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RISK ASSESSMENT AND COMPLIANCE

*Note: The content presented below for creating a risk assessment only represents a rough description and does not claim to be complete. Requirements for this can differ significantly in detail from the product or applicable guidelines and standards, as can the term risk assessment, risk or hazard analysis, etc. For the sake of simplicity, the term risk assessment is used below as a synonym for recording all risks of a product.*
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The risk assessment can rightly be regarded as the heart of any technical documentation, as this important document is a basic requirement for proving product conformity for the CE marking.

As the basis for recording all risks, it must be distinguished from the risk assessment. The latter falls within the area of ​​occupational health and safety for companies with electrical or mechanical systems and equipment.

For many product manufacturers, the preparation of a risk assessment is often viewed with certain reservations regarding the amount of work involved. Many an engineer entrusted with it has already been able to make their hair tear through the creation with the following initial questions: Which specific risks should be recorded? What are acceptable risks? What are suitable measures to eliminate those risks? What is the form in which these should be recorded?

Concrete specifications of how and what must be included in a risk assessment or which risks must be considered depend on the respective device or technical system as well as the respective area of ​​application. The specifications range from generally formulated requirements for device safety for consumer products to special ones, e.g. for equipment for laboratory facilities or medical products. The creator is free to choose which of the numerous possible risk management tools may be used. Proven methods such as the FMEA (Failure Mode Effects Analysis) or the well-known procedure based on the Hazard Rating Numbers can be selected for this.

Of course, in-depth technical knowledge of the product in question is required to specifically identify the risks, but potential risks can be roughly divided into those that affect the user or people in the vicinity of the device and those that affect equipment and property organize.

Potential risks can roughly be classified into the following categories:
1. electrical hazards
2. hazards from high contact temperatures
3. fire resistance
4. mechanical hazards
5. hazardous substances
6. radiation

Once the corresponding risks have been recorded, they must then be evaluated with regard to the extent of damage and the probability of their occurrence or detection.

The aim of recording all risks and evaluating them is also a statement about a remaining residual risk. This belongs in the operator's manual as important information. The manufacturer or distributor of the product is obliged to make this available to its customers.

Understandably, the risk assessment should not be understood as a static but rather as a kind of "living" document. This is the only way to guarantee proof of product compliance. Feedback on anomalies from the field or market should be continuously recorded and evaluated or provided with appropriate measures to eliminate these risks. The manufacturer should also do the same if critical components are changed or replaced.

Even if it doesn't need to be explicitly mentioned: a risk assessment must always be based on  engineering expertise. Apparently unrealistic scenarios, which with an extremely low probability will never occur, should not be part of this important document. In the end, only a risk assessment that is designed in a meaningful and manageable manner will serve its actual purpose in a safe product.

If you want us to write the risk assessment for your product, then contact us today and arrange a free initial consultation.

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