Product Compliance

Factors that determine market dynamics are, on the one hand, increasing customer demands on product innovation and functionality, and, on the other hand, regulations and legislation.

In developing innovative products and services as a result of this, product complexities also increase. These challenge a company's entire ecosystem as they require the control and fulfilment of increased requirements in product compliance.

This Insight gives an overview of the background as well as the resulting challenges for industrial companies.

Understanding

To establish a consistent understanding, we would like to precisely define what we mean by product compliance and which requirements are linked to it.

Product compliance ensures that laws, rules and regulations over the entire life cycle of a product, from the idea through development and production to delivery and disposal, are consistently and transparently followed, and that compliance with them is verified. To integrate market and legal requirements as well as the accompanying product complexity, companies need suitable processes and management methods to harmonise their ecosystem in terms of organisation and requirements. Therefore product compliance management combines two aspects. On the one hand, your own organisation and on the other hand your supplier's, because, in today's world, increasing globalisation and interdisciplinary cooperation show that hardly any companies map the entire product development process in their own organisation.

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Challenges

Since the first industrial revolution, product development and manufacture has had to cope with increasing complexity and requirements. Today's ecosystems combine technologically sophisticated products with intelligent functions to create systems. The coupling of components with software must be harmonised down to the bit level in order to ensure traceability with regard to laws, rules and regulations. As a powerhouse for technological advancement and organisational change, we are convinced that today's organisations must maintain a constant dynamic regarding roles and responsibilities, processes and systems. This is the key to making complexity manageable and ensuring supplier performance and compliance. Only in this way can the following challenges be mastered:

1. Establishment of a uniform understanding of requirements
2. Uniform, cross-departmental understanding of when a requirement is fulfilled
3. Knowledge development in order to be able to master and control increasing product complexity
4. Structured procedures for checking compliance
5. Better communication and a clear cascade of requirements to internal and external suppliers
6. Shorter development cycles due to cost and time pressure
7. Compliance traceability throughout the product life cycle
8. Coping with increasing demands in the next 10-15 years, e.g.sustainability and climate protection, supply chain law, disruptive technologies, etc.

Thenewboxes approach addresses these challenges in the overall context of product compliance.

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Our approach

Our consulting approach provides the methodical and procedural framework for compliance solutions tailored to your specific requirements.

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We define, together with you, all necessary measures to ensure compliance from a strategic as well as organisational and process-related perspective, and that also anchor them in your management system.

Our approach consists of six phases or epics and is structured generically with the aim of adapting the building blocks individually to the initial situation and needs of our customers. Nevertheless, we don't lose sight of the entire ecosystem, as we always follow an end-to-end approach to establish a living system and build sustainable knowledge. Through the E2E approach, the full potential of our consulting approach unfolds, giving your processes an enormous boost in efficiency.

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Fit for Compliance

During the gap analysis, the management system is checked thoroughly with defined and targeted interviews and document analyses. In most cases, the basis for this analysis is formed by laws, rules and regulations such as ISO 9001, EN 9100, Supplier Requirements, ISO 27001, TISAX, ISO 14001 and many more. With the help of the gap analysis, the inventory is completed with the identification and prioritisation of gaps as well as the project timeline and responsible parties.

The implementation phase forms the core of our approach, as it is here that questions can be clarified such as:

• Are those responsible aware of the procedural framework of the product development process?
• Which quality gates are defined from the inquiry to the delivery of products?
• How are requirements within the organisation identified, analysed, reviewed and documented?
• How are these requirements cascaded into the supply chain with the appropriate granularity?

The aim of this approach is to understand in detail how processes are defined in the management system since, in reality, there is usually a discrepancy between documented and lived roles and responsibilities and processes. Building on the first phase and the intensification of the workshops in the implementation, appropriate concepts and solution approaches are now developed, defined and established to close the compliance gaps. Constant support of employees ensures that tailor-made solutions and lived processes are defined and that knowledge is sustainably anchored through additional workshops and trainings. Of course, we don't work in a vacuum here, but use our best practices approaches and our network of experts.

In the benchmarking phase, the extent to which the developed and new management system processes are established in the organisation is examined. Here, we check whether the solutions have closed the identified gaps. Potential for improvement is identified during benchmarking, which significantly increases the maturity level of the organisation.

The next step is "scaling up". This is where the final touches are put to the management system and processes. Gaps that are still open and potential for improvement are closed or resolved together with the organisation. With this know-how, the external certification can then be prepared and the know-how or knowledge can be handed over in a consolidated way, so that the preparation for the external certification is completed.

In the certification phase, an external supervisory body such as an agency, certification company, OEM, etc. checks the maturity of the organisation, the management system and the processes with regard to the compliance requirements. This increases confidence for customers, suppliers, etc. in an intact ecosystem that operates according to clear standards. Our concrete approach here is to provide technical and organisational support for this certification in order to ensure successful completion, even in the face of critical questions from the auditors, and also to record deviations and resolve them together with the customer.

The final phase is "graduation and phase out." After we've guided your ecosystem from gap analysis to successful external certification, we ensure in the final phase that the relevant discrepancies are resolved, and that project handover and closure take place. An important cornerstone in this phase is the lessons learned, as it allows both our customers and us as newboxes to take a critical look at the course of the project. Because we also want to continuously develop as a powerhouse to improve our approach and respond to the individual and tailor-made needs of our customers with the goal of ensuring holistic compliance.

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Conclusion

Increasing government regulations and supply chain harmonisation by OEMs require contiguous integration of product compliance requirements throughout the organisation. Only then can your entire ecosystem strengthen the guidelines for competitiveness and strengthen the organisation's market position. The path to holistic compliance can be taken based on the analysis and evaluation of the strategic orientation as well as the structural and process organisation. We work together with you as a partnership to develop innovative concepts and solutions that your entire organisation can get behind. With our competencies and network, we bring the methodological and procedural framework for a structured review of your management system, uncover compliance-relevant gaps and establish best-practice approaches.  

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"Non-compliance means, no certification and that means no business. So if you think compliance is expensive - try non-compliance"

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Our solutions

Set the course for holistic compliance and innovation with newboxes by connecting your processes with efficiency and compliance needs. Together we dive end-to-end into your ecosystem. Our processes, methods and tools help you with the following tasks:

• Development of a holistic management system with standardised and harmonised processes to operationalise the efficient fulfilment of compliance requirements
• Seamless cascade and traceability of requirements across the entire product development process
• Establishment of digital knowledge managements olutions
• Structured approach to the implementation of transformation projects