Standard Operating Procedure for Quality Risk Management

1) Purpose

This SOP outlines the procedures for implementing a systematic approach to quality risk management (QRM) to assess, control, communicate, and review risks associated with pharmaceutical operations, ensuring patient safety, product quality, and regulatory compliance.

2) Scope

This SOP applies to all departments and personnel involved in pharmaceutical manufacturing, quality assurance, regulatory affairs, and related functions within the company.

3) Responsibilities

The Quality Assurance (QA) department is responsible for establishing and maintaining the QRM process. All personnel are responsible for identifying, assessing, and managing risks within their respective areas of responsibility.

4) Procedure

4.1 Risk Identification

1. Identify potential risks associated with processes, systems, products, and activities using tools such as FMEA (Failure Mode and Effects Analysis), HAZOP (Hazard and Operability Study), and other risk assessment methods.
2. Document identified risks and their potential impact on product quality, patient safety, and regulatory compliance.

4.2 Risk Assessment

1. Evaluate identified risks based on severity, likelihood, and detectability to prioritize risks for further analysis and risk control.
2. Assign risk levels (e.g., high, medium, low) and determine the need for risk mitigation strategies.

4.3 Risk Control

1. Develop risk mitigation plans and strategies to reduce or eliminate identified risks.
2. Implement risk controls, including process modifications, procedural changes, additional testing, or enhanced monitoring.

4.4 Risk Communication

1. Communicate identified risks, risk assessments, and risk control measures to relevant stakeholders, including management, departments, and personnel affected by the risks.
2. Ensure clear and effective communication to facilitate understanding and implementation of risk mitigation actions.

4.5 Risk Review

1. Regularly review and reassess identified risks to ensure effectiveness of risk controls and mitigation strategies.
2. Update risk assessments and risk management plans as necessary based on new information, changes in processes, or emerging risks.

4.6 Documentation and Records

1. Maintain accurate records of risk assessments, risk management plans, risk control measures, and risk review activities.
2. Ensure that all documentation is accessible for audits, regulatory inspections, and management review.

5) Abbreviations, if any

QA: Quality Assurance
SOP: Standard Operating Procedure
QRM: Quality Risk Management
FMEA: Failure Mode and Effects Analysis
HAZOP: Hazard and Operability Study

6) Documents, if any

Risk Assessment Reports, Risk Management Plans, Communication Logs, Review Reports

7) Reference, if any

Regulatory guidelines such as FDA, EMA, ICH Q9 (Quality Risk Management), and ISO 31000 (Risk Management)

8) SOP Version

Version 1.0