Check Sheet Model SCC

Teleflex PSO / PPAP Process
Part Name Part Number Engineering Change Level Engineering Change Level Date Supplier Contact Supplier Name Supplier Code Street Address City State Zip Phone Number Customer Name Division Application File Name
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PRODUCT/PROCESS QUALITY CHECKLIST

Customer or Internal Part No.
Question
1 Is the assistance of the customer's quality assurance or product engineering activity needed to develop or concur to the control plan? 2 Has the supplier identified who will be the quality liaison with the customer? 3 Has the supplier identified who will be the quality liaison with its suppliers? 4 Has the quality assurance system been reviewed using the Teleflex Automotive Group Quality System Assessment? Are there sufficient personnel identified to cover: 5 / 6 / 7 /
l Problem resolution analysis? / Is there a documented training program that: 9 l Includes all employees? / 10 l Lists whose been trained? / 11 l Provides a training schedule? / Has training been completed for: l l l
Yes No
Comment / Action Required
Person Responsible
Due Date
Control plan requirements? Layout inspection? Engineering performance testing?
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Question
12 / 13 / 14 / 15 / 16 17 18 19
l Other topics as identified? / Is each operation provided with process instructions that are keyed to the control plan? Are standard operator instructions available at each operation? Were operator/team leaders involved in developing standard operator instructions? Do inspection instructions include: l Easily understood engineering performance specifications? l Test frequencies? / l Sample sizes? / l Reaction plans? / l Documentation? / Are visual aids: l l l l
Yes No
Person Responsible
Due Date
Statistical process control? Capability studies? Problem solving? Mistake proofing?
20 21 22 23 24
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Question
25 / 26 / 27 / 28 / 29 30
l l l l
Yes No
Person Responsible
Due Date
Easily understood? Available? Accessible? Approved?
31 32
33
34 35 36 37
l Dated and current? / Is there a procedure to implement, maintain, and establish reaction plans for statistical control charts? Is there an effective root cause analysis system in place? Have provisions been made to place the latest drawings and specifications at the point of the inspection? Are forms/logs available for appropriate personnel to record inspection results? Have provisions been made to place the following at the monitored operation: l Inspection gages? / l Gage instructions? / l Reference samples? / l Inspection logs? /
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Question
Yes No
Person Responsible
Due Date
38 Have provisions been made to certify and routinely calibrate gages and test equipment? Have required measurement system capability studies been: 39 l Completed? / 40 l Acceptable? / 41 Are layout inspection equipment and facilities adequate to provide initial and ongoing layout of all details and components? Is there a procedure for controlling incoming product that identifies: 42 l Characteristics to be inspected? / 43 l Frequency of inspection? / 44 l Sample size? / 45 / 46 47
l Disposition of nonconforming products? / Is there a procedure to identify, segregate, and control nonconforming products to prevent shipment? Are rework/repair procedures available? Is there a procedure to requalify repaired/reworked material? Is there an appropriate lot traceability procedure? l
Designated location for approved product?
48 49 50
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Question
51 Are periodic audits of outgoing products planned and implemented? 52 Are periodic surveys of the quality system planned and implemented? 53 Has the customer approved the packaging specification?
Yes No
Person Responsible
Due Date
Revision Date
Prepared By:
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FLOOR PLAN CHECKLIST

Question
1 Does the floor plan identify all required process and inspection points? 2 Have clearly marked areas for all material, tools, and equipment at each operation been considered? 3 Has sufficient space been allocated for all equipment? Are process and inspection areas: l Of adequate size? 4 / l Properly lighted? 5 / 6 Do inspection areas contain necessary equipment and files? Are there adequate: l Staging areas? 7 / l Impound areas? 8 / 9 Are inspection points logically located to prevent shipment of nonconforming products? 10 Have controls been established to eliminate the potential for an operation, including outside processing, to contaminate or mix similar products? 11 Is material protected from overhead or air handling systems contamination? 12 Have final audit facilities been provided? 13 Are controls adequate to prevent movement of nonconforming incoming material to storage or point of use?
Yes No
Person Responsible
Due Date
Revision Date
Prepared By:
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PROCESS FLOW CHART CHECKLIST

Question
1 Does the flow chart illustrate the sequence of production and inspection stations? 2 Were all appropriate FMEA's (SFMEA, DFMEA) available and used as aids to develop the process flow chart? 3 Is the flow chart keyed to product and process checks in the control plan? 4 Does the flow chart describe how the product will move, i.e., roller conveyor, slide containers, etc.? 5 Has the pull system/optimization been considered for this process? 6 Have provisions been made to identify and inspect reworked product before being used? 7 Have potential quality problems due to handling and outside processing been identified and corrected?
Yes No
Person Responsible
Due Date
Revision Date
Prepared By:
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PROCESS FMEA CHECKLIST

Question
1 Was the Process FMEA prepared using the AIAG / PPAP guidelines? 2 Have all operations affecting fit, function, durability, governmental regulations and safety been identified and listed sequentially? 3 Were similar part FMEA's considered? 4 Have historical campaign and warranty data been reviewed? 5 Have appropriate corrective actions been planned or taken for high risk priority items? 6 Have appropriate corrective actions been planned or taken for high severity numbers? 7 Were risk priorities numbers revised when corrective action was completed? 8 Were high severity numbers revised when a design change was completed? 9 Do the effects consider the customer in terms of the subsequent operation, assembly, and product? 10 Was warranty information used as an aid in developing the Process FMEA? 11 Were customer plant problems used as an aid in developing the Process FMEA? 12 Have the causes been described in terms of something that can be fixed or controlled? 13 Where detection is the major factor, have provisions been made to control the cause prior to the next operation?
Yes No
Person Responsible
Due Date
Revision Date
Prepared By:
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CONTROL PLAN CHECKLIST

