Moudling Operation

GSIC Process

Moulding
Raw Material (PP58 - Polypropylene)

Load Hopper (Storage for raw material)

Injection Equipment (To melt and plastizing the raw material)

Mold Injection ( Injection of hot liquid raw material in to cavity)

Cooling (To reduce the temperature of mold)

Movement of mold (It opens & turns 180 degree )

Gel Injection ( Injection of Gel in to plastic molded part)

Cooling (To reduce the temperature)

Material Ejection ( Robot takes our product)

Activate Hinge ( Robot open & close the molded parts)

Cooling ( To reduce the temperature)

Inspection ( Visual inspection by operator)

Assembly of Wedge ( Assembling the wedge in to plastic part)

Packaging ( Kitting inbox + Oil + Instruction)

 FMEA Process - Template
Document No: CS-PL-2011-03
Template Revision Date: 14 Aug 2017

FAILURE MODE AND EFFECTS ANALYSIS - PROCESS (PFMEA)

FMEA Title GSIC Process Responsibility FMEA Number

Model, Program or Device Initial Due (Key) Date Prepared By

Project
Name GSIC Project Number Original FMEA Date Revision

Team Bala, Alexander, Frank, Christi, Steven

Team
Leader Mr.Alexander Ampe, Mr.Frank Cuypers Project RPN threshold

Target Completion
Detection Controls Action Results (Anticipated/ Actual)

Responsibility
Occurrence
Potential

Detection
Criticality
Severity
Potential Potential

Occurrence
Process Causes/ Prevention

Detection
RPN

Date

Effective

Severity
Function and Requirements Failure Effects of Recommended Actions Actions

Date

RPN
Step Mechanisms Controls Controls
Mode Failure
of Failure Taken

Raw Raw material: (Good level of Moisture content too high Poor quality product Fail to meet drying time and
Material moisture content as per temperature Drying Units- Not Visual Inspection on end
Requirred for GSIC part/process
requirement)

Wrong material selection Not suitable for moulding Mistake by supplier Visual Inspection on end
operation No prevention Control part/process
Wrong material selection Not suitable for moulding wrong material choosen by Visual Inspection on end part/
operation operator Manual Startup check process

Raw material : (Resin should Resin contaminated Poor Quality Product Fail to protect the resin (not
not contaminated) closed ) from natural Visual Inspection on end
Cover on each barrell part/process
environment, workplace..etc
Resin contaminated Poor Quality Product Bad delivery from supplier No Prevention control by Visual Inspection on end
commscope part/process

Load Load hopper: (Stores the Load hopper incapable to store No Operation Defects may present in Load
Hopper raw material) the raw material hopper No Prevention Machine Alarm

Load hopper able to store only Operation stops in the Defects may present in Load
partial raw material middle hopper No prevention Machine Alarm

Load Hopper: (Feeds the Load hopper inadequate to feed Operation failure Defects or other particles may Visual Inspection on end
raw material to screw) the raw material to screw present in end position Magnetic metal parts part/process

Load hopper partially feeds the Not able to finish the Defects or other particles may
raw material to the screw complete planned operation present in end position Visual Inspection on end
Magnetic metal parts part/process

Load hopper should be clean Load hopper is not clean Mixture of material Operator mistake during
and empty for the next completely changeover Standard work Visual Inspection on end
instructions part/process
operation
Load hopper is not clean Moisture is too high in Operator mistake during Standard work Visual Inspection on end
completely rawmaterial changeover instructions part/process

Injection Screw: (To melt and Screw is incompetent to melt Not able to perform Mechanical or temperature
Equipme plastizing the raw material) and plastizing the raw material moulding operation failure Yearly Maintenance Machine sensors
nt
(Screw)
Screw is partially melts and Poor quality product Not optimal parameters
plastizing the raw material (temperature, Standard Settings Machine sensors

Page 3 of 13
 Target Completion
Detection Controls Action Results (Anticipated/ Actual)

