1.Purpose目的
To establish a standardized quality risk management mechanism for the entire lifecycle of medical devices, standardize activities such as risk identification, assessment, control, communication, review, and continuous improvement, ensure that risk control measures are commensurate with the risks associated with the products, and safeguard product safety, effectiveness, and quality controllability, this procedure is formulated in accordance with the requirements of the 2025 Edition of the "Good Manufacturing Practice for Medical Devices" (No. 107 of 2025).
為建立標(biāo)準(zhǔn)化的醫(yī)療器械全生命周期質(zhì)量風(fēng)險(xiǎn)管理機(jī)制，規(guī)范質(zhì)量風(fēng)險(xiǎn)的識(shí)別、評估、控制、溝通、回顧及持續(xù)改進(jìn)等活動(dòng)，確保風(fēng)險(xiǎn)控制措施與產(chǎn)品存在的風(fēng)險(xiǎn)相適應(yīng)，保障產(chǎn)品安全性、有效性和質(zhì)量可控性，依據(jù)2025 年版《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》（2025 年第 107 號(hào)）要求，特制定本程序。
2.Scope范圍
This procedure is applicable to all risk control activities related to product quality throughout the entire lifecycle of the company's medical devices. It covers design and development, procurement and raw material management, manufacturing, quality control and product release, sales and after-sales services, as well as delegated activities such as research and development, production, outsourcing, and third-party testing. This includes, but is not limited to:
本程序適用于公司醫(yī)療器械全生命周期內(nèi)所有與產(chǎn)品質(zhì)量相關(guān)的風(fēng)險(xiǎn)管控活動(dòng)，涵蓋設(shè)計(jì)開發(fā)、采購與原材料管理、生產(chǎn)制造、質(zhì)量控制與產(chǎn)品放行、銷售與售后服務(wù)、委托研發(fā)/生產(chǎn)/外協(xié)加工/委托檢驗(yàn)等環(huán)節(jié)，包括但不限于：
Technical and compliance risks during the product design and development phase;
產(chǎn)品設(shè)計(jì)開發(fā)階段的技術(shù)風(fēng)險(xiǎn)、合規(guī)風(fēng)險(xiǎn)；
Supply chain quality risks related to raw material procurement and supplier management;
原材料采購、供應(yīng)商管理相關(guān)的供應(yīng)鏈質(zhì)量風(fēng)險(xiǎn)；
Quality risks arising from processes, equipment, environment, and personnel during production;
生產(chǎn)過程中工藝、設(shè)備、環(huán)境、人員引發(fā)的質(zhì)量風(fēng)險(xiǎn)；
Quality control risks associated with testing methods, testing equipment, and sample retention management;
檢驗(yàn)方法、檢驗(yàn)設(shè)備、留樣管理相關(guān)的質(zhì)量控制風(fēng)險(xiǎn)；
Risks related to product storage, transportation, installation, use, and after-sales services;
產(chǎn)品貯存、運(yùn)輸、安裝、使用及售后服務(wù)相關(guān)的風(fēng)險(xiǎn)；
System risks in the operation of the quality management system, change control, deviation handling, and non-conforming product control;
質(zhì)量管理體系運(yùn)行、變更控制、偏差處理、不合格品控制等過程中的體系風(fēng)險(xiǎn)；
Quality risks arising from delegated activities (research and development, production, outsourcing, and testing);
委托相關(guān)活動(dòng)（研發(fā)、生產(chǎn)、外協(xié)、檢驗(yàn)）引發(fā)的質(zhì)量風(fēng)險(xiǎn)；
Compliance risks triggered by external factors such as updates to regulations and standards or feedback from adverse events.
法規(guī)標(biāo)準(zhǔn)更新、不良事件反饋等外部因素引發(fā)的合規(guī)風(fēng)險(xiǎn)。
3.Basis依據(jù)
"Good Manufacturing Practice for Medical Device Production" (Decree No. 107 of 2025).
《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》（2025年第107號(hào)）。
4.Terms and Definitions術(shù)語與定義
4.1.Quality Risk Management質(zhì)量風(fēng)險(xiǎn)管理
In the entire lifecycle of medical devices, it is a systematic activity that adopts prospective or retrospective approaches to identify, evaluate, control, communicate, and review quality risks.
在醫(yī)療器械全生命周期中，采用前瞻或回顧的方式，對質(zhì)量風(fēng)險(xiǎn)進(jìn)行識(shí)別、評估、控制、溝通和審核的系統(tǒng)性活動(dòng)。
4.2.Risk Identification風(fēng)險(xiǎn)識(shí)別
Using appropriate methods to systematically identify potential factors that may affect product quality and safety throughout the entire product lifecycle, thereby clarifying the sources of risks and risk points.
