http://thelittersitter.com/doc.php?_wpcf7_version=5.7.6 The goal of the Pilot Production phase is to successfully transfer the product design into manufacturing specifications for full scale production, and to validate and document the manufacturing processes for the developed product.
Some re-verification may also be required. Suppliers are qualified and a supply chain is developed. A comprehensive validation protocol is generated. Once pilot production units have been built under manufacturing control, the tests comprising the validation protocol are carried out to validate and document that the products resulting from the design process meet the defined user needs and intended uses.
Device History and Master Records are developed. The validation test results are then evaluated by the Project Team. OTI designs and builds quality control and production fixtures/equipment as necessary.
Phase 3 Inputs
- Functioning Engineering Prototype (looks-like, works-like)
- Updated DHF
- Test Plans
- Test Reports
- Trace Matrices
- Verification Report
- Updated Regulatory Assessment(if OTI is managing submission)
- Completed Risk Analysis
- Human Factors Engineering Report
- Phase 2 Design Review Report
- Updated PDP
Phase 3 Outputs
- Validation Protocol
- Validation Report
- Supplier Qualification
- Device History Record (DHR)
- Device Master Record (DMR)
- Phase 3 Design Review Report
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