The device design once complete, must be adequately transferred to manufacturing. This is typically accomplished through product specifications, standard operating procedures, work instructions and training.
Collection of Documents
Often a product specification is thought of as a document. The reality is the product specifications should be thought of as an association of written documents.
The product specifications typically include:
- Assembly drawings
- Component procurement specifications
- Manufacturing instructions
- Test instructions
- Digital data files
- Manufacturing fixtures (jigs and molds)
- Training materials
- Artwork associated with labels
- Acceptance criteria
Device Master Record (DMR)
The ultimate document to ensure adequate design transfer is the Device Master Record, or DMR.
The DMR is somewhat theoretical in that it is really a compilation of all the documents which are needed to realize the product.
For that reason, the DMR, is often established as an index which simply lists all of the documents needed to realize the product.
Contents of the DMR
The DMR typically includes the following documents:
- Product specifications
- Work instructions for device realization
- Device history records/Forms to generate device history records
- Component drawings/Specifications
- Label artwork/Specifications
- Test/Inspection methods
- Validation Master Plan (VMP)
Since these documents may be revising and changing and may be at various distribution points, the DMR typically is an index of all the documents.
Chocolate Chip Cookie Analogy
One very common analogy is to envision the DMR as a chocolate-chip cookie recipe. If the DMR is complete, by providing the DMR to someone they can make the exact same chocolate-chip cookies.
While this is somewhat simplified, it’s an excellent analogy, but in order to make the perfect chocolate-chip cookie we would want specifications for the grade of flour, chocolate chips, sugar and other components.
We’d also like to know which equipment was validated, how they are tested/inspected, what are the instructions for each processing step, etc.
If we have all the relevant information we can reproduce the cookies exactly.
The DMR is the key to any successful design transfer whether it is an internal transfer to manufacturing or a transfer to a Contract Manufacturing Organization (CMO).