運(yùn)用適當(dāng)?shù)姆椒ǎ到y(tǒng)識(shí)別產(chǎn)品全生命周期中可能影響產(chǎn)品質(zhì)量安全的潛在因素，明確風(fēng)險(xiǎn)來源和風(fēng)險(xiǎn)點(diǎn)的過程。
4.3.Risk Assessment風(fēng)險(xiǎn)評估
The process of analyzing and evaluating identified quality risks to determine the risk level, which includes two stages: risk analysis and risk evaluation.
對識(shí)別的質(zhì)量風(fēng)險(xiǎn)進(jìn)行分析和評價(jià)，確定風(fēng)險(xiǎn)等級(jí)的過程，包括風(fēng)險(xiǎn)分析和風(fēng)險(xiǎn)評價(jià)兩個(gè)環(huán)節(jié)。
4.4.Risk Control風(fēng)險(xiǎn)控制
The process of developing and implementing appropriate control measures based on risk assessment results to reduce risks to an acceptable level.
針對風(fēng)險(xiǎn)評估結(jié)果，制定并實(shí)施適宜的控制措施，將風(fēng)險(xiǎn)降低至可接受水平的過程。
4.5.Risk Review風(fēng)險(xiǎn)回顧
The activity of periodically collecting quality risk information throughout the product lifecycle, evaluating the effectiveness of risk control measures, and adjusting risk management strategies based on changes in internal and external factors.
定期收集產(chǎn)品全生命周期質(zhì)量風(fēng)險(xiǎn)信息，評估風(fēng)險(xiǎn)控制措施的有效性，根據(jù)內(nèi)外部因素變化調(diào)整風(fēng)險(xiǎn)管理策略的活動(dòng)。
4.6.Risk Communication風(fēng)險(xiǎn)溝通
The process of sharing quality risk information among different departments, levels, or with relevant stakeholders such as clients and regulatory authorities.
在不同部門、層級(jí)或與委托方、監(jiān)管機(jī)構(gòu)等相關(guān)方之間，分享質(zhì)量風(fēng)險(xiǎn)信息的過程。
4.7.Residual Risk殘余風(fēng)險(xiǎn)
Risks that remain uneliminated or not reduced to an acceptable level after the implementation of risk control measures.
實(shí)施風(fēng)險(xiǎn)控制措施后，仍未消除或降低至可接受水平的風(fēng)險(xiǎn)。
5.Responsibilities職責(zé)
5.1.Quality Department質(zhì)量部
Responsible for the formulation, revision, maintenance, and dissemination of this procedure.
負(fù)責(zé)本程序的制定、修訂、維護(hù)和宣貫；
Coordinate and oversee quality risk management activities company-wide, and organize cross-departmental risk assessments and reviews.
統(tǒng)籌協(xié)調(diào)全公司質(zhì)量風(fēng)險(xiǎn)管理活動(dòng)，組織跨部門風(fēng)險(xiǎn)評估和回顧；
Review risk assessment reports, risk control plans, and risk review reports.
審核風(fēng)險(xiǎn)評估報(bào)告、風(fēng)險(xiǎn)控制計(jì)劃及風(fēng)險(xiǎn)回顧報(bào)告；
Monitor the implementation of risk control measures and verify their effectiveness.
監(jiān)督風(fēng)險(xiǎn)控制措施的執(zhí)行情況，驗(yàn)證措施有效性；
Manage the archiving of quality risk-related records.
負(fù)責(zé)質(zhì)量風(fēng)險(xiǎn)相關(guān)記錄的歸檔管理；
Track updates in external regulations, standards, and industry risk information, and integrate them into the risk management system in a timely manner.
跟蹤外部法規(guī)標(biāo)準(zhǔn)更新、行業(yè)風(fēng)險(xiǎn)信息，及時(shí)融入風(fēng)險(xiǎn)管理體系。
5.2.風(fēng)險(xiǎn)發(fā)起 / 責(zé)任部門
Responsible for identifying, conducting preliminary analysis, and reporting quality risks within the scope of this department's duties.
負(fù)責(zé)本部門職責(zé)范圍內(nèi)質(zhì)量風(fēng)險(xiǎn)的識(shí)別、初步分析和上報(bào)；
Participate in cross-departmental risk assessments and provide professional technical support and relevant data.
參與跨部門風(fēng)險(xiǎn)評估，提供專業(yè)技術(shù)支持和相關(guān)數(shù)據(jù)；
Formulate and implement risk control measures, and document the execution process and outcomes.
制定并實(shí)施風(fēng)險(xiǎn)控制措施，記錄實(shí)施過程和結(jié)果；
Collect risk control-related information within the department, and participate in risk review and effectiveness evaluation.
