Quality Risk Management in Pharma
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ICH Q9QUALITY RISK MANAGEMENT
Gaurav Singh
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FMEAFAILUER
MODE
EFFECT
ANALYSIS
Potential
Possibility Type
Negative effective
Study the risk and
reduce to accept
WHAT CAN GO WRONG
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QRM PROCESS INITIATION
OUTPUT/RESULT OF QUALITY RISK MANAGEMENTR
ISK
CO
MM
UN
ICAT
ION
RIS
K M
AN
AG
EM
EN
T TOO
LS
RISK IDENTIFICATION
RISK ANALYSIS
RISK EVALUATION
RISK REDUCTION
RISK ACCEPTANCE
REVIEW EVEDENTS
RIS
K
AS
SE
SS
ME
NT
RIS
K
CO
NTR
OL
RIS
K
RE
VIE
W
UN
AC
CE
PTA
BLE
Identity Failure mode (s)
S,O,D
RPN
Mitigation Plan and Action
Residual Risk Analysis
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FMEA“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.
“Effects analysis” refers to studying the consequences of those failures.
When to Use FMEA When a process, product or service is being designed or redesigned, after quality
function deployment. When an existing process, product or service is being applied in a new way. Before developing control plans for a new or modified process. When improvement goals are planned for an existing process, product or service. When analyzing failures of an existing process, product or service. Periodically throughout the life of the process, product or service
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Process Mapping Preliminary hazard analysis (PHA) Hazard Analysis and Critical Control Points (HACCP) Hazards Operability analysis Fault tree analysis Failure mode effects analysis (FMEA) Failure mode, effects and criticality analysis (FMECA) Risk ranking and filtering Informal risk management Taguchi, variation risk management method.
RISK MANAGEMENT TOOLS
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STEP-I
STEP-II
STEP-III
STEP-IV
STEP-V
STEP-VI
STEP-VII
STEP-VIII
STEP-IX
Assemble a cross functional team
Identify the Scope of FMEA
Identify the function of your Scope
Identity Failure mode (s)
Potential effect of failure (s)
Determine the severity rating (S): 1-10
Determine the occurrence rating (O): 1-10
Identify the process controls in-place
Determine the detection rating (D) : 1-10
STEP-X
RPN= S x O x D
FMEA PROCESS
RCA MITIGATION PLAN
EXECUTION RESIDUAL
STEP-XI
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FMEA TEMPLET
Severity (S) Occurrence (O) Detection (D) RPN
After Action Completion
Function
Potential
Failure Mode
Potential effect (s)
of Failure
Severity (S)
Potential Cause of Failure
Occurrence (O)
Current Process Controls
Detection (D)
RPN
Mitigation Plan
(S)
Responsibility and Target Completion
Date
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FMEA CASE STUDYFuncti
on
Potential
Failure Mode
Potential effect (s)
of Failure
Severity (S)
Potential Cause of Failure
Occurrence (O)
Current Process Controls
Detection (D)
RPN
Mitigation Plan
(S)
Responsibility and Target Completion
Date
Stock Inventor
y
Material found
on wrong
location
Unable to locate the material
5 Specified location was full
7 Stock check twice a year
9 315 1. Warehouse management system shall be implemented2. Warehouse expansion
Gaurav SinghMarch, 2017
Do the Investigation using RCA tool and determine the root cause of failure and accordingly prepare the mitigation plan.
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Reference: ICHQ9,USFDA,PIC,ASQ,SIX SIGMA
Gaurav SinghMasters in ChemistryLinkedIn: https://www.linkedin.com/nhome/?trk=