to use and it cannot be calibrated.
A. First we determine if the item being manufactured will be affected in a manner not to meet customer specifications.
a. If customer specifications are not meet then approval from the customer must be obtained then move to B.
b. If customer specifications are not affected we move to B.

B. Quality Manager or Quality Manager and Engineering Manager give approval in written form via e-mail.
a. Form is electronically saved for number of years specified in your process.

C. Calibration is extended with results recorded in calibration system along with all information on the extension, details, and time frames.
a. Yellow calibration sticker is used on this product to show that the calibration was extended for a specific reason.

D. Once item is repaired and calibrated then results are inspected to again make sure that items being manufactured are not out of customer specification or out of approval range from customer.

Now this is a procedure and is listed in work instructions for these circumstances. Hopefully this will give you a general idea of a process that can be used if needed.

Thanks
Dale

Dale, excellent post! Thank you for the details on your system, and it further illustrates how we can all approach things slightly different, but still have good processes.

Dale:
Good info! Could you give us a bit more detail on the criteria used in step 1 and 1A.

The reason I ask is that in many calibration systems, the extension to recall is based on (among other things) the past history of the equipments' calibrations. This data can be used to see if there's any drift etc in the results of the equipment, 'as found' and can help to make more robust decisions regarding how long the extension can be allowed for.........

Without this trend data, any other period of recall extension is very risky, IMHO

Yes all data on calibrations are kept in our Gagetrak system. Even that being said calibration extensions are only used in situations that are forced. Never in a situation of "I can't get it done, can I have an extension". Only if the machine cannot be shut down or a part is needed. That being said calibration extensions are only issued for the least amount of time as possible. Even if a gage history shows that the calibration would be good for another 30 days the extension will only be given till the item can be done. An example would be if they can't calibrate it in time for the calibration date or parts are needed and they can do it in 5 days then the calibration extension is only given for 6 days. This keeps everyone accountable to ensure that the item is done in the quickest manner and if it isn't done in the 6 days then the whole process is started over which normally makes the higher ups start asking questions.

Hopefully this answered the other questions. We depend highly on Gagetrak and its systems to set calibration dates based on history of gages and equipment.

Thanks
Dale