The results that must be achieved by the design and development process are those that the organization has deemed necessary to achieve its objectives and to adhere to customer needs and stakeholder expectations.
The design process will most likely be unique to each new product or service, although each may be based on a particular design and development strategy. Without an objective or standard against which to evaluate the performance of the process, however, there is no basis for defining it as truly "under control".
The objectives of the design and development process may include, where appropriate:
- all requirements that the product or service should meet (these are the design inputs);
- the requirements that constrain how these requirements must be met (this is the design budget);
- the timeframes within which each phase of the project must be completed;
- the estimated cost to produce the product or provide the service.
To demonstrate that the results to be achieved through the process have been defined, it is sufficient to present a design and development plan that includes the statements of the process objectives and the criteria for determining whether these objectives have been achieved. Section 8.3.4b of ISO 9001: 2015, then, requires a design review to verify its suitability and adequacy with respect to the design requirements or the effectiveness of an object in achieving the established objectives.
In this context, "suitability" means that an adequate design solution has been developed, "adequacy" means, instead, that the design solution satisfies all the design requirements while "effectiveness" means that the design has focused on the right objective. Design represents a considerable investment on the part of any organization.
There is, therefore, a great need for a formal mechanism to be put in place to assess the main stages of the project and to detect any weaknesses before proceeding to the next phase. Only by proceeding in this way, in fact, can you avoid throwing away work if these problems were detected at a later stage.
The purpose of this review is to determine whether the proposed design solution is the most practical and economical way to meet the requirements and should continue in this way or whether it would be better to change course before moving on to the next phase. Another purpose related to this moment is to determine whether the documentation prepared to address the next phase is adequate or should be rethought or integrated. The review, in essence, is that part of the design control process that measures the performance of the project, compares it with the predefined requirements and provide feedback, so that any shortcomings can be corrected before the project is started to the next phase.
For each design of a product or service, a program of reviews of the different phases of development should be established. In some cases, for example, only one review will be necessary while in others, more complex, it may be necessary to carry out multiple reviews: one to establish whether the design requirements can be met and reflect the customer's needs before the start of the design, one to review the concept of the project itself and establish whether it meets the requirements before starting the definition phase and one, finally, in the preliminary phase of the design to establish that all known risks have been addressed and development specifications have been produced for each sub-element of the product or service before the detailed design begins.
A critical review of the project may then be necessary to establish that the detail of each sub-element complies with the development specifications, a review to prepare for the validation of the project and a final review to ensure that the project meets the requirements of its development specifications before starting the production of the product or the provision of the service.