Risk Assessment and Management for Healthcare Manufacturing

Tim Sandle has published a new book titled “Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies.”

Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always be mindful of risk.

Tim Sandle's newest book incorporates regulatory perspectives, scientific methods and practical examples to describe approaches to problem solving when assessing, managing and reviewing risk. The book is divided into four sections that present a formal approach to risk. The first section provides a look at risk assessments and hazards, exploring the origins, looking at key concepts and philosophies and assessing the regulatory perspective. An overview of available tools for risk assessment and problem solving leads into specific 'soft skills' that can help to run an effective meeting, oversee a project and report root cause analysis and risk outcomes. The book concludes with an extensive set of case studies to show real-world applications of the tools and techniques presented. The wide range of topics presented throughout the four sections includes risk considerations for aging pharmaceutical facilities, application of quality risk management to cleanroom design and process incident investigation.

Further details about the book and ordering details can be found via the PDA Bookstore: https://store.pda.org/ProductCatalog/Product.aspx?ID=3329

The contents of the book are:

Part A: Risk Assessment and Hazards

• Risk Assessment and Risk Management
• Regulatory Perspectives on Risk
• Pharmaceutical Processing Hazards
• Root Cause Analysis

Part B: Risk Assessment Tools and Problem Solving Approaches

• Question Based Approaches: The "Five Whys" and "What if" Methods
• Is/Is not Approach
• Simple Risk Assessment Tools
• Fishbone (Ishikawa) Diagram
• Contradiction Matrix and Knot Charts
• Pareto Charts and Control Charts
• Hazard Analysis and Critical Control Points
• Failure Modes and Effects Analysis
• Monte Carlo Method
• Fault Tree Analysis
• Hazard and Operability Study
• Six Sigma and Associated Quality Tools

Part C: Practical Tips

• Effective Meetings and the Process of Brainstorming
• Project Management and Research
• Reporting Risk Outcomes

Part D: Case Studies

• Application of Quality Risk Management to Cleanroom Design
• Case Study: Hepa Filter Failure
• Aseptic Transfer Risk Assessment: A Case Study
• Importance of Risk Assessment for Aseptic Transfer in Pharmaceutical Compounding
• Risk Assessment for Intervention Scoring in Relation to Aseptic Processing
• General Considerations for the Risk Assessment of Isolators Used for Aseptic Processes
• Risk Considerations for the Use of Unidirectional Airflow Devices
• Risk Consideration for Aging Pharmaceutical Facilities
• Process Incident Investigation
• Addressing Manufacturing Constraints by Increasing Production Throughput
• Risk Assessment of Production Formulation Stages
• Risk Based Approach to Internal Quality Auditing
• Risk Assessment for Data Integrity
• Assessment of Raw Material Handling and Expiration
• Risk Management and the Supply Chain
• Risks Associated with Clinical Trials
• Application of Risk Assessment to Develop an Environmental Monitoring Program
• Detection and Risk: Environmental Monitoring Data Deviations
• Application of Risk Assessment for Personnel Safety
• Risk Considerations for the Installation of a New Pharmaceutical Facility Autoclave
• Safety Risk Assessment for the Ozonation of a Purified Water System
• Error Risk Reduction: Concept and Case Study

The reference is:

Sandle, T. (2016) Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies, PDA / DHI, Bethesda, MD, USA.

Posted by Dr. Tim Sandle