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 accommodated. Permanent 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.

FAQs

Why is standard deviation used in manufacturing?

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What is deviation in pharma industry?

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What is deviation and types?

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