The responsibility for authorisation of the resumption of examinations lies with the Consultant in conjunction with the Chief Medical Scientist. Non-conformances are reported via Q-Pulse. The Quality Co-ordinator is responsible for the tracking and trending of non-conformances at regular intervals enabling a review of effectiveness of Corrective and Preventative Actions. Non-conformances and emerging trends are discussed at Monthly Quality Meetings and Management Review Meetings. Following investigation / review of a non-conforming pre-examination, examination and post-examination process where it is found that it could recur or that there is doubt about the compliance the department with its own policies or procedures as stated in the Quality Manual, then trouble shoot/cause and analysis methods are used to identify, document and eliminate the root cause of this problem. This corrective action is promptly implemented. All supporting documentation is attached to the non-conformance. As defined in if is a QP-GEN-0005 Control of Non-Conformances, which has an impact on results, the release of such results or review of previously released results will be investigated by the Chief Medical Scientist and the Consultant, as appropriate. 4.10 Corrective Action ensures an investigative process to QP-GEN-0005 Control of Non-Conformances determine the cause of the problem is performed and includes the following: Reviews non-conformances Determines the root cause of non-conformances Evaluates the need for corrective action to ensure that non-conformances do not The nature of the corrective action depends on the classification of the 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. 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
The responsibility for authorisation of the resumption of examinations lies with the Consultant in conjunction with the Chief Medical Scientist. Non-conformances are reported via Q-Pulse. The Quality Co-ordinator is responsible for the tracking and trending of non-conformances at regular intervals enabling a review of effectiveness of Corrective and Preventative Actions. Non-conformances and emerging trends are discussed at Monthly Quality Meetings and Management Review Meetings. Following investigation / review of a non-conforming pre-examination, examination and post-examination process where it is found that it could recur or that there is doubt about the compliance the department with its own policies or procedures as stated in the Quality Manual, then trouble shoot/cause and analysis methods are used to identify, document and eliminate the root cause of this problem. This corrective action is promptly implemented. All supporting documentation is attached to the non-conformance. As defined in QP-GEN-0005 Control of Non-Conformances, if is a which has an impact on results, the release of such results or review of previously released results will be investigated by the Chief Medical Scientist and the Consultant, as appropriate. 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: Reviews non-conformances Determines the root cause of non-conformances Evaluates the need for corrective action to ensure that non-conformances do not The nature of the corrective action depends on the classification of the 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. 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
pathology-quality-manual.docx