Consulting

Our consultancy fields

We support you with practical, efficient and tailor-made solutions in all relevant areas of quality management and process optimization.

Quality Management Systems (QMS)

We help you to establish, maintain and integrate QMS frameworks, ensuring compliance with regulations, product safety, quality and customer satisfaction. We help design and implement effective quality control measures and processes and guide you through certification.

A reliable and effective QMS is the prerequisite for processes to function smoothly and efficiently. Attention must always be paid to strike the right balance between excessive and inadequate documentation. Especially in regulated industries such as medical technology or automotive engineering, it is essential to ensure that the documentation effort has exactly the right depth and breadth. Our expertise covers the relevant standards and regulations, including:

• ISO 9001
• ISO 13485
• FDA 21 CFR Part 820 QSR
• EU MDR
• EU IVDR
• ISO 14971
• ISO 14001

Qualification and Validation

The transfer of a product to series production requires precise validation steps to ensure consistent product quality. We help you to efficiently implement the requirements of ISO 13485:2016, to hedge risks from risk analysis and to strategically plan qualification measures such as IQ, OQ and PQ. We also support the validation of production environments with practical solutions.

CAPA Management

Efficient CAPA management ensures the identification and elimination of problems and at the same time ensures preventive measures for long-term process reliability. We help you overcome typical challenges – from time delays to unclear responsibilities to incomplete documentation – and optimize your processes in accordance with ISO 13485 and FDA 21 CFR Part 820.

As an audit or official inspection approaches, the tension in the company increases. In our experience, the three major points of conflict in management of Corrective and Preventive Actions (CAPA) are:

The time aspect
Corrective and preventive actions are often planned incorrectly. As a result, the CAPA system gets into a temporal imbalance or even out of control.

The cultural aspect
Issuing CAPAs is perceived by owners as a punishment rather than a problem-solving tool that improves product quality.

The aspect of evidence and documentation
Insufficient attention is paid to technical details and wording in the documentation, or evidence cannot adequately support effectiveness of the implemented actions, leading to re-opening the CAPA and unnecessary waste of time.
StingOrg consultants know how to master such situations. We can train your employees and also take over the management of the CAPA system according to ISO 13485 and 21 CFR Part 820 on an interim basis.

Supplier Management

The selection and qualification of suppliers is crucial for product quality and process reliability. StingOrg supports you in all phases of supplier management – from selection to the Production Part Approval Process (PPAP) to supplier audits. Our goal: a resilient and reliable supply chain that meets your quality requirements in the long term.

Process Optimization

We analyze and optimize your processes in a targeted manner in order to increase efficiency, make optimal use of resources and streamline production processes. By identifying bottlenecks, redundant processes and optimization potential, we develop tailor-made solutions and implement them in a practical way. Our approach ensures leaner structures, reduced waste and a sustainable improvement in overall productivity.

Design transfer to production

The transition from development to series production is a critical phase that is often associated with unexpected challenges. We ensure a smooth start to production by optimizing interfaces, identifying bottlenecks at an early stage and coordinating all relevant departments. We also implement change requests during the ramp-up phase efficiently and pragmatically.

Production Optimization

To address the growing demands of shortened product development cycles and increased product diversity, products are frequently transferred into production while still in an immature state. This often leads to undesirable outcomes, such as elevated scrap rates and reduced production output. When a production line fails to meet expected output rates, the underlying causes are typically consistent:

• Workload distribution among workstations is uneven
• The production department’s involvement during the production line development phase was delayed
• Changes during the line’s ramp-up phase went unnoticed
• Organizational barriers hinder effective problem-solving

StingOrg’s approach involves analyzing operations in alignment with lean principles, developing value streams and process flow diagrams collaboratively, and providing training to your staff in practical lean management tools. In this way, we create a robust and scalable production environment that increases efficiency and sustainably reduces reject rates.

Ramp-up Management

During the ramp-up, numerous organizational units need to work together – a challenge that often leads to friction and inefficient processes. We accompany you during this crucial phase with strategic advice and operational support to ensure quality requirements from the beginning and avoid costly delays.

Your benefits with StingOrg

• Ensure compliance: meet regulatory requirements and audit readiness
• Cost efficiency: Reduction of error costs and optimization of processes
• Sustainable improvement: Implementation of robust quality management and production processes
• Practice-oriented implementation: Tailor-made solutions that are integrated directly into your processes

Our experts have many years of experience in medical technology and other regulated industries. With our strategic and operational support, we ensure that your company meets the current requirements and successfully asserts itself in the market in the long term.
Let’s optimize your processes together – we are on your side as a reliable partner.