Risk Management风险管理
Risk management is the systematic process of identifying hazards, estimating and evaluating risks, implementing control measures, and monitoring their effectiveness throughout a product’s life cycle. In translation and localization, it appears in risk management plans, risk analyses, FMEA records, and design control files, where it supports safety and compliance for medical devices, pharmaceuticals, and combination products across the product life cycle.
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
Risk management content appears in regulatory submissions, design history files, post-market surveillance plans, risk tables, and usability engineering documents. Translators must keep hazard, hazardous situation, harm, and risk control terms aligned with the client’s risk vocabulary, because these words carry specific technical meanings in life-science risk management frameworks and are often shown as defined terms.
Translation checks
A common mistake is collapsing severity, probability, and detectability into everyday words like “danger” or “chance,” which makes risk tables and risk acceptance criteria ambiguous. Another is translating “hazard” and “cause” interchangeably; that can misrepresent what the risk control is meant to prevent and weaken audit or submission content.
Chinese document application
Risk Management in context · risk file
- English source
- Risk control measure
- Chinese rendering to review
- 风险控制措施
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
A risk control is not the risk estimate itself. Keep the named control connected to the hazard, assessment row and verification reference. Do not silently replace the source rationale with wording that sounds more acceptable in Chinese.
Check the returned Chinese file
In the Chinese review set, select one hazard row and follow its control reference into the supplied procedure. Record an unresolved or missing reference in the handover query list rather than filling it in.
Prepare the connected files
List the source risk-file revision, approved hazard terms and referenced control procedures. Ask who can decide a conflict between a table and its supporting text.
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
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
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.