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Product Compliance Management System

Product compliance and its management love order. The resulting transparency and clear structure are worth the effort in many respects: they minimize erroneous and repeat services, provide the right information at the right place and at the right time, demonstrate competence to external market partners and, above all, ensure that the products you place on the European market are marketable.

In setting up such a product compliance system in a company, we consider seven areas which, when meshed with each other, form a smoothly operating system.

Inventory of Legal Provisions

Everything that is law!

To act confidently in accordance with the law, one must know all the relevant laws and regulations and apply them in their currently applicable versions. This is manageable for a single product or product group, but will be much more complex if a company’s product range contains products from many different product groups.

A legal cadastre is an indispensable aid regardless of your product range’s breadth. It provides valuable orientation within your company and lets the authorities know that your company appreciates the importance of product compliance. When compiling the inventory, we start with the basic requirements of ISO 14001 : 2015, go on to classify the company’s products into product groups and then compile the relevant statutory regulations, guidelines, standards and internal instructions for each product group. In doing so, we also include materials, labelling, attendant documents, packaging and rules for transport.

Only regular controls protect

Once it has been compiled, the legal cadastre must be checked and updated at regular intervals. We do this for our customers and thus ensure that the latest regulations are applied.

Keeping an up-to-date legal cadastre does not relieve companies of their responsibilities to implement these regulations, to make them known in the company and to undertake actions that are in line with the law! This is why we derive detailed product and company specific instructions from each customer’s legal cadastre and give our customers timely notice of new laws and reforms of existent regulations.

Specification Sheets

According to all the rules of compliance

All legal requirements presuppose specific activities for products and companies. The more complex a product and value creation chain, the more diverse the obligations and hence the greater the potential for mistakes.

This is why employees need to comprehend both the entire process and to possess detailed knowledge about carrying out individual tasks.

This is achieved by detailed specification sheets for your employees. They describe comprehensively which tasks are carried out by whom and when, which information and proofs must be obtained and how they are passed on in the process. We assist you with formulating these instructions, assume responsibility for drawing them up in their entirety, and, if you wish, also train your team in using these specification sheets.

Implementation of the Process

In order to implement a product compliance management system, one must know which processes, structures and data are required, and these must be available.

Then the decisive thing for product compliance is that items of information be linked and that specific inter-company processes such as answering SVHC inquiries, attaching special declarations of conformity, and updating EU safety data sheets be initiated.

We find that in many cases the processes required are present in the company, but have just not been recognized as such. We root out such processes together with you, define them and then link them with the information required.

Documentation

Fit for the flow of information

Various legal foundations, such as, for example, the Product Safety Act and the REACH Regulation, require complex procedures even for “simple” products. Then a flood of documents arises along the delivery chain. In addition to establishing liability or serving as basis for further proofs, these documents must be kept up to date at all times and passed on to customers and governmental authorities as needed.

This extraordinary documentation effort frequently pushes personnel and IT structures to the limits of what they can bear. In many cases, such administrative procedures can be streamlined and standardized to relieve these structures of the pressure on them. Together with each customer, we identify the data which is truly required, develop the secure and reliable filing system.

Communication

Don’t make lots of data

The company is a channel of economic and quality-related data. On the one hand, information flows from your suppliers and external services providers into your organisation, and on the other hand information flows from your organization to your customers and governmental authorities.

You need two things in order to respond to enquiries from customers and governmental authorities completely, correctly and on time: the data collected from suppliers and external services providers must be complete and formatted uniformly to avoid redundancies and the data released to customers and governmental authorities must be in compliant standardized form so that processing effort is reduced.

We assist you with bundling and organizing communication at each interface. We develop questionnaires and response letters that are standardized in accordance with your processes and assist with establishing your communication paths. Problematic cases can be taken over by our specially trained employees who can also communicate with customers, suppliers and governmental authorities on technical matters.

Monitoring

Let’s see where this is going

Every system that works also lives and changes, sometimes more, and sometimes less. Weaknesses might be present in the system or might develop slowly over time − possibly through the persons who use the system, possibly through new internal procedures or possibly through changes in the law. It is often difficult for employees who are involved to recognize the system’s weaknesses as such and take corrective measures. That entails risks for your company. You can counteract them with regular monitoring of your company processes.

Effective monitoring considers both internal and external processes. The company’s most important instructions on taking action and the employees’ state of knowledge are a part of every recurring audit. The weaknesses that are uncovered are then set aside by appropriate adjustments.

The most important external monitoring measure is that of observing all legislative activities continually so that there is time to react to possible changes in the framework conditions of the company’s business. We are always very well informed here owing to our network and our work with professional associations. We also conduct appraisals of products in the form of our Quick Check. The customers receive a report of this as well as a catalogue of measures that can be taken to optimize results.

Protection against Risks

As the complexity of an organization rises, the risk of claims asserted against it rises too, for no system is stronger than its weakest building block. The costs for a recall action or for remedying a defect can drive a company into insolvency. On top of that, during the past few years the lawgivers have immensely increased the fines for violations and even provided for imprisonment for the executive managers and board members who are held accountable.

It is therefore of utmost importance that not only the company but also the individuals responsible be protected against risks. A precise analysis of a company and its potential risks as well as comparison with various insurers is indispensable.

To cover this case, we avail ourselves of or refer our customers directly to the services of our cooperation partner, which is independent of the various insurers. We also recommend that contracts that have been in force for a fairly long period of time be checked against the latest statutory regulations for deficient cover and obsolete risk assessments and that they be renegotiated accordingly.

Documents such as Standard Terms and Conditions of Business and other sets of contracts ought to be checked on a regular basis. Here, too, we can recommended the services of a specialized law firm.