Incident/ Accident Reporting SOP

Incident/ Accident Reporting SOP

1.0   PURPOSE:

1.1.         The purpose of incident/accident report is to help ___________Pharmaceuticals regarding manufacturing facilities, identify risks and thus eliminate hazards.        

2.0    SCOPE:

2.1.         This procedure provides the guidelines for reporting accident resulting from work related injuries and investigation of all such accidents including measures to prevent recurrence.

3.0   RESPONSIBILITY:

3.1.      All Department Heads

3.2.      QA Officer

3.3.      Admin Officer

4.0    PROCEDURE:

4.1.      Reporting of Incident/Accident:

4.1.1.   All employees especially section supervisors and department heads must

    report all Incidents/accidents or “near miss” on Incident/Accident report form

    (F-07-006).

4.1.2.   The report must be submitted to Admin department within 24 hours.

4.2.      Corrective Action:

4.2.1.   On receiving report, Admin Officer initiates immediate corrective action in 

    case of serious injury by providing required first aid or arranging visit to 

     nearby clinic/hospital in case of serious injuries.

4.3.      Incident/Accident Investigation:

4.3.1.   All the Incidents/Accidents regardless of severity must be investigated.

4.3.2.   Section supervisor for the area where accident occurred conducts investigation

    with Admin officer to determine cause of the accident by observing the

    area/equipment & collecting information from workers present as well as from

    the injured employee.

4.3.3.   Investigation team examines hazards and current controls available and

    determines preventive measures to be taken to avoid recurrence. The

     investigation report is then forwarded to Director for final closing.

4.4.      Q.A. Officer maintains records of Incidents/Accidents at _________ Plant premises.

5.0    REVIEW FREQUENCY:

SOP will be reviewed at least annually.

6.0      RISK ANALYSIS:

EVIDENCES OF RECORDS & REFERENCES			Incident/Accident Report (F-07-006)
FORMAL KPIs (Key Performance Indicators)			Reduction in incidents/accidents in plant
GENERAL RISKS			CONTROL   MEASURES		CUSTODIAN
Risks	Impact
Preventive measure has not been taken after incident	Chances of reoccurrence of the same incident	After every incident must ensure that the root cause has been identified and eliminated completely		QA Officer/ Admin Officer
Incident reports records has not been maintained and submitted to Admin Dept.	It will be difficult to identify the risks and to eliminate hazards	Always make sure to generate a report with complete information regarding incident