MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Failure S Potential causes O Current control measures D RPN Proposed
No Failure Mode Effect (SXOXD) Action
Plan
1.0 Power Breakdown of 7 Power failure by 5 Power supply through Main drive of 2 70 System in
Failure machine leading to Electric board . the machine with UPS attached . control
less usage. Improper wiring to PPM is carried by trained personnel.
Machine Soft ware the machine. No Earthing connection to the machine
damage . positive earthing frequently checked in PPM.
connection to
machine.
2.0 PLC Errors Product fails to 7 Not Following 4 Trained personnel are carried out the 4 112 Validation
meet standard relevant SOP. No activity. Password protected PLC. Required
specification password protection Well defined SOP available to operate
procedure is the PLC.
followed as per
SOP .No verification
after setting process
parameter

Page 1 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Effect S Potential causes O Current control measures D RPN Proposed
No Failure (Process/End Users (SXOXD) Action Plan
Mode or Consequences)
5.0 Improper Cross 7 Improper 3 Operation carried by well trained 3 63 System in
material Contamination and labeling of personnel, proper following of SOP, control
loading to Material loss materials, Not Counter checking by the production
Compressio follow up of supervisor/ Executive the operation
n machine SOP, improper before and after loading.
hopper maintenance of
equipment,
Equipment
handling by un-
trained personnel
6.0 Improper Damage of 8 Improper 4 Counter checking of setting by 3 96 Validation
selection of tooling, product training of production officer, trained persons are Required
cam track fails to meet personnel, Not carried out setting .Proper following
standard followed SOP. if wrong selection cam than
specification relevant SOP show in PLC .
7.0 Damaged Improper 7 Not following 3 Issuance of right tooling by trained 3 63 System in
tooling’s identification of relevant SOP and persons and Proper checking and control
product wurst storage maintenance as per SOP.
fails to meet condition.
required
specification
8.0 Improper Damage of 7 Improper 3 Counter checking of setting by 2 42 System in
fitting of tooling’s during training of production officer, trained persons to control
tooling’s initial setting personnel, Not carry out setting.

Page 2 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Effect S Potential causes O Current control measures D RPN Proposed
No Failure (Process/End Users (SXOXD) Action Plan
Mode or Consequences)
accidents during followed
compression and relevant SOP
fail to meet
required
Specification .
9.0 Improper Damaged to the 7 Improper 5 Counter checking of setting by 2 70 System in
setting of turret and chances training of production officer, trained persons to control
Feeder of emerging the personnel, Not carry out setting. LHS and RHS mark
metal fines leads to followed in Feeder .
undesirable effect relevant SOP and
on product and fail impact in
to meet required powder flow .
Specification .
10.0 Improper Excess material 7 Improper setting 3 Availability of well defined SOP for 3 63 System in
assembling loss. weight of scrapper plate. operation of equipment, Machine control
of Scrapper variations. product Not following of setting by trained personnel. counter
plate fail in specification SOP, Setting by checking by production officer .
. untrained
personnel
11.0 Improper Product fails to 7 Accumulation of 3 Rubber cups are fixing to all Upper 3 63 System in
Punch meet standard Dust on Punches. punches. Availability of SOP for control
movement specification Rubber (Dust operation of equipment, parts setting
cups) cups are done by trained personnel. machine
not properly stop immediately due to present of
fixed. Improper Sensor than show in PLC alarm .
Lubrication

Page 3 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Effect S Potential causes O Current control measures D RPN Proposed
No Failure (Process/End Users (SXOXD) Action Plan
Mode or Consequences)
12.0 Excess Tablet Quality. 7 Heavy ejection 4 Ant vibrant pad is present with 4 112 Validation
Machine pressure,Imprope machine. Reduce Machine Rpm .check required
Vibration r pressure the hydrollic pressure .
releasing
13.0 Improper Impacting on 7 Improper 3 Recommended oils incorporated in 3 63
Lubrication smooth working of selection of SOPs. PPM carries as per schedule.
machine. lubricants. Automated lubrication system System in
Reduction of life of Unclean available and can be set at required control
the machine. lubrication intervals.
points.
Excessive
lubrication. No
PPM followed.
Activity carried
by untrained
personnel.

