Machining Process Transfer

Background

ECI was engaged by a medical device manufacturer to support the transfer project of medical device components, including machined screws and secondary processes, from planning through to production.

Approach and Solution

ECI was engaged by a medical device manufacturer to support the transfer project of medical device components, including machined screws and secondary processes, from planning through to production.

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Comprehensive Action

ECI engaged multiple quality engineers to provide expertise for Quality Engineering activities related totechnology assessment, sub-assembly, and secondary processes for machinedscrews used in medical device production. The project deliverables includedcritical quality documentation such as process instructions, essential designoutputs, process specifications, process flow diagrams, and risk managementdocuments. ECI also supported the creation, revision, and approval ofvalidation documents, including installation qualification (IQ), operationalqualification (OQ), performance qualification (PQ), computerized systemvalidation (CSV), and test method validation (TMV).

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Approach and Solution

The ECI team collaborated with the client to produce written validationprotocols, support the execution, and the final validation reports and other engineering studies performed as part of the transfer process. The following deliverables were completed:

·        59 Test method validations(TMV) Protocols / Equivalences created

·        44 Test method validations (TMV) Reports created

·        43 sets of documents created (Costa Rica & Warsaw Control Plans, first articleinspections (FAIs), Zero Escape)

·        Processfailure mode and effects analysis (pFMEA) updated

·        100+ Calibration Notifications reviewed / approved

·        7 Priority documents reviewed / approved for manufacturing enterprise system(MES)

·        5 Performance qualification (PQ) Protocols / Reports reviewed / approved

·        2 Operational performance and performance qualification (OQ/PQ) Protocols / Reports for secondary processes were reviewed / approved

·        8 Essential design outputs (EDOs) / Non-essential design outputs (Non-EDOs) Procedures created

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Results

ECI successfully supported the strategy and knowledge transfer to execute the validation of machining and secondary processes transferred for seven (7) groups or product families.

This project resulted in significant process efficiencies for the client in addition to lowering overall costs of the manufacturing process.

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