September 1, 2022
Siegfried Schmitt
Parexel技术副总裁Siegfried Schmitt说，一张流程图能够有助于制定关于第三方审计标准作业规程的达成共识的流程。
问题：在我们定期评审“第三方审计”标准作业规程（SOP）期间，质量和运营小组对于内容不能达成一致意见。一些人想要展开更多细节，另外一些人则不怎么想展开。您推荐有哪些最佳做法呢？
答案：质量体系会持续演进，并且这种演进会带来文件内容的各种变更，比如SOP。法规不会强行要求各系统和规程必须是有效和高效的，但这当然是任何一家公司所关注的事情。不过，他们的确要求必须符合法律和法规的各项活动均记录完备。在开始撰写正文之前，请记住：
可以把组成为质量体系一部分的全部各项活动描述为各项流程。
可以用流程图对全部各项流程进行描述。
对各项活动、角色和责任的描述以及相关数据和文件均与特定流程步骤相关联。
最佳做法会将此考虑在内。因此，SOP应当基于达成一致意见的流程。不幸的是，各项流程往往是在SOP已经被撰写好的时候的一个事后的想法。根据既有文本来绘制一张流程图在很少情况下是容易的，或者甚至是行不通的。不过，反过来的情况则是简单明了的。
因此让我们看一看你们的第三方审计SOP的例子。首先，您需要绘制一份流程图。图1展示了一般示例。
图1. 第三方审计标准作业规程的流程图。图由原文作者提供。
根据该流程，您可以现在开始编写，对各项活动加以详述。正如您所见，对各个步骤进行了编号。这个编号确立了文本和图形之间的联系；从而使任何人都能快速地找到流程图或规程中的信息。
关于您所提的问题，文本需要展开或精炼到什么程度——并没有简单的答案。它取决于很多因素，比如你的组织的大小、你是怎样构建你的质量体系，或你的人员所掌握的专家知识。一家员工数为五人的公司对细节程度和文本总量的要求与一家员工人数在多个地点有几千人的公司是不同的。
如果您把您的质量体系构建成SOP含有“做什么”以及工作规程（WI）含有“怎么做”的信息，那么关于SOP中步骤1的描述则可以简短到以下程度：
步骤1
公司的质量和运营管理层识别审计的需求，并要求公司审计骨干人员来准备审计。
遵循工作规程eyfds开启审计管理申请。
由公司审计骨干人员所进行的审计准备工作应遵循工作规程xyzzy。
注意：一般而言，该需求作为供应商评估的一部分或者作为偏差的一部分
注意：进行审计的权利应当被记录在与第三方之间的质量/技术协议中
注意：审计可以采取现场或远程（虚拟或纸面）方式
然后进行到步骤2
不过，如果您把“做什么”和“怎么做”打包放在一份文件里面，那么这将会成为一份巨大并且使用起来更加麻烦的文件。
把您现行SOP的结构变更为这种最佳实践的版本是相当容易的，每次您都需要对既有SOP进行修订。这使您的员工不断地变得更加熟悉新设计和新布局。并且，它应该有助于在您的各个部门之间就所需细节的总量方面能够迭代地达成共识。
Siegfried Schmitt is VP Technical at Parexel.
BioPharm International
Volume 35, Number 9
September 2022
Pages: 50, 49
When referring to this article, please cite it as S. Schmitt, 'Best Practices for Developing a Third-Party Auditing SOP,' BioPharm International 35 (9) (2022).
原文如下
Siegfried Schmitt
BioPharm International, BioPharm International, September 2022 Issue, Volume 35, Issue 9
Pages: 50, 49
A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.
Q. During the periodic review of our 'Third-Party Auditing’ standard operating procedure (SOP), the quality and the operational teams could not agree on the contents. Some wanted more detail, others less. What best practices can you recommend?
A. Quality systems evolve, and this evolution brings changes to the contents of the documents, such as SOPs. The regulations do not demand effective and efficient systems and instructions, but this of course is in the interest of any company. They do, however, require that activities that must comply with the laws and regulations are documented. Before starting to write any text, please remember:
All activities that form part of a quality system can be described as processes.
All processes can be described in a process flow diagram.
The description of the activities, roles and responsibilities, and associated data and documents are associated with specific process steps.
Best practices take this into account. Thus, a SOP shall be based on an agreed process flow. Unfortunately, all too often process flows are an afterthought when the SOP has already been written. It is rarely easy or even possible to create a process diagram based on existing text. The opposite, however, is straightforward.
Let us therefore look at the example of your third-party auditing SOP. First, you need to prepare a process flow diagram. A generic example is given in Figure 1.
Figure 1. Process flow diagram for a third-party auditing standard operating procedure. Figure courtesy of the author.
Based on this process flow, you can now start writing, detailing the activities. As you can see, the steps are numbered. This numbering establishes a connection between the text and the graphic; allowing anyone to quickly find the information either in the process diagram
or the instructions.
Regarding the question,how much or how little text is required—there is no simple answer. It depends on many factors, such as the size of your organization, how you structure your quality system, or the expertise of your personnel. A company with a staff count of five requires a different level of detail and amount of text than a company with thousands of staff in multiple locations.
If you structure your quality system such that the SOPs contain the “what to do” and the Work Instructions (WI) the “how to do” information, then the description for step 1 in the SOP can be as short as:
Step 1
Company quality and operational management identify the need for an audit and request the company audit cadre to prepare for the audit.
Open the request in the audit management application following WI eyfds.
The audit preparation by the company audit cadre follows WI xyzzy.
Note: Typically, the need is identified as part of a supplier assessment or as part of a deviation
Note: The right to perform an audit should be documented in the quality/technical agreement with the third party
Note: The audit can be an on-site or a remote (virtual or paper) audit
Then go to Step 2
If, however, you pack the “what to do” and the “how to do” all into one document, then this will become a large and more cumbersome-to-use document.
It is quite easy to change the structure of your current SOPs into this best practice one, every time you need to revise an existing SOP. This allows your staff to become continually more familiar with the new design and layout. And it should, iteratively, help achieve consensus between your departments as to the amount of detail required.
Siegfried Schmitt is VP Technical at Parexel.
BioPharm International
Volume 35, Number 9
September 2022
Pages: 50, 49
When referring to this article, please cite it as S. Schmitt, 'Best Practices for Developing a Third-Party Auditing SOP,' BioPharm International 35 (9) (2022).
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