FMEA - Early identification and assessment of potential causes

Create FMEAs in team work - worldwide and easy.

Connect your teams across locations with modern web technology - the PLATO FMEA software. All teams and members work on the same system model, but with different task-oriented accesses.

FMEA is a method of preventive error prevention. Possible errors in products and processes should be identified and minimized or eliminated by appropriate measures. Complaint and development costs can be reduced and potential harm to the product user averted.

The FMEA is especially used in the design or development phase of new products or processes. This method is widely used in the automotive and aerospace industries, but also in other industries where a properly performed FMEA is required.

Simple FMEA can be created with a normal spreadsheet program. But they aren't prepared for complex relation structured documents like FMEA. Each process can have many requirements and each requirement can have many potential failure modes. For larger projects and complex relation structured documents a special FMEA software is useful.

You should update your FMEA:

  • when you begin a new cycle (new product or process)
  • when there is a change in design
  • when there is a change to the operating conditions
  • when there are new regulations
  • when a customer indicates a problem

Standards

The focus of our FMEA software are automotive, aviation industry, healthcare, electronics, machinery and plant, services and food industries, pharmaceutical industries and chemical industries. PLATO FMEA connected is integrated in methods and engineering processes by PLATO e1ns, a modern web technology.

PLATO e1ns is based on the following requirements:

Automotive

  • VDA:Quality assurance before series manufacture - Product- and Process-FMEA, Volume 4 Issue 2006
  • AIAG: Potential Failure Mode and Effects Analysis (FMEA), 4th Edition
  • IATF 16949: General requirements for quality management systems

Healthcare

  • MPG: Medical Devices Act
  • DIN EN ISO 13485
  • DIN EN ISO 14971

Food industry

  • HACCP: Hazard Analysis and Critical Control Points

Pharmaceutical and chemical industry

  • GxP: Good X Practice (FDA compliance: X can mean: Clinical,Laboratory, Manufacturing, Pharmaceutical,etc.)
  • I Q9: International Conference on Harmonization
  • PIC: Pharmaceutical Inspection Convention
  • AMG: German Pharmaceutical Act

We provide you with tools for engineering,  risk management and document control that meet the high demands of your industry, the utmost respect.

PLATO e1ns - Engineering Framework

Risk and Knowledge Management in the customer-oriented development of products and processes - even more effective FMEA with this software.

PLATO XERI™-Document Control System

Guiding documents with system. Your industry-independent software solution for document Control - perfect organization of content and documents.