Responsibility
Occurrence
Potential

Detection
Criticality
Severity
Potential Potential

Occurrence
Process Causes/ Prevention

Detection
RPN

Date

Effective

Severity
Function and Requirements Failure Effects of Recommended Actions Actions

Date

RPN
Step Mechanisms Controls Controls
Mode Failure Taken
of Failure

Mold Mold injection: (Injection of No injection of raw material in to No operation Jam may happens in entering
Injection liquid raw material in to mold point of mold Mould Maintenance Machine sensors
cavity(mold) )

Too much injection of raw Flash on the product Settings (volume,closing

material in to mold force) problem Standard Settings Visual Inspection

Too low injection of raw material Bad product Settings (volume, speed,
in to mold buffer) problem Standard settings Visual Inspection

Right shape of the mold and Wrong shape and not clean Product failure Contaminated and mold
clean product damaged Mould Maintenance Visual Inspection

Cooling Cooling : (To reduce the No cooling/ little cooling Mold can be damaged Cooling channels are
temperature of molded parts) obstructed Mould Maintenance Visual Inspection

Deformation of product Cooling channels are

obstructed Mould Maintenance Visual Inspection

No cooling/ little cooling Deformation of product Wrong connection Standard work Visual Inspection
instructions

Moveme Movement of mold: (It Mold does not open Process stops Defects may present in mold/
nt of opens& back side of mold mechanical failure (friction) Mould Maintenance Machine sensor
mold turns 180 degree)
Mold does not open Process stops Error in programming/
No Prevention control Machine sensor
software failure

Mold does not open completely Process stops Defects may present in mold/
mechanical failure (friction) Mould Maintenance Machine sensor

Mold doesnot turn 180 degree Gel filling is not possible Defects or programming error
No Prevention Control Machine sensor
on back side in mold

Mold turns more than 180 Wrong gel filling happen Obstruction in mechanis of Moulding machine Machine sensor
degrees machine Maintenance

Loading Correct Pre-swell Wrong Pre - swell type loading Non functional product Operator mistake
of Gel in Startup check Visual Inspection/processing issue
machine
Bad Identification on barrell Prevention PS1 Visual Inspection/processing issue

Correct Loading Incorrect loading Air inclusion in gel Operator mistake Standard work instructions Visual Inspection

Non Contaminated Pre-swell Contaminated Pre-swell Air inclusion in gel PS1 line or supplier mistake
Prevention PS1 Visual Inspection

Gel Gel Injection:(Injection of gel No injection of gel into plastic Gel moulding operation Defects may present in gel Mould and Mould machine Machine sensor
Injection in to molded parts) parts failure injection equipment maintenance

Too much gel injection in molded Flash on product Not optimal parameters Visual Inspection and Machine
Standard settings
parts choosen sensor
Too much gel injection in molded Flash on product Wrong Programm selected Visual Inspection and machine
parts No Prevention control sensor

Too less gel injection in molded Not completely filled/ sink Not optimal parameters
parts holes choosen Standard settings Visual Inspection

Page 4 of 13
 Target Completion
Detection Controls Action Results (Anticipated/ Actual)

Responsibility
Occurrence
Potential

Detection
Criticality
Severity
Potential Potential

Occurrence
Process Causes/ Prevention

Detection
RPN

Date

Effective

Severity
Function and Requirements Failure Effects of Recommended Actions Actions

Date

RPN
Step Mechanisms Controls Controls
Mode Failure Taken
of Failure

Too less gel injection in molded Not completely filled/ sink Wrong Programm selection Visual Inspection and Machine
parts holes No Prevention control sensor

Cooling Cooling : (To reduce the No cooling/ little cooling Mold can be damaged Cooling channels are
temperature of Gel) obstructed Mould Maintenance Visual Inspection

Deformation of product Cooling channels are

obstructed Mould Maintenance Visual Inspection

No cooling/ little cooling Deformation of product Wrong connection Standard work instructions Visual Inspection

Material Robot handling ( Robot Robot not taking out the product Process Stop Mechanical error
Ejection takes out the product) Robot Maintenance Machine Sensor

