Potential Failure Mode and Effects Analysis (Pfmea)
Potential Failure Mode and Effects Analysis (Pfmea)
Potential Failure Mode and Effects Analysis (Pfmea)
F/NPD/06-MCM
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PFMEA) Revisio
06
n No.
Product : Automotive Inner Butyl Tube Process : Master Compound Mixing ……. Process-02 Revision 12.05.2021
Customer : All Customer Process Responsibility : Technical / QA
Page
Respo 1OF 1
Process Owner : Production Head Recomme nsibilit
nded y&
Target Action Results
DETECT
Potential
OCCUR
CLASS
Sub Process Current Process
Potential Failure Potential Effects(s) of Current Process Control Compl
RPN
SEV
Step/ Requirement cause(s) Control
Mode Failure Mechanism(s) (Detection) etion
Function (Prevention)
of Failures ActionSDO R
1-Calibration of M/c - Once in Month Action(s)
SG out of specification Certification of M/c 2-SG of every batch in shift tested
Weighing
( A Portion of the 5 2 with Weights in by Prod. Officer 5 50 -
Scale Faulty
production run may Start of Shift 3-One test for SG / Day by QA
have to be reworked Officermatrix - operatorwise
1-Skilled operator 1-Skill
Unskilled
Proper (Next offline and accepted.) 5 Man power
2 for weighing 2-Training Plan /execution / 1 10
2.1 / 2-On Job Training 1-Calibration
Effectivenessofcalculation
Weight of Imprope Proce M/c - Once in Month
Weighing ss) Green Tube Wt Standardisation of 2-SG of every batch in shift tested
Ingradient r Weighing
of Raw Variation
s Ready Weighm Our 5
Scale Faulty
2 M/c with Weights - by Prod. superwiser 5 50
Material as End ( A Portion of the Start of Shift 3-One test for SG / Day by QA
for ent
per Spec. production run may Officermatrix - operatorwise
Mixing. 1-Skilled operator 1-Skill
have to be reworked Un skilled
offline and accepted.) 5 Man power
2 for weighing 2-Training Plan /execution / 1 10
2-On Job Training Effectiveness calculation
Daily QA Checksheet
- 5 - 2 - 5 50
Custo ( PFM)
mer No effect 1 - - 1 - N/A 1 1
End 8 72
1-Mixing 1-Visual / Mixing Operator
Sequence of
sequence- 2-Sequence for every Compound
3 3 Mixing as per
Out of -in shift, checked by Prod.Officer
specification
Spec , 3-One Check / Day by QA Officer
2 12
Electronic 1-Visual / Mixing Operator
2-Mixing
Controlled and 2-Mixing-time for every Compound
3 Time-Out of 2
Extra Mixing time on Digital Display for -in shift, checked by Prod. Officer
Spec ,
dump mill Time 3-One Check / Day by QA Officer
(Next (A Portion of the
Homogen 1-Alarm Installed for Low Pressure 2 6
Unmixe Proce production run may
Indication.
2.2 / Mixing eous ss) have to be reworked 3-Air pr of Air pressure set &
d 2-Visual / Mixing Operator
of Batch in Mixing of
Compo Our in-station before it is 3 RAM- 1 Cutt off at Main
3-Air pr for every Compound -in
Mixer. Compoun End processed) Incorrect Compressure.
und shift, checked by Prod.Officer
d
3-One Check / Day by QA Officer
1-Digital temperature display 2 12
Drop-door
2-Round temperature chart
interlocked with
4-Dump 3-Visual- Mixing Operator
dump-temp and
6 E Temp-Out 1 4-Every Compound check in shift /
will open when
of Spec Production Officer
mixing temp
5-One compound check per day by
reaches specified
QA Officer
dump-temp
- 3- - 3 - Daily QA Check Sheet (PFM) 8 72
Custo
mer No effect 1 - - 1 - N/A 1 1
End 8 72
Number of 1-Every compound sheet in shift
Skilled operator
3 Cuts - Out 3 checked by Prod. Officer
deployed
Homogen Poor Dispersion of Spec 2-One Check / Day by QA Officer
2.3 / eously (Next (A Portion of the
Compound Mixed production run may 8 72
Unmixe Proce Gap 1-Templet check by Mill-Operator
Sheet Compoun
d ss) have to be reworked
making on d Sheet in-station before it is between 2-Guage checked for every sheet in
Compo Our Skilled operator
3 Rolls/Sheet 3 shift by Prod. Officer
Batch-off with
und End processed) deployed
(Dump)Mill Sheet Guage - 3-One Check / Day by QA Officer
. Guage As Out of Spec as per F/QAD/11 .
per Spec.
- 3 - 3 - Daily QA Check Sheet (PFM) 8 72
Custo
mer No effect 1 - - 1 - N/A 1 1
End Sticky Comp. Sheet 5 30
(Slight inconvenience Insufficient Daily top-up
Visual check by Mill operator/Prod
to Soap 3 according to
officer/QA
process,operation,or Solution specifications
operator.) 2
Insufficient Daily top-up 5 30
Visual check by Mill operator/Prod
Hot Comp. Sheet Soap 3 according to
officer/QA
(Slight inconvenience 2 Solution specifications
to 1-Visual-Compound-cooling 5 30
process,operation,or Halt for Skilled operator checked in shift by Prod. Officer
Master (Next 3
2.4 / Hot & Proce operator.) cooling deployed 3-Visual-One check/Day by QA
Compoun Officer
Compound Sticky ss) 2
d sheet - Wet Comp. Sheet
Sheet Compo Our 1-Visual-Compound-cooling 5 30
Cooled , (Slight inconvenience
Cooling & und End Halt for Skilled operator checked in shift by Prod. Officer
Lubricate to 3
Storage . sheet cooling deployed 3-Visual-One check/Day by QA
d & Dried. process,operation,or
2 Officer
operator.)
5 45
FM Contamination
(Slight inconvenience Soap solution
Dirty Soap Visual check by Mill operator/Prod
to 3 changed in every 3
Solution Officer/QA
process,operation,or months
operator.)
3
5 45
- 3 - 3 - Daily QA Check Sheet (PFM)
Custo
mer No effect 1 - - 1 - N/A 1 1
Abbreviati End
E - indicates error-proofing
on :
P - indicates pokayoka
S - indicates special cherecteristics
Revision History
Revision
S No. Revision Date Revision Details Prepared By Checked by Approved By
No