How to Perform a Failure Mode Effect Analysis (FMEA) – Part 2


Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified Risks and acceptance of residual risks. Upon completion of this course you will understand the overall concept of Quality Risk Management (QRM), where does risk come from, the potential areas for Quality Risk Management application, the regulatory requirements and the various risk management tools

Curriculum for this course:
Overview 1 min 33 secs
Learning objectives 1 min 25 secs
Who should take this course? 1 min 49 secs
Course modules 49 secs
Glossary 50 secs
Module 1: FMEA – A General Overview
The advantages of a FMEA 1 min 22 secs
So what is a FMEA? 1 min 04 secs
Endorsed by the FDA 1 min 13 secs
How did FMEA start? 1 min 25 secs
ICH Q9: Quality Risk Management 45 secs
Application of FMEA in the pharmaceutical industry 1 min 15 secs
What can FMEA do for you? 55 secs
When to conduct FMEA? 1 min 25 secs
Module 2: Getting Started with FMEA
The FMEA process 1 min 10 secs
Risk identification 1 min 22 secs
Risk analysis 50 secs
Risk analysis – Probability of Occurrence (O) 1 min 31 secs
Risk analysis – Severity (S) 55 secs
Risk analysis – Likelihood of Detection (D) 1 min 42 secs
Risk evaluation – Quantitative Method 1 min 52 secs
Risk evaluation – Qualitative Method 1 min 43 secs
The hybrid method 51 secs
Risk – Should we quantify or qualify? 1 min 33 secs
Risk control 1 min 28 secs
FMEA – Table format 1 min 20 secs
FMEA – Granulation suite qualitative approach example 1 min 30 secs
Example of a risk assessment management plan 57 secs
Example of a FMEA table for a granulation suite – Quantitative approach 1 min 49 secs
Module 3: Who Carries Out a FMEA?
The FMEA team 1 min 13 secs
Qualification of the team members 1 min 39 secs
Module 4: Limitations of FMEA
What are the limitations of a FMEA process? 1 min 51 secs
Subjective and tedious 1 min 42 secs
Single failure mode 1 min 33 secs
Rank reversal 57 secs
Outputs and inputs 1 min 24 secs
Inconsistency 1 min 19 secs
Limited scope 54 secs
Only an assessment tool 1 min 08 secs
Time consuming 1 min 17 secs
Only as good as the team 1 min 24 secs
Examination of external influences 51 secs
Examination of human error 1 min 29 secs
Reasons for ineffective FMEAs 1 min 30 secs
Tips for successful implementation of a FMEA 1 min 37 secs
Primary FMEA facilitation skills 1 min 25 secs
Final Assessment

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