Legal compliance

Technical information - instructions, warning signs, as well as training documents or product information on the Internet - has to meet minimum legal standards.

For example, the EU Machinery Directive requires that operating instructions and sales brochures be consistent. Especially companies that are active in the USA should be aware of the importance of consistent representation of information in respect to liability risks. The management and fulfillment of these legal requirements demands experience and structured procedures.

Different knowledge levels of employees and unclear responsibilities are often the reason for unclear information processes. As a result, the legal compliance of the technical documentation and information is not ensured. Liability cases and handicaps to trade are only the tip of an iceberg of customer complaints, costs due to rework, goodwill and contractual penalties.

A common understanding of the legal requirements, clarified responsibilities, and clear rules are the most important prerequisites for legally compliant action.

Based on an analysis of the need for action, clear and effective processes can be developed and the necessary tools introduced. For information development, the question of the legally required information quality is central. This basically results from the target groups of the information. Necessary steps are:

  • Clarification of entrepreneurial risks, fields of activity and people involved
  • Legal research and standards research
  • Target group analysis
  • Risk assessment
  • Compilation of requirements (requirements management)
  • Analysis of existing documentation based on requirements and assessment of the need for action
  • Training and sensitization
  • Implementation and standardization of measures for legally compliant information
  • Optimization of information processes, interlinkage of information development with product development, risk assessment and quality assurance
  • Implementation of rules, processes and tools

Our many years of experience in the field of law and standards, in testing and certification of documentation and in participating in standardization is the basis for the correct interpretation of standards.

For central documentation standards, we have comprehensive, current and proven catalogs of requirements that we supplement in individual cases. We have experience in numerous industries such as machinery and plant engineering, medical products, automotive or equipment engineering.

Risk assessment

A risk assessment considers the risks caused by a product and determines measures to reduce them. It is not only a central step in the CE conformity assessment procedure but also basically necessary from the perspective of project liability. A special challenge is presented by the risks that can result from the foreseeable behavior of users (§3 ProdSG).

Graphic for the risk graph

You have developed a technically safe product and are now faced with the question of what user-related residual risks there are.

Minimizing the design risks of products is a familiar area in product development. Less well-known, however, are the methods for determining and estimating the risks of user-related product utilization and "human factors". The measures to be derived range from constructive protection measures and the determination of the performance levels (PL according to 13849-1) or safety integrity levels (SIL according to EN 61508-5) up to suitable warning messages with the correct warning levels according to EN 82079-1 and ANSI Z535.

Risk assessment is team work and therefore requires a clear and simple method. Our preferred method is FMEA (Failure Mode and Effects Analysis), which is oriented to the user process. The method can be connected to the risk graphs for PL/SIL. This procedure is especially suited as a final risk analysis and for determining the residual risks for constructive protection measures and warning messages.

For this purpose, we process the user-related lifecycle of the products and the foreseeable risks related to individual activities in a detailed manner. An analysis of the target groups and activities provides the required information on likely users.

We coordinate the process and introduce the method to all those involved. In a joint workshop with your knowledge carriers from the development, application and authoring departments, we methodically guideline you through the risk assessment using a specific current project. In doing so, we name and assess the risks and formulate specific measures for risk reduction. This not only produces a risk assessment but establishes the necessary methodical knowledge at the company.

Safety instructions

"Safety chapters" in instructions have the unpleasant characteristic of growing uncontrollably: The desire for "legal cover" leads to long and barely comprehensible instructions and thereby ends up creating legal risks that are to be avoided. The solution is to consistently pursue the principle of comprehensibility.

Safety instructions are often legal protection texts. These texts are often difficult to understand. A didactic preparation is therefore essential for this type of text, in order to make it easier to understand and remember the information.

Based on pertinent standards such as ANSI Z535.6 regarding safety information in instructions and IEC 82079-1 "Preparation of instructions", we define rules for the structure, design and formulation of safety instructions. The procedure corresponds to the functional design standardization method and can be seamlessly integrated in corresponding standardization projects.

A qualitative analysis of the existing safety instructions – we use the problem topology method for this purpose –, the existence of a meaningful risk assessment with statements on the target groups as well as legal and standards research are important prerequisites for optimizing safety instructions.

In workshops with correspondingly authorized authors and, if needed, the product safety officer, we develop rules, structure and texts as part of a guideline. A central objective here is to develop corresponding skills in the company.

This results not only in example texts but in the formulation of basic rules and principles as well. This procedure has proven itself time and again. For example, we have developed a guideline and corresponding templates for safety instructions in the area of agricultural technology together with the German Association of Machine and Plant Builders (VDMA).

Product liability in the USA

The US market is characterized, among other things, by high product liability risks that result from the particularities of the legal system, the structure of the labor market and the safety expectations of users. A suitable package of measures significantly reduces the liability risks. Indicative safety plays an especially important role here.

Companies are faced with great uncertainty in the US market because the risks are difficult to calculate. In addition to design and production risks, the risks especially include so-called instruction risks; these are risks that result from erroneous information. Information is already considered erroneous when it is not understood by the users.

Economic logic demands low complexity: reducing market-specific procedures to a minimum and designing standards and processes so that the requirements of the US market can be efficiently covered. In particular, instructions should not be completely reinvented for the US market; a "parallel world" of information is not only expensive but also creates additional liability risks through inconsistent information in the markets.

In order to reduce the instruction risks, the quality of all information must meet sufficiently high requirements. This is the only way to ensure the comprehensibility and thus the effectiveness of information and instructions. The US market can thus in a sense become a catalyst for high-quality information.

The necessary measures concern the design of information as well as the basic internal information processes. The tasks for improving information quality are the same as for all information management projects: the systematic analysis and optimization of information, standardization and process optimization.

Proven methods such as problem topology, functional design, modularization or training are used for this purpose. However, the main emphases must be set specially for the US market, depending on the product.

We have additionally compiled everything that you should know specifically about measures for the US market in our list of measures.

Information development is as global as the companies that require the information. We supplement our many years of experience in developing information concepts for globally active companies with the expertise of law firms, engineering offices and testing institutions in the USA. In the VDMA, we regularly hold a highly regarded expert forum on US law.

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(Wie) kann man mit der IEC 82079-1 Anwenderfreundlichkeit erreichen? (tekom 2013)

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White Paper Problem Typology

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