CE • ISO 12100 • audit trail
Machine Risk Assessment
built on ISO 12100 logic, not a loose spreadsheet
Safety Software takes your team through the full risk assessment flow: machine limits, hazard identification, risk estimation and evaluation, selection of risk reduction measures, and residual risk assessment. The outcome is coherent technical reasoning and a report where the logic can be reconstructed decision by decision.
For teams that need to show their reasoning, not just attach a table to the technical file
ISO 12100
machine limits, hazards, risk
Risk reduction
risk reduction measures and residual risk
Audit trail
author, time and rationale for changes
Documentation
full risk assessment generated from process data
The real value is continuity of reasoning.
The system makes sure the risk assessment does not stop at a hazard list. Every lifecycle phase, hazardous situation and hazardous event can lead to estimation, evaluation, a risk reduction measure, validation evidence and residual risk.
ISO
12100
assessment flow: limits, hazards, risk and reduction
▲ UP
12
phases
transport, assembly, operation, maintenance, jam clearing and scrapping
▲ UP
1
trail
one consistent history of changes, decisions and accountability
▲ UP
Machine lifecycle phases
transport -> assembly -> installation -> commissioning
normal operation -> setting-up -> cleaning
maintenance -> jam clearing -> diagnostics
dismantling -> scrapping
For each phase:
task/zone -> hazard -> hazardous situation
-> hazardous event -> possible harmFrom machine limits to hazardous situations
A solid risk assessment starts before the first hazard is even listed.
ISO 12100 does not start with a table full of columns. It starts with defining the machine limits: intended use, reasonably foreseeable misuse, operating modes, hazard zones, exposed persons and lifecycle phases.
Safety Software lets you work through transport, assembly, installation, commissioning, normal operation, setting-up, cleaning, maintenance, jam clearing, diagnostics, dismantling and scrapping. Only against that background does it make sense to describe hazards, hazardous situations and hazardous events.
That is how risk stops being a rough guess and becomes the result of a clear chain: lifecycle phase → task/zone → hazard → hazardous situation → hazardous event → possible harm.
- machine lifecycle phases as mandatory assessment context
- zones, tasks and exposed persons linked to hazardous situations
- hazards derived from context, not copied from a checklist
Assessment method and rationale for the criteria
Risk estimation has to be readable, whatever method you choose.
Risk assessment can be qualitative or semi-quantitative. But a scale on its own proves nothing if the team cannot explain why specific criteria were adopted.
Safety Software helps you retain the rationale for severity of harm, exposure, probability of the hazardous event and possibility of avoiding harm. That means the result of estimation and evaluation is not just a lonely number, but a technical decision grounded in the machine context.
- qualitative or semi-quantitative method selected to fit the project
- criteria rationale: severity of harm, exposure, probability and possibility of avoidance
- estimation result linked to evaluation and the risk reduction decision
Estimation rationale
severity of harm: S
exposure: E
probability of the event: P
possibility of avoiding harm: A
result -> evaluation -> risk reduction decisionEvidence for the risk reduction measure
B/C standard
PLr / PL
stopping-time measurement
safety distance
guard selection
test protocol
instruction
acceptance checklistValidation of risk reduction measures
A risk reduction measure needs evidence, not just a description.
Risk reduction does not end when someone types in a guard, an interlock or a procedure. What matters to a technical customer is whether the measure has evidence proportionate to the risk and whether it can be tied to a specific hazardous situation and hazardous event.
Safety Software helps you keep that evidence with the risk reduction measure: B/C standard, PLr/PL calculation, stopping-time measurement, guard selection, safety distance, test protocol, instruction or acceptance checklist. That strengthens full risk assessment documentation and cuts the risk of hollow declarations in the conformity process.
- risk reduction measure assigned to the hazardous situation and hazardous event
- validation evidence: standard, calculation, measurement, protocol, instruction or checklist
- residual risk assessed after the measure is applied and verified
The difference shows up when you have to reconstruct the reasoning
The question is not whether a tool can produce a table. The question is whether it shows the link between lifecycle phase, machine, hazard, hazardous situation, hazardous event, risk reduction measure, validation evidence and residual risk.
