Risk management using FMEA in pharma

Risk Management in Pharma
using FMEA @ Sandeep.LeanSixSigma
Sandeep.LeanSixSigma

What we do in Pharma?
PRODUCTS & SERVICES

Every Process has...
Probability of Failure or Loss or
Exposure to Danger

Quality Issues
Compliance
Customer Satisfaction
Product Functionality
Business and Profits
This processes have RISK of Failures..

Measure Risk Manage Risk
We Can’t totally avoid RISK
RISK GUARANTEED
&

International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use
ICH - Q9
ICH Defines the
Standard of Quality
Risk Management
ICH Defines the
Standard of Quality
Risk Management

Managing Risk
4 STEPS of Risk management as per ICH Q9
RISK
COMMUNICATION
RISK
ASSESSMENT
RISK
REVIEW
RISK
CONTROL
Risk Analysis
Risk Evaluation
Risk Reduction
Risk Acceptance
Step 1 Step 2 Step 3 Step 4
Risk Identification

Risk reviewRisk review
Risk controlRisk control
Risk AssessmentRisk Assessment
QRM Process - ICH Q9
Initiate QRM process
Risk identificationRisk identification
Output / result of QRM process
Risk analysisRisk analysis
Risk evaluationRisk evaluation
Risk reductionRisk reduction
Risk acceptanceRisk acceptance
Review eventsReview events
Unacceptable
Riskmanagementtools
Riskcommunication

ICH Q9 vs ISO 14971(medical devices)
Risk Review
RiskCommunication
Risk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
Initiate
Quality Risk Management Process
Output / Result of the
Quality Risk Management Process RiskManagementtools

Risk Management Scope
Risk Management
Preventive
Maintenance
Preventive
Maintenance
IPC sampling /
testing
IPC sampling /
testing
QualificationQualification
ValidationValidation
Out of SpecOut of Spec Change controlChange control
Environmental.
Monitoring.
Environmental.
Monitoring.
DeviationsDeviations
Equipment.
cleaning
Equipment.
cleaning
CalibrationCalibration

Risk Management ToolsRisk Management Tools
There are many
tools of Risk
Management. We
will learn FMEA in
this training

What you will Learn
• What is FMEA?
• Why is an FMEA important
• How to identify Risk
• How to mitigate Risk using FMEA
• Live Example of FMEA
• Do it your self

What is FMEA
Failure Mode Effect Analysis
Analysis
Mode
Failure
Effect
Types , Ways
Possibilities
Potential
Negative Effect
on process
under study
Study RISK and
Reduce it
What can go WRONG in your process or product

FMEA
a Tool and a process to Identify Potential
Failures, its Effects and Risks in your Process and
Product Design and then Eliminate or Reduce
them.
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
What is FMEA
Failure Mode Effect Analysis

History of FMEA

Application of FMEA in Pharma

DesignDesign
• Parts
• Components
• Sub Comp
• Parts
• Components
• Sub Comp
ProcessProcess
• Man
• Method
• Material
• Machine
• Procedures
• Man
• Method
• Material
• Machine
• Procedures
OthersOthers
• Service FMEA
• System FMEA
• Concept FMEA
• Service FMEA
• System FMEA
• Concept FMEA
Types of FMEA

Application of FMEA
Implementing
FMEA at early
stage reduce the
Cost of error

• Get it right the first time
• Indentifies 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 procedures
The Reasons for FMEA

Creating an FMEA

Risk Assessment - Creating FMEA
The FMEA process begins by identifying “Failure Modes,” the ways
in which a product, service or process could fail wrt Customer
Requirement.
A project team examines every element of a service, starting from
the inputs and working through to the output delivered to the
customer.

At each step, the team ASK ONE QESTION ?”
WHAT CAN GO WRONG HERE

What is Customer Requirements?
Critical To Customer
Analyze how your process can fail to deliver CTC

List down the Process Steps in the system under analysis ?List down the Process Steps in the system under analysis ?

