Root Cause Analysis and Critical Thinking Training Course

Course overview

Root Cause Analysis (RCA) is the process of discovering the root causes of problems to identify solutions. When used with critical thinking, the ability to think clearly and rationally, understanding the logical connection between ideas this provides a highly effective method for identifying the source of faults, failures, decision making, and undesired outcomes for processes. This approach is extremely effective when used by the pharmaceutical and associated healthcare industries to solve problems. In addition, RCA procedures with the application of critical thinking are an increasing focus by regulatory inspectors.

Often organisations waste a great amount of time and money in fixing the symptoms of a problem, rather than the problem itself. Using Critical thinking applied to RCA will enable you to solve problems far quicker, and much more effectively.

This one-day course introduces delegates to different RCA and critical thinking problem-solving tools and techniques which are then applied throughout a series of highly interactive and practical exercises putting these theories into practice to apply a systematic end-to-end process for analysing problems and decision making.

Benefits of attending

• Apply best practice tools and techniques to identify, and document the root causes of problems
• Propose and evaluate solutions to prevent problems recurring and manage regulatory inspection findings
• Communicate your findings and recommendations to colleagues and senior management
• Gain an overview of the increasing importance of RCA and critical thinking skills for pharmaceutical and biopharmaceutical and associated healthcare sectors
• Understand the critical thinking and application to RCA
• Be aware of key tools and approaches to apply critical thinking to RCA for pharmaceutical and associated healthcare industries

Who should attend?

Anyone working in the pharmaceutical, biopharma, medical device and veterinary industries who wants to maximise RCA and critical thinking skills, particularly applied to problem solving and decision making including the following:

• Managers responsible for process and quality improvements
• Professionals working in R&D and production
• Quality managers, internal and external auditors, inspectors
• Line managers and supervisors
• Anyone involved in managing customer and/or supplier/CMOs, CRO relationships
• Problem solving team members and leaders
• Product or process designers
• Operational and production professionals

Background and defining RCA and critical thinking

Steps in RCA and applying critical thinking

Preventive/Mitigating problems

• Preventive action
• Risk analysis
• Failure Mode and Effects Analysis (FMEA)

Diagnosing RCA

RCA Methodologies

• Brainstorming
• Ishikawa Diagrams
• Five “Why?”s
• Is/is not
• Process maps

Critical Thinking

• Overview of background
• Define critical thinking, decision making and problem solving and understand the differences
• Examine types of decisions & problems in the pharma industry
• Understand the focus of critical thinking in ICH Designing Quality
• Applying critical thinking to thinking questions to go beyond checklists
• Tools and approaches for critical thinking to use in the pharmaceutical and associated healthcare industries including
  • RED
  • thinking outside the box
  • ways to improve your critical thinking
  • application to RCA