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  • https://bio.libretexts.org/Bookshelves/Biotechnology/Quality_Assurance_and_Regulatory_Affairs_for_the_Biosciences/02%3A_Introduction_to_Quality_Principles/2.9%3A_Nonconformance
    When a process, product, or raw material is out of specification, it is called a nonconformance. Inspections, audits, and surveillance will occasionally uncover nonconformance or defects. Nonconforman...When a process, product, or raw material is out of specification, it is called a nonconformance. Inspections, audits, and surveillance will occasionally uncover nonconformance or defects. Nonconformance problems are placed in one of three categories based on the product defect: critical, major, and minor.

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