Manufacturing Outsource Process
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1 Manufacturing Outsource Process Your Template For Success Delivering Innovative Medical Technologies
2 Manufacturing Outsource Process How to plan and execute an outsource project Understand objectives and requirements, review alternative solutions and develop proposal for recommended solution. Project scope and definition Review of alternative options Proposal based on recommended option Agreement to move to next stage Develop detailed project plan. Project teams in place Project communications, review and management processes in place Full due diligence complete on all aspects of the project Detailed project plan developed Major risks identified and risk management plan in place Agreement on detailed plan including scope, schedule and budget Complete product development, including testing as per customer criteria. Product changes / enhancements proven to meet customer requirements All required integration or functional testing complete at customer site
3 Transfer all available equipment and tooling and purchase remaining equipment & tooling. Set up manufacturing lines and IQ all equipment. Manufacturing lines set up and operational All IQs complete Staff hired and trained All required documents (procedures, drawings, specifications) approved and released for use Execute all process validations (OQ/PQ) and product validations (PPQ) for finished devices. All validations executed and reports approved MVR approved FAI complete Ramp lines to full volume while ensuring yield and quality targets are met. Manufacturing line capable of delivering target output and quality metrics Safety / consignment stock in place Ongoing management of manufacturing operation with appropriate metrics and reviews in place. QBR metrics and review process established
4 Delivering Innovative Medical Technologies Manufacturing Outsource Process Template Stage 1 - Project Feasibility Understand Customer Requirements Complete Technical Assessment Complete Financial Assessment Develop Outline Proposal Customer Review of Proposal Feasibility Stage Closeout Review Stage 2 - Detailed Planning Confirm Scope of Project Creganna Project Lead and Team Identified Steering Team and Review Process Agreed Customer Project Lead and Team Identified Define Project Management and Controls Risk Management Process Defined Develop Detailed Project Plan Review Budget and Product Pricing Supply Agreement Developed MVP Drafted and Approved Review and Agree Changes to Project Detailed Planning Stage Closeout Review Period 1 Period 2 Period 3 Period 4 Period 5 Period 6 Period 7 Period 8 Duration CREGANNA SERVICE NETWORK Reducing your time to market, cost and risk Stage 3A - Development Complete Product Development as per Plan Test Product Development as per Customer Criteria Develop Stage Closeout Review Stage 3B - Transfer / Install Purchase, Install & IQ Equipment & Tooling Facilities Set Up and Validation Hire and Train Staff Transfer, Install & IQ Equipment & Tooling Set Up and Qualify New Suppliers Order Materials and Consumables Transfer and ECO all Documents and Specifications Draft Validation protocols Execute Test Method Validations Transfer / Install Stage Closeout Review Stage 4 - Validation Execute DOE's and Engineering Studies Finalise and approve validation protocols Build and Test OQ Lots Build and Test PQ Lots PQ Reports Complete Master Validation Report Complete FAI Notify Regulatory Agency Validation Stage Closeout Review Abbreviation List Stage 5 - Manufacturing Ramp Line Audit for Manufacturing Start Up Confirm Ramp Plan and Metrics Build Safety / Consignment Stock Review Manufacturing Performance Manufacturing Stage Closeout Review Stage 6 - Ongoing Operations Agree Performance Metrics Set up Performance Review Process Set up Forecast Review Process Manage Safety / Consignment Stock Project Closeout Review Contact Details: Global Tel: +353 (0) US Tel: outsourcing@creganna.com
5 Creganna is a leading supplier of products, technologies and services to medical device and lifescience companies. The company is ranked as one of the Top 10 global providers of medical device outsourcing solutions worldwide and has expertise in the design and manufacturing of minimally & less invasive delivery & access devices for a range of therapy areas. The template inside outlines our approach to planning and execution of your outsource projects. Our staged process ensures a structured approach and stakeholder alignment, with specific objectives and deliverables throughout the project. For medical device companies seeking a manufacturing partner for products, sub-assemblies or component parts, Creganna offers an outsourced manufacturing service with the lowest risk and total cost of ownership. Our proven approach allows Creganna to function as a reliable outsourcing partner, for single manufacturing lines through to complete facility transfer. Creganna is fully compliant to industry standard ISO certification, is an FDA registered Contract Manufacturer and is registered with the Japanese MHLW as a foreign medical device manufacturer. Contact Details: Parkmore West, Galway, Ireland Tel: (0) Donald Lynch Boulevard, Marlborough, MA 01752, USA Tel: Fernbrook Lane North, Plymouth, MN 55447, USA Tel: Suite 2103, The Landmark at Shoreline, 2103 Landings Drive, Mountain View, CA 94043, USA Tel: outsourcing@creganna.com
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