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Root Cause Analysis

4/5 December 2024, Berlin, Germany

Seminar-Nr. 21346

Referent:innen

Energy Kristina Hansen

Energy Kristina Hansen

MilCor Consulting

Tim Ohlrich

Tim Ohlrich

gempex

Cecilie Hejlskov

Cecilie Hejlskov

Syntese

Wolfgang Schmitt

Wolfgang Schmitt

CONCEPT HEIDELBERG

Zielsetzung

During this course, you will get to know the principles and discuss all relevant aspects to perform failure investigations to get to the true Root Cause of a problem. This is the key for efficient Event Management and CAPA Systems.

Hintergrund

Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedures in place to deal with such situations. When an unplanned event arises, it must be handled accordingly.

EudraLex Vol. 4, EU-GMP Guidelines,
Chapter 1 (Pharmaceutical Quality System):
1.4 (xiv): “An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems.”

In any case a sound failure investigation is the key to identify appropriate actions and CAPAs. Here, understanding how to handle both human error- and non-human error-based non-conformances is crucial.

EudraLex Vol. 4, EU-GMP Guidelines,
Chapter 1 (Pharmaceutical Quality System):
1.8: […] “The basic requirements of GMP are that: (vii) Any significant deviations are fully recorded, investigated with the objective of determining the root cause and appropriate corrective and preventive action implemented”

Root cause analysis (RCA) is a process that attempts to identify the exact cause of a problem, such as a deviation. Only by identifying the exact underlying fault is it possible to take the right action to solve the problem and prevent it from occurring again.
 

Zielgruppe

This course is designed for all personnel involved in failure investigation/Root Cause Analysis concerning events, deviations and CAPA activities in their company. It is addressed to persons from Quality Assurance and Control, Manufacturing and R&D.

Presentations / Certificate

The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.

After the event, you will automatically receive your certificate of participation.

Programm

Root Cause Analysis

Gesamtes Programm als PDF herunterladen

Kick-off: When it’s human

  • Expectations on Humans
  • Why human error could not be a root cause
  • Blame culture vs. Root Cause
  • Error Culture

Excerpt from FDA Warning Letter
“…the investigation failed to establish a root cause and your quality unit failed to ensure the implementation of adequate corrective actions to prevent future recurrence.”

Presentation and Workshop:
Using 5 Whys und Ishikawa

  • Short Introduction of the methods
  • Strengths and weaknesses of each method
  • Typical mistakes in application
  • Workshop: Real Life Examples and Experiences

Interactive Session: Comparative Analyses

  • Identifying and documenting errors with worksheets
  • The need for a systematic approach
  • The key for success: comparison of occurred deviations with available facts

Bow-Tie Risk Management and Problem Solving Analysis

  • Controls, connection and causality
  • Risk velocity
  • Preventive- detective and corrective controls
  • The link to Fault Tree Analysis and Event Tree Analysis

Interactive Session: A3 Methodology

  • What is a problem?
  • The causes investigation; point of cause, direct cause and root cause
  • The 8-steps, structure and methodology
  • Deep Dive: Point of Cause Analysis
  • Solving a murder case

Human Error Related Deviations

  • The What
    - Top 10 Categories: FDA Warning letters (2021 -2022)
    - The Commonality
    - Undesirable behaviour…what is it?
  • The How
    - The KAP Model
    - Factor in the Social Element
  • The Recurrence
    - Human Error is NEVER a Root Cause
    - Blame it on the Culture
Behavioural Root Cause Analysis (bRCA) for Human Error Related Deviations (HErD)
  • Behavioural Root Cause Analysis Tool (3B Method)
  • Theory behind 3B Method
    - Informative Construct (brain)
  • - Motivational Construct (beating heart)
    - Perceived Barriers Construct (brick)
  • Utilize the Solution
    - Sort the HErD - 3B Method
    - Practice in groups

RCA Completion

  • How to document a Root Cause Analysis
  • How to define the right actions based on the outcome

Deviation Management and CAPA

Principles and all relevant aspects to implement, improve and/ or work with a Deviation Management and CAPA System are topic of ECA’s Deviation Management and CAPA training course. For more information see www.gmp-compliance.org/ or send an e-mail to w.schmitt@concept-heidelberg.de.

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

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