PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
RISK ASSESSMENT
REPORT BY FMEA
Product/System/Equipment COLLOID MILL (30 LTRS)
Risk Assessment Report No.
Report Date
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
TABLE OF CONTENTS
[Link]. 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 ASSESSEMENT FOR COLLOIDAL MILL
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
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
1.0 Introduction
The “Colloid Mill” is intended to use for Homogenization of color pigments with solvents.
Mixing is achieved by rotate the ingredients with high speed rotator with assurance of product
safety.
2.0 Objective
Objective of this report is to assess the risk associated with the equipment Colloid Mill in pre
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 “Colloid Mill” 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 ASSESSEMENT FOR COLLOIDAL MILL
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 “Colloid 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
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
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
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.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
8.0 ACCEPTANCE CRITERIA FOR RISK ASSESSMENT BY FMEA
Acceptance criteria for FMEA are as follows:
[Link]. 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
A
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
9.0 PRE-RISK ASSESSMENT AS PER FMEA:
Name of facility/Utility/Equipment/Process/Operation: Colloid Mill
Current Control
Action Results
Occurrence (O)
RPN (S x O x D)
Detection (D)
Responsibility
Severity (S)
and TCD
Occurrence
Potential
New RPN
Detection
Potential Potential cause/ Recommended
Severity
[Link]. effect (s) of
Action
taken
Failure Mode Mechanism of failure action
failure
Required Area Area will not 6 No or less clarity of the 3 Approved layout is 3 54 Care has to be Engineering,
(floor, be suitable for product requirement and in place. taken during QA,
Temperature, proper machine functionality. Area Production
RH, functioning of Qualification &
Differential Equipment. equipment
1 pressure) not qualification
proper for the
Colloid Mill.
Required Systems not 4 No or less clarity of the 3 Preparation of URS 2 24 Current control NA NA NA NA NA NA
parameter not receive product requirement and before procurement measures are
defined in suitable for machine functionality. of equipment is in adequate
URS/URS not proper output place with all pre-
proper for of quality with specified parameter.
2 system all parameter
as per
specification.
Affect the
product
quality.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
Current Control
Action Results
Occurrence (O)
RPN (S x O x D)
Detection (D)
Responsibility
Severity (S)
and TCD
Occurrence
Potential
New RPN
Detection
Potential Potential cause/ Recommended
Severity
[Link]. effect (s) of
Action
taken
Failure Mode Mechanism of failure action
failure
Required Machine will 7 No or less clarity of the 2 URS is in place for 1 14 Current control NA NA NA NA NA NA
utilities not function as product requirement and system with all measures are
((compressed expected. machine functionality predefined adequate
3 air, purified with respect to utility requirement of
water, requirement. utility like water,
electricity) are electricity,
not available compressed air.
Wrong Installation 6 No or less clarity of the 2 URS is in place for 1 12 Current control NA NA NA NA NA NA
machine will be machine. dimension , capacity measures are
selection in affected if and rated output of adequate
terms of dimension is the of the Colloid
Dimension, not considered. Mill
4
capacity and Output will
output. also get
affected if
capacity is not
considered.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
Current Control
Action Results
Occurrence (O)
RPN (S x O x D)
Detection (D)
Responsibility
Severity (S)
and TCD
Occurrence
Potential
New RPN
Detection
Potential Potential cause/ Recommended
Severity
[Link]. effect (s) of
Action
taken
Failure Mode Mechanism of failure action
failure
MOC and Not meting 7 No or less clarity of the 3 URS is in place for 1 21 Current control NA NA NA NA NA NA
machine GMP machine contact part and MOC ( contact part measures are
contact parts requirements MOC. should be of SS316 adequate
,Seals & and product or 316L and non
gaskets not get affected. contact parts will be
meeting GMP of SS304 and
5
requirement machine contact
parts to fulfill GMP
requirements.
Gasket used shall be
of food grade
rubber.
Castor wheel Accident may 10 No or less clarity of the 2 Requirement of 1 20 Current control NA NA NA NA NA NA
with locking happen. requirement castor wheel with measures are
6 not provided locking adequate
arrangements is
defined in URS.
Equipment not Accident may 10 No or less clarity about 2 Requirement of 1 20 Current control NA NA NA NA NA NA
received with happen. equipment safety Safety measures like measures are
the process measures. discharge port, adequate
7
safety flame proof motor,
measures. arrangements is
defined in URS.
PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT
PRE RISK ASSESSEMENT FOR COLLOIDAL MILL
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 ASSESSEMENT FOR COLLOIDAL MILL
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 ASSESSEMENT FOR COLLOIDAL MILL
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 ASSESSEMENT FOR COLLOIDAL MILL
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