收集本部門風(fēng)險(xiǎn)控制相關(guān)信息，參與風(fēng)險(xiǎn)回顧和效果評價(jià)。
5.3.相關(guān)部門（生產(chǎn)部、技術(shù)部、采購部等）
Participate in risk identification and assessment within relevant processes, and provide department-specific risk information.
參與相關(guān)環(huán)節(jié)的風(fēng)險(xiǎn)識(shí)別和評估，提供部門相關(guān)風(fēng)險(xiǎn)信息；
Cooperate in the implementation of risk control measures and fulfill relevant responsibilities within the department.
配合風(fēng)險(xiǎn)控制措施的實(shí)施，落實(shí)本部門相關(guān)職責(zé)；
Promptly report issues identified during the risk control process.
及時(shí)反饋風(fēng)險(xiǎn)控制過程中發(fā)現(xiàn)的問題。
5.4.管理者代表
Review the assessment results and control plans for major quality risks.
審核重大質(zhì)量風(fēng)險(xiǎn)的評估結(jié)果和控制計(jì)劃；
Oversee the effective operation of this procedure and coordinate the resolution of major issues in risk management.
監(jiān)督本程序的有效運(yùn)行，協(xié)調(diào)解決風(fēng)險(xiǎn)管理中的重大問題；
Report major quality risks identified in the operation of the quality management system to the principal responsible person of the enterprise.
向企業(yè)主要負(fù)責(zé)人報(bào)告質(zhì)量管理體系運(yùn)行中的重大質(zhì)量風(fēng)險(xiǎn)。
5.5.企業(yè)主要負(fù)責(zé)人
Approve major quality risk control plans and risk review reports.
批準(zhǔn)重大質(zhì)量風(fēng)險(xiǎn)控制計(jì)劃和風(fēng)險(xiǎn)回顧報(bào)告；
Ensure the allocation of resources such as human resources and infrastructure required for risk management activities.
確保風(fēng)險(xiǎn)管理活動(dòng)所需的人力資源、基礎(chǔ)設(shè)施等資源配置；
Assume overall responsibility for the company's quality risk management activities.
對公司質(zhì)量風(fēng)險(xiǎn)管理工作全面負(fù)責(zé)。
6.Procedure程序
6.1.Basic Principles of Risk Management風(fēng)險(xiǎn)管理基本原則
6.1.1.Full Lifecycle Principle全生命周期原則
Risk management runs through all stages of medical devices, including design and development, production, sales, after-sales services, and other related processes, covering the entire lifecycle of a product from research and development to market withdrawal.
風(fēng)險(xiǎn)管理貫穿醫(yī)療器械設(shè)計(jì)開發(fā)、生產(chǎn)、銷售、售后等全部環(huán)節(jié)，覆蓋產(chǎn)品從研發(fā)到退市的完整生命周期。
6.1.2.Risk Appropriateness Principle風(fēng)險(xiǎn)適配原則
The rigor of risk control measures shall correspond to the level of risk, with enhanced management and control applied to high-risk aspects to ensure that measures are scientific and feasible.
風(fēng)險(xiǎn)控制措施的強(qiáng)度與風(fēng)險(xiǎn)等級(jí)相匹配，高風(fēng)險(xiǎn)環(huán)節(jié)強(qiáng)化管控，確保措施科學(xué)可行。
6.1.3.Evidence-Based Principle基于證據(jù)原則
The identification, assessment, and control of risks must be based on laws, regulations, rules, standards, scientific knowledge, and practical experience to ensure the objectivity and accuracy of risk management activities.
風(fēng)險(xiǎn)識(shí)別、評估和控制需以法律、法規(guī)、規(guī)章、標(biāo)準(zhǔn)、科學(xué)知識(shí)和實(shí)踐經(jīng)驗(yàn)為依據(jù)，確保風(fēng)險(xiǎn)管理活動(dòng)的客觀性和準(zhǔn)確性。
6.1.4.持續(xù)改進(jìn)原則
Risk information is dynamically updated through regular risk reviews, adverse event monitoring, data analysis, and other methods, while risk control measures are continuously optimized to enhance the level of risk management.
通過定期風(fēng)險(xiǎn)回顧、不良事件監(jiān)測、數(shù)據(jù)分析等方式，動(dòng)態(tài)更新風(fēng)險(xiǎn)信息，優(yōu)化風(fēng)險(xiǎn)控制措施，持續(xù)提升風(fēng)險(xiǎn)管理水平。
6.2.Risk Identification風(fēng)險(xiǎn)識(shí)別
6.2.1. Timing of Identification識(shí)別時(shí)機(jī)
During each stage of product design and development (planning, input, output, verification, validation, etc.)
