Transforming the QMS Document Paradigm for SOPs

All organizations operate on procedures. To achieve any goal, it is essential to follow a defined set of steps. In smaller organizations, communicating procedures is straightforward, as you can easily gather everyone to discuss new methods for enhancing product quality. However, as your organization grows, particularly in industries such as healthcare or finance, it becomes necessary to move beyond verbal communication of procedures.

In this post, we will explore the three levels of organizational structure (as outlined in this post) and the considerations for implementing effective procedures. When your organization is small and the consequences of not following a procedure only affect your own efficiency, verbal communication may suffice. However, as you expand or when procedures could impact the safety of others, it is crucial to document these procedures and inform your staff whenever new procedures are created or existing ones are updated.

Level 1 Organizations

As a Level 1 organization, you are probably already communicating when things do not go as expected. However, when issues arise, consider taking a moment to pause and spend 5 minutes documenting the procedure that would have prevented the issue while keeping the following points in mind:

  • Identify the entry criteria (when to start the procedure)
  • Specify who is responsible for each step
  • Use an active voice
  • Be concise and clear
  • Be specific

Let’s examine a good example and a bad example.

Bad Example via Email

When we hire someone, they need an email account. Make sure it gets done! - The Boss

Good Example in Document

One to two weeks before an employee joins, the office manager will:

  • Notify the IT system administrator to ensure the new hire has the following items ready for day one:
    • Company laptop
    • Functional email address
    • Company phone, if requested by the employee
  • Register the employee's contact information in the account management system
  • Gather the employee's tax ID and register them with the local tax authority
  • Prepare and send a welcome email to test the employee's email account

These written procedures clarify the 5 Ws for employees without the burden of a traditional, highly controlled set of procedures. The IT administrator can use the bullet points as a checklist to enhance the new hire experience and everybody avoids being reprimanded by their PHB.

Level 2 Organizations

If you're level 2 organization, this is where more rigor and structure is needed for procedures. When you have multiple individuals that could be executing the same procedures you should start considering layering on the following 5 Ws by breaking procedures into departments and enforcing a document structure that includes:

  • Purpose: Why is it important to follow these procedures
  • Scope: What things do these procedures apply to
  • Roles and Responsibilities: Who needs to follow these procedures
  • Entry/Exit Criteria: When do we apply these procedures
  • Procedures: How do I achieve the purpose

Our system backup and recovery sop is an living example of the above points in action. By breaking the procedures up into departments and having a consistent layout, you're preparing for an enterprise level of scale that we'll cover in our next section.

Level 3 Organizations

As organizations expand or operate within heavily regulated sectors, the need for formalized procedures becomes paramount. This is the stage where we embrace the much loved Standard Operating Procedures (SOPs). With growth comes the necessity for heightened standards, ensuring that every team member is well-versed in key procedures to deliver a quality service. Achieving compliance at this level demands a greater degree of rigor and a structured process framework. This methodology aligns with Good Documentation Practices (GDP) in clinical settings or more broadly as part of a Quality Management System (QMS) as outlined by ISO 9001 standards.

In addition to the points discussed for L1 and L2 organizations, it is important to consider incorporating more metadata into your documents. This metadata provides employees with the context needed to understand what has changed, how it impacts their work, and when the new procedures take effect. For L3 organizations, the following elements must now be tracked:

  • A revision history with all changes made to the document
  • References to a central glossary of well-defined terms
  • Adherence to the separation of concerns principle, including an author, reviewer, and approver who are qualified SMEs and/or members of a QA group
  • Electronic signatures for all SOPs in accordance with standards such as CFR 21 part 11 (clinical trials), the ESIGN Act (US), or eIDAS (EU), among others
  • Document versioning and identification
  • Publication and effective dates
  • Markings to indicate whether the document is an official or working copy
  • Number indicators for pages, chapters, sections, and subsections for reference in training materials and other documents.

In addition to the metadata mentioned above, the following procedural steps are typically required:

  • A notification system to inform all impacted roles when a new version of the SOP becomes effective
  • For certain heavily regulated industries, formalized training that includes acknowledgment and tests for employees to demonstrate their understanding of the procedures, satisfying regulations such as ICH E6 (R3)
  • A process for authoring, reviewing, and approving documents that incorporates electronic signatures

Many organizations offer paid services to manage a system that encompasses all of the above requirements. Alternatively, you can achieve similar outcomes by integrating general systems like Word and DocuSign. However, at Neosofia, we believe that quality management systems should be accessible to everyone. A combination of open-source tools, innovative approaches to maintaining a QMS, and a user-friendly interface led us to create Neosofia QMS Docs.

Neosofia QMS Docs

Neosofia QMS Docs is a document management system designed to efficiently meet the needs of any organization requiring a QMS.

How is it Different?

Traditional SaaS document management platforms that satisfy QMS requirements often demand substantial operational expenditures (OpEx) for user licensing or rely on labor-intensive procedures involving Word documents. Flexible options like Word documents lead to inconsistencies and errors due to what we call the "truffle shuffle" style of quality document management as workflows and document templates are not centrally managed. And modern SaaS systems (in addition to their cost) can pose challenges regarding traceability and transparency.

Truffle Shuffle1

Neosofia QMS Docs revolutionizes the approach by:

  • Allowing document authors to focus entirely on content rather than formatting or metadata management.
  • Eliminating all metadata management; the process of authoring and reviewing changes automatically generates the necessary metadata for building a QMS document.
  • Providing all content in a portable format (git).
  • Continuously validating the structure of documents.
  • Producing an official version of documents that matches the content of the working copy.
  • Reducing operational overhead.

Gone are the days of forgetting to enable track changes, manually curating change logs, struggling with formatting level 4 headings in Word documents, dealing with wet signatures, and relying on overpriced SaaS software.

It's Too Good to Be True -- What's the Catch?

As of the writing of this blog post, there are two limitations that will be addressed in the future:

  1. The user interface for document management is currently limited.
  2. Advanced features, such as structural validation and separation of concerns, require a SaaS system like GitHub or GitLab. These services may incur monthly fees if your organization does not already use them or if you prefer not to make your QMS documents public.

Improvements to the UX surrounding document management and guides on how to self-host Neosofia QMS Docs will be made available over time.

How Do I Get Started?

When the consumer product launches (end of April), you will be able to copy a set of templates, customize them for your organization, and automatically generate a set of version-controlled documents with rich metadata embedded in the final QMS documents. Organizations of any size can benefit from a fully featured set of QMS documents without the cost or overhead of maintaining one.

How Does It Work?

For those curious, the system is built on the world's best version control system (git) and is divided into three parts:

  • Markdown files for the content of the QMS Docs.
  • Git (and optionally GitHub/GitLab) for document metadata.
  • Code (bash and LaTeX) that manages all structural validation and document generation based on the markdown (content) and metadata (git).

You don't need to know how to use git to make changes to documents, as providers like GitHub and GitLab offer user-friendly document editing tools accessible through your browser, along with a variety of text editors that support local editing and previewing of markdown files.

The markdown file linked earlier is already being programmatically generated into a pdf version based on our alpha version of the code.

We will explore the architecture, design, and implementation details in another blog post as the system approaches its first official release.

Conclusion

QMS documents do not need to be expensive or difficult to manage. By separating the content of the document from its presentation and metadata, we can automate mundane aspects of the process, simplify collaboration, and enforce standards that provide your company with a competitive edge.

Footnotes

  1. Created using DALL•E 3 XL v2 on Huggingface with the prompt: Goonies style Truffle Shuffle dance with paper documents ↩