FAILURE MODE AND EFFECT ANALYSIS

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Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)
No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
1 Incorrect Lumps during 5 Human error 1  Trained staff 1 5x1x1 Current
sieve used dry mixing (Incorrect  Activity is carrying out =5 control
for sifting leading to sieve used) under supervision of measures
improper Production officer. are
mixing adequate.
 Sieve size mentioned on
each sieve.
 Specifying size of sieve to
be used for raw material
sifting in a respective
BMR.

2 Loss of sieve - Non uniform 5 Defective 1  Visual examination for 5 5x1x5

integrity particles sieve received integrity before and after = 25
Current
- Impact on from sifting and observation control
characteristics manufacturer recording in a BMR. measures
of granules  Vendor audit done to are
review the control adequate.
measures are taken by
Vendor to reduce such
type of risk.
Due to 1  Trained staff 1 5x1x1 Current
- Washing  Visual examination for =5 control
- Storage - integrity before and after measures
sifting and observation are
- Use
recording in BMR. adequate.
 FAILURE MODE AND EFFECT ANALYSIS
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Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
3 Forgot to Product fail 5 Human error 1  Trained staff 1 5 x1x1 Current
load any raw  Instructions are given in a =5 control
material in BMR for addition of raw measures
RMG during materials. are
dry mixing adequate.
 Addition of material in
and
presence of Production
granulation
Officer and same is
recording in a BMR as
processed by and checked
by.
 FAILURE MODE AND EFFECT ANALYSIS
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4 No Quality issue 5 Human Error 1  Trained staff. 5 5 x1x5
sequential  Loading of material in = 25
loading of presence of Production
raw material Officer and same is
in RMG for recording in a BMR as
dry mixing processed by and checked
and by.
granulation
 Specify loading sequence
of raw material in RMG Current
and instruction of same control
was given in a BMR. measures
Inadequate 5  Master BMR checked by 1 5 x5x1 are
methodology / Officer-QA, Production- = 25 adequate.
instruction Head and QA- Head.
given in a  Issued authorized
BMR controlled copy of Master
BMR for batch execution.
 Specify loading sequence
of raw material in RMG
and instruction of same
menntioned in a BMR.

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
 FAILURE MODE AND EFFECT ANALYSIS
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5 Improper Impact on 5 Human error 1  Trained staff. 1 5 x1x1 Current
mixing of characteristics (improper  Adequately binder solution =5 control
ingredients of granules addition of preparation procedure is measures
or improper ingredients) given in a BMR and same are
preparation is recording in a BMR as adequate.
of binder processed by and checked
solution. by.
Inadequate 1  Master BMR checked by 1 5 x1x1 Current
methodology Officer-QA, Production- =5 control
given in a Head and QA- Head. measures
BMR  Issued authorized are
controlled copy of Master adequate.
BMR for batch execution.
Unqualified 1  Trained staff 1 5 x1x1 Current
binder  SOP for qualification and =5 control
solution re-qualification of measures
preparation equipment is in place. are
equipment adequate.
Abnormal 1  Trained staff 1 5 x1x1 Current
temperature  Specified the limit of =5 control
of solvent temperature in a measures
respective BMR and same are
is recording in a BMR as adequate.
processed by and checked
by.
 Qualified equipment
 Temperature sensor of
equipment calibrating
once in a year.
 FAILURE MODE AND EFFECT ANALYSIS
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Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)
No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
6 Variation in Impact on 5 Human Error 1  Trained staff. 1 5 x1x1 Current
rate of characteristics  Specified binder solution =5 control
addition of of granules addition time and measures
binder adequate instruction in a are adequate
solution for respective BMR and same
wet is recording in a BMR as
granulation processed by and checked
by.
Inadequate 1  Master BMR checked by 1 5 x1x1 Current
methodology Officer-QA, Production- =5 control
given in a Head and QA- Head. measures
BMR  Issued authorized are adequate
controlled copy of Master
BMR for batch execution.
7 Improper Impact on 5 Human error 1  Trained staff 1 5 x1x1 Current
setting of characteristics  PLC-MMI operation is =5 control
Equipment of granules controlled with security measures
(RMG) password. are adequate
parameters
 Specified equipment
setting parameters in a
respective BMR and same
is recording in a BMR as
Processed by and checked
by.
 FAILURE MODE AND EFFECT ANALYSIS
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-- -- -- 5 Inadequate 1  Master BMR checked by 1 5 x1x1 Current
procedure in Officer-QA, Production- =5 control
a BMR about Head and QA- Head. measures
setting of  Issued authorized are adequate
equipment controlled copy of Master
parameter BMR for batch execution.

