Is it a requirement to include a process flow in a SOP?
No, it's not an absolute requirement. However, a process flow can be very helpful, especially for complex SOPs with many branches and decision points. Including a process flow can provide clarity and assist in establishing the SOP.
You might choose to include it in the appendix or at the beginning as an overview, depending on your template structure. Use it when it adds value; if it doesn't, omit it. For complex processes, consider incorporating the process flow into a training module rather than the SOP itself. The decision depends on the complexity of the procedure and the training needs of your audience.
How do you manage documents that are co-owned between departments?
I recommend that each document should have a single owner. One department needs to take ownership of that document, while other stakeholders and subject matter experts (SMEs) contribute. This can be challenging, as departments might be reluctant to take ownership. In such cases, QA may need to step in and ask for a volunteer. If no one volunteers, QA might need to nominate an owner.
When another department wants to update the document, they should engage with the owner to ensure the changes are approved. This requires negotiation and collaboration, with input from SMEs representing each stakeholder in the discussion.
What is the difference between purpose & scope?
Some places combine them into one section called "Purpose and Scope" or simply "Purpose" that includes both elements. However, I believe they serve distinct roles. The purpose answers, "What is the purpose of the document?" For instance, the purpose might state that the SOP describes the requirements for material management at a particular site and follows specific regulations. This section only needs to be a couple of sentences.
The scope, on the other hand, defines "Who is involved?" It specifies which departments or sites the document applies to. The scope might include details about the people, departments, or aspects of the process that are covered. Both sections should be concise, just a few lines each, making them easy to write and understand.
Regarding Slide 18: Why (and in which cases) is a separate instruction necessary? We usually go with Procedure (including details) and Form.
If you have more than half a page of "how" information, your SOP can become overly detailed and cumbersome. This is when you should consider creating a separate work instruction. Aim for at least a page, preferably two, of detailed "how" information before breaking it out into a work instruction.
You can also consolidate related "how" information from different sections of a procedure into a single work instruction if it makes sense for the user. Consider the document's audience and how they will use it. Users find it frustrating to switch between a procedure and a work instruction repeatedly, so avoid unnecessary back-and-forth.
For example, equipment setup might require detailed instructions: how to set it up, perform a first run, do in-process checks, use it, clean it, and shut it down. These can be combined into one comprehensive work instruction with multiple sections. Always consider who will be using the document and tailor the Work Instruction to their needs.
Do you suggest a dedicated tech writer only for writing procedures / QMS documents or also for other types of documents, e.g., equipment qualification documents?
It depends on your structure, but typically, a tech writer is involved in procedural documents like procedures, work instructions, forms, and policies. They might also handle user manuals generated internally.
For equipment qualification documents, equipment specialists usually handle the validation because they focus on technical specifications and criteria. These specialists and tech writers have different thought processes: the tech writer considers usability, audience, and training, while the equipment specialist delves into the technical details. Thus, having separate roles can be beneficial.
Do independent reviewers need to be in the review process?
If independent reviewers are stakeholders in the process described by the document, their involvement is helpful. Even if they only use a part of the process, their input is valuable. They may not own the document or handle most of the activities, but excluding them can create issues with how their processes interface with the updated one.
Ensuring that all related processes integrate smoothly is crucial to avoid process hotspots and mistakes. Thus, if someone plays a role in the process, it's beneficial to include them in the review.
However, it's important to balance the size of the SME team. A large team can slow down reviews, so aim to include necessary stakeholders without overloading the team.
How to handle already created (but not approved) documents when a new template version is created?
There needs to be clear communication on the date the new template is expected to be used. This allows everyone to plan. If a draft document is still in draft before the cutoff period, then it should be updated. Unless the template change is significant, it shouldn't be too difficult to transfer the drafted content to the new template.
Who should sign a Job Description? Are there specific requirements/ guidelines for writing a Job Description?
There should be a good template for job descriptions, including all the standard company and legal clauses, already embedded in the template. That way, the line manager can draft the content. It might depend on the tech writer's seniority if it is appropriate for them to draft the document. HR and the Training Manager (if separate from QA) should also review to ensure linkage with the QMS.
Struggling with the notion of separating the writing from the actual activities, how do you ensure that the content is technically correct and really captures the true relevant technical aspects?
The easiest way to ensure that the document captures all the relevant technical details is to have the SME complete the task in front of the tech writer. Once a mature draft is created, have an operator follow the document - this is good at showing where errors or anything is confusing. Sometimes the technical person also does not explain all the necessary details because they just know it, or they may do things out of order or not consistently. It's good practice to have someone not too familiar with the activity use the document as a test run before proceeding to signoffs. Technical SMEs rarely write user-friendly documents because they are thinking of the technical details, not the users of the document.
Do you think that work instructions must necessarily follow a template, and version-control embedded? Do we really need Word documents for regulation or could we consider other forms, such as Confluence pages?
Yes! If you want user-friendly documents and tasks completed consistently, then work instructions must be part of the QMS and the information controlled. All information must be included in the QMS, not just some. I would recommend that if an electronic solution is required, then look at an eQMS where workflows can be validated to 21CFR Part 11 requirements. Otherwise, you would need to demonstrate that an alternative electronic solution meets the regulatory requirement for software.
Should I change the form version number during the SOP review, even if it has no change in its core?
If there is no change to a document's content during the periodic review, then I still recommend up-versioning it to the next version number and adding "No change" in the change history table as evidence that the review was completed. Otherwise, how do you present evidence to an auditor that the review was done?
What is the difference between Protocol and SOP?
The difference depends on your industry. In GMP, a protocol provides comprehensive background, methods, materials, criteria, and instructions to complete a study, such as an equipment or process validation protocol or a development study protocol. Protocols are typically one-off studies or are repeated only if something changes.
In contrast, an SOP describes a routine process that occurs frequently and is completed by the same roles to the same criteria every time. In GLP and GCP, a protocol may refer to a test method or be specific to a clinical trial, while an SOP serves the same purpose as in GMP.
Some GLP companies use "protocol" instead of "SOP," but there is a difference. If your company uses both terms or confuses them, clarify their definitions in your document management SOP.
What kind of document would fit recommendations based on the results of an investigation of a problem?
This sounds like the outcome of a deviation/non-conformance or complaints investigation, which is then implemented in the CAPA system. The quality system records should detail these recommendations. If they impact the process you may need to update the relevant SOP/WI, but only if the process changes, and not just to document outcomes of an investigation - use the right quality system record for that.
What could be the best way to train scientists for plain writing as small companies cannot afford writers alone?
Even in small companies, you likely have someone who is naturally inclined toward documentation. Have this person draft or review documents from a plain language perspective. If no one stands out, train the entire team in plain writing and implement a system where team members cross-check each other’s work. This collaborative approach ensures that all documents are clear and accessible.
Are WIs classified as QMS critical documents?
Yes!
