Specific considerations

The design process has types of activities whose specificities must be taken into account in the quality assurance system. The basic activities in the design process are the following:

• Planning

• Inputs and requirements

• Verification and validation

• Change control and outputs.

Planning

In the area of planning, every organization involved in design should plan the activities at the earliest opportunity, according to their scope, and in a chronological and documented way. The plans should include, where appro­priate, the following:

• Scope of work

• Schedule of activities

• Inputs from disciplines such as safety, reliability, human factors and standardization

• Design methods

• Requirements (software, tests)

• Verification and validation activities

• Training requirements

• Controls and assessments.

Inputs and requirements

As for design inputs, procedures should be established in order to ensure that data and their modifications are adequately identified, documented, approved and controlled. Procedures should assure that data have enough detail to allow the development of the associated activities. Examples of design inputs are the following:

• Functional and performance requirements

• Applicable codes, regulations and standards

• Technical parameters such as pressure and temperature, among others

• Physical requirements such as mechanical, chemistry, electrical and structural, among others

• Requirements to prevent undue risk to the health and safety of the public

• Maintenance, reliability and test requirements

• Experience feedback

• Probabilistic safety analysis

• Human error prevention

• Interface requirements.

Analysis of design criteria should be performed in order to confirm or clarify the design basis parameters. The analysis, addressing the general criteria specified for the project, should be sufficiently detailed and docu­mented to enable assessment by qualified personnel other than those who carried out the analysis.

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