WINTHROX LABORATORIES PVT.

LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA

1.0 OBJECTIVE:
To provide a procedure for reporting and investigation of accident/incident

2.0 SCOPE:
This SOP is applicable to all accident/incidents occurring in factory premises.

3.0 RESPONSIBILITY:
All departmental heads and EHS members.

4.0 ACCOUNTABILITY:
Head of departments (HODs).

5.0 PROCEDURES

5.1 Definition:
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
doctor. The injured person may or may not come to work on the same day as per the advice of the
medical doctor.

5.3 Reporting an Accident/ incident:

5.3.1 The person who first witnesses the event shall report to concerned departmental HOD.
5.3.2 On receiving the information, the departmental HOD shall assess the situation and shall inform
immediately to Leader EHS..
5.3.3 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/Form.
5.3.4 If the injury is beyond the scope of first aid, the EHS Leader shall send the injured person to the
nearest hospital.

5.4 Accident/ incident Investigation:

 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA

5.4.1 Concern department HODS shall inform about the incident to EHS leader, after completion of the
investigation, a report shall be prepared. The report shall be completed within 48 hours on starting the
investigation.

5.5 The Accident/incident investigation Report Communication:

5.5.1 The leader EHS shall ensure the compliance of corrective and preventive actions recommended in
accident/incident investigation report.
5.5.2 He/She shall communicate the accident/incident investigation report to the concerned departmental
Head.
5.5.3 Departmental 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 ABBREVIATION:

SOP: Standard operating procedure

EHS: Environment Health and safety

7.0 CHANGE HISTORY:

Sr. # Revision no. Effective date Reason

01 00 New
02
03

8.0 DISTRIBUTION:

Documents Distributed to Signature with date

Master Regulatory Affairs department
Copy QA

9.0 REFERENCE DOCUMENT:

1. Health and Safety Incident Report.
2. CAPA Report.
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA
 WINTHROX LABORATORIES PVT. LTD
QUALITY CONTROL DEPARTMENT

Title:- STANDARD OPERATING PROCEDURE

Document # :
Subject:- SOP OF HEALTH AND SAFETY INCIDENT REPORTING
QC/
Issue Date: 25-01- Review Date: 25-01-2023 Revision #: 00 Supersedes: NIL
2021
Prepared by: Checked by: Reviewed by: Approved by:
Analyst QC Officer RA Executive HR Manager QA