This is a ready-to-use Supplier Corrective Action Request (SCAR) form for driving a fix across the boundary between your quality system and a supplier’s, on any trigger, not only an audit finding. Send the form to the supplier with sections A through C completed by your organization, and sections D through F completed by the supplier and returned within the assigned response window. A worked filled specimen follows. Verify each cited regulation against the current published source before you rely on it. This template is an educational reference for you to adapt to your own quality system, products, and regulatory context; it is not legal, regulatory, or professional advice.
Field list
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| SCAR number | Text, sequential | Yes | QA | On issue |
| Issue date | Date | Yes | QA | On issue |
| Supplier name / site | Text | Yes | QA | On issue |
| Material or service affected | Text | Yes | QA | On issue |
| Trigger source | Audit finding, CoA trend, OOS/deviation link, complaint, delivery pattern, other | Yes | QA | On issue |
| Severity and response window | Critical (per below), Major, Minor | Yes | QA | On issue |
| Description of nonconformance | Text, factual, tied to objective evidence | Yes | QA | On issue |
| Containment action | Text | Yes | Supplier | Immediately, before root cause completes |
| Root cause | Text, method stated | Yes | Supplier | Within response window |
| Corrective action | Text | Yes | Supplier | Within response window |
| Preventive action | Text | Yes | Supplier | Within response window |
| QA adequacy review outcome | Accepted, returned for more detail | Yes | QA | On receipt |
| Verification evidence | Text, reference to objective evidence | Yes | QA | After acceptance |
| Effectiveness check date and result | Date, result | Yes | QA | After defined interval |
| Closure decision | Closed, escalated | Yes | QA | On completion |
Section A: SCAR administrative details
| Field | Entry |
|---|---|
| SCAR number | <<FILL: e.g. SCAR-2026-014>> |
| Issue date | <<FILL: date>> |
| Supplier name / site | <<FILL>> |
| Material or service affected | <<FILL>> |
| Issued by | <<FILL: name, role>> |
Section B: Severity and response window
| Severity | Typical trigger | Response window | Escalation if missed |
|---|---|---|---|
| Critical | Confirmed patient safety or product quality impact, data integrity failure | <<FILL: e.g. 5 business days for containment, 15 for full response>> | Immediate suspension consideration |
| Major | Confirmed OOS or deviation link, recurring rejects, CoA trend near limit | <<FILL: e.g. 10 business days>> | Conditional approval status, escalation to management |
| Minor | Documentation or process gap, no direct product impact identified | <<FILL: e.g. 20 business days>> | Extended monitoring, next review shortened |
Assigned severity for this SCAR: <<FILL>> Response due date: <<FILL>>
Section C: Description of nonconformance
<<FILL: state the nonconformance in specific, factual terms tied to objective evidence: what was observed, where, when, and against what requirement or specification>>
Trigger source: <<FILL: audit finding / CoA trend / OOS or deviation link / complaint / delivery pattern / other, specify>>
Reference: <<FILL: audit report number, deviation number, CoA lot numbers, complaint number, as applicable>>
Section D: Supplier containment (complete and return immediately)
<<FILL: immediate action taken to limit further exposure, e.g. holding affected lots, pausing a process step>>
Section E: Supplier root cause, corrective action, and preventive action (complete within response window)
| Element | Entry |
|---|---|
| Root cause | <<FILL: state the actual cause and the method used to determine it, not a restated symptom>> |
| Corrective action | <<FILL: what corrects the specific occurrence>> |
| Preventive action | <<FILL: what prevents the same failure mode elsewhere in the operation>> |
| Target completion date | <<FILL>> |
| Supplier respondent | <<FILL: name, role, date>> |
Section F: QA disposition (complete on receipt)
| Field | Entry |
|---|---|
| Adequacy review outcome | <<FILL: Accepted / Returned for more detail>> |
| Reviewer notes | <<FILL: if returned, state exactly what is missing>> |
| Verification evidence reviewed | <<FILL: e.g. revised procedure, training record, updated specification>> |
| Verification date | <<FILL>> |
| Effectiveness check basis | <<FILL: e.g. next 3 lots, 3 months of data>> |
| Effectiveness check date | <<FILL>> |
| Effectiveness check result | <<FILL: effective / not effective>> |
| Closure decision | <<FILL: Closed / Escalated to conditional approval, suspension, or disqualification>> |
| QA approver | <<FILL: name, signature, date>> |
Retention
Retain this SCAR and all attachments per the records retention schedule, for not less than <<FILL: retention period>>. Link the SCAR number to the supplier’s performance record and, where the tier or status changes as a result, to the AVL change history.
Filled specimen
A worked SCAR for the CoA trend example described in the supplier qualification article, where a related impurity result crept from 0.08 percent toward a 0.20 percent specification limit over five lots.
| Field | Entry |
|---|---|
| SCAR number | SCAR-2026-014 |
| Issue date | 2026-07-02 |
| Supplier name / site | Coastal Chemical Supply, Site 1 (illustrative name) |
| Material or service affected | Related-substance-controlled excipient, lot family A-24xx |
| Issued by | R. Gomez, QA |
| Assigned severity | Major |
| Response due date | 2026-07-16 |
Description of nonconformance: Five consecutive lots (A-2401 through A-2417) show a related impurity result rising from 0.08 percent to 0.19 percent against a 0.20 percent not-more-than specification. Every lot passed, but the trend indicates the margin to the limit is eroding and the process is not in a state of statistical control.
Trigger source: CoA trend, identified during routine trend review, reference CoA-Trend-2026-06.
Containment (supplier): Next lot (A-2421) held pending investigation; not released to buyer pending SCAR resolution.
Root cause (supplier): Investigation traced the trend to a raw material lot change with a slightly different particle size distribution entering the purification step, reducing purge efficiency for the related impurity. Root cause method: process parameter review plus comparative purge data across raw material lots.
Corrective action: Incoming specification for the raw material tightened to a particle size range that restores prior purge efficiency; current in-process inventory re-screened against the tightened range.
Preventive action: Tightened raw material specification extended to two other products manufactured on the same purification line that share the same upstream material.
QA disposition: Adequacy review outcome, Accepted. Verification evidence reviewed: updated raw material specification document, dated and approved in the supplier’s change control system. Effectiveness check basis: next three lots. Effectiveness check result: lots A-2425, A-2429, A-2433 returned to baseline (0.09 percent, 0.10 percent, 0.09 percent). Closure decision: Closed, 2026-09-03.
Common inspection findings this form prevents
- A supplier corrective action tracked only in email, with no defined response window and no closure record.
- A root cause of “operator error” or “isolated incident” accepted with no supporting investigation.
- A SCAR closed on the strength of the supplier’s written response, with no verification and no effectiveness check.
- No link between the SCAR outcome and the supplier’s tier, monitoring level, or AVL status.
How to adapt this form
- Set your severity bands and response windows to match your quality system’s existing conventions if one already exists, rather than running two different standards.
- Confirm the SCAR numbering scheme is unique and traceable across your supplier base, not reused per supplier.
- Wire the closure decision back into the approved vendor list register and the supplier’s periodic review record so a pattern of SCARs is visible at the next review, not only at the moment each one closes.