balloon project summary

Balloon Project SummaryInterface Extrusion Qualification

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Extrusion Qualification

Goals: Validate Interface Internal Extrusion Use Interface Balloon Data Significantly Reduce Balloon Component Cost

-Lower service level and reduce backorder risk -Significantly Increase Interface balloon yield -Significantly Reduce Scrap BSC in IQA-Use Interface Data to decrease IQA cost



Strategy:

- Identical Inspection & Measurement Methods - Validate methods at BSC and Interface

- Transition to “Supplied Data” via Interface

- Eliminate BSC 100% proof loading



Requirements:-Continue current strategy to validate internal extrusion

- Manage measurement anomalies- Document SCARs and NCMRs- PpK evaluation memos- Supplier Quality, Sustaining R&D and DA - Document & Lock Requirements

-Purchase Interface inspection station ($35K)- Duplicate Interface measurement method -Equipment Lead-Time – Four to Five Weeks

-Develop and Validate BSC and Interface Inspection procedures

-Execute Design and Process changes:- Align balloon burst requirement with finished device- IQA lot acceptance per AQL 95/99.9 confidence.



Estimate for Method Validation:

-$13K EE IV/O of Inspection Station

-$20K for MG Sustaining Engineering

-$15K for Travel (SJ and Maple Grove)



Quarter Scrap FARF IQA Labor External Extrusion

Q1 $15,700 $2,000 $25,000Q2 $31,000 $3,500 $46,400Q3 $33,000 $4,000 $45,000Q4 $17,000 $2,000 $35,000

Total $96,700 $11,500 $151,400

Interface Requirements for legacy balloons:Pay for extrusion

Pay for scrapCost Incurred & Forecast


Detail & Back-UP Slides

Detail & Back-UP Slides


Balloons for Measurement

Balloon Part Numbers and Inspection PriorityBSC P/N Size Priority SO PO# Qty

RequestShip date

Received date

InterfaceWO#

BSC Batch #

FA Status Comment

12565 2.5x103 1 17468 6234623 31 27-Oct 28-Oct N/A 5001026435 Done Completed. See CR 101738011800 2.5x20 1 17468 6234623 31 27-Oct 28-Oct N/A 5001025939 Done Completed. See CR 101738012468 5.0x103 2 17472 6234624 31 8-Oct 1-Oct N/A 5001014922 In CR Pending CR 101981311597 5.0x20 2 17472 6234624 31 8-Oct 28-Sep N/A 5001013157 In CR Pending CR 101981311598 6.0x20 3 17473 6234603 31 15-Oct 1-Oct N/A 5001014921 Passed Pending FAIR approval

12469 6.0x103 3 17473 6234603 31 21-Oct 12-Oct N/A 5001020041 FailedBalloon Length failed

Statistical & practical test11802 3.5x20 5 17476 6234614 31 22-Oct 7-Oct N/A 5001017602 Passed Pending FAIR approval

13158 3.5x103 5 17476 6234614 31 22-Oct N/A 5001040707 Passed Pending FAIR approval

11599 7.0x20 4 17474 6234610 31 22-Oct 8-Oct N/A 5001018219 PassedPending FAIR approval by

John L.

12044 7.0x83 4 17474 6234610 31 22-Oct 15-Oct N/A 5001021097 Failed

Rejected due to Banana Shape Pending NCMR E-

6879

12575 2.0x103 6 17454 6234616 31 26-Oct 21-Oct N/A 5001023633 FailedBalloon Length failed

Statistical & practical test

11799 2.0x20 6 17454 6234616 31 26-Oct 21-Oct N/A 5001023634 FailedBalloon length failed Ppk. 0.95

from measurement < 1.33

11804 2.0x23 6 17454 6234616 31 26-Oct 4-Nov N/A 5001029716 Failed

Balloon length failed Ppk. 0.53 from measurement < 1.33

(Linda)

