概述:提供调查和识别差异发生原因的程序。包括建议适当的纠正措施和确保及时实施纠正措施的规定，通过验证已实施的纠正措施是否满足批准的差异报告、归档、跟踪和月度总结报告中确定的纠正措施的要求，关闭差异报告。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括附件/附录: 差异报告表、环境监测差异报告表、差异报告取消通知关于本文件:这不是一个通用模板，它是一个13页的程序，实际上是在FDA监管机构的质量保证操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）已被编辑，但内容和格式已基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，哪些公司会从中受益: 质量保证经理制造经理质量控制人员

Summary:Provides procedures for investigating and identifying causes for discrepancy occurrences. Includes provisions for recommending appropriate corrective action and assuring the corrective action is implemented in a timely fashion, closing out Discrepancy Reports by verifying the implemented corrective action satisfies the requirements of the corrective action identified on an approved Discrepancy Report, filing, tracking and monthly summary reports.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Discrepancy Report Form, Environmental Monitoring Discrepancy Report Form, Notice of Discrepancy Report CancellationAbout This Document:This is not a generic template, it's a 13-page procedure that was actually created and used in the Quality Assurance operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Quality Assurance ManagersManufacturing ManagersQuality Control Personnel