PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

RISK ASSESSMENT
REPORT BY FMEA

Product/System/Equipment STRIP PACKING MACHINE

Risk Assessment Report No.

Report Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

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 8-17

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

Risk Control Measures
10.0 19

11.0 Summary and Conclusion Report for Risk Assessment 20

12.0 Final Report Approval 21

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

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 STRIP PACKING MACHINE

1.0 Introduction
The “STRIP PACKING MACHINE” is intended to use packing of tablets and capsules .Packing
is achieved by Feeding system, Sealing system, Batch coding unit, Cutting System. Product is fed
into the hopper guided into the bowl mounted on a vibrator released into the sealing roller.
Sealing rollers draws the heat sealing packing material and product gets packed and seal in the
foil. Cutter assembly cut the strip into desired strip length with assurance of product safety.

2.0 Objective
Objective of this report is to assess the risk associated with the equipment “STRIP PACKING
MACHINE” in post assessment in the manufacturing facility of Cepha 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 “STRIP PACKING MACHINE” 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 STRIP PACKING MACHINE

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 “STRIP PACKING MACHINE” 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

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Occurrence Scale Description

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

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 STRIP PACKING MACHINE

9.0 POST-RISK ASSESSMENT AS PER FMEA:
Name of facility/Utility/Equipment/Process/Operation: STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

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

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

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

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

Requirement
of utilities
(power and
3 4 2 24 NA NA NA NA NA NA
compressed
air) will not
be clear. URS is prepared by
Functional experienced personnel
design with the help of
Design specification 4 3 engineering, QA & 2 24 NA NA NA NA NA NA
Qualification will not be No or inadequate clarity department Head. Current control
document available. (Knowledge) in preparation measures are
received is Generally of URS. Well experienced adequate
inadequate assembling Personnel from QA,
4 4 1 16 NA NA NA NA NA NA
diagram will Engineering & user
not be clear department verified
DQ against URS.
Instrument
list connected
with
4 3 2 24 NA NA NA NA NA NA
equipment
will be
missing
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

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

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

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

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

Reference Installation 6 Inadequate knowledge for 4 Qualification team will 1 24 Current control NA NA NA NA NA NA
document not will be verification of reference ensure Physically for measures are
available at site improper, documents on receipt. the availability of adequate
during IQ. Equipment documents before
(FDS, PLC will not execution of IQ.
FDS, GA and perform as
electrical intended
5 drawing,
installation &
Operational
manual,
Material chart
with test
certificate &
Manual.)
MOC Product may 7 MOC Test certificate not 4 Procedure is in place 2 56 Molybdenum kit

Engineering,
verification not gets provided by vendor. for verification during to be procured
done during IQ contaminated IQ.
6
( For contact Molybdenum Kit Not
and non contact available
parts )
Equipment Equipment 4 Equipment name plate not 3 Procedure is in place 2 24 Controlled NA NA NA NA NA NA
name plate not will not be provided by vendor for verification during measures are in
7 available during identified. IQ. place
IQ
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

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

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

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

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

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

completed prior be proceed 2. Installation not completed perform OQ after measures are in
10 to OQ successful completion place
of IQ

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

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

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

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

equipment is may happen safety measures are not performed by Trained measures are in
not followed personnel. place
disconnected.
Procedure are in place
for verification during
OQ
Temperature Accuracy of 7 Inadequate knowledge 3 Procedure are in place 1 21 Controlled NA NA NA NA NA NA
sensors are not temperature /training for verification during measures are in
12 calibrated will not be OQ place
achieved
Equipment Equipment 10 Inadequate 2 Procedure are in place 1 20 Controlled NA NA NA NA NA NA
operation will not knowledge/training for for verification during measures are in
13 verification not perform as operating the equipment. OQ place
done. (Noise intended
level).
Equipment Equipment 7 Inadequate 3 Procedure are in place 1 21 Controlled NA NA NA NA NA NA
control will not knowledge/training for for verification during measures are in
functions, function as operating the equipment. OQ place
14 interlocks & desired.
alarm
verification test
not done.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

Adequate safety Accident 10 Inadequate knowledge 2 Procedure are in place 1 20 Controlled NA NA NA NA NA NA

features for men may happen for verification during measures are in
and material not IQ & OQ place
provided with
the equipment
Flame proof Accident 10 Inadequate knowledge 2 Procedure are in place 1 20 Controlled NA NA NA NA NA NA
motors not may happen for verification during measures are in
provided IQ & OQ place

Equipment is Accident 10 Inadequate 2 Procedure is in place 1 20 Control measures NA NA NA NA NA NA

not assembled may happen. knowledge/training for for proper assembling are in place.
after cleaning, operating the equipment after properly
15 preventive Equipment cleaning, preventive
maintenance, not maintenance,
break down, functioned as calibration
calibration expected
Major changes Performances 6 Inadequate 3 Change control Sop is 1 18 Control measures NA NA NA NA NA NA
done without of equipment knowledge/training in place are in place.
any will not
documentation guaranteed.
16
Product
quality may
get affected
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

Product Performances 6 No or inadequate clarity 3 Performance 1 18 Control measures NA NA NA NA NA NA

designing is not of equipment about equipment design and qualification will be are in place.
done will not capacity carried out on
considering guaranteed. equipment considering
17
current design
equipment Product
design quality may
get affected
Process Performance 8 Inadequate 2 Process validation 1 16 Control measures NA NA NA NA NA NA
validation of the knowledge/training protocol will cover the are in place.
18 guidance is not equipment sampling location.
clear (sample will not be
withdrawal). guaranteed.
Equipment is Product will 8 Cleaning procedure is not 2 Line clearance & 1 16 Control measures NA NA NA NA NA NA
not cleaned contaminated followed correctly cleaning procedure is are in place.
19 properly in place

Improper Strips fail in 7 Machine parameters (Sealing 3 Activity will 1 21 Control measures NA NA NA NA NA NA
Knurling of Leak test. temperature & pressure) not performed by Trained are in place.
Strips set properly personnel.
20 Product
Quality
affected

Feeding system Tablets gets 7 Improper alignment of 3 Activity is controlled 1 21 Control measures NA NA NA NA NA NA
is not working damaged hopper to guide track. by vibrator .Activity are in place.
21 will performed by
Trained personnel
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

Current Control
Occurrence (O)
Action Results

RPN (S x O x D)
Detection (D)

Responsibility
Severity (S)

and TCD

Occurrence
Potential

New RPN
Detection
Potential Potential cause/ Recommended

Severity
S.No. effect (s) of

Action
taken
Failure Mode Mechanism of failure action
failure

Batch coding is Quality 7 Inadequate 3 Procedure for manual 1 21 Control measures NA NA NA NA NA NA

23 missing affected knowledge/training inspection is in place are in place.

Cutting system Product 4 Inadequate 3 Procedure for manual 1 21 Control measures NA NA NA NA NA NA

is not affected, knowledge/training inspection is in place are in place.
24 functioning .
proper.
Non fill Market 7 Inadequate 3 Challenge test to be 1 21 Control measures NA NA NA NA NA NA
detection complaint knowledge/training carried out to reject are in place.
25 system are not may arise during Qualification
functioning activity
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

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

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

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

POST RISK ASSESSEMENT FOR STRIP PACKING MACHINE

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 ASSESSEMENT FOR STRIP PACKING MACHINE

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