QMS Consultants in Germany

• Customer Quality: revitalization of complaint management (8D, FMEA/PLP) until de-escalation at individual OEMs in the first quarter
• Lean Management: development and implementation of corrective actions in the affected production lines or departments
• Consulting (QMB and Executives): briefing, interpretation and preparation of the entire organization on relevant and current requirements for the successful certification audit

Supported the implementation of the QMS according to ISO 9001, conducted internal audits, and completed the project with certificate renewal.

• Consulting on quality management and operational quality assurance (software testing)
• Creating binding templates for quality-related documents based on DIN EN ISO 9000 ff. and NATO AQAP standards
• Advising on document control and approval processes
• Reviewing and approving project-related documents
• Proofreading English-language white papers in basic research
• Implementing corporate design/identity guidelines
• Supporting audits

• In a traditional third-generation company in the field of surface finishing of single parts as well as small and large series in the metal and plastics industry, the quality management system according to DIN EN ISO 9001:2015 was completely revised and aligned to practical needs. As an external quality management representative (QMB), the preparation and follow-up of internal and external audits as well as certification audits were among the main tasks. Other activities included the creation of management reports, the review and active revision of quality assurance agreements, and the training of employees. Through targeted measures, the complaint rate was successfully reduced.
• As part of a part-time assignment, a quality management system according to DIN ISO 9001:2015 was introduced and implemented in a tool shop with around 40 employees working in a 3-shift system. This included creating the complete documentation, such as the quality manual, management review, work and process instructions, forms and procedures, as well as training the employees. In addition, the preparation and follow-up of internal and external audits as well as certification audits were carried out. The certification was successfully passed with flying colors. The assignment ended after 5 months, during which the internal quality management representative was successfully trained.
• As part of an interim assignment as head of quality management at an international automotive supplier for well-known OEMs in the field of body sheet metal parts, the quality management system according to IATF 16949:2016 was completely revised and aligned in a practical way. This included streamlining processes, creating management reports, and preparing and following up internal and external audits as well as certification audits. Customer visits were also organized and supported, and the further qualification of employees was driven forward. Complaint handling was carried out using methods such as 8D, 5-Why, and Ishikawa. In addition, the quality team was led in a disciplinary role and complaint costs were successfully reduced. Quality assurance agreements were reviewed and actively revised. The interim assignment ended after 6 months due to a permanent hire.
• As part of a root cause analysis, the assembly process of a company producing plastic housings for the integration of electronic components to amplify GPS signals was examined. After delivery of the assemblies, cracks increasingly appeared in the plastic housings, allowing water to enter and causing the assemblies to fail. By identifying opportunities for improvement in the material, assembly, and sealing, targeted improvement measures could be implemented. After redesigning and optimizing the assembly line, the cause of the failure was permanently eliminated. This led to a significant increase in customer satisfaction and a significant reduction in scrap costs.
• As part of an interim assignment as head of quality management at an international automotive supplier for well-known OEMs, the quality management system according to IATF 16949:2016 was completely revised and aligned in a practical way. The tasks included the preparation and follow-up of internal and external audits as well as certification audits, the introduction of CAQ software, and complaint handling using methods such as 8D, 5-Why, Ishikawa, and problem-solving sheets. Processes were also streamlined and realigned, management reports were created, and customer visits were supported. The further qualification of employees and cooperation with internal and external material testing companies and suppliers were also actively promoted. In addition, the disciplinary leadership of 16 quality management employees and a successful reduction in complaint costs were part of the role. Quality assurance agreements were reviewed and actively revised. The interim assignment ended after 20 months due to a permanent hire.
• In preparation for the recertification of DIN ISO 9001:2015 for a globally active industrial company in Lower Saxony with 1,200 employees, the implementation of internal audits across the entire company was organized. This included planning, carrying out, and documenting the audits as well as reporting and tracking measures. In addition, the coordination of the implementation of the identified improvement opportunities was ensured. The audit was successfully passed, confirming the company's sustainable compliance with quality standards.
• Lead auditor 9001-2015, working for three certification bodies.
• After the sale of the traditional injection molding company to a new owner, a comprehensive restructuring was carried out. The goal was to optimize production processes, especially by reducing setup times, improving tool provision, preheating, and material flow, as well as minimizing downtime and scrap. Further measures included introducing an organized material and color batch warehouse, structured workstations, and efficient work routes. In addition, investments were made in modern operating equipment and the focus was placed on securing customer orders and jobs. Processes were streamlined to increase the company's efficiency and competitiveness in the long term.
