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Consulting Services
Services/Tools/Templates: Summary
Tailored to your needs and your quality system with a consulting relationship
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Product design decision matrix based on target cost/UMC, development costs/timeline, business and technical risk, capitalization costs, Operations labor & overhead costs.
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Phase and Gate Process outlines for new product development, manufacturing process development, and production system implementation.
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Value Stream mapping and maintenance through all program phases.
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Operations Requirements to be met by New Product Development (NPD) teams and Operations in satisfying requirements for centralized or regional installations that lead to efficient operational performance meeting world-wide demand and capacity growth.
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Business and technical risk management for Operations.
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Design for Manufacturability (DFM) Analysis against Operations Requirements.
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Quality Function Deployment-QFD (Management of CTQs in NPD through production implementation, leading to Operation’s control plans).
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Risk-Based Validation Planning for Manufacturing Systems using GAMP and ISPE guidance (Validation Plan, User Requirements Specification, Functional Specification, Requirements Traceability Matrix, Design Review, DQ/IQ/OQ/PQ).
(See Validation Services Section) -
Manufacturing Readiness for Validation and Sales templates based on comprehensive Value Stream models.