RISK ASSESSMENT & MANAGEMENT

(FMEA Qualitative Risk Management)

QRM Topic: RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
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QUALITY RISK ASSESSMENT &

MANAGEMENT
(FMEA Quantitative Risk Management)

Risk Assessment for FLUID BED DRYER

QRM Document No. :
Revision No. :
Effective Date :
Next Review Date :
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TABLE OF CONTENTS

Sr.
Content Page No.
No.
1.0 APPROVAL 3
2.0 INTRODUCTION 4
3.0 PURPOSE 4
4.0 SCOPE 4
5.0 RESPONSIBILITIES 4
6.0 ABBREVIATION 5
7.0 CROSS FUNCTIONAL TEAM 5
8.0 REFERENCE DOCUMENT 5
9.0 RISK ASSESSMENT APPROACH 6
10.0 RISK MANAGEMENT TOOLS 7-25
11.0 CONCLUSION 26
12.0 RISK COMMUNICATION 26
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1.0 APPROVAL
Prepared by:
Function Name Designation Sign & Date

Reviewed & approved By:

Function Name Designation Sign & Date
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2.0 INTRODUCTION
The “Fluid Bed Dryer” is intended to create a fluidal turbulence in a granulated or powdery wet product by
means of hot air (or dehumidified air) flowing in an upward direction & to dry the same to the final
required degree in a careful manner with assurance of uniform drying and product safety.

3.0 PURPOSE
Prepose of this risk assessment is to assess the risk associated with the equipment “Fluid Bed Dryer”
installed in the Granulation area, in line with the guidance of the Risk Management manual of and ICH Q9

4.0 SCOPE
This QRM document is applicable to the design, installation, operation, performance and safety of
equipment “Fluid Bed Dryer” and identify its failure mode.

5.0 RESPONSIBILITIES

Department/Function Description
Quality Assurance • To provide leadership and adequate resources for QRM as an
ongoing process
• To assure that QRM process is defined, deployed and reviewed
• To select multi-disciplinary team (QRM Team) of qualified personnel
from concerned stakeholders on need base
• To communicate, promote and co-ordinate QRM across various
functions and departments
• To evaluate the adequacy and completion of risk management report.
• To ensure appropriate CAPAs are recommended and implemented.
• To review and approve Risk Management Reports
CFT/QRM Team • To adhere QRM Standard Operating Procedure.
• To conduct a risk assessment by identification, analysis, evaluation
and mitigation of potential risk
• To evaluate risks and its impact and determine which one should be
controlled and which ones can be accepted.
• To recommend and implement adequate control measures for risk
reduction.
• To consider the impact of risk findings on related or similar products
and/or processes.
• To inform output/result of QRM process to site management (QA
Head and Unit Head), ensuring that significant risks are immediately
escalated.
• To ensure recommended CAPAs initiated, monitored and
implemented timely.
• To ensure that the adequate training on the subject is available to
team members and training records are accessible
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6.0 ABBREVIATION

QA Quality Assurance EHS Environment, Health and safety

QC Quality Control HRA Human Resource and Admin
QRM Quality Risk Management BMR Batch Manufacturing Record
FMEA Failure Mode Effect Analysis SFM Solid Flow Meter
CFT Cross functional team SS Stainless steel
RPN Risk Priority number SOP Standard operating procedure

7.0 CROSS FUNCTIONAL TEAM

Sr. No. Name Department Designation

8.0 REFERENCE DOCUMENT

Title Document No.
Quality Risk Management
Validation Master Plan
SOP for Operation of Fluid Bed Dryer
SOP for Cleaning of Fluid Bed Dryer
SOP for Preventive Maintenace of Fluid Bed Dryer
SOP for Handlining of FBD Finger Bags
SOP for Challenge Test of SFM
SOP for Calibration of Instruments
SOP for Filter Cleaning of Air Handling Units
SOP for Qualification of Equipment/Facility
SOP for Air Handling Unit Qualification
SOP for Handlining of Breakdown
SOP for Handlining of Power Failure
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9.0 RISK ASSESSMENT APPROACH
The Quality Risk Management (QRM) tool, Failure Mode Effect Analysis (FMEA) Qualitative Approach is
considered as the basis for the risk assessment procedure. The following parameters are to be evaluated
during risk assessment:

