Key takeaways:
This article discusses the components of the complete technical documentation required by the Machinery Directive 2006/42/EC and shows how to structure it using a robotic workstation as an example.
- Directive 2006/42/EC requires the preparation and retention of documentation for machinery placed on the EU market.
- The technical documentation describes the design, operation, installation, and maintenance, and demonstrates compliance with occupational health and safety requirements.
- The scope includes, among other things, a general description of the machine, assembly drawings, diagrams, and instructions for assembly, commissioning, and operation.
- Calculation documents and test results must be attached, for example finite element analysis calculations and strength and functional tests.
- Risk analysis in accordance with EN ISO 12100:2012 is essential: hazard identification, risk assessment, and selection of protective measures
In today’s industrial environment, where production process automation plays a key role, technical documentation has become an essential part of every machine design and build project. Technical documentation not only ensures compliance with legal requirements, but also provides the foundation for safety and operational efficiency. In particular, Machinery Directive 2006/42/EC requires manufacturers to prepare and retain appropriate documentation for every machine placed on the European Union market. In this article, we explain how to prepare technical documentation correctly in line with the requirements of this directive.
Technical documentation: Definition
Technical documentation is a set of documents that describes in detail the machine’s design, operation, installation, and maintenance. This documentation is necessary to demonstrate that the machine meets all essential health and safety requirements. Under the Machinery Directive 2006/42/EC, complete technical documentation should include:
- General description of the machine
- Assembly drawings and diagrams
- Calculation documents and test results
- Instructions for assembly, commissioning, use, and maintenance
- Risk assessment
- EC Declaration of Conformity
- Operating instructions
Technical documentation: General description of the machine
The general description of the machine should include basic information about its intended purpose, operating principles, and main structural components. This description should cover:
- Name and type of machine
- Manufacturer and contact details
- The machine’s intended purpose and scope of application
- General description of the design and main machine components
An example of a general machine description could be as follows:
Name and type of machine: XYZ-100 robotic welding cell
Manufacturer: ABC Robotics, Industrial Street 1, 00-001 Warsaw
Intended purpose: A robotic welding cell designed for automatic welding of metal components in the automotive industry
Design description: The cell consists of a robotic arm, a control unit, a welding power source, and a tooling system for clamping components. The robotic arm is made of lightweight aluminium alloys and has six degrees of freedom, enabling precise positioning of the welding tool. The control unit is equipped with the latest software for programming and monitoring welding processes. The tooling system includes clamping modules and rotary tables that allow accurate positioning of the welded components.
Assembly drawings and diagrams
Assembly drawings and diagrams are a key part of technical documentation. They should include:
- Assembly drawings showing the complete machine and its main subassemblies
- Electrical, pneumatic, and hydraulic diagrams
- Detailed drawings of individual components
Assembly drawings show the machine in different views, allowing its design to be examined in detail. They should include all relevant dimensions and descriptions of individual parts. Electrical, pneumatic, and hydraulic diagrams should be clear and contain all necessary information on connections, components, and their functions. In the case of a robotic welding cell, these drawings must include the connections between the control unit, robotic arm, welding power source, and tooling.
Calculation documents and test results
These documents should include all technical calculations and the results of tests carried out to confirm the machine’s compliance with the relevant standards and requirements. This section of the documentation should include:
- Strength calculations (finite element analysis)
- Results of strength, functional, and safety tests
- Laboratory and field test reports
Strength calculations (finite element analysis) make it possible to assess the structural strength of the machine under different loads. The results of these calculations are necessary to confirm that the machine is safe to use. The results of strength and functional tests should be documented and include detailed descriptions of the tests performed, the results obtained, and the conclusions drawn. For example, strength tests of the robotic arm may include simulations of dynamic and static loads, while functional tests may include verification of movement precision and the reliability of the welding system.
Instructions for assembly, commissioning, use, and maintenance
These instructions should be clear and easy for users and service technicians to understand. They should include:
- Detailed instructions for machine assembly and commissioning
- Instructions for daily operation and maintenance
- Safety recommendations and precautions
Assembly instructions should guide the user step by step through the machine assembly process, from installing the main components, through electrical, pneumatic, or hydraulic connections, to machine start-up.
Operating instructions should include detailed descriptions of the machine’s functions, how it is operated, and the maintenance procedures needed to ensure long-term, trouble-free performance. Safety recommendations are also an essential part and must be followed by users. For example, the assembly instructions for a robotic welding cell should include steps for safely installing the robotic arm, connecting the control unit, and calibrating the welding system.
