Quality Assurance, Documentation, and Reporting
Assurance versus control
Quality assurance is the system that builds quality in - procedures, training, calibration, design control, supplier qualification, audits. Quality control is the measurement that catches defects - inspection, testing, sampling. A question describing a new procedure is QA; one describing a test result is QC.
Document control is heavily examined. Every controlled document needs an owner, a unique identifier, a revision number, an effective date, an approval signature, and a defined distribution; superseded copies are withdrawn so no one works from the wrong version. Distinguish records (evidence of what happened, never revised - only corrected) from documents (instructions, which are revised).
Apply the data-integrity convention - attributable, legible, contemporaneous, original, accurate - and know the correction rule: a single line through the error, the correct entry beside it, initial and date, and the reason if required. Never obliterate, never backdate, never pre-sign. Backdating is falsification, not a formatting error.
Nonconformance and reporting
A nonconformance triggers containment, disposition, root cause, corrective action, and an effectiveness check. Audit findings are usually graded major (systemic or a serious breach), minor (isolated lapse), and observation (improvement opportunity). Reports should state criteria, evidence, conclusion, and required action, distinguishing fact from opinion.
Worked example
An operator realizes at 16:00 that a 14:00 check was skipped and writes "14:00 - OK" to keep the log continuous. This is falsification: the correct action is to record the actual time, note the gap, and raise a nonconformance so the cause is addressed.