Question
1 Was the control plan methodology referenced in Section 6 used in preparing the control plan? 2 Have all known customer complaints been identified to facilitate the selection of special product/process characteristics? 3 Are all special product/process characteristics included in the control plan? 4 Were SFMEA, DFMEA, and PFMEA used to prepare the control plan? 5 Are material specifications requiring inspection identified? 6 Does the control pan address incoming (material/components) through processing/assembly including packaging? 7 Are engineering performance testing requirements identified? 8 Are gages and test equipment available as required by the control plan? 9 If required, has the customer approved the control plan? 10 Are gage methods compatible between supplier and customer?
Yes No
Person Responsible
Due Date
Revision Date
Prepared By:
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REVIEW DATE SUPPLIER PART NUMBER PART NAME
0 0 0
MODEL YEAR VEHICLE LINE SUPPLIER CODE
Initial Risk Evaluation Checklist

Item No. DESIGN CATEGORY 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 - New Commodity For Selected Supplier? (RISK DRIVER*) - New Materials or Technology? (RISK DRIVER*) -New/Different Application of a Carry-Over Part? (RISK DRIVER*) - New Design Concept? - Are there Safety/Emissions/Noise Requirements? - Offshore Engineering Site? - Will Design Need To Be Coordinated With Mating Parts For Fit, Function, or Appearance? - Are There Other Car Line Applications Planned? - Any Historic Quality/Warranty Issues? -Is Program Timing An Issue? - Are Sample Submission Dates Too Late for MTS's? MANUFACTURING CATEGORY - New Manufacturing Facility? (RISK DRIVER*) - Is there a New Manufacturing Process? (RISK DRIVER*) - A Part or System With Historical Launch Problems? (RISK DRIVER*) - Offshore Manufacturing Site? - Will Supplier Need Source Evaluation? - Is New production Equipment Required? - Are Special Tools or Tooling Fixtures Required? - Are Gages or Check Fixtures Required to Ensure Dimensional Integrity? - Any Potential Handling or Shipping Issues? - Will Parts Ever Be Shipped From a Location Other Than The Primary Source (i.e. Warehouse, Offshore, etc.) 22 23 24 25 26 27 28 29 - Will Returnable Packaging Be Required? - Is JIT Delivery or Sequenced Part Delivery Required? ASSEMBLY CATEGORY - Is Part installation an Issue? - Are Special Tools/Fixtures Required to Install Part in Vehicle? SERVICE CATEGORY - Is part Serviceability a Problem? - Are Special Tools/Fixtures Required? OTHER CATEGORY - Other? - Other? Questions Levels of Concern Low Med. High Comments
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REVIEW DATE SUPPLIER PART NUMBER PART NAME
0 0 0
MODEL YEAR VEHICLE LINE SUPPLIER CODE
NOTE: * INDICATES RISK DRIVER - PROCESS SPECIALIST ASSISTANCE MAY BE REQUIRED
Initial Risk Evaluation Summary

INITIAL RISK EVALUATION RATING (Select One Below) (Refer to Initial Risk Evaluation Checklist) LOW LEVEL OF CONCERN INITIAL RISK EVALUATION TEAM INDICATES A LOW LEVEL OF CONCERN REGARDING THE SUCCESS OF SUPPLYING THIS PRODUCT.
MEDIUM LEVEL OF CONCERN
INITIAL RISK EVALUATION TEAM INDICATES THAT THERE IS A MEDIUM LEVEL OF CONCERN REGARDING ONE OR MORE CATEGORIES ASSURING THE SUCCESS OF SUPPLYING THIS PRODUCT. INITIAL RISK EVALUATION TEAM INDICATES THAT THERE IS A HIGH LEVEL OF CONCERN REGARDING ONE OR MORE CATEGORIES, (OR ONE OR MORE RISK DRIVERS) ASSURING THE SUCCESS OF SUPPLYING THIS PRODUCT
HIGH LEVEL OF CONCERN
LIST HIGH CONCERN ITEMS
LIST MEDIUM CONCERN ITEMS
SIGNATURE TEAM MEMBERS ENGINEERING SUPPLIER QUALITY SUPPLIER MANAGEMENT ADVANCED MFG. SUPPLIER SERVICE
DATE
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PRODUCT QUALITY PLANNING SUMMARY AND SIGN-OFF

DATE: PRODUCT NAME: CUSTOMER:
0 0
PART NUMBER: MANUFACTURING PLANT:
0 0
1. PRELIMINARY PROCESS CAPABILITY STUDY REQUIRED Ppk - SPECIAL CHARACTERISTICS 2. CONTROL PLAN APPROVAL (If Required) 3. INITIAL PRODUCTION SAMPLES CHARACTERISTIC CATEGORY SAMPLES DIMENSIONAL VISUAL LABORATORY PERFORMANCE 4. GAGE AND TEST EQUIPMENT MEASUREMENT SYSTEM ANALYSIS REQUIRED SPECIAL CHARACTERISTIC 5. PROCESS MONITORING APPROVED: YES / NO*
QUANTITY ACCEPTABLE PENDING*
DATE APPROVED
QUANTITY CHARACTERISTICS PER SAMPLE ACCEPTABLE PENDING*
QUANTITY ACCEPTABLE PENDING*
QUANTITY PROCESS MONITORING INSTRUCTIONS PROCESS SHEETS VISUAL AIDS 6. PACKAGING/SHIPPING REQUIRED PACKAGING APPROVAL SHIPPING TRIALS 7. SIGN-OFF QUANTITY ACCEPTABLE PENDING* REQUIRED ACCEPTABLE PENDING*
TEAM MEMBER/TITLE/DATE
* REQUIRES PREPARATION OF AN ACTION PLAN TO TRACK PROGRESS.
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TELEFLEX PROCESS SIGN-OFF CHECKLIST
ALL PROCESS SIGN-OFF ELEMENTS APPROVED:

