Clause 7.3.6 Design and development validation

After the design and development verification is completed, the actual product (or service) is produced (or provided). Design validation is checking that the actual physical product meets the original input requirements. This is final stage of the design and development process and is valuable opportunity to prevent serious financial loss. Design and development validation should be performed before delivery of the product to the customer so that any problems can be corrected.

Sometimes it is impractical to perform design and development validation before delivery of the product to the customer. For example: certain types of oilfield equipment, medical prostheses, and customized power saving devices. With these sorts of products, the organization should perform checks on the parts of the final product.

In other cases, performing design and development validation before introducing the new product is required by law, for example, in case of introducing a new medicine.

If the design and development output, in itself, is the actual product (see 7.3.3), then design and development verification and validation are one and the same activity. This may be the case, for example, for an engineering design firm.

Design and development validation should:

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  actual capability of output (7.3.3) to meets input (7.3.2)


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  identify problems (if any) and propose (solution) necessary action
  

Records (4.2.4) of design and development validation and actions taken thereof shall be maintained.

External Document Reference: Documentation Kit

Methodology for Product Design and Development
Design and Development Plan/Review Record