All the work that Keystone and the customer has done in the first three phases, from taking a product idea and refining it, through extensive design and then testing of prototypes, leads to this critical juncture. Transferring the design to the production process requires a comprehensive assessment of design documentation, a precise definition of production methods, and a careful selection of components.
If we don’t get this transfer right, it can lead to production workflow interruptions, parts that are unavailable or more expensive than anticipated, and a reduction in quality. If Keystone and our customer, working in close collaboration, do handle the design transfer correctly, we can realize lower material and production costs, and shorten the time for the product to reach the market. Most importantly, the result of all that is to generate enthusiasm for the product by the end user.
To get it right, Keystone constructs a Quality Plan and all Manufacturing Assembly Procedures.
The quality plan builds on the testing we conducted on prototypes during Phase 3. We already know the product as designed for the prototype meets specifications and identified product-failure limits when stressed to well beyond specifications. Our quality plan must ensure the transfer of solid design and testing documentation, and set any inspection and analysis procedures to ensure quality is maintained and validated during the manufacturing process.
Manufacturing Assembly Procedures
A key element in setting MAPs requires planning for and assessing compliance with any regulatory requirements. This is especially essential for medical devices to meet a company’s business and financial objectives. Because regulatory compliance is so important for many of the products that Keystone develops, we realize that careful attention to those issues during the design process helps ensure quality features are built in during manufacturing. Working with with a contract manufacturer, we coordinate methods to manage all documents connected with design transfer.
Setting assembly procedures verifies that each product is built according to specifications. MAPs also set down assembly, inspection and production test methods. Any regulatory compliance efforts coordinated with contract manufacturers help assure the manufactured products meet reliability, quality, budget and scheduling goals.
Whether a developed product falls under regulatory compliance or not, MAPs allows Keystone and our customer to verify lead times for component and sub assemblies, identify contractions and production bottlenecks in the manufacturing process, and set supply chain and spare parts requirements.
Equipment and Production Quotes
In the design transfer phase, Keystone can design, build and qualify the manufacturing equipment and fixtures needed for the product. As we move into production, Keystone will transfer any equipment and fixtures we built to the manufacturer’s location. We can also qualify contracted manufacturers and suppliers to produce the product to meet all specifications and comply with any regulatory requirements.
Keystone will submit final production quotes and place purchase orders with all suppliers.
Yet this isn’t the end of a new product’s development. In Phase 4, we are on the verge of manufacturing and releasing a product onto the market place. We will still need to go through Phase 5 to validate the product’s design from the actual manufacturing process.