How to Implement Risk Management Principles and Activities Within a Quality Management System

This two-day course is designed for quality managers, engineers, auditors, regulatory/quality compliance professionals, production managers and top management interested in learning the value of Risk Management Principals and how to enhance existing systems by better utilizing resources through the optimization of risk management techniques.

This program will provide a broad introduction to the subject of risk management for more experienced personnel, including middle and upper management. It will allow participants to update and broaden their knowledge of US and International Risk Management requirements. It explores both the positive and negative aspects of risk and aims to improve knowledge and practical skills in the identification assessment and control of business risk.

Learning Objectives

Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of risk management for medical devices, pharmaceutical and biologics products and processes. An emphasis will be placed on the effective use of resources in a production and quality system environment by developing strategies based on risk.

The first day will cover the general context for risk management, required procedures and the discussion of the general ISO 14971, FDA, and GHTF requirements of risk management. The second day will discuss and apply several risk management techniques which will be covered as they relate to a products and production processes.

Course Description

Risk management is a practice with processes, methods, and tools for managing risks in a project. It provides a disciplined environment for proactive decision making to continuously assess what could go wrong within an organization and with its products. The course will cover which risks are important to deal with and how the implementation of strategies can mitigate risks. Additionally, the curriculum provides attendees with the skills to use, maintain, and extend the functionality of a Risk Management system by effectively analyzing and producing firm-wide risk management tools and measures.

Specifically, this training will teach and reinforce the skills needed to acquire data from disparate data sources, configure your risk environment, develop appropriate risk factor models, perform risk analysis and create results-based reports.

Topics cover current US and International regulatory requirements with respect to development and implementation of effective risk management. A focus will be placed on basic regulation and the Global Harmonization Task Force’s recent supplemental guideline on “Implementation of Risk Management Principles and Activities within a Quality Management System”

Among the topics to be discussed are: HACCP (Hazard Analysis and Critical control Points) within the overall quality system and regulation, risk management procedures, strategies, forms, records, safety/risk management strategies, documentation strategies, manufacturing validation strategies based on risk, and strategies for integrating general risk management into quality system process.

This course will also provide participants with a systematic approach for recognizing potential failure modes and analyzing effects for product design and manufacturing processes. Once potential failure modes have been identified a process FMEA can be used to identify the level of validation testing.

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COURSE AGENDA

DAY ONE

Introduction to Risk Management

 Regulatory Perspective
- Exploring the Risk Management Process as defined in GHTF
- 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

How Does A Manufacturer 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?

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

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).

DAY TWO

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