PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

RISK ASSESSMENT
REPORT BY FMEA

Product/System/Equipment POWDER TRANSFER SYSTEM

(250 kg & 500 kg)
Risk Assessment Report No.

Report Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

TABLE OF CONTENTS

S.No. Description Page No.

1.0 Introduction 4

2.0 Objective 4

3.0 Scope 4

4.0 Risk Assessment Approach 4

5.0 Responsibility 4

6.0 Reference Documents 5

Risk Ranking Parameters
7.0 5-6

8.0 Acceptance Criteria for risk assessment by FMEA 7

9.0 Risk assessment as per FMEA 8-20

9.1 Review of Risk assessment as per FMEA after action taken. 21

Risk Control Measures
10.0 22

11.0 Summary and Conclusion Report for Risk Assessment 23

12.0 Final Report Approval 24

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

DOCUMENT APPROVAL:
This risk analysis study for the preapproval of report by following:

Responsibility Department Name Signature Date

Prepared by Quality assurance

Production

Quality control

Reviewed by Engineering

Store

Quality assurance

Approved by Head-QA
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

1.0 Introduction
The “Powder Transfer System” is intended to powder transferring system in the lean phased
Vacuum conveying mode, which achieves material transfer by introducing the material into the
moving stream of air at desired rate. Conveying is achieved automatically and continues till the
material reaches its final destination & to dry the same to the final required degree in a careful
manner with assurance of product safety.

2.0 Objective
Objective of this report is to assess the risk associated with the equipment “Powder Transfer
System ” in post assessment in the manufacturing facility of Cepha Oral Block of ………….., in
line with the guidance of the Risk Management manual of ……………and ICH Q9.

3.0 Scope
The scope of this document is limited to the design, installation, operation, performance and
safety of equipment “Powder Transfer System” and define its failure mode at pre assessment in
the manufacturing facility at ……………….

4.0 Risk assessment approach

Risk assessment is carried out as per FMEA (Failure mode, effects analysis) method.

5.0 Responsibility
Quality Assurance
Engineering
Production
Quality Control
Store

6.0 Reference Documents

1. ICH Q9-Quality Risk Management

2. …………………. guidance on Risk Assessment.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Background
………………..is intended to start manufacturing of solid oral facility at ………….. Risk assessment is a
part of corporate quality assurance. Post Quality Risk Assessment of “Powder Transfer System” is done to
check the system is capable of providing quality product throughout the life cycle of the drug product.

7.0 RISK RANKING PARAMETERS

7.1 Rating parameters for Severity

Effect Scale Description

No effect 1 No effect on output

Very slight 2 Customer not annoyed

Slight 3 Slight

Minor 4 Minor effect on performance

Moderate 5 Moderate effect on performance

Significant 6 Partial failure but operable

Major 7 Product performance severely affected, but some operability and safe

Extreme 8 Very dissatisfied, product inoperable but safe

Serious 9 Potentially hazardous effect, time-dependent failure

Hazardous 10 Hazardous effect, safety related sudden failure

7.2 Rating parameters for Occurrence

Occurrence Scale Description

Almost never 1 Failure unlikely; history shows no failures

Remote 2 Rare number of historical failure

Very Slight 3 Very few failures likely

Slight 4 Few failures likely

Low 5 Occasional number of failures likely

Medium 6 Medium number of failures likely

Moderately High 7 Moderately high number of failures likely

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Occurrence Scale Description

High 8 High number of failures likely

Very High 9 Very high number of failures likely

Almost certain 10 Failure almost certain

7.3 Rating parameters for Detection control

Detection Scale Description

Almost certain 1 Proven detection methods with high reliability

Very High 2 Proven detection methods available

High 3 Detection tools have high chance of detecting methods

Moderately High 4 Almost certain not to detect failure

Medium 5 Detection tools have moderate chance of detecting defect

Low 6 Detection tools have a low chance of detecting failure

Slight 7 Detection tools may not detect failure

Very Slight 8 Detection tools will probably not detect failure

Remote 9 Detection tools most likely will not detect failure

Impossible 10 Failure not detected

Note: Individual contributory factor for each potential failure mode shall be rated. Other scale parameters
may also be selected based on the process.