SUPPLIER MFG. LOCATION PART NUMBER(S) CHANGE LEVEL(S) PROGRAM PART NAME(S) PSO PLANT VISIT DATE
YES
NO
PROCESS ELEMENTS TO BE VERIFIED DURING PLANT VISIT

DOCUMENTATION ACCEPT UNACCEPT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 PART NUMBER, DESCRIPTION AND CHANGE LEVEL PROCESS FLOW DIAGRAM AND MANUFACTURING FLOOR PLAN PROCESS FMEA CONTROL PLAN SPECIAL PRODUCT AND PROCESS CHARACTERISTICS IDENTIFIED ENGINEERING STANDARDS IDENTIFIED TEST SAMPLE SIZES AND FREQUENCIES GAGE AND TEST EQUIPMENT EVALUATION PREVENTIVE MAINTENANCE PLANS TOOLING, EQUIPMENT, AND GAGES IDENTIFIED PROCESS MONITORING AND OPERATING INSTRUCTIONS INCOMING AND OUTCOMING MATERIAL QUALIF/CERT PLAN CONTAINMENT PLAN RAMP-UP PLAN PARTS PACKAGING AND SHIPPING SPECIFICATIONS LINE SPEED DEMONSTRATION (R@R) : see "EP07 - Run at Rate - Index A" PROCESS AUDIT (made by the supplier) CO-WORKER TRAINING PROCESS ACCEPT UNACCEPT
CORRECTIVE ACTION REQUIRED ON-SITE REVISIT REQUIRED
YES YES
NO NO
DATE DATE
Note: Open issues and required corrective actions are noted on sheet 2 of this report.
Teleflex Automotive Process Sign-Off Team
Supplier Sign-Off
Engineering
Print Name And Sign
Quality Assurance Manager
Print Name And Sign
Supplier Quality
Print Name And Sign
Manufacturing Manager
Print Name And Sign
Plant Manager
Print Name And Sign
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TELEFLEX PROCESS SIGN-OFF Comments And Required Corrective Actions

ITEM # ISSUE
Corrective Action Required YES
Note: All corrective actions plans must be submitted to the Teleflex Supplier Quality Engineer within (5) business days of the signature date below.
Authorized Customer Signature
Title
Date
Supplier Signature
Title
Date
page 15/39
page 16/39
SIT
UNACCEPT
Print Name And Sign
Print Name And Sign
Print Name And Sign
page 17/39
NO
page 18/39
PROCESS / INSPECTION FLOWCHART

Product Program Supplier Name Supplier Location Legend: Operation Transportation Operation or Event Inspection Description of Operation or Event Receiving of raw material Delay Storage Evaluation and Analysis Methods 0 0 0 Issue Date Part Name Part Number 6/16/2001 0 0 ECL 0
10
10
Receiving inspection of raw material
Review / verify certs and melt flow results and file under customer / program
20
30
Transport material
30
Store material until trial day
40
Blend raw material and concentrate
50
Transport material to press
60
Mold parts
70
In-process inspection
100% visual inspection for short shots, warp, sink marks, excess splay, contamination, stress, flash, color match
80
Degate parts
Inspection
90
100% visual verification of all above Allow parts to cool before packing
100
Cool Parts
110
Wrap parts in foam and pack parts
100% visual inspection
120
Label box
100% visual inspection
130
Transport to storage / shipping
Dock audit
140
100% visual inspection for correct part/label 100% review of documentation
150
Ship parts to customer
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PROCESS / INSPECTION FLOWCHART

