Quality manual

4.10 Corrective Action

QP-GEN-0005 Control of Non-Conformances ensures an investigative process to determine the cause of the problem is performed and includes the following:

1. 
   Reviews non-conformances
   

2. 
   Determines the root cause of non-conformances
   

3. 
   Evaluates the need for corrective action to ensure that non-conformances do not recur.
   

4. 
   The nature of the corrective action depends on the classification of the non-conformance and of its potential risk to the patient. This also applies to Haemovigilance & Traceability and Phlebotomy activities. Any changes required resulting from corrective action investigations are documented and implemented as described in QP-GEN-0019 Management of Change Control.
   

5. 
   The effectiveness of the corrective action is reviewed on an ongoing basis and discussed as required at Quality Review Meetings. A formal review of effectiveness of corrective actions is presented at the Annual Management Review.
   

When the identification of non-conformance or the corrective action investigation casts doubt on compliance with policies and procedures or the quality management system, the Department of Pathology Management ensures that appropriate areas of activity are audited in accordance with the QP-GEN-0002 Internal & External Audit. The results of the audits are discussed at Quality Review meetings and the Management Review Meetings as described in MP-GEN-0021 Quality Meetings and MP-GEN-0001 Management of the Laboratory.

Action taken at the time of the non-conformance to mitigate its immediate effects is considered “immediate” action. Only action taken to remove the root cause of the problem that is causing the nonconformities is considered “corrective” action.

4.11 Preventative Action

The Department of Pathology Management ensures that an appropriate form of preventative action is implemented. Preventative action is a pro-active, pre-emptive process for identifying opportunities for improvement rather than a reaction to the identification of complaints or non-conformances. Preventive action is taken in order to ensure required improvements or potential sources of non conformances identified are managed thus minimising non-conformances relating to technical or quality processes.

Where the implementation of preventative action requires a change to existing procedures, all changes are carried out in accordance with MP-GEN-0019 Management of Change Control.
Preventative actions regardless of their origin, contribute to continual improvement in the service as described in QP-GEN-0004 Continual Improvement.
The procedure describes the action to eliminate the causes of potential nonconformities in order to prevent their occurrence. The preventive actions are appropriate to the effects of the potential problems.

The procedure includes:

1. 
   Reviewing laboratory data and information to determine where potential non-conformances exist
   

2. 
   Determining the root cause of potential non-conformances
   

3. 
   Evaluating the need for preventive action to prevent the occurrence of nonconformities
   

4. 
   Determining and implementing preventive action needed
   

5. 
   Recording the results of the preventive action taken
   

6. 
   Reviewing the effectiveness of the preventive action taken. Tracking and trending of the non-conformances and the audit process provides a forum to review the effectiveness of the preventive actions. These reports are discussed at the monthly quality meetings as described in MP-GEN-0021 Quality Meetings.
   

4.12 Continual Improvement

As indicated in MP-GEN-0002 Management of Documentation, Preparation and Control, all procedures are reviewed biennially, or as required. These reviews may identify potential sources of non-conformance or other opportunities for improvement in the Quality Management System or in Standard Operating Procedures. All changes are made in accordance with QP-GEN-0019 Management of Change Control.
Where a major change, as defined in QP-GEN-0019 Management of Change Control, is made as a corrective action to remove a source of non-conformance or to improve the Quality Management System, the effectiveness of the action is evaluated by discussion at a subsequent Quality Meeting. If required, the area may be audited to evaluate effectiveness.
The laboratory is continually improving the effectiveness of the quality management system, including pre-examination, examination and post-examination processes. Action plans for improvement are developed, documented and implemented as appropriate. Continual Improvement is addressed at Management Review Meetings, as described in MP-GEN-0001 Management of the Laboratory, through a systematic review of significant issues which have arisen in the course of the year in all aspects of the Quality Management System and the contribution of services to patient care.
Laboratory management ensures that the laboratory participates in continual improvement activities that encompass relevant areas and outcomes of patient care. When the continual improvement programme identifies opportunities for improvement, laboratory management addresses them regardless of where they occur. Laboratory management communicates to staff improvement plans and related goals.
Quality Indicators are reviewed and monitored, by the Quality Co-ordinator in conjunction with the Chief Medical Scientist, on an on-going basis in order to systematically monitor and evaluate the contribution of services to patient care. This is described in QP-GEN-0004 Continual Improvement.
All personnel involved in the delivery of services have access to suitable education and training opportunities, as described in MP-GEN-0001 Management of the Laboratory, and QP-GEN-0004 Continual Improvement.