產(chǎn)品設(shè)計(jì)開發(fā)各階段（策劃、輸入、輸出、驗(yàn)證、確認(rèn)等）；
During the selection, evaluation, and re-evaluation of raw material suppliers
原材料供應(yīng)商選擇、評價(jià)及再評價(jià)過程；
During the formulation and changes of production processes, as well as the control of key processes/special processes
生產(chǎn)工藝制定、變更及關(guān)鍵工序/ 特殊過程控制過程；
During the establishment, operation, internal audits, and management reviews of the quality management system；
質(zhì)量管理體系建立、運(yùn)行及內(nèi)部審核、管理評審過程；
After the occurrence of product adverse events or receipt of customer complaints；
產(chǎn)品不良事件發(fā)生、顧客投訴反饋后；
After updates to regulations and standards or the issuance of industry risk warnings；
法規(guī)標(biāo)準(zhǔn)更新、行業(yè)風(fēng)險(xiǎn)預(yù)警發(fā)布后；
When establishing, changing, or adjusting delegated collaboration relationships；
委托合作關(guān)系建立、變更或調(diào)整時(shí)；
In other scenarios that may trigger quality risks (e.g., major equipment repairs, facility renovations, etc.).
其他可能引發(fā)質(zhì)量風(fēng)險(xiǎn)的場景（如設(shè)備重大維修、廠房改造等）。
6.2.2.Identification Methods識(shí)別方法
Common methods include: brainstorming, Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), historical data analysis, on-site inspections, etc.
常用方法包括：頭腦風(fēng)暴法、故障樹分析法（FTA）、失效模式與影響分析法（FMEA）、歷史數(shù)據(jù)統(tǒng)計(jì)法、現(xiàn)場巡查法等；
The department initiating the risk may select appropriate identification methods based on the risk scenario. Cross-departmental identification may be conducted in collaboration with the Quality Department and other relevant departments when necessary.
風(fēng)險(xiǎn)發(fā)起部門可根據(jù)風(fēng)險(xiǎn)場景選擇適宜的識(shí)別方法，必要時(shí)聯(lián)合質(zhì)量部及相關(guān)部門開展跨部門識(shí)別。
6.2.3.Identification Output識(shí)別輸出
The department initiating the risk shall complete the "Quality Risk Identification Form," specifying details such as the risk name, risk source, description of the risk point, potential impacts on product characteristics or system processes, identification date, and personnel involved.
風(fēng)險(xiǎn)發(fā)起部門填寫《質(zhì)量風(fēng)險(xiǎn)識(shí)別表》，明確風(fēng)險(xiǎn)名稱、風(fēng)險(xiǎn)來源、風(fēng)險(xiǎn)點(diǎn)描述、可能影響的產(chǎn)品特性或體系環(huán)節(jié)、識(shí)別日期及識(shí)別人員等信息；
Upon completion of identification, the form shall be submitted to the Quality Department for filing and consolidation.
識(shí)別完成后，提交質(zhì)量部備案匯總。
6.3.Risk Assessment 風(fēng)險(xiǎn)評估
6.3.1.Evaluation Organization評估組織
General risks shall be assessed by relevant personnel organized by the department initiating the risk.
一般風(fēng)險(xiǎn)由風(fēng)險(xiǎn)發(fā)起部門組織相關(guān)人員進(jìn)行評估；
Major risks (those that may significantly impact product safety and effectiveness or require coordination across multiple departments for control) shall be evaluated by a cross-departmental assessment team organized by the Quality Department. External experts may be invited to participate if necessary.
重大風(fēng)險(xiǎn)（可能嚴(yán)重影響產(chǎn)品安全有效性或需跨多個(gè)部門協(xié)同管控的風(fēng)險(xiǎn)）由質(zhì)量部組織跨部門評估小組，必要時(shí)邀請外部專家參與。
6.3.2.Risk Analysis風(fēng)險(xiǎn)分析
Analyze the likelihood of risk occurrence: Determine the probability of risk occurrence (e.g., high, medium, low) by integrating historical data, industry experience, technical characteristics, and other relevant factors
分析風(fēng)險(xiǎn)發(fā)生的可能性：結(jié)合歷史數(shù)據(jù)、行業(yè)經(jīng)驗(yàn)、技術(shù)特性等，判定風(fēng)險(xiǎn)發(fā)生的概率（如高、中、低三級(jí)）；
Analyze the severity of risk impact: Assess the degree of impact on product quality, patient safety, compliance, and other aspects if the risk materializes (e.g., severe, moderate, minor).
