Operating instructions and technical documentation

Operating Instructions and Technical Documentation: A Comprehensive Guide Compliant with the Machinery Directive 2006/42/EC

The Importance of Operating Instructions and Technical Documentation

Operating instructions and technical documentation are key elements in ensuring the safe and efficient use of machinery. This documentation is not only a legal requirement, but also the foundation for user safety and long machine service life. Properly prepared operating instructions can prevent many accidents, failures, and costly downtime, so their role in industry cannot be overstated.

In the context of machinery safety and use, the term DTR (Technical and Operational Documentation) is often encountered. It is worth noting, however, that this term is not used in the Machinery Directive 2006/42/EC. DTR is a customary name for documentation that was used in Poland before the introduction of essential requirements aligned with European Union standards. In this article, when we use the term DTR, we mean technical documentation compliant with current legal requirements.

The purpose of this article is to present, step by step, the process of creating effective operating instructions in accordance with the requirements of the Machinery Directive 2006/42/EC. We will focus on the most important elements such instructions should contain and on how to prepare them correctly to ensure regulatory compliance and the highest level of safety.

Fundamentals of Preparing Operating Instructions and Technical Documentation

Definition and Purpose of Operating Instructions

Operating instructions are a document that provides the user with the information necessary for the safe and efficient use of a machine. Technical documentation (DTR), by contrast, covers the full set of technical information relating to the machine, necessary for its design, manufacture, installation, operation, and maintenance.

The purpose of both documents is to ensure that the machine is used as intended and in a safe manner, minimizing the risk of accidents and failures. The requirements for operating instructions and technical documentation are clearly set out in the Machinery Directive 2006/42/EC.

Legal Requirements: Machinery Directive 2006/42/EC

The Machinery Directive 2006/42/EC requires manufacturers to provide complete technical documentation and operating instructions for every machine placed on the market. These documents must comply with safety standards and the regulations governing CE marking.

Operating Instructions (Original Instructions) under the Machinery Directive

The Machinery Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 is a fundamental document governing machinery safety in the European Union. It requires manufacturers to provide detailed operating instructions that are essential for the safe and efficient use of machinery. These instructions must comply with specified standards so that users are properly informed about operation, assembly, maintenance, and the potential hazards associated with using the machine.

Operating Instructions: General Drafting Principles

Language and Versions of the Instructions

1. Language:
   • The operating instructions must be prepared in at least one official Community language that is understandable to users in the country where the machine will be used. If the machine is to be used in Poland, the instructions must be available in Polish.
   • Language versions verified by the manufacturer must be marked “Original instructions”. If the “Original instructions” are not available in the language of the country where the machine will be used, a translation marked “Translation of the original instructions” must be provided.
2. Adaptation to users:
   • For machines intended for use by non-professional users, the language and layout of the instructions should take into account the education level and mental capacity of typical users. The instructions should be written in a clear and understandable way to ensure full understanding of how the machine works and the hazards associated with it.

Detailed Requirements for the Content of the Instructions

The operating instructions must contain the following information, where applicable:

1. Manufacturer details:
   • The instructions must include the name and full address of the manufacturer and of the authorized representative, if any. This information is necessary to identify the source of the machine and to ensure contact can be made in the event of questions or problems.
2. Machine identification:
   • The machine must be clearly identified in line with the markings on the machine itself, excluding the serial number. The information provided should allow the model and version of the machine to be identified unambiguously.
3. EC Declaration of Conformity:
   • The instructions should include the EC Declaration of Conformity or a document setting out the contents of the declaration. This declaration includes detailed information about the machine and confirms that it meets all requirements of the Machinery Directive.
4. Machine description:
   • The instructions should include a general description of the machine and how it operates. This description should be detailed enough for the user to understand how the machine works, as well as its main components and their functions.
5. Operating instructions:
   • The instructions must include the drawings, diagrams, descriptions and explanations necessary for operation, maintenance and repair of the machine, as well as for checking that it functions correctly. They should be presented clearly, using plain language and clear illustrations.
6. Safe use:
   • The instructions should describe operator workstations and the safety measures associated with use of the machine. They should specify what precautions must be taken to minimize the risk of accidents and injuries.

Special requirements for assembly instructions for partly completed machinery

Partly completed machinery is machinery that has been partially assembled and requires further assembly before it can be used as intended. The assembly instructions for such machinery must include a detailed description of the conditions that must be met for correct incorporation of the partly completed machinery into the final machine, so that no health or safety hazard is created.

Operating instructions: Maintenance requirements

1. Maintenance instructions:
   • Maintenance instructions should be intended for use by specialized personnel. They may be supplied in only one of the Community languages, provided that language is understood by that personnel.
   • The instructions must clearly specify which maintenance tasks may be carried out only by specialized personnel and which may be carried out by users.
2. Maintenance principles:
   • Regular inspections and maintenance are essential to keep the machine in a safe condition. The instructions should include an inspection schedule and a list of maintenance tasks that must be carried out regularly.
   • They should also describe the procedures to follow in the event of a failure, along with recommendations for repairs and replacement of parts.

