Material Compliance
Material Compliance
Would you like to find out the best way to achieve successful material compliance?
Material compliance includes adherence to material-specific requirements resulting from globally applicable laws, regulations, standards and guidelines as well as customer specifications. These include, for example, the European chemicals regulation REACH, the RoHS directive, the SCIP database, PFAS, US regulations such as Conflict Minerals, CalProp65 or the Toxic Substances Control Act (TSCA) and many more. These requirements apply to substances, mixtures and articles, regardless of whether they are available as in-house manufactured parts (products) or commercial goods.
In short: Material compliance describes the adherence to all material-specific specifications that affect your product!
6 steps to material compliance
tec4U-Solutions has developed a 6-step plan on how manufacturers and importers of products can ensure their material compliance requirements efficiently and sustainably:
The 6-step plan in detail
Are you affected by material compliance legislation?
- Does your company manufacture products and/or is it part of the supply chain?
- Do you import products into the European Economic Area?
If so, then the probability that you will have to comply with regulations on substance bans is greater than 99%! If you fail to comply, you may face consequences such as administrative offense proceedings, product recalls, loss of customers and loss of market share.
However, many companies are not fully aware of the regulatory context in which their products are actually located. Whether legal requirements at the production site, product-specific specifications, requirements for placing on the market or special customer requirements, all these specifications need to be recorded and reflected in the existing processes and the product.
As part of the status analysis, we research and evaluate the requirements that are relevant to your product portfolio. We also focus on the resulting liability risks for your company. In dialog with your specialist departments, we then discuss strategies for achieving compliance and evaluate various implementation scenarios.
At the end of the status analysis, you will receive a concept with various implementation options and necessary expenses as well as remaining risks, which will provide a competent basis for your operational material compliance implementation.
Which process adaptations are necessary to ensure compliance and data processing?
Companies must ensure the material-specific conformity (material compliance) of their products with laws and customer specifications during production. Failure to comply with material specifications can result in product liability risks as well as loss of image and market share.
tec4U-Solutions advises and supports manufacturers and their suppliers as well as retailers in all matters relating to product design in compliance with requirements. A particular focus is on the implementation of material-related laws and regulations in the areas of product development, production and purchasing.
Process design is another focal point. The aim is to implement operationally successful processes with the aim of saving costs across the board and improving the quality of the product.
What internal measures and resources are necessary to ensure compliance?
When developing measures for the legally compliant implementation of material compliance requirements, tec4U-Solutions is strictly guided by the state of the art, which is currently represented by DIN EN IEC 63000 (successor standard to DIN EN 50581 and IEC 63000). In a potential liability case, compliance with the state of the art is the yardstick that determines the amount of damage.
The standard formulates the following procedure as a benchmark for implementing the material compliance requirements:
- Determining the credibility of the supplier
- Contractual agreement with the supplier
- Request for item-related MC from the supplier
- Risk analysis for missing parts
- Hedging risk components via analytics
How can the relevant requirements be communicated internally and externally in a binding manner?
Specification management is a core process in the company. It must also be implemented for the requirements of material compliance, which are subject to constant change. However, this requires that the company closely records and evaluates the various requirements and communicates them to the supplier and within the company in the form of binding specifications.
tec4U-Solutions researches the material compliance requirements from laws, standards, guidelines and customer specifications and compiles them in a material compliance requirements register. The requirements are then assessed and, if relevant, summarized in a material compliance specification. The specification is updated on a regular basis, forms part of contractual documents from purchasing, quality and development and is sent to the supplier via these departments.
Which software is suitable for legally compliant data documentation and evaluation in accordance with IEC 63000 (state of the art)?
The multitude and dynamics of substance-regulating specifications and requirements for supply chain due diligence obligations cannot be managed without software. It is essential that the software is based on DIN EN IEC 63000 and offers the greatest possible variety of regulations. In addition to consistent legal certainty across all sustainability topics, this also results in a large number of synergy effects, which greatly reduce the costs of implementing sustainability and enable extensive information networking.
All steps should be accompanied by continuous supplier communication and supplier development. The aim is to constantly improve the quantity and quality of data.
How do I improve the internal and external data communication process? How do I deal with missing information?
The number of your suppliers may be too high to request compliance from all suppliers individually, or some of your suppliers may not respond. There will always be a residue of missing information. In these cases, a risk assessment must be carried out. The assessment determines how high the risk is that a regulated and/or prohibited substance is present in an individual article. If the risk is correspondingly high, the actual compliance is determined by means of a chemical analysis.
tec4U-Solutions has developed a system for risk assessment that determines item-specific risks for different sets of rules. The database is based on various factors, such as
- standardized statistical methods,
- the many years of experience of tec4U-Solutions and
- the broad knowledge base of a large number of material compliance officers from a wide range of industries.
The risk assessment system is part of the DataCross software. As part of consulting projects, it is tailored to the individual needs of your company and can then also be used independently of DataCross.