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Improvement

Improvement

Early error detection and efficient process improvement are crucial to be successful as a company in the market.

It is of great importance to detect errors at an early stage, ideally before they occur, and to identify their causes. Tools for error analysis and prevention support this at various points, be it in the evaluation of complaints or in proactive error prevention in complex processes. To achieve the greatest possible benefit from these tools, we offer you support in the implementation of corresponding measures and develop practice-relevant solutions to optimise your processes. Here we would like to give you a brief overview of tools that have proven their worth over the years.

CAPA-Report

Corrective Actions and Preventive Actions (CAPA) are an important part of the quality management system according to EN ISO 13485 as well as the European regulations MDR or IVDR and the Good Manufacturing Process (GMP).

The purpose of this process is to systematically investigate non-conformities, e.g., errors, deviations, or discrepancies from your requirements to result in appropriate corrective and preventive actions. Such process enables continuous improvement and is part of the continuous improvement process (CIP). The CAPA system is usually part of your quality management system and implemented by quality assurance staff on site. Due to the integration of parts of the ISO guide (EN ISO 13485) into the EU GMP Guideline, it is binding for the company. To ensure that the important functions of the CAPA system are fulfilled and your company gains the maximum benefit from it, we would be happy to support you in developing practice-relevant solutions thus helping your staff to deal effectively with CAPAs and increasing the company value internally.

8D-Report

The 8D report is an important document in the quality management complaints system, both internally and between suppliers and customers. It consists of eight mandatory disciplines or process steps that ensure that the underlying problems are solved effectively. A systematic approach and consistent documentation of the solution steps make this method particularly suitable for more challenging problems and can be used in conjunction with other tools such as the Six Sigma model.

The team responsible for the 8D report describes the problem, derives appropriate measures, identifies the causes of the error, plans, and implements measures to correct it and ensures that errors are not repeated. Seamless integration into existing systems is crucial for sustainable functioning and should be stabilised and implemented with expert guidance to establish an effective complaints system with improved information processing in the company.

FMEA

Failure Mode and Effects Analysis (FMEA) is a reliability engineering method that evaluates potential failures in products and processes. Key figures are used for the probability of occurrence, the significance for the customer and the probability of detection of faults. FMEA is often used in industries such as the automotive and aerospace industries to increase technical reliability and avoid errors as early as the development phase. The focus is on preventing errors from the beginning instead of discovering and correcting them afterwards. This is particularly important for complex and critical products to avoid high control and error follow-up costs, e.g., in the aircraft industry. Careful documentation also makes it possible to avoid errors in future product developments.

Our many years of practical experience in this area support you in the smooth implementation of FMEA, so that your employees recognise potential errors early and competently, which leads to a reduction in correction costs and an increase in yield. Through our external view, we promote thorough application and a critical mindset to achieve long-term cost savings.

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