Friday Facts – Management Review

Management Review is a requirement of both 21 CFR 820 and ISO 9001.  21 CFR 820.20 states “Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and…

Friday Facts – Quality Audits

In 21 CFR 820, the FDA requires manufacturers to conduct quality audits “to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.”  This is also a requirement of ISO 9001 and ISO 13485.  It is imperative that these audits be performed…

Friday Facts – Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…

Amilabo is Now Mesa France!

Mesa Labs is pleased to announce that Amilabo is now Mesa France! Sterilization and process validation/monitoring require a high level of expertise and specialized tools. Mesa Labs’ Biological Indicators (BIs) are specifically designed to meet the most stringent requirements and expectations. With the addition of Mesa Labs’ Lyon, France location (formerly Amilabo), Mesa now brings…

Friday Facts – Fault Tree Analysis

The other evaluation tool mentioned in the Risk Analysis discussion is Fault Tree Analysis (FTA).  The fault tree explicitly shows all the different relationships that are necessary to trigger the undesired state.  Through the process of constructing the fault tree, you will gain a thorough understanding of the basic causes that led to the current…