SOP for Quality Control (QC) Laboratory Instruments

 Precision is the backbone of the QC Lab. When high-performance instruments like HPLCs, GCs, or Spectrophotometers fail, the following steps are mandatory:

1. Cease Operations: Stop all testing on the instrument immediately upon calibration failure.

2. Tagging: Place an "UNDER MAINTENANCE" sign on the system.

3. Expert Intervention: For malfunctions or "Out of Calibration" results, contact the original manufacturer or authorized supplier to request a Service Engineer.

4. Rectification: The service engineer must investigate the root cause, perform the necessary repairs, and provide a detailed service report.

5. Re-Validation/Calibration: After maintenance, the lab must perform either a partial or complete calibration to verify the instrument's performance.

6. Documentation: File the service report (detailing the cause of failure and actions taken) alongside the new calibration report in the instrument's history file.

7. Impact Assessment: The investigation must determine if the failure could have affected the results of samples tested since the last successful calibration.

8. QA Evaluation: The Head of Quality Assurance (QA) will evaluate the need to re-analyze previous samples. This ensures that no "false pass" results were generated due to the faulty equipment.

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Summary of Comparison: Engineering vs. QC Lab

Feature	General Equipment	QC Laboratory
Primary Responder	Internal Engineering Dept	External Service Engineer/Manufacturer
Documentation	Incident Report	Service Report + Calibration Report
Quality Check	Product Impact Assessment	Sample Re-analysis (QA Lead)
Replacement	Change Control (if non-identical)	Performance Qualification (PQ) required