Improving the Supplier Corrective Action Request Process with the QMS

When I first started developing supplier quality management programs in pharma manufacturing, tracking supplier corrective action requests was incredibly manual.

Every supplier replied in a different format. Vague root cause analysis and surface-level investigations often necessitated follow-up, prodding suppliers to look deeper at the problem. The back-and-forth emails asking ‘Is this enough documentation?’ or ‘Did I answer this right?’ consumed countless hours.

But when the company adopted an enterprise quality management system (EQMS) arrived, everything changed. Today, companies can completely digitize the supplier corrective action request (SCAR) process to bring structure, traceability, and accountability to supplier quality management.

Below, we explore some of the most effective strategies to improve the SCAR process with the QMS, and how you can tell whether your efforts are paying off.

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How to Standardize Your Supplier Corrective Action Request (SCAR) Workflow

Inconsistency is the biggest challenge in managing supplier corrective actions. Each supplier may use different templates, timelines, and definitions of what constitutes a major, minor, or moderate issue. That’s why the most foundational step in improving the process is to create a standardized SCAR workflow in your QMS.

A configurable QMS allows you to create a workflow that links each step of the process together and defines clear expectations across teams and suppliers. Key workflow elements to consider are:

• SCAR template: This form should provide all the information and data needed to ensure the supplier understands the problem.
• Containment procedures: How will you contain the issue while the corrective action is in progress?
• Root cause analysis: Define the level of detail required and whether suppliers should use specific root cause analysis tools (e.g., 5 Whys, 8D) for different types of issues.
• Corrective and preventive action plans: Define the format that suppliers should use and what supporting evidence to provide.
• Effectiveness checks: The SCAR should identify who is responsible for verifying that the corrective action worked, and how it should be documented.
• Reviews and approvals: Use automated routing rules, notifications and digital signatures to streamline approvals.
• Integration with related QMS processes: Tying supplier corrective actions to nonconformances, deviations, past corrective actions, and supplier performance scorecards provides broader visibility into the full context of supplier issues.

Linking these processes also helps uncover trends and patterns. When you can see that three different SCARs from the same supplier all relate to training gaps, for instance, you’ve identified a systemic issue that needs attention.

In my experience, creating these structured workflows delivered almost immediate impact.  We went from fielding constant questions from suppliers to a much smoother process for everyone involved, with clear expectations for all. Just as important, this standardization is what allowed me to scale my team while ensuring everyone handled supplier corrective actions the same way.

Define SCAR Closure Criteria Early in the Process

One of the most common questions I hear when I give Corective Action Preventive Action webinars is, “When can we close out a corrective action?”

The answer: not until the effectiveness check is complete.

Too many companies rush to close SCARs to improve their closure time metrics, but this defeats the entire purpose of corrective action. You need to verify that your corrective actions actually worked, and that verification can take months depending on the complexity of the issue.

As a best practice, you want to build closure criteria into your workflow from the start, including:

• Evidence that the effectiveness check took place
• Signoff from designated approvers
• Documentation showing the supplier closed the loop

I’ve seen SCARs that were prematurely closed get reopened later, creating rework and frustration for everyone. When we standardized our SCAR process with proper closure criteria, the number of reopened SCARs dropped sharply—a clear sign the process was maturing.

Add Suppliers as EQMS Participants

Another key way you can improve efficiency and transparency within the SCAR process is to loop in suppliers as participants in your QMS.

That means instead of having to email documents back and forth, you give suppliers limited, secure access to the QMS so they can:

• See clear examples and acceptance criteria
• Upload their own evidence
• Respond directly to requests and questions
• Track the status of SCARs in real time

When I led supplier quality teams, the effect of adding suppliers to the QMS was huge. Closure times dropped. The quality of root cause analysis improved, because suppliers understood exactly what we were asking for. Communication got much clearer all around.

Adding suppliers to the Enterprsie Quality Management System also drives transparency in several key ways:

• Everyone is looking at the same data, what steps come next, and what’s needed to move forward.
• When suppliers log into the system themselves and upload their own evidence, there’s no confusion about whether an email was received or a document was lost.
• Everything is documented clearly and consistently, so there’s no chance of misunderstandings based on conversations.

