质量合规管理 Quality compliance management

gaowenhua

允许“例外放行”的条件（特殊情形）

在极少数情况下，可以进行“有条件放行”或“例外放行”，但必须满足严格的前提：

✅ 必须同时满足以下条件：

• 产品不影响最终质量与安全

  • 经过评估，未检验项目对产品的关键性能、安全性、有效性无影响。
    

• 有可靠的追溯系统

  • 能够唯一标识该批产品，确保一旦检验不合格可立即召回。
    

• 后续检验必须完成

  • 放行后必须继续完成所有检验项目。
    

• 检验结果不合格时能有效追回

  • 制定召回预案，确保能及时通知客户并收回产品。
    

• 经过正式审批流程

  • 由质量负责人（QA Manager）或授权人书面批准，填写《例外放行申请单》，说明理由、风险评估和应对措施。
    

• 客户同意（如适用）

  
  
  • 对于定制产品或关键客户，需提前沟通并获得书面同意。
    

Conditions for allowing "exceptional release" (special circumstances)
In rare cases, "conditional release" or "exceptional release" can be carried out, but strict conditions must be met:

✅  The following conditions must be met simultaneously:
The product does not affect the final quality and safety
After evaluation, the untested items have no impact on the critical performance, safety, and effectiveness of the product.
Have a reliable traceability system
Being able to uniquely identify the batch of products ensures immediate recall in case of inspection failure.
Subsequent inspections must be completed
After release, all inspection items must continue to be completed.
Can effectively recover unqualified inspection results
Develop a recall plan to ensure timely notification to customers and recall of products.
After the formal approval process
Approved in writing by the Quality Assurance Manager or authorized person, fill out the "Exception Release Application Form", stating the reasons, risk assessment, and response measures.
Customer consent (if applicable)
For customized products or key customers, prior communication and written consent are required.

gaowenhua

如何预防“未检验放行”？

预防措施

说明

建立清晰的放行流程

明确各环节放行责任人（如：IQC放行原料，FQC放行成品）。

系统化控制（MES/ERP/QMS）

系统自动拦截未完成检验的产品，无法生成发货单。

强化质量授权

最终放行权必须由质量部门掌握，生产不能自行放行。

加强培训与文化

培养“质量第一”文化，杜绝“赶产量、轻质量”的思想。

定期审计

内审和管理评审中重点检查放行记录的完整性和合规性。

Preventive measures explanation
Establish a clear release process and assign responsible personnel for each stage of release (such as IQC releasing raw materials and FQC releasing finished products).
The MES/ERP/QMS system automatically intercepts products that have not completed inspection and cannot generate a shipping order.
The ultimate authority to strengthen quality authorization must be held by the quality department, and production cannot be released on its own.
Strengthen training and cultural cultivation of the "quality first" culture, and eliminate the idea of "rushing production and neglecting quality".
Regular audits, internal audits, and management reviews focus on checking the integrity and compliance of release records.

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