About 160 participants from the fields of engineering, risk management and quality management accepted the invitation and met at the events to exchange ideas. In addition to field reports from leading companies, the networking opportunities were particularly well received.
PLATO Medical Summit on September 17th, 2019
The Medical Summit convinced with its versatile program. Expert lectures introduced the event:
Mr. Randolph Stender (General Manager and Consultant, PROSYSTEM GmbH) presented the new and changed requirements of the third edition of ISO 14971:2019. Among other things, the influence on technical documentation was discussed and the interaction with other process standards was considered.
Mr. Jöbstl (management consultant, QM Jöbstl) gave an overview of the FDA requirements for design control and compared the European requirements for the design of medical devices. He also explained the connection to the risk management and software development process.
The lecture by Dr. Benerice Heid (Quality Project and Risk Management, AESCULAP AG) met with particular interest of the participants. AESCULAP AG offers a wide range of different products in risk classes I to III. Dr. Heid gave an exclusive insight into how the implementation of risk management can be guaranteed with such a wide range of products.
In the afternoon, further current topics of the industry were dealt with within the scope of various session slots. These included technical documentation and the networking of process FMEAs. In addition, the linking of Risk Management 14971 with Technical Risk Management was discussed.
PLATO Automotive Summit on September 19th, 2019
The event started with Ronny Jakubasch, member of the FMEA working group. He gave the participants an overview of the contents of the new FMEA manual. Using the 7 steps of the method, he also presented the tools for creating an FMEA.
Dr. Oliver Arp (Manager IAM Quality EMEA, CLARIOS) completed the topic and showed in an exclusive practical insight how Clarios prepares itself for FMEA harmonization. Afterwards there was the opportunity to discuss questions openly.
Various session slots provided the framework for intensive discussions e.g. on topics like:
- Functional Safety and MSR
- Using Templates and Managing them
- Action Management - from 8D to FMEA
Another point on the agenda was the Quality Chain Management - the preventive, production-related quality assurance - of ADIENT. The presentation by Daniel Holland (Manager Quality Chain, ADIENT) covered structural analysis and process flow diagrams, risk analysis to identify critical characteristics and linking characteristics from design to process.
The following panel discussion under the main topic "AIAG & VDA recommend the use of basic and family FMEAs for the re-use of knowledge" rounded off the event and provided discussion material, which could be deepened at the common dinner.
We look back on two successful events and would like to thank all participants and speakers.
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