Supplier Corrective Action

Your BRCGS auditor asks for corrective action records on a supplier that shipped mislabeled packaging eight months ago. If that SCAR is in an email thread, you're assembling it manually while the auditor waits. If it's in a structured system with the root cause response, supporting documents, and closure record attached, you pull it in under two minutes. GFF, Inc. reached exactly that point: during their organic audit, auditors had no need for binders because everything was already in the system.

A quality manager at a U.S. importing company receives a failed COA from a Mexican co-manufacturer. Under 21 CFR 1.508, that triggers an FSVP corrective action obligation, not just an internal hold. The SCAR must document what the foreign supplier did to address root cause, and the importer's FSVP may need to be updated based on findings. This is a distinct obligation from what a domestic manufacturer faces under Part 117, and it requires the same level of retrievable documentation.

If your quality team is two or three people covering multiple sites, email is often what gets used for supplier follow-up because nothing else exists. That works until a SCAR from 14 months ago needs to be produced in 30 minutes. The documentation gap is a system problem.

A dairy manufacturer receives out-of-spec moisture readings on incoming dry ingredients from the same supplier, third occurrence in six months. Each prior issue was handled with a phone call. Now the pattern matters as much as the individual event. A documented SCAR history makes the escalation decision clear and defensible.

A CAR (Corrective Action Request) is the general term for any formal corrective action request, internal or external. Directed specifically at an external supplier, a SCAR is a CAR that names the vendor, sets a response deadline, and defines what an acceptable fix looks like. CAPA (Corrective and Preventive Action) is the broader system-level process that includes both corrective actions (fixing what went wrong) and preventive actions (changing the system so it doesn't recur). Under 21 CFR 117.150, regulators expect both dimensions.

No. Minor, isolated issues can be addressed through documented corrections without a full corrective action investigation. But certain conditions should reliably trigger a SCAR: pathogen-positive results, undeclared allergens, foreign material, repeated failures across multiple shipments, mislabeled materials, or temperature abuse. The decision to issue or withhold a SCAR is itself a quality decision that should be documented either way.

Not on its own. "We retrained the operator" is a corrective action. A defensible root cause response looks like: "We found the SOP was unclear on step 4, revised it, and confirmed the operator completed retraining." Accepting the first version closes the SCAR without actually fixing anything. See the root cause analysis guide for structured approaches.

Verification means confirming effectiveness across multiple subsequent lots or production runs using objective evidence, such as re-test results, COAs, or updated process records. A single clean lot isn't verification. This is the step that most frequently generates audit findings when it's skipped or documented with a single data point.

Yes. Importers operating under FSVP (21 CFR Part 1.508) have a distinct corrective action requirement that can include discontinuing a foreign supplier until the noncompliance is resolved, and potentially modifying the FSVP itself based on findings. The documentation requirements parallel those under Part 117, but the regulatory trigger and scope differ. If you're importing food, your SCAR process needs to account for both frameworks.

Under 21 CFR 117.150, corrective action records must be retained for a minimum of two years. That applies to the SCAR itself, the root cause investigation, the remediation plan, and the verification evidence. Make sure your records system supports retrieval by supplier, lot, date, and issue type, not just by file name.