Operating instructions: Safety measures

The operating instructions should include detailed information on the safety measures that must be applied when using the machine. This includes both technical and organizational measures intended to minimize the risk of accidents and injuries. In particular, the following should be covered:

1. Warning signs and signals:
   • The instructions should include a description of all warning signs and signals placed on the machine. Their meaning should be explained, together with the actions to be taken when they are observed.
2. Personal protective equipment:
   • The required personal protective equipment (e.g. helmets, gloves, safety glasses) for operating the machine should be specified. It should be selected appropriately for the type of work performed and the potential hazards.
3. Emergency procedures:
   • The instructions should include procedures for emergency situations, such as stopping the machine in the event of a hazard, evacuating the operator, or actions to be taken in the event of fire.

Operating instructions: Compliance with standards and regulations

The machine manufacturer is required to ensure that the machine complies with all applicable safety regulations and standards. To do this, the following should be addressed:

1. Application of harmonized standards:
   • Machines manufactured in accordance with harmonized standards, references to which have been published in the Official Journal of the European Union, are presumed to comply with the essential health and safety requirements covered by those standards.
2. Conformity assessment procedures:
   • The manufacturer or its authorized representative must carry out the appropriate conformity assessment procedures to confirm that the machine meets the requirements of the Machinery Directive. Depending on the type of machine, these may include different procedures, such as internal checks on manufacture, EC type-examination, or the full quality assurance procedure.
3. CE marking:
   • A machine that meets the requirements of the Machinery Directive must bear the CE marking. This marking confirms that the machine meets all health and safety requirements. It should be affixed to the machine in a visible, legible, and durable manner.

Under Machinery Directive 2006/42/EC, the operating instructions are a key document for ensuring the safe and effective use of machinery. They must be supplied in the appropriate language, include detailed information on use, maintenance, and hazards associated with the machine, and be available to both professional and non-professional users. Compliance with these requirements is essential to meet the Directive and protect machine users. The manufacturer must ensure that every machine is supplied with complete and detailed operating instructions that meet all Directive requirements, which is crucial for safe and effective machine use.

The role of safety audits and CE certification of machinery

Safety audits and CE certification of machinery are key elements of the process of ensuring compliance with the Machinery Directive. A safety audit helps identify potential hazards and assess risk, while CE certification confirms that the machine meets all safety requirements and may be legally placed on the market.

The importance of CE marking and harmonized standards

CE marking and compliance with harmonized standards demonstrate that a machine meets all applicable European safety requirements. The operating instructions should clearly state that the machine bears CE marking and provide information on the standards with which it complies.

The process of preparing operating instructions and technical documentation

Gathering information: working with a design office and engineering outsourcing

The process of preparing operating instructions and technical documentation begins with collecting the necessary information. Cooperation with a design office and the use of engineering outsourcing can significantly streamline this process. This makes it possible to obtain detailed technical data and practical guidance on machine operation.

Machine design and the preparation of operating instructions and technical documentation

Machine design and the preparation of operating instructions and technical documentation are closely linked. Documentation-related aspects such as safety requirements, maintenance procedures, and operating instructions should already be taken into account at the design stage.

Production process automation and its impact on operating instructions and technical documentation

Production process automation has a significant impact on the content of operating instructions and technical documentation. The introduction of advanced technologies such as Industry 4.0 requires detailed descriptions covering the operation of automated systems, their maintenance, and fault diagnosis.

Compliance with CE marking and harmonised standards

The operating instructions should include information on the machine’s compliance with CE marking and harmonised standards. They should specify which standards have been applied and how they meet the requirements of Directive 2006/42/EC.

Examples and best practices

Using risk analysis in accordance with EN ISO 12100

Risk analysis is a key part of preparing technical documentation. The EN ISO 12100 standard provides guidance on hazard identification and risk assessment, which is essential for ensuring machine safety.

Integration of production automation and Industry 4.0

Integrating modern technologies such as production automation and Industry 4.0 requires a specific approach to preparing operating instructions and technical documentation. Describing advanced systems and diagnostic procedures is essential for the effective operation of machinery.

The role of safety audits and harmonised standards

Safety audits and compliance with harmonised standards are important for maintaining a high level of safety. Regular audits help identify potential hazards and implement appropriate corrective measures.

Under Machinery Directive 2006/42/EC, the operating instructions are a key document for ensuring the safe and effective use of machinery. They must be provided in the appropriate language, include detailed information on use, maintenance, and machine-related hazards, and be accessible to both professional and non-professional users. Compliance with these requirements is essential to meet the directive and protect machine users. The manufacturer must ensure that every machine is supplied with complete and detailed operating instructions that satisfy all directive requirements, which is critical to safe and efficient machine use.