8.0 ACCEPTANCE CRITERIA FOR RISK ASSESSMENT BY FMEA

Acceptance criteria for FMEA are as follows:

S.No. RPN Rating RPN Category Action Status

1. ≥ 76 Critical CAPA Required

2. 51 to 75 Major CAPA Required

3. 26 to 50 Moderate CAPA Required

4. Up to 25 Minor Not applicable

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

9.0 POST-RISK ASSESSMENT AS PER FMEA:
Name of facility/Utility/Equipment/Process/Operation: Powder Transfer System

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Equipment may
N N N N
not function as 4 3 2 24 NA NA
A A A A
desired.

c-GMP
URS is prepared by N N N N
requirement will 7 3 1 21 NA NA
experienced A A A A
not meet
personnel with the
help of engineering ,
Design Safety measures QA & department
with respect to No or inadequate clarity Current control
Qualification Head. N N N N
operator and 4 (Knowledge) in 3 2 24 measures are NA NA
1 document A A A A
environment will preparation of URS. adequate
received is Well experienced
inadequate. not be clear. Personnel from QA,
Engineering & user
department verified
Clarity on P & DQ against URS. N N N N
ID diagram will 3 3 2 18 NA NA
A A A A
not be clear

Major
components list N N N N
6 2 2 24 NA NA
will be missed A A A A
out.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Requirement of
utilities (power
N N N N
and compressed 3 4 2 24 NA NA
A A A A
air) will not be
clear.

Functional
design N N N N
Design 4 3 Well experienced 2 24 NA NA
specification will A A A A
Qualification not be available. No or inadequate clarity Personnel from QA, Current control
document (Knowledge) in Engineering & user measures are
1
received is Generally preparation of URS. department verified adequate
inadequate assembling DQ against URS. N N N N
4 4 1 16 NA NA
diagram will not A A A A
be clear

Instrument list
connected with N N N N
4 3 2 24 NA NA
equipment will A A A A
be missing
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Document
verification
related to design
verification, c
GMP
requirement, Well experienced
Design
Instrument & Personnel from QA,
Qualification Current control
control Inadequate knowledge or Engineering & user
document is not measures are N N N N
2 verification, 4 inadequate training to all 3 department verified 2 24 NA NA
checked and adequate A A A A
components concerned. DQ against URS.
verified
verification,
properly.
utility
verification &
safety
verification will
not be
appropriate.
Interpretation of
Installation URS along with DQ. Current control
Inadequate Inadequate information
Qualification measures are N N N N
3 Installation of 4 in IQ. 3 2 21 NA NA
document is SOP is in place for adequate A A A A
equipment
inadequate verification of IQ
document.
Interpretation of Current control
Identification of
Inadequate information URS along with DQ. measures are
major N N N N
6 in IQ. 2 2 24 adequate NA NA
components will A A A A
SOP is in place for
be missing
verification of IQ
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

No or inadequate document.
clarity on
equipment /
N N N N
documents 3 3 2 18 NA NA
A A A A
required for
completion of
IQ.
Calibrated Installation will 6 Inadequate training 4 1 24 . Current control NA
Measuring be improper, measures are
equipment not Equipment will Ensure Physically for adequate
available at site.( not perform as the availability of
multi meter, intended equipments before N N N N
4 NA
spirit level, execution of IQ. A A A A
Tachometer)

Reference Installation will 6 Inadequate knowledge for 4 Qualification team 1 24 Current control NA
document not be improper, verification of reference will ensure measures are
available at site Equipment will documents on receipt. Physically for the adequate
during IQ. (FDS, not perform as availability of
PLC FDS, GA intended documents before
and electrical execution of IQ.
N N N N
5 drawing, NA
A A A A
installation &
Operational
manual, Material
chart with test
certificate &
Manual.)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

MOC Product may gets 7 1. MOC Test certificate 4 Procedure is in place 2 56 Molybdenum kit Engineering,
verification not contaminated not provided by vendor. for verification to be procured
done during IQ ( 2. Molybdenum Kit Not during IQ.
6
For contact and available
non contact parts
)
Equipment name Equipment will 4 Equipment name plate not 3 Procedure is in place 2 24 Controlled NA NA N N N N
plate not not be identified. provided by vendor for verification measures are in A A A A
7 available during during IQ. place
IQ

Instrumentation IQ will not be 5 Inadequate Knowledge or 3 Procedure is in place 1 15 Controlled NA NA N N N N

& calibration performed training to concern for verification measures are in A A A A
8 check not personnel during IQ. place
performed.

