Defining QA and QC in the Lab
Quality Control (QC) and Quality Assurance (QA) are both essential but serve different purposes in the laboratory’s quality system.
- QC: Day-to-day checks that test systems are performing within expected limits.
- QA: Broader, systematic evaluation of all processes to ensure overall quality and regulatory compliance.
Examples of QC Activities
- Running control materials with each test batch.
- Reviewing Levey-Jennings charts and Westgard rules.
- Documenting corrective action for failed controls.
- Verifying calibration and instrument performance.
Examples of QA Activities
- Evaluating specimen rejection rates and turnaround times.
- Reviewing proficiency testing performance and trends.
- Conducting internal audits and management reviews.
- Managing corrective and preventive action (CAPA) programs.
How QA and QC Work Together
QC identifies immediate issues with test performance, while QA evaluates whether the lab’s systems, policies, and procedures effectively prevent and manage those issues. Both are required for CLIA compliance and are essential for a robust QMS.
Managing QA and QC in mylabcompliance.io
mylabcompliance.io brings QA and QC together by:
- Digitizing QC logs and linking them to instruments and methods.
- Capturing QA events, nonconformities, and action plans.
- Providing dashboards that summarize QC issues and QA outcomes.
- Supporting documentation for CLIA inspections and accreditation surveys.