Corrective and Preventive Actions

15.1 Corrective Action

Procedures must be documented for corrective actions to be taken 

whenever the validity of results is questioned or departures from quality management system policies and procedures occur.
 The procedures shall include an investigation process to determine the root cause of the problem. Corrective actions taken to eliminate the basic cause  of non-conformances and discrepancies shall be of a degree appropriate to the magnitude of the problem and commensurate with the risks encountered. The results of the corrective actions must be monitored to ensure their effectiveness.

When the validity of the results are questioned, for example, through proficiency testing or quality control results, the procedure(s) involved must be reviewed  and, if necessary, withdrawn from use. The procedure(s) may be reinstated only when exhaustive review and testing demonstrate that they are not, or no longer, the source of error.

Where the identification of non-conformances or departures casts doubt on the laboratory's compliance with its own policies and procedures or with the  accreditation criteria, it shall be ensured the relevant areas of activity are promptly audited. Records shall be maintained forthe corrective actions, investigations and analysis. The laboratory must promptly notify the clients in writing when any event casts doubts on the validity of the  results or conclusions given in forensic report. The results of corrective actions shall be  submitted to the management review. Internal audits, NABL assessments, quality  control data, proficiency testing etc. generate recommendations for corrective actions which must be evaluated, prioritised, implemented and evaluated for effectiveness. Consequently, the system for monitoring progress must be comprehensive and adequately cross  referenced. The Quality Manager should coordinate this system.

15.2 Preventive Action

All operational procedures shall be systematically reviewed at regular intervals to identify any potential sources of non-conformances and any opportunities for improvement, either technical or with the quality management system. Action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of non-conformances and to take advantage of improvement opportunities. After the implementation of preventive actions, the laboratory shall monitor the results to establish any reduction in deficiencies or improvements  to operations, thereby establishing the effectiveness of the preventive action. The results of preventive actions shall be submitted for the management review. Preventive action is aproactive process to identify improvement opportunities, rather than a reaction to the identification of problems or complaints.