分析風(fēng)險(xiǎn)影響的嚴(yán)重程度：評估風(fēng)險(xiǎn)發(fā)生后對產(chǎn)品質(zhì)量、患者安全、合規(guī)性等方面的影響程度（如嚴(yán)重、一般、輕微三級(jí)）；
Document the basis and process of risk analysis to ensure traceability
記錄風(fēng)險(xiǎn)分析的依據(jù)和過程，確?？勺匪荨?/span>
6.3.3.Risk Evaluation風(fēng)險(xiǎn)評價(jià)
Based on the likelihood and severity of risk occurrence, establish a Risk Level Determination Matrix to classify risks into three levels: high, medium, and low:
依據(jù)風(fēng)險(xiǎn)發(fā)生的可能性和嚴(yán)重程度，制定《風(fēng)險(xiǎn)等級(jí)判定矩陣》，將風(fēng)險(xiǎn)劃分為高、中、低三個(gè)等級(jí)：
lHigh Risk: High likelihood of occurrence with severe impact, or medium likelihood with severe impact. Requires immediate implementation of emergency control measures.
l高風(fēng)險(xiǎn)：發(fā)生可能性高且影響嚴(yán)重，或發(fā)生可能性中且影響嚴(yán)重，需立即采取緊急控制措施；
lMedium Risk: High likelihood with moderate impact, medium likelihood with moderate impact, or low likelihood with severe impact. Requires the formulation and implementation of control measures.
l中風(fēng)險(xiǎn)：發(fā)生可能性高且影響一般，或發(fā)生可能性中且影響一般，或發(fā)生可能性低且影響嚴(yán)重，需制定并實(shí)施控制措施；
lLow Risk: Low likelihood with moderate impact, medium likelihood with minor impact, or low likelihood with minor impact. May maintain existing control measures while continuously monitoring.
l低風(fēng)險(xiǎn)：發(fā)生可能性低且影響一般，或發(fā)生可能性中且影響輕微，或發(fā)生可能性低且影響輕微，可維持現(xiàn)有控制措施并持續(xù)監(jiān)控。
The evaluation team shall determine the risk level based on the assessment results and compile the Quality Risk Assessment Report.
評估小組根據(jù)判定結(jié)果確定風(fēng)險(xiǎn)等級(jí)，形成《質(zhì)量風(fēng)險(xiǎn)評估報(bào)告》。
6.4.Risk Control風(fēng)險(xiǎn)控制
6.4.1.Formulation of Control Measures控制措施制定
The department responsible for the risk shall develop a Risk Control Plan based on the risk assessment results, specifying control measures, responsible personnel, completion deadlines, verification methods, etc.
風(fēng)險(xiǎn)責(zé)任部門針對風(fēng)險(xiǎn)評估結(jié)果，制定《風(fēng)險(xiǎn)控制計(jì)劃》，明確控制措施、實(shí)施責(zé)任人、完成時(shí)限、驗(yàn)證方法等；
Control measures should prioritize eliminating risks at the source. If elimination is not feasible, measures to reduce the likelihood of risk occurrence or mitigate its impact may be adopted. Common measures include:
控制措施應(yīng)優(yōu)先選擇從源頭消除風(fēng)險(xiǎn)的方式，無法消除時(shí)可采取降低風(fēng)險(xiǎn)發(fā)生可能性或減輕影響程度的措施，常用措施包括：
lOptimizing design solutions and refining process procedures;
l優(yōu)化設(shè)計(jì)方案、完善工藝規(guī)程；
lStrengthening supplier audits and process monitoring;
l強(qiáng)化供應(yīng)商審核與過程監(jiān)控；
lIncreasing inspection frequency and optimizing inspection methods;
l增加檢驗(yàn)頻次、優(yōu)化檢驗(yàn)方法；
lEnhancing personnel training and clarifying job responsibilities;
l加強(qiáng)人員培訓(xùn)、完善崗位職責(zé)；
lImproving equipment and facilities and optimizing environmental controls;
l改進(jìn)設(shè)備設(shè)施、優(yōu)化環(huán)境控制；
lEstablishing early warning mechanisms and developing contingency plans.
l建立預(yù)警機(jī)制、制定應(yīng)急預(yù)案等。
6.4.2.Approval of Control Measures控制措施審批
Low-risk control plans shall be approved by the head of the risk-responsible department and submitted to the Quality Department for filing.
低風(fēng)險(xiǎn)控制計(jì)劃由風(fēng)險(xiǎn)責(zé)任部門負(fù)責(zé)人批準(zhǔn)，報(bào)質(zhì)量部備案；
Medium-risk control plans shall be reviewed by the head of the risk-responsible department and submitted to the Quality Department for approval.
中風(fēng)險(xiǎn)控制計(jì)劃經(jīng)風(fēng)險(xiǎn)責(zé)任部門負(fù)責(zé)人審核后，報(bào)質(zhì)量部批準(zhǔn)；
High-risk control plans shall be reviewed by the risk-responsible department and the Quality Department, and submitted to the Management Representative or the principal responsible person of the enterprise for approval.
