Risk assessment documentation, Annex IV (b)

The problem this solves

Teams run a hazard-first risk assessment, then rebuild it by hand into a clause-ordered table for the file, and the two drift apart at the first design change. From then on every assessor question means reconciling two documents that were supposed to be the same one. Generated from the register, the clause view is simply another ordering of the same data, current every time it is re-run.

How it works

The hazard register rebuilt as the clause-ordered table the Regulation indexes the file by. For each applicable Annex III clause: the hazards under it, the requirements implementing the protective measures, the verification evidence and the residual risk, each clause with a status. The engineering view and the compliance view become one dataset.

Run the audits first

Regulation (EU) 2023/1230 applies from 20 January 2027, and the technical file is kept for ten years after the machine is placed on the market. This workflow generates a document from the model; it is not a conformity assessment, and it assumes the audits have been run and their findings acted on.

1. 01Run the Annex III requirement gap audit and close the gaps it finds, so the clauses this document reports on are backed by requirements rather than listed as not addressed.
2. 02Run the Annex IV readiness audit and have the team confirm the Annex III clause list it proposes: that confirmed list is this workflow's input.
3. 03Run the hazard register integrity audit and close its findings, so the register this document is built from holds together.

Generate the risk assessment documentation for a technical file under Regulation (EU) 2023/1230, Annex IV Part A item (b), from the connected Dalus model. Do not modify the model.

Input: the list of applicable Annex III clauses, pasted below the prompt as clause number and title. If none is pasted, propose the list from the model and mark every clause as "proposed, unconfirmed" throughout the document.

Step 1. Read all hazards with every field, all requirements with statement, customer ID, type, assigned systems and constraints, all test cases with linked requirements and runs, and all parts and connections.

Step 2. Item (b)(i): produce the list of applicable essential health and safety requirements as a table: clause number, title, applicable yes or no, and a one-line rationale grounded in a model element or in the machine type.

Step 3. Item (b)(ii): for each applicable clause, produce a coverage entry:
- Clause number and title
- Hazards under this clause: ID, name, initial severity and likelihood, assigned systems. Assign a hazard to a clause from its description, mishap and harm types. If a hazard maps to no listed clause, put it in a final section "Hazards not assigned to a clause".
- Protective measures: the mitigating requirements, with customer ID and statement. Classify each as inherently safe design, safeguarding or complementary protective measure, or information for use, following the order of the three-step method without quoting any standard.
- Verification: linked test cases with latest run status.
- Residual risk: residual severity and likelihood and disposition per hazard.
- Clause status: "covered" if every hazard under it has mitigating requirements with Passed verification and residual risk is eliminated or negligible; "covered with residual risk" if measures exist but residual risk remains; "not addressed" if the clause is applicable and no hazard or requirement maps to it.

Step 4. Residual risk summary: every hazard with residual risk, its disposition, and whether an acceptance rationale exists.

Step 5. Gap annex, ranked: applicable clauses with status "not addressed"; hazards whose notes describe a control with no mitigating requirement; mitigating requirements with no Passed verification; hazards with no residual assessment; accepted dispositions with no rationale.

Step 6. Provenance annex: the element IDs behind every coverage entry and table row.

Output rules:
- Word document titled "Risk Assessment Documentation, Annex IV Part A (b)", title block with model name, date and revision placeholder.
- Body ordered by Annex III clause number.
- Authored sections, marked as such with a one-line instruction: intended use and reasonably foreseeable misuse; the risk assessment procedure and team; acceptance rationales absent from the model.
- Do not invent hazards, measures or applicability. Do not reproduce standard text.

What you get

Common questions