P

制程失效

POTENTIAL FAIL

专案名稱: 过程責任:
Project Name Process Responsibility Rodeth L Marquez
型號: 關鍵日期:
Model Key Date: 5/26/2019
核心小组（Core team）：

分
類
主要功能 C
項目/工序 潛在失效模式Potential 潛在失效效應Potential
Function or SEV
嚴重度 l
item/step Failure Mode Effect(s) of Failure
Requirement a
s
s

Danger to life and and health

of employees.

Harmfulness/Toxicity of Penalties from goverment

purchased materials
Harmful to environment

Purchasing
Purchasing Too high priced of purchased Loss for the company/
materials in relation to design uncompetetive product in
assumptions terms of price

Purchased materials out of Line stoppage/ Stop

stocks Production

Human Line stoppage/ Stop

Insufficient Manpower
Resources Production

Does not comply

Wrong issuance of material customer's specification
5
coming from Warehouse and may inhibit part
performance
 Cannot meet the target
Lacking quantity issuance of J.O.I.S. quantity 4
material versus J.O.I.S requirements

Does not comply

customer's
Wrong loading of material to specification,may inhibit 6
Material the hopper dryer
1 part performance,
Preparation downtime in production

Insufficient drying time of Occurrence of silver streak 5

resin on the product
 Partial part and does not
comply with cosmetic
Shortshot 5
requirements and may
inhibit part performance

Does not comply with

cosmetic requirements and
Blister 5
may inhibit part
performance
 Uneven surface that may
Silver Streak 5
inhibit part performance

Will add another process

which is deburring or
deflashing and also high risk
Flash or Burrs 5
2 Injection of overcut in parting line,
may inhibit part
performance
 Uneven surface that may
Sink marks 5
inhibit part performance

Doest not comply with

Blackspot 5
cosmetic requirements
 Cracking or the product
Delamination 5
becomes brittle

No available QC personnel in Delay shipment or

QA/QC Costumer feedback
certain process
pertaining to quality
 Logistic Delay shipment Low credibility of supplier

BA1-QAW-11-01A
 潛在
制程失效模式與效應分析 (PFMEA)

POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS

PROCESS FMEA

主管簽核:
arquez Approved By: Mr. Jiantao Wang

RPN S*O*D
現行預防 現行偵測
潛在失效原因
Potential Cause(s) Occ 發生率
过程控制 过程控制 DET探測度
of Failure Current Process controls Current Process controls
（Prevention） （Detection）

Prohibit substances used by supplier/ V

erification of Certificate of
Inspection of ICP Test results and compliance, MSDS during IQC
Prohibit substances exceed in
MSDS
threshold process

Selection of uncompetetive supplier
Poor inventory / wrong forecasting
High absentism/ High Attrition rate
Wrong issuance of Job Order
Instruction Slip versus the
customer requirement, unable to
identify the material type or no
proper label
Inclusion of Price list during Inclusion of Price list during
selection of new supplier selection of new supplier
Monthly inventory checking vs Physical inventorry count of
purchased order from costumer materials
Pull out Manpower from non
Monitoring of daily attendance
critical process
Strict implementation of
Always check the issued
4 proper tagging or labelling of 2 40
material versus the requirement.
the material

