Introduction
In modern industry, ensuring the safety of industrial machinery, workers and complying with current regulations is an unavoidable priority. Regulation (EU) 2023/1230, together with the Machinery Directive 2006/42/EC and Royal Decree 1215/1997, establish clear requirements to protect those who operate or interact with industrial machinery.
However, retrofitting a machine is not just about installing a sensor or a barrier. To achieve a real, sustainable and compliant level of safety, a holistic approach is required: a comprehensive project, addressing all technical, legal and operational aspects from a global perspective.
Apply a structured and proven methodology, carrying out a turnkey project. turnkey project project, combining normativeengineering , technical design, adaptation, functional validation and document management, ensures a complete and seamless execution.
What does “turnkey” mean in machinery retrofitting?
A turnkey project implies that the supplier assumes full responsibility for the entire process of adaptation, from the initial diagnosis to the final delivery in compliance with regulations.
This allows the customer to have a comprehensive industrial safety solution, with a single technical interlocutor, absolute control of traceability and the guarantee of legal and functional compliance.
What phases are included in a turnkey project of machinery adaptation?
Turnkey machinery retrofitting projects must be developed following clearly defined phases that ensure consistency, control and regulatory compliance at each stage.
PHASE 0. Functional Safety Plan (FSP) and initial diagnosis
- Complete inventory of equipment and machine assemblies.
- Review of existing technical documentation (dossiers, risk assessments, CE declarations).
- Analysis of compliance with applicable regulations.
- Preparation of the Functional Safety Plan (FSP), which defines the scope and expected safety requirements.
This phase establishes the technical and regulatory basis of the project, on which the adaptation actions are built.
PHASE 1. Risk assessment and safety requirements
- Risk assessment according to UNE-EN ISO 12100.
- Determination of the required Performance Level (PLr) according to UNE-EN ISO 13849-1.
- Elaboration of the Checklist of Essential Health and Safety Requirements (Annex I of the Machinery Directive).
- Verification of compliance with RD 1215/1997.
The result is a technical and operational risk map, the basis for subsequent engineering solutions.
Analysis of electrical diagrams and calculation of safety levels.
- Study of electrical and control diagrams.
- Calculation of safety levels achieved (PL) according to UNE-EN ISO 13849-1.
- Preliminary validation of the safety PLC software and control architecture.
PHASE 3. Engineering of technical solutions
- Design of guards, enclosures, handrails, walkways and platforms according to EN ISO 14120 and EN ISO 14122.
- Integration of active safety systems (photocells, laser scanners, light curtains, safety relays).
- Redefinition of access and safe areas, prioritizing ergonomics and maintainability.
- Preparation of technical report, plans and execution budget.
Intervention and Appropriation Instructions (LOTO)
- Preparation of the Technical File in accordance with Annex VII of Directive 2006/42/EC.
- Advice on the drafting of the Instruction Manual (Annex I, point 1.7.4).
- Generation of the CE Declaration of Conformity and CE plate model.
- Follow-up of the execution of measures and final verification.
PHASE 5. Documentary execution and CE marking
- Preparation of the Technical File in accordance with Annex VII of Directive 2006/42/EC.
- Advice on the drafting of the Instruction Manual (Annex I, point 1.7.4).
- Generation of the CE Declaration of Conformity and CE plate model.
- Follow-up of the execution of measures and final verification.
PHASE 6. Functional validation and PL verification
- On-site testing of safety functions according to UNE-EN ISO 13849-2.
- Verification that the PL achieved matches the required PLr.
- Issuance of the Functional Validation Report.
PHASE 7. Final review and certification
- Integral verification of corrective measures.
- Validation of compliance with RD 1215/1997 and the Machinery Directive.
- Issuance of the Certificate of Conformity that certifies the full adequacy of the installation.
Benefits of the turnkey model in machinery adaptation projects
- A single technical interlocutor who centralizes all management.
- Guaranteed and documented regulatory compliance.
- Reduction of legal and labor risks.
- Optimized planning with minimum production interference.
- Full traceability and auditable documentation.
- Real functional security, not just formal.
Limitations of the turnkey model in machinery retrofitting projects and how to mitigate them.
- Less flexibility during execution → avoided by defining the scope with precision and continuous communication.
- Higher initial investment → offset by reducing reprocessing and risks of penalties for non-compliance.
- Dependence on a single supplier → mitigated by technical solvency and proven experience.
- Integration with existing systems → provide for prior compatibility audits.
- Risk of longer lead times → coordinate with scheduled shutdowns and evaluation of time reduction due to reprocessing between different industrialists.
- High documentation requirements → define the customer-supplier information flow from the beginning.
Cases in which a turnkey project is not advisable in machinery adaptation projects.
Although the turnkey model is very effective, there are situations where it is not the most appropriate or proportional option.
1. Facilities under continuous redesign
🔹 Alternative: progressive adaptation by phases as the line stabilizes.
Machinery with shared integration
🔹 Alternative: technical coordination and suitability consulting between manufacturers and integrators.
3. Newly acquired equipment
🔹 Alternative: independent post-installation compliance verification.
4. Partial interventions on safety systems
Before acting, it must be assessed whether the modification is substantial, as it could invalidate the manufacturer’s CE marking.
🔹 Alternative: prior technical-legal impact analysis; if not substantial, documented action; if substantial, new integral adequacy process.
5. Equipment without technical documentation
🔹 Alternative: documentary audit and reconstruction of the technical file.
6. R&D or prototyping environments
🔹 Alternative: operational safety protocols and dynamic risk assessments.
In a nutshell
The turnkey model is ideal when you are looking for a complete, certifiable and traceable adaptation in stable and well-documented environments.
But in changing contexts, with external dependencies or documentary limitations, Proden Group offers modular and consultative solutions in industrial safety, always guaranteeing safety, legality and technical proportionality.
At
Proden Group
we analyze each case with rigor and honesty.
Our priority is not to offer a closed format, but the most coherent and adequate solution to the real needs of each client.
Because industrial safety is built on trust and technical criteria:
will never propose a turnkey project if it is not what you really need.
