Validation

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Validation

Your product is at a late stage of product development and you need to think about how the product can be produced industrially to a consistent standard. For this, the methods of validation are generally applied. Whether it’s securing the identified risks from the risk analysis in the production process, IQ, OQ or PQ activities, or validating entire production environments, we can help you with these challenges.

In particular, the standard ISO 3485:2016 places increased demands on validation, which have to be taken into account. Numerous customer projects have shown us that the issue of validation is often underestimated and not scheduled accordingly.


CAPA management

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CAPA management

Before an audit or an official inspection, tension usually mounts in a company. Could the quality management system be in trouble? StingOrg will show you how to manage these kinds of Corrective and Preventive Action (CAPA) situations. We train your employees and also take over the management of the CAPA system according to ISO 13485:2016 and 21 CFR Part 820 on an interim basis.

In our experience, these are the three major conflict points in CAPA management:

  1. Timing
    Often Corrective and Preventive Actions are planned incorrectly. The CAPA system goes into a time lapse or even out of control as a result.
  2. Culture
    Dealing with CAPAs is seen by owners as a punishment rather than a problem-solving tool that improves product quality.
  3. Evidence and documentation
    Verbalization and documentation do not provide the necessary attention, attention to detail and technical language.

Our experts will help you to overcome all the difficulties surrounding the CAPA process according to ISO 13485:2016 and 21 CFR Part 820. Find out today and get some references!


Ramp-up

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Ramp-up

You’ve successfully managed the development of your new product, have followed through with all customer requests and complied with the planned timeline. The customer is gradually starting to move designs to production. But now you realize that important changes that the customer still wants can no longer be taken into account in production planning. The designs are pending, the Run@Rate and the MFU have yet to be made, the customer releases the ramp-up for the product and suddenly there is a lot of unplanned work.

From our experience, we know that the transition from the development phase to production is always a challenge. With ramp-up management, it is important to involve all relevant departments so as to provide the desired production rates in installments to the customer. The challenge is juggling multiple variables when coordinating everyone involved.


Quality Management System (QMS)

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Quality Management System (QMS)

We are happy to assist you with introduction, review, improvement and implementation in the following areas:

  • 9001
  • ISO 13485:2016
  • EU MDR
  • MDD
  • Requirements from QSR 820 according to FDA
  • Risk management according to DIN EN ISO 14971
  • in the field of environmental management according to ISO 14001

Our many years of professional experience in the implementation of these standards and their daily application have given us the expertise needed to deal with quality management systems.


Supplier management

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Supplier management

We help suppliers tap into new business areas and build the right quality management system with them. Thus, StingOrg offers suitable support in all areas, such as supplier selection, execution of production part approval processes (PPAP), supplier audits, process validation or on-site support. We qualify suppliers so that they can guarantee all quality and quantity requirements.


Production Line Optimisation

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Production Line Optimisation

To meet the growing demands of shorter product development cycles and higher product diversity, products are often presented for to production before they are ready. This results in high waste rates and low output numbers. If a production line fails to produce the expected output rate, there are always similar causes:

  • The work content is unevenly distributed between jobs.
  • In the development of the production line, the production department was not involved early enough.
  • During the line run-up, changes occurred which were not identified before.
  • There is an organizational obstruction that prevents real problem solving.

StingOrg will work with you to find suitable solutions and provide LEAN management advice. We analyze using LEAN principles, work with you to create value streams and timing diagrams, and train your employees to use simple LEAN management tools. In this way, we drive the visibility and implementation of optimization measures.


Training & coaching

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Training & coaching

Only when a company becomes a learning organization will it be successful in the long term. We have developed our consulting products in such a way that your employees can already learn during our joint project and then apply and pass on what they have learned on their own. This increases not only motivation, but also specialist knowledge in the company.

Shortly after the start of the project in your organization, we will select together with you the right experts, who are trained by us. At the end, we hand over the work to these experts, so that the change process initiated does not come to a standstill and leads to lasting improvement.

Got any questions about our services? Then feel free to get in touch.