SilverHawk said:
During the surveillance audit, the auditors issued an NCR as follows :-
(a) SOP as to how the determination of the monitoring and measurement requirements as well as the determination of the monitoring and measuring devices required could not be establsihed.
(b) Steps to ensure protection, handling and storage requirements was not explicitly defined in SOP
(c) criteria for acceptance of calibration reports conducted by external calibration lab could not be establ;ished and implementation could not be ascertained for the basis of accepting or rejecting the MMD.
Pls. help me out with provide proposed corrective actions. I am stuck for a while.
Thanks.
SH,
(a) is from the first paragraph of the 7.6:
"The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements".
This information should be present in your product control plans or Inspection test plans. For every product, I guess you identify the monitoring and measurement to be undertaken under CTQ/KCC and identify the measuring devices needed to provide evidence of conformity of product/process in the other column.
(b) Protection (as safeguard) is the main issue usually. How to do you ensure that the equipment is tamper proof during usage. (7.6.d) For equipment that uses software controls, what is the security level to make any adjustments to the source code?
Handling and storage information should available in the corresponding manual.
(temp, humidity, vibration, ESD, Clean room,?? etc)
(C) I think (c) is a good finding. Most people do not to verify-review the external lab report and just file the copy (as long as the equipment pass the calibration).
Keep in mind; the equipment only passed the tolerance requirements for the equipment standard. Is it usable for that measurement application? We should ask that question as well every time equipment is put to usage. There are times where the equipment would have passed on the limit. Risk has to be assessed with respect to putting the equipment back on field.
The equipment could wear out the next day, next week or next month depending on the usage. You may be shipping defective products to customer based using the "potential- out of calibration" equipment.
Also Measurement uncertainty comes into play. Even without potential wear out, if you apply the measurement uncertainty to the above scenario, there could be probability of accepting reject products.
For my curiosity: Why the auditor is finding these basic compliance issues in a surveillance audit? This should have come up in your internal audits prior to registration or at the least in the Registration audit by the external auditors!
Regards,
Govind.
