Recapture Program for Measurement Devices found Out of Calibration

[saf one]

Hi all....
Recently my company audited by new customer and she asked either we have procedure/format product recapture program for instrument found of calibration. I informed her that all equipment to be re-calibrate we will make recall letter to inform owner. Equipment found out of calibration send outside for repairing or re calibration. I also shown her that list of decommissioned equipment list with details on serial no. equipment type date and owner. Audit report findings said we have no proper format for equipment recapture list.. i think my format was okay..anyone can help me?
any idea on her report findings.

 

[dwperron]

Re: Recapture Program for Measurment Devices found Out of Calibration

I'm not sure what standard you were being audited to, so I don't know if there are specific requirements for your recapture program.

ISO 17025 in section 4.9 gives a guideline as to what should be seen in such a program. it states that when you have a non-compliance issue (such as a standard being out of calibration) that the following steps must be taken:

* That you have a policy and procedure established to cover these events
* That you evaluate the significance (impact) of the nonconformance
* That corrective actions are immediately taken
* That, when necessary, the customer is notified and work is recalled
* That the person responsible for authorizing the resumption of work is defined
* That a formal corrective action be performed to prevent the event from recurring

I'm not sure if this would satisfy the auditor in your specific case, but this is the industry standard as to how to deal with these problems.

What standard are you being audited to?

 

[saf one]

good explain..that one seem like how we apply when have non conformance issues on quality. She audited based on her company checklist and im not sure maybe general iso9001 2008.
based on standard you mentioned, we need to do as you listed?right?

 

[dwperron]

I hate those kinds of audits!!!
Ones where you don't know what the auditor / customer is holding you to.

If the customer has a documented requirement on how they expect you to handle your recapture program they need to present it to you and tell you that it needs to be implemented. This is important - if you agree to their "terms" you are obligated to fulfill them, so you need to know, in detail, what they expect.

 

[Cari Spears]

Re: Recapture Program for Measurment Devices found Out of Calibration

* That, when necessary, the customer is notified and work is recalled

I think this is specifically what she was asking about. When you find that an instrument is out of calibration, how do you go back and verify that any product inspected with that instrument is actually good - back to the last point in time that the instrument was known to be in calibration.

 

[dwperron]

Re: Recapture Program for Measurment Devices found Out of Calibration

Now that is a BIG topic.

It is all going to depend on your calibration database (and I am going to assume that they have one with a "Reverse Traceability" function). You do the reverse trace back to the last time the standard was known to be good. - Commercial interruption here: this is why you should have a program for checking your standards on a regular basis between calibrations. If you know it was good a month ago it can greatly shorten the search period! - Then you are going to have to determine what the OOT deviation was on the standard and determine which instruments calibrated using this standard would not possibly be affected by that ( if you have a multifunction calibrator that was off on temperature accuracy you can eliminate all customer instruments that don't measure temperature). Then you check the calibration results for each possibly affected instrument and see if the OOT deviation could have produced a false fail or pass condition. Those are the ones where you notify the customer and arrange a recall. It is also good practice to notify customers of the OOT condition even if their instruments do not warrant a recall, just to let them be aware of any possible impact on their measurement program.

A pain, but a very necessary part of the business.

 

[BradM]

Re: Recapture Program for Measurment Devices found Out of Calibration

A good discussion. Geeze I love this place!

I think this is specifically what she was asking about. When you find that an instrument is out of calibration, how do you go back and verify that any product inspected with that instrument is actually good - back to the last point in time that the instrument was known to be in calibration.

I might put one section in front of this... and that is to determine potential impact.

Say for example my standard is ±.05°C accuracy and the instruments (whether internal or external) best accuracy is ±.2°C. Suppose my standard exceeded the tolerance by... say .048°C. That really has very little (to no) potential impact on the instruments calibrated.

Was some kind of verification performed prior to shipping? Did everything work correctly before shipping and then bammo! They find it significantly out of specification? Was it error that would have been quite detectable during use? Would the lab technicians/metrologists been adjusting a bunch of instruments due to that error?

It's really about establishing a program to mitigate risks for you and for your customers.

I would:

• Be sure to study each calibration performed and assure there aren't patterns/trends. There should have been trend analysis on the standards to determine if there was drift.
• Establish suitable uncertainty (accuracy) ratios; or adjust recalibration frequencies accordingly to mitigate risk.
• Establish a program for dealing with an out of calibration notice, based on potential impact and magnitude, detectable error, and potential adjustments made.
• Once an instrument is found out of calibration, begin the investigation immediately.
• Train, train, train! Make sure the individuals using standards truly understand they are not indestructible. Also, if they are using the standard and it seems... out of the ordinary, it probably is. Like DWperron suggested, see if some kind of lab inter-comparison can be performed among standards between calibration intervals.

Failures cannot be avoided. But the # of failures and their potential impact can certainly be managed. Any expenses related to managing this, is certainly marginal compared to failures, investigations, and having to contact a customer about a failed standard.

 

[BeeSting]

There are a few ways to get ahead of this in the future.

The best without being over prescriptive - Require a final inspection on all products. On the inspection report, have the inspector write down which gages they used and the calibration date of those gages. If the gages are out of calibration, the only thing you've lost is one inspection report (and then you can scold your inspector).

 

[ace3838]

What we do at my calibration lab is a monthly standard check. Basically a paper trail so that in the event of a failed calibration etc.. We only have to check work done from the last monthly standard check. So for a pressure gauge it could be just comparing it against another pressure gauge to make sure it's working. You can also trend data with this. As long as you have a document that explains what you are doing, why and what forms to use. You should be in-compliance.