Product Program Supplier Name Supplier Location Legend: Operation Transportation Operation or Event Inspection Description of Operation or Event Delay Storage Evaluation and Analysis Methods 0 0 0 Issue Date Part Name Part Number 6/16/2001 0 0 ECL 0
page 20/39
CHARACTERISTIC MATRIX
Part Number Engineering Change Level Part Name
0 C = Characteristic at an operation used for clamping L = Characteristic at an operation used for locating X = Characteristic created or changed by this operation should match the process flow diagram form
DIMENSION NUMBER
OPERATION NUMBER DESCRIPTION TOLERANCE
page 21/39
Print # Item: Model Year(s)/Vehicle(s) Team:
0 0 0 0
Rev.
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA) Process Responsibility: Key Date 0 6/16/2001
FMEA Number: Prepared by: Date (Orig.) Date (Rev.)
Process Function/ Requirements
Potential Failure Mode
Potential Effect(s) of Failure
S e v
C l a s s
Potential Cause(s)/ Mechanism(s) of Failure
O c c u r
Current Process Controls
D e t e c
R. P. N.
Recommended Actions
Responsibility & Target Date
Actions Taken
Action Results S O e c v c
D e t
R. P. N.
10 Receiving of Raw Materials
Incorrect/sub -standard material
Unable to mold loss of physical properties Unable to mold loss of physical properties Poor appearance / wrong color parts after molding Poor appearance after molding operation Loss of Material Can not make parts / Shut down customer Part will not meet specifications Delay in production
Incorrect material shipped
Supplier Cert.
42
None
None
Incorrect Melt Flow Incorrect concentrate
7 7
Incorrect physical properties Incorrect material shipped Incorrect blending of material from supplier Forklift Damage / Spillage/ Contamination Material improperly tagged or stored, operator training Operator Error/Dirty mixer
2 2
Supplier Cert. / Melt flow index review Incoming inspection / Supplier certs
3 3
42 42
None None
None None
Concentrate off color 20 Transportation 30 Warehouse/Storage 40 Color Mixing 50 Transportation Handling Damage Lost material
6 6
2 3
Incoming inspection / Supplier certs Trained material handler Designated location for material
4 2
48 36
None None None
None None None
2 1) Mixing instructions from supplier 2) Operator training 3) Mixing procedure 4) Scale and mixer certification Trained material handler 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 4) PM schedule 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 4) PM schedule 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 4) PM schedule 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 4) PM schedule 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 4) PM schedule 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 4) PM schedule 1) 100% Visual inspection 2) Process verification 3) Process parameter sheets from material supplier 4) PM schedule
28 None None None
Improper Color Mix Handling Damage
6 2 Forklift Damage / Spillage/ Contamination 1) Incorrect molding parameters and set-up 2) Equipment failure
3 2
4 1
72 4 None
60 Molding Operation
Short shot
Poor fit and function 7 1) Poor fit and function 2) Poor assembly Poor Appearance 3 1) Poor appearance 2) Loss of strength 3) Shearing of material 1) Poor appearance 2) Loss of strength 1) Poor fit and function 2) Poor appearance 1) Poor fit and function 3
None 2 28
None
Warp
1) Incorrect molding parameters and set-up 2) Equipment failure 1) Incorrect molding parameters and set-up 2) Equipment failure 1) Irregular heat and/or moisture 2) color change 1) Contamination in mold
None 3 48 None 4 48 None 4 48 None 4 48 None 4 48 None 4 48
None
Sink Marks
None
Excess splay on "A" surface
None
Contamination
None
3 1) Improper demolding of part 3 1) Incorrect molding parameters 2) Tool wear 1) Improper set-up of concentrate feeder 2) Improper hand mix of concentrate
Stress
None
Flash
None
Off color
1) Poor appearance 6
None 4 72
None
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Print # Item: Model Year(s)/Vehicle(s) Team:
0 0 0 0
Rev.
POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS (PROCESS FMEA) Process Responsibility: Key Date 0 6/16/2001
FMEA Number: Prepared by: Date (Orig.) Date (Rev.)
Process Function/ Requirements
Potential Failure Mode
Potential Effect(s) of Failure
S e v
C l a s s
Potential Cause(s)/ Mechanism(s) of Failure
O c c u r
Current Process Controls
D e t e c
R. P. N.
Recommended Actions
Responsibility & Target Date
Actions Taken
Action Results S O e c v c
D e t
R. P. N.
70 In-process Inspection
Short shot, warp, sink, splay, contamination, stress, flash Off color
1) Poor part quality and appearance 2) Poor fit and function Poor appearance
1) Incorrect molding parameters and set-up 2) Equipment failure 1) Improper set-up of concentrate feeder 2) Improper hand mix of concentrate Incorrect / Dull knife
1) Visual Inspection 2) PM Schedule 4 1) Visual Inspection 2) PM Schedule 4 1) Operator instructions 2) Customer approval 3 60 3 84
None
None
None
None
5 80 Degate Part Uneven cut No short shots, warp, sink marks, splay, contamination, stress, flash, color match Warped parts 1) Poor appearance 2) Poor fit and function 1) Poor appearance 2) Poor fit and function 1) Poor appearance 2) Poor fit and function 1) Loose parts in transit to customer 2) Un-safe internal transit 1) Parts warped due to over packing 2) Bar code label wrong 1) Parts warped due to packing 1) Shipped wrong parts 2) Shortage of parts at customer
36
None
None
90 Inspection
1) Incorrect molding parameters and set-up 2) Equipment failure 1) Incorrect molding parameters 2) Inadequate cooling time
1) Visual Inspection 2) PM Schedule 3 1) Visual Inspection 2) Parts allowed to cool on table 3 63
None
None
100 Cooling
None 3 63
None
110 Packaging
Broken box
1) High-lo damage 2) Wear and tear 1) Availability of correct packaging 1) Availability of correct packaging 1) Wrong label applied to carton
1) Operator instructions 2) Visual inspection at shipping 1) Production control ordering correct box
