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!
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!