Robot taking the product and Process Stop Mechanical error

Robot Maintenance Machine Sensor
stops in the middle of operation

Robot damaging the product Product get damaged Mould issue, cooling problem,
No Prevention Machine sensor
Gripping of robot

Ejection pins ( correct Wrong movement of pins Product damaged Damaged pins
movement of all pins) Mould Maintenance Machine sensor

Limited friction between Too much friction Product damaged Process related problem and Mould maintenance and Machine sensor and visual
mould and parts mould related problem standard settings inspection

Not Enough friction Product may falls down Process related and mould Mould maintenance and Lost of product
related problem standard settings

Activate Activate Hinge:(Robot open No Activation of hinge Product hinge may not be Error in robot programming
Hinge and close the molded part flexible and robust No Prevention Initial Process release
once)
No Activation of hinge Product hinge may not be Defects may present in robot
flexible and robust Startup check Visual Inspection

No Activation of hinge Product hinge may not be Hinge tool not mounted
Startup check Visual Inspection
flexible and robust

Partial activation of hinge Product hinge may not Error in robot programming
completely flexible and No Prevention Initial Process release
robust

Cooling Cooling Process:Conveyor No cooling/ little cooling Gel melts each other Not enough time for cooling Work instructions and No detection control
process belt settings

Inspection Inspection:(Visual inspection Operator fails/partially to do Defected product may Rules and regulations not Quality Inspectors cross Sampling check by quality and
by operator) visual inspection received by customer followed by operator check supervisor

Operator fails/partially to do Defected product may Not enough inspection Sampling check by quality and
visual inspection received by customer equipment available Visual standards supervisor

Operator fails/partially to do Defected product may Not enough inspection

visual inspection received by customer training received by operator No Prevention control Sampling check by quality and
supervisor

Operator fails/partially to do Defected product may Attention of operator Sampling check by quality and
visual inspection received by customer No Prevention control supervisor

Assembly of Assembly of wedge: Not fixing the wedge in to plastic Not able to close the Operator mistake (forgotten
wedge (Assembling the wedge in to molded parts product the wedge)
plastic molded parts) Work instructions Visual Inspection

Page 5 of 13
 Target Completion
Detection Controls Action Results (Anticipated/ Actual)

Responsibility
Occurrence
Potential

Detection
Criticality
Severity
Potential Potential

Occurrence
Process Causes/ Prevention

Detection
RPN

Date

Effective

Severity
Function and Requirements Failure Effects of Recommended Actions Actions

Date

RPN
Step Mechanisms Controls Controls
Mode Failure Taken
of Failure

Partial fixing of wedge in the Not able to close the Wrong wedge product
plastic part product completely Startup check. Visual Inspection

Burr may present Supplier prevention Visual Inspection

Retention clip deformed Operation not completed Attention of operator Visual Inspection

Packaging Packaging:(Kitting inbox+Oil Not packing according to Customer received 100 % Operator not checking the Sampling check by quality and
+Instruction) requirement not ok pieces requirements (start up check) Startup check supervisor
Not packing according to Customer received 100 % Spec is incorrect
CMX process No detection control
requirement not ok pieces
Not packing according to Customer received 1 on x is Partiall attention/work method Sampling check by quality and
requirement not ok pieces No Prevention control supervisor

Revison History
Revision Date Description
10-Aug-17 Detection Ranking table changed.

Page 6 of 13
 FMEA Process - Template
Document No: CS-PL-2011-03
Template Revision Date: 14 Aug 2017

FAILURE MODE AND EFFECTS ANALYSIS - PROCESS (PFMEA)

FMEA
Title Process Responsibility FMEA Number

Model, Program or Device Initial Due (Key) Date Prepared By

Project
Name Project Number Original FMEA Date Revision

Team

Team
Leader

Target Completion
Detection Controls Action Results (Anticipated/ Actual)

Responsibility
Occurrence
Potential

Detection
Criticality
Severity
Potential Potential
Process Functions and Causes/ Prevention