None 4 32 None 3 24 None None 3 72 None
None
Expendable
Box too big Box too small
None None None
2 2 6
4 4 4 1) Production control ordering correct box 1) Dock audit to verify label and contents match 1) Operator instructions for Hi-Lo drivers
24
120 Labeling
Wrong Label
130 Transportation 140 Dock Audit 150 Shipping
Handling damage
Misidentified parts Label does not match part
1) Parts damaged 2) Parts lost 1) Overshipement 2) Undershipment Shipped wrong parts
1) Hi-Lo damages box 2) Parts put in wrong area
3 48 2) Trained material handler 1) Label verification 1) Dock audit to verify label and contents match
None
4 4
1) Wrong label applied to carton 1) Wrong label applied to carton 2) Shortage of parts at customer
4 4
3 48
None None
None None
3 48
page 23/39
CONTROL PLAN
Prototype Control Plan Number Pre-Launch Production Key Contact/Phone Date (Orig.) Date (Rev.)
0
Part Number/Latest Change Level Core Team
0 0
Supplier/Plant Approval/Date Supplier Code Other Approval/Date (If Req'd.) CHARACTERISTICS SPECIAL CHAR. PROCESS CLASS Material content Material content Material to be stored in warehouse until needed Store until needed Mix Ratio Loading system Raw material initial process parameters Check for visual defects first piece and start-up Check for visual defects first piece and start-up 50 to 1
6/16/2001
6/16/2001
Customer Engineering Approval/Date (If Req'd.) Customer Quality Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) METHODS PRODUCT/PROCESS SPECIFICATION/ TOLERANCE EVALUATION/ MEASUREMENT TECHNIQUE Supplier Certs and incoming inspection Supplier Certs and incoming inspection Visual inspection Visual inspection Calibrated Scale Loading system must fill at appropriate intervals 100 % visual inspection All SAMPLE SIZE FREQ. REACTION PLAN
0
Part Name/Description
0
Supplier/Plant
MACHINE, PART/ PROCESS NAME/ DEVICE, PROCESS OPERATION JIG,TOOLS, NUMBER DESCRIPTION FOR MFG. Receiving Inspection Raw Materials
NO.
PRODUCT Color Concentrate PC-GE Lexan EM3110 Raw material /concentrate Material Color + PC Raw material /concentrate
CONTROL METHOD
1 2
1 1 Each Each
Per lot Per lot All All Per lot Each run
Receiving Log Reject to Supplier Receiving Log Reject to Supplier Visual Visual Supplier Material Cert. Segregation of material Contact supplier
10
20 30 40 50
Transport Warehouse/Storag e Color Mixing operation Transport
HI-Lo
1 1 1 1
Segregate and adjust ratio Trained material P.M. Schedule handler
60
Molding Operation
Injection molding machine 75 ton
Process Set-up Sheet
Visual inspection
100%
Continuous
100% inspection
Evaluate and requality
70
In-process Inspection
Short Shot
Free of short shots
Visual inspection
100%
100% Continuous inspection
Adjust and document machine parameters
Warp
Free of warp
Visual inspection
100%
page 24/39
CONTROL PLAN
0
0 0
Supplier/Plant Approval/Date Supplier Code Other Approval/Date (If Req'd.) CHARACTERISTICS SPECIAL CHAR. PROCESS CLASS Check for visual defects first piece and start-up Check for visual defects first piece and start-up Check for visual defects first piece and start-up Check for visual defects first piece and start-up Check for visual defects first piece and start-up
6/16/2001
6/16/2001
Customer Engineering Approval/Date (If Req'd.) Customer Quality Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) METHODS PRODUCT/PROCESS SPECIFICATION/ TOLERANCE EVALUATION/ MEASUREMENT TECHNIQUE SAMPLE SIZE FREQ. REACTION PLAN
0
0
Supplier/Plant
MACHINE, PART/ PROCESS NAME/ DEVICE, PROCESS OPERATION JIG,TOOLS, NUMBER DESCRIPTION FOR MFG.
NO.
PRODUCT
CONTROL METHOD
Sink Marks
Free of sink marks
Visual inspection
100%
Continuous
100% inspection
Excess Splay
Free of excessive splay
Visual inspection
100%
100 % Continuous inspection
Contamination
Free of contamination
Visual inspection
100%
100 % Continuous inspection
6 In- process Inspection con't
Stress
Free of stress
Visual inspection
100%
Flash
Free of flash
Visual inspection
100%
page 25/39
CONTROL PLAN
0
0 0
Supplier/Plant Approval/Date Supplier Code Other Approval/Date (If Req'd.) CHARACTERISTICS SPECIAL CHAR. PROCESS CLASS
6/16/2001
6/16/2001
Customer Engineering Approval/Date (If Req'd.) Customer Quality Approval/Date (If Req'd.) Other Approval/Date (If Req'd.) METHODS PRODUCT/PROCESS SPECIFICATION/ TOLERANCE Color master EVALUATION/ MEASUREMENT TECHNIQUE Visual inspection SAMPLE SIZE FREQ. REACTION PLAN Adjust and document machine parameters 100% inspection
0
0
Supplier/Plant
MACHINE, PART/ PROCESS NAME/ DEVICE, PROCESS OPERATION JIG,TOOLS, NUMBER DESCRIPTION FOR MFG.
NO.
PRODUCT
CONTROL METHOD
Color
Verify color
100%
80
Degate
Trim Knife
Trim and degate parts Verification of all the above Cool parts Proper packing Proper labeling
Gates to be flush without gouges and white marks
Visual inspection
100%
Continuous
Operator instructions Operator instructions
90 100 110 120
Inspection Cooling Time Packaging Labeling
1 1 1 1
Visual defects, appearance, Visual inspection color match to master Allow parts to cool on table before packing Pack in box Label box inside and out/Loose label on inside of box Transport molded part to storage/shipping Visual inspection Visual Inspection Visual inspection
100% 100% 100% 100%
Continuous Continuous
100% inspection 100% inspection 100% inspection Operator instructions Storage Procedure / shipping procedure Notify production control for instructions Shipping instructions
Operator instructions Operator Continuous instructions Continuous 100% inspection Trained material handler
130
Transport
HI-Lo
Molded part
Visual inspection
100%
Each container
140
Dock Audit
Identification
Proper barcode label to contents
Visual inspection
100%
Each container
Label verification
150
Shipping
Shipping to paint source
Invoice to JCI
100%
Each container
page 26/39
Prototype Control Plan Number
Pre-Launch
Production Key Contact/Phone
CONTROL PLAN SPECIAL CHARACTERISTICS

