PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

RISK ASSESSMENT
REPORT

Product/System/Equipment Compression Machine (General Block)

Risk Assessment Report No.
Report Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSMENT FOR COMPRESSION 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 8-11

9.1 Review of Risk assessment as per FMEA after action taken. 12

Risk Control Measures
10.0 13

11.0 Summary and Conclusion Report for Risk Assessment 14

12.0 Final Report Approval 15

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

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

Responsibility 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

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

1.0 Introduction
The “Compression machine“ is intended to make tablets and slugs of the lubricated granules by means of
feeding ,dosing and compaction of lubricated granules and ejection of tablets and slugs with assurance of
product safety. The compression of tablet depends upon the compaction force.

2.0 Objective
Objective of this report is to assess the risk associated with the equipment compression machine in pre
assessment in the manufacturing facility of General 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 “Compression Machine” 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

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

Background

…………………. is intended to start manufacturing of solid oral facility at ……………. Risk assessment is a
part of corporate quality assurance. Pre Quality Risk assessment of “Compression 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

 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

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

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

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

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

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

9.0 PRE-RISK ASSESSMENT AS PER FMEA:
Name of facility/Utility/Equipment/Process/Operation: Compression Machine

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence
Potential

New RPN
Detection
S. Potential effect Potential cause/ Recommended

Severity
Failure

Action
taken
No. (s) of failure Mechanism of failure action
Mode

Required Area
(floor,
Temperature, Area, Air Care has to be
RH, preparation unit taken during
Differential will not be No or less clarity of the Area Engineering
Approved layout is in
1 pressure) & suitable for 6 product requirement and 3 3 54 Qualification & , QA,
place.
Air preparation proper machine functionality. equipment Production,
unit not proper functioning of qualification
for the Equipment.
Compression
Machine.
Systems not
Required receive suitable
Preparation of URS
parameter not for proper output Current control
No or less clarity of the before procurement of
defined in of quality with measures are
2 6 product requirement and 3 equipment is in place 2 36 NA NA NA NA NA NA
URS/URS not all parameter as adequate
machine functionality. with all pre-specified
proper for per specification.
parameter.
system Affect the
product quality.

URS is in place for

Required No or less clarity of the
system with all Current control
utilities ( Machine will not product requirement and
predefined measures are
3 compressed function as 7 machine functionality with 3 2 42 NA NA NA NA NA NA
requirement of utility adequate
air, electricity expected. respect to utility
like electricity,
) not available requirement.
compressed air.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence
Potential

New RPN
Detection
S. Potential effect Potential cause/ Recommended

Severity
Failure

Action
taken
No. (s) of failure Mechanism of failure action
Mode

Installation will
Wrong
be affected if
machine URS is in place for
dimension is not Current control
selection in dimension, capacity
considered. No or less clarity of the measures are
4 terms of 5 3 and rated output of the 3 45 NA NA NA NA NA NA
Output will also machine. adequate
Dimension, of the Compression
get affected if
capacity and machine.
capacity is not
output.
considered.
URS is in place for
MOC ( contact part
MOC and should be of SS316 or
machine Not meting 316Land food grade
Current control
contact parts GMP No or less clarity of the material and non
measures are
5 ,Seals & requirements and 5 machine contact part and 2 contact parts will be of 2 20 NA NA NA NA NA NA
adequate
gaskets not product get MOC. SS304 and machine
meeting GMP affected. contact parts to fulfill
requirement GMP requirements.
Gasket used shall be of
food grade.
FOOD grade lubricant Certificate to be
is required defined in received from
URS. the vendor for QA,
Lubricant
Not meting FOOD grade purchase/
used is of no No or less clarity of the
6 GMP 7 4 2 56 against the production, NA NA NA NA NA
food grade requirement
requirements. supply. This \engineerin
quality
shall be a part of g.
SOP.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSMENT FOR COMPRESSION MACHINE

Current Control
Occurrence (O)

RPN (S x O x D)
Action Results

Detection (D)

Responsibility
Severity (s)

and TCD

Occurrence
Potential

New RPN
Detection
S. Potential effect Potential cause/ Recommended

Severity
Failure

Action
taken
No. (s) of failure Mechanism of failure action
Mode

Requirement of Safety
Equipment measures like
Current control
not received interlocking of safety
Accident may No or less clarity about measures are
7 with the 9 2 guards and side 2 36 NA NA NA NA NA NA
happen. equipment safety measures. adequate
process safety guards, Earthing,
measures. Powder level sensor,
is defined in URS.
Dust collector No or less clarity of the
Current control
not provided Dusting and product requirement and
Dust collector unit measures are
8 to suck congestion 5 machine functionality with 2 2 20 NA NA NA NA NA NA
provided by the utility. adequate
powder occurs respect to utility
generated requirement
Other
Current control
accessories Inspection of
No or less clarity about the Requirement will measures are
9 not received punch and die 10 1 1 10 NA NA NA NA NA NA
tooling accessories mention on the URS. adequate
by equipment are not possible
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ASSESSMENT FOR COMPRESSION 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

PRE RISK ASSESSMENT FOR COMPRESSION 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

PRE RISK ASSESSMENT FOR COMPRESSION 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

PRE RISK ASSESSMENT FOR COMPRESSION 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