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Supplier Corrective Action Requests (SCARs)

A Supplier Corrective Action Request (SCAR) is a formal mechanism for documenting quality issues with suppliers and requiring them to investigate, identify root causes, and implement corrective and preventive actions. SCARs track the full lifecycle from issue identification through supplier response, effectiveness verification, and closure.

  1. On the left sidebar, select SCARs.
  2. Select New SCAR.
  3. From the Supplier dropdown, select the supplier associated with the issue.
  4. Enter a Title (minimum 5 characters) summarizing the issue.
  5. Enter a Description (minimum 10 characters) including the impact and any immediate actions taken.
  6. From the Source dropdown, select the source that triggered this SCAR.
  7. Optionally, enter a Source Reference (for example, AUD-2026-001 or NC-2026-005).
  8. In the Response Due field, enter the number of days from today for the supplier to respond (1 to 90 days, default is 14).
  9. Optionally, in the Affected Products field, enter one product per line in the format: product name, lot number, quantity.
  10. Select Create SCAR.
  1. On the left sidebar, select SCARs.
  2. To search by SCAR number or title, enter text in the Search SCARs field.
  3. To filter by lifecycle status, select a value from the All Statuses dropdown.
  4. To filter by originating source, select a value from the All Sources dropdown.
  5. To open a SCAR, select its row in the table or select View in the Actions column.
  1. On the left sidebar, select SCARs.
  2. Select the SCAR you want to update.
  3. In the Supplier Response section, select Record Response. If a response already exists, the button reads Update Response.
  4. Enter the Root Cause Analysis (required).
  5. Enter the Corrective Action (required).
  6. Optionally, enter a Preventive Action.
  7. Select Save Response.
  1. On the left sidebar, select SCARs.
  2. Select the SCAR you want to verify.
  3. In the Effectiveness Check section, select Record Check.
  4. Check or uncheck the Effectiveness verified checkbox (checked = effective, unchecked = not effective).
  5. Enter Notes documenting the verification evidence and findings (required).
  6. Select Save.

The effectiveness result displays as “Effective” (green) or “Not Effective” (red) after recording.

  1. On the left sidebar, select SCARs.
  2. Select the SCAR you want to close.
  3. At the bottom of the detail page, select Close SCAR.
  4. Enter Closure Notes summarizing the outcome and justification for closing (required).
  5. Select Confirm Close.
  1. On the left sidebar, select SCARs.
  2. Select the SCAR you want to review.
  3. In the header area, select View Supplier to navigate to the associated supplier’s profile.
  1. On the left sidebar, select SCARs.
  2. Select Settings to open supplier settings in the Admin panel.
StatusDescription
OpenSCAR has been created and issued to the supplier; awaiting their response
Response ReceivedSupplier has submitted their root cause analysis and corrective action plan
Effectiveness CheckCorrective actions have been implemented; verification of effectiveness is in progress
ClosedSCAR has been resolved, effectiveness verified, and formally closed
SourceDescription
Customer ComplaintIssue identified through a customer complaint
Audit FindingNonconformance found during a supplier audit
Incoming InspectionIssue detected during incoming material inspection
Trend AnalysisPattern identified through trend analysis of supplier performance data

The SCAR list page displays three summary statistics at the top:

MetricDescription
Total SCARsTotal count of all SCAR records
OpenSCARs that have not been closed
OverdueSCARs past their response due date

Practical example: full SCAR lifecycle for an incoming inspection failure

Section titled “Practical example: full SCAR lifecycle for an incoming inspection failure”

Scenario: During incoming inspection of excipient lot EXC-2026-042 from supplier ChemPure Ltd., your QC lab finds that the particle size distribution is outside the accepted specification (D90 exceeds 150 microns vs. the 120 micron limit). You need to issue a SCAR, track ChemPure’s response, verify effectiveness, and close the record.

  1. Navigate to SCARs and select New SCAR.
  2. Fill in the form:
    • Supplier: ChemPure Ltd.
    • Title: Out-of-specification particle size distribution -- Lot EXC-2026-042
    • Description: Incoming QC testing of microcrystalline cellulose lot EXC-2026-042 revealed D90 of 163 microns, exceeding the specification limit of 120 microns (per SP-RAW-018 Rev 3). Lot has been quarantined. Impact: potential tablet content uniformity failure if used in manufacturing.
    • Source: Incoming Inspection
    • Source Reference: IIR-2026-089
    • Response Due: 21 days
    • Affected Products: Microcrystalline Cellulose NF, EXC-2026-042, 500 kg
  3. Select Create SCAR. The system assigns SCAR number SCAR-XXXX with status Open.

After ChemPure submits their investigation report (within the 21-day deadline):

  1. Open the SCAR and select Record Response.
  2. Fill in the response:
    • Root Cause Analysis: Investigation determined that the milling screen (mesh size 100) had developed micro-fractures after extended use, allowing oversized particles to pass through. Screen replacement was overdue per the preventive maintenance schedule (PM was 3 weeks late).
    • Corrective Action: Replaced the damaged milling screen immediately. Retested and released replacement lot EXC-2026-043 (D90 = 98 microns, within specification). Implemented mandatory pre-batch screen integrity check.
    • Preventive Action: Updated preventive maintenance SOP (SOP-MILL-007) to reduce screen replacement interval from 6 months to 4 months. Added milling screen integrity check to the batch start-up checklist.
  3. Select Save Response. The SCAR status advances to Response Received.

After two subsequent lots have been received and tested:

  1. Open the SCAR and select Record Check in the Effectiveness Check section.
  2. Check the Effectiveness verified checkbox.
  3. Enter notes: Reviewed particle size data for two subsequent lots received after corrective action: Lot EXC-2026-043 (D90 = 98 um) and Lot EXC-2026-051 (D90 = 105 um). Both within specification. Confirmed ChemPure updated SOP-MILL-007 Rev 4 and provided evidence of completed PM on all milling equipment.
  4. Select Save. The effectiveness result displays as Effective (green). The SCAR status advances to Effectiveness Check.
  1. At the bottom of the SCAR detail page, select Close SCAR.
  2. Enter closure notes: Root cause identified as worn milling screen with overdue preventive maintenance. Corrective and preventive actions verified effective over two subsequent lots. No further action required. Lot EXC-2026-042 was returned to supplier per disposition decision.
  3. Select Confirm Close. The SCAR status changes to Closed.

The closed SCAR remains visible on ChemPure’s supplier profile under the SCARs tab and is included in the supplier’s quality performance history for future classification reviews.