PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

RISK ASSESSMENT
REPORT

Product/System/Equipment Tablet and Capsule Sorter (General Block)

Risk Assessment Report No.

Report Date
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

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 ANALYSIS FOR TABLET AND CAPSULE SORTER

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 ANALYSIS FOR TABLET AND CAPSULE SORTER

1.0 Introduction
The “Tablet and Capsule Sorter” is intended to use for inspection of tablet and capsule. The
conveyer motor and vibrator starts vibrating which enables the tablet and capsule move forward,
the orientation motor starts rotating and this in turn rotates the tablet and capsule to make it
convenient for visibility checking of tablet and capsule with assurance of product safety.

2.0 Objective
Objective of this report is to assess the risk associated with the equipment Tablet and Capsule
Sorter 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 “ Tablet and Capsule Sorter “ 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 ANALYSIS FOR TABLET AND CAPSULE SORTER

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 “Tablet and Capsule Sorter “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

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

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

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

9.0 PRE-RISK ASSESSMENT AS PER FMEA:

Name of facility/Utility/Equipment/Process/Operation: Tablet and Capsule Sorter
Action Results

Current Control
Occurrence (O)

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

Responsibility
Severity (s)

and TCD

Occurrence
Potential

New RPN
Detection
Potential effect Potential cause/ Recommended

Severity
S.No. Failure

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

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

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

Action Results

Current Control
Occurrence (O)

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

Responsibility
Severity (s)

and TCD

Occurrence
Potential

New RPN
Detection
Potential effect Potential cause/ Recommended

Severity
S.No. Failure

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

Required Machine will not No or less clarity of the URS is in place for Current control
utilities ( function as product requirement and system with all measures are
compressed expected. machine functionality with predefined adequate
air, respect to utility requirement of utility
3 7 3 2 42
electricity requirement. like electricity,
,light compressed air, light
facility)are facility
not available
Wrong Installation will No or less clarity of the URS is in place for Current control
machine be affected if machine. dimension , capacity measures are
selection in dimension is not and rated output of the adequate
terms of considered. of the Tablet and
4 5 3 3 45
Dimension, Output will also Capsule Sorter
capacity and get affected if
output. capacity is not
considered.
MOC and Not meting No or less clarity of the URS is in place for Current control
machine GMP machine contact part and MOC ( contact part measures are
contact parts requirements and MOC. should be of SS316 or adequate
,Seals & product get 316L and food grade
gaskets not affected. material and non
5 meeting GMP 5 2 contact parts will be of 2 20
requirement SS304 and machine
contact parts to fulfill
GMP requirements.
Gasket used shall be of
food grade rubber.
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

Action Results

Current Control
Occurrence (O)

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

Responsibility
Severity (s)

and TCD

Occurrence
Potential

New RPN
Detection
Potential effect Potential cause/ Recommended

Severity
S.No. Failure

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

Lubricant Not meting 7 No or less clarity of the 4 FOOD grade lubricant 2 56 Certificate to be QA,
used is of no GMP requirement is required defined in received from Purchas
food grade requirements. URS. the vendor for e/
quality FOOD grade Producti
6 against the on,
supply. This \Engine
shall be a part of ering
SOP.

Equipment Accident may 9 No or less clarity about 2 Requirement of Safety 2 36 Current control
not received happen. equipment safety measures. measures like Earthing measures are
7 with the is defined in URS. adequate
process safety
measures.
Dust collector Dusting and 6 No or less clarity about 2 URS is in place for 1 12 Current control
not provided congestion equipment safety ,product dust collector unit for measures are
8 to suck occurs safety and human safety Tablet and Capsule adequate
powder measures Sorter
generated
 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

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

Action Results
Remarks
Action Taken Severity Occurrence Detectability RPN

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

PRE RISK ANALYSIS FOR TABLET AND CAPSULE SORTER

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 ANALYSIS FOR TABLET AND CAPSULE SORTER

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 ANALYSIS FOR TABLET AND CAPSULE SORTER

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