In this issue, we wrap up a series of six articles focused on the design controls process from a standpoint of design transfer, changes and the design history file (DHF) in the orthopaedic medical device marketplace. I hope that you have enjoyed reading the previous articles, which are all available online at www.orthoworld.com, in the BONEZONE archives. –JG
Introduction and Review
As you may recall from the first and second articles in this series, each manufacturer of orthopaedic medical devices is required to establish and maintain a quality system that is appropriate for the specific device(s) designed or manufactured and that meets the requirements of 21 Code of Federal Regulations (CFR), Part 820. The details of design control systems will vary depending on the complexity of the orthopaedic device or process being designed.
Because design transfer must apply to a wide variety of devices and manufacturing systems, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework for transfer and any changes to the design that manufacturer must use when developing and then implementing this relationship between, for example, design engineers and manufacturing engineers.
This framework provides orthopaedic manufacturing companies with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes. Even very small manufacturers and those that design less-complex devices or processes are expected to define, document and implement design transfer procedures and other quality system procedures, as called for in the regulation. All changes must be accounted for during the design process.
Basically, most of the details of the change control system are left to the manufacturer to develop, document and implement. As the design activity progresses toward its final stages, it is expected that the degree of change control will increase. The Quality System Regulation (QSR) also requires that the DHF shall contain or reference the documentation necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
As noted, this requirement cannot be met unless the manufacturer develops and maintains plans that meet the design control requirements. The plans and subsequent updates should be part of this DHF in continuum.
Definitions of Regulatory/Quality Requirements from the CFR
§ 820.30(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
§ 820.30(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
§ 820.30(j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.
The design controls require that each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications. The transfer process must be a part of the design plan. It is not uncommon for the design to be transferred in phases.
For successful design transfer to occur, manufacturers have found that communication between manufacturing and design personnel must be initiated during early development phases and continued throughout the product’s life-cycle. Historically I have not seen this work very well, because development groups have often simply released specifications to manufacturing and have failed to ensure that the production specifications are well understood or effectively implemented.
Production specifications typically comprise written documents such as assembly drawings, inspection and test specifications and manufacturing instructions. These production specifications must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. If a manufactured device deviates outside of those capabilities, performance may be compromised. Thus, the process of summarizing knowledge about the device into production specifications is important for establishing the device’s quality throughout the life cycle of design controls, as well post-commercialization. This transfer of knowledge in the form of documentation (such as assembly drawings, component procurement specifications, workmanship standards, manufacturing instructions and inspection and test specifications) from product development to the manufacturing process should be a well-orchestrated process resulting in the issuance of the Device Master Record (DMR) as part of the design output. (The DHF is the basis for the DMR.) This information becomes the basis for any other additional documentation, e.g.
- training materials
- digital data files
- manufacturing jigs and aids