DISCLAIMER: This blog post solely represents my own opinion based on experience, my own opinions and/or interpretations.
A certificate of Conformity or COC is a statement of a supplier which says that the product delivered meets your predefined specifications and/or the specifications of known standard(s). It’s a way of saying ‘our product was made in accordance with your required specification’
DISCLAIMER: This blog post solely represents my own opinion based on experience and/or interpretations.
A mock recall is an exercise in which the process for executing a recall is demonstrated in a theoretical setting.
The mock recall process should be linked to the field actions process.
Motto ‘Practice makes perfect’
EPISODE – 1 In this series I will give an in-depth view on the different risk assessment techniques, starting with FMEA. The FMEA series will contain 5 episodes.
DISCLAIMER: This blog post solely represents my own opinion based on experience and/or interpretations. As a former Subject Matter Expert Quality Risk Management and trainer in one of the pharmaceutical big 5 companies I have extensive experience in performing and guiding failure mode and effect analyses.
FMEA is used to define, identify, and eliminate known and/or potential failures, problems, errors… from the system, design, process, and/or services before they reach the customer.
FMEA’s motto ‘ DO THE BEST YOU CAN WHEN YOU CAN‘.
The FMEA technique was developed by army reliability engineers in the late 1950s (9 november 1949 to be exact) to study problems that might arise from malfunctions of military systems.
Generally, four types of FMEA can be distinguished, they all gave their own focus and objective:
Aurélia Excellence Exchange 