The QA plan shall address supporting procedures including technical procedures and shall outline the structure of the documentation used in the quality system, including but not limited to the following:
- (1) ensuring that all records required are retained
- (2) control and maintenance of documentation through a document control system which ensures that all standard operating procedures (SOPs), manuals, or documents clearly indicate the time period during which the procedure or document was in force;
- (3) achieving traceability of measurements;
- (4) handling submitted samples;
- (5) feedback and corrective action whenever testing discrepancies are detected or departures from documented policies and procedures occur;
- (6) dealing with complaints;
- (7) protecting confidentiality (including national security concerns) and proprietary rights;
- (8) audits and data review; and
- (9) establishing that personnel are adequately experienced in the duties they are expected to carry out and are receiving any needed training.
Added at 25 Ok Reg 2247, eff 7-11-08