高風(fēng)險(xiǎn)控制計(jì)劃經(jīng)風(fēng)險(xiǎn)責(zé)任部門、質(zhì)量部審核后，報(bào)管理者代表或企業(yè)主要負(fù)責(zé)人批準(zhǔn)。
6.4.3. Implementation of Control Measures控制措施實(shí)施
The risk-responsible department shall organize and execute the measures in accordance with the approved Risk Control Plan, ensuring their effective implementation
風(fēng)險(xiǎn)責(zé)任部門按照批準(zhǔn)的《風(fēng)險(xiǎn)控制計(jì)劃》組織實(shí)施，確保措施落地到位；
Relevant data and circumstances shall be promptly documented during the implementation process. If any measures are found to be unfeasible or require adjustment, the Quality Department shall be notified immediately for re-evaluation and plan revision.
實(shí)施過程中及時(shí)記錄相關(guān)數(shù)據(jù)和情況，若發(fā)現(xiàn)措施不可行或需調(diào)整，應(yīng)及時(shí)上報(bào)質(zhì)量部，重新評估并修訂計(jì)劃。
6.4.4.Verification of Control Effectiveness控制效果驗(yàn)證
After the implementation of control measures is completed, the risk-responsible department shall conduct effectiveness verification according to the predefined validation methods, collecting relevant data to demonstrate whether the risk has been reduced to an acceptable level.
控制措施實(shí)施完成后，風(fēng)險(xiǎn)責(zé)任部門按驗(yàn)證方法開展效果驗(yàn)證，收集相關(guān)數(shù)據(jù)證明風(fēng)險(xiǎn)是否降低至可接受水平；
The Quality Department shall supervise and review the verification process and results, and compile the Risk Control Effectiveness Verification Report.
質(zhì)量部對驗(yàn)證過程和結(jié)果進(jìn)行監(jiān)督審核，形成《風(fēng)險(xiǎn)控制效果驗(yàn)證報(bào)告》；
If the verification results indicate that the risk remains at an unacceptable level, control measures shall be redeveloped or optimized until the risk is effectively controlled.
若驗(yàn)證結(jié)果顯示風(fēng)險(xiǎn)仍未達(dá)到可接受水平，需重新制定或優(yōu)化控制措施，直至風(fēng)險(xiǎn)可控。
6.4.5.Residual Risk Evaluation殘余風(fēng)險(xiǎn)評價(jià)
After risk control measures are implemented, conduct a re-evaluation of the residual risks.
完成風(fēng)險(xiǎn)控制后，對殘余風(fēng)險(xiǎn)進(jìn)行再次評估；
If the residual risks remain at a high level, continuous improvement of control measures is required. If the residual risks are at a medium or low level and within an acceptable range, document the residual risk status and maintain ongoing monitoring.
若殘余風(fēng)險(xiǎn)仍為高風(fēng)險(xiǎn)，需持續(xù)改進(jìn)控制措施；若殘余風(fēng)險(xiǎn)為中、低風(fēng)險(xiǎn)且在可接受范圍內(nèi)，記錄殘余風(fēng)險(xiǎn)情況并持續(xù)監(jiān)控。
6.5.Risk Communication風(fēng)險(xiǎn)溝通
6.5.1.Internal Communication內(nèi)部溝通
The Quality Department shall regularly disseminate risk information internally, reporting on the progress and effectiveness of risk control measures.
質(zhì)量部定期在內(nèi)部發(fā)布風(fēng)險(xiǎn)信息，通報(bào)風(fēng)險(xiǎn)控制進(jìn)展和效果；
Cross-departmental risk-related information shall be promptly conveyed through meetings, reports, emails, and other means to ensure that relevant departments are consistently updated on risk developments.
跨部門風(fēng)險(xiǎn)相關(guān)信息通過會(huì)議、報(bào)告、郵件等方式及時(shí)傳遞，確保相關(guān)部門同步掌握風(fēng)險(xiǎn)動(dòng)態(tài)；
Issues arising during the risk control process shall be communicated and coordinated among relevant departments in a timely manner.
風(fēng)險(xiǎn)控制過程中出現(xiàn)的問題，及時(shí)在相關(guān)部門間溝通協(xié)調(diào)。
Records of risk communication content are documented in the Quality Risk Communication Record Form.
風(fēng)險(xiǎn)溝通內(nèi)容記錄在《質(zhì)量風(fēng)險(xiǎn)溝通記錄表》中。
6.5.2. External Communication外部溝通
Communicate relevant risk information with clients (e.g., research and development, production, outsourcing, inspection) to clarify risk management responsibilities between both parties.
與委托方（研發(fā)、生產(chǎn)、外協(xié)、檢驗(yàn)）溝通相關(guān)風(fēng)險(xiǎn)信息，明確雙方風(fēng)險(xiǎn)管控責(zé)任；
Report major quality risks and their handling to regulatory authorities as required by regulations.
