How to build a change control workflow [+ free change control workflow checklist]

Change is a constant, but in a GxP-regulated environment, it also has to be controlled. Without a formal process, even a small change can cause unexpected process breakdowns, product risk, or other major issues.

That’s why auditors take them so seriously. 

The key is finding the balance between unnecessary red tape and critical compliance guardrails. So, how do you build a workflow that’s both effective and efficient? Let’s break it down.

What’s the Purpose of a Change Control?

In any controlled environment, you can’t just implement a change without first thinking through the consequences. At its core, a change control workflow provides the framework to do exactly that, and then establishes a plan based on the expected impact.

Beyond just formalizing the change approval process, it forces you and your team to ask critical questions before a change is made, including: 

• What is the potential risk of this change to our product, process, or people?
• How will we mitigate that risk?
• Who needs to be aware of this change?
• What documentation needs to be updated?
• How will we know if it’s successful?

It’s a structured way to ensure that every modification is deliberate and documented, giving you a clear, auditable trail of what changed, why it changed, and what you did to ensure it worked.

What Steps Need to be Included in a Change Control Workflow?

You have a lot of flexibility in how you set up your change control stages and questions (that is, as long as you have an eQMS that is truly configurable), but no matter how you organize the steps, a compliant change control needs to include these components:

The Change Request:

To control change you have to first… request a change. Simple enough. But as with all things quality, compliance is in the details. As part of the change request, be sure to include the 5 Ws:

• What: Describe the exact change you’re requesting to occur.
• Why:  Why is this change necessary? What sparked the request? 
• When: When should the change be implemented? 
• Where: What locations are affected? This could be a specific site, a manufacturing line, a certain room, a document location, etc.
• Who: Who will be impacted? Think about not only who will carry out the change, but also the other departments that could be affected. 
  

Risk Assessment & Implementation Plan:

The risk assessment is where you dig into the potential impact of the change. Why is this important? It sets the guide posts for risk mitigation steps you need to include in your implementation plan. Ask questions like: 

• What is the potential impact on our product? Processes? People?
• Does this impact our documentation?
• Will this change affect any validated systems?
• Does it require us to notify a regulatory body?
• Could it impact data security or privacy?
• What else could go wrong? 

After the risk assessment (and informed by it), comes the implementation plan. Think of this as a project plan that details every task required to carry out the change successfully, as well as who is responsible for what and when. Beyond the logistics of the change (e.g. Physically replacing all instances of a particular reagent with a new one), don’t forget to also think about things like:

• Revising relevant SOPs and/or Work Instructions
• Creating/changing any related courses
• Assigning new training to team members
• Conducting revalidation
• Defining how you will verify the change was effective

Pre-Implementation Approval:

This is a critical control point. The tasks in the implementation plan can’t start until the request, risk assessment, and plan have been reviewed and approved. Typically, this approval comes from a manager/subject matter expert (SME) who can verify the technical details, along with a Quality Assurance representative who ensures the plan meets compliance standards.

Implementation:

Once the plan’s approved, it’s time to roll with the changes. Tasks are officially assigned and team members can take action. This is the "doing" phase where the change actually happens.

Verification:

Auditors don’t appreciate assumptions; you have to prove the change was executed and that it worked. This proof is two-fold: during the implementation phase, you’ll need task assignees to provide evidence they completed their tasks, and after implementation you’ll need to execute tests and/or checks to confirm the change was effective and didn't cause any unintended problems. Remember, these verification steps should already be defined in your implementation plan. 

Final Review & Closure:

After the change has been implemented and verified, a final review officially closes out the record. This stage also serves as a decision point. If your verification checks show something went wrong, this review can trigger a rework that sends the change back to the implementation team with instructions on what needs to be fixed.

Who Should Be Involved in a Change Control Workflow?

A successful change control process involves more than just the person making the change. Key stakeholders typically include:

• The Requester: Just like it sounds, this is the person(s) requesting the change. They’re responsible for detailing the what, why, when, where, who, and how of the change. 
• The Implementers: These are the people responsible for actually carrying out the tasks in the implementation plan. This could be anyone from a lab technician to a software developer.
• The Approvers: For every change control, someone needs to review and approve the request, risk assessment, and implementation plan. They also need to carry out the final review and closure. This could be a combination of management/an SME and a Quality person, or you could establish a Change Control Board or committee. A committee ensures that representatives from every department can weigh in on the plan, which helps reveal potential risks or impacts that might otherwise have gone undetected.

How to improve your change control process

Follow these change control pro tips to make your process more efficient, effective, and resilient.

• Categorize Your Changes: Not all changes carry the same weight. A typo correction in an SOP is very different from onboarding a critical new vendor. Different change control categories allow you to tailor the workflow to the risk and complexity of the change. (Plus, categorizing also makes it much easier to mine data and report on change control metrics). For example:
• Categorize by Type: For example, maybe you have separate categories for "General" changes, "Software" updates, or "Vendor Onboarding." Each workflow still follows the core principles, but a Vendor Onboarding workflow might include a required field to assess supplier risk, a question that would be irrelevant for a simple SOP update.
• Categorize by Urgency: You absolutely need a process for emergency changes. If you discover a critical security vulnerability or a risk to patient safety, you can't wait for a standard review cycle. An emergency process allows you to implement the fix immediately and complete the formal documentation after the fact.
• Plan for Detours: Workflows shouldn't just map out the best-case scenario. What happens if a change is logged by mistake, or if you realize it's the wrong approach during implementation? You need a "way out." Build branches into your process to formally cancel a change or divert to a rework, ensuring the entire history remains documented.
• Require Evidence: A task isn't done until you have proof. A common mistake is allowing team members to simply check a box without providing objective evidence that the task was completed correctly. Your process must require uploading screenshots, test results, signed documents, or other forms of verification to stand up to an audit.
• Think Beyond Your Department: A change in one area can have ripple effects you didn't anticipate. The risk assessment should guide you to think holistically about how a change impacts other departments and processes. This is where a cross-functional review committee comes in handy.

The Best Tool for Managing Change Control Workflows

Trying to manage a robust change control process with paper forms, spreadsheets, and email chains is a recipe for missed steps, lost documents, and compliance gaps. The manual follow-up alone can be a full-time job.

That’s why many Quality teams rely on an electronic Quality Management System (eQMS) instead. An eQMS is designed to automate, enforce, and document your quality processes, making change controls more manageable. Look for a system that provides:

• Configurable Workflows: A flexible eQMS allows you to build the exact workflow you need and gives you the option to create custom fields and forms based on your change control requirements. 
• Automated Notifications and Task Management: The system should automatically route tasks and send reminders to ensure approvals and action items are completed on time.
• Centralized, Auditable Records: An eQMS acts as a single source of truth, housing the request, risk assessment, implementation plan, evidence, and approvals all in one secure record.
• Integrated Quality Processes: The real power of an eQMS is its ability to connect your processes. You can link a change control directly to the SOPs that need revision, the training that needs to be assigned, or the CAPA that initiated the change.
• Built-in Reporting: A good eQMS makes it easy to track metrics and report on your change control process, helping you identify bottlenecks and demonstrate compliance to auditors and leadership.

The Ultimate Change Control Workflow Checklist

Want to make sure your change control workflows have all of the components they need? Whether you’re building a new process from scratch or auditing your existing workflow, this Change Control Workflow Checklist will help guide you toward a more efficient, effective, and compliant change control workflow.