Supplier Corrective Action Request (SCAR)

A Supplier Corrective Action Request (SCAR) is a mandatory process initiated by a purchasing organization that requires a supplier to formally investigate and resolve deficiencies in the quality of the product or service provided.

A Supplier Corrective Action Request (SCAR) is a documented demand from a purchaser to a supplier requiring the supplier to:

1. Investigate a detected deficiency in the supplier’s product, service, or quality system.
2. Provide a formal Root Cause Analysis.
3. Develop and implement documented corrective action(s) to prevent the deviation from recurring.

The SCAR process ensures that issues identified in incoming materials or services are addressed at their source within the supply chain.

The SCAR process is a specific application of the broader Corrective and Preventive Action (CAPA) system, focused externally on the supply chain to maintain high standards of quality and regulatory compliance.

Mandatory Requirement in Quality Agreements

The use of a SCAR is formally mandated through contractual Supplier Quality Agreements as a core component of Purchasing Controls ($\S 820.50$).

• Supplier Obligation: Upon notice from the purchaser of any deficiency in the supplier’s quality system, product, or service, the supplier must provide documented corrective action(s) to prevent future deviations from the specification or quality system requirement.
• Documentation Requirement: Upon the purchaser's request, the supplier must provide their established SCAR document and all supporting documentation to the purchaser's Supplier Quality team.
• Timeliness: All documentation and actions pertaining to the SCAR must be provided within the timeframe required by the purchaser’s compliance system, often specified as ten (10) calendar days, or less if the problem impacts the supplied material or serviceSCAR Components and the CAPA Link

SCAR Components and the CAPA Link

The SCAR structure mirrors the required steps of a formal CAPA process, ensuring the supplier follows a systematic approach to problem-solving, rather than just solving the immediate issue.

Here is a list of SCAR componants and the purpose and action required:

Problem/Defect Description: Details the specific deficiency (including similar product issues).

Containment Actions: Describes immediate steps taken to isolate the problem and prevent further distribution of defective material.

Initial Investigation: Performed by the supplier.

Root Cause Analysis (RCA): The supplier must provide the RCA to determine the underlying, fundamental causes of the issue.

Corrective/Preventive Action: Actions taken to minimize any risk to the purchaser and end users, specifically aimed at preventing recurrence of the deviation.

Supporting Documentation: Includes the SCAR document itself and evidence that actions are effective in preventing and eliminating defects.

Connection to Broader Quality Management

Effective SCAR implementation is crucial for maintaining the integrity of the overall supply chain quality.

Continuous Improvement: The actions implemented through the SCAR process are intended to be part of a continuous improvement action. A robust CAPA system, of which SCAR is an extension, reduces risks and enhances product safety.

Nonconformity Management: SCARs are generated when nonconforming products or services are received. The supplier must implement and maintain a documented system to quarantine and report any product issue that may compromise safety or diminish quality, thereby warranting ceasing continued shipment or requiring a product recall.

Supplier Evaluation: The purchasing organization's procedures for Purchasing Controls require evaluating and selecting suppliers based on their ability to meet specified requirements, including quality requirements. A supplier's effectiveness in responding to SCARs contributes to the ongoing monitoring of their performance.

Analogy for Understanding SCAR

If a Corrective and Preventive Action (CAPA) is an internal doctor's report diagnosing a systemic illness in a manufacturing facility, a Supplier Corrective Action Request (SCAR) is a formal prescription sent to an external pharmacy (the supplier).

The pharmacy (supplier) is required to use their own internal diagnostic tools (Root Cause Analysis, or RCA) to figure out why they provided the wrong ingredient (the deficiency). They must then use the SCAR form to document not just that they fixed that batch (containment), but what systematic changes they made to their operating procedures (corrective action) to ensure they never send the wrong ingredient to the factory (purchaser) again. The purchaser retains the authority to approve the plan before the supplier can proceed, ensuring the quality prescription is effective..

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