| Spreadsheet | Document generator | Safety Software | |
|---|---|---|---|
| Machine limits as the starting point | Partly manual | Partly description | Yes assessment structure |
| Machine lifecycle phases | Partly list | Partly section | Yes risk context |
| Link between tasks, zones and hazardous situations | Partly columns | Partly form | Yes data relationships |
| Rationale for the risk estimation method | Partly scale | Partly description | Yes criteria + reason |
| Estimation and evaluation before and after reduction | Partly columns | Partly description | Yes full process |
| Validation of the risk reduction measure | Partly attachment | Partly mention | Yes evidence at the decision |
| Residual risk visible in the documentation | Partly comment | Partly section | Yes part of the decision |
| Change history and accountability | None file copies | Partly PDF version | Yes audit trail |
| Full risk assessment documentation | Partly manual assembly | Yes PDF | Yes PDF + history |
Yes
Partly
None
Don't wait for 2027. You need to factor in the new regime now.
Machinery Regulation 2023/1230 is already in force, and some of its provisions apply before 20 January 2027. That date marks the key moment when the new regime becomes fully mandatory in place of the Machinery Directive 2006/42/EC. Manufacturers should already be reflecting the new requirements in risk assessment, machine classification, full risk assessment documentation and planning of the conformity assessment route — especially where a product may fall under Annex I Part A or B. For machines or related products that may be classified under Annex I Part A or B, analysis against Regulation 2023/1230 should not be postponed until 2027. At the design stage, you need to establish the correct product classification, the possible conformity assessment route and whether notified body involvement will be required.
What really changes when you move from a file to a risk assessment model
This is not interface cosmetics. It is a shift from a hand-edited document to a process that preserves the relationships between ISO 12100 elements.
| Working document | Safety Software | |
|---|---|---|
| Machine limits | description next to the table or in a separate file | part of the assessment structure linked to the next steps |
| Lifecycle phases | often described broadly or ignored outside normal operation | transport, assembly, installation, commissioning, operation, setting-up, cleaning, maintenance, jam clearing, diagnostics, dismantling and scrapping |
| Hazards | list of items, often with no relation to the task | linked to zone, task, hazardous situation and hazardous event |
| Assessment method | scale with no explanation of the adopted criteria | rationale for severity of harm, exposure, probability and possibility of avoidance |
| Risk reduction | text description that is hard to verify after changes | risk reduction measures with before/after assessment, validation evidence and residual risk |
| Validation | evidence scattered across attachments or email | B/C standard, PLr/PL, measurement, guard selection, protocol, instruction or checklist at the decision |
| Changes | overwritten cells or successive file versions | change history, author and decision rationale |
| Report | manual assembly of material for the file | report generated from the same model the team worked in |
This is a tool for people who take responsibility for technical decisions
A year after a retrofit, it is not enough to remember that 'the table said so'. You need to show the assessment path: lifecycle phase, machine limits, hazard, hazardous situation, hazardous event, risk, measure, validation evidence and the result after reduction.
The biggest value is not the PDF itself. The value is that the team can reconstruct why a given risk was judged acceptable after a specific risk reduction measure was applied.
machine risk assessment and risk documentation
The system does not pretend risk assessment is a form. It treats it like an engineering process where every element is connected to the step before and the step after.
ISO 12100 logic in the application
Common questions about machine risk assessment
Does Safety Software replace ISO 12100?
No. The system does not replace the standard or engineering responsibility. It helps you work through ISO 12100 logic in a structured way: from machine limits, through hazards, hazardous situations, hazardous events and risk assessment, to risk reduction measures and residual risk.
Can you start with a single machine?
Yes. The best starting point is one real machine, retrofit or workstation where you can properly describe machine limits, operator tasks, hazards, hazardous situations, hazardous events, risk reduction measures and the required risk assessment documentation.
Does the system help with design changes and retrofits?
Yes. That is exactly where the advantage of a model over a file becomes obvious: you can return to the previous assessment, point to the changed hazardous situation or hazardous event, reassess the risk and keep the decision history.
Is the report enough to count as full risk assessment documentation?
The report is the structured output of the process, but full risk assessment documentation should also retain the machine context, applicable standards, the chosen assessment method, the rationale for the criteria, validation of protective measures and the responsibility of the manufacturer or integrator.
Build a risk assessment that shows your reasoning
Start with one machine and run the full path: lifecycle phases, machine limits, hazards, hazardous situations, hazardous events, estimation, evaluation, validation of risk reduction and residual risk. No breaking the process into loose files.
Get started in Safety SoftwareThe best start is one real machine where you can show the full chain of technical decisions.
From the knowledge base
Practical articles on risk assessment, machinery directives and compliance — supporting this product page.