Quality Assurance, Records, and Documentation
The quality system
Quality assurance covers the planned and systematic actions needed to give confidence that requirements are met. Know the difference between quality control (testing and measurement), quality assurance (the system), and quality management (the broader organisational framework). Key elements: documented procedures, traceability, calibration, training records, non-conformance and corrective action, and management review.
Records
Records must be legible, identifiable, retrievable and retained for the required period. Know the difference between a record (evidence of a completed activity) and a procedure or instruction (how to do it). Traceability links a measurement to its instrument, calibration, operator and date.
Traps
- Confusing QA with QC.
- Assuming electronic records are exempt from signature and audit-trail requirements.
- Forgetting that calibration certificates have expiry dates and that out-of-calibration instruments invalidate results.
- Treating a corrective action as complete before effectiveness is verified.
Rule of thumb
If the question asks "how do we know the result is valid", the answer lies in traceability: instrument, calibration, method, operator and date.
Worked example
A dose-rate survey used an instrument whose calibration expired two weeks earlier. The results cannot be relied upon for compliance; the instrument must be recalibrated, the survey repeated, and a non-conformance raised with a corrective action.