• System critical components, functions and processes

• Possible risk and damage if those components, functions and processes fail
• Possible risk to the product quality, operators and environment
The final outcome of the risk assessment is the introduction of measures to be taken in the event of a possible
failure. Flow chart below explains the procedure of risk assessment:

RISK IDENTIFICATION

Possible Risk to Facility Critical Components, Process and Functions

RISK ASSESSMENT

RISK ANALYSIS

Probability of Occurrence Probability of Detection

Severity (S)
(O) (D)

RISK EVALUATION

Low Medium High

RISK MANAGEMENT

RISK ACCEPTANCE

Acceptable Unacceptable Intolerable

PERIODIC
RISK MITIGATION CONTROL / SPECIFY MEASURES REVIEW

POST MITIGATION RESIDUAL RISK EVALUATION

Low Medium High

POST MITIGATION RESIDUAL RISK ACCEPTANCE

Acceptable Unacceptable Intolerable

RISK KNOWLEDGE COMMUNICATION

Reference: Quality Risk Management, ICH Q9

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10.0 RISK MANAGEMENT TOOLS
FMEA- Qualitative Risk Management

10.1 RISK IDENTIFICATION

Identification of possible risk and damage to critical components, functions and processes.

10.2 RISK ANALYSIS

Estimation of the possible risk to the product quality, operator, Machine and environment safety; if those
components, functions and processes fail.

10.2.1 PROBABILITY OF OCCURRENCE (O)

Occurrence (O) refers to the probability that a specific cause will result in a specific failure mode. The
Probability of Occurrence is evaluated and graded as high (will probably occur), medium (may occur at
some time) or low (unlikely to occur in most circumstances).

10.2.2 SEVERITY (S)

Severity is the measurement of the possible consequences of a hazard.
The Severity is evaluated and graded either as high (very significant non-compliance with GMP or injury to
patients), medium (significant non-compliance with GMP or impact on patients) or low (minor
infringement of GMP and no impact on patients).

10.2.3 PROBABILITY OF DETECTION (D)

Probability of Detection is the ability to discover or determine the existence, presence, or fact of a hazard.
The Risk Level is evaluated and graded as high (unlikely to be detected in most circumstances – detection
Low), medium (may be detected at some time – detection Medium) or low (will probably be detected –
detection High).

10.3 RISK EVALUATION

Risk evaluation will be done following qualitative method, the factors Probability of Occurrence (O),
Severity (S) and Probability of Detection (D) must be graded as low, medium or high as shown in the
following table:

unlikely to occur in most

Probability of may occur at some time will probably occur
Definition circumstances
Occurrence (O) (Medium) (High)
(Low)
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Severity (S) Definition minor infringement of significant non-compliance very significant non-
GMP and no impact on with GMP or impact on compliance with GMP
patients patients or injury to patients
(Low) (Medium) (High)

may be detected at some unlikely to be detected

Probability of will probably be detected
Definition time in most circumstances
Detection (D) (High)
(Medium) (Low)

The Overall Risk Level is defined according to Combination of Severity and Occurrence to get a Risk Class first
and then Combination of Risk Class & Detectability to determine overall risk.

Risk Classification
Occurrence
Low Medium High
High Class 2 Class 1 Class 1
Severity

Medium Class 3 Class 2 Class 1

Low Class 3 Class 3 Class 2

Overall Risk Level

Detectability

Low Medium High

1 High High Medium

Class

2 High Medium Low

3 Medium Low Low

The overall risk level defines the risk to be acceptable, un-acceptable and intolerable. Consequently, the risk must
be defined as “Yes” (acceptable) or “No” (not acceptable) based on criteria defined in table below:

Risk Acceptance Overall Risk Level Risk

Yes L (Low) Acceptable

No M (Medium) Un-acceptable

No H (High) Intolerable
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The following risk control actions are to be undertaken in accordance to the risk:

