JSA VALIDATION SERVICES

BADDI (H.P.) INDIA

TEMPLATE OF RISK BASED PRIORITIZATION PLAN

RISK BASED PRIORITIZATION PLAN

Mitigate
the Risk

Identify
the
Risk

Planing and
Prioritization
 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

1. INTRODUCTION :

2. SCOPE :
The risk ranking exercise for prioritizing the QRM is applicable for …………….XYZ Facility.
The prioritizing exercise covers elements as mentioned below:
• Product
• Process
• Equipment
3. ABBREVIATION :
4. REASON FOR REVISION :
Sr. No. Changes Incorporated Reason for changes

5. RESPONSIBILITY :
6. DEFINITITONS :
7. RISK PRIORITIZATION PROCESS :
Formal risk ranking is based on well-defined analytical processes and enhances the quality, transparency, and,
potentially, the performance of risk management programs.
The risk ranking procedure uses an analytical process to pose a risk question; Identify potential hazards and risks;
characterize factors that can be used as variables for quantifying risk; and mathematically combine the variables to
yield an overall risk score for risk ranking.
The overall process is schematically outlined in below mentioned Figure.

Define the “Risk

Question”

For complex
Identify and List all
system s, categorize
Risk Factors
risk factors logically,
(Variables)
administratively etc.

Estimate risks for

each item in
Inventory /Portfolio

No: Rescale Rank Items (Risks)

Objective Met? Filter Ranked List

Yes End

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 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

8. TOP LEVEL COMPONENTS FOR RISK BASED PRIORITIZATION :

Factor Category Description Example(s)

Product Factors pertaining to the intrinsic properties of drug Dosage form; intrinsic chemical properties,
products /Intermediates/API such that quality deficiencies highly potent molecules, , key starting
could potentially and adversely impact public health. materials

Facility & Factors relating to characteristics of a manufacturing site Poor cGMP compliance
Equipment believed to be predictive of potential quality risks, such
as the lack of effective quality systems. History, Complaints received suggesting
Class I or Class II health hazard situations

Process Factors pertaining to aspects of drug manufacturing Cleaning Procedures, Processing &
operations that may predict potential difficulties with Controls, Environmental controls &
process control and/or vulnerability to various forms of Management, compression; Cartoning /
contamination. packaging, etc.

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 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

9. CONCEPTUAL ORGANIZATION OF SITE RISK POTENTIAL :

QRM initiatives

Equipment Facility Process Product

Processing equipment’s Contamination control Cleaning procedures High Impact Products

Utility equipment’s Level of automation & Processing and controls High Cost Products
Alarm Management
Packing machines Distribution Mgmt. High Volume Products
Control storage area
Detection and scanning Maintenance Mgmt.
devices Environmental Controls
& Management Waste Management
Monitoring and
recording devices FP Transportation Mgmt.

Hold period Mgmt.

Printed Packaging
Material Handling

A Site Risk Potential (SRP) is a function of the weighted risk potentials for each of the categories, Product, Facility
and Process & Equipment. The risk potential for each top-level component is, in turn, a function of select potential
risk factors. Thus, a SRP score is derived by mathematical combination of weights or ranks assigned to select
potential risk factors. The assignment of weights or ranks to select potential risk factors is based on either
empirical evidence or expert judgement or combination of both.
9.1 Quality risk indicators :
Quality risk indicators are top level components for risk based prioritization which include:
▪ Facility & Equipment
▪ Product
▪ Process
9.2 Risk scoring criteria :
Individual risk factors are rated from 1 to 3 with increasing level of priority and total risk score is calculated by
summing individual risk factor values. Based upon individual risk score, particular risk items are ranked.
Three point risk scale are depicted in the table as described below:

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 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

Color codification criteria for Process/Equipment/Product/Facility Risk Factors

RISK INDICATOR VALUE COLOR CODIFICATION

Equal to 1 (Minor) The color of the cell in risk rating table is shown as green

Equal to 2 (Major) The color of the cell in risk rating table is shown as yellow

Equal to 3 (Critical) The color of the cell in risk rating table is shown as Red

9.3 Risk prioritization criteria :

Risk Prioritization is done based upon calculated risk ranks.

Color codification criteria for items of Process/Equipment/Product Risk Factors

RISK RANK COLOR CODIFICATION

Risk ranks for identified Product and
The font color of the item is shown in red italics
Equipment/ facility and Process

9.3.1 Existing QRM initiatives :

Existing QRM Initiative section indicates that QRM has been performed for that particular item if the
corresponding item is marked as ‘’.

