Nonconformance不符合项
A nonconformance is a failure to meet a specified requirement, standard, or procedure, including deviations in products, processes, documentation, supplier materials, equipment, or records. In translation and localization, it appears in quality event reports, CAPA records, audit findings, and supplier complaint files that document what went wrong, how it was classified, and what corrective and preventive actions were taken and verified.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
Nonconformance terminology appears in quality management system documentation, internal and external audit reports, supplier corrective action requests, and CAPA investigation summaries. Translators must use the client’s approved QMS terms consistently and must not soften the wording, because the classification of a nonconformance affects investigation and escalation.
Translation checks
A frequent error is translating nonconformance as a synonym for “defect” or “complaint,” which may be narrower or broader than the quality-system meaning. That can change how a deviation is recorded and prioritized, making audit responses look inconsistent or causing a CAPA to be opened at the wrong level.
Chinese document application
Nonconformance in context · nonconformance record
- English source
- Record the nonconformance and its disposition.
- Chinese rendering to review
- 记录不符合项及其处置。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Keep the observed nonconformance separate from its disposition and later corrective action. These may occupy different fields and have different owners. A smoother Chinese sentence must not imply that an unresolved item was accepted or closed.
Check the returned Chinese file
Compare one record row with the linked disposition form. Check that the Chinese name of the finding and its record identifier remain paired through any spreadsheet wrapping, page breaks or bilingual layout changes.
Prepare the connected files
Send the current form and procedure references, including permitted disposition terms. Keep blank approval and closure fields blank unless the source contains entries.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
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Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.