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).
為建立標準化的醫(yī)療器械全生命周期質(zhì)量風險管理機制，規(guī)范質(zhì)量風險的識別、評估、控制、溝通、回顧及持續(xù)改進等活動，確保風險控制措施與產(chǎn)品存在的風險相適應(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）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)的風險管控活動，涵蓋設(shè)計開發(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)計開發(fā)階段的技術(shù)風險、合規(guī)風險；
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)量風險；
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)量風險；
Quality control risks associated with testing methods, testing equipment, and sample retention management;
檢驗方法、檢驗設(shè)備、留樣管理相關(guān)的質(zhì)量控制風險；
Risks related to product storage, transportation, installation, use, and after-sales services;
產(chǎn)品貯存、運輸、安裝、使用及售后服務(wù)相關(guān)的風險；
System risks in the operation of the quality management system, change control, deviation handling, and non-conforming product control;
質(zhì)量管理體系運行、變更控制、偏差處理、不合格品控制等過程中的體系風險；
Quality risks arising from delegated activities (research and development, production, outsourcing, and testing);
委托相關(guān)活動（研發(fā)、生產(chǎn)、外協(xié)、檢驗）引發(fā)的質(zhì)量風險；
Compliance risks triggered by external factors such as updates to regulations and standards or feedback from adverse events.
法規(guī)標準更新、不良事件反饋等外部因素引發(fā)的合規(guī)風險。
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）。
4.Terms and Definitions術(shù)語與定義
4.1.Quality Risk Management質(zhì)量風險管理
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)量風險進行識別、評估、控制、溝通和審核的系統(tǒng)性活動。
4.2.Risk Identification風險識別
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.
運用適當?shù)姆椒ǎ到y(tǒng)識別產(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，明確風險來源和風險點的過程。
4.3.Risk Assessment風險評估
The process of analyzing and evaluating identified quality risks to determine the risk level, which includes two stages: risk analysis and risk evaluation.
對識別的質(zhì)量風險進行分析和評價，確定風險等級的過程，包括風險分析和風險評價兩個環(huán)節(jié)。
4.4.Risk Control風險控制
The process of developing and implementing appropriate control measures based on risk assessment results to reduce risks to an acceptable level.
針對風險評估結(jié)果，制定并實施適宜的控制措施，將風險降低至可接受水平的過程。
4.5.Risk Review風險回顧
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)量風險信息，評估風險控制措施的有效性，根據(jù)內(nèi)外部因素變化調(diào)整風險管理策略的活動。
4.6.Risk Communication風險溝通
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、層級或與委托方、監(jiān)管機構(gòu)等相關(guān)方之間，分享質(zhì)量風險信息的過程。
4.7.Residual Risk殘余風險
Risks that remain uneliminated or not reduced to an acceptable level after the implementation of risk control measures.
實施風險控制措施后，仍未消除或降低至可接受水平的風險。
5.Responsibilities職責
5.1.Quality Department質(zhì)量部
Responsible for the formulation, revision, maintenance, and dissemination of this procedure.
負責本程序的制定、修訂、維護和宣貫；
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)量風險管理活動，組織跨部門風險評估和回顧；
Review risk assessment reports, risk control plans, and risk review reports.
審核風險評估報告、風險控制計劃及風險回顧報告；
Monitor the implementation of risk control measures and verify their effectiveness.
監(jiān)督風險控制措施的執(zhí)行情況，驗證措施有效性；
Manage the archiving of quality risk-related records.
負責質(zhì)量風險相關(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)標準更新、行業(yè)風險信息，及時融入風險管理體系。
5.2.風險發(fā)起 / 責任部門
Responsible for identifying, conducting preliminary analysis, and reporting quality risks within the scope of this department's duties.
負責本部門職責范圍內(nèi)質(zhì)量風險的識別、初步分析和上報；
Participate in cross-departmental risk assessments and provide professional technical support and relevant data.
參與跨部門風險評估，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.
