Root Cause Analysis in Life Sciences

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Conduct effective RCA investigations to improve the performance of your business.

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Course Overview

 

Effective root cause analysis is both a regulatory expectation and a valuable tool for business improvement.  More and more life science organisations are creating a deep RCA culture and working environment to improve their processes and reduce the number of non-conformities.

 

This training course sets out a systematic and structured approach for determining the most likely root cause of a problem or non-conformance. It will provide you with a range common tools used during root cause identification such as brainstorming, Ishikawa diagrams and process maps. The key steps in root cause analysis are explained using practical examples supporting your understanding. You will also learn the common pitfalls in root cause analysis.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development.

 

Learn more about how we deliver online and classroom training.

Key Learning Objectives

 

  • Understand regulatory expectations and definitions relevant to root cause analysis.
  • Appreciate the importance of precise problem definitions.
  • Learn how to conduct a root cause analysis investigation in a logical, unbiased manner.
  • Understand the importance of assembling an appropriate team for root cause investigation.
  • Appreciate how to assign appropriate corrective actions and preventive actions.
  • Be able to select appropriate root cause analysis tools.
Post Learning Implementation Plan (PLIP)

Pre-course

  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Day 1

Introduction to Root Cause Analysis (RCA)

  • Regulatory expectations
  • RCA definitions, benefits and goals
  • Steps in RCA:
    • Problem definition
    • Problem history
    • Possible causes
    • Linking the problem to root cause(s)
    • Corrective and preventive actions

 

Problem Definition

  • Problem statements
  • Event descriptions
  • Examples

 

Problem History

  • Problem timeline
  • Chronology of causal factors
  • Examples

 

Possible Causes

  • Root causes
  • Causal factors
  • Non-causal factors

 

Linking the Problem to Root Cause(s)

  • Identifying root cause(s)
  • Introduction to problem analysis tools
  • Examples

 

Preventive/Mitigating Actions

  • Goals
  • Preventive action risk analysis
  • Examples
Day 2

Challenges in RCA

  • Availability/quality of information
  • Multiple causes
  • Knowledge/perspective of the person conducting the investigation

 

Root cause analysis tools and how to use them, including:

  • Brainstorming
  • Five “Why?”s
  • Ishakawa Diagrams/The Six Ms
  • Process Maps
  • Is/is not
  • Failure Mode and Effects Analysis
  • Fault Tree Analysis/Causal Factor Tree Analysis

 

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.

 

In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, RCA, CAPA, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.

 

Mark has delivered many training courses on Root Cause Analysis, both online and in-person. He has helped professionals to develop competence in RCA so that they are aware of the available RCA tools and know how to use them. Mark draws on his extensive experience of RCA and provides multiple examples throughout the course.

This course is aimed at professionals who are involved in identifying the causes of problems or non-conformities through the pharmaceutical, biopharmaceutical and medical device industries. These include:

  • Quality Assurance Personnel
  • Quality Control Professionals
  • Laboratory Personnel
  • Product Development Specialists
  • Qualified Persons
Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

 

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.