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AS9120B - ESD monitoring devices part of 7.1.5

QualityStandardsGirl

Starting to get Involved
#1
If we have ESD monitoring devices that we purchase new each year (because it's cheaper to purchase new than to get it calibrated) do we have to explain that in clause 7.1.5 under Monitoring and Measuring resources since we are not technically having the devices calibrated. We were taking an exclusion to that clause in the previous version of the standard but were told that we couldn't exclude it anymore.
 
#2
If the ESD monitoring device is a monitoring and measuring equipment, you cannot exclude 7.1.5 from the quality system. When you purchasing the new ESD equipment, do you get a calibration certificate with it? It should be calibrated when you receive it so you cannot claim that the device is not calibrated.
 
#3
While I do not have access to AS 9120B, I presume due to its kinship to the other standards that usual calibration best practices apply to monitoring and measuring equipment. These do not only deal with what is in essence adjusting/confirmation for the coming period.

(Re-)calibration is also intended to confirm your presumption that the device was within acceptable deviation in the past period.
If it is found to not be within calibration, actions must be taken to assess the impact on past measurements, which might extend to field recalls in the worst case.

That calibration would also be executed when the tool is (potentially) damaged in a way that affects its function or reliability (e.g. because of a fall), or has experienced conditions for which it was not designed/specified that might influence outcomes after that fact (e.g. environmental excursions), thus not only when the period expires.

Lastly it should occur when terminating the use of the device, even when this is within the period that it was presumed to be in calibration.

Each of these leads to a possibility of change in or substantiation to keep its status identification.

Now I know that ISO 9001:2015 or :2008 requirements don't fully match to the above practices if you have a smooth talker on your hands, but it isn't about the requirement (often happy path based), but the value you gain from the principles they require. No-one can deny the need to have a process to accomodate for the above two unhappy paths for when unfortunate events occur, and the value they bring for reliability in your products.
I don't even know whether someone ever highlighted the risk in leaving this expectation unrequired/implicit (as safeguarding against (unintended) adjustements, damage or deterioration is not as clear-cut same as determine confidence upon detection of "", and the initiating trigger can be interval or prior to use based, without risk based considerations justifying why you can choose one or the other).
The validity determination upon finding unfit equipment is weak in this sense as it does not require when to scan for unfitness. In some cases a tool will function, but simply not produce reliable results, and neither does it require the need to calibrate when terminating a tool prior to the expiration of its current validity period. The best practice mentioned above fills these holes.
 

dsanabria

Quite Involved in Discussions
#4
If we have ESD monitoring devices that we purchase new each year (because it's cheaper to purchase new than to get it calibrated) do we have to explain that in clause 7.1.5 under Monitoring and Measuring resources since we are not technically having the devices calibrated. We were taking an exclusion to that clause in the previous version of the standard but were told that we couldn't exclude it anymore.
For recall purposes you need to have it in your QMS - no exclusion or NA if you have equipment that is used forverification - it should have an ID for traceability.
 
#5
You are using a devise that requires validation. The fact that you don't calibrate it yourself is irrelevant. Buying a new one every year is just your way of keeping it in calibration.
 
#7
If we have ESD monitoring devices that we purchase new each year (because it's cheaper to purchase new than to get it calibrated) do we have to explain that in clause 7.1.5 under Monitoring and Measuring resources since we are not technically having the devices calibrated. We were taking an exclusion to that clause in the previous version of the standard but were told that we couldn't exclude it anymore.
The clause states that measuring equipment shall be calibrated. If you buy it new, it needs to come with a certificate and an indication of when that calibration period expires. It does not state that you have to have it calibrated yourself - it just has to be calibrated, and done under suitable conditions.
It's not an exclusion - you are required to have calibrated equipment if traceability is a requirement, or the company feels that it's an essential part of providing confidence in the results. You just do it in a different way.
 
#8
The clause states that measuring equipment shall be calibrated. If you buy it new, it needs to come with a certificate and an indication of when that calibration period expires. It does not state that you have to have it calibrated yourself - it just has to be calibrated, and done under suitable conditions.
It's not an exclusion - you are required to have calibrated equipment if traceability is a requirement, or the company feels that it's an essential part of providing confidence in the results. You just do it in a different way.
Be careful here. The organization is the one that determines the calibration interval, not the equipment maker or the calibration shop.
 
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