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Potential Failure Mode and Effects Analysis Process Fmea
Potential Failure Mode and Effects Analysis Process Fmea
Potential Failure Mode and Effects Analysis Process Fmea
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
Purchasing
Purchasing Too high priced of purchased Loss for the company/
materials in relation to design uncompetetive product in
assumptions terms of price
BA1-QAW-11-01A
潛在
制程失效模式與效應分析 (PFMEA)
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)
Provide Orientation to
Wrong setting of temperature, no Have visual reference of standard Material Loader about the
knowledge of the Loader base on drying temperature of resin, required drying time each
the standard dyring temperature of 3 2 30
have daily checklist on the material and give him a copy
resin Hopper of Resin Drying Temperature
and Time Guidelines
Plastics material too low,
insufficient injection capacity, the Should provide proper
bush doesn't match with the Raise barrel temperature, lighting illuminations
nozzle resulting in material too low, injection speed, injection time (Minimum of 300 Lux).
injection time too short, injection and injection pressure must be Conduct 100% Visual
speed too low, mold temperature 3 increase, raise the back pressure Checking of the machine 2 30
uneven, poor mold venting, gate or slightly, adjust mold cooling operator . And hourly
runner too small, insufficient back piping and add vents at suitable inspection of In-process QC,
pressure, plastics melt feeding position. based on AQL Level.
uneven, not enough lubricant in
plastic material
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
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
3. Recognition on
employees with best
performance
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.