Risk Assessment & Management for Additive Manufacturing (AM)

Course Description

Be Ready for the Approval of your AM product

Every (regulated) industry requires a certain degree of risk assessment and risk minimization.

Medical technology can be cited here as an example. The quality management standard ISO 13485, which is relevant for the medical sector, explicitly requires risk management and all associated documentation for the entire product realization process. The requirements in ISO 14971 for this purpose must in turn be transferred to additive manufacturing technology.

The training is intended to provide a holistic overview of risk assessment and -management for AM-products with focus on medial and give you the required know-how and input how to conduct that. This includes a risk assessment and thus an assessment of whether an acceptable risk can be achieved. In addition, risk management refers to the systematic management of the analysis, evaluation and control of risks.

The second part will be a workshop to discuss specific situations in conjunction with the new input, so that you will have first results and ideas that will be useful for your specific situation and can continue working on them in your company in an effective manner.

Examples and use-cases will focus on medical sector.

Completion of this course will result in a certificate of participation from TÜV SÜD Academy.

Course Benefits

• You receive comprehensive, product-specific and compact knowledge about risk assessment using Additive Manufacturing
• You learn how to manage AM specific risks
• You get an overview of the risk management criteria, e.g. mentioned in ISO 14971 (for medical)

Who Will Benefit?

Target groups of this course are quality and production managers as well as risk and product managers who are or want to become active in AM serial production.

Course Agenda

• Risk assessment for AM-Products
• Risk assessment for AM-Process-Chains
• AM-specific risk management
• Focus on medical sector
• Workshop
  • to discuss specific situations and cases
  • to bring first possible solutions to you company to proceed in an effective manner
  • to deepen the new gained knowledge
• Summary and outlook

Prerequisites

It is recommended to attend the AM Quality and Production Management training in conjunction with this course.

Duration

1.5 Days

Timing

09:00 AM – 05:00 PM

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