Stephen R. Covey’s advice to “begin with the end in mind” cannot be stressed enough when it comes to device design transfer. Design transfers can occur between an OEM’s facilities, from OEM to a contract manufacturer or from one contract manufacturer to another. In each case, a successful transfer requires an understanding of regulatory requirements, a comprehensive review of all documentation, a thorough understanding of manufacturing methods and process, and most importantly, a good plan.
This is especially true for new products. Engineers should work closely with manufacturing personnel early in the design phase of new product development to assure that the design can be economically produced from standpoints of equipment capability, assembly complexity and component sourcing. It is equally important that the in-house or outsource supply decision not be set in stone at the onset, as product sourcing decisions may change over its lifecycle.
For established products, do not assume that because something is manufactured it is ready to be transferred, or that the transfer will be easy and without issue. Products transferred from in-house to contract manufacturer, or from an established contract manufacturer to a new supplier, pose the additional risk of miscommunication beyond product specifications due to differences in corporate culture, department alignment, business/quality systems and experience, sometimes referred to as “tribal knowledge.”
It is important to note that both FDA and ISO design control guidance documents refer to design transfer as a way to ensure the transfer maintains product specifications that meet user needs. But there is limited information available on the specific steps to ensure success, generally because each product and transfer is unique, so there is no “one-size-fits-all” solution.
The first step in a design transfer project is having a solid plan in place before you begin. Although planning does not guarantee a successful transfer, it does lay the groundwork. Any plan should clearly describe the current state, reasoning for transfer and desired outcome, as well as a definition of success. Roles and responsibilities of the supporting departments should be identified, along with a preliminary timeline that works back from the desired completion date. This allows for identification of conflicts early on, so they can be addressed before the project begins.
The importance of cross-functional participation through the entire process cannot be stressed enough. Poor communication and misunderstanding are the primary cause for most transfer project failures. The time to identify requirements, shortfalls and risks is early in the transfer project, not during the transfer or in the cGMP manufacturing run. Depending on the scope of the transfer, this could include multiple internal departments representing quality, regulatory, engineering, manufacturing, purchasing and others, as well as external participants from one or more suppliers. The entire team must remain in place until the design transfer has been successfully completed.
Design Transfer Checklist
Use of a design transfer checklist can be an effective way to reduce risk and have a successful transfer. A properly designed checklist can:
- Ascertain the state of readiness of the product and production process to be transferred
- Assure required input and participation of all stakeholders
- Reduce the risk of transfer failure
- Result in a more dependable transfer timeline and budget
The checklist is a proven preparation method. Combined with early participation by all stakeholders, it is a means to reduce risk and improve the chances of a successful transfer. It can be used in preparation for the transfer to assure that preliminary requirements are in place, can function as the basis for project timeline and budget and should also be included in the closeout documentation. At that point, the checklist serves as evidence of completion of critical steps and a reference for future inquiries or subsequent transfers.
The following elements are recommended for inclusion in any design transfer checklist:
- Has a risk analysis been completed?
- Have you defined terms that will be shared by all participants and used in related documentation, such as supply or quality agreements, validations, testing, approval, etc.?
- Has a design for manufacturability assessment been completed? (This should include both the physical manufacturing process and assembly as well as sourcing for raw materials and components.)
- Have critical product and component functional requirements been identified?
- Have manufacturing processes and assembly instructions been documented and validated?
- Are all drawings and specifications complete for product, component and raw materials?
- Is the bill of material complete, including approved suppliers for all raw materials and purchased components?
- Have dependable cost estimates or targets been established?
- Are all regulatory requirements for immediate and future distribution requirements identified?
- Have all inspection criteria, methods and equipment been identified and validated?
- Have training requirements been established?
- Have any specialized or unique fixtures been identified, including availability and sourcing?
- Have labeling and packaging requirements, including material and sourcing, been identified, documented and tested?
- If required, has the hazard analysis been completed?
- Will the product require first article approval, and have inspection and approval requirements been documented?
- Has the demand forecast been properly vetted and accepted by all stakeholders?
- Has a timeline, including risk assessment and contingencies, been completed and accepted by all stakeholders?
- Have team members, alternate and subject matter experts been identified, and are they committed to the transfer’s success?
- Have you established your mechanism for communication, including methods, timing, participants and distribution?
- If required, have you identified the planning and project management tools to be used including escalation plans?
- Has all documentation been compiled to assure that the receiving location understands every aspect of the transfer as it relates to them?
- Have you defined critical supplier capability requirements to be outsourced?
- Have you defined success and gotten buy-in from all participants?
This is a commonly overlooked step, as it is often assumed that everyone knows how success is defined. Wrong. Individuals, departments and participating companies can have diverse and conflicting definitions of success. To avoid delays, disappointment and argument, the expectation and definition of success must be established at the outset. This should include finished product functionality, process validation, intermediate and final quality approval, timeline, cost and other elements as applicable, including prioritization of each (should the need for compromise arise).
- Although regulatory agencies provide guidance for design transfers, there is no “one-size-fits-all” solution, due to the differences in specific designs and manufacturing requirements.
- It is crucial for the success of the transfer that you start early and have cross-functional involvement.
- A design transfer checklist can be used for a gap analysis before the project begins, and is a means of reducing the probability of problems or failure.