• As an external quality management representative (QMB) for an international manufacturer and supplier of plain and rolling bearing technology, the quality management system according to DIN EN ISO 9001:2015 was fully revised and aligned to practical needs. The tasks included the preparation and follow-up of internal and external audits as well as certification audits. Complaint handling processes were also optimized according to the 8D method in order to respond more efficiently and in a more targeted way to customer feedback. Other activities included creating management reports, further training employees, reviewing and revising quality assurance agreements, and recording and reducing internal complaint costs. Through targeted measures, the complaint rate was significantly reduced and costs were considerably lowered.
• As part of an interim assignment as head of quality management at a renowned automotive supplier in Germany, the quality management department of a company whose products are used in many premium vehicles was supported. The tasks included maintaining customer portals, coordinating internal quality assurance employees, creating IMDS entries, and preparing and submitting sample submissions according to APQP and PPAP. In addition, the internal quality management system according to ISO 9001:2015 was further expanded and optimized. Other key areas were support for customer, certification, and customer audits as well as the further qualification of the existing quality management employees in the company.
• As part of an assignment as an external quality management representative (QMB) in an injection molding and toolmaking company in the plastics industry, an outdated QM system was brought up to date and adapted to the specific needs of the company. The complete revision and practical alignment of the quality management system according to DIN EN ISO 9001:2015 was carried out in close cooperation with the departments. The tasks included the preparation and follow-up of internal and external audits as well as certification audits, creating management reports, and reviewing and revising quality assurance agreements. In addition, complaint costs were significantly reduced and employees were trained in relevant quality processes. The assignment ended after 2 years due to a long-term alternative in a permanent position.
• As part of preparing a globally active textile company for its first project-related VDA 6.3 audit by its end customer (OEM), the company's quality management system was aligned with the specific requirements of the automotive industry. The goal was to integrate the VDA requirements into the existing ISO 9001:2015 quality management system. This included adapting processes, documenting relevant procedures, and training employees. The audit was successfully passed, confirming the company's suitability for the automotive industry.
• As part of an interim assignment as head of quality management at a global company in the field of exhaust gas recirculation systems, the main goal was to resolve major quality problems in produced components. Measures included setting up a Q-gate to identify quality problems at an early stage, as well as feeding problems back into the previous production stages for root cause analysis. In close cooperation with the upstream departments, solutions were developed for production issues. In addition, employees were trained on defect characteristics and knowledge tests were introduced to strengthen quality awareness. These measures significantly reduced scrap rates and complaints and restored customer confidence. As a result, follow-up projects were successfully placed with the customer. In addition, the interim manager took over disciplinary leadership of the quality area in both plants. The project ended successfully with a planned permanent position with the client.
• On behalf of a German OEM, a quality project was carried out at a Southern European supplier to analyze and solve recurring functional failures in a component. The goal was to identify the causes of the quality problems and, together with the supplier, develop measures that were then monitored for compliance. During a process review at the supplier, various irregularities in the production process were discovered, which had caused the functional failures. Measures were agreed on together and immediately integrated into the production process. The implementation and continuous monitoring of these measures led to a clear improvement in quality and the stabilization of the redesigned processes after a short time. A follow-up audit, carried out on the basis of a comprehensive sample, confirmed the success of the measures. No further production problems or irregularities could be found, and the supplier had regained its usual high performance.

• Potential analysis of potential new suppliers, VDA 6.3 audits in different scopes.
• Component sampling.
• On-site support during escalations, process approvals, and audits.
• Areas of work (Germany, Czech Republic, Belgium, Bosnia and Herzegovina, Switzerland)

• Quality management, system audit IATF 16949

• Qualification of production facilities and process validations of a new production line for the manufacture of implants incl. URS, IQ, OQ and PQ
• Quality remediation project (optimization of procedures, SOP and test methods and work instructions incl. change management)
• Project lead for a test method validation
• CAPA management
• Non-conformance management
• Gap analysis

• Consulting on quality management processes through re-certification for DIN EN ISO 9001 and 50001

• Conducting internal audits