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A company in the supplier industry has identified a risk of deviations in its products in the course of regular series monitoring in production (CoP = Conformity of Production). As the components in question and the suspected deviation appeared to affect not only product conformity, but possibly also product safety, the company in question immediately decided to call in the specialist lawyers.
Finally, in the event of deviations that (may) affect conformity and safety, remedial measures must be initiated immediately, i.e. a recall.
In order to be able to assess the impact of the suspected fault on safety, an expert opinion on the component in question and the effects of possible faults and their detectability for the user was prepared after consultation with our company. Attention was also paid to the controllability of the error for the affected user.
Legal expertise + technical expertise
Each field has its experts who specialize in exactly that. One of our cooperation partners is a law firm with a very high expertise in product liability and product safety. In this regard, some of the firm’s lawyers focus on the requirements of the automotive industry.
However, these requirements do not result solely from legal requirements. A plethora of industry standards complement these specifications. Buzzwords such as product compliance, product liability, product safety or product conformity characterize the broad field of obligations that must be fulfilled as an approval holder or manufacturer.
An increase in complexity results from a closely intertwined combination of legal and technical issues. Legal texts must be translated into technical specifications so that engineers can design compliant and safe products. This also applies to the quality management of companies. Specifications from legal texts must be translated into specifications for quality management.
In case of (assumed) deviations on the products, the translation must be made in the opposite direction. Is a technical implementation compliant with the legislation?
This already demonstrates a perfect combination of the expertise of a product liability law firm and our company.
Our team of experts was called in for a mandate with a technical focus.
No recall!
Sounds complex? Yes, it is! But for that there are the experts on the part of the lawyers and the team around Mark Haacke!
Is the effort excessive? No way! The questions to be clarified, are the questions that also need to be clarified in the course of a risk assessment according to RAPEX. And the more detailed and well-founded an assessment is and the more justified it is, the less problematic communication with the authority will be should a recall prove unavoidable.
And in this case, our expert opinion has been able to show that the evaluation standard of the serial monitoring tests would be suitable for a worst-case consideration, but in the applied form clearly exceeds the legally required level and the intended and foreseeable use. The products are therefore as safe as required by law and as safe as the customer can expect.
A recall of the products could thus be avoided.