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FAILURE MODES AND EFFECTS ANALYSIS FMEA Team Designation Signature

PROCESS DESCRIPTION : INJECTION MOLDING PROCESS TYPE OF FMEA : PROCESS

PROCESS LOCATION : DESIGN

PRODUCTS AFFECTED : PROCESS

DOCUMENT NO. : REV. NO. : 00 DATE OF ORIGIN : REVISED DATE :

EXISTING PROCESS CONDITIONS ACTION RESULTS

RISK PRIORITY

RISK PRIORITY
OCCURRENCE

OCCURRENCE
SEVERITY

DETECTION

DETECTION
PROCESS STEP RESPONSIBILITY &

SEVERITY
NO. (RPN)

NO. (RPN)
PROCESS STEP / POTENTIAL FAILURE RECOMMENDED
FUNCTIONS / POTENTIAL CAUSES OF FAILURE POTENTIAL EFFECTS OF FAILURE TARGET COMPLETION ACTIONS TAKEN &
FUNCTION MODES CURRENT PREVENTION CONTROL CURRENT DETECTION CONTROL ACTIONS
REQUIREMENTS DATE COMPLETION DATE

1. In-Coming Inspection Check Sheet (GEN-


Receiving material
1. Control plan - COC, label & packaging check. INSP-004-01) 2) Part Inspection Plan (GEN-
Receiving incoming which is conforming
Accept wrong material Wrong labelling Unable to mold parts 5 2. Part Inspection Plan (GEN-INSP-002-02) for 4 INSP-002-02) for resin. 2 40 No action required NA NA NA NA NA NA
material with material
resin. 2. Inspection and Acceptance Status
specification
Procedure (MD-INSP-002)

Maintain the material Caused failure in the subsequent


Material storage Material contaminated Packaging damaged or torn 3 All incoming materials are stored in specific rack 4 Visual Checking 2 24 No action required NA NA NA NA NA NA
quality in warehouse process

Label & packaging check for startup inspection


a. Transfer Journal
Material handling from Maintain the material 1. Inspection & Acceptance Status
Caused failure in the following
warehouse to quality during Material contaminated Packaging damaged or torn 4 4 Procedure ( MD-INSP-002). 4 64 No action required NA NA NA NA NA NA
process
production site transportation
b. Material
Lot Number (MD-PROD-006-01)
1. Material Data Specification Sheet
1. Material Preparation Guide (GEN-PROD-
2. PM Checklist for Hopper Dryer (GEN-PROD-
Impact subsequent process and result 001-01)
008-11)
Faulty Euipment in scraps of molded component as 5 4 2. PM Checklist for Hopper Dryer 3 60 No action required NA NA NA NA NA NA
parts become brittle

1. Material Data Specification Sheet


1. Material Preparation Guide (GEN-PROD-
2. PM Checklist for Hopper Dryer (GEN-PROD-
Under drying Impact subsequent process and result 001-01)
008-11)
Insufficient Drying Time in scraps of molded component as 6 3 2. PM Checklist for Hopper Dryer 3 54 No action required NA NA NA NA NA NA
parts become brittle
1. Material Data Specification Sheet
1. Material Preparation Guide (GEN-PROD-
2. PM Checklist for Hopper Dryer (GEN-PROD-
Remove moisture from Impact subsequent process and result 001-01)
Material Drying Drying temperature set lower than 008-11)
the resin in scraps of molded component as 6 3 2. PM Checklist for Hopper Dryer 3 54 No action required NA NA NA NA NA NA
the required drying temperature
parts become brittle

1. Material Data Specification Sheet


1. Material Preparation Guide (GEN-PROD-
2. PM Checklist for Hopper Dryer (GEN-PROD-
Impact subsequent process and result 001-01)
008-11)
Faulty Euipment in scraps of molded component as 3 3 2. PM Checklist for Hopper Dryer 3 27 No action required NA NA NA NA NA NA
material is degraded

Overdrying 1. Material Data Specification Sheet


1. Material Preparation Guide (GEN-PROD-
2. PM Checklist for Hopper Dryer (GEN-PROD-
Impact subsequent process and result 001-01)
Drying temperature set above than 008-11)
in scraps of molded component as 3 3 2. PM Checklist for Hopper Dryer 3 27 No action required NA NA NA NA NA NA
the required drying temperature
material is degraded