Risk Risk control actions

Acceptable No actions or new measures are required

Actions or new measures are required. The risk must be reduced to an acceptable level
Unacceptable
either technically or by SOP’s
Actions or new measures are required. The risk should be reduced either technically or by
Intolerable
SOP’s

10.4 POST MITIGATION RESIDUAL RISK ACCEPTANCE

Residual Risk Residual Overall

Residual Risk Acceptance
Acceptance Risk Level
Risk acceptable with current mitigation steps in design without any further
Yes L
additional mitigation steps
Risk can be reduced to acceptable level with proposed additional mitigation steps
Yes M
(as low as possible)
Risk is not acceptable with current or proposed additional mitigation steps, still
No H needs elimination either by technical measures or by SOP’s, risk-benefit analysis
shall be explored
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FMEA-Qualitative Risk Management
Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.1 Process Utilities for the FBD

6.1.1 Compressed Air - Failure / Fluctuations - Interruption of L H 2 M M No - Check sensors - Installation L H 2 H L Yes -
in compressed air process due to installation, Qualification
supply (pressure) Instrumentation calibration
and automation certificate
functionality - Check all joints for
- Hazard to product / tightness and
staff leakage proof
- FBD Seal inflate - Guarantee alarm - Operational L H 2 H L Yes -
and product
function for failure/ Qualification
powder leakages
fluctuations in
from chamber compressed air
supply
- Operation /
Maintenance SOP

- Air filter defective - Product M H 1 M H No - Verification of - Installation L H 2 M M Yes 0.2 micron

Contamination filter Integrity test Qualification Filter to be
certificate Installed at
user points

- Testing of - Operational L H 2 H L Yes -

Compressed air Qualification
User point after
filter as per
ISO8573

6.1.2 Heating Steam - Failure / Fluctuations - Impact on granules L H 2 M M No - Check installation - Installation L H 2 H L Yes -
in saturated steam drying due to of pressure Qualification
supply (pressure) improper infeed air /Temperature
heating sensor /calibration
- Error in granules - Check the proper
moisture content installation of
- Longer drying time Steam controlling
valve

- Guarantee alarm - Operational L H 2 H L Yes -

function / error Qualification
message, signal
function in heating
steam supply
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

- Failure / Fluctuations L H 2 M M No - Check installation / - Installation L H 2 H L Yes -

in saturated steam calibration of Qualification
temperature temperature sensor
for heating steam

- Guarantee alarm - Operational L H 2 H L Yes -

function / Qualification
Guarantee error
message, signal
function for
saturate steam
temperature

- Guarantee alarm - Operational -

function / Qualification
Guarantee error
message, signal
function for failure/
fluctuations in
chilled water flow

6.1.3 Electricity - Voltage breakdown - Interruption of L H 2 M M No - Check of proper - Installation L H 2 H L Yes -

- Fluctuations in process connection of Qualification
voltage - Uncontrollable electricity
start up - Availability of
- Hazard to staff and uninterrupted
product power supply

- Guarantee alarm - Operational L H 2 H L Yes -

function / error Qualification
message for
breakdown
- Verification of
power supply until
process shuts down
to safe status
- System recovery
study after power
failure
- Data integrity after
power failure
- Emergency
handling SOP
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.2 Design And Construction of FBD

6.2.1 Equipment / - Product contact - Corrosion of L H 2 L H No - Verification of - Design Qualification L H 2 H L Yes -

Components ( components surfaces component and material of - Installation
FBD) not GMP-compliant inadequate construction / Qualification
cleaning certificate and
- Hazard to staff and surface finish
environment specifications of
product contact
- Microbial parts
contamination

- Incorrect design - Effect on the - Design parameter - Design Qualification

specifications of process efficacy verification of - Installation
components / and product quality component / Qualification
equipment e.g. granules equipment (FBD
uniformity, etc.) as per URS
moisture content,
size etc.