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
8 Incorrect Impact on 5 Human error 1  Trained staff 1 5 x1x1 Current
loading of characteristics  PLC-MMI operation is =5 control
product of granules controlled with security measures
recipe in password. are adequate
MMI.
 Specified equipment
setting parameters in a
respective BMR and same
is recording in a BMR as
Processed by and checked
by.
9 Malfunctioni Impact on 5 Un-qualified 1  SOP for qualification and 1 5 x1x1 Current
ng of characteristics equipment re-qualification of =5 control
equipment of granules equipment is in place. measures
(RMG) are
adequate.
 FAILURE MODE AND EFFECT ANALYSIS
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10 Incorrect Impact on 5 Human error 1  Trained staff 1 5x1x1 Current
screen used characteristic (Incorrect  Screen size embossed on =5 control
for wet of granules screen used) each sieve. measures
milling are
 Specifying size of screen
adequate.
to be used for wet milling
in a respective BMR.
 Activity is carrying out
under supervision of
Production officer.

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
11 Loss of - Non uniform 5 Defective 1  Visual examination for 5 5x1x5 Current
screen wet granules screen integrity before and after = 25 control
integrity - Improper received from milling and observation measures
drying manufacturer recording in BMR. are
adequate.
 FAILURE MODE AND EFFECT ANALYSIS
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- Impact on Due to 1  Trained staff 5 5x1x1 Current
characteristics - Washing  Visual examination for =5 control
of granules - Storage integrity before and after measures
milling and observation are
- Use
recording in BMR. adequate.
12 Spillage of Product fail 5 Human error 1  Trained staff 1 5x1x1 Current
raw material  Activity is carrying out =5 control
or binder under supervision of measures
solution or Production officer. are
wet granules adequate.
 SOP for incidence is in
during
place.
processing
13 100 % wet Low yield 5 Human error 1  Trained staff 1 5x1x1 Current
granules not  Discharging of wet =5 control
discharged granules by rotating measures
from RMG impeller. are
bowl adequate.
 Activity is carrying out
under supervision of
Production officer.

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
 FAILURE MODE AND EFFECT ANALYSIS
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14 Running - Impact on 5 Human error 1  Trained staff 1 5x1x1 Current
process i.e. characteristic  Process execution is in an =5 control
dry mixing of granules Auto cycle of equipment. measures
or - Process delay are
 Activity is carrying out
granulation adequate.
under supervision of
stopped
Production officer.
before
completion PLC-MMI 1  PLC-MMI operation is 1 5x1x1 Current
of cycle operation controlled with security =5 control
assessed by password. measures
un-authorized are
person adequate.
-- -- -- 5 Power failure 2  SOP for precaution to be 1 5x2x1 Current
taken in case of Power = 10 control
Failure. (Ref. No.: measures
SOP/XXXXXXX). are
adequate.
15 Wrong Product fail 5 Wrong 1  Checked and approved 1 5x1x1 Current
dispensed requisition of requisition is sending to =5 control
quantity RM warehouse for dispensing. measures
are
adequate.
 FAILURE MODE AND EFFECT ANALYSIS
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Human error 1  Trained staff 1 5x1x1 Current
 Approved requisition =5 control
measures
 Dispensing activity is
are
carrying under supervision
adequate.
of Production officer as
checker.
 Counter verification of
gross weight in a
manufacturing area before
taking to process.
Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)
No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
16 Low/failed Product fail 5 API not sifted 3  Trained staff 1 5x3x1
Assay and before sifting  Adequate instruction =
Blend of in-active shall be given in a BMR if 15
Uniformity ingredients. concentration of API is
test result less than 25 % or 25 % in Current
for API a dry blend, rinse the API control
containing polybag or IPC measures
with sufficient quantity of are
in-active ingredient and adequate.
that material (in-active
ingredient) to be passed
from respective size of
sieve.
 FAILURE MODE AND EFFECT ANALYSIS
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API 3  Trained staff 1 5x3x1
containing  Adequate instruction =
polybag or shall be given in a BMR if 15
IPC not rinsed concentration of API is
with in-active less than 25 % or 25 % in
ingredient. a dry blend, rinse the API
containing polybag or IPC
with sufficient quantity of
in-active ingredient and
that material (in-active
ingredient) to be passed
from respective size of
sieve. .