Not calibrated of weighing scale,
improper handling of material
from one area to another.
Confusion of the Material Loader
Wrong setting of temperature, no
knowledge of the Loader base on
the standard dyring temperature of 3
resin
Ensure that the weighing scale is Provide dummy or jig to verify
calibrated, use jack pallet or
4 the accuracy of weighing 2 32
trolly for transferring material
scale.
from one area to another
Production leader or Line
Material Loader must be well Leader conduct proper
4 oriented based on the material training and material 2 48
type. orientation to the Material
Loader
Provide Orientation to
Have visual reference of standard Material Loader about the
drying temperature of resin, required drying time each
2 30
have daily checklist on the material and give him a copy
Hopper of Resin Drying Temperature
and Time Guidelines
 Plastics material too low,
insufficient injection capacity, the
bush doesn't match with the
nozzle resulting in material too low,
injection time too short, injection
speed too low, mold temperature 3
uneven, poor mold venting, gate or
runner too small, insufficient back
pressure, plastics melt feeding
uneven, not enough lubricant in
plastic material
Tool or material is too hot,often
caused by lacking of cooling 3 increase of decrease, if
around the tool or faulty heater
Should provide proper
Raise barrel temperature, lighting illuminations
injection speed, injection time (Minimum of 300 Lux).
and injection pressure must be Conduct 100% Visual
increase, raise the back pressure Checking of the machine 2 30
slightly, adjust mold cooling operator . And hourly
piping and add vents at suitable inspection of In-process QC,
position. based on AQL Level.
Fill speed faster or slower in
proper segment, barrel
temperatures up or down, hot Should provide proper
runner temperatures up or lighting illuminations
down, back pressure increase or
(Minimum of 300 Lux).
decrease, decompression Conduct 100% Visual
2 30
Checking of the machine
applicable, valve gate firing operator . And hourly
positions advance or delay, inspection of In-process QC,
correct mold polish if dull, clean based on AQL Level.
the mold surface if resin or
volatiles are represent, and open
the vents as needed.

Moisture in the material, usually
when hygroscopic resins are dried
improperly, air trapped in
plasticizing barrel, improper flow
of melt in mold cavity, plastic
material temperature or mold
temperature too high
Tool damage, too much injection
pressure and injection speed,
insufficient mold agent release,
overpacking, plastic material too
high, insufficient mold clamping
pressure and poor parting line or
mating surface
Should provide proper
Masterbatch isn't mixing lighting illuminations
properly, or the material has run (Minimum of 300 Lux).
out and it's starting to come Conduct 100% Visual
3 2 30
through as natural only. Previous Checking of the machine
colored material "dragging" in operator . And hourly
nozzle or check valve. inspection of In-process QC,
based on AQL Level.
Always check the the type of Should provide proper
resin during drying process and lighting illuminations
see the reference of standard (Minimum of 300 Lux).
dyring parameter of resin, Conduct 100% Visual
3 2 30
increase back pressure, reduce Checking of the machine
rear stage injection machine in operator . And hourly
order to avoid insufficient inspection of In-process QC,
clamping force based on AQL Level.

Holding time/pressure too low,
cooling time too short, with
sprueless hot runners this can also
be caused by the gate temperature
being set too high
Burnt marks produced during
injecting, material overheated and
adhered to barrel wall, material
contains foreign matter such as
paper, overheated stagnant dead
area in barrel
Should provide proper
lighting illuminations
Increase the set value of holding (Minimum of 300 Lux).
pressure, holding speed and Conduct 100% Visual
3 cooling time and check the 2 30
Checking of the machine
setting temperature of hot operator . And hourly
runner inspection of In-process QC,
based on AQL Level.
Should provide proper
Dismantle the barrel for lighting illuminations
cleaning. Reduce the material (Minimum of 300 Lux).
temperature, decrease the Conduct 100% Visual
3 2 30
heating time, check the material Checking of the machine
before loading to the hopper, operator . And hourly
slightly reduce inspection of In-process QC,
based on AQL Level.

