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.

What is a Manufacturing Deviation


Why is standard deviation used in manufacturing?

Standard deviation is used in manufacturing to help distinguish between acceptable or normal variation and errors in a quality control program. Ultimately, it is an indicator of how well the manufacturing process is controlled.

*Source: https://www.thesharpener.net

What are the different types of deviation?

The deviation is any modification or temporary change in any approved procedure, documentation, or specifications. Deviation could be process or procedure related. The following types of deviation can be found in a manufacturing process: planned vs unplanned, temporary vs permanent, lot- specific vs multiple lot, product-specific vs multiple products deviations.

Source: https://pharmaguddu.com

What are the steps in manufacturing process?

The steps in the manufacturing process are:

  1. Product concept
  2. Research
  3. Design
  4. Create the final design
  5. Testing
  6. Manufacturing and assembly
  7. Feedback and testing
  8. Official release

*Source: https://www.score.org

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