DE= German only | DE->EN= Original language German, simultaneous translation into English | EN->DE= Original language English, simultaneously translated into German
09:00 - 09:15 am CEST
Welcome
09:15 - 10:00 am CEST
Implementing Quality Center APQP at Witzenmann
Nadine Hanakam (Project Engineer, Witzenmann) (DE->EN)
The Witzenmann Group has about 4300 employees within 22 subsidiaries and 6 market divisions and produces flexible metallic elements with a wide range of diversification for many different markets and customer requirements. Decentralisation and transformation increase the need collaboration in customer projects across all divisions, which made a harmonisation of processes and software necessary. Implementing Quality Center APQP as the new software for projects & project controlling entailed challenges – especially regarding acceptance of the users. Some functions achieved the status “essential and appreciated” within our improvement process. We look forward to the further development.
10:00 - 10:45 am CEST
Inalfa Roof System's FMEA Journey
Mert Tascioglu (Engineering Manager – Advanced Engineering Std. Parts Team, Inalfa Roof Systems BV) (EN->DE)
Inalfa Roof Systems is a global automotive roof system Tier1 supplier to all premium OEMs. Headquartered in Venray NL, Inalfa has more than 5000 employees in 15 locations worldwide, including 5 engineering offices, manufacturing more than 6 million roofs every year.
FMEA has always been at the core of engineering at Inalfa. Release of the new FMEA guideline by AIAG&VDA was seen as an opportunity to improve the quality of the process within the organization. Main focus areas were:
- Adapting FMEA process to AIAG & VDA FMEA Handbook (2019)
- Use of dedicated software, with the ability to link P/DFMEA and Control Plan in a structured manner
- Lessons learned transfer to all projects via use of templates (Base FMEA's)
- Meet OEM Requirements for FMEA Process
10:45 - 11:30 am CEST
Coffee break & networking
11:30 - 12:30 pm CEST
How to get to the Digital Thread - Motivation and roadmap for your journey to PeakAvenue
Dr. Karin Ammon, Martina Müller (Product Management PeakAvenue) (DE->EN)
We start together with the status quo of our solutions for document management, engineering, FMEA and CAQ. Next, we will look into the future of the existing solutions and design your path to a digital thread on an integrated digital solution - the PeakAvenue platform. The aim is to encourage you to join us on the path to PeakAvenue.
- Roadmap XERI, e1ns and QC
- Roadmap PeakAvenue
- How will the transition to the PeakAvenue platform be organized?
PARALLEL
Risk analysis methods in medical technology - a field report
Carolin Schulz & Oliver Mannuß (Fraunhofer-Institut für Produktionstechnik und Automatisierung IPA) (DE)
We will show you a way to implement holistic risk management by systematically identifying and assessing application risks and technical risks. Using practical examples, we classify risk types in the development process and explain the aim and purpose of the corresponding analysis method:
- Gefährdungs- und Risikobeurteilung Hazard and risk assessment
- Technical risk analyses:
- Design FMEA
- Process FMEA
- Functional Safety (FuSa)
- Analysis of security-relevant cyber risks
We present possible links between the methods that ensure traceability and consistency in holistic risk management.
12:30 - 13:30 pm CEST
Lunch & networking
13:30 - 14:45 pm CEST
PeakAvenue-FMEA: Presentation and discussion of initial ideas and concepts
Andreas Wilhelm (Consultant PeakAvenue) (DE-> EN)
The PeakAvenue platform will of course also include an FMEA module. With the aim of combining the best of both worlds, this completely new module will incorporate the ideas and experience of iqs and PLATO. Of course, we do not want to do without your ideas and experience and would therefore like to present and discuss initial ideas and concepts with you in this workshop.
PARALLEL
Continuous information flow in the product life cycle using the example of risk management for medical devices
Dr. Thomas Schmitz (Consultant PeakAvenue) (DE)
We will present methods and processes for implementing risk management in accordance with DIN EN ISO 14971. Discuss with us the requirements for software support and implementation options with PeakAvenue:
- Risk assessment according to DIN EN ISO 14971 with a focus on product application,
- Linking the risk control measures with the requirements and functional analysis,
- Traceability Matrix,
- FMEA (Failure Mode and Effects Analysis) to increase technical reliability,
- CAPA workflow,
- Control and structuring of documentation,
- Linking the management system with the technical documentation.
14:45 - 15:00 pm CEST
Farewell