What a SCAR is
A supplier corrective action request (SCAR) is a formal request asking a supplier to investigate a problem with its product or service, find the root cause, correct it and prevent it from happening again. It is the supplier-facing part of your CAPA system.
Regulators expect this kind of follow-through:
- ICH Q10 section 2.7 asks companies to monitor supplier and contractor performance and pursue “the identification and implementation of any essential improvements.”
- EU GMP Chapter 5 (5.29) expects supplier audit deficiencies to be “clearly identified” and followed by corrective and preventive actions.
- ISO 13485 clause 7.4.1, incorporated into FDA’s QMSR since February 2, 2026, requires supplier monitoring and re-evaluation, with controls proportionate to the risk associated with the medical device.
What regulators do not accept is closing the loop on paper. FDA’s quality agreement guidance makes the owner’s quality unit “ultimately responsible” for CGMP compliance, so a supplier’s corrective action counts only once the owner has verified that it worked.
For a template to check whether a corrective action worked, see CAPA Effectiveness Check Template for Medical Device and GMP Teams.
When to raise a SCAR
Not every problem needs one. Over-using SCARs dilutes them. Typical triggers:
| Trigger | SCAR? |
|---|---|
| Single minor nonconformance, low risk | Usually not; record and monitor |
| Repeated nonconformances of the same type | Yes |
| Any nonconformance affecting product quality, safety or compliance | Yes |
| CoA results that conflict with your testing | Yes, with investigation |
| Unnotified change to material, process or site | Yes |
| Major or critical audit finding | Yes, or as part of the audit response |
| Complaint traced to supplier material | Usually yes |
Define these triggers in your procedure, with severity levels and response timelines.
What a SCAR should contain
From you:
- Clear problem description: what, where, when, how many, which lots
- Evidence: test results, photos, nonconformance records
- Requirement that was not met (specification, drawing, quality agreement clause)
- Containment expectations and response deadlines
From the supplier:
- Containment actions: stock at the supplier, in transit and at your site
- Root cause analysis using a structured method, not “operator error” alone
- Corrective actions addressing the root cause
- Preventive actions extending to similar products or processes
- Implementation evidence and dates
- Effectiveness check plan
Reviewing the response
The weakest point in most SCAR processes is the review of the supplier’s response. Check:
- Is the root cause supported by evidence? Or is it a guess?
- Does the corrective action address that root cause? Retraining alone rarely does.
- Is the scope right? Other lots, other products, other sites.
- Is there implementation evidence? Revised procedures, records, photos, data.
- How will effectiveness be shown? Defined metric, period and target.
Reject responses that fail these tests and say why.
Verifying effectiveness
A SCAR should stay open until effectiveness is shown, for example:
- No recurrence in a defined number of lots or months
- Improved incoming inspection or CoA agreement data
- Confirmation at the next audit
Feed the outcome into supplier performance scorecards and re-qualification decisions. A supplier with repeated ineffective SCARs is a candidate for probation or disqualification.
SCAR metrics
| Metric | Why it matters |
|---|---|
| SCARs issued per supplier per period | Shows problem suppliers |
| Time to first response | Responsiveness |
| Time to closure | Speed of correction |
| Responses rejected | Quality of supplier investigations |
| Recurrence after closure | Effectiveness |
Common weaknesses
- SCARs closed when the supplier responds, not when effectiveness is shown
- Root causes such as “human error” accepted without challenge
- SCARs not linked to the internal nonconformance or CAPA
- No escalation for overdue or repeated SCARs
- Contract manufacturers requalified while SCARs are still ineffective
SCAR checklist
- Triggers and severity levels defined
- Problem description and evidence complete
- Containment confirmed
- Root cause supported by evidence
- Corrective and preventive actions address the root cause and scope
- Implementation evidence received
- Effectiveness criteria defined and met before closure
- Outcome fed into supplier scorecard and qualification
- Escalation path for overdue or repeated SCARs
Review SCAR responses with AskDona
Reviewing supplier responses well takes time: reading the investigation, checking the evidence, comparing it with the original problem. AskDona reads the SCAR, the supplier’s response and attached evidence together and flags unsupported root causes, actions that do not match the cause and missing implementation evidence, each linked to the source page. Run a sample SCAR review on a recently closed request. AskDona shows the evidence; your supplier quality team decides.
FAQ
What is a SCAR? A supplier corrective action request: a formal request for a supplier to investigate, correct and prevent a problem with what it supplies.
What is the difference between a SCAR and supplier CAPA? They refer to the same process. “SCAR” is the request; “supplier CAPA” is the corrective and preventive action the supplier takes in response.
When should a SCAR be issued? For significant or repeated nonconformances, problems affecting quality or compliance, unnotified changes and major audit findings.
How long should a supplier have to respond? Set timelines by severity in your procedure, for example days for containment and weeks for root cause and corrective action.
When can a SCAR be closed? Only after implementation evidence is reviewed and effectiveness has been shown.
References
All pages opened and checked by October 14, 2026.
| Source | Type | Used for |
|---|---|---|
| ICH Q10 (FDA) | ICH guideline | Section 2.7 improvements |
| EU GMP (EudraLex Vol. 4), Chapter 5: Production | EU GMP guideline | EU GMP 5.29 |
| ISO 13485:2016, Medical devices: Quality management systems | International standard | ISO 13485 7.4.1 |
| FDA, Contract Manufacturing Arrangements for Drugs: Quality Agreements (Nov 2016) | FDA guidance | Owner responsibility for supplier quality |
| NAMSA, Industry Update: QMSR | CRO / consultancy article | QMSR date |