Date (Orig.) Date (Rev.)
0
Part Number/Latest Change Level
0
Core Team
0
Customer Engineering Approval/Date (If Req'd.) Customer Quality Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)
0
0
Supplier/Plant Approval/Date Supplier Code Other Approval/Date (If Req'd.)
0
Supplier/Plant
0 No.
0 Description/Rationale
Specification/Tolerance
Class
Illustration/Pictorial
page 27/39
Production Part Approval Dimensional Results

SUPPLIER PART NUMBER
0
NAME OF INSPECTION FACILITY PART NAME
0 0
ITEM
DIMENSION/SPECIFICATION
SUPPLIER MEASUREMENT RESULTS
OK
NOT OK
SIGNATURE
TITLE
DATE
page 28/39
Production Part Approval Material Test Results

0
NAME OF LABORATORY TYPE OF TEST PART NAME
0 0
MATERIAL SPEC. NO./DATE/SPECIFICATION SUPPLIER TEST RESULTS OK NOT OK
SIGNATURE
TITLE
DATE
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Production Part Approval Performance Test Results

0
NAME OF LABORATORY REF. NO. PART NAME
0 0
REQUIREMENTS TEST QTY. FREQ. TESTED SUPPLIER TEST RESULTS AND TEST CONDITIONS OK NOT OK
SIGNATURE
TITLE
DATE
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APPEARANCE APPROVAL REPORT

PART NUMBER PART NAME SUPPLIER NAME REASON FOR SUBMISSION DRAWING APPLICATION (VEHICLES) E/C LEVEL DATE SUPPLIER
0 0 0
PART SUBMISSION WARRANT PRE TEXTURE LOCATION
NUMBER BUYER CODE MANUFACTURING SPECIAL SAMPLE FIRST PRODUCTION SHIPMENT
0 0 0 0
RE-SUBMISSION ENGINEERING CHANGE
CODE OTHER
APPEARANCE EVALUATION
CUSTOMER
SUPPLIER SOURCING AND TEXTURE INFORMATION
PRE-TEXTURE EVALUATION CORRECT AND PROCEED CORRECT AND RESUBMIT APPROVED TO TEXTURE
REPRESENTATIVE SIGNATURE AND DATE
COLOR EVALUATION
COLOR COLOR SUFFIX DL* Da* Db* DE* CMC TRISTIMULUS DATA MASTER MASTER MATERIAL MATERIAL NUMBER DATE TYPE SOURCE
RED YEL GRN BLU LIGHT DARK GRAY CLEAN HIGH LOW
HUE
VALUE
CHROMA
GLOSS
METALLIC SHIPPING BRILLIANCE SUFFIX

HIGH LOW
PART DISPOSITION
COMMENTS
SUPPLIER SIGNATURE
PHONE NO.
DATE
CUSTOMER REPRESENTATIVE SIGNATURE
DATE
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GAGE REPEATABILITY AND REPRODUCIBILITY REPORT SHORT FORM ATTRIBUTE RESULTS

Part Number Gage Name Gage Number Gage Type Appraiser A Appraiser B Date Performed
0
Part Name
0
Characterisitic/Specification
APPRAISER A
PART # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 TRIAL #1 TRIAL #2
APPRAISER B
PART # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 TRIAL #1 TRIAL #2
All measurement decisions agree?
Yes
No
Accept Gage
Reject Gage
Remarks
page 32/39
GAGE REPEATABILITY AND REPRODUCIBILITY REPORT LONG FORM ATTRIBUTE RESULTS

Part Number Gage Name Gage Number Gage Type Upper Limit Appraiser Date Performed Lower Limit
0
Part Name
0
Characterisitic
# 1 2 3 4 5 6 7 8 9
ATTRIBUTE DATA XT P'a a 0.000 0.025 0.025 0.025 0.025 0.025 0.025 0.025 0.025
After "Press for Graph" : 1) Copy "X Variable 1 Line Fit Plot" from the data sheet to here. 2) Size and and add gridlines. 3) Label as follows: X Variable Line Fit Plot to Gage Performance Curve X Variable 1 to Xt Y to Probability 4) Click the Chart and double click a predicted Y point and change the line pattern to automatic. 5) Estimate the points below from the graph. 6) Move the chart to cover these instructions. NOTE: If an error occurs see page 60 of the manual.
FROM THE GRAPH ENTER THE FOLLOWING: XT (P=.5) = XT (P=.995) = XT (P=.005) =
Measurement Unit Analysis

Bias B = = Repeatability R = =
t Statistic t = = = 31.3 IBI / R t0.025,19 = 2.093
Result
Reviewed Title
page 33/39
GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET VARIABLE DATA RESULTS

Part Number Gage Name Gage Number Gage Type Trials Parts Appraiser A Appraiser B Appraiser C Appraisers Date Performed

Part Number Gage Name Gage Number Gage Type Trials Parts Appraiser A Appraiser B Appraiser C Appraisers Date Performed
0
Part Name
0
Part Name
0
Characteristic/Specification Characteristic Classification
0
0 APPRAISER/ TRIAL # 1. A 2. 3. 4. 5. 6. B 7. 8. 9. 10. 11. C 12. 13. 14. 15. 1 2 3 AVE R 1 2 3 AVE R 1 2 3 AVE R PART 1 2 3 4 5 6
0 AVERAGE 7 8 9 10 EV = = = Xa= Ra=

Repeatability - Equipment Variation (EV) R x K1 Trials 2 3 K1 4.56 3.05
% Total Variation (TV)

% EV = = = % AV = = 100 (AV/TV) 100 (EV/TV)
Reproducibility - Appraiser Variation (AV) 2 2 1/2 {(XDIFF x K2) - (EV /nr)} AV = = =