1. Part Inspection Plan (GEN-INSP-002-02)


2. Mold 1. Start-up & In-Process Inspection
Start Up and shutdown Work Instruction (MD- checksheet (MD-INSP-004-01)
PROD-006-W06A) 3)Master Set Up Sheet - 2) Current Set Up
Wrong Inserts Caused failure in the following process 7 2 2 28 No action required NA NA NA NA NA NA
Cincinnati Machine (GEN-PROD-009-05) Sheet - Cincinnati Machine (MD-PROD--
Mold set up and Start Wrong Product 4) Mold 006-09)
Set - up Maintenance Tool Requisition -(GEN-PROD-007-
up produced
01)
1. Start-up & In-Process Inspection
1. Part Inspection Plan (GEN-INSP-002-02)
checksheet (MD-INSP-004-01)
Caused failure in the following 2. Mold
Wrong Material 7 2 2) Current Set Up Sheet -Cincinnati 3 42 No action required NA NA NA NA NA NA
process Start Up and shutdown Work Instruction (MD-
Machine (MD-PROD-006-09)
PROD-006-W06A)
1. Start-up & In-Process Inspection
checksheet (MD-INSP-004-01)
Perform PM per Mold Impact subsequent process and result
In process Mold PM Contamination Too much lube or improper cleaning 5 Training provided for Mold Maintenance 2 2)Mold and Robot Cleaning Log - GEN 3 30 No action required NA NA NA NA NA NA
Maintenace Manual in scraps of molded components.
-PROD-001-07)

MD-DOC-006-01C (13APR2012) Page 1 of 4


FAILURE MODES AND EFFECTS ANALYSIS FMEA Team Designation Signature

PROCESS DESCRIPTION : INJECTION MOLDING PROCESS TYPE OF FMEA : PROCESS

PROCESS LOCATION : DESIGN

PRODUCTS AFFECTED : PROCESS

DOCUMENT NO. : REV. NO. : 00 DATE OF ORIGIN : REVISED DATE :

EXISTING PROCESS CONDITIONS ACTION RESULTS

RISK PRIORITY

RISK PRIORITY
OCCURRENCE

OCCURRENCE
SEVERITY

DETECTION

DETECTION
PROCESS STEP RESPONSIBILITY &

SEVERITY
NO. (RPN)

NO. (RPN)
PROCESS STEP / POTENTIAL FAILURE RECOMMENDED
FUNCTIONS / POTENTIAL CAUSES OF FAILURE POTENTIAL EFFECTS OF FAILURE TARGET COMPLETION ACTIONS TAKEN &
FUNCTION MODES CURRENT PREVENTION CONTROL CURRENT DETECTION CONTROL ACTIONS
REQUIREMENTS DATE COMPLETION DATE

1. Master Set-up Sheet - Cincinnati Machine


1. Current Run Set Up Sheet - Cincinnati
Impact subsequent process and result (GEN-PROD-009-05)
Degradation of Temperature setting too high Machine (MD-PROD-006-09)
in scraps of molded component as 7 2. PM Checklist Hydraulic Injection 3 3 63 No action required NA NA NA NA NA NA
material 2. Process Control Checklist (MD-PROD-
material is degraded Machine(GEN-PROD-008-12)
006-23)

1. Master Set-up Sheet - Cincinnati Machine


1. Current Run Set Up Sheet - Cincinnati
High peak pressure Need to change cores and cavities (GEN-PROD-009-05)
Melt Temperature was not able to Machine (MD-PROD-006-09)
which shorten the life more often, resulting in high 6 2. PM Checklist Hydraulic Injection 3 3 54 No action required NA NA NA NA NA NA
reach setting 2. Process Control Checklist (MD-PROD-
span of mold maintenance cost and downtime Machine(GEN-PROD-008-12)
006-23)
Aids in melting of
Barrel Heating
resins
1. Master Set-up Sheet - Cincinnati Machine
1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Temperature setting too low Impact subsequent process and result Machine (MD-PROD-006-09)
Short molding 7 2. PM Checklist Hydraulic Injection 4 2 56 No action required NA NA NA NA NA NA
in scraps of molded component 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
006-23)

1. Master Set-up Sheet - Cincinnati Machine


1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Temperature setting too high Impact subsequent process and result Machine (MD-PROD-006-09)
Flashing 7 2. PM Checklist Hydraulic Injection 4 2 56 No action required NA NA NA NA NA NA
in scraps of molded component 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
006-23)

