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QUALITY RISK MANAGEMENT
Part 2: Failure Mode Effects Analysis (FMEA)

HUYNH NGOC SANG

TECHNICAL SECTOR
CONTENT 2

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1. Objectives
2. Target group
3. Introduction
4. Creating FMEA
5. Example
1. Objectives 3

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 What is FMEA?
 The area of uses
 How to create an FMEA process
 FMEA illustration
2. Target groups 4

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 Technical Department
 Regulatory Affairs Department
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3. INTRODUCTION
Definition 6

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"Failure modes" means the ways, or modes, in which something might fail. Failures
are any errors or defects, especially ones that affect the customer, and can be potential
or actual.
Example: a home fire alarm can fail because of:
 a dead or missing battery,
 faulty wiring,
 defective detector
 defective alarm.

"Effects analysis" refers to studying the consequences of those failures.

Definition 7

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What can go wrong with your product or process?
Definition 8

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 FMEA is a tool to identify Potential Failures, its Effects and Risks in your
process, product and then Eliminate or Reduce them.
Potential Areas of Use 9

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 Equipment and facilities
 Manufacturing operation
The reasons for FMEA 10

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 Get it right the first time
 Identify any inadequacies in the development of the product
 Tests and Trials may be limited to a few products
 Regulatory reasons
 Continuous improvement
 Preventive approach
 Team building
 Required produces
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4. CREATING FMEA
Risk Assessment 12

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Risk Assessment 13

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 The FMEA process begins by identifying “Failure Modes”
 The project team examines every element/ component of a system, equipment or
process, starting from the inputs and go through the current control to the output.
Risk Assessment 14

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 The question: WHAT CAN GO WRONG HERE?
 Aspect focused: Patient safety, Staff safety, Regulatory compliance, Business.
 List down the components/ steps in the system/ process under analysis using
facilitation methods (flowcharts, check sheets, process mapping, fish-bone
diagrams,..)
Let us make coffee for our customer 15

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CTQ: Critical To Quality
Input output mapping 16

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Process Map for making coffee 17

OUTPUT OUTPUT

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INPUTS INPUTS

Customer, Order, Size

Water, Maker Pour water into Maker Maker with water Receive coffee order Complete order
specification

Maker with water, filter Place filter in Maker Maker w/filter Complete Order, Hot
Pour coffee into cup Filled cup
coffee, Cup

Maker w/filter, Fresh Filled cup, customer, Customer reply, amount

Put coffee in filter Maker w/filter & coffee Offer cream & sugar
coffee, dosing scoop cream, sugar, amount specified, complete
desired order

Operating maker, heat, Make change,

Maker w/filter & coffee Turn Maker on Complete Order, money Complete transaction
brewed coffee Temperature, Taste,
Strength

Select temperature
Maker w/filter & coffee Hot coffee Coffee delivery Say thank you Smile, Happy customer
setting
Risk Assessment 18

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 Take the first process step of coffee making
Risk Assessment 19

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 List various ways how the process can fail to deliver at various aspects of CTQ
 We can use rule 5M & 1E to identify failure modes
Risk Assessment 20

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 How can the product fail to deliver satisfaction to customer if the failure mode
occurs?
Risk Assessment 21

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 Numerically rating what is the Severity of this Failure Effect on the customer
Severity Ratings 22

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Risk Assessment 23

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 The rate should reference the scale of severity
Risk Assessment 24

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 We have to find the CAUSEs of the Failure Modes
 Brainstorm among SMEs and even operators what are the cause of failures in the
system.
Risk Assessment 25

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Risk Assessment 26

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Risk Assessment 27

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 Numerically rating what is the OCCURRENCE of this Failure Cause
Probability Ratings 28

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Risk Assessment 29

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Risk Assessment 30

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 What are the Present Controls to Detect that this Cause has occurred?
Detection Ratings 31

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Risk Assessment 32

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Risk Control 33

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Risk Control 34

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Risk Control 35

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 Severity typically stays the same. This can only be changed through product/
process redesign
 Occurrence is the primary item to reduce/ focus on
 Detection is reduced only as a last resort

 Do not plan to reduce RPN with detection actions!!

 100% inspection is only 80% effective
 Reducing RPN with detection does not eliminating failure mode, or reduce probability
of causes
 Detection of 10 is not bad if occurrence is 1.
Risk Control 36

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Specific Cases and Thumb Rules 37

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Specific Cases and Thumb Rules 38

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Recipe in FMEA 39

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 What can go wrong in Process – Failure Mode
 Potential Failure Effects on product – Quantify Severity of Effect
 Potential Causes of the Failure Mode – Quantify Occurrence of Potential Failure
 Present Controls may impact on Cause or detect Failure Mode – Quantify
Occurrence and Detectability of Potential Failure
 Calculate RPN (Risk Priority Number) – RPN = S x O x D
 Create a CAPA plan to mitigate the risks (reduce RPNs)
 Do CAPA and then assess the residual risks and the new risks arising
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5. EXAMPLES
FMEA Examples: Technology Transfer 41

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FMEA Examples in Cross-contamination 42

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FMEA Examples in Process validation 43

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Reference 44

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 Presentation: Risk Management in Pharma using FMEA, Sandeep LeanSixSigma,
https://www.slideshare.net/sandeepleansixsigma/risk-management-using-fmea-in-pharma.
 Quality Risk Management – Q9, International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH), www.ich.org.
 ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process
Validation, International Society for Pharmaceutical Engineering (ISPE), First Edition, 2019,
www.ispe.org.
 Good Practice Guide: Technology Transfer, International Society for Pharmaceutical
Engineering (ISPE), Third Edition, 2018, www.ispe.org.
 Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products, International
Society for Pharmaceutical Engineering (ISPE), Second Edition, 2017, www.ispe.org.
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THANK YOU