Appraisers
2 3.65 Parts 2 3 4 5 6 7 8 9 10
3 2.70 K3 3.65 2.70 2.30 2.08 1.93 1.82 1.74 1.67 1.62 % PV % R&R
= n = number of parts r = number of trials
K2 Xb= Rb= Repeatability & Reproducibility (R & R) {(EV2 + AV2)}1/2 R&R = = = Xc= Rc= X= Rp= R= XDIFF= UCLR= LCLR= Part Variation (PV) RP x K3 PV = = = Total Variation (TV) TV = = = {(R&R2 + PV2)}1/2
= = = = = =
100 (R&R/TV)
100 (PV/TV)
16. PART AVE ( Xp ) 17. 18. 19. 20. (Ra + Rb + Rc) / (# OF APPRAISERS) = (Max X - Min X) = R x D4* = R x D3* =
All calculations are based upon predicting 5.15 sigma (99.0% of the area under the normal distribution curve). K1 is 5.15/d2, where d2 is dependent on the number of trials (m) and the number if parts times the number of operators (g) which is
* D4 =3.27 for 2 trials and 2.58 for 3 trials; D3 = 0 for up to 7 trials. UCLR represents the limit of individual R's. Circle those that are beyond this limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or discard values and re-average and recompute R and the limiting value from the remaining observations. Notes:
assumed to be greater than 15. AV - If a negative value is calculated under the square root sign, the appraiser variation (AV) defaults to zero (0). K2 is 5.15/d2, where d2 is dependent on the number of operators (m) and (g) is 1, since there is only one range calculation. K2 is 5.15/d2, where d2 is dependent on the number of parts (m) and (g) is 1, since there is only one range calculation. d2 is obtained from Table D3, "Quality Control and Industrial Statistics", A.J. Duncan.
page 34/39
GAGE REPEATABILITY AND REPRODUCIBILITY DATA SHEET VARIABLE DATA RESULTS - INCLUDING WITHIN-PART VARIATION
Part Number Gage Name Gage Number Gage Type Trials Parts Appraiser A Appraiser B Appraiser C Appraisers Date Performed Part Number

Gage Name Gage Number Appraiser A Appraiser B Appraiser C Parts Appraisers Date Performed
0
Part Name Part Name
0 0
Characteristic/Specification Characteristic Classification Gage Type Trials
0
PART APPRAISER/ 1 2 3 4 5 APPRAISER TRIAL # MAX MIN RGE MAX MIN RGE MAX MIN RGE MAX MIN RGE MAX MIN RGE AVERAGE 1. A 2. 3. 4. 5. 6. B 7. 8. 9. 10. 11. C 12. 13. 14. 15. 1 2 3 AVE R 1 2 3 AVE R 1 2 3 AVE R Xc= Ro = Rp = RXwiv= RREP= XDIFF= UCLR= LCLR= Xb= Xa=

Repeatability - Equipment Variation (EV) R x K1 EV = = = Reproducibility - Appraiser Variation (AV) AV = = =
Appraisers
% Total Variation (TV)

K1 4.56 3.05 % AV % EV = = = = = 2 3 2.70 = n = number of parts r = number of trials 100 (AV/TV) 100 (EV/TV)
Trials 2 3
{(XDIFF x K2) - (EV /nr)}
1/2
K2 Repeatability & Reproducibility (R & R) {(EV2 + AV2)}1/2 R&R = = = Part Variation (PV) PV = = = Within-Part Variation (WIV) WIV = = XWIV = = WIV = # APPRAISERS, r = # TRIALS EVWIV = = Total Variation (TV) TV = = {(R&R2 + PV2 + WIV2)}1/2 SXWIV(LINE 17)/# XWIV READINGS RP x K 3
3.65
% R&R Parts 2 3 4 5 K3 3.65 2.70 2.30 2.08 % PV
= = = = = =
100 (R&R/TV)
100 (PV/TV)
16. Part Ave ( Xp ) 17. Ave of Xwiv 18. 19. 20. 21. RREPEAT = (SRANGE(LINES 5, 10, & 15))/(#RANGE READINGS) (MAX/MIN ONLY)= Xdiff = [ Max X ] - [Min X ] = UCLR = R x D4* = LCLR = R x D3* = D4 =
((XWIV + (RXwiv x K3)2 - (EVWIV)2/(nWIVr))1/2)/2
% WIV
= = =
100 (WIV/TV)
K1 x SRRGE(LINES 5,10, & 15)/# RRGE READINGS
* D4 =3.27 for 2 trials and 2.58 for 3 trials; D3 = 0 for up to 7 trials. UCLR represents the limit of individual R's. Circle those that are beyond this limit. Identify the cause and correct. Repeat these readings using the same appraiser and unit as originally used or discard values and re-average and recompute R and the limiting value from the remaining observations.
Notes:
page 35/39
REPEATABILITY RANGE CONTROL CHART

PLANT DEPT. DATES OF STUDY APPRAISER A OPERATION CHARACTERISTIC APPRAISER B DATE CONTROL LIMITS CALCULATED ENGINEERING SPECIFATION PART NAME PART NO.
0
MACHINE NO. NUMBER OF APPRAISERS SAMPLE SIZE FREQUENCY APPRAISER C
0 0
X= UCL = LCL =
AVERAGES (X BAR CHART)
1.20
1.00
0.80
0.60
0.40
0.20
0.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
R=
UCL =
LCL =
RANGES (R CHART)
1.00 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
D U A R L
NUMBER DATE/TIME
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
R E A D I N G S
1 2 3 4 5
SUM
X R
SUM NUM HIGHLOW ** = POINT OUT OF CONTROL
page 36/39
PART APPRAISER AVERAGE CHART

PLANT DEPT. DATES OF STUDY APPRAISER A OPERATION CHARACTERISTIC APPRAISER B DATE CONTROL LIMITS CALCULATED ENGINEERING SPECIFATION PART NAME PART NO.
0
MACHINE NO. NUMBER OF APPRAISERS SAMPLE SIZE FREQUENCY APPRAISER C
0 0
X= UCL = LCL =
AVERAGES (X BAR CHART)
1.00 0.90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
R=
UCL =
LCL =
RANGES (R CHART)
1.20
1.00
0.80
0.60
0.40
0.20
0.00 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
NUMBER DATE/TIME
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
R E A D I N G S
1 2 3 4 5
SUM
X R
SUM NUM HIGHLOW ** = POINT OUT OF CONTROL
page 37/39
Part Submission Warrant

