Before the requirements, the risks.
Optima Machine Risk will focus on risk assessment, with EN ISO 12100 as the framework. It is under development: we will discuss it with you during a 30-minute exchange, based on your own approach.
In development
30 minutes via video, free of charge, no commitment required.
Optima Machine Risk is a software product developed by Optima AI. It focuses on the assessment of machine risk, with EN ISO 12100 as the framework. The risk assessment remains the responsibility of the manufacturer, and the resulting decisions are also their responsibility.
The problem · What the text says · On which he will bear · For whom · What he will not do · In the meantime · Your documents · Price · Frequently asked questions
We start with the limits of the machine: its normal use and the reasonably foreseeable misuse. Then come the dangers, the estimation and evaluation of each risk, and then its reduction. And we go back to it: the approach is iterative; each reduction measure is reassessed.
The risk assessment carried out during design does not conflate with the employer’s occupational risk assessment, that of the single document. The INRS reminds of this in its brochure ED 6389. The first is the matter of the manufacturer; the second is that of the employer who uses the machine.
It is she who determines the essential requirements that apply to the machine, and the machine is designed taking its results into account. As long as the design changes, the analysis changes with it.
Whether it is stored in a spreadsheet or a dedicated software program, its conclusions serve elsewhere: the technical documentation summarizes the list of applicable requirements, the protective measures and residual risks, and users must be informed of these residual risks. An analysis that is not up to date dilutes everything that is relevant.
We start with the limits of the machine: its normal use and the reasonably foreseeable misuse. Then come the dangers, the estimation and evaluation of each risk, and then its reduction. And we go back to it: the approach is iterative; each reduction measure is reassessed.
The risk assessment carried out during design does not conflate with the employer’s occupational risk assessment, that of the single document. The INRS reminds of this in its brochure ED 6389. The first is the matter of the manufacturer; the second is that of the employer who uses the machine.
It is she who determines the essential requirements that apply to the machine, and the machine is designed taking its results into account. As long as the design changes, the analysis changes with it.
Whether it is stored in a spreadsheet or a dedicated software program, its conclusions serve elsewhere: the technical documentation summarizes the list of applicable requirements, the protective measures and residual risks, and users must be informed of these residual risks. An analysis that is not up to date dilutes everything that is relevant.
Optima Machine Risk will focus on risk assessment, with EN ISO 12100 as the framework. We are developing it, and we will describe its functions only once they exist: this page does not present a software that does not yet exist.
It will be located in the Design and Risks section of Optima Compliance, alongside Optima Machine Design, which drafts the machine’s design documentation.
If risk analysis of your machines is on your mind today, let’s talk about it: your approach, your documents, what you would expect from such a tool.
Optima Machine Risk will address those who conduct the risk assessment of a machine at the time of its design. Not the employer’s occupational risk assessment: that is a different exercise, with a different document.
In the design office, the risk assessment states which essential requirements apply and guides your design choices. It follows the project until the final plan modification.
Regulation (EU) 2023/1230 includes the risk assessment of interactions between machines that form a system. Each machine has its own analysis; the risks of their interactions are also included in the assessment.
The principles of risk assessment also apply to your approach as a manufacturer of quasi-machines (Annex III, Part B, point 5 of the regulation).
Optima Machine Risk will follow a procedure for which the manufacturer remains responsible. It will not decide anything on your behalf.
We are not selling it today and we are not announcing a date.
None of these agents makes risk assessments. They work around it: on the documents that precede it, or on those that follow it.
Pilot version, with support
Does your risk analysis exist? Optima Doc Creation, in part, along with the functional analysis of the machine, writes the first draft of the instructions manual and indicates what is missing.
Pilot version, with support
On the operator's side, at the workstation: based on the instructions, risk analyses of the machine and your single document, he identifies and classifies the hazards of the workplace, then prepares the safety sheet in the ED 126 format (model from the INRS).
Optima Machine Risk is not yet in service: it does not receive any documents. In Optima Compliance, apart from test tools, your documents are stored in France. They are never accessible to another client. They are not used to train an AI model.
Optima Machine Risk is not for sale today. The 30-minute exchange is used to discuss your case.
The exchange is free of charge.
30-minute exchangeIn the vocabulary of EN ISO 12100, which is adopted by the INRS, risk analysis involves three steps: determining the limits of the machine, identifying dangerous phenomena, and estimating the risks. Risk assessment is the analysis plus evaluation, which determines whether a reduction is necessary. Risk reduction then follows, and the process is iterative.
No. The risk assessment carried out during the design of the machine is not the same as the employer’s occupational risk assessment, that of the single document; the INRS reminds of this in its brochure ED 6389. The first is the responsibility of the manufacturer, the second of the employer.
The manufacturer. Directive 2006/42/EC (Annex I, General Principles, point 1) and Regulation (EU) 2023/1230 (Annex III, Part B, point 1) require him to ensure that it is carried out; the directive also cites his agent. The manufacturer of quasi-machines is also required to do so according to the same principles (Regulation, Annex III, Part B, point 5).
In Annex I to Directive 2006/42/EC, and then in Annex III to Regulation (EU) 2023/1230, which applies from January 20, 2027. They are mandatory. It is the risk assessment that determines which apply to a given machine.
Point 1.1.2(b) sets out an order, the same in the directive and in the regulation. First, eliminate or minimize risks through inherently safe design. Then, take protective measures for those risks that cannot be eliminated. Finally, inform users of residual risks, specifying whether specific training or personal protective equipment is required.
The approach remains the same, in five steps. The regulation adds the foreseeable hazards associated with evolving behavior or logic, according to the levels of autonomy of the machine, and the risks of interactions between machines forming a system (Annex III, Part B, point 1). It applies from January 20, 2027.
It includes: the list of applicable essential requirements, the protective measures implemented and the residual risks. This is point b) of Part A of Annex IV to Regulation (EU) 2023/1230, and Annex VII, A, 1(a) of Directive 2006/42/EC.
Optima Machine Risk is part of the Design and Risks axis of Optima Compliance. Another agent is already working on the design documents.
Pilot version, with support
He or she will draft the design documents for the machine with you, based on the documents from your project. No online testing: we’ll show you the documents during a 30-minute exchange.
To go further:
Machine Regulations 2023/1230: What changes on January 20, 2027 ›
30 minutes via video, free of charge, no commitment required.
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30-minute exchange
Free, no commitment. With our customer relations manager, via video conference, on the task, the file or the machine of your choice.
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