CE marking and risk assessment: How can costs be reduced?

Specialised CE software for risk assessments (such as Safexpert) addresses the above-mentioned difficulties through a structured approach and intelligent functions. The most important advantages for designers and CE managers are:

• Structured process and completeness: The software guides the user step by step through the risk assessment process. A risk assessment module enforces a systematic approach in accordance with EN ISO 12100 – from defining limits and identifying hazards to documenting measures. This ensures that no important points are overlooked. For example, with just a few clicks, you can determine which hazards occur at which danger points and in which phases of the machinery life. You get a clear overview of which hazard situations have been considered and which risks are still open. Status evaluations show at a glance, for example, for which identified hazards the risk has not yet been adequately reduced. This structured approach makes it easier for designers to avoid overlooking anything that could prove costly later on.
• Consistent, standard-compliant documentation: CE software ensures that the results of the risk assessment are documented consistently and in accordance with standards. For example, Safexpert automatically generates reports based on ISO/TR 14121-2, a technical rule for the documentation of risk assessments. All projects follow the same format and quality standard. In the event of audits, customer enquiries or the preparation of the EC declaration of conformity, all necessary evidence is available in full and in order. This reduces the coordination effort with auditors and increases legal certainty.
• Time savings and efficient processes: Good CE software saves time above all else – in every phase of risk assessment. Many steps that were previously manual are now automated or significantly simplified. For example, there is no longer any need to maintain Excel lists manually; instead, data is entered once and can be evaluated in a variety of ways. Existing knowledge becomes reusable: Design engineers can refer to hazard checklists and stored solutions instead of starting from scratch every time. The computer completes recurring tasks in seconds that would take humans days or weeks to complete manually. A drastic example: By intelligently linking digital knowledge databases, the system can automatically determine which ongoing projects are affected by the withdrawal of a standard – an analysis that would be extremely time-consuming if done manually. Overall, the engineering workflow is accelerated, and developers can focus more on the actual design while the software takes care of the ‘grunt work.’ This significantly reduces the turnaround time for CE documentation.
• Better traceability and teamwork: In a software environment, every hazard, decision and measure is fully traceable. Changes to the design can be quickly updated in the risk assessment, and the history is retained. Modern solutions such as Safexpert are also network-compatible, allowing multiple team members to work on projects in parallel. Everyone uses the same data, which prevents confusion with different file versions. This facilitates collaboration between the design, electrical engineering and CE coordination departments. At the same time, the system serves as a central knowledge archive: experience and solutions from previous projects are available to everyone. If an experienced ‘CE expert’ leaves the company, their know-how remains in the database – an enormous advantage for continuity. Last but not least, the complete documentation increases traceability for third parties: in the event of an accident or an inspection, it is possible to trace exactly what considerations were made and what measures were taken.
• Up-to-date status and standards management: Product developers face the challenge of always working with the latest standards and regulations. CE software with integrated standards management significantly reduces the workload for the team in this area. Risk reduction measures can be linked directly to standards, and the software automatically monitors whether these standards are still up-to-date. As soon as a relevant standard changes, this is displayed in the project. Safexpert offers a change assistant for this purpose, which shows the designer which requirements have changed as a result of standard changes, right down to the section level of the standard texts. This means that you know at an early stage whether a protective measure that has already been selected may need to be adapted to new rules. Without such a tool, engineers would have to manually track all standard updates and comb through their projects – with a high level of effort and risk. The software performs these updates in the background, ensuring maximum legal compliance with minimal effort.

In summary, the use of CE software brings structure, speed and security to the risk assessment process. Many of the problems described above – from forgetting a hazard to working with outdated information – are eliminated by intelligent functions. This has a positive impact not only technically, but also economically.
 

