Assessment Team: Participate in risk evaluation and develop mitigation strategies.

QA Manager: Review and approve the risk assessment report and actions.

4. Accountability

The Head – Quality Assurance is accountable for ensuring compliance with this SOP and the effective execution of risk assessment procedures across all sterile injectable operations.

5. Procedure

5.1 Risk Assessment Planning

1. Define the purpose and scope of the risk assessment (e.g., new equipment, process change, deviation analysis, etc.).
2. Appoint a cross-functional team comprising QA, Production, Engineering, QC, and Regulatory Affairs.
3. Prepare a Risk Assessment Plan (Annexure-1).

5.2 Risk Identification

1. Use tools such as Process Flow Diagrams, Cause-and-Effect (Fishbone) Diagrams, and Brainstorming sessions.
2. Document all potential hazards, failure points, or deviations from predefined quality attributes or process parameters.
3. Record identified risks in the Risk Register (Annexure-2).

5.3 Risk Analysis

1. Analyze the severity (S), probability (P), and detectability (D) of each risk using a scoring scale (e.g., 1–5).
2. Calculate Risk Priority Number (RPN): RPN = S × P × D.
3. Rank risks based on RPN value.

5.4 Risk Evaluation and Control

1. Classify risks as Low, Medium, or High based on predefined RPN thresholds.
2. Determine appropriate control actions:
   • Elimination of the risk source
   • Substitution with a safer method
   • Implementation of engineering or administrative controls
3. Record mitigation strategy in Risk Control Sheet (Annexure-3).

5.5 Risk Mitigation and Implementation

1. Assign responsible personnel and deadlines for risk mitigation actions.
2. Monitor implementation progress.
3. Verify effectiveness through impact assessments or validation reports.

5.6 Risk Review and Approval

1. Compile a Risk Assessment Report summarizing the process, findings, mitigation measures, and outcomes (Annexure-4).
2. QA reviews and approves the final document.
3. Maintain records for audit and regulatory submission.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• RPN: Risk Priority Number
• FMEA: Failure Mode and Effects Analysis
• PFD: Process Flow Diagram

7. Documents

1. Risk Assessment Plan – Annexure-1
2. Risk Register – Annexure-2
3. Risk Control Sheet – Annexure-3
4. Risk Assessment Report – Annexure-4

8. References

• ICH Q9 – Quality Risk Management
• WHO TRS 986 Annex 2 – GMP Guidelines
• ISO 31000: Risk Management – Principles and Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Risk Assessment Plan

Area	Filling Line (SVP)
Purpose	New Equipment Installation
Date	01/06/2025
Team Members	Sunita Reddy, Rajesh Kumar, Anita Mehta

Annexure-2: Risk Register

Risk ID	Description	Severity	Probability	Detectability	RPN
R001	Power failure during filling	5	4	3	60

Annexure-3: Risk Control Sheet

Risk ID	Control Strategy	Owner	Deadline	Status
R001	UPS system installation	Engineering	15/06/2025	Completed

Annexure-4: Risk Assessment Report

Report No.	RAR/2025/015
Summary	Risk assessment conducted for SVP filling line installation. One high-risk and two medium-risk issues identified and mitigated. No unacceptable risk remains.
Approved By	QA Head
Approval Date	16/06/2025

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Revised structure, updated annexures	Periodic Review	QA Head