Out of Tolerance Gage - Justification for not Recalling Product

P

pangchiaboon

#1
Dear Sirs,

I face difficulty to justify the acceptance of out of tolerance (base on standard) gage and not to recall product. If happened that external calibrator reported that a gage with 1 micron off spec, normally what are the details should we consider and to use as justification not to recall the product and continue to use the gage?

Pang Chia Boon
 
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harry

Super Moderator
#2
A gage that's out by 1 micron would most likely be still good enough for normal use. Investigate and if so, there's no necessity to recall your product. What are you measuring and what is the specification.
 

somashekar

Staff member
Super Moderator
#3
Dear Sirs,

I face difficulty to justify the acceptance of out of tolerance (base on standard) gage and not to recall product. If happened that external calibrator reported that a gage with 1 micron off spec, normally what are the details should we consider and to use as justification not to recall the product and continue to use the gage?

Pang Chia Boon
Not to recall a product and continue to use the gage are two completely different aspects.
Not to recall is based on the fitness for use assessment and a simple risk assessment to take a very practical and logical decision.
(Without knowing much about your product and situation, its pretty difficult to make a judgement here and now)
However ...
The gage when detected to be out of spec must be prevented from use rightaway.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
Is the gage reading too large or too small?
Where does the product it measures run vs the specification? If teh product runs well within spec (more than a micron away) then there is no need to recall product.

Other considerations are the R&R of the gage for the product it emasures. is the R&R more than a micron?
 

BradM

Staff member
Admin
#5
Hello there!:bigwave:

An out of tolerance gage is comparing the found error to some established requirement. So, you have two things to look at:

Harry and Bev hit upon the as-found error. Given the magnitude, could it have yielded bad product? Could the gage have suggested that product is good, when in actuality it is bad? If 1 micron would have no impact, then you're done.

To make the numbers easy, let's say your error is:

.01

But your process (and product) is not affected unless there are deviations of say.. .5

That .01 error is insignificant to the .5

Which leads to the second part which is your tolerance. There is a whole Art and discussion on establishing tolerances. But understand that depending on what you are using (like mfg. tolerance), you may find your instrument failing many times on tolerance.

So like above, if you process critical parameter is .5 and my current tolerance is .01; maybe I could increase my tolerance to .05 to avoid so many failures. Just a thought..

Moving forward, however you handle this I would write it up. Note the failure, document what investigation you conducted, and complete with whatever action is necessary. Even if the error had no impact, you would still want to document that. :):agree1:

For the future, consider developing a remedial action plan that can give you a plan up-front, of how to handle failures. It might even involve steps to take given what the magnitude of the failure is.
 
J
#6
Dear Sirs,

I face difficulty to justify the acceptance of out of tolerance (base on standard) gage and not to recall product. If happened that external calibrator reported that a gage with 1 micron off spec, normally what are the details should we consider and to use as justification not to recall the product and continue to use the gage?

Pang Chia Boon
All good answers already.
The bottom line is whether a 1 micron error on the gage is significant enough on your product to cause the product to be unfit for use. If not then don't recall. If so, recall. If not sure after investigation, contact customer. Odds are that, for such a small deviation, no recall will be needed.

Peace
James
 
A

Al Dyer

#7
All good responses, and maybe mine is too simple.

Have you called the customer to ask if everything is alright? The answer will give the direction needed.

Al...
 
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