Contamination of the material e.g.
PP mixed with ABS, very dangerous
if the part is being used for a safety
critical application as the material
has very little strength when
delaminated as the materials
cannot bond
Imbalance skill level
Should provide proper
lighting illuminations
Proper segregation of material (Minimum of 300 Lux).
type during disposal and clean Conduct 100% Visual
3 2 30
thoroughly the crasher machine Checking of the machine
before using operator . And hourly
inspection of In-process QC,
based on AQL Level.
Per area assignment of QC Matrix table of skills per
personnel individual
 Regular maintenance of delivery
No available delivery truck to use Scheduling of deliveries
truck
 FMEA 編號:
FMEA Number:
FP
頁碼(Page) of
編制者:
r. Jiantao Wang Prepared By:

FMEA編制日期
FMEA Date(Orig.)
FMEA修訂日期
FMEA Date(Rev.)
措施執行結果
Action Results
建議改進措施 負責人/完成日期
Action(s) Responsibility
Recommended & Target Completion 採取措施/

OCC
DET

RPN
SEV

Date Actions Taken&

Completion Date

Revision of Purchasing
management which include PCO
compliance of suppliers to Purchasing
EU regulatives for QA/QC
hazardous substances.
Provide list of approved Purchasing
suppliers

Warehouse leader
and Purchasing
incharge

1. Conduct counselling for

operators with high
abestism rate.

2. Conduct cross training

HR Personnel
for critical processes

3. Recognition on
employees with best
performance

Location Map of the Raw

Materials should always Warehouse Leader
be implemented. Ensure Material Loader 1/10/19 3 2 2 12
accuracy of tagging and Logistic Staf
labeling.
 Quantity of materials
need on J.O.I.S are
properly reviewed to Warehouse Leader
avoid shortage. Ensure Material Loader 1/10/19 3 2 2 12
the accuracy of the Logistic Staf
weighing scale as well
the calibration status.

Shall update the Material

description of product
running attached on the Warehouse Leader
hopper. And always Material Loader 1/10/19 3 2 2 12
visible and seen by the Logistic Staf
loader during loading of
materials.

Posting of Resin Drying

Temperature Guidelines
in the visible location of
working area. Regular Warehouse Leader
orientation on the Material Loader 1/10/19 3 2 2 12
materials requirements Logistic Staf
and specification should
be conducted to Material
Loader.
 Machine Operators
should be properly
oriented on Short Shot
defects of the items. Shall Injection
conduct orientation to Technician, In-
the assigned operator process QC, Team 1/10/19 3 2 2 12
before the mass Leader and
production to understand Operators
the criticality, locations
and disposition needed
once found the defect.

Machine Operators
should be properly Injection
oriented on Blister Technician, In-
defects of the items. Shall process QC, Team 1/10/19 3 2 2 12
conduct orientation to Leader and
the assigned operator Operators
before the mass
production.
 Machine Operators
should be properly
oriented on Silver Streak
defects of the items. Shall Injection
conduct orientation to Technician, In-
the assigned operator process QC, Team 1/10/19 3 2 2 12
before the mass Leader and
production to understand Operators
the criticality, locations
and disposition needed
once found the defect.

Machine Operators
should be properly
oriented on Flush or
Burrs defects of the Injection
items. Shall conduct Technician, In-
orientation to the process QC, Team 1/10/19 3 2 2 12
assigned operator before Leader and
the mass production to Operators
understand the criticality,
locations and correction
needed once found the
defect.
 Machine Operators
should be properly
oriented on Sink Marks
defects of the items. Shall Injection
conduct orientation to Technician, In-
the assigned operator process QC, Team 1/10/19 3 2 2 12
before the mass Leader and
production to understand Operators
the criticality, locations
and disposition needed
once found the defect.

Machine Operators
should be properly
oriented on Black Spot
defects of the items. Shall Injection
conduct orientation to Technician, In-
the assigned operator process QC, Team 1/10/19 3 2 2 12
before the mass Leader and
production to understand Operators
the criticality, locations
and disposition needed
once found the defect.
 Machine Operators
should be properly
oriented on
Delaminations defects of
Injection
the items. Shall conduct Technician, In-
orientation to the process QC, Team 1/10/19 3 2 2 12
assigned operator before Leader and
the mass production to Operators
understand the criticality,
locations and disposition
needed once found the
defect.

All QC personnel reach

atleast 90% of skill level
Find back up delivery truck
in case assigned truck is
not available