Let us make Coffee for our Customer
CTQ
1. Taste,
2. Strength
3. TemperatureSandeep.LeanSixSigma

Input Output Mapping
MATERIAL
Man
Method
Machine
Product or Output
Inputs Outputs
Every process has
Processing
Let us do the
process flow map
of Coffee making
process

Coffee Process Map
Inputs OutputsInputs Outputs
Filter
Maker w/Filter
Fresh Coffee
Dosing Scoop
Maker w/Filter &
Coffee
Brewing Coffee
Maker with
water
Maker w/Filter
Maker w/Filter &
Coffee
Operating Maker
Heat
Brewed Coffee
Hot Coffee
Customer
Order
Size Specification
Complete Order
Hot Coffee
Cup
Filled Cup
Customer
Cream
Sugar
Amount Desired
Complete Order
Money
Coffee Delivery
Complete Order
Filled Cup
Customer Reply
Amount Specified
Complete Order
Make Change
Temperature
Taste
Strength
Smile
Happy Customer
Pour Coffee
into Cup
Pour Coffee
into Cup
Offer
Cream &
Sugar
Offer
Cream &
Sugar
Complete
Transaction
Complete
Transaction
Say Thank YouSay Thank You
Receive
Coffee
Order
Receive
Coffee
Order
Pour Water
into Maker
Pour Water
into Maker
Place Filter in MakerPlace Filter in Maker
Put Coffee
in Filter
Put Coffee
in Filter
Select Temperature
Setting
Select Temperature
Setting
Turn Maker OnTurn Maker On
Process Map for making Coffee
Water
Maker
Maker with water

Pour Water in
the Maker
Let us take the First process step of Coffee making.

Raw Material / Information SOP / WI / Checklist
Equipment / Infrastructure Process Control / Method / Policy
Utilities Environment / Regulation
Human Resources Measurement
List various ways how the Process can fail to deliver at various aspects of CTQ.List various ways how the Process can fail to deliver at various aspects of CTQ.
We can use the following Key Process Inputs to identify failures.
Wrong amount
of water
Coffee Maker
not Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
This are the potential
Failure Modes for
step of pouring water
Failure Modes for
step of pouring water

How the product can fail to deliver satisfaction to customer if the failure
mode occurs?
How the product can fail to deliver satisfaction to customer if the failure
mode occurs?
Coffee too
Strong or weak
Contamination
of Coffee
Change in Taste
of Coffee
Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
Failure effects of the
Failure mode - “Wrong
amount of water”
Failure effects of the
Failure mode - “Wrong
amount of water”

Numerically rate what is the Severity of this Failure Effect on the CustomerNumerically rate what is the Severity of this Failure Effect on the Customer
Example Which consequence is more severe?
1. A fire in an open area where no one was present.
2. A fire in a house with 3 people affected.
3. A fire in a factory with 30 employees affected
Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
Coffee too Strong or
weak
Contamination of
Coffee
Change in Taste
of Coffee
Most Severe

Severity Ratings
10 Dangerous
ly High
Failure could lead to death or permanent injury to the customer. Financial:
>1,00,00,000 INR
9 Extremel
y high
Failure could lead to injury to the customer. Failure would create non-
compliance with registered specifications. Failure likely to lead to recall.
Financial: 1,00,00,000 INR
8 Very High Failure could lead to adverse reaction for customer. Failure would create
noncompliance with GMP regulations or product registrations. Failure possible
to lead to recall. Financial: 50,00,000 INR
7 High Failure leads to customer percept ion of safety issue. Failure renders individual
unit(s) unusable. Failure causes a high degree of customer dissatisfaction.
Recall for business reasons possible but Authority required recall unlikely.
Financial: 10,00,000 INR
6 Moderate Failure causes a high degree of customer dissatisfaction and numerous
complaints. Failure unlikely to lead to recall. Financial: 5,00,000 INR
5 Low Failure likely to cause isolated customer complaints. Financial: 1,00,000 INR
4 Very Low Failure relates to non-dosage form issues (like minor packaging problems) and
can be easily overcome by the customer. Financial: 50,000 INR
3 Minor Failure could be noticed by the customer but is unlikely to be perceived as
significant enough to warrant a complaint. Financial 10,000 INR
2 Very
Minor
Failure not readily apparent to the customer. Financial: <$1,000
1 None Failure would not be noticeable to the customer. Financial: none