制定并實施風險控制措施，記錄實施過程和結(jié)果；
Collect risk control-related information within the department, and participate in risk review and effectiveness evaluation.
收集本部門風險控制相關(guān)信息，參與風險回顧和效果評價。
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)的風險識別和評估，提供部門相關(guān)風險信息；
Cooperate in the implementation of risk control measures and fulfill relevant responsibilities within the department.
配合風險控制措施的實施，落實本部門相關(guān)職責；
Promptly report issues identified during the risk control process.
及時反饋風險控制過程中發(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)量風險的評估結(jié)果和控制計劃；
Oversee the effective operation of this procedure and coordinate the resolution of major issues in risk management.
監(jiān)督本程序的有效運行，協(xié)調(diào)解決風險管理中的重大問題；
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)主要負責人報告質(zhì)量管理體系運行中的重大質(zhì)量風險。
5.5.企業(yè)主要負責人
Approve major quality risk control plans and risk review reports.
批準重大質(zhì)量風險控制計劃和風險回顧報告；
Ensure the allocation of resources such as human resources and infrastructure required for risk management activities.
確保風險管理活動所需的人力資源、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)量風險管理工作全面負責。
6.Procedure程序
6.1.Basic Principles of Risk Management風險管理基本原則
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.
風險管理貫穿醫(yī)療器械設(shè)計開發(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風險適配原則
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.
風險控制措施的強度與風險等級相匹配，高風險環(huán)節(jié)強化管控，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.
風險識別、評估和控制需以法律、法規(guī)、規(guī)章、標準、科學(xué)知識和實踐經(jīng)驗為依據(jù)，確保風險管理活動的客觀性和準確性。
6.1.4.持續(xù)改進原則
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.
通過定期風險回顧、不良事件監(jiān)測、數(shù)據(jù)分析等方式，動態(tài)更新風險信息，優(yōu)化風險控制措施，持續(xù)提升風險管理水平。
6.2.Risk Identification風險識別
6.2.1. Timing of Identification識別時機
During each stage of product design and development (planning, input, output, verification, validation, etc.)
產(chǎn)品設(shè)計開發(fā)各階段（策劃、輸入、輸出、驗證、確認等）；
During the selection, evaluation, and re-evaluation of raw material suppliers
原材料供應(yīng)商選擇、評價及再評價過程；
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)標準更新、行業(yè)風險預(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；
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)量風險的場景（如設(shè)備重大維修、廠房改造等）。
6.2.2.Identification Methods識別方法
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.
風險發(fā)起部門可根據(jù)風險場景選擇適宜的識別方法，必要時聯(lián)合質(zhì)量部及相關(guān)部門開展跨部門識別。
6.2.3.Identification Output識別輸出
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.
風險發(fā)起部門填寫《質(zhì)量風險識別表》，明確風險名稱、風險來源、風險點描述、可能影響的產(chǎn)品特性或體系環(huán)節(jié)、識別日期及識別人員等信息；
Upon completion of identification, the form shall be submitted to the Quality Department for filing and consolidation.
識別完成后，提交質(zhì)量部備案匯總。
6.3.Risk Assessment 風險評估
6.3.1.Evaluation Organization評估組織
General risks shall be assessed by relevant personnel organized by the department initiating the risk.
一般風險由風險發(fā)起部門組織相關(guān)人員進行評估；
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.
重大風險（可能嚴重影響產(chǎn)品安全有效性或需跨多個部門協(xié)同管控的風險）由質(zhì)量部組織跨部門評估小組，必要時邀請外部專家參與。
6.3.2.Risk Analysis風險分析
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
分析風險發(fā)生的可能性：結(jié)合歷史數(shù)據(jù)、行業(yè)經(jīng)驗、技術(shù)特性等，判定風險發(fā)生的概率（如高、中、低三級）；
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).
