balloon project summary
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Balloon Project SummaryInterface Extrusion Qualification
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 2
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
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Extrusion Qualification
Strategy:
- Identical Inspection & Measurement Methods - Validate methods at BSC and Interface
- Transition to “Supplied Data” via Interface
- Eliminate BSC 100% proof loading
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Extrusion Qualification
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.
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 5
Extrusion Qualification
Estimate for Method Validation:
-$13K EE IV/O of Inspection Station
-$20K for MG Sustaining Engineering
-$15K for Travel (SJ and Maple Grove)
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Extrusion Qualification
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
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 7
Detail & Back-UP Slides
Detail & Back-UP Slides
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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
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 9
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
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 10
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
Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 11
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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