Overview
Quality control (QC) is the set of run checks that show a method is working today. Quality assurance (QA) is the broader system, including SOPs, training, documentation, and review, that keeps laboratory work reliable over time.
Classification
| Term | Scope | Typical bench examples |
|---|---|---|
| QC | Today's run/method check | Control materials; accept/reject run |
| QA | Ongoing system reliability | SOPs, training, records, reviews |
Morphologic Features
Not applicable, this entry compares quality concepts, not morphology.
Laboratory Characteristics
- QC is shift-visible and run-linked
- QA is structural and ongoing
- Both are required for patient-safe work
Reference Intervals
Not applicable . QC acceptance limits are method/SOP-defined; this entry is conceptual, not a patient reference interval.
Clinical and Laboratory Significance
Confusing QC with QA can leave system weaknesses unaddressed. Passing controls do not correct missing training, unclear SOPs, or poor documentation.
Differential Considerations
Not a disease differential. Distinguish run QC failure from broader QA problems (process, training, documentation) when investigating recurring issues.
Comparison Tables
QC vs QA checkpoints
| Statement | Safe understanding | Unsafe shortcut |
|---|---|---|
| Controls passed | Today's run may be analytically acceptable | Assume entire quality system is fine |
| Repeated labeling near-misses | QA issue, training/process review needed | Ignore because QC passed |
| Failed QC | Hold patients; follow SOP | Release 'obvious' patient results anyway |
Classification Frameworks
Not applicable . WHO disease classifications do not define QC versus QA.
Laboratory Notes
- QC = working today?
- QA = reliable over time (SOP, training, docs, review)
- QC pass does not replace QA
References
Authoritative textbooks, guidelines, and reviews supporting this reference entry. Verify reference intervals, critical limits, and reflex criteria against institutional protocols and current guideline editions.
Textbooks
- McPherson RA, Pincus MR. Henry's Clinical Diagnosis and Management by Laboratory Methods. 24th ed. Elsevier; 2021. (Laboratory quality and management chapters, verify current edition.)
CLSI and Professional Guidelines
- Institutional laboratory SOPs, locally adopted quality policies, and manufacturer instructions for use (IFU). Always verify current local practice.
Frequently Asked Questions
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