and accidents occurring in API production, warehouses, laboratories, maintenance areas, and administrative zones, including chemical exposures, equipment malfunctions, injuries, near misses, and environmental incidents.

3. Responsibilities

• Employees: Promptly report all incidents or unsafe conditions to supervisors.
• Supervisors: Initiate first-level documentation and notify the EHS team.
• EHS Officer: Lead formal investigation, conduct root cause analysis, and recommend CAPA.
• QA Representative: Verify procedural compliance and maintain documentation.
• HR Department: Coordinate medical attention, if required, and handle insurance-related processes.

4. Accountability

The Head of EHS is accountable for the implementation and effectiveness of the incident and accident management system, including corrective and preventive actions, closure timelines, and communication to stakeholders.

5. Procedure

5.1 Definitions

• Incident: Any unplanned event that does not result in injury but has the potential to do so (near miss).
• Accident: An unplanned event that causes injury, illness, or property/environmental damage.

5.2 Immediate Reporting

1. Any person witnessing or involved in an incident/accident must inform their supervisor immediately.
2. Initial details to be noted in the Incident Reporting Log (Annexure-1).
3. Serious injuries must be reported to EHS, QA, and plant management within 30 minutes.

5.3 First Response and Containment

1. Secure the area and prevent access to others.
2. Provide first aid or medical attention as necessary.
3. Isolate energy sources if equipment is involved (lock-out/tag-out).
4. Take photographs and gather evidence before cleanup (where safe).

5.4 Formal Investigation

1. EHS shall form an investigation team for moderate to major incidents.
2. Use the Incident/Accident Investigation Form (Annexure-2) for:
   • Sequence of events
   • Personnel involved
   • Witness statements
   • Root cause analysis (5-Why/Fishbone)

5.5 Classification of Severity

1. Incidents shall be classified as:
   • Level 1: Minor incident – no injury or loss
   • Level 2: Moderate – first aid injury/property damage < ₹10,000
   • Level 3: Major – hospitalization, regulatory reportable, fire, or environmental damage
2. Level 3 incidents must be reported to local authorities as per the Factories Act.

5.6 Corrective and Preventive Action (CAPA)

1. Investigators shall define CAPAs based on root causes.
2. Each CAPA must be assigned to a responsible person with target dates.
3. Track CAPAs in the Incident CAPA Tracker (Annexure-3).

5.7 Closure and Review

1. Close incident only after CAPA completion and verification by EHS and QA.
2. Record final closure in the Incident Closure Log (Annexure-4).
3. Serious incidents to be reviewed during monthly EHS Committee meetings (Annexure-5).

5.8 Training and Communication

1. Lessons learned shall be communicated via toolbox talks and bulletin boards.
2. Annual refresher training shall include real-life case discussions.

6. Abbreviations

• EHS: Environment, Health & Safety
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action
• PPE: Personal Protective Equipment
• SOP: Standard Operating Procedure

7. Documents

1. Incident Reporting Log – Annexure-1
2. Incident/Accident Investigation Form – Annexure-2
3. Incident CAPA Tracker – Annexure-3
4. Incident Closure Log – Annexure-4
5. EHS Committee Meeting Record – Annexure-5

8. References

• Factories Act, 1948 – Sections on Safety and Health
• OSHA 1904 – Recording and Reporting Occupational Injuries and Illnesses
• ICH Q10 – Pharmaceutical Quality System
• ISO 45001 – Occupational Health and Safety Management System

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Incident Reporting Log

Date	Location	Type	Reported By	Initial Action
13/04/2025	Solvent Area	Near Miss	Sunita Reddy	Area Isolated

Annexure-2: Incident/Accident Investigation Form

Incident ID	Type	Description	Root Cause	Investigator
INC-024	Accident	Slip on wet floor	No caution signage	Rajesh Kumar

Annexure-3: Incident CAPA Tracker

CAPA ID	Action	Owner	Status	Due Date
CAPA-024	Install caution boards	Maintenance	Completed	15/04/2025

Annexure-4: Incident Closure Log

Incident ID	Date	Closed By	QA Verified	Remarks
INC-024	15/04/2025	EHS Officer	Yes	Closed

Annexure-5: EHS Committee Meeting Record

Date	Chairperson	Key Topics	Decisions
01/04/2025	Plant Head	Review of Incidents	Install additional safety posters

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
14/04/2025	2.0	Updated classification and annexures	Regulatory Update	QA Head