Quality Management System
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.
- We have expertise in these standards and regulations:
- ISO 9001
- ISO 13485
- FDA 21 CFR Part 820 QSR
- EU MDR
- EU IVDR
- ISO 14971
- ISO 14001
Qualification and Validation
Your product is at a final stage of product development and you are exploring how it can be manufactured on an industrial scale at a consistent quality. In particular, ISO 13485:2016 places increased requirements on validation. Numerous projects with customers have shown us that validation efforts are often underestimated and not planned properly.
Whether it’s about hedging the identified risks from the risk analysis in the production process, or about activities related to IQ, OQ, PQ or validating entire production environments, we can help you with these challenges.
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.
StingOrg offers appropriate support in supplier selection, execution of Production Part Approval Process (PPAP) and supplier audits. We qualify suppliers in such a way that they can guarantee all requirements for quality and quantity.
We analyze, streamline, and optimize processes to maximize efficiency, reduce waste, and enhance overall productivity. We identify bottlenecks, redundancies, and areas for improvement within existing processes, suggest and implement solutions to enhance their effectiveness.
Design transfer to Production
As the design phase is ending and production is set to commence, recurring friction and coordination issues arise again and again. Precisely at this critical juncture, it becomes clear that the work has not yet been fully completed. These situations necessitate ad hoc troubleshooting with suppliers, development, quality control, work preparation, or validation. Additionally, there are instances where customers request significant changes that may not have been incorporated into the production planning.
In such scenarios, we serve as a trusted partner capable of extinguishing operational fires and ensuring a smooth and largely care-free launch.
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.
Organizational units and people representing very different interests are involved in the entire process management. This inevitably has the potential for friction, misunderstandings, and stress.
It is often only discovered in the ramp-up phase that fundamental quality requirements have been disregarded. In this case, fires must be extinguished at short notice. StingOrg is your reliable, goal-oriented partner in this critical phase.
To avoid firefighting in the first place, we can act at your side right from the start, in all phases of product development.
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your company forward?
Let’s take the first steps together!