- Dented/Scratched - Corrosion of
Product contact parts component and
inadequate - Installation - Installation L H 2 H L Yes -
cleaning Verification Qualification
Checklist for
- Product Residue
Physical
Deposition
verification

6.2.2 Capacity of - Insufficient capacity - Required batch L H 2 L H No - Verification of - Design Qualification L H 2 H L Yes -
components / size cannot be capacity
equipment achieved (granulator, wet
mill, dry mill, FBD
etc.) as per URS

6.2.3 Drying of - Error in fluidization, - Effect on product L H 2 L H No - Verify 12 bar ex - Design Qualification L H 2 H L Yes -
Product drying of granules moisture content protected
- Risk of explosion - Hazard to staff and equipment
environment
- Verify explosion - Installation L H 2 H L Yes -
protection valves Qualification
for inlet and
exhaust air

6.2.4 Product - Defected Bottom - Inadequate drying L H 2 M M No - Check design - Design Qualification L H 2 H L Yes -
Container / FBD Screen process specifications of
Bowl - Leakage of product - Product FBD bowl as per
user requirement
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

- Improper (in -swung Contamination - Test of limit switch - Installation L H 2 H L Yes -

or out - swung) - Environmental / - Test of material Qualification
position of product Operator Hazard for pneumatic seal
container to machine
tower

- Error in design of - Sample wastage - Check design - Design Qualification

sample point / side - Product specification of
discharge valve contamination sampling port / side
discharge valve

6.2.5 Product - Construction error in - Improper filter M H 1 M H No - Check proper - Installation L H 2 H L Yes -
Retaining filter cable, catch shaking installation of FBD Qualification
System / Filter cable, product filter, - Product Loss bags chamber,
Housing lock, vibration retarding chamber,
cylinder, filter filter cable, catch
housing cable, product
filter, lock,
vibration cylinder,
filter housing etc.

6.2.6 Sealing System: - Leakage of air - Hard to clean L H 2 M M No - Check proper - Installation L H 2 H L Yes -
installation of Qualification
• Expansion - Product Leakage to - Product
environment Contamination sealing system
Chamber Seal
- Check the valve for
• Product filter - Environmental /
Operator Hazard tightness and tight
seal
fit
• Filter housing
- Check installation
seal
of pressure gauge
• Lower plenum
seal

6.2.7 Supply Air - Construction / - Inadequate supply L H 2 M M No - Check design - Design Qualification L H 2 H L Yes -
System: installation error air specifications of
(G4, F6, F9 and - Filter collapses, - Supply air supply filter
H14 filters) insufficient filtering contamination
- Filter doesn’t fit tight hence product
in frame contamination
- Proper installation - Installation
- Filter damaged - Filter integrity test Qualification
report
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

- Check proper - Installation

differential pressure Qualification
monitoring
between, coarse
fine and ultra-fine
filters
- Display the
pressure differential
on the panel with
alarm

6.2.8 Supply Air - Insufficient - Breakdown causes L H 2 L H No - Check design - Design L H 2 H L Yes -
System: dehumidification, insufficient pre- specifications of Qualification
Dehumidifier breakdown conditioning of dehumidifier
supply air
temperature
- Breakdown may - Check humidity - Installation
cause failure of sensor installation / Qualification
complete system calibration

6.2.9 Supply Air - Insufficient Steam - Breakdown or L H 2 L H No - Check design - Design L H 2 H L Yes -
System: heating, Coil leakages in coil specifications of Qualification
- Steam Coil Leakages or causes insufficient freeze protection
breakdown heating of supply heater
air - Main Heater
- System is not
achieving setpoint - Freeze protection - Installation
temperature sensor Qualification
- Drying air
humidity raised - Inlet air
cause wetting of temperature sensor
material calibration
- Exhaust air
temperature sensor
calibration