Operational inadequate 6 Inadequate information in 4 1 24 Controlled NA NA N N N N

document is Operation of OQ SOP is in place for measures are in A A A A
9 inadequate equipment verification of OQ place
Protocol.

IQ not OQ Cannot be 6 1. Incomplete 4 SOP is in place to 1 24 Controlled NA NA N N N N

completed prior proceed documentation. perform OQ after measures are in A A A A
10 to OQ 2. Installation not successful place
completed completion of IQ
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Prequalification Accident may 10 Inadequate knowledge or 2 Activity will 1 20 Controlled NA NA N N N N

requirement not happen safety measures are not performed by measures are in A A A A
checked during followed Trained personnel. place
OQ.
(Tools are not
removed from
the equipment.)
Emergency Equipment will 6 Inadequate knowledge 4 Procedure are in 1 24 Controlled NA NA N N N N
“STOP” button not run place for verification measures are in A A A A
11 not released. during OQ place

External Accident may 10 Inadequate knowledge or 2 Activity will 1 20 Controlled NA NA N N N N

equipment is not happen safety measures are not performed by measures are in A A A A
disconnected. followed Trained personnel. place

Procedure are in
place for verification
during OQ
Temperature Accuracy of 7 Inadequate 3 Procedure are in 1 21 Controlled NA NA N N N N
sensors are not temperature will knowledge/training place for verification measures are in A A A A
12 calibrated not be achieved during OQ place

Equipment Equipment will 10 Inadequate 2 Procedure are in 1 20 Controlled NA NA N N N N

operation not perform as knowledge/training for place for verification measures are in A A A A
13 verification not intended operating the equipment. during OQ place
done. (Noise
level).
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Filters(coarse, Product & 10 Inadequate 2 Procedure are in 1 20 Controlled NA NA N N N N

pre, fine, HEPA, environment will knowledge/training place for verification measures are in A A A A
14 exhaust filters be contaminated during IQ & OQ place
are not available
in APU unit
APU unit is not Product & 10 Inadequate 3 Procedure are in 1 30 Controlled Engineering,
functioning environment will knowledge/training place for verification measures are in QA,
be contaminated, during OQ place, Production,
15 Performance
Desired drying checks to be
temperature will verified during
not achieved PQ.
Equipment Equipment will 7 Inadequate 3 Procedure are in 1 21 Controlled NA NA N N N N
control not function as knowledge/training for place for verification measures are in A A A A
functions, desired. operating the equipment. during OQ place
interlocks &
alarm
verification test
not done.
Adequate safety Accident may 10 Inadequate knowledge 2 Procedure are in 1 20 Controlled NA NA N N N N
16
features for men happen place for verification measures are in A A A A
and material not during IQ & OQ place
provided with
the equipment
Flame proof Accident may 10 Inadequate knowledge 2 Procedure are in 1 20 Controlled NA NA N N N N
motors,& happen place for verification measures are in A A A A
Explosion flaps during IQ & OQ place
not provided
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Equipment Recipe 8 Inadequate 3 Procedure for 7 SOP will be Production

168
control functions preparation will knowledge/training for Preparation of prepared for
verification test not be possible operating the equipment. Recipe is available in preparation of
not done. operational manual Recipe

Equipment will 8 Recipe is not prepared 4 Procedure for 6 SOP will be Production

192
not be under through password Preparation of prepared for
password protection Recipe is available in preparation of
protection operational manual password
protection