On a wider level, this visibility helps build trust and creates a collaborative problem-solving relationship with suppliers rather than an adversarial one.

Adopt a Risk-Based Approach to Supplier Corrective Actions

Risk-based thinking is a core principle of ISO 9001 and ISO 13485. The QMS puts risk-based thinking into practice by allowing you to link SCARs to supplier scorecards to hone in on trends like:

• Which suppliers have repeat issues
• Where the longest closure times are
• If certain types of issues are recurring

The QMS also bakes risk-based thinking into the process by allowing you to:

• Assign risk levels to individual SCARs or suppliers
• Monitor supplier corrective action data and other supplier performance metrics from one centralized dashboard
• Collect data to build a more targeted approach to supplier management

This risk-based approach becomes especially valuable when preparing for supplier audits. By connecting SCAR data with supplier performance scorecards and performance metrics, you can identify patterns before an audit.

For example, if you notice three or four SCARs tied to training gaps at a particular supplier, you know exactly where to focus your audit efforts. This targeted approach is exactly what ISO 9001 and ISO 13485 emphasize: focusing resources on areas of highest risk and recurrence.

Build Your Own Supplier Corrective Action Playbook

One strategy that made a significant difference early in my career was creating an internal SCAR playbook for my quality team. This simple one-page reference document included:

• Examples of good versus inadequate root cause analysis from suppliers
• Red flags that indicate a need to look deeper
• Templates showing what acceptable documentation looks like
• Guidelines on how to push back on supplier responses

This type of playbook can especially helpful when suppliers provide superficial root causes. When suppliers blame “operator error” or “insufficient training,” the playbook can remind team members to ask deeper questions:

• Why did the operator make that mistake?
• Why wasn’t the training effective?
• Was the SOP unclear or too cumbersome?

Sometimes problems are people-related, but there’s almost always a deeper process issue underneath.

Ultimately, this playbook can make supplier responses significantly more usable and can help standardize how your entire team evaluates SCAR quality. By housing the playbook in the QMS, you can:

• Link it directly to relevant SCAR workflows so it’s easily accessible when team members need it during the review process.
• Integrate with QMS training management to ensure anyone with SCAR review responsibilities is trained on the playbook.
• Automatically push updates to the team to ensure they’re trained on any changes, such as when you add new examples or refine your guidance.

How Can You Tell If Your SCAR Process Is Improving?

As for how to assess whether your SCAR process is improving, there are several key factors and metrics you’ll want to watch.

 Fewer Repeat Issues

If the same problems keep recurring at a supplier, corrective actions aren’t working. A well-functioning SCAR process should show declining recurrence rates over time.

 Reduced Cycle Times

Track how quickly SCARs move through the process start to finish. Understand that speed shouldn’t come at the expense of thoroughness, and that the ultimate goal is efficiency.

 Improved Quality of Supplier Data

Are suppliers submitting more thorough root cause analyses? Are they using problem-solving correctly and consistently? These improvements matter just as much as speed when it comes to efficiency of problem-solving.

 Fewer Reopened SCARs

This metric is one of the clearest indicators of process maturity. When the number of reopened SCARs drops, this tells you that issues are being resolved the first time around.

Conclusion: The Value of Digitizing Supplier Corrective Actions in the QMS

The shift from manual SCAR management to a structured QMS approach represents a fundamental change in how you collaborate with suppliers. When suppliers have clear expectations, transparent processes, and direct system access, they become partners in quality improvement rather than sources of friction.

What’s more, suppliers actually appreciate the structure. No more guessing what customers want, no more multiple revision cycles, no more hand-holding. The clarity makes their job easier, which strengthens the relationship.

The investment in standardizing and digitizing your SCAR process pays dividends in faster solutions, stronger supplier relationships, and ultimately, better product quality.

Success Story: Automating SCAR and Nonconformance Management.  Learn how one cardiovascular device manufacturer saved thousands of hours annually by automating non-conformance reporting and SCAR processes

About the Author

Stephanie Ojeda is Vice President of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 18 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.