1. Master Set-up Sheet - Cincinnati Machine


1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Impact subsequent process and result Machine (MD-PROD-006-09)
Material Drooling Back Pressure Setting too high 4 2. PM Checklist Hydraulic Injection 4 3 48 No action required NA NA NA NA NA NA
in high cycle time 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
006-23)
Back pressure control
of injection press 1. Master Set-up Sheet - Cincinnati Machine
1. Current Run Set Up Sheet - Cincinnati
Impact subsequent process and result (GEN-PROD-009-05)
Back Pressure Setting too low Machine (MD-PROD-006-09)
Sink Marks in scraps of molded component as 5 2. PM Checklist Hydraulic Injection 5 2 50 No action required NA NA NA NA NA NA
2. Process Control Checklist (MD-PROD-
cosmetics appearance is affected Machine(GEN-PROD-008-12)
006-23)

1. Master Set-up Sheet - Cincinnati Machine


1. Current Run Set Up Sheet - Cincinnati
Impact subsequent process and result (GEN-PROD-009-05)
Machine (MD-PROD-006-09)
Short mold Decompression too short in scraps of molded component as 4 2. PM Checklist Hydraulic Injection 5 2 40 No action required NA NA NA NA NA NA
2. Process Control Checklist (MD-PROD-
cosmetics appearance is affected Machine(GEN-PROD-008-12)
Decompression 006-23)
Plasticizing Phase control of injection
press 1. Master Set-up Sheet - Cincinnati Machine
1. Current Run Set Up Sheet - Cincinnati
Impact subsequent process and result (GEN-PROD-009-05)
Machine (MD-PROD-006-09)
Silver streak Decompression too long in scraps of molded component as 4 2. PM Checklist Hydraulic Injection 5 3 60 No action required NA NA NA NA NA NA
2. Process Control Checklist (MD-PROD-
cosmetics appearance is affected Machine(GEN-PROD-008-12)
006-23)

1. Master Set-up Sheet - Cincinnati Machine


1. Current Run Set Up Sheet - Cincinnati
Screw Speed Setting too high (GEN-PROD-009-05)
Part weaken in strength and need to Machine (MD-PROD-006-09)
Bubbles 4 2. PM Checklist Hydraulic Injection 5 2 40 No action required NA NA NA NA NA NA
be scrap 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
006-23)
Screw speed control
of injection press 1. Master Set-up Sheet - Cincinnati Machine
Impact subsequent process and result 1. Current Run Set Up Sheet - Cincinnati
Screw Speed Setting too low (GEN-PROD-009-05)
Material non in scraps of molded component as Machine (MD-PROD-006-09)
4 2. PM Checklist Hydraulic Injection 2 4 32 No action required NA NA NA NA NA NA
homogenity cosmetics appearance is affected & 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
cause drooling 006-23)

1. Master Set-up Sheet - Cincinnati Machine


Impact subsequent process and result 1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Short molding / Sink in scraps of molded component as Machine (MD-PROD-006-09)
Injection Speed too Low 5 2. PM Checklist Hydraulic Injection 2 4 40 No action required NA NA NA NA NA NA
Marks cosmetics appearance is affected & 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
cause short molding 006-23)
Injected melted plastic
Injection Phase
into mold
1. Master Set-up Sheet - Cincinnati Machine
Impact subsequent process and 1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
result in scraps of molded component Machine (MD-PROD-006-09)
Flashes Injection Speed too High 5 2. PM Checklist Hydraulic Injection 4 3 60 No action required NA NA NA NA NA NA
as cosmetics appearance is affected 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
& cause dimensions out of specs 006-23)

1. Master Set-up Sheet - Cincinnati Machine


Impact subsequent process and 1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Packing Setting too high result in scraps of molded component Machine (MD-PROD-006-09)
Flashes 5 2. PM Checklist Hydraulic Injection 4 2 40 No action required NA NA NA NA NA NA
as cosmetics appearance is affected 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
& cause dimensions out of specs 006-23)

