Introduction to Risk Management

Regulatory Perspective

• Exploring the Risk Management Process as defined in GHTF 
• Reviewing ISO 14971
• Discussing when and where Risk Management is appropriate

  Risk Management Process

• Discussing what risk is
• Learning how to develop a Risk Management Plan
• Establishing and using a Risk Management Team
• Identifying and Assessing Risks
• Determining what to do once you know the risk

  Exploring the Risks and Benefits of Risk Management

• Identifying benefits of Risk Management
• Discussing Risk ranking and filtering

Analysis and Comparison of Risk Management Standards ISO 14971

  Review the similarities and differences between ICH Q9 and ISO 14971, Medical devices - Application of risk management to medical devices.

• Providing an overview of ICH Q9 and ISO 14971
• Reviewing the Risk Management Process in a regulated environment

Interactive Exercise: participants will identify linkage to Impact Assessment (a tool to identify which areas of a process or equipment should be validated, driven by the impact & risk on the product/process)

People and Process - Building the Infrastructure for Risk Management

• Overview of what elements would be included in the design of a scaleable and flexible process for risk management
• Organizational foundation for risk aware culture
• Developing policy and setting expectations
• Defining standard processes
• Training in the use of risk technologies
• Verifying compliance and improving the practice

Interactive Exercises: As each of the Risk Management Steps are reviewed and discussed, the group will perform interactive tasks including identifying Risks, Assessing the Risks, and determining what to do as a result of the Risk Assessment.

Benefit Assessment and Benefit/Risk Balance

• Reviews the current status of benefit assessment and balancing benefit/risk methodologies.
• Measurements used in benefit assessment
• Factors affecting benefit assessment
• Current status of balancing benefit/risk studies
• Quantitative methods in balancing benefit/risk

Effectively Documenting and Managing Your Design and Process FMEA

• Introduction to FMEA
  - What is FMEA, Design vs. Process?
  - Benefits and limitations of implementing FMEA
• Conducting FMEA Studies
  - Defining FMEA Terminology
  - Determining steps in the FMEA study process

Identifying Team Requirements

• Setting up FMEAs
• Time required for FMEA
• Hazard identification, record keeping and verification
• Identifying and avoiding pitfalls and delays in implementing FMEA

How does a manufacturer we prepare a process FMEA?

• What levels of validations are required for critical processes vs. the non-critical ones?
• Can the results of the PFMEA be used to determine the level of testing and qualification during Validation?

Interactive Exercise: Participants will generate will create/complete a process FMEA sheet for a specific process (the specific processes will be identified during the course).

Quality System Aspects & Risk Management Procedure

• Discussion of risk management procedure
• Purpose of quality system 
• Quality system strategy for compliance with Design Control 
• Typical quality system procedures, forms, and records relating to Design Control 
• Implementing Top Level Risk Management Procedure
• Examples of Risk Management models and risk analyses 
• Effective use of risk management techniques

Using Hazard Analysis and Critical Control Points (HACCP) to Identify and Control Process Risk

  Introduction to HACCP

• Defining HACCP
• Understanding why is it important
• Current status of Regulation (an FDA perspective)
• Benefits of implementing HACCP

  Conducting HACCP

• Initiating a HACCP study
• Seven principles of HACCP
• Record keeping and verification
• HACCP manual recommendations
• Identifying and avoiding pitfalls and delays in implementing HACCP

  Introduction to Various Hazards Identification Methodologies

• Procedural approach verses continuous process approach
• Hazards and Operability Analysis (HAZOP)
• Identifying the "what-ifs"
• Failure Mode and Effects Analysis FMEA

  Integrating HACCP with GMP and Risk Management

• Managing HACCP activities
• Consolidating strategy for HACCP, GMP, and risk management
• Validation, auditing, and training considerations

Corrective and Preventative Action (CAPA): Mitigating Risk in Manufacturing

• Evaluation and Risk Assessment of nonconformance/deviation
• Identify Corrective actions based on risk level
• Addressing deviations and nonconformance's within a CAPA program based on risk

Interactive Exercise: Participants should come prepared to discuss nonconformance/deviation issues they encounter at their work place. We will attempt to address these issues by applying some of the CAPA/Risk based principles discussed above.

Integrating Risk Management into Quality System

• CAPA procedures 
• Configuration management/change control procedures 
• Validation procedures
• Training procedures 
• Auditing procedures

General Discussion


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