RPN

Date
Failure Effects of Recommended Actions

Occurrence
Step Requirements Mechanisms Controls

Detection
Severity
Mode Failure
of Failure Actions Effective

RPN
Control
Taken Date

The Process step terminology shall be consistent The severity of the effect is concerned only with the effect and not Detection controls are the methods utilized to detect the Target completion date is the Estimated completion date of the
with the Process Flow Diagram. (i.e. QIP, Control the failure mode. For example, an effect will have the same failure cause (C) in time to take corrective action or the failure Recommended Actions.
Plan, Operator instructions etc). 'Rework or repair severity rating regardless of the associated failure modes. mode (M) before the failure effect results. Determine which of
instructions are included in process steps. For these categories the specified control will primarily address and
existing items with completed FMEAs, list the item use the C/M column to indicate it. Detection controls must be Action results (Anticipated/ Actual) are initially completed when the actions
and the FMEA number. considered when evaluating the detection rating. In a process, are recommended.
examples of detection controls are inspections, workmanship
Functions and Requirements are tasks which a standards, etc. control. If no action was required. Leave the row blank.
The potential cause(s)/mechanisms of failure is defined as
process step is expected to perform. It should be how the failure could occur and is described in terms of
well defined using active verbs such as insert, mount, If action is required, occurrence, detection, and RPN are reviewed and
something that can be corrected or can be controlled. Document Detection Detection rating is assessed as the ability to
form, bend, etc. that will allow better identification of recalculated once the corrective actions have been completed to determine if
as many causes for each failure mode as possible. The cause determine if the potential failure cause will lead to the listed
potential failure modes. A function is described in - the recommended action met expectations or if occurrence &/ or detectiion
should be detailed concisely and completely. The causes can be failure mode, or detect the occurrence of the listed failure
descriptive terms. ratings must be changed.
separated and should result in a focused analysis for each and mode. It is the effectiveness of a control to identify an issue in
- further action is required or
may yeild defferent measurement, controls, and action plans. a timely manner. Note: Detection controls reduce the
- if the actions taken have reduced the risk to an acceptable level.
The potential failure mode is the way the process detection rating. Preventative controls reduce the occurrence
step may fail to perform the specified function or fail to rating. If none of the current controls are detection controls (ie
meet the requirements or design intent. The they are all preventative), then detection must be given a
Preventive controls are activities that support design choices Action(s) taken is the summary of the actual actions taken.
assumption must be made that the incoming which prevent or reduce the occurrence of failure causes that lead rating of 10)
part(s)/material(s) are correct. Exceptions can be to active failure modes. Items in this column are controlled by the
made if historical data indicates deficiencies in the Effective date is the date that all reported Action(s) Taken
Process Engineer and are completed or already planned and will RPN (Risk Priority Number) is a qualitative method for were completed.
incoming material quality. The failure could occur but happen as a result of procedure or process. Preventive controls assessing and rating risk using the calculation RPN = Severity
may not necessarily occur. Each requirement may reduce the occurrence rating. (i.e orienting fixtures, alignment * Occurrence * Detection. Once all of the RPN's have been The severity rating does not change because it is associated
have multiple failure modes but a large number of tools, etc.) calculated, they can be assessed to determine if any with the consequences of the effect. The previously assigned
failure modes for a single requirement usually
recommended action should be identified. severity rating is populated in this field.
indicates that the requirement is not clearly defined.
The occurrence is the probability of a failure cause occurring. The RPN number has no inherent meaning. For example, an
Do not rate the probability of the failure mode existing, but rather RPN of 300 does not indicate twice as much risk as an RPN of Occurrence, detection, and RPN (2 Actions to complete:)
The potential effects of failure is what the customer the probability the cause exists and will lead to the mode becoming 150. RPN is used as a tool to rank the failure chains in order of 1. Occurrence, detection, and RPN in the Action Results section are
might notice or experience. The customer could be active. priority for action. populated at the time the actions are recommended.
an internal customer (subsequent operation or
location) as well as the end user. For the end user, Recommended actions are taken to reduce the occurrence
or detection ratings, or eliminate the effect by eliminating the 2. Occurrence, detection, and RPN are reviewed and recalculated once the
effects should be stated in terms of performance. If corrective actions have been completed to determine if
Criticality is calculated by multiplying Severity and possibility of the failure mode.
the customer is a subsequent operation, the effects - the recommended action met expectations or if occurrence &/ or
Occurrence values. Criticality ratings help identify failure
should be stated in terms of process/operation detectiion ratings must be changed.
modes items that are critical and should be eliminated or
performance. If the failure mode could impact safety Responsibility is the name of the action item - further action is required or
significantly reduced.
or cause a noncompliance to regulations, it must be Pageassignee.
7 of 13 - if the actions taken have reduced the risk to an acceptable level.
clearly identified in the effects column.
 Target Completion
Detection Controls Occurrence, detection, and RPN Action
(2 Actions to complete:)
Results (Anticipated/ Actual)

