Annex IV readiness audit

The problem this solves

The technical file under Regulation (EU) 2023/1230 is assembled from many sources, and only some of its content can come from the system model. Teams work out which by opening the model and guessing, usually the week the writing starts. This audit answers it item by item, in the Regulation's own order, with the element IDs behind every judgment.

How it works

Which Annex IV items the model can already support, which need a few additions, and which live elsewhere. Walks Annex IV Part A in the Regulation's order: what each item asks for, what the model holds toward it with counts and IDs, and whether the gap is closable in the model or belongs to CAD, EDA, the test lab or technical writing. Proposes the applicable Annex III chapters for the team to confirm.

Where this sits in the Regulation

Regulation (EU) 2023/1230 replaces the Machinery Directive and applies from 20 January 2027. Annex IV Part A lists what the technical file must contain, and the file must be kept for ten years after the machine is placed on the market. This audit reads the model and reports gaps: it is a readiness check, not a conformity assessment.

Audit the connected Dalus model for readiness to support the technical documentation required by Regulation (EU) 2023/1230, Annex IV Part A. Do not modify the model.

Step 1. Read everything: the system part and its notes and attributes, subsystems, parts, ports, connections, flows, global variables, requirements (type, priority, status, constraints, verifications, assigned systems), hazards (severity, likelihood, residual values, disposition, assigned systems and connections, mitigating requirements, notes), test cases (linked requirements, systems, runs, attachments), and any states, transitions and actions.

Step 2. Machine characterisation. State what the machine is from the system part. Propose which Annex III chapters apply: Chapter 1 always; Chapter 3 if the machine is mobile; Chapter 4 if it lifts loads; others if the hazards justify them. Note that the general clauses on control system safety and reliability and on protection against corruption apply to any machine with a programmable safety controller. Label this a proposal for the team to confirm. Give one model element as rationale per chapter.

Step 3. Item-by-item readiness. For each Annex IV Part A item in the Regulation's order, report:
- What the item requires, in one line
- What the model contains toward it, with element counts and IDs
- What is missing
- Closable in the model, or belongs to another system (CAD, EDA, test lab, technical writing, quality)
- Readiness: ready, partial, not in model
Apply these tests:
(a) Description and intended use: system part has notes; every subsystem has at least one attribute and a note; intended use is stated somewhere in the model.
(b) Risk assessment documentation: at least one hazard; every hazard has mitigating requirements; every hazard has residual severity and likelihood; every mitigating requirement is linked to a test case; dispositions of "accepted" have a rationale.
(c) Drawings and schemes: report only whether parts carry Onshape links or linked documents. Everything else belongs to CAD and EDA.
(d) Explanations of drawings and operation: every connection has a flow; every flow has a quantity with a unit; every port is connected; the system has states and transitions.
(e) Standards applied: report which requirements and test cases cite a standard by number, and which safety requirements cite none. Do not judge currency.
Test reports item: every requirement has a verification method; safety requirements have a test case with a Passed run.
Instructions and declaration items: not in model. Report only that residual risks from (b) can feed the instructions.

Step 4. Findings list, ranked: safety-relevant gaps first (hazards without mitigation, safety requirements without verification, missing residual risk), then structural gaps (missing flows, unconnected ports, no states), then documentation gaps (missing notes, no intended use).

Step 5. Provenance: the element IDs behind every finding.

Output: a findings report with a readiness table (one row per Annex IV item) at the top, the chapter proposal, the ranked findings, and provenance. State clearly that this is a readiness check of the model and not an assessment of conformity.

What you get

Common questions