Risk Management in Procurement – Standard Operating Procedure
1) Purpose
To establish guidelines for identifying, assessing, mitigating, and managing risks associated with procurement activities within the pharmaceutical purchase department.
2) Scope
This SOP applies to the proactive management of risks throughout the procurement lifecycle, from supplier selection to contract execution.
3) Responsibilities
Risk Management Team: Responsible for implementing risk management strategies and processes.
Procurement Team: Responsible for identifying and reporting procurement-related risks.
4) Procedure
4.1) Risk Identification:
4.1.1) Identify potential risks associated with procurement activities, including supplier reliability, quality issues, and regulatory compliance.
4.1.2) Document identified risks using a standardized risk register or similar tool.
4.2) Risk Assessment:
4.2.1) Assess the likelihood and impact of identified risks on procurement objectives and project timelines.
4.2.2) Prioritize risks based on their severity and potential consequences.
4.3) Risk Mitigation:
4.3.1) Develop risk mitigation strategies and action plans to reduce the likelihood or impact of identified risks.
4.3.2) Implement control measures, such as supplier assessments, contract terms, or contingency plans.
4.4) Monitoring and Control:
4.4.1) Monitor identified risks throughout the procurement process to ensure effectiveness of mitigation strategies.
4.4.2) Review and update risk management plans as needed based on changing circumstances or new information.
4.5) Communication and Reporting:
4.5.1) Communicate identified risks and mitigation strategies to relevant stakeholders, including procurement and project teams.
4.5.2) Provide regular reports on risk status, mitigation efforts, and emerging risks to management and key stakeholders.
5) Abbreviations, if any
N/A
6) Documents, if any
- Risk Register
- Risk Assessment Reports
- Risk Mitigation Action Plans
- Risk Monitoring and Control Logs
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.22, ICH Q9
Industry Standards: ISO 31000:2018
8) SOP Version
Version 1.0