More efficient risk assessment processes pay off for companies directly in euros and cents, as well as in shorter project times. Positive effects on budget and timing can be seen particularly in the following areas:

• Less costly rework: When risks are identified and addressed early on, companies avoid expensive changes at the last minute. Any design adjustments or additional protective measures that are only identified during commissioning can set project plans back by weeks and eat up unscheduled budgets. With an accompanying risk assessment during the development process, problems are solved on the drawing board – significantly cheaper and without project delays. A practical example: Inherently safe design solutions (such as safer positioning of a drive) incur hardly any additional costs if they are planned from the outset, whereas retrofitting mechanical protective grilles involves considerable additional expense. Companies can exploit significant savings potential here.
• Optimised selection of safety measures: A systematic approach prevents both under-engineering and over-engineering in safety technology. Without a thorough risk analysis, it is sometimes necessary to install ‘more protection than necessary’ as a precautionary measure, resulting in unnecessary costs. On the other hand, important protective functions may be missing, which can lead to enormous follow-up costs (product liability, recall campaigns) in the event of damage. A good risk assessment determines the appropriate level of protection. The result is machines that meet all legal safety requirements but are not overloaded with unnecessary technology. This has a positive effect on the material budget. In addition, suitable safety solutions increase productivity (because the machine remains operable), which indirectly increases economic efficiency.
• More efficient deployment of personnel and use of knowledge: CE software also has a noticeable impact on working time budgets. Instead of highly qualified engineers spending hours maintaining Word tables or researching changes to standards, the system takes care of these tasks in seconds. This takes the pressure off project schedules: teams can handle more projects in the same amount of time or meet tight deadlines more easily because the ‘CE ballast’ is reduced. In addition, risk assessments that have already been carried out can be used as templates for new, similar projects (keyword: template or copy template). Existing projects can be used in Safexpert as copy templates, for example, with the system checking in the background what effects changes to standards would have on the new project. This drastically reduces the effort required for recurring tasks. Overall, this increases predictability: if a company has defined processes and tools for CE conformity, the effort and time required can be estimated much more accurately in advance – an important basis for reliable project plans and budgets.
• Avoid duplication of work and loss of knowledge: In many companies, time (and therefore money) is lost because lessons learned are not properly documented. With centralised CE software, knowledge is recorded once and is then available to everyone. If, for example, a particular hazard on a machine type has already been assessed and resolved in a previous project, this information can be directly transferred to the next project. This prevents duplication of work and significantly reduces the costs of risk analysis over time. It also reduces external consulting costs, as internal knowledge is systematically built up. Finally, the risk of costly
• Non-compliance: A tool that constantly checks compliance with current standards prevents you from accidentally working with outdated standards – which, in the worst case, could lead to market bans or retrofitting obligations. One company reports that it ‘previously used Excel and always had a lot of work to do when standards changed. With the software maintenance contract, we always stay up to date.’ This is also a tangible economic advantage.

In short, optimised risk assessment acts as a form of preventive quality management: it saves costs before they arise and keeps projects on track. What initially appears to be ‘additional effort’ turns out to be both a time saver and cost insurer when the right tools are used.
 

What specific software tools enable these advantages? Modern CE software is usually modular in design and covers the entire CE conformity process – from the initial risk analysis to the final test. Using IBF's Safexpert as an example, we can highlight some practical modules and functions that help designers in their everyday work:

