Machine safety and compliance
Building or assembling machines and production lines means that the manufacturer must draw up a CE declaration. The CE declaration for an assembly is much more than the sum of the declarations of conformity of each individual sub-assembly.
Machine safety risk assessment
Risk assessment is the basis of every safety study and a crucial part of our services. At Prohead Engineering, we start with a thorough task analysis to identify all possible risks in every phase of a machine's life, from installation and normal use to maintenance and dismantling. We use proven methodologies to guarantee a detailed and comprehensive approach.
An important aspect of our approach is integrated safety. This means that we not only look at adding safety measures afterwards, but also at integrating safety into the design and operation of the machine from the very start. We follow, for example, Machinery Directive 2006/42/EC or Machinery Regulation (EU) 2023/1230, ensuring that risks are eliminated first wherever possible.
Conformity assessment
At Prohead Engineering, we carry out detailed conformity assessments to determine whether your equipment complies with the applicable safety standards. In this phase, we examine, among other things, electrical control cabinets and cabling, safety control systems, and pneumatic and hydraulic equipment. To do so, we analyse the underlying documentation, such as electrical diagrams, cable calculations, pneumatic and hydraulic diagrams, safety software, the shutdown matrix and the performance level calculations.
Our approach includes site visits, a thorough study of the available engineering documents and, where necessary, carrying out missing studies. The results are compiled in clear reports in accordance with EN 60204-1 and ISO 13849-1, with practical recommendations for any modifications. If desired, we also carry out additional technical analyses such as cable calculations or PL verifications.
Verification of performance levels (PL)
At Prohead Engineering, we help you verify the Performance Level (PL) of your safety components. The risk assessment determines which measures must be implemented and which PL is required. Based on these requirements, we design the safety concept.
Our experts can carry out the basic engineering for you and design the safety function according to the required PL. The verification demonstrates that the required level of the entire safety circuit has actually been achieved, which is essential for the reliability of your safety functions. We carry out this verification using specialised software, which allows us to evaluate the performance of your safety components accurately.
In doing so, we follow the relevant standards and legislation, such as ISO 13849, to ensure that your safety functions meet the highest standards.
Validation of safety circuits
At Prohead Engineering, we offer comprehensive services for the validation of safety circuits in machines and installations. Failing to check that these circuits actually work can result in safety functions failing when they are needed, with real safety risks as a consequence.
After design, verification checks whether the required Performance Level (PL) or Safety Integrity Level (SIL) is achieved. Validation then checks whether the function actually works in practice. For new installations, this responsibility lies with the manufacturer. Anyone who assembles or modifies machines is responsible for it themselves. It is recommended to repeat validations regularly.
We carry out both verification and validation in accordance with ISO 13849 and IEC 62061. This is how we guarantee safe and compliant safety functions in your installation.
Technical file
The technical file is a collective term for all parts of the safety study. At Prohead Engineering, we compile comprehensive technical files documenting how the risks have been assessed and reduced. This includes detailed risk assessments, justification of how the essential health and safety requirements have been met, and the verification and validation of the safety controls. We make sure that your technical file is complete and compliant with regulations, so that you can always demonstrate that your machines meet the highest safety standards.
Safety upgrade
Not every existing machine or assembly of machines is still eligible for a full CE declaration of conformity. In such cases, a safety upgrade offers a practical alternative. We carry out a risk assessment based on the Work Equipment Directive 2009/104/EC, which applies to operators. Together with the client, we determine which risks will be addressed and which measures are feasible and desirable.
Prohead Engineering designs these measures, coordinates their implementation and takes care of validation afterwards. This brings existing installations back to a higher level of safety, tailored to how they are used — without having to go through the full CE process.
A safety upgrade combines workable solutions with clear substantiation towards inspection services and internal prevention services.
Procurement support
In procurement support, we make sure that the specifications and the RFQ procedure are drawn up in such a way that the client is relieved as much as possible of concerns about CE declarations and assembly obligations.
We formulate requirements aimed at obtaining the right documentation and declarations of conformity, so that the final CE declaration for the assembly can be drawn up smoothly. When a CE II.1.A declaration is not possible, we advise on which alternative declarations and substantiation can be requested instead.
We go a long way in this, including audits and FAT support outside the EU to assess conformity and improve the design. In this way, we lay the foundation for a technical file that stands up legally and remains administratively workable for the end client.