Pfmea 08-11-2022
Pfmea 08-11-2022
Pfmea 08-11-2022
Classification
Step
Occurrence
Occurrence
Severity
Detection
Detection
Severity
RPN
Potential Effect(s) of Potential Cause(s) of Recommended Responsibility &
Requirement Potential Failure Mode
RPN
Failure Failure Controls Action Target Completion Actions Taken
Controls Prevention
Detection Date Completion
Function Date
OP: 20
Store Material
100% visual inspection of
Operator did not store
Unable to produce Train operator per warehouse material location -
Materials stored in material in correct location
Materials stored in incorrect parts Receiving Instructions Train operator per receiving
warehouse in correct 3 of warehouse causing 2 8 48 None
location of the warehouse Unable to ship parts W-QA-108 instructions
Store materials in location incorrect inventory count -
Possible line shut down Form: F-QA-117 W-QA-108
warehouse unable to produce parts
Form: F-QA-117 Receiving Log
Classification
Step
Occurrence
Occurrence
Severity
Detection
Detection
Severity
RPN
Potential Effect(s) of Potential Cause(s) of Recommended Responsibility &
Requirement Potential Failure Mode
RPN
Failure Failure Controls Action Target Completion Actions Taken
Short Controls Prevention
Detection Date Completion
Function Date
Classification
Step
Occurrence
Occurrence
Severity
Detection
Detection
Severity
RPN
Potential Effect(s) of Potential Cause(s) of Recommended Responsibility &
Requirement Potential Failure Mode
RPN
Failure Failure Controls Action Target Completion Actions Taken
Controls Prevention
Detection Date Completion
Function Date
Operator Instruction
O-MFG-MO-302
Shortage of parts to Packaging instruction Training on Operator In-process Inspection per
LH & RH parts mixed 3 3 5 45 None
produce finshed part were not followed Instruction F-QA-158
In-process Inspection Audit
Record
& Target Completion
In-process Inspection per
Incorrect Inventory F-QA-158
OP:50 Container was labeled count. Incorrect Labels delievered In-process Inspection Audit
6 2 8 98 None
WIP Storage incorrectly Unable to complete to press Operator Training Record
secondary process. Operator Instructions
O-MFG-MO-302
Operator Instructions
Incorrect Inventory O-MFG-MO-302
Operator Instructions
count. Packaging instructions In-process Inspection per
LH & RH parts mixed 3 O-MFG-MO-302 3 5 45 None
Unable to complete were not followed F-QA-158
WIP Packaging
secondary process. In-process Inspection Audit
Record
OP: 60
Molding
Move material to Contamination and/or Hilo Training Certificate - Train
Container Damaged by
machine Damage to container loss of material / WIP 3 Hilo Training 3 operator correct procedure for 8 72 None
Hilo during movement
Product material movement
Correct Material
Move WIP Hilo Training Certificate - Train
TPV 9273A Black Contamination and/or Container Damaged by
product to Damage to containers 4 Hilo Training 3 operator correct procedure for 8 72 None
WIP Product loss of WIP Product Hilo during movement
machine material movement
Placed at machine
Items and foreign material First Piece Approval & Job Train operator per
First Piece Approval & Job Set-
not being used for current Non-conforming parts - Set-Up / Shut Down b Set-Up / Shut Down
2 2 Up / Shut Down Check List: 8 32 None
job were not removed from unable to produce parts Check List Check List
F-MFG-218
work station F-MFG-218 not used F-MFG-218
Classification
StepMolding
Occurrence
Occurrence
Severity
Detection
Detection
Severity
RPN
Potential Effect(s) of Potential Cause(s) of Recommended Responsibility &
Requirement Potential Failure Mode
RPN
Failure Failure Controls Action Target Completion Actions Taken
Controls Prevention
Detection Date Completion
Function Date
Classification
Step
Occurrence
Occurrence
Severity
Detection
Detection
Severity
RPN
Potential Effect(s) of Potential Cause(s) of Recommended Responsibility &
Requirement Potential Failure Mode
RPN
Failure Failure Controls Action Target Completion Actions Taken
Controls Prevention
Detection Date Completion
Function Date
No annual validation
Parts are to be sent to an Annual Part Validation Annual Part Validation Schedule
Annual Part Parts did not get sent out Non-conforming part schedule was generated
approved supplier for 4 Schedule to ensure 2 setup in Google Calendar to alert 8 64 None
Validation for annual CMM validation Unable to assemble causing no annual
Annual CMM validation part is sent annually for annual part validation date
validation of part
Finished Packaging
In-process and Final Inspection
Incorrect Inventory per F-QA-157
Container was labeled count. Incorrect Labels delievered Final Inspection Audit Record.
6 Operator Training 2 8 98 None
incorrectly Unable to make to press Operator Instructions
shipment to customer O-MFG-MO-302
Dock Audit O-QA-100
OP: 80 100% Visual Inspection to Shortage of parts to Final Inspection was not Safe Launch Inspection Safe Launch Plan for Standard
Defective Parts 6 2 8 98 None
Safe Launch Safe Launch Plan ship to the customer done correctly Instructions Profil
OP: 90
Finished Goods In-process and Final Inspection
Storage Incorrect Inventory per F-QA-157
Container was labeled count. Incorrect Labels delievered Final Inspection Audit Record.
6 Operator Training 2 8 98 None
incorrectly Unable to make to press Operator Instructions
shipment to customer O-MFG-MO-302
Dock Audit O-QA-100
OP: 100
Shipping
Customer releases were Plant Mgr., and/or
Non-shipment of parts 100% visual check of releases
Ship parts per customer Shipment not sent to not verified and caused Quality to review/verify
Possible line shut down 6 2 per Standard Profil/Rivian 8 96 None
releases customer non-shipment of parts and customer releases
Short Shipment requirements
possible line shut down daily.
Ship parts to
Customer
100% visual check of releases
Operator sent incorrect Operator training:
Ship parts per customer Incorrect part sent to Possible line shut down per Standard Profil/Rivian
6 parts - Releases 2 8 96 None
releases customer Short Shipment requirements
Possible line shut down - Shipping