• Risk assessment module: At the heart of the system is a module for hazard analysis and risk assessment. It helps designers to record and evaluate all hazardous situations in a structured manner and to define appropriate measures. An intuitive user interface with predefined hazard categories (e.g. mechanical, electrical, ergonomic hazards) and phases of the machinery life facilitates the start. A risk graph helps to ensure consistent assessment of the level of risk. For each hazard identified, the developer can determine and document the risk (combination of severity, frequency, probability and possibility of avoidance) at the click of a mouse. The module reminds the user of all open points in the risk assessment so that nothing is overlooked. Overall, the often complex process is broken down into individual steps – simple and intuitive, without requiring in-depth knowledge of standards.
• Standards management & change assistant: Another central component is the standards management module (Safexpert StandardsManager). It serves as an intelligent standards database that can do much more than just provide PDF documents. Interfaces to standards directories allow designers to keep track of relevant standards and their status (is the standard still valid? Are there any successors?). The automatic update monitoring is particularly valuable: all standard references in the risk assessment are monitored by the system. If, for example, a harmonised standard changes, the software marks the measures in the project that are affected. The integrated Change Assistant goes one step further: It even analyses what has changed in the standard at section level and clearly compares old and new requirements. This speeds up the updating process enormously – the design engineer immediately sees whether action is required instead of having to compare lengthy standard documents. This interaction between standards management and risk assessment ensures that risk mitigation measures are always based on the latest state of the art.
• Solution and pictograms libraries: Efficiency is also achieved by not having to reinvent the wheel every time. That is why CE tools offer libraries where knowledge is stored centrally. Safexpert, for example, has a solution library that stores standardised solutions for recurring hazards (e.g. ‘protective cover with limit switch for rotating shaft’). Developers can draw on this pool of knowledge and don't have to start from scratch. A pictograms library is equally helpful: This contains numerous relevant safety and warning symbols (in accordance with EN ISO 7010, etc.) that can be transferred to the documentation with a single click. Designers and technical editors save time because they do not have to search for suitable symbols or create graphics manually. Both types of libraries also promote standardisation within the company – the same hazards are addressed with the same means and labelled uniformly.
• CE Guide and Templates: A unique feature of modern CE software is often an integrated CE guide that guides you through the entire conformity process. Safexpert, for example, offers project-related guides for the Machinery Directive (or Machinery Regulation) or Low Voltage Directive, which accompany the user step by step from start to finish. The guide reminds you of all the necessary steps – e.g. clarifying the applicable directives, performing risk assessment, creating technical files and printing the declaration of conformity. The software provides practical checklists and templates for each step. Safexpert, for example, includes a ready-made template for the declaration of conformity and checklists to ensure that the technical documentation is complete. The benefit: Designers or project managers always know what to do next and never forget any necessary intermediate steps. At the same time, you save a huge amount of time because you don't have to create format templates or lists yourself – everything you need is available out of the box and complies with the latest legal requirements.
• Operating instructions assistant: In many companies, the results of the risk assessment are still transferred to the operating instructions manually, which can lead to errors. This is where the operating instructions assistant comes in. This module ensures that all residual risks and necessary protective/informative measures are automatically transferred to the draft operating instructions. The information is either incorporated into a supplied instruction template in accordance with EN IEC/IEEE 82079-1 or can be transferred to common editing systems (e.g. Schema ST4) via an interface. The advantage is obvious: the instructions are developed in sync with the risk assessment. Technical editors receive all safety information first-hand, which saves time and ensures that the warning notices are complete. This module thus bridges the gap between design and technical documentation.
• Check and Acceptance Assistant (CheckManager): Once the machine has been built, safety functions and protective measures must also be checked in practice. A checklist manager such as the Safexperts CheckManager provides support here. This module enables inspections and acceptance tests of machines to be carried out and documented in a uniform manner. Defined checkpoints can be used, for example, to create a final acceptance checklist that checks whether all measures specified in the risk process have actually been implemented and are effective. The advantages of standardised test procedures lie in increased comparability and quality assurance: all testers work according to the same scheme. In addition, checkpoints can be centrally managed in libraries and updated when standards change. For designers, this means that feedback from practice (e.g. defects discovered during acceptance) is systematically fed back into the development process. CheckManager thus closes the CE process: from the initial risk analysis to final acceptance, everything is integrated in a single software environment.

As the above functions show, a CE software solution covers all phases of risk assessment and beyond. It acts as a toolbox for the CE manager and the development team. Each module brings efficiency gains on its own, but together they create a continuous process in which all the cogs mesh together. Companies can use exactly the modules they need (Safexpert, for example, is licensed on a modular basis – you only pay for what you use) and expand them as required. This allows the solution to be adapted to the size and needs of the business, from small machine manufacturers to large corporations.