Avoiding time delay in product certification

Basic problem in the product certification process is the time delay. Designing a product is an iterative process and always contains contradictive requirements. Besides, if the development time is long enough other requirements pop up or become more important then the first selected assumptions. The biggest problem that occur in the certification process is confusion. This confusion is delaying the process and can result in repeating submittals. How to avoid this?

  • First suggestion for the engineering phase, to avoid problems later on in the compliance demonstration and acceptance phase, is therefore to officially freeze your design and report the most important requirements including the chosen values and assumptions. This can be seen as the boundary conditions of the design. This is important to judge the validity of the performed verification and tests on key characteristics.
  • Second suggestion is to define a product-break-down structure. The essence is to make such a structure that it acts as a boundary in the design phase and impact of changes can be easily detected/discussed and accepted.
  • Third suggestion is to number that structure in a systematic uniquely way and designate the design. Designating the design avoids confusion in the design projects that are running in parallel. The numbering, configuration identification numbering, helps to identify the exact design that has been or will be demonstrated since the design will evolve as a result of improved insight or demands.

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