Capability example

A controller built across three vendors, brought under one roof.

Board house, assembler and test provider, none of whom could answer a traceability question. Production consolidated onto our own lines.

All capability examples

Sector

Therapeutic devices

Device type

External controller for an implanted therapy

Services involved

Contract manufacturing

Duration

7 months, transfer to first sustained batch

The challenge

Three vendors, no answer.

A field question about one shipped unit took eleven days to answer and the answer was partial. Boards were fabricated at one supplier, populated and assembled at a second, tested at a third, and the records lived in three formats that did not reconcile. Nothing had gone wrong yet. The exposure was that nobody could prove it had not.

What we did

Consolidated the process and the record with it.

SMT, assembly, functional test, quality release and supply moved onto our own lines under our quality system. The transfer was run as a project with first-article inspection, requalified fixtures and a single batch record that carries a unit from component lot to shipped device. Supplier qualification was redone against our own criteria rather than inherited.

What it took

First article found what the old test missed.

The inherited functional test passed a board with an intermittent connection on a signal the test never exercised under load. We found it at first-article inspection because the requalified fixture applied the load the field applies. Test coverage was rebuilt against the failure modes in the risk file rather than against the pin list, which lengthened the test by nineteen seconds and closed a real gap.

The outcome

What came out of it.

Unit-level traceability from component lot to shipped device, answerable in minutes rather than days.
First-pass yield of 97.4 percent across the first sustained batches.
12 batch releases with no deviation raised.
Functional test coverage rebuilt against the risk file rather than the pin list.