ETD

• CE marking
• instruction manual
• machinery directive 2006/42/EC
• rebuilt paper machine
• risk assessment
• safety upgrading
• substantial modification
• technical documentation
• technical file

The present thesis describes the CE Marking Process of the PM2 Paper Machine at Cartiere di Guarcino, following a major rebuilding. Since this rebuilding constituted a substantial modification according to the Machinery Directive 2006/42/EC, the user assumed the role of the new manufacturer, with the obligation to carry out a new conformity assessment and proceed with a new CE marking.
The work details the activities carried out by Studio Micheloni, the machine-safety consultancy, throughout the CE marking process. The author actively participated in all technical phases as part of her professional role supporting the user.
The process involved on-site inspections and the analysis of existing technical documentation to verify the machine’s compliance with the Essential Health and Safety Requirements (EHSRs) of the Machinery Directive and with the applicable harmonized standards, particularly those for paper machines (EN 1034-1 and EN 1034-16).
A central element of the safety upgrade was the Risk Assessment, conducted according to EN ISO 12100 and ISO/TR 14121-2. A structured Excel model was used to input the risk parameters and automatically calculate the resulting risk level, using the HaRMONY numerical method for risk estimation. For safety functions, the assessment and subsequent design followed EN ISO 13849-1.
For each identified non-conformity, the necessary protective measures were selected through a shared and iterative process with the paper mill, carefully evaluating their impact on production processes and maintenance activities. Once the chosen protective measure—either mechanical or part of the Safety-Related Control System (SRCS)—had been identified, its technical specifications were defined to ensure compliance with the relevant safety standards. After implementation, all measures were validated to verify conformity with the required safety criteria.
The process concluded with the preparation of the Technical File, the Instruction Manual and the new EC Declaration of Conformity.
This case study highlights how a methodical and multidisciplinary approach ensures full regulatory compliance and, at the same time, improves the level of safety without compromising the operational efficiency of the machine.