"As Found" (aka "As Received") Calibration Data - ISO 13485 Requirements

[MEDQA]

Hello -

When sending instruments / equipment out for calibration, do you request "as found" data?

If not, how do you satisfy the following 13485 requirement?

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.

Just wondering if I am missing something simple here..

thanks!

 

[Phil Fields]

Re: "As Found" Calibration Data - ISO 13485 Requirements

We get information as "found within specification" or "found not within specification". When "found not within spedcification" data is provided by the calibration service. The data is then evalauted to determine what effect the maeasuremnts may have on the final product.

 

[Marc]

Re: "As Found" Calibration Data - ISO 13485 Requirements

"As Found" data should always be required. If you calibrate a measurement device and "As Found" data shows the instrument was out of calibration, all measurements made since the last calibration are suspect. I can't speak to ISO 13485 requirements specifically, but this is standard in calibration.

What to do when a measurement device is found to be out of calibration has been discussed here a number of times, and how far you go depends upon the product and measurement being made, but the bottom line is you essentially have to go back and determine whether it is critical enough for you to recall all product which was measured with the measurement device. This is where traceability comes into play.

I'm sure some others here will add to my brief reply.

 

[MEDQA]

Re: "As Found" Calibration Data - ISO 13485 Requirements

I agree with you entirely. -thanks

 

[arios]

Re: "As Found" Calibration Data - ISO 13485 Requirements

" I can't speak to ISO 13485 requirements specifically, but this is standard in calibration.

ISO 13485 has he same requirement as in ISO 9001, except that 13485 requires a documented procedure.

The "as found" condition is called by some "As received condition". The standard does not say that you have to require it literally, but this information is absolutely necessary, otherwise you will not be able to assess the status of your instrument prior to recalibration. Bottom line, ask for it.

Don't be satisfatied only with an statement on the calibration certifcate saying that the instrument was found "in tolerance". It is important to check at the actual data on the report. I have seen for example calibration certs for pin gage sets where the calibration lab says that the "set" was in tolerance, but there are some pin gages out of range in the box and noted as such on the detail report.

 

[BradM]

Re: "As Found" Calibration Data - ISO 13485 Requirements

"As Found" data should always be required. If you calibrate a measurement device and "As Found" data shows the instrument was out of calibration, all measurements made since the last calibration are suspect. I can't speak to ISO 13485 requirements specifically, but this is standard in calibration.

What to do when a measurement device is found to be out of calibration has been discussed here a number of times, and how far you go depends upon the product and measurement being made, but the bottom line is you essentially have to go back and determine whether it is critical enough for you to recall all product which was measured with the measurement device. This is where traceability comes into play.

I'm sure some others here will add to my brief reply.

Yep. Pretty much covered it, Marc. Nice reply.

Additionally from Section 7.6:

The organization shall take appropriate action on the equipment and any product affected.​

I would argue that taking appropriate action would depend on the magnitude of the error. If I have 4 to 1 ratio, and I have a thermometer with a .25 degree tolerance. Being out of specification with .36 degree error is totally different than being out of specification by .92 degree error; as far as investigation/remedial action.​

Too, if I get the report with the .92 degree error, something is wrong with the measurement system.​

Even if the instrument does not fail, having the values let's you know if you are at the optimal calibration interval, by how much error is found at calibration.​

Now... NOTE: I believe (don't quote me) that 17025 requires the calibration supplier to provide the data should the instrument be found out of specification. But, that is certainly something to arrange with your calibration vendor. So if the vendor provides data if it is out of tolerance, then there is no need to provide as-found data with every calibration.​

 

[Marc]

Re: "As Found" Calibration Data - ISO 13485 Requirements

By the way - This is an aspect many people do not take into account when setting calibration interval (aka 'frequency') for a measurement device. You may have a stable measurement device which is always found to be in calibration, but in some cases calibration frequency (aka 'interval') is more important with respect to the potential costs of a recall, not to mention liability aspects. I'm sure in the medical device industry this is a more critical factor than in many other industries.

 

[Marc]

Re: "As Found" Calibration Data - ISO 13485 Requirements

<snip> Now... NOTE: I believe (don't quote me) that 17025 requires the calibration supplier to provide the data should the instrument be found out of specification. But, that is certainly something to arrange with your calibration vendor. So if the vendor provides data if it is out of tolerance, then there is no need to provide as-found data with every calibration.

My training (high reliability/mission critical military aerospace and marine electronic devices) was you always required "As Found" ("As Received") data, even if the device is found within calibration specs, to ensure you could track any drift or trend of the instrument. If the device needs any adjustment, it has to be watched. This is in part useful to watch for wear and related factors, as much as for use in determining calibration interval. It also goes to knowing the stability of the instrument over time.

 

[BradM]

Re: "As Found" Calibration Data - ISO 13485 Requirements

My training (high reliability/mission critical military aerospace and marine electronic devices) was you always required "As Found" ("As Received") data, even if the device is found within calibration specs, to ensure you could track any drift or trend of the instrument. If the device needs any adjustment, it has to be watched. This is in part useful to watch for wear and related factors, as much as for use in determining calibration interval. It also goes to knowing the stability of the instrument over time.

We're in agreement on this one.

Which illustrates the difference of having instruments calibrated, and managing your calibration program. As with any process, you need data to make effective management decisions; no different with calibrations.