Numerically rate what is the Severity of this Failure
Effect on the Customer with reference to the Scale
Numerically rate what is the Severity of this Failure
Effect on the Customer with reference to the Scale
Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7

Brainstorm among process experts what are the causes of failure in the systemBrainstorm among process experts what are the causes of failure in the system
Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level
marks on Maker
Person not
attentive
Person with No
knowledgeNow we have to find the CAUSEs of the Failure ModesNow we have to find the CAUSEs of the Failure Modes

Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level
marks on Maker
Person not
attentive
Person with No
knowledge
Ask WHY?
Why Wrong amount of WaterWhy Wrong amount of Water
Because of Faded level marks on JarBecause of Faded level marks on Jar
BrainstormBrainstorm

Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level marks
on Maker
Person not
attentive
Coffee maker not
washed properly
Person with No
knowledge
Coffee maker not
Stored properly
Person with No
knowledge
Failure Mode 1
Effect 1
Effect 2
Causes 1
Causes 2
Causes 1
Causes 2
Causes 3
One failure mode can have more then 1 Effects
Each effect can have more then one Causes

Which probability is more?
1. Chances of rain in the month of July.
2. Chances of rain in the month of January.
3. Chances of rain in the month of September
Numerically rate what is the Occurrence of this Failure CauseNumerically rate what is the Occurrence of this Failure Cause
Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level marks
on Maker
Person not
attentive
Person with No
knowledge
Most Certain

Probability Ratings
10 Very High: Failure
is almost
inevitable
1 per Day or > 3 in 10 Units
More than one occurrence per day or a probability of more than three occurrences in 10
units.
9 1 per 3 to 4 Days or = 3 in 10 Units
One occurrence every three to four days or a probability of three occurrences in 10 units.
8 High: Repeated
failures
1 per Week or = 5 in 100 Units
One occurrence per week or a probability of 5 occurrences in 100.
7 1 per Month or = 1 in 100 Units
One occurrence every month or one occurrence in 100 units.
6 Moderate:
Occasional
Failures
1 per 3 Months or = 3 in 1000 Units
One occurrence every three months or three occurrences in 1,000 units.
5 1 per 6 Month to 1 Year or = 1 in 10,000 Units
One occurrence every six months to one year or one occurrence in 10,000 units.
4 1 per Year or = 6 in 100,000 Units
One occurrence per year or six occurrences in 100,000 units.
3 Low: Relatively
few Failures
1 per 1 to 3 Years or = 6 in 10,000,000 Units
One occurrence every one to three years or six occurrences in 10,000,000 units.
2 1 per 3 to 5 Years or = 2 in 1,000,000,000 Units
One occurrence every three to five years or 2 occurrences in 1,000,000,000 units.
1 Remote: Failure is
unlikely
1 per >5 Years or < 2 in 1,000,000,000 Units
One occurrence in greater than five years or less than two occurrences in 1,000,000,000
units.

Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Person not
attentive
Person with No
knowledge
3
8
4
Let us give the Occurrence Ratings for the Causes based on Probability Chart
Faded level marks
on Maker
Evaluate how
often this
Cause has
occurred in
the past
Evaluate how
often this
Cause has
occurred in
the past
Based on:
1. Past Data
2. Trends
3. Experience
Based on:
1. Past Data
2. Trends
3. Experience
Faded level marks
on Maker
10 – Event Will Occur most Probably10 – Event Will Occur most Probably 1 – Event Will Not Occur1 – Event Will Not Occur

Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level marks
on Maker
Person not
attentive
Person with No
knowledge
3
8
4
What are Present Controls to Detect that this Causes have occurredWhat are Present Controls to Detect that this Causes have occurred
Visual Inspection
None
Trainings

Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level marks
on Maker
Person not
attentive
Person with No
knowledge
3
8
4
Visual Inspection
None
Trainings
Which Detection is the best is more?
1. Manual Check by operator for Defects
2. Machines give alarm if defects occurs
3. Machine stops if defect occurs
Numerically rate what is the Present Control Detection
10 -- Most Difficult to Detect and 1 – Most easy to detect
Numerically rate what is the Present Control Detection
10 -- Most Difficult to Detect and 1 – Most easy to detect
Best Detection

Detection Ratings
10 Impossible
to detect
The product is not inspected or the defect caused by the failure
is not detectable.
9 Very
Remote
Product is sampled, inspected, and released based on
Acceptable Quality Level (AQL) sampling plans.
8 Remote Product is accepted based on no defects in a sample.
7 Very Low Product is accepted based on double inspecting and no
defects in a sample.
6 Low Product is 100% manually inspected in the process.
5 Moderate Product is 100% manually inspected using go/no-go or other
mistake-proofing gauges.
4 Moderately
High
Some Statistical Process Control (SPC) is used in the process
and product is final inspected off-line.
3 High SPC is used and there is immediate reaction to out-of-control
conditions.
2 Very High All product is 100% automatically inspected.
1 Almost
Certain
The defect is obvious and there is 100% automatic inspection
with regular calibration and preventive maintenance of the
inspection equipment.

Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level marks
on Maker
Person not
attentive
Person with No
knowledge
3
8
4
Visual Inspection
None
Trainings
10 -- Most Difficult to Detect10 -- Most Difficult to Detect
4
8
5HOW GOOD IS MY TECTION SYSTEM?
Rate it NUMERICALLY
1 – Most Easy to Detect1 – Most Easy to Detect

Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
Pour Water in the
Maker
weak
Contamination of
Coffee
Change in Taste
of Coffee
8
10
7
Faded level marks
on Maker
Person not
attentive
Person with No
knowledge
3
8
4
Visual Inspection
None
Trainings
4
8
5
RPN = Severity X Occurrence X Detection
Risk Priority Number
96
640
140
8 3 4X X = 96

By Getting RPN for failure mode we
Complete the stage 1 of FMEA
Stage 2 is
RISK Mitigation
RISK ASSESSMENT

Risk Control – Acting on FMEA
Action
D
E
T
R
P
N
Recommend
ed
Action(s)
Responsi
bility
TCD
Potential Failure
Mode
(How the X fails?)
S
E
V
O
C
C
RPN
Should be as low as possible
1
10
1
10
1
10
1
1000
Min = ?? Max = ?? So Acceptable = ??
Min
Max

RPN
To 125
Occ
Det
Reduce the Occurrences of Failure by
Act on the Root Causes, fix the problem.
Improve Controls to Detect failure modes
Sev
Severity can’t be changed, it remains the
same.=
Actions Taken
O
C
C
D
E
T
R
P
N
Action ResultsD
E
T
R
P
N
Recommend
ed
Action(s)
Responsi
bility
TCD
Potential Failure
Mode
(How the X fails?)
S
E
V
O
C
C
Actions Taken
O
C
C
D
E
T
R
P
N
Action ResultsD
E
T
R
P
N
Recommend
ed
Action(s)
Responsi
bility
TCD
Potential Failure
Mode
(How the X fails?)
S
E
V
O
C
C
Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
8
10
7
3
8
4
96
640
140
4
8
5
So we have to reduce
Severity Occurrence Detection
So to mitigate or reduce RISK

RPN
To 125
Occ
Det
Sev=
Actions Taken
O
C
C
D
E
T
R
P
N
Action ResultsD
E
T
R
P
N
Recommend
ed
Action(s)
Responsi
bility
TCD
Potential Failure
Mode
(How the X fails?)
S
E
V
O
C
C
Actions Taken
O
C
C
D
E
T
R
P
N
Action ResultsD
E
T
R
P
N
Recommend
ed
Action(s)
Responsi
bility
TCD
Potential Failure
Mode
(How the X fails?)
S
E
V
O
C
C
Wrong amount of
water
Coffee Maker not
Clean
More or less Sugar
or Coffee powder
8
10
7
3
8
4
96
640
140
4
8
5
Replace Coffee
maker
Ram 10 July 14
Storage & Inspection
Standards
Krishna 10 July 14
2
3
3
48
120
63
3
4
3Std measurements
Hari 10 July 14
Back to our coffee making example
We recommend some actions to reduce Occurrence and increase Detection
After the action
completion Occurrence
will reduce and rating
will come down to 3
from 8
After the action
completion Occurrence
will reduce and rating
will come down to 3
from 8

