Developing the Risk Management Plan
Overview:
This presentation will review the requirements for the Risk Management Plan and discuss practical methods for meeting the requirements.
Examples of documentation of the Plan will be presented, including Risk Acceptability Criteria, risk review, verification activities, and information collection activities. While Risk Management Plans can be part of the Quality Plans for a product, important characteristics of the Risk Management Plan must be documented to meet requirements. In situations where development and manufacturing activities are located in different areas and are under different management structures, the Risk Management Plan must document the divided responsibilities and activities. The plan must cover all phases of the product lifecycle risk management activities. This presentation will discuss how to accomplish risk management planning in divided management structures.
Why you should attend: One of the major requirements of the medical device risk management standard ISO 14971 is to develop a Risk Management Plan. One of the least understood and executed requirements are the Risk Management Plan. As ISO 14971 becomes required for product safety certification and is audited by regulators this requirement will become a greater issue. The Risk Management Plan establishes the risk management activities required for product development, manufacturing and improvement. The plan also documents the responsibilities for various groups and positions in the manufacturer's organization. If the plan is not established, it is possible the activities required by the standard may not be executed or documented as required to be in compliance with the standard.
Areas Covered in the Session:
- ISO 14971 requirements for risk management planning
- Setting Risk Acceptability Criteria
- Planning for verification of risk control implementation and effectiveness
- Documenting responsibilities for risk activities
- Establishing risk review activities
- Example of a risk management plan
- Risk Management in various organizational structures
Who will benefit:
- Risk Managers
- Project Managers
- Quality Engineers
- Regulatory Managers
- Design Engineers
- Design Managers