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ISO 13485 Clause 7.6 Control of Monitoring and measuring devices - Requirements

R

rick poole

#1
Hi All, :bigwave:

I have been tasked to ensure we comply to ISO13485 clause 7.6 (as i look after the company calibration system), i have completed most of it, but am a little stuck on the part of the clause that states:-
'In addition, the organization shall assess and record tha validty of the previous measuring results when the equipment is found not to conform to requirements. the organization shall take appropriate action on the equipment and any product affected. records of the results of calibration and verification shall be maintained.'

so far we have managed to get all our calibration companies to amend their records so that they indicate if any adjustments were made to the equipment and also to supply us with the 'As received' results. so with this i know if anything was out of spec before handing back to the owner.

i gather this is not enough and i need to create some kind of document/record that proves we have assesed the 'risk' and determind that the out of tolerance results do or do-not have a negative impact on products that have already been manufactured or tested using the out of tolernace equipment? if this is the case i am a little stuck on what needs to be contained within this document / record as i have never been involved in any type of risk management in the past....... does anybody have an example of the form i need to use in order to satisfy this part of the standard.

TIA

Zla
 
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bobdoering

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#2
Re: 7.6 Control of Monitoring and measuring devices

Probably, more important than a form is a procedure. You need to know what products and processes the gage was assigned to, then you need to know what lots were made between the calibration periods, and finally you need to retrieve all of the data that exhibit the characteristics that the gage was used for to determine if the out of calibration shift would hold the parts suspect for out of specification.

That is more than just a form!
 
A

AG Kumar

#3
Re: 7.6 Control of Monitoring and measuring devices

It is true, it is more than just a form. We will need this to be addressed in the procedure and we need to have the previously tested products/ processes assessed for any adverse impact on the product (medical device) quality. This has been a traditional requirement an any GMP environment. The same is also insisted by USFDA QSR 21 CFR 820.72 (b) "Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented"

The same is also insisted in 21 CFR 211.160 (b) 4 "The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met.

Hence, your procedure should contain this requirement and such remedical actions to be evaluated and documented in a format. The attached format, may be of guidance to you.
 

Attachments

bobdoering

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#4
Re: 7.6 Control of Monitoring and measuring devices

Hence, your procedure should contain this requirement and such remedial actions to be evaluated and documented in a format.
This is great information on the back end. The real trick of a successful procedure - if you ever needed to employ it - is the up-front need to be able to identify which gage was used to measure what dimensions. That means when data is generated there needs to be a direct connection from the data to the gage used. It may be through thorough calibration records that include check-out information to a specific part or process, or data collection that included the device number. Whatever process you use, you need to make the connection.

Do a trial run - can you go from calibration data to specific process data? If not, you are not there yet...
 

Jim Wynne

Staff member
Admin
#5
Re: 7.6 Control of Monitoring and measuring devices

This is great information on the back end. The real trick of a successful procedure - if you ever needed to employ it - is the up-front need to be able to identify which gage was used to measure what dimensions. That means when data is generated there needs to be a direct connection from the data to the gage used. It may be through thorough calibration records that include check-out information to a specific part or process, or data collection that included the device number. Whatever process you use, you need to make the connection.

Do a trial run - can you go from calibration data to specific process data? If not, you are not there yet...
In general, this will tell you what device was supposed to be used, not what was actually used. The level of control needed to have reasonable confidence in what device was used in each instance over a period of time is nearly impossible to achieve in most instances. Knowing that a given out-of-calibration device might have been used should be enough to commence the investigation, especially where medical products are concerned.
 

bobdoering

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#6
Re: 7.6 Control of Monitoring and measuring devices

In general, this will tell you what device was supposed to be used, not what was actually used.
I agree - most systems are usually not "stress tested" to ensure that they would actually be effective if the issue occurred. I think most procedure writers hope that it never really occurs...since it usually goes right to the edge of a recall situation. It is possible to to do it correctly, but I think most people would believe it was too much paperwork - again, until it really happens. Then then "insurance" would kick in.


Knowing that a given out-of-calibration device might have been used should be enough to commence the investigation, especially where medical products are concerned.
Yes, you can commence the investigation, but the evidence will likely be too scant to achieve a reliable conclusion. This has been a requirement for automotive for years, and I bet you will find these situations promptly swept under the carpet. But, to do that in medical can become a much more severe liability.
 

Jim Wynne

Staff member
Admin
#7
Re: 7.6 Control of Monitoring and measuring devices

Yes, you can commence the investigation, but the evidence will likely be too scant to achieve a reliable conclusion. This has been a requirement for automotive for years, and I bet you will find these situations promptly swept under the carpet. But, to do that in medical can become a much more severe liability.
Let's say that it is possible to narrow down a particular device in a particular application. There's still nothing to say that the device was out of calibration at any particular point in time. In the best of systems, all you have to go on is tentative probability. The best you can do is make a good-faith effort to determine whether or not product was likely to have been affected by measurement error.
 

bobdoering

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#8
Re: 7.6 Control of Monitoring and measuring devices

Let's say that it is possible to narrow down a particular device in a particular application. There's still nothing to say that the device was out of calibration at any particular point in time. In the best of systems, all you have to go on is tentative probability. The best you can do is make a good-faith effort to determine whether or not product was likely to have been affected by measurement error.
This is true. I am sure that the standard writers were not thinking in terms of 'likely' or 'tentative probability', but it will typically be the endpoint. It falls into the same mindset of product traceability - the more consice the traceability, the smaller the affected quantity to be evaluated. Here - the more accurate you can trace the gage to the measurement, the smaller the affected quantity to be evaluated.

Another good reason to put forth a good-faith effort to determine the calibration frequency, too, to keep out of this situation in the first place!
 
R

rick poole

#9
Thanks for all this info guys, we are no where near ready yet, at present we do not know (without searching paper records) what was tested by what equipment. this task would be a huge one to tackle at the moment.

however, although we use test equipment during the build of instruments, we do give the instruments their final check (which is the only indication that the instrument actually works) using samples that are traceable and we do know which instrument had which sample. so in theory, could i create a procedure that states we dont need to worry about out of tolerance equipment as the final test will indicate that the instrument is actualy working correct to our published specs? (i know this could be a costly thing to do as we could be setting the instruments incorrectly at the build and test prep stages, but at least the instruments will go out the door - eventually - as a fully tested and working instrument)

This would only be a short term measure until we have full computerised traceability where we could identify which equipment was used on which instrument.

would this be acceptable?
 

bobdoering

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#10
however, although we use test equipment during the build of instruments, we do give the instruments their final check (which is the only indication that the instrument actually works) using samples that are traceable and we do know which instrument had which sample. so in theory, could i create a procedure that states we dont need to worry about out of tolerance equipment as the final test will indicate that the instrument is actualy working correct to our published specs?

would this be acceptable?
You can use this approach to identify the effect of the gage on the process output. You may also need to use the condition of previous check gages in the event the final tester indicates a calibration problem. The only issues you may have left is measurements not duplicated in the final tester - if any. It should be justifiable to an auditor as a 'good-faith effort' to ensure the product was acceptable. I would not put is as " a procedure that states we dont need to worry about out of tolerance equipment" but as the "procedure for verifying the impact of out-of-calibration gage on product output."
 
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