The customer prepared a risk assessment report on their own, believing they had "already done it in accordance with EN ISO 12100."
The report contained only a hazard list, with no risk assessment matrix, no measure verification, and no residual risk description. It was returned by the NB three times.
Rebuilt the risk assessment structure: hazard identification → risk estimation → risk evaluation → measures → residual risk. Recalculated the safety circuit PL level in accordance with EN ISO 13849-1 and supplemented the verification calculation report. Added a dedicated laser radiation assessment and interlock device verification records. Prepared instructions in the official EU languages and supplemented residual risk disclosure.
The fourth submission passed the NB review. The total project duration was extended from an estimated 25 days to 61 days.
Risk assessment is a traceable chain, not a single table. The PL level must be consistent across three aspects: "written in the documents, implemented in the physical product, and verifiable in the records." The language versions of the instructions are a mandatory requirement of the Machinery Directive, not an option.