The document outlines the principles and processes of Quality Risk Management (QRM) as per ICH Q9 standards, focusing on risk identification, analysis, evaluation, reduction, acceptance, communication, and review. It emphasizes the use of Failure Mode Effects Analysis (FMEA) to identify potential failures and prioritize risks based on probability, severity, and detectability using a Risk Priority Number (RPN). Additionally, the document discusses how to map processes to identify potential failures and their impacts, providing a structured approach to manage risks effectively.

2. WHAT IS QUALITY RISK MANGEMENT
Quality - Fulfillment of requirements
Risk– Probability of failure to fulfill the requirements and its severity
Management- Systematic process to review and manage the risk to quality

3. QRM PROCESS - ICH Q9

4. QRM PROCESS - ICH Q9
Risk identification is a systematic use of information to identify potential failure.
Risk analysis is the estimation of the risk associated with the identified potential failure.
Risk evaluation compares the identified and analyzed risk against given risk criteria

5. QRM PROCESS - ICH Q9
Risk reduction
Actions to mitigate the severity & probability of potential failure and/or to improve
detectability of failures.
Risk acceptance
Acceptance of residual risks

6. QRM PROCESS - ICH Q9
Risk Communication
Sharing of information about risk and risk management between the decision makers
and others.
The output/result of the quality risk management process should be appropriately
communicated and documented.

7. QRM PROCESS - ICH Q9
Risk Review
Sharing of information about risk and risk management between the decision makers
and others.
The frequency of any review should be based upon the level of risk. Risk review might
include reconsideration of risk acceptance decisions

8. RISK ASSESSMENT METHODS

9. FAILURE MODE EFFECTIVE ANALYSIS
(FMEA)
To identify potential failures before they occur and eliminate / minimize risk of failure

10. FAILURE MODE EFFECTIVE ANALYSIS (FMEA)
Every thing that can fail, will fail – Murphy's Law
The main reason behind FMEA
It will usually fails at worst possible moment
FMEA identifies ‘can fail’ situations and eliminate or minimize from ‘will fail’ situation

11. FAILURE MODE EFFECTIVE ANALYSIS (FMEA)
Review past Analyze present Control future
For frequency of occurrences For detection levels by reducing its impact
What will FMEA do
1 2 3
Probability Detectability Severity
IS CALLED RISK PRIORITY NUMBER (RPN)

12. RISK PRIORITY NMBER = (PXSXD)
• The likelihood that failure will
occur
Probability
(P)
• The potential effect of failure
Severity
(S)
• Likelihood that failure will be
detected immediately after
occurrence
Detectability
(D)
RPN is
to Prioritize actions
on Identified risks

13. FAILURE MODE EFFECTIVE ANALYSIS (FMEA)
Likelihood / Probability (P)
Severity (S)
Detectability (D)
RPN = P X S X D
To reduce RPN to acceptance level
RPN = P X S X D

14. FMEA APPROACH
Item or
Function
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN
Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)

15. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
ITEM /
FUNCTION
• Identifies individual function of the process.
• Top down approach Bottom Up approach
Up to what extent?, the extent it takes

16. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Potential
failures
• Identify the potential failure modes on each step or function
i.e To identify something that can fail.
• There can be several failures for single function – List all
Function
Potential Failure 1
?
Potential Failure 2
?
Potential Failure 3
?

17. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Potential
causes of
failures
• Identify the cause of each potential failure modes
i.e To identify something that can fail.
• There can be several causes for a single failure – List all
Function
Potential Failure 1 Cause ?
Potential Failure 2 Cause ?
Potential Failure 3 Cause ?

18. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Probability
Probability is the likelihood that failure will occur
Gather all related data
Review the old failures and their frequency
Come to a judgment on probability (or) likely hood
Potential Probability Rank
Certain 4
High degree 3
Occasionally 2
Unlikely 1

19. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Probability
It is very good if we have quantified data as follows
Potential Probability Rank
Certain 4
High degree 3
Occasionally 2
Unlikely 1
Unlikely – 1failure in 1000 cases
Occasionally – 5 failures out of 1000 cases
High Degree – 20 failures out of 1000
cases
Certain - 100 failures out of 1000
cases
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20. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Potential
effects of
failures
Identify what happens if this failure occurs.
There can be several effects – List them all
Activity – Working at height ,
Potential Failure – Fall down
Potential Impacts – Death of personnel
Injury of personnel
Death or Injury of personnel under him
Malfunction equipment under Him
Malfunction of PPE wear by personnel

21. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Severity
Severity is the rating of potential effect of failure
RANK
Potential Consequences
Patient /
Customer
Compliance Business
15
Death Import Alert 100% business
Loss
10
Permanent
Injury
Warning Letters 50% business Loss
5
Hospital stay
with full
recovery
Audit
Observations
25% business Loss
1
No health No impact No impact
List out potential impacts of failures w.r.t
Patient safety
GMP Compliance
Business loss
And judge the severity of the impact.

22. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Current
Controls
Identify current controls that are in place
Design controls
Process controls
Personnel controls
Detection controls

23. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Detectability
Likelihood that failure will be detected immediately after occurrence
Likelihood of detection Rank
Not detectable 4
Detectable between 1% - 50% time 3
Detectable between 50% - 99% time 2
Detectable more than 99% time 1

24. FMEA APPROACH
Item or
Functio
n
Potential
failure
mode
Potential
causes of
failure
Probability Potential
effect of
failure
Severity Current
Controls
Detectability RPN Recommended
actions
Probability Severity Detectability RPN With in
acceptance
(Yes / No)
RPN
RPN is Risk Priority Number = SEVERITY X DETECTABILITY X PROBABILITY
RPN is to categories risk and overall priority.
Severity
Rank
Detection
Rank
Probability
Rank
15 4 4
10 3 3
5 2 2
1 1 1
Zone RPN Score Action
High (Red) Above 60
High Risk. Action needed
Immediately.
Medium
(Yellow)
31 to 60
Low Risk. Some action
needed
Low (Green) Less than 30
Risk Acceptable. No action
needed

25. FMEA APPROACH
Recommended actions Probability Severity Detectability RPN With in
acceptance
(Yes / No)
Based on your RPN score,
Propose some actions to reduce the risk score.
After completion of actions
Redefine Risk score of Severity , detectability & Probability
and take actions accordingly
Identify
potential
failures & its
impact
Risk Rating
P X S X D
Risk
Reduction
Risk
Acceptance
Risk Rating
P X S X D
Priorities
Actions based
on RPN

26. FMEA PROCESS – CASE STUDY FOR UNDERSTANDING
REQUIREMENT: All staff should reach to office by 8.00 am in the morning.
Bus
Driver
Employees
Start point
End point
Route
No.of stops
Employee
reach office on
time.
Identify the potential
failures

27. Map the process
HOW TO DO PROCESS MAPPING
Vehicle driver pick up employee daily in the morning from each stop and reach office at 8.00 a.m.
daily
General shift vehicle driver collects vehicle key from security person and ensures petrol in the
vehicle and pick up employs daily in the morning from each stop and reach office at 8.00 a.m. daily
General shift vehicle driver collects vehicle key from security person and ensures petrol in the
vehicle and moves towards jebel ali road and pick up employees daily in the morning from each stop
of discovery garden & garden and reach office at 8.00 a.m. daily
Is above comes under process mapping

28. Map the process
General shift security person will report office at 6.00 am and keep all vehicle keys with him.
Every day morning at 6.50 am vehicle driver comes to security and collect vehicle key and ensure enough
petrol in the in the vehicle.
Driver starts from office at 7.00 to pick up employees and security records the time.
Vehicle moves through jebel ali road to IBN metro road and on to discovery garden of first pickup point.
Where there are 5 signal crossings and two school that can create delays due to traffic.
Vehicle starts picking up employees stop by stop and move towards DPS school road and to LF office.
Where there are one signal crossing and one school that can create delays due to traffic.
After picking up all employee vehicle moves on to jebel ali road and crosses JAFJA security check and reach
office at 8.00 a.m
1
2
3
4
5
6
Up to what extent?, the extent it takes
T
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O
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N
B
O
T
T
O
M
U
P
HOW TO DO PROCESS MAPPING

29. Map the process & Brainstorm on potential failures
IDENTIFICATION OF POTENTIAL FAILURES
Up to what extent?, the extent it takes
Process step Potential failure
General shift security person will report office at
6.00 am and keep all vehicle keys with him.
General shift security person not reported at office?
Reported but keys not available him.
Every day morning at 6.50 am vehicle driver comes
to security and collect vehicle key and ensure
enough petrol in the in the vehicle.
Driver not came? Or Driver came late?
Drive came on time but petrol not enough in the
vehicle?
Driver starts from office at 7.00 to pick up
employees and security records the time
Driver not started on time due to vehicle problem
Vehicle moves through jebel ali road to IBN metro
road and on to discovery garden of first pickup
point. Where there are 5 signal crossings and two
school that can create delays due to traffic.
Driver don’t know the root.
Traffic at signal crossings or at school area?
Vehicle met accident
Vehicle starts picking up employees stop by stop
and move towards DPS school road and to LF
office. Where there are one signal crossing and one
school that can create delays due to traffic.
Employee not available at stop.
Delayed due to employee called and told to wait
Traffic delays.

30. Map the process & Brainstorm on potential failures
IDENTIFICATION OF POTENTIAL FAILURES
Potential failure Controls & Actions
General shift security person not reported at
office?
Reported but keys not available him.
Measure current controls
Plan controls if require
Driver not came? Or Driver came late?
Drive came on time but petrol not enough in
the vehicle?
Measure current controls
Plan controls if require
Driver not started on time due to vehicle
problem
Measure current controls
Plan controls if require
Driver don’t know the root.
Traffic at signal crossings or at school area?
Vehicle met accident
Measure current controls
Plan controls if require
Employee not available at stop.
Delayed due to employee called and told to
wait
Traffic delays.
Measure current controls
Plan controls if require

31. KIRANREDDY MUNNANGI
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