4.11 Corrective action
Policy
The PTL laboratory is committed to implementing corrective action when nonconforming work or departures in the management system or technical operations have been identified.
Responsibility
The quality Manager is responsible for implementing this procedure.
Procedure
A documented procedure (PTL/QSP/08) has been developed to define the system.
4.11.1 General
The PTL laboratory has established a policy and a procedure and designated appropriate authorities for a problem with the management system or with the technical operations of the laboratory may be identified through a variety of activities, such as control of nonconforming work, internal or external audits, management reviews, feedback from customers and from staff observations.
4.11.2 Cause analysis
The documented procedure (PTL/QSP/08) for corrective action starts with an investigation to determine the root cause(s) of the problem.
Cause analysis is the key and sometimes the most difficult part of the corrective action documented procedure (PTL/QSP/08). Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include customer requirements, samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration.
4.11.3 Selection and implementation of corrective actions
Where corrective action is needed, the laboratories identify potential corrective actions. It selects and implements the action(s) most likely to eliminate the problem and prevent a recurrence.
Corrective actions taken are up to a degree appropriate to the magnitude and the risk of the problem.
The PTL laboratory document and implement any required changes resulting from corrective action investigations.
4.11.4 Monitoring of corrective actions
The PTL laboratory monitors the results to ensure that the corrective actions taken have been effective.
4.11.5 Additional audits
Where the identification of nonconformities or departures casts doubts on the laboratory's compliance with its own policies and procedures, or on its compliance with this International Standard, the PTL ensures that the appropriate areas of activity are being audited in accordance with the standard as soon as possible.
Such additional audits often follow the implementation of corrective actions to confirm their effectiveness. An additional audit is necessary only when a serious issue or risk to the business is identified.
Records
Records are defined in the documented procedure (PTL/QSP/08) of corrective action.
4.12 Preventive action
Policy
The laboratory is committed to taking preventive actions for improvements needed and identification of potential sources of nonconformities.
Responsibility
Quality Manager is responsible to implement this process.
Procedure
A documented procedure (PTL/QSP/09) has been developed to define the system.
4.12.1 Needed improvements and potential sources of nonconformities, either technical or concerning the management system, are identified. When improvement opportunities are identified or if preventive action is required, action plans are developed, implemented, and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement.
Preventive actions are initiated by Quality Manager on the basis of:-
- Observation internal auditor/NABL Assessor
- Equipment for identifying trends in deviation, error, and Uncertainty and intermediate checks.
- Feedback from customer
-- Performance of laboratory personnel through regular review.
- Borderline Results in Inter Lab Comparison.
- Point discussed by annual MRM.
Potential non-conformities related to quality system and technical operation is identified for initiating preventive action. These taken actions shall be accompanied by mistake-proofing methodology to a degree appropriate to the magnitude of problems & commensurate with the risk encountered.
Preventive actions are recorded; analyzed, and reviewed and necessary actions are taken. This shall be the responsibility of the Quality Manager. The preventive measures are implemented and their effectiveness is monitored.
Preventive actions are also initiated based on the outcome of the internal quality system audit, and proficiency testing and the effectiveness of all preventive actions are monitored in the management review meeting & necessary corrective actions are taken for their improvement in management/Technical systems.
4.12.2 Procedure (PTL/QSP/09) for preventive actions includes the initiation of such actions and the application of controls to ensure that they are effective.
Preventive action is a proactive process to identify opportunities for improvement rather than a reaction to the identification of problems or complaints.
Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results.
Records
Records are defined in the Procedure (PTL/QSP/09).
3. PTL /QSP/03 Procedure for Purchasing, Services, and Supplies
4. PTL /QSP/04 Procedure for Service to the Customer
5. PTL /QSP/05 Procedure for Customer Complaints
6. PTL QSP/06 Procedure for Control of Non-Conforming Testing.
7. PTL /QSP/07 Procedure for Improvement
8. PTL /QSP/08 Procedure for Corrective Action
9. PTL /QSP/09 Procedure for Preventive Action
10. PTL /QSP/10 Procedure for Control of Records
11. PTL /QSP/11 Procedure for Internal Audit
12. PTL /QSP/12 Procedure for Management Review
13. PTL /QSP/13 Procedure for Training
14. PTL /QSP/14 Procedure for Housekeeping
15. PTL /QSP/15 Procedure for Estimation of Uncertainty of measurement
16. PTL /QSP/16 Procedure for Equipment
17. PTL /QSP/17 Procedure for Measurement Traceability and Calibration
18. PTL /QSP/18 Procedure for Sampling
19. PTL /QSP/19 Procedure for Handling of Test and Calibration Items
20. PTL /QSP/20 Procedure for Assuring the Quality of Test
21. PTL /QSP/21 Procedure for Reporting of Results
22. PTL/QSP/22 Procedure for use of NABL Symbol
Note: Replace DTL with PTL for Drug Testing Laboratory.
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