SOP for QC Operations

Title: Standard Operating Procedure for Quality Control (QC) Operations

Objective: To establish a standardized procedure for conducting quality control tests and inspections
in compliance with regulatory requirements.

Scope: This SOP covers all aspects of QC operations, including sample collection, testing, data
recording, and reporting.

Responsibilities:

QC Analyst: Responsible for executing QC tests.

QC Supervisor: Oversees QC operations and ensures compliance.

QC Manager: Ensures the availability of necessary resources for QC.

Procedure:

Sample Collection:

Identify and label samples correctly.

Follow approved sampling methods.

Ensure proper sample storage conditions.

Testing and Analysis:

Conduct tests according to approved methods.

Use calibrated equipment and instruments.

Record test results accurately.

Data Recording:

Maintain detailed records of tests and inspections.

Include sample information, test methods, results, and date.

Sign and date entries.

Data Review:

Review and verify test results for accuracy.

Address any discrepancies promptly.

Approve or reject batches based on results.

Reporting:

Generate QC reports.

Provide reports to relevant departments.

File records appropriately.

Documentation:

Keep all records and reports in a secure, organized manner.

Retain records according to the document retention policy.

Training:

Ensure that QC personnel are adequately trained.

Maintain training records.

Equipment Maintenance:

Schedule and perform regular equipment maintenance.

Document maintenance activities.

Non-Conformance Handling:

Report and investigate any non-conformances.

Take corrective and preventive actions.

Audit and Compliance:

Periodically audit QC processes for compliance.

Address audit findings and implement improvements.