1. Master Set-up Sheet - Cincinnati Machine


Impact subsequent process and result 1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Packing Setting too low in scraps of molded component as Machine (MD-PROD-006-09)
Packing material to Sink Marks 5 2. PM Checklist Hydraulic Injection 4 2 40 No action required NA NA NA NA NA NA
Packing Phase cosmetics appearance is affected & 2. Process Control Checklist (MD-PROD-
make a complete fill Machine(GEN-PROD-008-12)
cause dimensions out of specs 006-23)

1. Master Set-up Sheet - Cincinnati Machine


Impact subsequent process and result 1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Packing Setting too low in scraps of molded component as Machine (MD-PROD-006-09)
Short molding 7 2. PM Checklist Hydraulic Injection 4 2 56 No action required NA NA NA NA NA NA
cosmetics appearance is affected & 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
cause dimensions out of specs 006-23)

MD-DOC-006-01C (13APR2012) Page 2 of 4


FAILURE MODES AND EFFECTS ANALYSIS FMEA Team Designation Signature

PROCESS DESCRIPTION : INJECTION MOLDING PROCESS TYPE OF FMEA : PROCESS

PROCESS LOCATION : DESIGN

PRODUCTS AFFECTED : PROCESS

DOCUMENT NO. : REV. NO. : 00 DATE OF ORIGIN : REVISED DATE :

EXISTING PROCESS CONDITIONS ACTION RESULTS

RISK PRIORITY

RISK PRIORITY
OCCURRENCE

OCCURRENCE
SEVERITY

DETECTION

DETECTION
PROCESS STEP RESPONSIBILITY &

SEVERITY
NO. (RPN)

NO. (RPN)
PROCESS STEP / POTENTIAL FAILURE RECOMMENDED
FUNCTIONS / POTENTIAL CAUSES OF FAILURE POTENTIAL EFFECTS OF FAILURE TARGET COMPLETION ACTIONS TAKEN &
FUNCTION MODES CURRENT PREVENTION CONTROL CURRENT DETECTION CONTROL ACTIONS
REQUIREMENTS DATE COMPLETION DATE

1. Master Set-up Sheet - Cincinnati Machine


1. Current Run Set Up Sheet - Cincinnati
Impact subsequent process and result (GEN-PROD-009-05)
Machine (MD-PROD-006-09)
Ejector marks on parts Cooling Time Setting too low in scraps of molded component as 6 2. PM Checklist Hydraulic Injection 3 3 54 No action required NA NA NA NA NA NA
2. Process Control Checklist (MD-PROD-
Cool down the cosmetics appearance is affected Machine(GEN-PROD-008-12)
006-23)
material (solidify)so
Cooling Phase
that it is hard and solid 1. Master Set-up Sheet - Cincinnati Machine
to eject Impact subsequent process and result 1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
in scraps of molded component as Machine (MD-PROD-006-09)
Part struck on slider Cooling Time Setting too low 7 2. PM Checklist Hydraulic Injection 3 3 63 No action required NA NA NA NA NA NA
cosmetics appearance is affected & 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
double clamping 006-23)

1. Master Set-up Sheet - Cincinnati Machine


Impact subsequent process and result 1. Current Run Set Up Sheet - Cincinnati
(GEN-PROD-009-05)
Eject the parts after Ejection stroke too short in scraps of molded component as Machine (MD-PROD-006-09)
Failed to eject parts 6 2. PM Checklist Hydraulic Injection 3 3 54 No action required NA NA NA NA NA NA
mold opens cosmetics appearance is affected & 2. Process Control Checklist (MD-PROD-
Machine(GEN-PROD-008-12)
double clamping 006-23)
Ejection Phase
1. Master Set-up Sheet - Cincinnati Machine
1. Current Run Set Up Sheet - Cincinnati
Impact subsequent process and result (GEN-PROD-009-05)
Eject the parts after Machine (MD-PROD-006-09)
Double Clamping Failed to eject parts in scraps of molded component as 6 2. PM Checklist Hydraulic Injection 3 3 54 No action required NA NA NA NA NA NA
mold opens 2. Process Control Checklist (MD-PROD-
parts and mold is damaged Machine(GEN-PROD-008-12)
006-23)

