# Machine Risk Assessment Checklist Based on ISO 12100 > Source: https://netray.co/tools/machine-risk-assessment-iso-12100-checklist > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer A structured checklist for the ISO 12100 risk assessment process on a new or modified machine, with critical items flagged. ## Category compliance-legal ## Industry Industrial Machinery ## Audience - Safety engineer - Machine designer - Quality manager ## Tool **Kind:** checklist **Groups:** #### 1. Machine limits **Items:** **Text:** Intended use and reasonably foreseeable misuse are written down **Critical:** true Operating modes defined (automatic, manual, setup, maintenance, cleaning) Space limits recorded (range of movement, clearances, access) Time limits recorded (lifespan, service intervals) Operator, maintenance and other user groups and skill levels listed Environmental limits recorded (temperature, dust, washdown, explosive atmosphere) Interfaces with other machines and utilities listed #### 2. Hazard identification **Items:** **Text:** Mechanical hazards identified (crushing, shearing, entanglement, ejection) **Critical:** true Electrical hazards identified (contact, stored energy, arc) Thermal hazards identified (hot or cold surfaces) Noise and vibration hazards identified Hazards from materials and substances identified (dust, fumes, fluids) Radiation and laser hazards identified where relevant Ergonomic hazards identified (posture, lifting, controls layout) Hazards during all life phases considered: transport, installation, commissioning, use, decommissioning Hazardous situations and events listed for each hazard #### 3. Risk estimation and evaluation **Items:** **Text:** Method for severity, exposure and avoidance defined and applied consistently **Critical:** true Risk estimated for each hazard before measures **Text:** Required performance level (PLr) or SIL set for each safety function **Critical:** true Risk evaluated against acceptance criteria Assessment covers all users and all operating modes #### 4. Risk reduction **Items:** **Text:** Inherently safe design measures applied first **Critical:** true Safeguarding (guards, interlocks, light curtains) applied for remaining risk Information for use (manual, signs, training) used only for residual risk **Text:** Safety functions designed and verified to required PL or SIL **Critical:** true Emergency stop function provided and checked Lockout and energy isolation points provided New hazards introduced by each measure checked Risk re-estimated after measures #### 5. Validation and documentation **Items:** **Text:** Safety functions validated by test and recorded **Critical:** true Standards applied and editions recorded Risk assessment retained in the technical file Residual risks communicated in the instructions Assessment reviewed after any modification or incident Assessor names, roles and dates recorded **Scoring Note:** Tick each item you can evidence. Any unticked critical item means the assessment is not ready to support CE marking or release. This checklist follows the structure of ISO 12100 but is not a replacement for the standard or for qualified safety assessment. ## Content **Intro:** A risk assessment under ISO 12100 is the base of every CE-marked machine technical file. This checklist walks through the five stages, from machine limits to validation, so nothing is skipped before release. **Sections:** #### How to use the checklist **Body:** Run it with the design lead, a controls engineer and someone from service or operations. Tick what you can evidence by document, drawing or test record, not what you believe is true. Keep the filled checklist with the risk assessment file and repeat it on each major change. A short checklist run at design freeze catches more than a long audit at delivery. **Bullets:** - Include service and operator voices - Keep evidence links, not only ticks - Review at design freeze and before shipment - Re-run after any modification #### The three step method **Body:** ISO 12100 asks you to reduce risk in a fixed order: first by inherently safe design, then by safeguarding and complementary protective measures, then by information for use. Warning signs and training are the last resort, not a substitute for a guard. Group four of this checklist follows that order, and auditors check it. #### Worked example **Body:** On a pallet wrapper, crushing at the turntable is identified in group two. Severity is serious, exposure is frequent, avoidance is possible only with a slow table speed. Design reduces speed and removes pinch gaps, a perimeter guard with an interlock covers the rest, and the interlock function gets a required PL d. The result is recorded and validated by test. #### Common mistakes **Body:** Assessing only normal operation and forgetting setup, jam clearing and cleaning, where most injuries happen. Others set risk scores to justify the existing design instead of the reverse. Also frequent: no re-assessment after a customer modification, and no link between hazards and the safety functions that control them. **Cta:** If you want the risk assessment, safety function register and technical file linked to each machine serial number in your ERP, we can help scope it. **Faq:** #### Is a risk assessment legally required for CE marking? **Answer:** Yes. Under the EU Machinery Directive and the Machinery Regulation, the manufacturer must carry out a risk assessment and document it in the technical file. ISO 12100 is the standard method most often used. #### How often must it be updated? **Answer:** Whenever the design, intended use or operating conditions change, and after relevant incidents or new findings. There is no fixed calendar interval, but a review at each design release is good practice. #### Who should perform it? **Answer:** A cross functional team with knowledge of the design, operation, maintenance and safety standards. The manufacturer remains responsible even if consultants support it. #### Does this replace a third party review? **Answer:** No. Some machines listed in Annex IV of the Directive need a notified body or specific procedures. This checklist helps you prepare but does not replace formal assessment where required. ## Search terms machine risk assessment checklist, iso 12100 risk assessment template, machinery hazard identification checklist, ce marking risk assessment, risk reduction three step method, machine safety assessment form, machine builder risk assessment, pre-delivery safety checklist --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json