PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

RISK ASSESSMENT

REPORT BY FMEA

Product/System/Equipment MULTIMILL

Risk Assessment Report No.

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

Report Date

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 4

7.0 Risk Ranking Parameters 5-7

8.0 Acceptance Criteria for risk assessment by FMEA 7

9.0 Risk assessment as per FMEA 8-17

9.1 Review of Risk assessment as per FMEA after action taken. 18

10.0 Risk Control Measures 19

11.0 Summary and Conclusion Report for Risk Assessment 20

12.0 Final Report Approval 21

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

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 ASSESSMENT FOR MULTIMILL

1.0 Introduction

The “MULTI MILL” is intended for particle size reduction through impact & shear in between
the rotary blades and screen at variable speeds inside a cylindrical hopper. With assurance of
product safety. It is necessary to achieve size reduction as well as output of uniform size before
subsequent operations.

2.0 Objective

Objective of this report is to assess the risk associated with the equipment MULTI MILL 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 “MULTI MILL” and define its failure mode at post 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 ASSESSMENT FOR MULTIMILL

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 “MULTI MILL” 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

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

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
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

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

7.4 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 ASSESSMENT FOR MULTIMILL

9.0 POST-RISK ASSESSMENT AS PER FMEA:

Name of facility/Utility/Equipment/Process/Operation: MULTI MILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
1 Design Equipment may 4 No or inadequate 3 URS is prepared by 2 24 Current control NA NA N NA N NA
Qualification not function as clarity (Knowledge) in experienced measures are A A
document desired. preparation of URS. personnel with the adequate
received is help of engineering,
inadequate. cGMP 7 3 QA & department 1 21 NA NA N NA N NA
requirement will Head. A A
not met
Safety measures 4 3 Well experienced 2 24 NA NA N NA N NA
with respect to Personnel from QA, A A
operator and Engineering & user
environment will department verified
not be clear. DQ against URS.

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

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
1 Design Requirement of 3 No or inadequate 1.4 URS is prepared by 2 24 Current control NA NA N NA N NA
Qualification utilities (power clarity (Knowledge) in experienced measures are A A
document supply) will not preparation of URS. personnel with the adequate
received is be clear. help of engineering,
inadequate QA & department
Head.
Functional 4 3 2 24 NA NA N NA N NA
design 2. Well experienced A A
specification will Personnel from QA,
not be available. Engineering & user
department verified
Generally 4 4 1 16 NA NA N NA N NA
DQ against URS.
assembling A A
diagram will not
be clear

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

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
2 Design Document 4 Inadequate knowledge 3 Well experienced 2 24 Current control NA NA N NA N NA
Qualification verification or inadequate training Personnel from QA, measures are A A
document is not related to design to all concerned. Engineering & user adequate
checked and verification, department will
verified verify DQ against
properly. cGMP URS.
requirement
Instrument &
control
verification,
components
verification,
utility
verification &
safety
verification will
not be
appropriate.

3 Installation inadequate 7 Inadequate information 3 Interpretation of 1 21 Current control NA NA N NA N NA

Qualification Installation of in IQ. URS along with DQ. measures are A A
document is equipment adequate
inadequate SOP is in place for
verification of IQ
document.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
Identification of 6 Inadequate information 2 Interpretation of 2 24 NA NA N NA N NA
major in IQ. URS along with DQ. A A
components will
be missing SOP is in place for
verification of IQ
No or inadequate 3 3 document. 2 18 NA NA N NA N NA
clarity on A A
equipment / Current control
documents measures are
required for adequate
completion of
IQ.