1. Startup Inspection Report (GEN-PROD-


Result in product failure that could
1. Mold Maintainance Tool Requisition (GEN- 001-06)
Oil residue from ejetor pins, guide impact health and safety.
PROD-007-01)
Oil Stains; black dots pins and return pins. Contamination Impact subsequent process and result 5 4 3 60 No action required NA NA NA NA NA NA
2. Mold Preventive Maintenance Checklist (GEN-
of material in some scraps of molded component
PROD-007-06) 2. Start-Up In-Process
due to the contamination 1. Final inspection Procedure (MD-INSP-005)
Inspection Check Sheet (MD-INSP-004-01)
Mass Production Production
1. Final inspection procedure (MD-INSP-
2. Part
005)
Inspection Plan (GEN-INSP-002-02)

Mix parts Poor Line Clearance Customer Complaints 4 2 3 24 No action required NA NA NA NA NA NA


2. Part Inspection Plan (GEN-
3.
INSP-002-02)
Packaging Spec Sheet (GEN -BD-001-06)
3. Packaging Spec
Sheet (GEN -BD-001-06)
4.Line
1. Label and
Clearance Packaging
Checklist Change (MD-LP-001-01)
(GEN-PROD-001-08)
Result in product failure that could 1. Batch Production Record (MD-DOC-004-
Packaging Phase Packaging Wrong Label Label Printed wrongly 3 2. Packaging Spec Sheet (GEN-BD-001-06) 3 2 18 No action required NA NA NA NA NA NA
impact health and safety 01)

MD-DOC-006-01C (13APR2012) Page 3 of 4


FAILURE MODES AND EFFECTS ANALYSIS FMEA Team Designation Signature

PROCESS DESCRIPTION : INJECTION MOLDING PROCESS TYPE OF FMEA : PROCESS

PROCESS LOCATION : DESIGN

PRODUCTS AFFECTED : PROCESS

DOCUMENT NO. : REV. NO. : 00 DATE OF ORIGIN : REVISED DATE :

EXISTING PROCESS CONDITIONS ACTION RESULTS

RISK PRIORITY

RISK PRIORITY
OCCURRENCE

OCCURRENCE
SEVERITY

DETECTION

DETECTION
PROCESS STEP RESPONSIBILITY &

SEVERITY
NO. (RPN)

NO. (RPN)
PROCESS STEP / POTENTIAL FAILURE RECOMMENDED
FUNCTIONS / POTENTIAL CAUSES OF FAILURE POTENTIAL EFFECTS OF FAILURE TARGET COMPLETION ACTIONS TAKEN &
FUNCTION MODES CURRENT PREVENTION CONTROL CURRENT DETECTION CONTROL ACTIONS
REQUIREMENTS DATE COMPLETION DATE

1. Final Inspection Record (MD-INSP-005-


1. Final inspection procedure (MD-INSP-005) 01)
Transfer of finished Impact subsequent process and result
Damage carton boxes
Delivery Phase palletized parts to Run the pallet into obstacles in some scraps of molded component 2 4 5 40 No action required NA NA NA NA NA NA
during transport
customer warehouse due to the damage. 2. Part 2.
Inspection Plan (GEN-INSP-002-02) Final Inspection Check Sheet (MD-INSP-
005-02)
Overlook the need to fabricate 1. Mold Preventive Maintenance Checklist (GEN- 1. Mold Preventive Maintenance Checklist
Insufficient spares Impact subsequent process 6 2 4 48 No action required NA NA NA NA NA NA
spares PROD-007-06) (GEN-PROD-007-06)
Mold PM Check spare inventory
Impact subsequent process and result
Mold/component Mishandling during production or 1. Mold Set Up Work Instruction (MD-PROD- 1. Mold Set Up Work Instruction (MD-
in scraps of molded component as 6 2 4 48 No action required NA NA NA NA NA NA
damage mold assembly 006-W06A) PROD-006-W06A)
parts is damaged.

Customer feedback Customer is not able


Post market Defective part Product recall 7 1. Customer survey. 3 1. Customer complaint. 2 42 No action required NA NA NA NA NA NA
complaint to use the part

CONCLUSION : ALL ACTIVITIES OUTLINE IN THIS DOCUMENT ARE CARRIED OUT. THE OVER ALL RISK IS FOUND TO BE ACCEPTABLE AND APPROPRIATE METHODS ARE IN PLACE.

Risk Category Lower RPN Limit Upper RPN limit


Broadly acceptable 1 64

Recommended actions to be taken 65 124

Intolerable 125 1000

Rev. No. Revision Description


00 New Release

MD-DOC-006-01C (13APR2012) Page 4 of 4