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
 FAILURE MODE AND EFFECT ANALYSIS
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17 Shade - Quality issue 5 Colour not 3  Trained staff 1 5x3x1
variation in - Out of sifted before  Adequate instruction =
granules/ specification sifting of in- shall be given in a BMR 15
tablets active for taking the Colour for
batch to ingredients. sifting on Vibratory Sifter
batch before in-active
ingredients and in case of
different size of sieves
require for sifting of
Colour and in-active
ingredients, rinse Colour
sifted sieve with sufficient
quantity of in-active Current
ingredient. control
measures
Colour 3  Trained staff 1 5x3x1 are
containing  Adequate instruction = adequate.
polybag or shall be given in a BMR 15
IPC not rinsed for taking the Colour for
with in-active sifting on Vibratory Sifter
ingredient. before in-active
ingredients and in case of
different size of sieves
require for sifting of
Colour and in-active
ingredients, rinse Colour
sifted sieve with sufficient
quantity of in-active
ingredient.
 FAILURE MODE AND EFFECT ANALYSIS
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Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
18 Low yield at Quality, efficacy 5 Raw material 1  Trained staff and 1 5x1x1 Current
wet and left in IPCs, or activity carrying out under =5 control
granulation commercial Sifter or supervision of Production measures
stage issue Polybag or officer. are
bowl of RMG.  Yield reconciliation adequate.
step in a BMR for dried
granules.
Improper 1  Equipment designed 1 5x1x1 Current
design of as per cGMP and cGEP. =5 control
equipment measures
are
adequate.
19 Wrong - System 5 Poor 1  Trained staff 1 5 x1x1 Current
product Failure Identification/  Two labels affixed to the =5 control
taken for - Product fail Improper container (one inside and measures
wet labeling another one is outside the are
granulation container). adequate.
 Dispensed raw material
storing in a one container.
 FAILURE MODE AND EFFECT ANALYSIS
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5 Human error 1  Trained staff 1 5 x1x1 Current
 Activity is carrying out =5 control
under supervision of measures
production officer. are
adequate.
20 Cross - Quality issue 5 Deficient 1  Equipments cleaning 1 5 x1x1 Current
contaminati - Adverse effect equipments procedures is validated =5 control
on of cleaning and capable to remove measures
previous procedures API, cleaning agent and are
product or microbial residue. adequate.
other
product

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
 FAILURE MODE AND EFFECT ANALYSIS
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-- -- -- 5 Improper 1  Trained staff 1 5 x1x1 Current
execution of  Periodic training program =5 control
cleaning schedule is in place. measures
procedures are
 Executions of cleaning
adequate.
procedures are verifying
by analyzing rinse water of
each equipment for API
and cleaning agent
contaminations during
every product change
over.
 Line clearance by
Production officer and QA
officer for product to
product changeover.
Checklist is given for Line
clearance in a BMR.
Hand gloves 1  Used gloves are not using 1 5 x1x1 Current
again. =5 control
 Trained staff measures
are
adequate.
21 Cross Quality issue 5 Hand gloves 1  To do the vendor audit of 5 5 x1x5 Current
contaminatio supplier Instruction shall = 25 control
n of foreign be given in a BMR as hand measures
particles and gloves and polybag to be are
microbes checked visually for adequate.
foreign particles
contamination before use.
 Once in a month, any one
 FAILURE MODE AND EFFECT ANALYSIS
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lot of hand gloves of each
supplier shall be tested for
microbial contamination.