4 Calibrated Installation will 6 Inadequate training 4 Qualification team 1 24 Current control NA NA N NA N NA

Measuring be improper, will ensure measures are A A
equipment not Physically for the adequate
available at site. Equipment will availability of
not perform as equipment before
( multi meter, intended execution of IQ.
Tachometer)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

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

6 MOC Product may gets 7 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 ( during IQ.
For contact and Molybdenum Kit Not
non contact parts available
)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
7 Equipment name Equipment will 4 Equipment name plate 3 Procedure is in place 2 24 Controlled NA NA N NA N NA
plate not not be identified. not provided by vendor for verification measures are in A A
available during during IQ. place
IQ

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

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

9 Operational Inadequate 6 Inadequate information 4 SOP is in place for 1 24 Controlled NA NA N NA N NA

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

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

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

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
11 Main motor not Equipment will 7 Inadequate 3 Procedure are in 1 21 Controlled NA NA N NA N NA
rotating. not run knowledge/training for place for verification measures are in A A
operating the during OQ place
equipment.

Required input supply

of suitable frequency of
motor not provided

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

operation not perform as knowledge/training for place for verification measures are in A A
verification not intended operating the during OQ place
done. (Main equipment.
motor
performance
(Noise level).

13 Adequate safety Accident may 10 Inadequate knowledge 2 Procedure are in 1 20 Controlled NA NA N NA N NA

features for men happen place for verification measures are in A A
and material not during IQ & OQ place
provided with
the equipment
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
Flame proof Accident may 10 Inadequate knowledge 2 Procedure are in 1 20 Controlled NA NA N NA N NA
motors & happen place for verification measures are in A A
earthing not during IQ & OQ place
provided
Equipment Equipment will 7 Inadequate 3 Procedure are in 1 21 Controlled NA NA N NA N NA
control functions not function as knowledge/training for place for verification measures are in A A
verification test desired. operating the during OQ place
not done. equipment.
14 Equipment is not Accident may 10 Inadequate 2 Procedure is in place 1 20 Control measures NA NA N NA N NA
assembled after happen. knowledge/training for for proper are in place. A A
cleaning, operating the assembling after
preventive Equipment not equipment properly cleaning,
maintenance, functioned as preventive
break down, expected maintenance,
calibration calibration

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

done without equipment will knowledge/training is in place are in place. A A
any not guaranteed.
documentation
Product quality
may get affected
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
16 Product Performances of 6 No or inadequate 3 Performance 1 18 Control measures NA NA N NA N NA
designing is not equipment will clarity about equipment qualification will be are in place. A A
done considering not guaranteed. design and capacity carried out on
current equipment
equipment Product quality considering design
design may get affected

17 Equipment is not Product will 8 Cleaning procedure is 2 Line clearance & 1 16 Control measures NA NA N NA N NA
cleaned properly contaminated not followed correctly cleaning procedure is are in place. A A
in place
18 Improper Product quality 7 No or inadequate 3 Procedure is in place 3 63 Hardness to be Production,
hardness of contaminated Knowledge for verification checked from QA,
gasket vendor
Vendor has to provide certificate.
test certificate
mentioning hardness

19 Machine Accident 4 No or inadequate 3 Activity will 2 24 Control measures NA NA N NA N NA

operation happens Knowledge performed by Trained are in place. A A
without screen, personnel.
screen holding
plate, discharge
hopper.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

S.No. Potential Potential effect Potential cause/ Recommended Action Results

Current Control
Occurrence (O)
Mechanism of failure

RPN (S x O x D)
Failure Mode (s) of failure action

Responsibility
Detection (D)

Occurrence
Severity (S)

and TCD

New RPN
Detection
Severity
Action
taken
20 Grease leakage Contamination 4 Shaft seal worm out, 3 Preventive 2 24 Control measures NA NA N NA N NA
from bearing with material excessive lubrication. maintenance schedule are in place. A A
housing will follow
properly.(checking of
seal and gaskets and
do not pump
excessive lubrication)
21 Machine will not Product quality 7 No or inadequate 2 Activity will 1 14 Control measures NA NA N NA N NA
operating with affected Knowledge performed by Trained are in place. A A
desired speed, personnel. Activities
desired screen will perform as per
and improper SOP.
rate of feeding.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

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

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

POST RISK ASSESSMENT FOR MULTIMILL

10.0 RISK CONTROL MEASURES

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

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

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

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(Sign/Date)
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

11.0 SUMMARY AND CONCLUSION REPORT FOR RISK ASSESSMENT

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

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

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSMENT FOR MULTIMILL

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