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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:
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.
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:
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.
Volume 35, Number 9
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).