质量风险管理

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“质量风险管理有以下两条基本原则：

1.质量风险评估要以科学知识为基础，最终目的在于保护患者的利益。

2.质量风险管理程序实施的力度、形式和文件的要求应科学合理，并与风险的程度相匹配。”

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"There are two basic principles for quality risk management:

1.Quality risk assessment should be based on scientific knowledge, with the ultimate goal of protecting the interests of patients.

2.The strength, form, and documentation requirements for the implementation of quality risk management procedures should be scientific and reasonable, and match the degree of risk.

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"什么是风险？

• “风险”是指危害发生的可能性和严重性的组合

• 质量风险管理的目的是按照一个完整的风险管理流程，使风险发生的可能性降低或者提高风险发生时的可预测性，将风险危害降低到可接受程度

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"What is risk?

• "Risk" refers to the combination of the likelihood and severity of hazards occurring

The purpose of quality risk management is to follow a complete risk management process to reduce the likelihood of risk occurrence or improve the predictability of risk occurrence, and reduce risk hazards to an acceptable level

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对于风险，我们能做什么？

• 风险的严重程度，我们无法降低

• 风险的发生可能性，我们可以通过措施来降低风险发生的可能性

• 风险的可探测性，我们可以通过措施来提高发现的机会

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What can we do about risk?

• The severity of the risk, which we cannot reduce

• The possibility of risk occurrence, which can be reduced through measures

• The detectability of risks, and we can take measures to improve the chances of discovery

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如何进行质量风险管理？

• 制定风险管理的程序

• 制定风险管理的方法

• 执行风险分析

• 降低风险与风险接受

• 风险分析的总结、分享、回顾

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How to conduct quality risk management?

• Develop procedures for risk management

• Develop a risk management approach

• Perform risk analysis

• Reducing risk and risk acceptance

• Summary, sharing, review of risk analysis

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什么条件下启动风险管理程序？

• 偏差、变更、CAPA、投诉的评估

• 新项目/新系统/新工艺/新设备引入时

• 前瞻性风险分析

• 回顾性风险分析

• 关键工艺步骤

• 关键公用系统/设备

• 验证与确认

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Under what conditions will the risk management process be initiated?

• Evaluation of deviations, changes, CAPAs, complaints

• When introducing new projects/systems/processes/equipment

• Prospective risk analysis

• Retrospective risk analysis

• Key process steps

• Critical utility systems/equipment

• Verification and Validation