Specific Cases and Thumb Rules
2 10 10 200
10 2 10 200
10 10 2 200
10 4 2 80
3 10 4 120
2 8 10 160
Failure Mode 1
Which Failure Mode
would you take to Top
Priority. All are having
same RPN of 200
Failure Mode 2
Failure Mode 3
Failure Mode 1
Failure Mode 2
Failure Mode 3
Which Failure Mode
would you take to Top
Priority

Specific Cases and Thumb Rules
2 10 10 200
10 2 10 200
10 10 2 200
10 4 2 80
3 10 4 120
2 8 10 160
Failure Mode 1
Failure Mode 2
Failure Mode 3
Failure Mode 1
Failure Mode 2
Failure Mode 3
Higher the
SEVERITY
more should
the priority
1st
2nd
Higher the
SEVERITY
more should
the priority

Examples
Source : Bio Pharm International
Volume 24, Issue 3, pp. 44-48

Recipe in FMEA
What can Go Wrong in Process – Failure Mode
Potential Failure Effect on Product
Quantify Severity of Effect on Product
Potential Cause of the Failure Mode
Quantify Occurrence of Cause
Present Controls to detect of cause Failure Mode
Quantify Detection of Cause
Calculate RPN (Risk Priority Number)
RPN = Severity x Occurrence x Detection
Act and Control High RPN CausesSandeep.LeanSixSigma

Ranking Severity (S) Probability (P) Detection (D)
10 Death More than once a day Impossible to detect
9 ↓ 3 – 4 times a day Remote
8 Permanent injury Once a week Very slight
7 ↓ Once a month Slight
6 Temporary injury Once in three month Low
5 ↓ Once in half – one year Medium
4
Reported/
dissatisfied
Once a year Moderately high
3 ↓ Once in 1 – 3 years High
2 Notice/ no report Once in 3 – 5 years Very High
1 ↓
Less than once in 5
years
Virtually certain
FMEA Ratings – SPD simplified

FMEA – Template
Identify failure modes
and their effects
Identify causes of the
failure modes
and controls
Prioritize Determine and assess
actions

Now complete one FMEA on your OWN
And you will learn things that I
have NOT thought you.

Hope it helps

Disclaimer
The opinions expressed in this
presentation and are solely those of the
presenter and not necessarily those of
in line with regulatory or other
guidelines. Use this presentation only
for the purpose of reference. The author
does not guarantee the accuracy or
reliability of the information provided
herein.

References
1. ICH, Q7A Good Manufacturing Practice Guideline
2. ISO 14971 Guidelines
3. Failure Mode and Effect Analysis : FMEA from Theory to
Execution, 2nd Edition by D H Stamatis.
4. Pharmamanufacturing Journal
5. Pharmmirror Journal
6. Bio Pharma International Journal
6. www.stockfreeimages.com

@ the author
is a Business Excellence Consultant
a Lean Six Sigma Black Belt
an Engineer with MBA in Operations
a Decade of experience in
Manufacturing and Pharma
stays in Goa, India.
Email : sandeep.leansixsigma@gmail.com
: www.slideshare.net/sandeepleansixsigma
: www.youtube.com/user/sandeepleansixsigma
Sandeep U Naik
Do Get in touch

Thank You
Please comment below

Risk management using FMEA in pharma

Empfohlen

Empfohlen

Weitere ähnliche Inhalte

Was ist angesagt?

Was ist angesagt? (20)

Ähnlich wie Risk management using FMEA in pharma

Ähnlich wie Risk management using FMEA in pharma (20)

Kürzlich hochgeladen

Kürzlich hochgeladen (20)

Risk management using FMEA in pharma