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lecture_12 - Manufacturing and Quality Control S Laguette...

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Unformatted text preview: Manufacturing and Quality Control S. Laguette ME 128 Fall 2007 November 9,2007 11/09/07 Me 128 1 Manufacturing and Quality Control Medical Device Manufacturing Design for Manufacturability Design for Assembly Pre-production activities Production Release Commercial Release 11/09/07 Me 128 2 Medical Device Manufacturing Designing medical devices and submitting devices for FDA approval are time-consuming, costly activities for medical device manufacturers. The day-to-day operations of manufacturing in a controlled environment present continual challenges that vary as regulations change and the cost of manufacturing increases. 11/09/07 Me 128 3 Company Organization President R&D Operations Finance RA/QA Marketing Sales Human Resources 11/09/07 Me 128 4 R&D Organization R&D Manager Sr. R&D Engr R&D Engr R&D tech 11/09/07 Me 128 5 Operations Organization Ops Manager Mfg Engr Production Supervisor Facilities 11/09/07 Me 128 6 Regulatory Affairs and Quality Assurance (RA/QA) RA/QA Mgr RA Quality Assurance Quality Control 11/09/07 Me 128 7 Manufacturing Controlled areas Clean rooms Employee gowning and training Monitoring of areas 11/09/07 Me 128 8 Manufacturing Type of Cleanroom Cost (per sq ft) Class 100,000 Class 10,000 Class 1000 Class 100 Class 10 Class 1 11/09/07 $100 $200 $300 $400 $500-$1000 $3000-$5000 Me 128 9 Manufacturing 11/09/07 Me 128 10 Manufacturing 11/09/07 Me 128 11 Manufacturing 11/09/07 Me 128 12 Design for Manufacturability (DFM) Assures that a design can be repeatedly manufactured while satisfying the requirements for quality, reliability, performance, availability, and price. Less costly due to Simpler design with fewer parts Simple production processes Higher quality and reliability Easier to service 11/09/07 Me 128 13 DFM Process Eliminate nonfunctional parts Reduce functional parts Process for a defect rate of no more than a few parts per million 11/09/07 Me 128 14 Design for Assembly (DFA) Overall Design Concept Component Mounting Test Points Stress Levels and Tolerances Printed Circuit Boards Miscellaneous 11/09/07 Me 128 15 Manufacturing Process Pre-production activity Pilot run build Production run Delivery to customer 11/09/07 Me 128 16 Design Control 11/09/07 Me 128 17 Pre-Production Activities Selection of Suppliers Develop Pilot Run plan Develop Manufacturing Strategy Production plan Quality plan Test plan Materials plan Supplier plan 11/09/07 Me 128 18 Pilot Run Build Validate manufacturing process against objectives set forth in manufacturing strategy and product specification Standard cost Product quality Documentation Tooling Training Process control Validates supplier plan and contracts Internal failure analysis and corrective action 11/09/07 Me 128 19 Prototype Release Documents and Drawings are reviewed, approved, and released for use All documents are now subject to Document Change Control Revisions are probable and anticipated Design Engineer (R&D) typically is responsible authority 11/09/07 Me 128 20 Production Release Design Transfer from R&D to Manufacturing Design is finalized. Minor to few changes are expected. Processes are complete and validated Acceptance criteria are complete and approved Transfer of authority from R&D to Mfg Formal Document Change Control 11/09/07 Me 128 21 Production Run Produce high quality product on time, while continuing to fine tune the processes 1st order manufactured Verification of Product cost 11/09/07 Me 128 22 Commercial Release All Regulatory approvals are complete Initial inventory builds are complete All marketing and promotional materials are complete Sales/Marketing are typically responsible authority 11/09/07 Me 128 23 Customer Delivery Deliver 1st production units to customer Continue to refine manufacturing processes Monitor field unit performance to correct any problems 11/09/07 Me 128 24 Post Market 11/09/07 Me 128 25 References PH King Lecture Series 11/09/07 Me 128 26 ...
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