1. (a) The laboratory shall implement general procedures to be followed when departures from documented policies, procedures, and quality control (QC) measures have occurred.
2. (b) The laboratory shall document departures from documented policies, procedures, and QC measures and the corrective actions taken as specified in Volume 1, Module 2, Sections 4.9 and 4.11 of the TNI standards.
3. (c) The laboratory’s documented corrective action shall include a description of the nonconforming work or departure from a policy or procedure, a root cause analysis, a selection of corrective action, an implementation of corrective action, monitoring of corrective action, additional audits performed, and signed and dated approval of laboratory management.
4. (d) Where possible, the laboratory shall report data only if all laboratory policies and procedures have been followed and QC measures are acceptable.
5. (e) If a QC measure is found to be a departure from documented policies, procedures, and QC measures and the data is to be reported, all samples associated with the failed QC measure shall be reported with appropriate data qualifier(s).

Source. (See Revision Note at chapter heading for Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21