按法規(guī)要求向監(jiān)管機(jī)構(gòu)報(bào)告重大質(zhì)量風(fēng)險(xiǎn)及處置情況；
Communicate risk information with relevant stakeholders, such as customers and suppliers, when necessary, to ensure coordinated and consistent risk management efforts.
必要時(shí)與顧客、供應(yīng)商等相關(guān)方溝通風(fēng)險(xiǎn)信息，確保風(fēng)險(xiǎn)管控協(xié)同一致。
6.6.Risk Review風(fēng)險(xiǎn)回顧
6.6.1.Review Frequency回顧頻次
Regular Risk Review: Conduct a company-wide quality risk management review at least once per year.
常規(guī)風(fēng)險(xiǎn)回顧：每年至少開展一次全公司范圍的質(zhì)量風(fēng)險(xiǎn)管理回顧；
Special Risk Review: Promptly conduct a specialized review under the following circumstances:
專項(xiàng)風(fēng)險(xiǎn)回顧：出現(xiàn)以下情況時(shí)，及時(shí)開展專項(xiàng)回顧：
lOccurrence of major adverse events or batch complaints related to products;
l產(chǎn)品發(fā)生重大不良事件或批量投訴；
lSignificant updates to regulations or standards;
l法規(guī)標(biāo)準(zhǔn)重大更新；
lMajor changes in product design, processes, raw materials, suppliers, etc.;
l產(chǎn)品設(shè)計(jì)、工藝、原材料、供應(yīng)商等發(fā)生重大變更；
lIdentification of significant systemic risks during internal audits or management reviews;
l內(nèi)部審核、管理評審發(fā)現(xiàn)重大體系風(fēng)險(xiǎn)；
lRisk-related rectification requirements raised by regulatory inspections;
l監(jiān)管機(jī)構(gòu)檢查提出風(fēng)險(xiǎn)相關(guān)整改要求；
lOther major changes that may impact quality risk conditions.
l其他可能影響質(zhì)量風(fēng)險(xiǎn)狀況的重大變化。
6.6.2.Review Content回顧內(nèi)容
Completeness of Risk Identification: Assess whether any risk points have been overlooked;
風(fēng)險(xiǎn)識(shí)別的完整性：是否存在遺漏的風(fēng)險(xiǎn)點(diǎn)；
Accuracy of Risk Assessment: Evaluate whether the determination of risk levels is reasonable;
風(fēng)險(xiǎn)評估的準(zhǔn)確性：風(fēng)險(xiǎn)等級(jí)判定是否合理；
Effectiveness of Control Measures: Determine whether existing measures remain effective and whether optimization is needed;
控制措施的有效性：現(xiàn)有措施是否持續(xù)有效，是否需要優(yōu)化；
Updates to Risk Information: Check whether new risk-related information has been collected;
風(fēng)險(xiǎn)信息的更新：是否收集到新的風(fēng)險(xiǎn)相關(guān)信息；
Controllability of Residual Risks: Verify whether residual risks remain within acceptable limits;
殘余風(fēng)險(xiǎn)的可控性：殘余風(fēng)險(xiǎn)是否仍在可接受范圍；
Suitability of the Risk Management System: Assess whether this procedure and related processes require adjustments.
風(fēng)險(xiǎn)管理體系的適宜性：本程序及相關(guān)流程是否需要調(diào)整。
6.6.3.Review Output回顧輸出
The Quality Department shall organize relevant departments to conduct the risk review and compile the Quality Risk Management Review Report, specifying review conclusions, improvement recommendations, and responsible departments.
質(zhì)量部組織相關(guān)部門開展風(fēng)險(xiǎn)回顧，形成《質(zhì)量風(fēng)險(xiǎn)管理回顧報(bào)告》，明確回顧結(jié)論、改進(jìn)建議及責(zé)任部門；
After the report is reviewed by the Management Representative and approved by the principal responsible person of the enterprise, relevant departments shall implement the improvement recommendations.
報(bào)告經(jīng)管理者代表審核、企業(yè)主要負(fù)責(zé)人批準(zhǔn)后，相關(guān)部門落實(shí)改進(jìn)建議。
6.7.Risk Management for Delegated Activities委托相關(guān)風(fēng)險(xiǎn)管控
6.7.1.Responsibilities of the Delegating Party委托方責(zé)任
Prior to delegation, the delegating party shall assess the risk management capabilities of the entrusted party and incorporate risk management requirements into the quality agreement.
委托方在委托前，評估受托方的風(fēng)險(xiǎn)管理能力，將風(fēng)險(xiǎn)管理要求納入質(zhì)量協(xié)議；Collaborate with the entrusted party to identify quality risks associated with the delegated activities and clarify the risk management responsibilities of both parties.
