ISO 17025 Quality Manual Template
Monday, May 29, 2006
4.9 Control of nonconforming testing and/or calibration work
This section covers remedial action while section 4.11 covers corrective action.
Use the example of a balance past the calibration due date. The following would be the results of section 4.9 control of nonconforming testing and/or calibration work:
- stop using the balance
- check other balances to determine calibration status
- calibrated any balances past due
- review results of calibration: balances within calibration requires no recall on work while calibrations outside limits require notification of clients regarding recalls
- evaluate the significance to determine if this is potentially repetitive or related to a potential problem with procedures
- when the evaluation has confirmed that this is potentially repetitive or related to a system problem then initiate corrective action (i.e., a management system change beyond the remedial action of calibrating them). If there is no reason to suspect the recurrence of the problem then the nonconformity is closed and no further need for a corrective action.
The following requires corrective action:
- investigate all direct and indirect processes related to the maintenance of the balance calibration status: causes and potential causes of the problem
- determine the most likely cause or causes
- decide if any actions are needed to eliminate the causes
- undertake any action necessary to elminate these causes and to prevent such a mistake from recurring
- do necessary follow-up
- monitor for effectiveness
- close out the corrective action
Correction = remedial action = correcting the nonconformity
Corrective action = investigate related processes or systems to determine the root cause and eliminate
Use the example of a balance past the calibration due date. The following would be the results of section 4.9 control of nonconforming testing and/or calibration work:
- stop using the balance
- check other balances to determine calibration status
- calibrated any balances past due
- review results of calibration: balances within calibration requires no recall on work while calibrations outside limits require notification of clients regarding recalls
- evaluate the significance to determine if this is potentially repetitive or related to a potential problem with procedures
- when the evaluation has confirmed that this is potentially repetitive or related to a system problem then initiate corrective action (i.e., a management system change beyond the remedial action of calibrating them). If there is no reason to suspect the recurrence of the problem then the nonconformity is closed and no further need for a corrective action.
The following requires corrective action:
- investigate all direct and indirect processes related to the maintenance of the balance calibration status: causes and potential causes of the problem
- determine the most likely cause or causes
- decide if any actions are needed to eliminate the causes
- undertake any action necessary to elminate these causes and to prevent such a mistake from recurring
- do necessary follow-up
- monitor for effectiveness
- close out the corrective action
Correction = remedial action = correcting the nonconformity
Corrective action = investigate related processes or systems to determine the root cause and eliminate
