Root cause analysis and CAPA

2 Day/s

CPD Hours: 14

Classroom, online, in-house

Have you have ever wondered why you seem to investigate the same thing time and time again, or have to regularly raise the same corrective actions?

Maybe those improvements you’ve made recently aren’t as effective as you’d hoped. Well, you are not alone but maybe you are struggling to reach a root cause. This course provides an introduction to root cause analysis (RCA), problem solving and corrective and preventive action (CAPA) which should be part of any effective quality system. Continuous improvement, RCA and CAPA is certainly a requirement of EU GMP chapter 1 and ICH Q10 as it is in the USA via the FDA Guidance for Industry on Quality systems.

The course takes you through the process of identifying problems, gathering information to help with an investigation or problem-solving activity, and then applying a number of common tools and techniques to try and establish root cause.

It addresses the use of risk management as well as steps to avoid the, all to often accepted, human error. Taking action based on root cause is then essential in order to make the desired improvements. We finish by looking at what a Problem-solving organisation looks like with a dip into the world Lean and six sigma used in many organisations to underpin their operational excellence strategies. In many cases workshop exercises are used to practice the techniques discussed.

This course is suitable for anyone involved in problem solving in a regulated environment. You may be involved in problem solving as part of continuous improvement through operational excellence activities, risk management, investigating causes of non-conformances such as audit findings. You might be in an operational, quality or other similar role. You might be new to the team or experienced but with limited formal training. Either way this course would be ideal for you.

This course includes the following topics :

  • Failure Investigations and Regulatory Expectations
  • Current regulatory findings 
  • Understanding problems & event capturing
  • Overview of Root Cause Analysis
  • Brain storming
  • Fishbones
  • Pareto analysis
  • The 5-whys
  • Human error
  • Pareto Analysis
  • Out of specifications (OOS)
  • Risk assessment and management
  • Investigation reporting
  • A problem solving organisational culture

    By the end of the course you will be able to understand:

    • The regulatory background to root cause analysis investigations and corrective and preventative actions.
    • Risk analysis
    • The use of investigations in both prospective and reactive situations
    • Tools and techniques that can be used in Investigations to identify probable root cause
    • The requirements of a CAPA system for effective implementation of actions
    • The importance of documenting the process used
    • The tools and techniques for a problem solving organisation focused on continual improvement
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We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Andy Martin

Andy has over 35 years of pharmaceutical industry experience, beginning at Smith and Nephew in 1985 as a microbiologist, progressing to QA Microbiology Manager in 1996. During that time, he gained experience in QA and QC activities of the manufacture of sterile eye drops (terminally sterilized and aseptically filled), aseptically filled sterile creams and non-sterile syrups. In 2003 he became the RSSL Pharmaceutical Training Manager with responsibility for providing commercial pharmaceutical training courses. In 2007, Andy moved to Catalent pharma Solutions, in Swindon, as Microbiology Manager leading a team responsible for microbiological control of freeze-dried tablets and soft gel capsules. Andy gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events. In 2012 Andy set up ABM Consulting Ltd which offers services specializing in Microbiology, QA and Good Manufacturing Practice. Andy is also treasurer for the UKs foremost microbiology organisation, Pharmig.

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