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.