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A repository of important documents used by your employees is an essential part of modern-day business. These critical documents can include policies, procedures, and work instructions—all relevant and needed to effectively manage operations, enforce compliance, and improve profitability. That's why you need document control.
Some may say that simply putting policy and procedure documents into a series of folders is good enough. That may be fine for small organizations. But for larger organizations, especially those exposed to serious risk and compliance, a more robust approach is needed.
In this blog post, we’ll discuss document control in the context of policies and procedures and point out the danger of not having a robust document control system in place. We’ll also clear up some common misunderstandings and provide guidance for assessing your own situation and a better solution designed specifically to ease the challenge of document control at scale.
Why Should You Care?
Imagine if a serious mishap occurred, and the only information an employee had was an outdated procedure written two years ago?
At its core, document control is about content integrity and reliability.
It’s about being 100% sure employees have the most up-to-date, accurate information to perform their jobs safely and adhere to regulatory compliance requirements. If people can’t be assured that they have access to the right version, they won’t trust or use your system.
Here’s a real-life example. Before working with us, one of our customers was experiencing a high degree of customer complaints. Upon investigation, management discovered that employees across all their stores were following an outdated policy that missed a crucial step.
Document control helps prevent catastrophes. The danger and risk associated with using the wrong version can result in a serious mishap or accident. If you have regulatory requirements, you will most likely need to show auditors that policies and procedures are properly controlled and are updated regularly.
Document control is also about traceability — being able to show what changed, when, and by whom. Proving that someone signed off on a specific policy version may be useful in a lawsuit.
If you’ve ever been a part of an organization handling sensitive documents, then you know how difficult this can be. Our typical customer has thousands of policies and procedures. An ad hoc, do-it-yourself approach won’t work.
Let’s dig deeper into what document control actually means.
What is Document Control?
So, what exactly is document control? And how does it differ from document management?
There’s a lot of confusion out there. People throw a lot of terms around and use them interchangeably. Getting clear on the basics will ensure that everyone in your organization has a common understanding and speaks the same language.
Below is a simple hierarchy to clarify.
Document Control Hierarchy
Think about document control as part of your organization’s overall change management process.
Change Management refers to the overall process of how an organization implements change. User-friendly documentation and document management are critical components of change management, and a robust document management system supports it. The primary focus at this level is not on content or documents.
Within Change Management:
Document Management (How do we manage a document throughout its entire life cycle?)
Document management is part of change management. It’s about everything related to a document. It’s a broad term used to describe the holistic process for administering all document activities throughout its life cycle: document creation, reviews, approval process, controlling, organizing, indexing, classifying, translating, attestation, distribution, and utilization. It's about tracking the document’s progress through the life cycle; for example, is it moving through reviews? So, document management is a subset of change management.
Within Document Management:
Document Control (How do we control document integrity?)
It’s the process of ensuring a document’s integrity, controlling document revisions, and maintaining a verifiable audit trail throughout its life cycle, including security and access permissions.
Some people go even further down the hierarchy, using the term document revision management (a subset of document control), so we want to call that out, but we’ll fold that into our discussion on document control.
Within Document Control:
Revision Management (What’s the right version?)
(Sometimes referred to as version control/revision control)
It’s the process of managing and preserving all document versions over time. It includes the process of assigning sequential numbers (major and minor revision numbering) and consistent naming convention when documents are modified, allowing users to compare versions. At this level, you’re concerned about designating major revisions and the various document versions within that revision group.
Now you know how the pieces fit together. For the purpose of this blog post, we’ll focus just on document control.
NOTE: Many people equate policies and procedures to document control. But as we’ve shown here, document control is just a piece of the puzzle; it doesn’t adequately address everything pertaining to policy and procedure management.
Document Control Through the P&P Life Cycle
We find it helpful to think about the entire policy and procedure life cycle as a complete flow; creation/editing, review/document approval, translation, distribution, attestation, implementation, audit, and maintenance. As the document moves through the life cycle, it's important that all changes are recorded in an audit trail. You should be able to identify the document version history at every point and see its changes.