11809 2.0x40 6 17454 6234616 31 26-Oct 21-Oct N/A 5001023635 Failed

Balloon length failed Ppk. 0.48 from measurement < 1.33

(Linda)

12567 4.0x103 7 17477 6234803 31 1-Nov 2-Nov N/A 5001028393 PendingP value too low. Need more

study

11596 4.0x20 7 17477 6234803 31 1-Nov 29-Oct N/A 5001027025 PendingP value too low. Need more

study11600 8.0x20 8 17471 6234612 31 25-Oct 28-Oct N/A 5001026431 Passed FAIR OK. Pending approval11615 8.0x43 8 17471 6234612 31 25-Oct N/A Not Received

12566 3.0x103 9 17475 6234779 31 29-Oct 29-Oct N/A 5001027024 Pending In Work

11801 3.0x20 9 17475 6234779 31 29-Oct 28-Oct N/A 5001025936 Pending

Missing Page 3 double wall thickness measurement. IQA

redo


Methods & MeasurementDetails:

Methods / Measurement Processes

Review ProceduresEvaluate Interface & BSC Processes

Methods Required:Balloon Body Dimensions

Duplicate Interface Inspection StationEquipment Capital Cost – Interface Quote

BSC to adopt Interface method for Stem IDs’

BurstValidate Interface Balloon Component Burst Process Interface burst data (AQL, 95/99.9 confidence)

Validate BSC and Interface DWT Measurement Processes


Methods & Measurement

Mar-10 Nov-10

1 April 2010 1 May 2010 1 June 2010 1 July 2010 1 August 2010 1 September 2010 1 October 2010

10/23/08 - 9/30/099/30/09 - 4/16/10

Validation & Scale Up6/30/10 - 7/15/10

Commercialization2/9/10 - 8/25/10

5/10/10 - 6/11/10Draft New IP

6/5/10Received Interface Quote

2 August 2010 - 6 October 2010NSMR Builds & Reports

Apr-10 - Sep-10Incoming Methods / Balloon Measurement Process

Jun-10 - Jul-10EE Validate Equipment

4/4/10 - 5/2/10Competed Review of MG,

Interface, & SJ Methods/ Procedures


Methods & Measurement

ID Task Name Duration Start Finish ResourceNames

1 Methods 112 days Mon 4/12/10 Tue 9/14/102 review MG work instructions, validations, observe process in MG 5 days Mon 4/12/10 Fri 4/16/10 John H

3 review SJ QP 1006 procedures 10 days Mon 4/12/10 Fri 4/23/10 John H

4 review / observe SJ incoming processes / equipment 5 days Mon 4/26/10 Fri 4/30/10 John H

5 Draft new IP 35 days Mon 4/12/10 Fri 5/28/1010 Interface Visit 1 day Tue 4/27/10 Tue 4/27/1015 Draft TMV (gage R&Rs) protocols 10 days Fri 5/28/10 Fri 6/11/1020 Equipment 80 days Mon 4/12/10 Fri 7/30/10 Ron Lee26 Update IP drafts 10 days Mon 7/5/10 Fri 7/16/10 John H

27 Update TMV (gage R&Rs) protocols 10 days Mon 7/5/10 Fri 7/16/1032 IP Due Diligence (verify gage R&Rs, train operators) 10 days Mon 7/19/10 Fri 7/30/1036 Update IP and TMVs 5 days Mon 8/2/10 Fri 8/6/1040 Release IP to Numeric 5 days Mon 8/9/10 Fri 8/13/10 John H

41 Execute TMVs 10 days Mon 8/16/10 Fri 8/27/10 John H45 Write TMRs and CR 7 days Mon 8/30/10 Tue 9/7/1049 Release IP to Alpha 5 days Wed 9/8/10 Tue 9/14/10 John H

50 Update prints (?) to use new IP 5 days Wed 9/8/10 Tue 9/14/10 R&D

John HJohn H

John H

M T W T F S S M T W T F S S MApr 11, '10 Apr 18, '10 Apr 25, '10

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