Step 1. 决定企业目标Determine Business Goals
先问问自己，撰写SOP的商业目标是什么？是为了把既有的流程写成SOP以便能统一被执行？是为了优化既有的流程？还是因为购买了新设备而需要新的SOP？确立目标后能帮助你考虑方方面面的需求，尽可能缩小SOP的范围，并让SOP更有实用性和可操作性。
Ask yourself, what is the business objective for the SOP? Are you merely documenting an existing processso it can be executed uniformly? Are you trying to optimize the performance of an existing process? Do you have a new piece of equipment whose use needs to be documented? Once this is determined, use this objective to drive all aspects ofthe SOP creation. This will help reduce "scope creep" as well as keep the SOP appropriately sized for the task at hand.
Step 2. 确定法规合规性 Determine Standards Compliance
其次，需确定SOP需遵守的法规合规性为何？GxP? ISO? FDA? EMEA? 一旦确定了遵循的法规后，确保你充分了解法规的合规性要求。在未了解法规的要求之前就撰写SOP初稿，再来来回回的审批修改再审批，是非常没有效率的做法。
What standards will your SOP comply with? GxP? ISO? EMEA? Internal Quality Standards and Policies? Once you are clear on which standards you need to meet, make sure you read and understand them. It’s inefficient to go through the entire draft, review and approval process only to find out you need to modify your SOP to comply with a standard.
Step 3. 文件控制 Engagewith the Document Control Group
与文件控制人员合作，确保SOP的撰写符合企业内部的文件创建规程。使用最新版已通过审核的文件模板，确定文件的审核人和最终放行人，并仔细研究新建的SOP是否会影响到其他的SOP，操作规程，或表单。事先确定以上的事项将会帮助你确认SOP的范围并减少日后的工作量。
Work with your document control group to ensure you are following your internal documentation procedures. Get the latest version of your SOP template. Determine who your reviewers and approvers are. Find any SOPs, work instructions or forms which may be impacted by your new or updated SOP. Collecting these items in advance will help you determine the scope of your SOP as well as reduce re-work later in the process.
Step 4. 参与人员 Engage with Team Members
除了文件的审核人和最终放行人，还必须确认谁正在负责新建SOP里包含的工作内容。如果SOP内容中涉及不止一个部门，或涵盖了整个公司，尽可能把相关的人员都找出来，他们将会对于SOP的优化和可操作性给予你最有价值的建议。只有在采纳了相关人员的意见后，SOP的初稿才能更完整也更加正确，最终大大降低日后反复修改和审批的时间。
In addition to the reviewers and approvers identified above, seek out individuals who currently perform the job function your SOP is covering. If the SOP covers more than one department or is companywide, seek out as many users as possible; they will have the most valuable feedback for process improvements and efficiencies. By incorporating user feedback, your initial draft of the SOP will be more complete and accurate, ultimately reducing time spent revising the document in the Review and Approval process.
Step 5. 撰写SOP初稿 Draft your SOP
以之前几个步骤所搜集的讯息开始撰写SOP初稿，初稿不可能尽善尽美，只要尽力去写就是，SOP的审批人员会协助你完善SOP初稿的不足之处，你能做的就是尽可能让SOP初稿完整，包括格式，缩写，定义，参照文件，并尽可能的描述清楚，避免模糊暧昧的叙述。
Using all the information gathered in the previous steps, create your initial version of the SOP. There is no expectation of perfection in this phase of the SOP’s life. Draft it as best you can with the information on hand. The review and approval processes will fill in any gaps in your knowledge of the subject matter. Make the SOP as complete as possible prior to sending it out for review. Fill in your acronyms, definitions and reference documents. Make sure your headers and footers are correct throughout the document. Review and update the boiler plate information included in the template as necessary. Be sure to run aspelling and grammar check.