Document control also ensures that once the document is published, no one can make unauthorized changes. We like Microsoft’s® term, “chain of custody.” If someone makes unauthorized changes, the chain of custody is broken.
Below are common document control violations:
- Multiple versions of a document reside in different places or various platforms.
- Authors publish a document version without going through the standard review.
- Various language versions get out of sync with the English (parent) version.
- The updated version never gets published.
- Authors fail to start a new revision when they need to make major changes to a document.
- Obsolete documents are left within the system instead of deleted.
Document Control Approaches
How do organizations handle document control? It runs the gamut!
Folder organization, do it yourself (DIY) – Essentially, this means there is no document control management in place.
MS Word file documents + SharePoint, or a general-purpose document management system – Just the fact that creation and editing is handled in a separate system opens the possibility of errors and manual hand-offs with new documents. It’s easy for things to fall through the cracks. With SharePoint, there’s still quite a bit of manual effort involved in setting up document control.
Specialized policy & procedure solutions with built in document control – Solutions like Zavanta handle all aspects of policy and procedure management in a complete ecosystem including content creation and maintenance. Document control is not an afterthought; it’s baked into the life cycle. Most of these systems provide automation and controls that eliminate manual tasks, prevent users from making mistakes, and save everyone time. This results in operational efficiency surrounding the management of documents.
Essential Document Control Features
If you need to shore up your document control, look for these key elements for effective document control practices.
- Robust document control paired with workflow is a powerful combo. You can define workflows that automatically handle tasks such as starting revisions, updating revision history, and incrementing revision numbers. Workflows prevent errors. For example, they can prohibit authors from publishing documents without first submitting the document for review.
- Centralized dashboard and master list reporting makes it easy to view and generate document lists –– on-demand ––for any criteria, including documents’ revision number, date last updated, status, and any other document metadata you want to include.
- Document revision history log lists each major and minor revision with a description of changes. When a record is added, the revision number is automatically incremented. The information in this log can be included in the document’s output.
- Rollback enables authorized users to restore the document to a previous version.
- Automatic archiving stores and preserves all obsolete document versions. Using a workflow, this step can be automated based on specific triggers you define.
- Document audit trail is a report of all the document’s changes over time, including the version number, date, person who made the change, and change details. If you are using a specialized system, this list will also include actions made by the system such as when a workflow was started, when an approver declined the document. This should be easy to find reports for auditors. Additionally, you should be able to see reviewer markup history for any version.
- Document compare gives you the ability to compare changes between any two versions.
- Security measures ensure your sensitive data is only accessed by those who need it.
Although not a document control feature specifically, user permissions are a huge enabler for document control. You can set permissions to protect against unauthorized access to documents and to any function that might impact document integrity. We often refer to this as “locking down the system.” For example, some organizations disallow documents to be printed. Others restrict their SMEs (authors) from starting new revisions. In large organizations, setting and managing permissions at a granular level is almost impossible to do without robust user and permissions management.
Impact on Checklists
If your organization relies on checklists, the need for tight, electronic document control systems cannot be overstated. Consider the situation where a checklist is used for a lab procedure, in the OR, or to perform maintenance on a piece of equipment. If the person performing the task is following the wrong or an outdated version, the consequences can be severe.
An online (electronic) system is vastly superior to a paper-based system because it can be more tightly controlled. It’s easier to ensure that employees are using the controlled version.
Zavanta Helps Elevate Your Document Control
We know how important content integrity is for policies and procedures. We’ve worked with companies in high-risk industries such as manufacturing, utilities, healthcare, life sciences industry, banking and more. A serious mishap can trigger a multi-million-dollar lawsuit, damage an organization’s reputation, or even result in loss of life.
Unlike other types of content, people USE policies and procedures to take action. They rely on the standard operating procedures they are given to make the right decisions, perform their jobs, and stay compliant. Many regulatory and accreditation bodies require that you have a document control system in place.
That’s why we designed Zavanta to check all the boxes for document control processes. Zavanta provides essential document control settings and rules that you can customize for your own organization's unique needs.
In addition to our technology, we provide training and expert advice based on what we’ve seen work and what doesn’t. Decisions you make early on can have a significant impact down the road.
Contact our team to learn more.
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