As part of the QMS, regulating and accreditation agencies require that laboratories maintain methods for detecting and evaluating errors, incidents, and non-conformities in their products/services that may impact patient care. These methods, reviewed by laboratory management, are intended to:
- Document the identification of a problem
- Investigate and analyze the cause of the problem
- Derive a corrective action to prevent the recurrence of the problem
- Implement and verify that the action is effective
- Communicate the corrective action to responsible parties