Approaching Supplier Corrective Action Requests

27 Nov 2024

The importance of suppliers in the medical device manufacturing business cannot be denied. Without them, manufacturers could not expand the reach of their products or boost their sales. But what happens when a supplier makes a mistake? In the medical device manufacturing industry jargon, we commonly refer to such mistake as a non-conformity and, depending on its severity, the repercussions can be significant.

Fortunately, a formal system exists for medical device manufacturers and suppliers to address any non-conformities. This system is known as the Corrective Action Request (CAR).

In this article, we will dive into what CARs are and their critical role in quality management.

What is a CAR?

A CAR is a formal request to resolve an organization’s non-conformity. A CAR is usually made after the audit of the Quality Management System (QMS) of an organization. Here, the CAR can be used in the following two ways:

1. As a method for notifying the non-conformity;
2. To document the corrective action taken to correct the non-conformity.

Altogether, these CARs are part of an organization’s Corrective and Preventive Action (CAPA) system. While a CAR is reactive (because it is submitted after a non-compliance is identified), it aims to prevent such non-conformity from happening again.

Apart from resolving the non-conformities, organizations must recognize the importance of CAR because:

1. ISO 13485 Compliance: CAR is an integral component of ISO 13485:2016, the international standard for QMS of medical devices. If an organization wants to be ISO 13485-certified, it must fulfill the standard’s requirements about CAR.
2. Risk Management: A CAR submitted to (or by) the organization can denote the need for a comprehensive risk assessment to identify and mitigate potential risks.

Reiterating the second point mentioned above, it would be important to note that the need to perform further risk assessment usually arises when any non-conformities originate from suppliers. This, ultimately, results in a Supplier Corrective Action Request (SCAR), emphasizing the importance of supplier oversight and corrective actions to mitigate potential risks.

What is a SCAR?

SCAR is a formal change request issued by an organization and send to the supplier. In SCAR, the organization asks suppliers to investigate and resolve a non-conformity or quality issue they found in their product.

Difference between CAR and SCAR

Although used interchangeably, SCAR refers to any non-conformance issues identified with an external supplier. CAR is broader and covers non-conformities across an organization. Think of a SCAR as a specialized type of CAR, focused on supplier-related issue.

A SCAR is not always mandatory. To illustrate this, consider the following example.

A medical device company has found some non-conformities from one of its external suppliers. Now, the company has two options:

• Issue a SCAR: this is appropriate for severe non-conformities that could lead to significant consequences, such as production interruptions or potential patient harm.
• Direct communication: for minor issues, the company may choose to address the problem directly with the supplier. If the issue can be resolved through discussion, it may show a strong supplier relationship.

However, if the issue escalates or the non-conformity poses serious risks, then issuing a SCAR remains a prudent course of action.

The SCAR process: a step-by-step guide

The process of issuing a SCAR goes through specific phases, as outlined below:

Let us look at each of these steps one by one:

Step 1 – Request Phase

• The process begins with a formal notice to the supplier. This notice includes key details such as:Supplier and product information;
• A clear description of the non-conformity;
• The expected response from the supplier.

Step 2 – Supplier Collaboration and Response Phase

After issuing the SCAR, the next step is collaborating with the supplier. This phase involves all the primary elements included in a CAPA response:

• Containing the issue to prevent further impact;
• Performing a root cause analysis to identify the source of the problem;
• Implementing corrective and preventive actions;
• Verifying that the actions have resolved the issue.

Step 3 – Disposition Phase

In this step, the medical device manufacturer’s internal personnel determine if the supplier’s responses are adequate. If that is not the case, the SCAR can be sent back for further elaboration. If the response is deemed irreparable or unacceptable, the manufacturer has the right to remove the supplier from their Approved Supplier List (ASL).

If the step is performed correctly, then the final stage of the SCAR begins.

Step 4 – Supplier Review Board Approval

The SCAR process is deemed complete when the supplier’s review board approves the corrective actions. Each approved process must be documented separately in its corresponding CAPA workflow (present within the medical device’s QMS).

How can TSQ&E Help You Across this Process?

It is a common phenomenon that medical device manufacturers focus mostly on corrective rather than preventive actions. This reactive approach to non-conformities can lead to long-term challenges.

At TSQ&E, we understand those challenges and with our exclusive CAPA management, we can help you address non-conformities efficiently and prevent future issues. To learn more, contact us today on our website.