Risk analysis
Risk analysis according to EN ISO 12100:2012 is an integral part of the technical documentation. It makes it possible to identify and assess potential hazards associated with machine use and to define corrective measures. The risk analysis should include:
- Identification of potential hazards
- Risk assessment for individual hazards
- Proposed protective measures and design modifications
The risk analysis process begins with identifying all possible hazards that may arise during machine use. Each hazard is then assessed in terms of the likelihood of occurrence and the potential consequences. Based on this assessment, decisions are made on implementing appropriate protective measures, which may include design modifications, installation of additional safeguards, or the introduction of safety procedures. In the context of a robotic welding cell, the risk analysis may include assessment of risks related to welding radiation, gas and dust emissions, and the possibility of the robotic arm colliding with operators or other parts of the cell.
EC Declaration of Conformity
The EC Declaration of Conformity is a document in which the manufacturer confirms that the machine meets all requirements of the Machinery Directive 2006/42/EC. It should include:
- Manufacturer details
- Description of the machine
- A statement of conformity with the relevant harmonised standards
- Signature of the person authorised to represent the manufacturer
The EC Declaration of Conformity must be prepared before the machine is placed on the market and must be included in the technical documentation. The manufacturer must also keep a copy of this declaration for a specified period, usually for at least 10 years from the date the machine is placed on the market. An example of a declaration of conformity for a robotic welding cell may include confirmation of compliance with standards relating to electrical safety, structural strength, and protection of health and the environment.
Operating manual
The operating manual is one of the most important parts of the technical documentation. It should include:
- Detailed information on machine installation, commissioning and operation
- Maintenance and repair instructions
- Information on safety and health protection
- Recommendations for machine disposal and dismantling
The operating manual should be written in language that users can understand and should contain all information necessary for safe and efficient use of the machine. For machines sold on international markets, the operating manual must be available in the appropriate languages. In the case of a robotic welding cell, the operating manual should describe in detail the procedures for safely starting and stopping the welding process, operating the control panel, maintaining the welding system, and recommendations for protection against welding radiation and the emission of harmful substances.
Technical documentation: Importance in industrial automation
In the context of industrial automation, technical documentation plays a key role in ensuring that machines operate in line with the design assumptions and meet safety requirements. This documentation is essential at every stage of a machine’s life cycle, from design and manufacturing to operation and maintenance.
Technical documentation: Role in production process automation
Technical documentation makes it possible to define all technical and operating parameters of machines precisely. This is particularly important in production process automation, where accuracy and reliability are critical. Thanks to technical documentation, engineers can carry out strength calculations (finite element analysis), analyse potential hazards, and develop preventive measures.
Examples of how technical documentation is used in machine design
During machine design, technical documentation makes it possible to describe every design and operational aspect of the machine in detail. This allows the production process to be planned accurately and ensures that all components and systems will perform as intended. Technical documentation is also essential for carrying out a risk assessment in accordance with EN ISO 12100 and preparing the EC Declaration of Conformity.
Technical documentation: Steps for preparation
Typical steps in preparing technical documentation
- Collecting data and information
- Gathering all required technical and operational information
- Consulting industry experts and design firms
- Preparing diagrams and technical drawings
- Developing detailed design drawings
- Machine design with safety requirements taken into account
- Preparing operating and maintenance instructions
- Writing clear, easy-to-understand instructions for operators and service personnel
- Taking into account aspects of production automation and Industry 4.0
The importance of a safety audit and risk assessment in accordance with EN ISO 12100
Safety audits and risk assessment in accordance with EN ISO 12100 are key elements in the process of preparing technical documentation. They make it possible to identify and evaluate potential hazards associated with machine use and to define appropriate protective measures. A safety audit involves a detailed review of all aspects related to machine safety, including design, operation, and operating procedures.
