AlienraverX
Registered
Hi Everyone,
We are registered to ISO 9001:2015, we just had our recertification audit at which time a major finding was issued. The verbiage is below, and we wish to appeal. The only thing is I have never (in my 18yrs as an auditor and quality professional) seen a major finding issued, hence I don't know how to formulate an appeal. Does anyone have any experience here? The auditor found no other calibrated items "out of cal" or "in use". Is one gage set enough to constitute major, more so since the operator realized his mistake and placed the product on hold? I don't think I'm sold that it should.
Statement of non
conformance:
Objective
evidence
We are registered to ISO 9001:2015, we just had our recertification audit at which time a major finding was issued. The verbiage is below, and we wish to appeal. The only thing is I have never (in my 18yrs as an auditor and quality professional) seen a major finding issued, hence I don't know how to formulate an appeal. Does anyone have any experience here? The auditor found no other calibrated items "out of cal" or "in use". Is one gage set enough to constitute major, more so since the operator realized his mistake and placed the product on hold? I don't think I'm sold that it should.
Statement of non
conformance:
The recall system for calibration is reliant on the calibration admins maintaining and controlling tools in the calibration database as active or inactive or lost
During the audit, it was learned that the calibration database was not well maintained resulting in Pin gages which were lost and made inactive to be put
back in service and used during incoming inspection. The recall records still showed the equipment to be inactive.
There is a significant doubt that effective process control is in place (essential part of providing confidence in the validity of measurement results). See also the OFI regarding clean up of this database.
During the audit, it was learned that the calibration database was not well maintained resulting in Pin gages which were lost and made inactive to be put
back in service and used during incoming inspection. The recall records still showed the equipment to be inactive.
There is a significant doubt that effective process control is in place (essential part of providing confidence in the validity of measurement results). See also the OFI regarding clean up of this database.
Objective
evidence
Pin gage set 61790 was not calibrated at the specified interval. Pin gages seen in use during incoming inspection were beyond their next calibration due date.
During the audit the inspector used these pin gages to accept incoming product. Objective evidence: Pin gage set 61790 next due calibration on sticker said 4/7/2014. Calibration database showed measuring equipment to be inactive.
During the audit the inspector used these pin gages to accept incoming product. Objective evidence: Pin gage set 61790 next due calibration on sticker said 4/7/2014. Calibration database showed measuring equipment to be inactive.