Design and development

Open: More > Design & Development. Typical preparer: Engineer or Quality Manager. Release authority: Quality Manager or administrator.

Build a design project

1. Open a project with a title and product description. Norma assigns a DP reference.
2. Record the design and development plan: responsibilities, stages, review points, and the evidence to be produced.
3. Record inputs: the requirements and constraints the design must meet.
4. Record outputs: the drawings, specifications, software, instructions, or other deliverables defining the result.
5. Address design reviews, verification, and validation. Each control accepts explanatory text or an explicit Not applicable selection.
6. Choose Save project. Review all fields together before submission so related information is preserved consistently.
7. The authorized user selects Release when the checklist on the Release card is complete and the technical evidence supports the decision. The button does not appear until every gate is met.

Understand the three controls

Control	Practical question
Review	Have the relevant people examined progress, suitability, and issues?
Verification	What evidence compares design outputs with the specified inputs?
Validation	What evidence addresses the product's intended use under the conditions you evaluated?

Use evidence references and dates. For example, identify the test report and reviewed revision rather than writing only “test completed.” An N/A checkbox is a recorded selection, not permission to omit work required by your own applicable requirements.

Trace inputs to outputs, verification and validation

On the project's Overview, the Traceability card works in one of two modes, chosen by a quality manager under Design control mode with Set mode:

• Summary (8.3 narrative): each input is covered by a written note. Use Add a design input (7.3.3), then Record what covers an input and Record coverage.
• Traced (7.3 design control): each input is traced to records. Release then requires, for every applicable input, a mapped output that is verified, a validation, a ruling at a design review with every issue raised there resolved, and the transfer to production recorded. Each is checked per input, not once for the project.

In traced mode:

1. Add inputs with Add input and outputs under Add a design output (7.3.4) with Add output. Under Map an output to an input, choose both and select Map.
2. Under Record verification or validation (7.3.6 / 7.3.7), choose the activity, its target (an output for verification, an input for validation), the method, acceptance criteria, date, who performed it, and Pass or Fail, then Record run.
3. A failed run stays on the record and keeps blocking release until a quality manager uses Approve a deviation on a failed run with a reason. The run still reads failed.
4. Under Record a design review (7.3.5), enter the stage, date, participants and conclusion, and rule on each input: Accepted, Accepted with actions, or Not accepted. An input that was not plainly accepted needs its issue written. Close issues with Resolve a review issue.
5. Under Record transfer to production (7.3.8), record what was transferred, the receiving process, and who verified it on what date, then Record transfer. If transfer does not apply, a quality manager sets Transfer applicability.
6. A quality manager can exclude an input with Exclude an input from this design, giving the reason.

The trace matrix shows each input's state: No output, Not verified, Not validated, Review open, Traced, or Not applicable. The Release card lists every gate with a tick; Release appears only when all are met. The traceability record does not cover risk management: Norma holds no ISO 14971 risk management file, and the card says so in traced mode.

After release

The released project is no longer an editable draft. Use Record change to describe a design change after release. The app retains that entry with actor and date. Coordinate controlled execution through Change Control where needed and update the authoritative drawings, configuration baseline, inspection plan, and product index separately.

The design module retains a structured design record; it does not replace CAD, simulation, test execution, or your technical approval process. If your shop builds entirely to customer drawings, resolve design applicability in the signed scope rather than assuming that a hidden or unused module establishes an exclusion.

Completion check: plan, inputs, outputs, reviews, verification, and validation are addressed; in traced mode every applicable input reads Traced and every failed run has an approved deviation; evidence references identify the released configuration; Release attribution is present.

In the user guide

This article is chapter 17, "Design and Development", of the NormaQMS User Guide (NORMA-UG-001), which is under Help > User guide. Chapter numbers in the text refer to that guide.