Page 4 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Effect S Potential causes O Current Process control D RPN Priority
No Failure (Process/End (SXOXD)
Mode Users or
Consequences)
14.0 Improper Damaged to 7 Handling by 3 Trained personnel are carried the 3 63 System in
working of Driven pulley and untrained activity. PPM schedule. PLC alarm control
Clutch worm shaft personal. checked .
engagement Improper
connection
between driven
pulley and worm
shaft. Buttons not
properly working
PLC is not
working properly
15.0 Improper Variance in the 7 Improper 3 Proper Lubrication system. 3 63 System in
Punch setting Physical functioning of Preventive maintenance is carried as control
parameter and lock in screws, per schedule. Trained personnel are
product fails to setting by carried the activity as per SOP
meet the standard. untrained
Damage the persons.
machine cam .
16.0 Variance in Variance in the 8 Improper 4 Preventive maintenance is carried 4 128 Validation
Thickness Physical functioning of out as per schedule. Trained Required
parameter and tightening personnel are carried the activity. As
fails to meet the screws. Variation per tooling SOP punches are
standard in punch length. verified for its dimensions
specification. Un equal periodically. Sizing done after
granules granulation. To followed the

Page 5 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Effect S Potential causes O Current Process control D RPN Priority
No Failure (Process/End (SXOXD)
Mode Users or
Consequences)
distribution. instruction as per BMR .If thickness
more than stander limit than
machine show in PLC .
17.0 Inconsistent Variance in the 8 Improper 4 Proper Lubrication system. 4 128 Validation
tablet Weight Physical working of Preventive maintenance is carried as Required
parameter of weight per schedule. As per SOP Tooling’s
tablets. adjustment dials. are verified for its dimensions.
Inconsistent Variation in Trained personnel are carried the
dissolution. Punch length. activity as per SOP. Filling cam is
Validation failure Improper checking at interval. Granule
granules flow. properties tested after granulation.
Feed frame Control the Machine RPM and
Emptied during carried out the activity as per BMR .
run.
Accumulation of
dirt and dust
under weight
adjustment cam.
Improper die fill.
Improper fitting
and working of
lower punch
brake plug.
Improper granule
properties

Page 6 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Effect S Potential causes O Current Process control D RPN Priority
No Failure (Process/End (SXOXD)
Mode Users or
Consequences)
18.0 Generating Undesirable 8 Improper setting 4 Proper setting and cleaning of the 3 96 Validation
of fine metal therapeutic effect of tablet scrapper machine part by trained personnel Required
and foreign plate, cam, by following SOP. Proper line
particle ejection chute, procedure for ensuring cleanliness.
Feeder frame, Proper dust cups are fixing to each
powder scrapper punches. Before start the machine
plate , improper will checked by Production and QA
lubrication of person . Metal detector to be used
tooling’s and before start the process .
improper
cleaning of
machine parts.
19.0 Improper Variance in the 7 Incorrect setting 4 Machine speed is setting as per 2 56 System in
material flow Physical of material flow BMR instruction. Regular control
parameter and against speed of controlling of butterfly valve.
fails to meet the machine. Verifying the feeder setting by
standard. Improper control production officer. Trained
by Butterfly personnel carried the activity by
valve, improper following the SOP.
setting of paddle
blade in feeder,
Input material
should not
exceed in feeder
frame.

Page 7 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Sr. Potential Potential Effect S Potential causes O Current Process control D RPN Priority
No Failure (Process/End (SXOXD)
Mode Users or
Consequences)
20.0 Breaking of Variance in the 7 Using of 3 Verification of proper setting of 3 63 System in
Tablets Physical damaged machine by production officer. control
parameter and tooling’s. Low Maintaining the overload pressure.
fails to meet the moisture content Maintaining the speed of the
standard. More in Granules machine. In process controls to meet
rejection Incorrect setting the standards. Monitoring the
of scrapper plate. granule properties. Proper machine
Improper setting setting by trained personnel
of lower punch
ejection height.
Insufficient load
at compression
point. High
machine speed
above the
validated speed.
Insufficient
powder filling in
die due to
improper feeder
setting.

S - SEVERITY, O - likelihood of occurrence , D - likelihood of Prior Detection , RPN - Risk Priority Number

Page 8 of 9
 MANKIND PHARMA LIMITED UNIT-II ,PAONTA SAHIB .

FAILURE MODE EFFECT ANALYSIS (Risk Assessment)

Process/Equipment : Compression
Machine no.:

Page 9 of 9