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Risk Analysis FMEA

Purpose

In short, risk analysis is an assessment of risks that exist or may arise during a process and/or activity. That is why we routinely analyze situations and take measures to minimize business risks. Failure Mode Effect Analysis or FMEA is an effective risk analysis method for design and manufacturing. It examines your design and manufacturing processes and identifies potential shortcomings and defects that could lead to unwanted results.

Target Audience

Employees of pharmaceutical and food organizations who are directly or indirectly involved in processes or activities that must result in products with a constant quality.

Intent

This training consists of 1 half day (4 hours) and covers the introduction of the FMEA technique, approach, determining risks, drawing up a protocol and implementation.

Program

·        Introduction FMEA

·        Simularities betwee HACCP and FMEA methodologies

·        Determining whether an object requires calibration

·        How do you determine the measurement values

·        Write protocol

·        Determining the freqency of execution of measurements

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·        Calculate and document results

 Qty participants   8 - 12