What is a Manufacturing Deviation?

Manufacturing Deviation Definition

A manufacturing deviation is an unplanned, temporary change to a documented procedure or design. Change control boards (CCBs) will approve deviations to products or manufacturing processes until a permanent change can be accomodated. Permante changes are normally approved via a formal engineering change order (ECO). Deviations for manufacturing products will have start and stop dates for the temporary change and/or may be based on available inventory. Manufacturing deviation software helps companies comply with FDA CFR Part 820, 21 CFR Part 11, and other related requirements.