ICH Q9QUALITY RISK MANAGEMENT

Gaurav Singh

FMEAFAILUER

MODE

EFFECT

ANALYSIS

Potential

Possibility Type

Negative effective

Study the risk and

reduce to accept

WHAT CAN GO WRONG

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

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

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

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

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

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.

Reference: ICHQ9,USFDA,PIC,ASQ,SIX SIGMA

Gaurav SinghMasters in ChemistryLinkedIn: https://www.linkedin.com/nhome/?trk=