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
-- -- -- 5 Polybag 1  Approved vendor 1 5 x1x1 Current
 Storage is proper. =5 control
measures
 Visual inspection for
are
foreign particles
adequate.
contamination at the time
of PM release.
 Once in a month, microbial
contamination verification
tests carrying out.
Raw materials 1  Approved vendor 1 5 x1x1 Current
 As per RM release =5 control
specification, doing measures
microbial examination. are
adequate.
 Microbial contamination
verification tests carrying
out on FG sample as per
specification.
 FAILURE MODE AND EFFECT ANALYSIS
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Personnel’s 1  Gowning procedure is in 1 5 x1x1 Current
place. =5 control
 Hand gloves using during measures
product handling. are
adequate.
 Once in a six month,
gowns checking for
microbial contamination.
-- -- -- 5 Equipments 1  Designed as per cGMP and 1 5 x1x1 Current
cGEP. =5 control
 Qualified equipments measures
are
 Preventive maintenance is
adequate.
doing as per defined
interval i.e. once in a three
months.
Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)
No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
22 Increased Bio Quality issue 5 Improper 1  Area cleaning and 1 5 x1x1 Current
load in the cleaning of sanitation is doing and =5 control
product due area. recording the same. measures
to wet  Bio load of an area are
granulation checking once in a adequate.
area fortnight.
 FAILURE MODE AND EFFECT ANALYSIS
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Failure of 1  0.3 micron HEPA filter is 1 5 x1x1 Current
HEPA filter installed at the terminal of =5 control
supply duct. measures
 Particle count test is doing are
once in a year. adequate.
 HEPA filter integrity test is
doing once in a year.
 Bio load of an area
checking once in a
fortnight.
23 Lid of RMG - Loss of raw 5 Human error 1  Trained staff 1 5 x1x1 Current
bowl not material  Activity carrying out under =5 control
closed - Safety issue supervision of Production measures
during officer. are
mixing adequate.
 Limit switch is provided to
lid of RMG bowl. RMG not
turns ON if lid is open.
24 Equipment Delay in process 2 Equipment 2  Preventive maintenance 1 2x2 x1 Current
break down parts schedule is in place. =4 control
Damages  Equipment history file measures
are
 SOP for equipment break
adequate.
down handling.

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
 FAILURE MODE AND EFFECT ANALYSIS
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25 Abnormal Impact on 5 Malfunctionin 1  Recording the 1 5x1x1 Current
area - Moisture g of AHU Temperature of =5 control
condition content. system. granulation area in measures
- morning and evening are
(Temperature/ Characteristics section. adequate.
Relative of material.  SOP for precaution to be
Humidity) taken in case of Power
Failure.
Electric 1  In case of Electric Power 1 5 x1x1 Current
Power failure failure, within 30 seconds =5 control
DG set is get turn ON measures
automatically. are
adequate.
-- -- -- 5 Malfunctionin 1  Calibrating once in a year 1 5 x1x1 Current
g of from NABL approved lab. =5 control
Hygrometer  Temperature and Humidity measures
Controller is installed in a are
pre-filter chamber of AHU. adequate.

Hygrometer 1  Locating the Hygrometer 1 5 x1x1 Current

not located at as per temperature =5 control
worst point. mapping report. measures
are
adequate.
 FAILURE MODE AND EFFECT ANALYSIS
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26 Improper - Cross 5 AHU damper 1  During performance 1 5 x1x1 Current
differential Contaminatio setting qualification of AHU =5 control
pressure in n system, proper setting of measures
area - Contaminatio damper is carried out and are
n locked. adequate.
 Differential pressure is
checking and recording
twice in a day. And also at
the starting of batch.
Malfunctionin 1  Differential pressure is 1 5 x1x1 Current
g of AHU checking and recording =5 control
system. twice in a day. And also at measure is
the starting of batch. adequate

Sr. Potential Potential S Contributory P Current control measures D RPN Remark(s)

No failure Effect (Process factors Rank
. mode / End Users) or (SxPxD)
Consequences
-- -- -- 5 Electric 1  In case of Electric Power 1 5 x1x1 Current
Power failure failure, within 30 seconds =5 control
DG set is get turn ON measures
automatically. are
 Stand by DG sets are adequate.
provided.
 SOP for precaution to be
taken in case of Power
Failure.
 FAILURE MODE AND EFFECT ANALYSIS
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Malfunctionin 1  Calibrating once in a year 1 5 x1x1 Current
g of from NABL approved lab. =5 control
Magnehelic  ‘0’ setting doing once in a measures
Gauge week. are adequate
27 Non- Environmental 5 Failing of 1  Filter integrity is checking 5 5 x1x5 Current
classified contamination HEPA filter on completion of = 25 control
area as per integrity installation at PQ stage measures
ISO class. and thereof after every are
one year. adequate.
 Replacing HEPA every
three years.
Improper 1  Adequate gowning is 1 5 x1x1 Current
gowning provided to personnel’s in =5 control
a classified primary measure is
change room. adequate

S-Severity Rating; P-Probability Rating; D-Detection Level Rating; RPN- Risk Priority Number
Prepared By Checked By Approved By

Signature
Date
Name
Department