SOP for Handling the Accidents : Pharmaceutical Guidelines

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SOP for Handling the Accidents

Standard operating procedure for the handling of accidents in pharmaceuticals.

1.0 OBJECTIVE

To provide a procedure for reporting and investigation of accident/ incident.

2.0 SCOPE

This SOP is applicable to all accidents/incidents occurring in factory premises.

3.0 RESPONSIBILITY

All Department Heads and Manager EHS

4.0 ACCOUNTABILITY

Head of Departments

5.0 PROCEDURE

5.1 Definitions

5.1.1 Accident: An event, which involves loss or damage to the property, plant, machinery along with injury or loss of human life.
5.1.2 Incident: An event, which involves loss or damage to the property, plant, machinery, material without injury or loss of human life.

5.2 Types of Accidents

5.2.1 First aid case: An accident occurring while on the job which is treated by a qualified, trained first aid provider. The injured person resumes work after taking rest as advised.
5.2.2 Recordable Injury/Illness: An accident occurring while on the job which is treated by a medical officer. The injured person may or may not come to work on the same day as per the advice of the medical officer.
5.2.3 Man days lost case (injury/illness): An accident occurring while on the job which is treated by a medical officer. The injured person does not come to work on the next day as per the advice of the medical officer.

5.3 Types of Incidents

5.3.1 Near-Miss Incident: An incident with no property loss or bodily injury, but had the physical conditions of the event changed it could have led to an accident.
5.3.2 Key-Potential Incident: An incident, which leads to property loss.

5.4 Reporting an Accident/ Incident

5.4.1 The person who first witnesses the event shall report to concerned departmental officer/ engineer immediately.
5.4.2 On receiving the information the departmental officer/ engineer shall assess the situation and shall inform immediately to shift incharge, GM production, Manager EHS.
5.4.3 If a person is injured he/ she shall be given first aid by the trained first-aid provider and this shall be recorded in the first aid treatment register.
5.4.4 If the injury is beyond the scope of first-aid, the concerned departmental officer/engineer shall send the injured person to the nearest hospital.
5.4.5 If the accident/ incident has a potential that can affect other persons in the vicinity and/or the plant, the concerned departmental officer/engineer shall stop the plant activities, shut off power sources if required, except exhaust fans, alarm systems and personnel safety protection devices.
5.4.6 If concerned departmental officer/ engineer is unable to control accident/ incident then he shall intimate Safety Squad, activate Emergency Activation Alarm (Manual Call point) so that everyone knows about the emergency. Report the accident in Accident /incident reporting form.

5.5 Accident/ Incident Investigation

5.5.1 Manager EHS shall inform Senior Vice-President (Technical) about the accident/ incident. Manager EHS shall form a cross-functional investigation team in consultation with Senior Vice President (Technical). This team shall have at least three representatives. One representative will be the person who reported the accident/ incident, one representative from any other department and one from the EHS Department.
5.5.2 After completion of the investigation, a report shall be prepared.
5.5.3 The report shall be completed within 48 hours on starting the investigation.

5.6 The Accident/ Incident Investigation Report Communication

5.6.1 The Manager EHS shall ensure the compliance of corrective and preventive actions recommended in accident/incident investigation report.
5.6.2 He shall communicate the accident/incident investigation report to the concerned Department Head.
5.6.3 Department Head shall communicate the root cause analysis and corrective and preventive actions of the accident/incident to all personnel in his/her department.

6.0 ABBREVIATIONS

SOP - Standard Operating Procedure
EHS - Environment Health and Safety





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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