Ensuring regulatory compliance for razor blade assembly machine

When consulting services company Laicon identified the need to appoint a European Authorised Representative (EUAR) in compliance with EU Regulation 2019/1020 for a razor blade assembly machine project, it turned to Hold Tech Files.

Haumiller Engineering builds assembly systems for high-volume products. It is based in South Elgin, Illinois, USA, yet it enjoys long-term relationships with customers globally. The company manages project risk to ensure reliability and on-time deliveries. Its engineers focus on adding value and use external expertise when appropriate.

A recent project was a razor blade assembly machine for a European customer. Keeping abreast of product regulations in every geographical region is challenging but ensuring compliance helps to manage risk – complying at the design stage is preferable to modifying a machine later. Machinery sold in the EU must be CE marked to the Machinery Directive 2006/42/EC, and sometimes other Directives.

Haumiller has worked with Laicon Consulting Services of Orlando, Florida, USA, for over 10 years. Each project is tailored to meet the customer’s needs, ranging from generic CE guidance up to full CE marking. Laicon also supports companies with UKCA marking for England, Wales and Scotland since the UK left the EU, as UKCA marking is similar to CE marking.

For the blade machine, Haumiller requested Laicon’s full CE marking support. The engineers had an outline design for a self-contained assembly and inspection system, and Laicon attended a design review meeting. The consultant identified that the machine must comply with the EU Machinery and EMC Directives. Furthermore, as there is no Type-C Harmonised Standard for this class of machinery, CE marking required compliance with the Essential Health and Safety Requirements, which can be achieved via Type-A and Type-B standards.

During the design review, Laicon identified non-compliances relating to guarding, electrical components, the safety circuit and colour coding for wiring. This sounds like a long list. However, through Haumiller and Laicon’s longstanding relationship, Haumiller’s engineers have become more familiar with EU regulations. Consequently, the non-compliances were relatively minor.

Laicon’s consultants have a detailed knowledge of regulations and standards but take a methodical approach. Laicon uses COMPLIANCE Risk Software for conducting risk assessments, generating reports for the equipment Technical File, drafting the Declaration of Conformity (DoC), EN 13849-1 assessments and more.

Another outcome of the design review was that Laicon identified the need for Haumiller to appoint a European Authorised Representative (EUAR) in compliance with EU Regulation 2019/1020. Essentially, an OEM appoints an EUAR to be responsible for the equipment in Europe.

Laicon has a relationship with Hold Tech Files, which is based in the Republic of Ireland, within the EU, and can therefore act as an EUAR. Hold Tech Files also provides online services by which it holds Technical Files securely in the EU, and can be named on a machine DoC as the person to compile the Technical File. Following the Design Review, Laicon sent Haumiller a report confirming its findings and listing documentation required for the Technical File.

As Haumiller’s engineers progressed with the design and documentation, they maintained an open line of communication with Laicon to maximise efficiency and minimise the need for remedial work.

Once the machine was built, Laicon conducted a CE Audit. An EN ISO 12100 Risk Assessment revealed non-compliances and residual risks, which were discussed with Haumiller’s engineers. The engineers then took the necessary action and provided photographic evidence so Laicon could sign-off the Risk Assessment.

Laicon also assessed the machine’s electrical safety, noise emissions and electromagnetic compatibility (EMC). Test reports were provided to Haumiller for the Technical File.

Another key element of the CE Audit was assessment of the safety circuit. Laicon undertook functional testing and reviewed schematics to ensure the safety circuit was as it should be. In addition, information was sent to Laicon’s validation engineer, who conducted a Sistema validation to confirm that each required Performance Level (PLr) had been met. A copy of the validation report was placed in the Technical File.

Laicon had already advised on the contents of the Instruction Manual. The instructions were checked during the CE Audit and they were found to meet the Machinery Directive requirements. A copy was therefore added to the Technical File. Various other documents were also checked and filed, such as schematics, drawings, and DoCs for CE marked components.

Towards the end of the CE Audit, the consultant generated a draft Electrical Name Plate for the main electrical enclosure. Haumiller had this made and affixed to the machine. Similarly, the consultant generated a draft Machine Name Plate, which Haumiller then had manufactured and attached.

Finally, Laicon drafted the DoC. Once all the Action List items had been completed, a senior Haumiller manager signed the DoC and forwarded a copy to Laicon for the Technical File. A copy was also inserted in the Instruction Manual, and another was placed with the shipping paperwork for European Customs and Excise.

This project between Laicon, Haumiller and Hold Tech Files demonstrates how the path to CE compliance can be navigated successfully. The process is multi-facetted and extensive but, when planned and executed by personnel committed to producing a world-class, safe machine, it is readily achievable.