6.2.10 Supply Air - Breakdown of seal - Breakdown causes L H 2 L H No - Check proper - Installation L H 2 H L Yes -
System: between the FBD decrease in the installation of air Qualification
Inlet and and the inlet or effectiveness of seal flap
Exhaust air seal exhaust air duct the process
flap - Environmental /
Operator Hazard
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.2.11 Exhaust Air - Construction/ - Inadequate air L H 2 M M No - Check design - Design L H 2 H L Yes -
Filter installation error exhaust specifications of Qualification
- Filter collapses, - Environment each filter
insufficient filtering hazard due to component

- Filter doesn’t fit product dust - Check proper - Installation

tight in frame installation of filter Qualification
- Filter damaged at exhaust

6.2.12 Duct work for - Leakage of air - Leakage leads to L H 2 M M No - Duct work must be - Installation L H 2 H L Yes -
Supply and higher tight Qualification
Exhaust Air energy - Test of correct
System consumption installation
- Contamination
leakages in the - Leakage test - Installation
services floor Qualification

6.2.13 WIP System - Under Capacity WIP - Inadequate L H 2 L H No - Check design - Design L H 2 H L Yes -
Pump cleaning specifications of Qualification
- Mechanical or - Product WIP system
design error in contamination (pressure,
cleaning/CIP nozzles temperature, spray
angle etc. of
cleaning solution)

- Check proper - Installation

installation of WIP Qualification
system

- Mechanical or - Design failure L H 2 M M No - Check design - Design L H 2 H L Yes -

design error in - Leakage specifications of all Qualification
cleaning solutions components
containers - Inadequate fill (provision of
level indicator specific cleaning
- Inadequate system for rotor
Cleaning shaft) connected to
WIP module

- Error in Flow Meter - Improper flow of L H 2 M M No - Check design - Design L H 2 H L Yes -

cleaning solution specifications of Qualification
flow meter
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level
- Inadequate - Proper installation - Installation
Cleaning of flow meter Qualification
- Calibration
certificate of flow
meter

- Error in Dosing unit - Improper dosage L H 2 M M No - Check design - Design L H 2 H L Yes -

of cleaning specifications of Qualification
solution dosing unit
- Inadequate
Cleaning

6.2.14 Printer - Dysfunctional - Data logged during L H 2 M M No - Verification of - Installation L H 2 H L Yes -

printer cycle cannot be printer Installation Qualification
printed leading to - Verification of the - Operational
serious GMP printer interface Qualification
infringement facility

6.3 Control & Safety System

6.3.1 Sensor - Fault / Failure of - Hazard to product L H 2 L H No - Check calibration - Installation L H 2 H L Yes -
sensor at Pressure and staff and installation of Qualification
control pneumatic process relevant
system, pressure pressure sensors
sensor inside
granulator etc. - Guarantee alarm - Operational L H 2 H L Yes -
function for Qualification
failure/ fault in
sensor

Analog or digital - Fault / Failure of - Actual condition - Check installation / - Installation L H 2 H L Yes -
display: ammeter, voltmeter, and parameters calibration - Qualification
Ammeter, water pressure maintained during certificate of
voltmeter, water gauge, air pressure process cannot be ammeter,
pressure gauge, gauge, timer for known voltmeter, water
air pressure granulator - Hazard to product pressure gauge, air
gauge, timer for and staff pressure gauge,
granulator timer etc.
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

- Guarantee alarm - Operational

function for Qualification
failure/ fault of
ammeter,
voltmeter, water
pressure gauge, air
pressure gauge,
timer for
granulator etc.

6.3.2 Sensors for rpm - Failure of impeller - Over / Under L H 2 L H No - Calibration - Installation L H 2 H L Yes -
of impeller / torque sensors speed of certificate of Qualification
chopper - Failure of impeller granulator cannot impeller sensor for
(Granulator) speed drive sensor be identified torque and speed

- Failure of chopper - Impact on - Guarantee alarm - Operational

torque drive sensor granulation
function for Qualification
process efficacy
- Failure of chopper failure/ fault of
speed drive sensor sensor

6.3.3 Inlet air velocity - Fault / Failure of - Fails to detect M H 1 L H No - Check sensor (air - Installation L H 2 H L Yes -
sensor (FBD) sensor improper supply velocity) Qualification
air velocity which installation /
results in calibration
inefficient certificate
granulation - Check VFD control
process
- Guarantee alarm - Operational
function / error Qualification
message, signal
function for fault /
failure of sensor

