产品召回流程 Product recall process

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产品召回（Product Recall）是企业为消除或降低因产品存在缺陷、安全隐患或不符合法规要求而对消费者、环境或公共安全造成的风险，主动或被动地从市场、分销渠道或消费者手中收回产品的紧急管理流程。一个高效、合规的产品召回流程是企业社会责任和质量管理体系的重要体现。



Product recall is an emergency management process in which a company actively or passively retrieves products from the market, distribution channels, or consumers to eliminate or reduce risks to consumers, the environment, or public safety caused by product defects, safety hazards, or non-compliance with regulatory requirements. An efficient and compliant product recall process is an important manifestation of corporate social responsibility and quality management system.

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召回通常由以下情况触发：

• 客户重大投诉或人身伤害事件
• 监管机构通报或责令召回（如市场监管局、FDA、NHTSA）
• 内部质量检测发现严重缺陷
• 供应商通报原材料存在安全隐患
• 竞争对手召回引发连锁反应
• 媒体曝光或舆情危机
  

Recall is usually triggered by the following situations:

Major customer complaints or personal injury incidents
Regulatory agencies notify or order recalls (such as the Market Supervision Administration, FDA, NHTSA)
Serious defects discovered during internal quality inspection
Suppliers report safety hazards in raw materials
Competitor recall triggers chain reaction
Media exposure or public opinion crisis

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阶段1：召回决策与启动
成立召回应急小组（Recall Team）
成员：质量负责人、生产、技术、采购、法务、公关、销售、高层管理者
指定召回协调人（Recall Coordinator）
初步风险评估
使用 风险矩阵 评估：
严重度（Severity）：对人身、财产、环境的危害程度
发生概率（Likelihood）
可探测性（Detectability）
判断召回等级（见下文分级）
做出召回决策
内部审批流程
必要时上报监管机构.

Stage 1: Recall Decision and Initiation
Establish a Recall Team
Members: Quality Manager, Production, Technology, Procurement, Legal, Public Relations, Sales, Senior Management
Designate a Recall Coordinator
Preliminary risk assessment
Use risk matrix assessment:
Severity: The degree of harm to individuals, property, and the environment
Likelihood probability
Detectability
Determine the recall level (see classification below)
Make a recall decision
Internal approval process
Report to regulatory authorities if necessary

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阶段2：召回范围界定

• 明确召回产品信息：

  • 产品名称、型号、批次号、生产日期、有效期
  • 包装规格、标识信息（如UPC、序列号）
    

• 追溯范围：

  • 使用ERP/MES系统追溯：
    • 原材料来源
    • 生产过程记录
    • 出货流向（客户、经销商、区域）
      
    
    

• 确定影响范围：

  
  
  • 已发货数量
  • 在途产品
  • 终端消费者数量（如适用）
    
• Stage 2: Definition of Recall Scope
• Clearly recall product information:
• Product name, model, batch number, production date, expiration date
• Packaging specifications, identification information (such as UPC, serial number)
• Traceability scope:
• Traceability using ERP/MES system:
• Sources of Raw Materials
• Production process records
• Shipping direction (customers, distributors, regions)
• Determine the scope of impact:
• Shipped Quantity
• In transit products
• Number of end consumers (if applicable)
  

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制定召回计划内容说明
召回策略主动召回 / 配合监管召回
召回等级根据风险划分：<br>• 一级召回：极高风险，可能导致死亡或严重伤害<br>• 二级召回：中等风险，可能导致暂时或可逆的健康问题<br>• 三级召回：低风险， unlikely to 引起健康问题
沟通计划• 对外：客户、经销商、公众、媒体、监管机构<br>• 对内：员工通报
物流方案• 退回地址、运输方式、包装要求<br>• 临时仓储安排
替代方案• 提供替换品、维修服务或退款
时间表各环节时间节点（如48小时内通知客户）

📌 输出：《产品召回行动计划书》

Develop a recall planContent DescriptionRecall Strategy: Proactive Recall/Cooperate with Regulatory RecallRecall levels are classified according to risk:<br>• Level 1 recall: extremely high risk, may cause death or serious injury<br>• Level 2 recall: moderate risk, may cause temporary or reversible health problems<br>• Level 3 recall: low-risk, unlikely to cause health problemsCommunication Plan • External: Customers, Distributors, Public, Media, Regulatory Agencies<br>• Internal: Employee NotificationLogistics plan • Return address, transportation method, packaging requirements<br>• Temporary storage arrangementAlternative solutions • Provide replacement parts, repair services, or refundsTime nodes for each stage of the schedule (such as notifying customers within 48 hours)📌  Output: Product Recall Action Plan

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阶段4：实施召回与沟通

• 内部沟通：

  • 通知全体员工，明确职责
  • 暂停相关产品生产与发货
    

• 外部沟通：

  • 客户与经销商：发送正式召回通知函（含产品信息、风险说明、处理方式）
  • 公众与媒体：发布召回公告（官网、社交媒体、新闻稿）
  • 监管机构：按要求提交召回报告（如中国NRA、美国FDA Form 3500A）
    

• 信息透明：

  
  
  • 设立召回专线电话和FAQ页面
  • 提供在线登记与查询服务
    

Stage 4: Implementation of recall and communication
Internal communication:
Notify all employees and clarify responsibilities
Suspend the production and shipment of related products
External communication:
Customers and dealers: send a formal recall notice letter (including product information, risk statement, and handling methods)
Public and media: Release recall notices (official website, social media, press releases)
Regulatory agencies: Submit recall reports as required (such as China NRA, US FDA Form 3500A)
Information Transparency:
Set up a recall hotline and FAQ page
Provide online registration and inquiry services

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