與受托方共同識(shí)別委托活動(dòng)相關(guān)的質(zhì)量風(fēng)險(xiǎn)，明確雙方風(fēng)險(xiǎn)管控職責(zé)；
Monitor the implementation of risk control measures by the entrusted party and regularly review risk management records provided by the entrusted party.
監(jiān)督受托方風(fēng)險(xiǎn)控制措施的執(zhí)行情況，定期審核受托方風(fēng)險(xiǎn)管理相關(guān)記錄。
6.7.2.Responsibilities of the Entrusted Party受托方責(zé)任
Establish a risk management mechanism appropriate for the delegated activities in accordance with the requirements of the quality agreement.
按照質(zhì)量協(xié)議要求，建立與受托活動(dòng)相適應(yīng)的風(fēng)險(xiǎn)管理機(jī)制；
Identify and control quality risks during the entrusted process, and promptly report significant risks and their handling to the delegating party.
識(shí)別并控制受托過程中的質(zhì)量風(fēng)險(xiǎn)，及時(shí)向委托方報(bào)告重大風(fēng)險(xiǎn)及處置情況；
Cooperate with the delegating party in conducting risk assessments and reviews, providing relevant data and records.
配合委托方開展風(fēng)險(xiǎn)評估和回顧，提供相關(guān)數(shù)據(jù)和記錄。
6.7.3.Risk Escalation Mechanism風(fēng)險(xiǎn)升級(jí)機(jī)制
If the risk-responsible department identifies a risk level exceeding its control scope during risk identification or control, it shall report to the Quality Department within two working days.
風(fēng)險(xiǎn)責(zé)任部門在風(fēng)險(xiǎn)識(shí)別或控制過程中，發(fā)現(xiàn)風(fēng)險(xiǎn)等級(jí)超出本部門管控范圍，應(yīng)在2 個(gè)工作日內(nèi)上報(bào)質(zhì)量部；
Upon receiving the report, the Quality Department shall promptly organize an assessment. If the risk is determined to be significant, it shall report to the Management Representative and the principal responsible person of the enterprise within three working days.
質(zhì)量部接到上報(bào)后，及時(shí)組織評估，若判定為重大風(fēng)險(xiǎn)，應(yīng)在3 個(gè)工作日內(nèi)上報(bào)管理者代表和企業(yè)主要負(fù)責(zé)人；
Activities related to significant risks shall be suspended until the risk is reduced to an acceptable level, provided that effective control has not yet been achieved.
重大風(fēng)險(xiǎn)未得到有效控制前，相關(guān)活動(dòng)應(yīng)暫停，直至風(fēng)險(xiǎn)降低至可接受水平。
7.Record Management記錄管理
7.0.1.All records related to quality risk management shall be truthful, accurate, complete, and legible, and shall be uniformly archived and managed by the Quality Department.
所有質(zhì)量風(fēng)險(xiǎn)管理相關(guān)記錄需真實(shí)、準(zhǔn)確、完整、清晰，由質(zhì)量部統(tǒng)一歸檔管理；
7.0.2.The retention period for records shall at least align with the lifespan of the medical device, and shall be no less than two years from the date of risk closure or the last review. If relevant regulations require a longer retention period, the regulatory requirements shall prevail.
記錄保存期限至少與醫(yī)療器械壽命期保持一致，且自風(fēng)險(xiǎn)關(guān)閉或末次回顧之日起不少于2 年，若相關(guān)法規(guī)要求更長保存期限的，從其規(guī)定；
7.0.3.Records may be maintained in either paper or electronic form. Electronic records must comply with data management requirements to ensure authenticity and traceability.
記錄形式包括紙質(zhì)記錄和電子記錄，電子記錄需符合數(shù)據(jù)管理要求，確保真實(shí)可追溯。
8.Relevant Record Forms相關(guān)記錄表單
8.1.Quality Risk Identification Form《質(zhì)量風(fēng)險(xiǎn)識(shí)別表》
8.2.Risk Level Determination Matrix《風(fēng)險(xiǎn)等級(jí)判定矩陣》
8.3.Quality Risk Assessment Report《質(zhì)量風(fēng)險(xiǎn)評估報(bào)告》
8.4.Risk Control Plan《風(fēng)險(xiǎn)控制計(jì)劃》
8.5. Risk Control Effectiveness Verification Report《風(fēng)險(xiǎn)控制效果驗(yàn)證報(bào)告》
8.6. Quality Risk Management Review Report《質(zhì)量風(fēng)險(xiǎn)管理回顧報(bào)告》
8.7.Quality Risk Communication Record Form《質(zhì)量風(fēng)險(xiǎn)溝通記錄表》
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