Deviation偏差
A deviation is a departure from an approved procedure, specification, or standard that occurs during manufacturing, testing, storage, or distribution. In translation and localization, the term appears in quality event reports, investigation records, audit findings, and corrective and preventive action documentation; it describes an unplanned event that must be documented and assessed for impact on product quality, safety, or data integrity.
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
Deviation appears in incident reports, batch records, investigation summaries, supplier quality documents, and regulatory inspection responses. Translators must preserve the difference between minor, major, and critical deviations and avoid language that implies a deliberate change, because deviation handling follows a specific quality system path. The term also appears in audit trail translations.
Translation checks
A common mistake is translating deviation as a synonym for 'change' or 'nonconformance' without noting that a deviation is an unplanned departure from an approved requirement. Conflating these categories can trigger the wrong quality process, mislead auditors, and weaken the seriousness of an investigation record. Translators may also soften 'unplanned' into neutral wording.
Chinese document application
Deviation in context · deviation report
- English source
- Document the deviation from the approved procedure.
- Chinese rendering to review
- 记录与已批准程序的偏离。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Distinguish an unplanned departure from an authorized change or a general difference in results. Preserve the procedure reference and the wording that describes what actually occurred. A translator should query an unclear source status rather than classify the event.
Check the returned Chinese file
Read the event description beside the cited procedure step. Confirm that Chinese wording describes the same departure and that no translated status label adds authorization or closure absent from the original record.
Prepare the connected files
Supply the relevant procedure revision, event description and approved event categories. Ask the document owner to resolve inconsistent classifications.
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.
Related document experience
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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.