Selection of 8 Inadequate 3 Verified in 6 SOP will be Production

144
appropriate mode knowledge/training for Operational checks prepared for
like Manual, operating the equipment during OQ. proper selection
Auto, Recipe, recipe for product
Maintenance, ,Maintenance,
wash will not be wash
possible
System will not 6 System run in Manual 4 Activity will 1 24 System should NA NA N N N N
give any alarm Mode performed by not run in manual A A A A
during Trained personnel. mode after
malfunctioning. validation,
accordingly SOP
will be prepared.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Equipment is not Accident may 10 Inadequate 2 Procedure is in place 1 20 Control measures NA NA N N N N

assembled after happen. knowledge/training for for proper are in place. A A A A
cleaning, operating the equipment assembling after
17 preventive Equipment not properly cleaning,
maintenance, functioned as preventive
break down, expected maintenance,
calibration calibration
Recipe not Consistent 6 Inadequate 4 Procedure for 5 Sop will be Production,

120
prepared for performance of knowledge/training for Preparation of prepared for
Product, Wash, equipment will operating the equipment Recipe is available in recipe
maintenance not be possible operational manual preparation for
18
cycle. Product, Wash,
`maintenance
cycle.

Major changes Performances of 6 Inadequate 3 Change control Sop 1 18 Control measures NA NA N N N N

done without equipment will knowledge/training is in place are in place. A A A A
any not guaranteed.
19
documentation
Product quality
may get affected
Product Performances of 6 No or inadequate clarity 3 Performance 1 18 Control measures NA NA N N N N
designing is not equipment will about equipment design qualification will be are in place. A A A A
done considering not guaranteed. and capacity carried out on
20 current equipment
equipment Product quality considering Min. &
design and may get affected Max. capacity &
capacity design
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

Process Performance of 8 Inadequate 3 Process validation & 1 24 Control measures NA NA N N N N

monitoring is not the equipment knowledge/training APR will cover the are in place. A A A A
21 done will not be monitoring part
guaranteed

Process Performance of 8 Inadequate 2 Process validation 1 16 Control measures NA NA N N N N

validation the equipment knowledge/training protocol will cover are in place. A A A A
22 guidance is not will not be the sampling
clear (sample guaranteed. location.
withdrawal).
Equipment is not Product will 8 Cleaning procedure is not 2 Line clearance & 1 16 Control measures NA NA N N N N
cleaned properly contaminated followed correctly cleaning procedure is are in place. A A A A
in place
23

Filter bag Filter Bag 6 Inadequate 2 Procedure are in 2 24 Control measures NA NA N N N N

shaking device Choked knowledge/training place for verification are in place. A A A A
not functioning during OQ
24
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR POWDER TRANSFER SYSTEM

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence

New RPN
Detection
Potential Potential effect Potential cause/ Recommended

Severity
S.No.

Action
taken
Failure Mode (s) of failure Mechanism of failure action

No Fluidization Product will not 7 Insufficient amount of air 5 Procedure is in place 2 70 PQ protocol & QA,
in the product meet the is available. for verification preventive Production,
specification during OQ maintenance
PQ protocol is not schedule will be Engineering,
prepared. prepared after
successful
Preventive maintenance completion of
schedule is not prepared. OQ to check
25 proper
fluidization in the
product

No dedicated Product will be 8 Insufficient FBD finger 4 Decision has been 2 64 Dedicated
FBD finger bag contaminated bags available taken for product product specific
26 specific to the dedicated FBD finger FBD finger bag
product bag to be procured
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

9.1 REVIEW OF RISK ASSESSMENT AS PER FMEA AFTER ACTION TAKEN:

Action Results
Remarks
Action Taken Severity Occurrence Detectability RPN
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

10.0 RISK CONTROL MEASURES

Investigation/ findings: (an extra sheet can be used if space is insufficient)

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Corrective Action: (an extra sheet can be used if space is insufficient)

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(Sign/Date)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

11.0 SUMMARY AND CONCLUSION REPORT FOR RISK ASSESSMENT

Summary: .....……………………………………………………………………………………………

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Conclusion: ………………………………………………………………………………………………

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

QUALITY RISK ASSESSEMENT AND MITIGATION PLAN

12.0 FINAL REPORT APPROVAL:

The final report shall be signed after identifying all the risks and critical control parameters. All the reports
or documents have been attached to the respective report (if applicable).

Signature in the block below indicates that all the control measures taken are documented and have been
reviewed and found to be acceptable.

Department Name Designation Signature Date

Quality assurance

Production

Quality control

Engineering

Store

Head-QA