Internal Quality Control SOP

Purpose

To ensure the accuracy and reliability of test results through systematic internal quality control.

Scope

This SOP applies to all laboratory personnel involved in quality control processes.

Responsibilities

• Quality Manager: Oversee quality control procedures
• Laboratory Technicians: Perform quality control tests
• Quality Assurance Officer: Review quality control data

Materials & equipment

• Quality control samples
• Control charts
• Calibration standards
• Data entry software
• Documentation forms

Procedure

1. Obtain quality control samples from the designated storage.
2. Prepare the quality control samples according to manufacturer's instructions.
3. Run the quality control samples alongside patient samples.
4. Record the results of the quality control samples in the designated log.
5. Compare the results against established control limits.
6. Investigate any results that fall outside of the control limits and document the findings.
7. Take corrective action if necessary and re-test samples if required.
8. Review and analyze quality control data monthly for trends.
9. Report any persistent issues to the Quality Manager.
10. Maintain records of quality control results for at least two years.

Records

• Quality control log
• Monthly quality control report
• Incident report for out-of-control results

Safety

• Follow standard laboratory safety protocols when handling samples.
• Wear appropriate personal protective equipment during testing.