As part of the QMS, regulating and accreditation agencies require that laboratories maintain methods for detecting and evaluating errors, incidents, and non-conformities in established processes that may impact patient care. These methods are an orderly process to include all aspects for the detection and evaluation of errors, incidents, and NCEs. The basic steps in order of completion are listed below:
- Document the identification of a problem
- Investigate and analyze the root or 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 the responsible parties
