Design Verification & Validation

Now that the prototype is all done, and it seems to perform well, how do you get the prototype manufactured reliably and at a reasonable cost? If you are at this stage, here are a few things to think about:

Perform Design Verification
Just turning your prototype pump on and seeing fluid flow at the desired volume and pressure is a good start, but we advise that you go further before product introduction and release for production scale. Each requirement (see our Design Requirements Compliance Matrix here) should be verified. Verifying that each product requirement is “working” is the purpose of Design Verification.

Do some field testing
Unfortunately, the probability of any new product surviving its first contact with a customer is not high. Before scaling, let customers run your prototypes through their paces in an as real-world environment as possible. We are always amazed at the learning that comes from early field trials, and the earlier this happens, the sooner these issues can be addressed.

It’s important to understand that you will learn stuff at a build quantity of 5, and different stuff at a build quantity of 50-100, and even different stuff again at a quantity of 500-1,000. Typically, it is wise to ramp production slowly and where possible delay intensive capital purchases (injection molds, production tooling, electronics, etc.) until this learning is complete.

Do not ignore red flags
Any failure, issue, oddity, etc., should be fully vetted in the early stage of product launch. Find the root cause of the failure and implement corrective action before you go any further. It’s important to understand why it failed. Did the user use it outside the specification? Did the manufacturer not follow the instructions/drawings? Do the drawings always produce a product that meets the requirements — tolerance stackup, inadequate QA procedures, etc.

A working prototype is a great first step, but it takes careful planning and a lot of work before your prototype turns into a product that can be manufactured successfully.

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Verification: Design verification seeks to determine that a product meets its design requirements (e.g., confirm that pump meet its requirement to provide 2 liters per minute of flow). Cascon takes responsibility for most design verification. Items such as operating life or reliability may not be included in the planned verification activities.

• Cascon’s responsibilities are explicitly indicated in your project’s Design Requirements and Compliance Review matrix.

Validation: Design validation seeks to determine that the design requirements adequately reflect the requirements for the application (e.g., is 2 liters per minute adequate to lubricate the transmission?).

• Cascon does not typically assume responsibility for validation, but we can support you in the definition and design of such procedures.