Risk assessment requirements
Risk assessment in accordance with EN ISO 12100 should include:
- Identification of potential hazards at every stage of the machine lifecycle, from design through use
- Assessment of the risk associated with each hazard
- Definition of measures aimed at minimizing risk
- Documentation of all risk management activities
| Error | Description | Consequences | How to avoid it |
|---|---|---|---|
| Lack of detailed instructions | Assembly, commissioning, operating, or maintenance instructions are too general and incomplete. | The machine may be used incorrectly, which can lead to accidents and damage. | Create detailed, step-by-step instructions with illustrations and diagrams. |
| Inaccurate risk assessment | Incomplete or incorrect identification of potential hazards. | Overlooking potential hazards can lead to unforeseen accidents and non-compliance with safety requirements. | Carry out a comprehensive risk assessment in accordance with EN ISO 12100. |
| Missing appropriate drawings and diagrams | Technical drawings and diagrams are incomplete or inaccurate. | Difficulties in machine assembly and servicing, and an increased risk of design errors. | Prepare detailed drawings with descriptions and dimensions, and have them verified by experienced engineers. |
| Incorrect or incomplete declarations of conformity | The declaration of conformity does not contain all required information or has been prepared incorrectly. | The machine cannot be placed on the EU market, which may result in financial penalties and legal liability. | Ensure that the declaration of conformity complies with the requirements of the Machinery Directive 2006/42/EC. |
| No translation of the documentation | The documentation is not available in the official language of the country where the machine is sold. | Users may not understand the instructions, which can lead to incorrect machine use and accidents. | Have the documentation translated into the relevant official languages by professional technical translators. |
Technical documentation: Legal requirements and harmonized standards
Introduction to the Machinery Directive 2006/42/EC
The Machinery Directive 2006/42/EC is the main legal act governing the placing of machinery on the EU market. It requires manufacturers to ensure that all machines meet specified health and safety requirements. Compliance with the directive can be achieved by applying the relevant harmonized standards.
The role of harmonized standards in preparing technical documentation
Harmonized standards such as EN ISO 12100 provide detailed guidance on safe machine design and risk assessment. Applying these standards makes the process of CE certification of machinery and CE marking easier. Harmonized standards form the basis for demonstrating that a machine complies with the requirements of the Machinery Directive 2006/42/EC.
CE marking and CE certification of machinery
CE marking confirms that a machine meets all essential health and safety requirements set out in EU directives. To obtain CE marking, the manufacturer must prepare the appropriate technical documentation, carry out a safety audit, and obtain an EC declaration of conformity.
Technical documentation: Practical guidance for engineers
How to manage engineering outsourcing and project management in the context of technical documentation?
Engineering outsourcing can be an effective way to access the specialist expertise needed to prepare technical documentation. However, the process must be well organized and properly supervised to ensure compliance with design and regulatory requirements. Project management in the context of technical documentation requires close cooperation between different teams and careful attention to detail.
Examples of best practices from design offices
Design offices often have extensive experience in preparing technical documentation. Working with such offices can significantly speed up the documentation process and help ensure high quality. Design offices can also support safety audits and the preparation of risk analysis in accordance with EN ISO 12100.
Technical documentation in the context of Industry 4.0
How does Industry 4.0 affect technical documentation requirements?
Industry 4.0 introduces new technologies such as SCADA and PLC programming, which require detailed technical documentation. Integrating these technologies into the production process increases the complexity of the documentation, while also improving its functionality and efficiency. Technical documentation must cover all aspects related to these new technologies to ensure full compliance with regulatory requirements.
Integration of SCADA, PLC programming, and other technologies in documentation
Preparing technical documentation for systems integrated with SCADA and PLC programming requires a detailed description of all components, interfaces, and operating procedures. This documentation is essential for the correct installation, commissioning, and maintenance of the systems. In the context of industrial automation, technical documentation must also address aspects related to Industry 4.0, such as system integration, process automation, and data management.
Key takeaways on technical documentation
Technical documentation is essential to ensuring machine safety and operational efficiency. It makes it possible to meet legal requirements, carry out safety audits, and manage projects effectively. Well-prepared technical documentation is the foundation for every stage of a machine’s life cycle, from design and production to operation and maintenance.
The future of technical documentation in the context of technological and regulatory developments
As new technologies develop and regulations become more stringent, the importance of technical documentation will continue to grow. Engineers must be prepared to continuously update and adapt documentation to changing market requirements and legal provisions. Technical documentation must evolve to meet the demands of Industry 4.0 and ensure full compliance with the Machinery Directive 2006/42/EC.
Technical documentation compliant with the Machinery Directive
This is a set of documents describing the machine’s design, operation, installation, and maintenance. It is used to demonstrate compliance with the essential health and safety requirements.
It should include, among other things, a general description of the machine, assembly drawings and diagrams, calculation documents and test results, installation/commissioning/operating/maintenance instructions, a risk assessment, the EC Declaration of Conformity, and the operating instructions.
State the machine name and type, manufacturer details, intended use and scope of application, and a general description of the design and main components.
Assembly drawings showing the complete machine and its main assemblies, as well as electrical, pneumatic, and hydraulic diagrams, are required. They should be clear and include the relevant dimensions, connections, components, and descriptions of their functions.
It helps identify hazards, assess risk, and select protective measures or design modifications. It is an integral part of the technical documentation required to demonstrate machine safety.