Evaluation of design and outputs: purpose
The design and output evaluation is part of design and development, and more than one evaluation is permitted as the product matures.
What clause 9.2.1 asks
The design and output evaluation belongs to the design and development work. It may be run more than once as the product matures. The clause does not ask for a single gate at the end; it asks for evaluation to be part of the build and to be repeated when the product changes enough.
Why it matters
The permission to evaluate more than once is also a warning. A product that matures through several design iterations should not rely on the first evaluation. The clause expects the evaluation to follow the design, so a change to the user interface, the data or the model can create a new reason to evaluate. The evaluation is not a compliance event at the end; it is a design activity.
What good looks like
Put the evaluation on the design schedule, not only on the release schedule. Define the points at which a new evaluation is required, such as a change to the model, the data, the interface or the target population. Record each evaluation and the design version it examined. Then use the findings in the next design decision, not only in the release note.
Evidence an assessor asks for
The assessor will ask which design version was evaluated. An evaluation that does not name the version cannot be tied to the product that shipped.
- Design schedule The evaluation points in the design and development stages
- Evaluation records Each evaluation, its date and the design version it examined
- Trigger list The changes that require a new evaluation
- Design decision log The design decisions that followed an evaluation finding
Where it commonly fails
- The evaluation happens once, at the end
- A design change ships without a new evaluation
- The evaluation is not on the design schedule
What to do before publication
Agree the evaluation points with the design lead at the start of the build.
Read across
- 9.1 Purpose
- 9.2.2 Evaluation of design and outputs: inputs
- 9.2.3 Evaluation of design and outputs: outputs
- 9.2.4 Evaluation of design and outputs: actions
← 9.1 Purpose9.2.2 Evaluation of design and outputs: inputs →