Responsibility
The potential effects of failure is what the customer

Occurrence
Potential 1. Occurrence, detection, and RPN in the Action Results section are

Detection
Criticality
might notice or experience. The customer could be

Severity
Potential Potential populated at the time the actions are recommended.
Process Functions and Causes/ Prevention

RPN

Date
an internal customer (subsequent operation orFailure Effects of Recommended Actions

Occurrence
Step as wellRequirements Mechanisms Controls

Detection
location) as the end user. For the end user,

Severity
Mode Failure 2. Occurrence, detection, and RPNActions
are reviewed and recalculated once the
of Failure Effective

RPN
effects should be stated in terms of performance. If Control corrective actions have been completed to determine if
Criticality is calculated by multiplying Severity and Taken Date
the customer is a subsequent operation, the effects - the recommended action met expectations or if occurrence &/ or
Occurrence values. Criticality ratings help identify failure
should be stated in terms of process/operation detectiion ratings must be changed.
modes items that are critical and should be eliminated or
performance. If the failure mode could impact safety Responsibility is the name of the action item - further action is required or
significantly reduced.
or cause a noncompliance to regulations, it must be assignee. - if the actions taken have reduced the risk to an acceptable level.
clearly identified in the effects column.

Page 8 of 13
 FMEA Process - Template
Document No: CS-PL-2011-03
Template Revision Date: 14 Aug 2017
Suggested Process FMEA Severity Evaluation Criteria
From CS-PL-2011
 FMEA Process - Template
Document No: CS-PL-2011-03
Template Revision Date: 14 Aug 2017
Suggested FMEA Occurrence Evaluation Criteria
From CS-PL-2011
 FMEA Process - Template
Document No: CS-PL-2011-03
Template Revision Date: 14 Aug 2017
Suggested PFMEA Detection Containment Criteria
From CS-PL-2011
 FMEA Process - Template
Document No: CS-PL-2011-03
Template Revision Date: 14 Aug 2017
Dynamics of the RPN
From CS-PL-2011

Sev Occ Det RPN Result Actions

1 1 1 1 Ideal Situation No Action
1 1 10 10 Assured Mastery No Action
10 1 1 10 Failure does not reach user No Action
10 1 10 100 Failure reaches user Improve Detection
1 10 1 10 Freq fails, detectable, costly Improve design/process
1 10 10 100 Freq fails, reaches user Work detection then design/process
10 10 1 100 Freq fails with major impact Improve design/process
10 10 10 1000 Big Trouble Improve detection and design/process
 FMEA Process - Template
Owner: Steve Beran Document No: CS-PL-2011-03
Approver: Stan Catey Template Revision Date: 14 Aug 2017
Approver: Hans-Peter Sandeck
Approver: Bill Ricci
Approver: Iain McMillan

Released Date DCR# Revisions

29 Nov 2016 111416-1 NEW Global Corporate Document
Not yet released to QMS, training only at 071817-1 No details provided by author
time of next revision (DCR 081417-1)

14 Aug 2017 081417-1 Tables updated to match CS-PL-2011