6.3.4 Supply air - Fault / Failure - Supply air L H 2 L H No - Check temperature - Installation L H 2 H L Yes -
temperature / temperature / temperature / / humidity sensor - Qualification
humidity sensor humidity sensor humidity too high installation and
(FBD) /low cannot be calibration
identified certificate
- Effect on drying of - Guarantee alarm - Operational L H 2 H L Yes -
product function / error - Qualification
- Effect on product message, signal
quality function for fault /
failure of sensor
(temperature /
humidity sensor) at
supply of FBD
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.3.5 Exhaust air - Failure of exhaust - Hazard to L H 2 L H No - Check sensor - Installation L H 2 H L Yes -
temperature Air temperature environment and installation and - Qualification
sensors (FBD) Sensor staff calibration
certificate

- Guarantee alarm - Operational L H 2 H L Yes -

function / - Qualification
Guarantee error
message, signal
function

6.3.6 Differential - Failure of - Explosion L H 2 L H No - Check sensor - Installation L H 2 H L Yes -

pressure sensors differential pressure - Hazard to installation and - Qualification
(FBD) monitoring sensors environment and calibration
across filter housing staff certificate

- Guarantee alarm - Operational L H 2 H L Yes -

function / - Qualification
Guarantee error
message, signal
function

6.3.7 Product - Failure of product - Explosion L H 2 L H No - Check sensor - Installation L H 2 H L Yes -

container sealing container sealing - Hazard to installation and Qualification
pressure sensor pressure environment and calibration
staff certificate

- Guarantee alarm - Operational

function / Qualification
Guarantee error
message, signal
function

6.3.8 Flow Regulator - Failure of flow - Product Leakages L H 2 L H No - Check sensor - Installation L H 2 H L Yes -
regulator from loose seals installation and Qualification
- Flow indication of and exhaust in calibration
compressed air in environment certificate
product container - SFM Sensor
seal and Finger Bag Calibrated and
Seal Installed in exhaust
duct
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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
Page 19 of 26
Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

- Guarantee alarm - Operational

function / error Qualification
message, signal
function for fault /
failure of Pressure
Regulator
- Guarantee alarm
function / error
message, signal
function for fault /
failure of SFM

6.3.9 No Access - Direct access to - It may cause L H 2 L H No - Verify that access - Installation L H 2 H L Yes -
Control during working & technical hazard / accident to working and Qualification
operation area of equipment technical area of
machine by guard
doors with
electromagnetic
safety switches

- When the doors - Operational

open, the machine Qualification
should stop
automatically

6.3.10 Interlocks - Interlocks failure - Explosion M H 1 L H No - Check all - Operational L H 2 H L Yes -

during granulation - Hazard to interlocks Qualification
process environment and functioning e.g.
staff start of process is
only possible if:
- Product Loss
- All components of
working vessel /
sieve are closed /
integrated
- All seals are
inflated
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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
Page 20 of 26
Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.3.11 Interlocks - Interlocks failure - Explosion M H 1 L H No - Check all - Operational L H 2 H L Yes -

during drying - Hazard to interlocks Qualification
process environment and functioning e.g.
staff Start of drying
process is only
- Product Loss possible if:
- All components of
machine tower are
closed / integrated
- All seals are
inflated

6.3.12 Interlocks - Interlocks Failure - Hazard to M H 1 L H No - Check all - Operational L H 2 H L Yes -

during WIP process environment and interlocks Qualification
staff functioning e.g.
Start of cleaning
process is only
possible if:
• All components
of working vessel
/ sieve are closed
/ integrated/
machine tower
are closed /
integrated
• All seals are
inflated
• Filters not
installed

6.3.13 Emergency - Emergency switch - Hazard to L H 2 L H No - Verify that - Installation L H 2 H L Yes -

switch not easily accessible operator/ product / emergency switch Qualification
- Fault / Failure of environment should be easily
Equipment during accessible to
operation operator