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 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

10. PRODUCT QUALITY RISK INDICATOR & ITS PRIOTRIZATION :

Risk Based Prioritization for performing Quality Risk Management

(Based on Risk Ranking Model)

Quality Risk Indicator - Product
Item Process Product Complaints Product Product Potency
control knowledge History Volume

residues, from the environment

recall (Class I & II) specific to
complaints specific to product
The product is known to have
difficult to achieve consistent

concerns pertaining stability,

(Large batch size or multiple

Is the product a high volume

vulnerable to contamination
Is there a history of product

(e.g. from previous product

Is this a difficult product to

Is this product more or less

Is there a history of market

product supply to patients.

make? In other words is it

Regulatory , Safety, OOS

batches), Interruption of
(Item in red

, to next product)
font indicates
product quality

that they are

product
ranked amongst
first five in
product risk
factors)
Sr
No

Existing QRM initiative

Risk score 1 Slightly Low or less Less than 5 Never Less than Therapeutic dose
difficult concern 20 batches > 10 mg

Risk score 2 Moderately Moderately 5 to 9 Less than 20 to 300 Therapeutic dose

difficult concern 3 events batches <10 mg > 100 µg

Total Score

Risk Rank
(0.1 mg)

Risk score 3 Very High >=10 More More than Therapeutic dose
difficult concern than 3 300 batches <100 µg (0.1 mg)
events

Product being
manufactured
at <Plant>

Summary and conclusion

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 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

11. EQUIPMENT QUALITY RISK INDICATOR & ITS PRIORITIZATION :

Risk Based Prioritization for performing Quality Risk Management

current detection methods

(Item in red
to vulnerability in quality
unit operation contribute
To what degree does this

automated & completed

If a problem does occur

Is this unit of operation

Is this unit of operation

more or less vulnerable

more or less vulnerable

to contamination from

to contamination from
operation in a state of
in control philosophy
of the final product?

How difficult is it to

how reliable are the

font indicates

previous product?
maintain this unit

the environment?
The equipment is
that they are

control?
rank among
first five in
product risk

Existing QRM initiative

factors)

Risk score 1 Minimal less Slightly Very Slightly Slightly

Complex difficult reliable vulnerable vulnerable

Total Score

Risk Rank
Risk score 2 Moderate to Moderately Moderately Moderately Moderately Moderately
high Complex difficult reliable vulnerable vulnerable
Risk score 3 Very high High Very Slightly Very Very
Complex difficult reliable vulnerable vulnerable
Processing Equipment
1
2
Packaging Equipment
3
4
Detection, inspection and scanning Equipment
5
6
Utility Equipment
7
8
9

Summary of conclusion

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 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

12. PROCESS QUALITY RISK INDICATOR & ITS PRIORITIZATION :

Risk Based Prioritization for performing Quality Risk Management

(Based on risk management model)

Quality Risk Indicator – process

Item Process control

To what degree How difficult is it If a problem does Is this unit of operation

does this process to maintain this occur, how more or less vulnerable to
contribute to process in the state reliable are the contamination from the

Existing QRM initiative

vulnerability in of control? correct detection environment, previous
(Item in red font quality of the final methods? product or next product?
indicates that they are product?
rank among first 3 in
process risk factors) 1=Minimal 1 = Slightly 1 = Very reliable 1 = Slightly vulnerable

Total Score

Risk Rank
difficult
2= Moderate to 2 =Moderately 2 = Moderately 2 = Moderately vulnerable
high difficult reliable
3 = Very high 3 = Very difficult 3 = Slightly 3 = Very vulnerable
reliable
1 Cross
contamination &
Mix UP
2 Raw Material and
Printed packing
material handling
& controls
3 Cleaning
procedure
4 Maintenance
Management
5 Waste
Management
6 Environment
control &
Management
7 Finished product
transportation
Management
8 Security
Assurance

Summary of rating:

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 JSA VALIDATION SERVICES
BADDI (H.P.) INDIA
TEMPLATE OF RISK BASED PRIORITIZATION PLAN

13. CONCLUSION & RECOMMENDATIONS :

Based up on the above exercise, a prioritization for performing Quality Risk Management has been proposed for
future QRM initiatives. The proposed initiatives shall be executed in phase as per the following table.

Broad Broad Broad Schedule

Process QRM Equipment & Utilities Product QRM

initiatives QRM initiatives initiatives

Risk Prioritization
items

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