分析風險影響的嚴重程度：評估風險發(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（如嚴重、一般、輕微三級）；
Document the basis and process of risk analysis to ensure traceability
記錄風險分析的依據(jù)和過程，確?？勺匪?。
6.3.3.Risk Evaluation風險評價
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)風險發(fā)生的可能性和嚴重程度，制定《風險等級判定矩陣》，將風險劃分為高、中、低三個等級：
lHigh Risk: High likelihood of occurrence with severe impact, or medium likelihood with severe impact. Requires immediate implementation of emergency control measures.
l高風險：發(fā)生可能性高且影響嚴重，或發(fā)生可能性中且影響嚴重，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中風險：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重，需制定并實施控制措施；
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低風險：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)果確定風險等級，形成《質(zhì)量風險評估報告》。
6.4.Risk Control風險控制
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.
風險責任部門針對風險評估結(jié)果，制定《風險控制計劃》，明確控制措施、實施責任人、完成時限、驗證方法等；
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險的方式，無法消除時可采取降低風險發(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)計方案、完善工藝規(guī)程；
lStrengthening supplier audits and process monitoring;
l強化供應(yīng)商審核與過程監(jiān)控；
lIncreasing inspection frequency and optimizing inspection methods;
l增加檢驗頻次、優(yōu)化檢驗方法；
lEnhancing personnel training and clarifying job responsibilities;
l加強人員培訓(xùn)、完善崗位職責；
lImproving equipment and facilities and optimizing environmental controls;
l改進設(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.
低風險控制計劃由風險責任部門負責人批準，報質(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.
中風險控制計劃經(jīng)風險責任部門負責人審核后，報質(zhì)量部批準；
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.
高風險控制計劃經(jīng)風險責任部門、質(zhì)量部審核后，報管理者代表或企業(yè)主要負責人批準。
6.4.3. Implementation of Control Measures控制措施實施
The risk-responsible department shall organize and execute the measures in accordance with the approved Risk Control Plan, ensuring their effective implementation
風險責任部門按照批準的《風險控制計劃》組織實施，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.
實施過程中及時記錄相關(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)及時上報質(zhì)量部，重新評估并修訂計劃。
6.4.4.Verification of Control Effectiveness控制效果驗證
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.
控制措施實施完成后，風險責任部門按驗證方法開展效果驗證，收集相關(guān)數(shù)據(jù)證明風險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)量部對驗證過程和結(jié)果進行監(jiān)督審核，形成《風險控制效果驗證報告》；
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.
若驗證結(jié)果顯示風險仍未達到可接受水平，需重新制定或優(yōu)化控制措施，直至風險可控。
6.4.5.Residual Risk Evaluation殘余風險評價
After risk control measures are implemented, conduct a re-evaluation of the residual risks.
完成風險控制后，對殘余風險進行再次評估；
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.
若殘余風險仍為高風險，需持續(xù)改進控制措施；若殘余風險為中、低風險且在可接受范圍內(nèi)，記錄殘余風險情況并持續(xù)監(jiān)控。
6.5.Risk Communication風險溝通
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)布風險信息，通報風險控制進展和效果；
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.
跨部門風險相關(guān)信息通過會議、報告、郵件等方式及時傳遞，確保相關(guān)部門同步掌握風險動態(tài)；
Issues arising during the risk control process shall be communicated and coordinated among relevant departments in a timely manner.
風險控制過程中出現(xiàn)的問題，及時在相關(guān)部門間溝通協(xié)調(diào)。
Records of risk communication content are documented in the Quality Risk Communication Record Form.
風險溝通內(nèi)容記錄在《質(zhì)量風險溝通記錄表》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）溝通相關(guān)風險信息，明確雙方風險管控責任；
Report major quality risks and their handling to regulatory authorities as required by regulations.
按法規(guī)要求向監(jiān)管機構(gòu)報告重大質(zhì)量風險及處置情況；
Communicate risk information with relevant stakeholders, such as customers and suppliers, when necessary, to ensure coordinated and consistent risk management efforts.
