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ISO 13485 7.6 Control of monitoring and measuring equipment - Assess the Validity

#1
Hi All,

Apologies, for my first post, it is quite a long one! I was hoping to get your input with regards the requirement for assessing the validity of previous measuring results please?

"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. The organization shall take appropriate action in regard to the equipment and any product affected"

I can come up with a few different ways of addressing this requirement and not sure which should be implemented.

Background: We have a system where all Inspection, Measuring, and Test Equipment (IMTE) is assessed before it is implemented into process. The IMTE, Process, and Calibration, ranges and tolerances are documented, assessed, reviewed, and approved for suitability. Classification is also determined. Product Critical, Business Critical, EHS Critical, Non-Critical.
If an IMTE fails calibration, an impact assessment is completed. This looks at possible impact to product. If possible impact determined, a non-conformance report is raised.

I do think that assessing the validity of previous measuring results is different to product impact but how should this be assessed?

1. I found this statement in an ISO-13485 guide publication:
When a monitoring and measuring device is found inappropriate for use, or its calibration proves to be inaccurate, the organization shall evaluate the validity of the accepted results, along with the ability of any products that were released with this device to meet their requirements
We have already determined that the device is appropriate for use during the implementation phase. But this is saying if the calibration proves to be inaccurate. Am I assessing previous calibration results to ensure these were valid/accurate?

2. This was also in the ISO 13485 guide publication:
To ensure valid measurement and monitoring results, Monitoring and Measurement Device’s must be controlled. A process is required, to control the identification of monitoring measurement, selection, purchase, status, identification, calibration, verification, adjustment or re- adjustment, use, handling, maintenance and storage, training, handling of nonconforming Monitoring and Measurement Device’s, etc
So here, to assess measurement validity, I would assess the form completed when implementing the IMTE to ensure the details here were valid, and that the IMTE was used by trained personnel, and was handled and stored appropriately?

3. This following statement found on a blog about the same:
Assess the affect of the measurements on the quality of the product and whether a potential nonconformity could occur as a result of the improper measurements
I believe we are doing this as part of the product impact assessment

4. My own interpretation was to assess the measurements taken using the out of tolerance IMTE and determine how the results would have been impacted as a result of the failed IMTE. Could we have accepted bad product/rejected good product.

After writing this I would be swaying towards a statement like:
When an Out of Tolerance is identified, a product impact assessment shall be completed, this will include an assessment of measuring results obtained - Possibility of accepting bad product, or rejecting good product. The IMTE implementation form shall also be assessed to ensure the IMTE is appropriate for use. The previous calibration results shall be reviewed to ensure results were valid.

What are your thoughts? Am I over thinking this or going over the top? Since it is specifically called out for in ISO13485, it's difficult not to give it a little extra attention to ensure it is implemented correctly.

Thanks All!
 
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Tagin

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#2
The primary concern, I think, is the risk of occurrence of escapes of nonconforming finished product to customer, where the nonconformance is due to the use of out-of-calibration or inappropriate m/m tools.

So, in my view, roughly, the product impact assessment should look at:
  • potential nonconforming finished product delivered to customers or enroute (escapes)
  • potential nonconforming finished product in finished goods
  • potential nonconforming WIP product
  • potential nonconforming received & inspected components
where the components and/or product was m/m using the discovered out-of-calibration or inappropriate m/m tool. The assessment determines whether the component/product is at risk of being nonconforming due to the specific nature of the m/m failure, and plan for how to mitigate/correct the nonconformances in the product.
 
#3
Thanks Tagin.

That's how I would have always addressed the requirement in the past, but the more I looked into it, the more I thought they were looking for more than a product impact assessment.
The product impact assessments we would have completed would not have looked at the previous calibration results, nor the calibration/device specifications assessment form.
It does seem like these would be beneficial assessments.
 

Tagin

Trusted Information Resource
#4
Thanks Tagin.

That's how I would have always addressed the requirement in the past, but the more I looked into it, the more I thought they were looking for more than a product impact assessment.
The product impact assessments we would have completed would not have looked at the previous calibration results, nor the calibration/device specifications assessment form.
It does seem like these would be beneficial assessments.
>> It does seem like these would be beneficial assessments

Agreed, but I think of those as in the category of root cause investigation: has this tool had a history of going out-of calibration?, is our way of using/storing of this tool causing it to go out-of calibration?, etc.

Whereas the product impact assessment is more about containment.
 
#5
>> It does seem like these would be beneficial assessments

Agreed, but I think of those as in the category of root cause investigation: has this tool had a history of going out-of calibration?, is our way of using/storing of this tool causing it to go out-of calibration?, etc.

Whereas the product impact assessment is more about containment.
Really good point, didn't think of it that way. Food for thought!
Thanks so much for your input
 
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