SOP on Reporting of Production Incidents / Deviations and Resulting Actions

1.0 Purpose: This SOP describes the method for reporting production incidents and deviations from established written procedures, or deviations from established specifications and the action taken.

2.0 Scope: This SOP applies to Production Chemist.

3.0 Responsibility: Production staff, supervisors and manager to ensure procedure is followed.

4.0 Materials and Equipment: None

Incident: Brief excursion from specifications not directly affecting product quality, purity or safety.

Deviation: Process parameter out of specification; product quality, purity or safety in  question.

Critical Deviation: Process performed incorrectly; product quality, purity, safety affected.

5.2.0 Procedure  

5.2.1Document all incidents and deviations on data record form and signed at the time of the event.

5.2.2. Record the corrective action recommended by the production manager and approved by signing the records.

5.2.3 Quality Assurance manager should be notified immediately for any deviation

6.1 Quality Assurance follows up the recommendations for action and prepare a final report when the recommendations have been implemented.