必要時與顧客、供應(yīng)商等相關(guān)方溝通風險信息，確保風險管控協(xié)同一致。
6.6.Risk Review風險回顧
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)風險回顧：每年至少開展一次全公司范圍的質(zhì)量風險管理回顧；
Special Risk Review: Promptly conduct a specialized review under the following circumstances:
專項風險回顧：出現(xiàn)以下情況時，及時開展專項回顧：
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)標準重大更新；
lMajor changes in product design, processes, raw materials, suppliers, etc.;
l產(chǎn)品設(shè)計、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)重大體系風險；
lRisk-related rectification requirements raised by regulatory inspections;
l監(jiān)管機構(gòu)檢查提出風險相關(guān)整改要求；
lOther major changes that may impact quality risk conditions.
l其他可能影響質(zhì)量風險狀況的重大變化。
6.6.2.Review Content回顧內(nèi)容
Completeness of Risk Identification: Assess whether any risk points have been overlooked;
風險識別的完整性：是否存在遺漏的風險點；
Accuracy of Risk Assessment: Evaluate whether the determination of risk levels is reasonable;
風險評估的準確性：風險等級判定是否合理；
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;
風險信息的更新：是否收集到新的風險相關(guān)信息；
Controllability of Residual Risks: Verify whether residual risks remain within acceptable limits;
殘余風險的可控性：殘余風險是否仍在可接受范圍；
Suitability of the Risk Management System: Assess whether this procedure and related processes require adjustments.
風險管理體系的適宜性：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)部門開展風險回顧，形成《質(zhì)量風險管理回顧報告》，明確回顧結(jié)論、改進建議及責任部門；
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.
報告經(jīng)管理者代表審核、企業(yè)主要負責人批準后，相關(guān)部門落實改進建議。
6.7.Risk Management for Delegated Activities委托相關(guān)風險管控
6.7.1.Responsibilities of the Delegating Party委托方責任
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，評估受托方的風險管理能力，將風險管理要求納入質(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.
與受托方共同識別委托活動相關(guān)的質(zhì)量風險，明確雙方風險管控職責；
Monitor the implementation of risk control measures by the entrusted party and regularly review risk management records provided by the entrusted party.
監(jiān)督受托方風險控制措施的執(zhí)行情況，定期審核受托方風險管理相關(guān)記錄。
6.7.2.Responsibilities of the Entrusted Party受托方責任
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，建立與受托活動相適應(yīng)的風險管理機制；
Identify and control quality risks during the entrusted process, and promptly report significant risks and their handling to the delegating party.
識別并控制受托過程中的質(zhì)量風險，及時向委托方報告重大風險及處置情況；
Cooperate with the delegating party in conducting risk assessments and reviews, providing relevant data and records.
配合委托方開展風險評估和回顧，提供相關(guān)數(shù)據(jù)和記錄。
6.7.3.Risk Escalation Mechanism風險升級機制
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.
風險責任部門在風險識別或控制過程中，發(fā)現(xiàn)風險等級超出本部門管控范圍，應(yīng)在2 個工作日內(nèi)上報質(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)量部接到上報后，及時組織評估，若判定為重大風險，應(yīng)在3 個工作日內(nèi)上報管理者代表和企業(yè)主要負責人；
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.
重大風險未得到有效控制前，相關(guān)活動應(yīng)暫停，直至風險降低至可接受水平。
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)量風險管理相關(guān)記錄需真實、準確、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，且自風險關(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，確保真實可追溯。
8.Relevant Record Forms相關(guān)記錄表單
8.1.Quality Risk Identification Form《質(zhì)量風險識別表》
8.2.Risk Level Determination Matrix《風險等級判定矩陣》
8.3.Quality Risk Assessment Report《質(zhì)量風險評估報告》
8.4.Risk Control Plan《風險控制計劃》
8.5. Risk Control Effectiveness Verification Report《風險控制效果驗證報告》
8.6. Quality Risk Management Review Report《質(zhì)量風險管理回顧報告》
8.7.Quality Risk Communication Record Form《質(zhì)量風險溝通記錄表》
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