- Functional - Operational
verification of Qualification
emergency switch

6.3.14 Acoustic alarms - No alarm control for - Hazard to L H 2 L H No - Verify the alarm - Operational L H 2 H L Yes -
breakdown/ operator/ product / list and control for Qualification
malfunction environment operation/ Hazard
control
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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
Page 21 of 26
Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.3.15 Control system - Improper - Loss of process L H 2 L H No - Verification of - Design L H 2 H L Yes -

(Software and functioning of control software and Qualification
Hardware) software / hardware - Improper hardware
- Incorrect functionality specification as per
specifications of URS
software/ hardware
- Verification of - Installation
proper installation Qualification

6.3.16 Programmable - Fault, Malfunction - Decrease in the L H 2 L H No - Check design - Design L H 2 H L Yes -
Logic Controller effectiveness of specification Qualification
(PLC) the granulation
process due to - Installation - Installation
communication verification Qualification
error
- Functional - Operational
verification of each Qualification
I/O

6.3.17 PC / SCADA - Fault, Malfunction - Loss of process L H 2 L H No - Design verification - Design L H 2 H L Yes -
System monitoring Qualification
- Desired process
parameters / - Installation - Installation
product verification Qualification
characteristics
cannot be defined - Functional - Operational
and monitored verification of each Qualification
program function

6.3.18 Control Cabinet - Incorrect Cabling, - Loss of process L M 3 L M No - Installation - Installation L M 3 H L Yes -
Fault, Malfunction control lead to verification Qualification
impact on product
quality parameters - Operational - Operational
verification Qualification

6.3.19 Warning - No warning sticker - Hazard to L H 2 L H No - Verify Warning - Installation L H 2 H L Yes -

Stickers for hot surfaces / operator/ product / stickers should be Qualification
component which environment placed on hot
may cause harm surfaces/
components which
may cause harm

6.3.20 Noise level - Noise level more - Hazard to operator L H 2 L H No - Verify that noise - Operational L H 2 H L Yes -
than specified limit level is not more Qualification
than specified
limits
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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.3.21 Earthing - Fault, Malfunction - Operator / L H 2 L H No - Check proper - Installation L H 2 H L Yes -

Machine Hazard earthing Qualification

6.4 Critical Process Parameters

6.4.1 Drying in FBD - Improper drying - Inefficient M H 1 L H No - Check proper - Installation L H 2 H L Yes -
process phases granules drying / installation of FBD Qualification
- Wrong drying end error in moisture system
point content - Installation of
- sensors / alarms
mentioned in
Control system

- Functional - Operational L H 2 H L Yes -

verification of Qualification
drying in FBD
- Functional test of
sensors / alarms
mentioned in
Control system

- Recipe - Performance L H 2 H L Yes -

management Qualification
- Performance
verification
- Process Validation

6.4.2 Filter Shaking - Filter shaking - Product Loss M H 1 L H No - Verification of - Installation L H 2 H L Yes -
process failure proper installation Qualification
- Improper shaking - -
Functional test Operational L H 2 H L Yes -
interval time
checks for filter Qualification
shaking process

- No filter / Filter - Product Loss - Alarm test / - Operational L H 2 H L Yes -

Damage - Environmental / Guarantee error Qualification
Operator Hazard message, signal
function for fault /
failure of filter
shaker

6.4.3 Product - Clogging of filters - Product Loss M H 1 L H No - Check filter - Installation L H 2 H L Yes -
Retaining Filter specifications Qualification
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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
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Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level
- Environmental / - Alarm test / - Operational L H 2 H L Yes -
Operator Hazard guarantee error Qualification
message, signal
function for
clogging of filter

6.4.4 Dry Milling - Improper milling due - Results in M H 1 L H No - Check proper - Installation L H 2 H L Yes -
to rotor / blade inadequate granule installation of mill Qualification
malfunction size
- Functional tests - Operational L H 2 H L Yes -
- Improper milling due - Qualification
to improper screens - Screen selection by
desired grain size
- Alarm functional
test for fault/
failure / error

