DESIGN TRANSFER & NEW MANUFACTURER READINESS

Transfers fail in a predictable way: the product ships from the new factory before the evidence that qualifies the new factory exists. We run the sequence so that never happens to you.

6–10 weeks Typical program
On site Shenzhen team at the factory
Both sides Spec owner and manufacturer
Dated evidence Generated as you go

THE PROBLEM IS SEQUENCE, NOT EFFORT

The commercial decision lands in January. Tooling moves in March. First articles arrive in April and look acceptable. Purchasing, under pressure, releases a production order in May. In June someone asks for the process validation supporting product that has already shipped.

By then every option is expensive. Halt shipment and miss the launch you moved production to hit. Or run the qualification behind the product and carry the exposure until it is finished. Neither is a decision anyone wants on their desk, and both are entirely avoidable eight weeks earlier.

One rule prevents nearly all of it. Evidence qualifying the new factory must exist before product from the new factory reaches a customer. Everything below is an elaboration of that sentence, and the reason transfers go wrong is not that people disagree with it. It is that the commercial calendar and the qualification calendar are set by different people, and only one of them has a customer waiting.

Which means the real intervention is early. The transfer plan has to be agreed before the tooling moves, and the first shippable date has to be derived from the qualification sequence rather than from the tooling arrival date. That is a conversation with operations and sales, and we will have it with you.

WHAT THE PROGRAM COVERS

Ordered the way the work actually has to happen.

  1. Design authority and responsibility mapping

    Who owns the design, who may change it, who validates the process, who approves critical suppliers, and how you learn what changed. Written down, agreed by both companies, before anything moves.

  2. Establish what is being transferred

    The as-built configuration: actual bill of materials with actual approved manufacturers, drawings at current revisions, firmware identity, critical characteristics, labeling, packaging, and the acceptance criteria the outgoing factory was really using.

  3. Product and process gap assessment

    What the new factory can do today against what your device needs. Process capability, equipment, measurement systems, environmental controls, and the document and change control that will actually notify you when something moves.

  4. Critical supplier and component controls

    Designating critical components explicitly and requiring written approval by name before substitution. This is the single control that prevents the most common post-transfer failure.

  5. Design transfer execution

    Transferred documentation with acknowledgement, process documentation the factory authors and you approve, tooling and fixture qualification, measurement system verification, and operator training records captured at the time rather than reconstructed later.

  6. Test-method readiness and pilot production

    A pilot build on production tooling, production equipment, run by production operators rather than engineers. Engineers can make almost anything work once; the pilot exists to reveal what happens when they are not standing there.

  7. Process validation

    Installation, operational and performance qualification for the processes whose output you cannot fully verify by inspecting the finished device. Welding, sealing, bonding, sterilization, potting and some overmolding usually qualify.

  8. Production release criteria

    An explicit release decision with a date, made by named people, referencing the evidence that supports it. Not a purchase order.

  9. Factory change control

    The mechanism that keeps the file accurate after go-live, so the next component substitution reaches your quality system instead of happening silently.

We have led this exact transfer

Class II device, U.S. to China
At Tria Beauty, Bob Jordan led the transfer of a flagship Class II device from in-house production to contract manufacturing in China, through EVT, DVT and PVT to production launch
Class III supplier quality
Multi-year China supplier-audit and quality program for a Class III medical device company
Engineering, not just oversight
Through BOM Quote: design, tooling, PCBA and assembly, functional testing and pilot builds when the fix is a design change

WHAT YOU HOLD AT THE END

A transfer produces a device from a new factory. Run properly, it also produces the file that lets you defend it.

  • Transfer plan and signed responsibility matrix
  • As-built configuration baseline
  • Factory assessment and gap closure record
  • Critical component and supplier control list
  • Tooling, fixture and measurement qualification
  • Pilot build report and training records
  • Process validation package
  • Production release decision, dated and signed

Every one of them generated as the work happens, so the evidence package exists the day you release rather than being assembled the week before an audit. More detail: the transfer sequence in full.

PLANNING A TRANSFER?

The best time to talk is before the tooling moves. If it has already moved, the second best time is now.

Book a discovery call See the diagnostic