Product Compliance

A large number of product manufacturers, product system consultants, distributors and importers attended seminars in 2012 to receive further training on the requirements of the PrSG. Thanks to their questions, an initial picture of their experience can now be drawn. The focus throughout is on the desire to bring "safe" products onto the market. In contrast, the authorities have created systematic market surveillance and are increasingly publishing product recalls. Product compliance has thus become an important corporate task.

What is a product?

Products within the meaning of the PrSG are all movable objects ready for use, even if they are built into immovable objects, regardless of whether they are offered to third parties or for personal use. Products are also individual parts that are delivered to a recipient for installation or assembly. Placing on the market means offering, supplying or making available products to consumers, customers or employees.

Conditions for placing on the market

The main requirement for placing a product on the market is that it meets the "Essential Health and Safety Requirements". As a rule, these are found in the EU product directives.

Evaluate products for conformity

lines. In this case, the harmonised standards whose fulfilment gives rise to a presumption of conformity may be applied. However, if none of these product directives or harmonized standards apply, the state of the art and science must be determined. (Graphic 1)

This represents a clear tightening of the previously required state of the art! With the high number of standards, it is a great challenge to determine what must be applied to one's own products. The EU alone has published around 5000 harmonised EN standards in its Official Journal. This elevates the standards, which in principle are to be applied voluntarily, to a legal status. A conformity assessment must be carried out for each product before it is placed on the market. The conformity assessment procedure is described in detail in the respective product directives and, in the case of critical products, requires certification by accredited bodies (Certified Body) or testing by a notified body (Notified Body). Within the scope of the design examination, the notified body checks the approvability of a product; with the product examination, the accredited testing body checks the conformity of a product with certain regulatory requirements, for example electrical equipment with regard to electromagnetic compatibility (EMC).

The obligations of the distributor

In order to place a product on the market, the PrSG requires the manufacturer to identify and avert hazards. This means that a product risk management system must be in place, which in particular assesses the possible hazards in the use and application of the product. Possible hazards must be warned of in the operating instructions. Furthermore, the person placing the product on the market, i.e. the manufacturer, dealer or importer, is obliged to carry out traceability so that possible causes of danger can be identified. Product monitoring over the entire service life of the product is now also required. Warnings must be issued in the event of possible hazards or the product must be withdrawn from circulation. Manufacturers will therefore not be able to avoid determining the possible service life and maintaining a product monitoring system. These after-market obligations also include the identification of possible misuse and, if necessary, warning.

Competences of the supervisory bodies

The State Secretariat for Economic Affairs (SECO) has been entrusted with the enforcement of the PrSG. This in turn has appointed control bodies that carry out systematic market surveillance (SUVA, bfu and other specialist organisations). These organisations have the authority to recall products, to warn against them and to impose bans. It is advisable to contact the relevant control body responsible for the company's own products. Product recalls and warnings are published, for example, by the Consumer Affairs Bureau (BFK).

Systematic market monitoring

cated. Recalls of products that are subject to special legislation are published by the relevant federal offices, e.g. medicinal products and medical devices by Swissmedic or foodstuffs and consumer goods by the Federal Office of Public Health (FOPH, FVO).

Who is liable in the event of potential danger?

The PrSG provides for clear penalty provisions in the event of intentional and negligent placing on the market of products that present a safety or health hazard. These penalty provisions supplement the liability provisions for products. The existing product liability and contractual liability continue to apply unchanged. (Graphic 2)

Tortious acts are generally not insurable. Damages from product liability can be insured. Contractual liability is only insurable to a limited extent. In the event of safety deficiencies in a product, the authorities will contact the governing bodies of the manufacturer, dealer or importer and demand proof of safety, as well as filing criminal charges in the event of possible legal violations. Product safety has thus clearly become a matter for the boss!

Planning product safety

The globalization of the development to place products on the market has led to increasing international and government regulation in recent years due to product recalls and scandals. Each incident has caused government bodies to tighten market surveillance and introduce new rules. As regulation has increased, normative requirements have also become much more important. In particular, standards have been elevated to a de facto mandatory legal instrument as "Harmonized Standards". For all those involved in placing products on the market, knowledge of the interrelationships is therefore of great importance. Access to this global context of regulatory and normative requirements requires a holistic view.

Product safety is a matter for the boss

The marketing of a new, refreshed or significantly modified product usually takes place within the framework of a defined innovation or change process. However, the path to a new, innovative and safe product leads along narrow guard rails due to regulatory and normative requirements! These constraints must be observed from the very beginning in order to bring an approvable and safe product to market. How can the creativity and enthusiasm of a development or design team be steered so that a safe product is created in compliance with the set constraints? How can it be ensured that valuable documents required for conformity testing are already prepared in the course of the development process?

At the latest when the Product Safety Act (PrSG) came into force, it became clear to everyone that product safety is primarily a matter for the boss. It is also the "boss" who is called to account in the event of product safety deficiencies, which can lead in particular to personal injury or fatal events. A responsible supervisor, or indeed the management of a company, must therefore ensure that the products meet the regulatory and normative standards.

Due to the complexity of the applicable regulations, it is advisable to train or call in a compliance management specialist. The Swiss Association for Standardization (SNV), in cooperation with the Lucerne University of Applied Sciences and Arts (HSLU), offers a course to become a certified product risk manager. The training of such a specialist comprises in particular the modules shown in chart 3.

The final responsibility for placing a product on the market always lies with the person who affixes his trademark. He is also responsible for checking conformity and, if necessary, affixing the CE mark. In the event of safety defects or liability for a defective product, the person placing the product on the market is always held accountable or liable. It is therefore important to take appropriate measures to protect oneself against unjustified claims.