Step 6. 审核过程 Conduct Review

请相关人员重新参与到过程中，审查SOP初稿并提供反馈，根据实际情况，最好的做法可能是召开审核会议请相关人员一同参加，并对SOP初稿提供其意见，如果无法召开审核会议，要特别留心记录不同人员的反馈中互相冲突的部分，并与不同人员充分沟通讨论究竟哪些反馈是需要采纳的。

Re-engage your team members to review the draft SOP and provide feedback. Depending on your team’s membership, it may make most sense to conduct a review session where everyone gets together and the document is reviewed and updated during the meeting. If you cannot conduct a reviews ession, be sure to take note of any conflicting information you may get back from your team. In this instance, you will need to work with the differing team members to determine what is the correct information for the SOP.

Step 7. SOP的要素 What Should Be Included in SOP

SOP通常包括下列要素：

目的 - 描述SOP文件的内容和基本原理。

范围 -描述SOP适用的人群和领域。不在范围内的内容对SOP的清晰度也同样重要。应确保目的和范围两部分各自独立。

职责 - 在SOP中应列出所有人员职责。如果SOP适用的人群范围过大，应考虑缩小SOP的适用人群范围，合理制定SOPs或工作指导。

参考 - 尽可能清晰地列出所有SOP相关的文件。参考文件包括管理方针、工作指导、表单、标准或其他文件。如果参考文件为内部文件，需要标明文件号和版本。如果参考的文件为外部文件，应标明URL。

可能发生的情况/预防措施/警告 - 起草或执行SOP时，列出所有可能发生的情况、预防措施或警告。

物料和设备 - 在物料和设备部分需要列出执行SOP所需的所有物料及设备。

使用图片和图表 - 在SOPs中可以使用图片和图表，包括流程图或显示好坏结果的图片。在审核、批准流程及培训SOP中，图示可以轻松消除困惑。

An SOP usually includes:

Purpose –The purpose statement describes the rationale and intent of the document.

Scope –The scope statement identifies who and what is governed by the SOP. It’s also important to note those items which are out of scope to provide 100% clarity. Be sure to keep your purpose and scope separate and distinct.

Responsibilities–List all the actors required to complete the process defined in the SOP. If you find yourself with a large list of actors, consider narrowing the scope of your SOP and create smaller, related SOPs or work instructions.

References –List all documents related to the SOP as clearly as possibly. This could include governing policies, work instructions, forms, standards or otherdocuments. If you are referencing internal documents, include the document number and revision. If your references are external, include the URL.

Assumptions /Precautions /Warning – List any assumptions made in the drafting or execution of the procedures as well as any precautions or warnings to the user.

Materials & Equipment –List any of the materials the user will need to complete the procedure as well as any equipment needed.

Use pictures and diagrams - Don’t be afraid to use pictures and diagrams in your SOPs, including flowcharts or pictures of a good or bad outcome. Graphical representations are a great way to clear up confusion in the review and approval process as well as for training to the SOP.

Step 8. 对SOP进行预演 Perform a Dry Run of the SOP

如果SOP审核完成，那么应对SOP中的活动进行预演，尽可能模拟真实的工作环境，这样可以发现SOP与实际工作之间存在的差异，并有利于SOP的更新和完善。

确保SOP有恰当的涵盖范围。如果某一SOP内容过于宽泛，应考虑将其分为两个附属SOPs或把工作指导、表单单独写出来。

可以从培训的角度判断SOP是否有恰当的涵盖范围。受训人员是要接收该SOP所有内容的培训还是该SOP部分内容的培训？如果大多数的受训人只需要接收该SOP某一部分的培训，那么该部分内容就应该成为独立的SOP。

如果对SOP中的活动进行预演后，认为该SOP需要进行修订，那么在该SOP被提交获批前，需要对其进行重复审核。

Step 9. 准备最终版本 Prepare Approval Version

将所有意见和反馈充分考虑后，形成的SOP才能作为最终版本被提交审批。确保最终版SOP是在充分考虑了所有意见和变更的基础上形成的，且最终版SOP应工整清晰。

如果最终版SOP没有获批，那么需要在对其进行适当修订后，重新提交获批，且之前批准其通过的人员，在其修订后需要重新审批。

Step 10. 进行培训 Train the Users

确保线管员工在SOP生效前都要接受相关SOP的培训与考核。培训可以包括对SOP内容的阅读、了解、测试或执行。

结语 Conclusion

依据上述十个步骤制定企业编撰SOP的方针和规程，可以确保企业的SOP更准确、更具可培训性，并且可以缩短审核周期。