RCA - Root Cause Analysis

Lecturer: Dr. Malcolm Ross

Date: 18, 19 December 2019
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 - Day Course
Hours: 09:00 – 17:00
Price: 4,300 NIS + VAT
Credit Points: 2
SKU: 19191
Course Language: Hebrew
About the Course
The legal action of the FDA against Bar Pharmaceuticals resulted in a ruling which established formally the need to carry out an investigation if something went wrong. This was followed by the publication of the Out of Specification [OOS] guidance in 1998. Al though these rules were primarily directed at the investigation of analytical results the door was opened to extend this to any deviations or unexpected results within the industrial environment.
The push by the FDA for Corrective Action Preventive Action [CAPA] has been the logical extension of the earlier OOS.
The course will start with a brief overview of the principles of CAPA and OOS and mention of Failure Mode and Effect Analysis and related techniques. The emphasis of the course, however, is on the requirements of both CAPA and OOS to find the real or root cause of the problem. The majority of citations for failed investigations both of CAPA and OOS refer back to the failure of the company to conduct a thorough investigation and to establish the root cause of this failure. Preventive action taken where the root cause has not been established is an invitation for the next investigation to take place.
Root Cause Analysis [RCA] is a systematic technique used to investigate such events in a manner that should reveal the intrinsic problems and thus allow their resolution. It is designed to answer the questions, what, when, how and why something happened. It employs techniques of task analysis, change analysis, barrier analysis and effect and causal factor charts. The course will discuss the general principles of RCA, the different methods of collecting and organising data and the work environment necessary to operate an effective RCA system. It will review the best way to form and maintain an RCA team.

Participants will work in groups and using actual incidents will look at different techniques such as HAZOP, 5W's and 1 H and Ishikawa diagrams to determine Root Cause Analysis.
Who should attend
  • Quality assurance staff
  • QC, Analytical and Production staff
  • Formulators
  • Validation and scale up specialists and those involved in trouble shooting, deviation reports and investigations.
  • Course Benefits
RCA - Root Cause Analysis
Benefits to the Participants
Participants will learn how the need to undertake investigations in a systematic manner came about. They will learn the philosophies of different systems that are used in various industries such as CAPA, FMEA, PHA and HAZOP and the difference between reactive and proactive systems.
They will be shown how Root Cause Analysis is an investigative technique that can provide the answers to many of the problems that occur in a company, ranging from administration to purchasing, to production, to R&D and QC through all aspects of quality assurance.
Systems for causal analysis and techniques of data collection will be considered together with change analysis, barrier analysis and event and causal factor charts.

In particular they will consider the work environment needed for RCA to be effective how to set up and maintain an RCA group in a company.

Attendees will see some specific industrial examples as to how RCA can be applied in a variety of situations ranging from technology transfer to troubleshooting.
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Issues to be covered
Day 1-morning
Section 1 Introduction

  • Corrective Action Preventive Action (CAPA) and Out of Specification (OOS) have consistently been found to be the prime cause of non-compliance over the last 10 years. Both have a fundamental necessity to determine the root cause because without this any action will likely only provide a temporary solution.
  • A brief overview of the history of CAPA and OOS development in the pharmaceutical industry together with a look at the interface between  RCA and Quality by Design
  • When not to carry out RCA-Investigation analysis, Process drift, criminal practice (data integrity).
Section 2 Root Cause Analysis–General Concepts & Processes
  • The overall process
  • Definition of the problem
  • Simple techniques such as the 5 Why’s
  • Definition of the problem- what, when, where, who, how,  how much and how many (5 W’s + 1H)?

Day 1-afternoon
Section 3 Data Collection
  • Sources of data
  • Task breakdown and analysis
  • Data acquisition
  • The walk through and the interview process
  • Data reliability-why not all data is good date
  • Data classification, sequencing and encoding
Section 4 Causal Analysis
  • Definition of different types of cause such as proximal and distal and causal factors
  • Identification of significant events
  • Evaluation of criticality and catastrophic events
  • Risk analysis as a precursor to RCA

Day 2 morning
Section 5 Change Analysis And Barrier Analysis
  • If a process used to work (worked in the past) and now does not work then something must have changed. This change may be analysed by a number of techniques.
  • Change analysis
  • Barrier analysis
Section 6 RCA High Level Techniques
  • Use of high level techniques such as Fish bone (Ishikawa)
  • diagrams and FMEA
  • Event and basal factor charts, event trees
  • Application of these techniques to specific case studies from actual industry examples
Day 2-afternoon
Section 7 Establishing RCA in a Company
  • The need for the right corporate culture
  • The blameless culture
  • Free flow of information
  • Setting up an RCA team
  • Reporting-how and to whom
Section 8 RCA as a Technique in Trouble Shooting & Technology Transfer
A consideration of how some RCA techniques can be applied to trouble shooting and technology transfer issues
About The Lecturer

Dr. Malcolm Ross

Dr. Malcolm Ross is a consultant specialising in training, project management and research and development in the pharmaceutical industry.

He holds a B.Pharm and Ph.D in medicinal chemistry from London University, was a lecturer at the Welsh School of Pharmacy, UWIST and a Visiting Senior Lecturer in the Dept. of Chemistry at Bar Ilan University and is a registered pharmacist in the State of Israel.
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