As we move into actual production of the new product that Keystone and our customer have worked to develop, there’s another level of of tests we need to carry out: validation of the design and manufacturing process.
We already verified the product design during extensive tests of prototypes in Phase 3. In essence, we tested the prototype we built to verify that it met all functional and appearance specifications. Those tests told us that the product when built to the design we came up with works as intended.
In the design validation phase, we confirm through examination and objective evidence that the manufacturing process results in a product that consistently meets design specifications, and that the end product conforms with user needs and its intended use. Keystone’s planning for validation begins early in the design process. We determine what performance characteristics should be identified and assessed, and establish validation methods and acceptance criteria. If the product design is complex, Keystone will set up a schedule of validation actions and assign organizational responsibilities to facilitate control over the process. Any validation plan needs to be reviewed for completeness and appropriateness, along with assurance that intended uses and user needs are addressed.
Because much of our product development has involved medical devices, Keystone is intimately familiar with the U.S. Food and Drug Administration’s requirements for clinical evaluation and tests conducted in actual or simulated use. The lessons we learned meeting FDA regulations covering product validation methods can be valuable when reviewing validation methods for many of the non-medical products we develop.
Testing for design and process validation should be on products and devices manufactured in the same manner and process planned to be employed for ongoing production. For instance, some manufacturers may be inclined to use their best assembly workers or skilled technicians to build articles that will be subjected to tests. If this is allowed, however, it can obscure problems in the manufacturing process that less skilled workers may be unable to overcome. Certainly it can be wise to have the best workers try out the process so they can offer their own evaluations and critiques. Pilot production, however, needs to simulate the actual manufacturing conditions for the validation method to be accurate.
Validation methods should also cover product packaging and labeling. Where design verification establishes a product works as intended, faulty labeling and instructions may leave the intended user unable to know how to make the product work. The packaging material may even cause problems during shipping. Some packaging can throw off an electrostatic discharge that could cause an electronic device to fail, but the problem will go unnoticed if pilot products are taken for testing without being packaged first.
Exposure to anticipated environmental conditions, such as humidity, temperature, vibration and shock, and even extreme conditions such as corrosive atmospheres should be considered for validation tests. It’s not just the environment during a product’s anticipated use, but the environments during manufacturing, shipping and storage that can impact the product.
Review and Documentation
Besides discovering problems in the manufacturing process, validation may reveal deficiencies in original assumptions about intended uses and user needs. During this phase, we will review any such deficiencies that arise, and determine how best to resolve them.
Validation documentation compiles the results of all validation activities. For a complex design, the documentation for detailed results may be voluminous, though summarized in a validation report. A final validation report that resolves all issues uncovered allows the product to finally reach the market, though periodic, ongoing testing may continue to ensure no faults slip into the manufacturing process.
The five phases of Keystone’s product development can help bring your idea into shape and reality, allowing the product you envisioned to find its place in market.
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