Part Name Safety and/or Government Regulation Yes
0
No Engineering Drawing Change Level
Part Number
0 0
Dated Dated
Additional Engineering Changes Shown on Drawing Number Checking Aid Number Purchase Order No. Engineering Change Level SUBMISSION INFORMATION
Weight (kg) Dated
SUPPLIER MANUFACTURING INFORMATION
0
Supplier Name
Dimensional
Materials/Function
Appearance
0
Street Address
Customer Name/Division Teleflex Buyer/Buyer Code
Automotive Group
0
City REASON FOR SUBMISSION Initial submission Engineering Change(s)
0
State
00000
Zip Application
Change to Optional Construction or Material Sub-Supplier or Material Source Change Change in Part Processing Parts produced at Additional Location
Tooling: Transfer, Replacement, Refurbishment, or additional Correction of Discrepancy Other - please specify REQUESTED SUBMISSION LEVEL (Check one)
Level 1 - Warrant, Appearance Approval Report (for designated appearance items only). Level 2 - Warrant, Parts, Drawings, Inspection Results, Laboratory and Functional Results, Appearance Approval Report Level 3 - At Customer Location - Warrant, Parts, Drawings, Inspection Results, Laboratory and Functional Results, Appearance Approval Report, Process Capability Results, Capability Study, Process Control Plan, Gage Study, FMEA. Level 4 - Per level 3, but without parts. Level 5 - At Supplier Location - Warrant, Parts, Drawings, Inspection Results, Laboratory and Functional Results, Appearance Approval Report, Process Capability Results, Capability Study, Process Control Plan, Gage Study, FMEA. SUBMISSION RESULTS The results for material and functional tests YES These results meet all drawing and specification requirements: DECLARATION I affirm that the samples represented by this warrant are representative of our parts and have been made to the applicable customer drawings and specifications and are made from specified materials on regular production tooling with no operations other than the regular production process. I have noted any deviations from this declaration below. EXPLANATION/COMMENTS: Print Name Supplier Authorized Signature FOR CUSTOMER USE ONLY Part Disposition Customer Name Approved Rejected Customer Signature Other Date Title Phone No. Date dimensional measurements appearance criteria statistical process package NO (If "NO" - Explanation Required)
page 38/39
CUSTOMER LIST
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 ACTIVE # IN DOCUMENT Teleflex Automotive Group 1
FMEA RPN CRITERIA

SEVERITY SCALE 10 Hazardous - w/o warning 9 Hazardous - w/ warning 8 Very High 7 High 6 Moderate 5 Low 4 Very Low 3 Minor 2 Very Minor 1 None OCCURENCE SCALE 10 >1 in 2 9 1 in 3 8 1 in 8 7 1 in 20 6 1 in 80 5 1 in 400 4 1 in 2,000 3 1 in 15,000 2 1 in 150,000 1 1 in 1,500,000 DETECTION SCALE 10 Absolute Uncertainty 9 Vey Remote 8 Remote 7 Very Low 6 Low 5 Moderate 4 Moderately High 3 High 2 Very High 1 Almost Certain
page 39/39

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Teleflex PSO / PPAP Process

PRODUCT/PROCESS QUALITY CHECKLIST

Comment / Action Required

Control plan requirements? Layout inspection? Engineering performance testing?

PRODUCT/PROCESS QUALITY CHECKLIST

Comment / Action Required

Statistical process control? Capability studies? Problem solving? Mistake proofing?

PRODUCT/PROCESS QUALITY CHECKLIST

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Easily understood? Available? Accessible? Approved?

PRODUCT/PROCESS QUALITY CHECKLIST

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Designated location for approved product?

PRODUCT/PROCESS QUALITY CHECKLIST

Comment / Action Required

FLOOR PLAN CHECKLIST

Comment / Action Required

PROCESS FLOW CHART CHECKLIST

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PROCESS FMEA CHECKLIST

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CONTROL PLAN CHECKLIST

Comment / Action Required

REVIEW DATE SUPPLIER PART NUMBER PART NAME

MODEL YEAR VEHICLE LINE SUPPLIER CODE

Initial Risk Evaluation Checklist

REVIEW DATE SUPPLIER PART NUMBER PART NAME

MODEL YEAR VEHICLE LINE SUPPLIER CODE

NOTE: * INDICATES RISK DRIVER - PROCESS SPECIALIST ASSISTANCE MAY BE REQUIRED

Initial Risk Evaluation Summary

MEDIUM LEVEL OF CONCERN

HIGH LEVEL OF CONCERN

LIST HIGH CONCERN ITEMS

LIST MEDIUM CONCERN ITEMS

PRODUCT QUALITY PLANNING SUMMARY AND SIGN-OFF

PART NUMBER: MANUFACTURING PLANT:

QUANTITY ACCEPTABLE PENDING*

QUANTITY CHARACTERISTICS PER SAMPLE ACCEPTABLE PENDING*

QUANTITY ACCEPTABLE PENDING*

* REQUIRES PREPARATION OF AN ACTION PLAN TO TRACK PROGRESS.

TELEFLEX PROCESS SIGN-OFF CHECKLIST

ALL PROCESS SIGN-OFF ELEMENTS APPROVED:

PROCESS ELEMENTS TO BE VERIFIED DURING PLANT VISIT

CORRECTIVE ACTION REQUIRED ON-SITE REVISIT REQUIRED

Teleflex Automotive Process Sign-Off Team

Print Name And Sign

Quality Assurance Manager

Print Name And Sign

Print Name And Sign

Print Name And Sign

Print Name And Sign

TELEFLEX PROCESS SIGN-OFF Comments And Required Corrective Actions

Authorized Customer Signature

Print Name And Sign

Print Name And Sign

Print Name And Sign

PROCESS / INSPECTION FLOWCHART

Receiving inspection of raw material

Store material until trial day

Blend raw material and concentrate

Transport material to press

Wrap parts in foam and pack parts

100% visual inspection

100% visual inspection