- Performance - Performance L H 2 H L Yes -

verification Qualification
- Process Validation

6.4.5 System Cleaning - Improper system - Product carryover M H 1 L H No - CIP functional - Installation L H 2 M M Yes Cleaning
cleaning - Product verification Qualification Verification
contamination - Cleaning SOP to be done

6.4.6 Improper usage - Improper usage of - Hazard to staff and L H 2 M M No - Preparing operating - Operational L H 2 M M Yes Practical
granulation system product SOP based on Qualification Training to
by operator operating manual be provided
- Training of
employees
(Operator, Service,
etc.) based on
operating SOP

6.4.7 No dedicated - Product will be - Product carryover M H 1 L H - SOP for Handling - Installation L H 2 M M Yes Cleaning
FBD finger bag contaminated by - Product of FBD Fingers Qualification Verification
specific to the using same bag in contamination Bags of FBD Bag
product multiple products to be done

- Dedicated Finger - Performance L H 2 H L Yes -

Bags for Every Qualification
Product

6.5 User Interface / Function

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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
Page 24 of 26
Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

6.5.1 Documentation - Lack of - Less documented L H 2 M M No - Verification of - Installation L H 2 H L Yes -

documentation evidence (e.g. documents Qualification
SOPs, drawings, availability
manual, certificate (Drawings, P&ID,
protocols etc.) certificate, manuals
etc.)

- Verification of - Operational L H 2 H L Yes -

document Qualification
availability (SOP)

6.5.2 User Interface / - Menu - Incomprehensible L H 2 M M No - Verify menu - Operational L H 2 H L Yes -

Function incomprehensible menu navigation navigation against Qualification
user operating
manual
- Training of
concerned
personnel

- Unauthorized access - Undesirable L H 2 L H No - Guarantee access - Operational L H 2 H L Yes -

to process change of process level system Qualification
parameters and parameters - Training of
settings concerned
personnel

- Parameter input - Process hazard L H 2 L H No - Compare with - Operational L H 2 H L Yes -

beyond defined - Error in results operating manual Qualification
limits possible - Test recipe locking
mechanism
- Training of
concerned
personnel

- Missing or improper - Relevant error L H 2 L H No - Verify list of - Operational L H 2 H L Yes -

error messages and messages not alarms and Qualification
trouble shooting displayed troubleshooting
- Error messages not recommendations
understandable required

- No troubleshooting - Complete error

possible message testing
- Training of
concerned
personnel
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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
Page 25 of 26
Risk Risk Risk Residual Risk
Risk Analysis Risk Control Residual Risk Analysis
Function/ Risk Identification Evaluation Acceptance Evaluation Acceptance Additional
Pos. Process/ Possible Failure / and conceivable Qualification Step / Proposed
No. Defect Overall Phase Residual Overall Mitigation
malfunction / Risk Actions for
Components O S D Risk Yes / No rO rS Risk rD Residual Yes / No (if any)
Consequence Class Correction
Level Class Risk Level

- Process / Batch date - Missing process L H 2 L H No - Test access - Operational L H 2 H L Yes -

erased information authorization Qualification
- Process not - Test data storage
repeatable (history)
- Test Back-up
function
- 21 CFR part 11
compliance system
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QRM Topic RISK ASSESSMENT FOR FLUID BED DRYER QRM No.
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11.0 CONCLUSION
Risk assessment for the Fluid Bed Dryer installed in Granulation Area has been done as per FMEA-Qualitative Risk Management approach to evaluate each unit
operation/steps/stage to identify the risks associated with the process step/stage and current control procedures available at site. Standard operating procedures are
available and effective. Hence facility has effective current control for the reduction of identified risk. No CAPA identified during the risk assessment.

12.0 RISK COMMUNICATION

12.1 CAPA/ CHANGE CONTROL REFERENCE

Sr. No. CAPA/ CHANGE CONTROL DATE OF CAPA/ CHANGE Responsibility

REFERENCE No. CONTROL APPROVAL
Name Department