SI-BONE | CAPA Form

Date of Request *

Requested By *

Department *

Source / Origin *

Source Reference Number(s)

Enter any related document or record numbers.

Problem / Issue Description *

0 / 2000

Affected Product(s) / Process(es)

Lot / Serial / Batch Number(s)

Quantity Affected

Potential Patient Safety Impact?

Yes

No

Unknown / Under Investigation

Regulatory Reportability (MDR / Vigilance)?

Yes — Reported

No

Under Assessment

Additional Background Information

0 / 1000

Signatures — Phase 1

21 CFR Part 11 Notice: By entering your name and the date below, you are applying an electronic signature to this record. This signature is legally binding and represents your review and approval of the content of this section. Signatures must be accompanied by verifiable user credentials in the electronic record system. This form is designed for use with DocuSign or an equivalent 21 CFR Part 11-compliant signing process.

Submitted By

Quality Review

Review Date *

Reviewed By *

CAPA Type *

Corrective Action Only

Preventive Action Only

Both CA & PA

Decision *

Continue — Open CAPA

Close — No CAPA Required

Justification for Closure *

0 / 1000

CAPA Owner *

Target Completion Date *

Scope & Rationale *

0 / 1000

Signatures — Phase 2

21 CFR Part 11 Notice: Entry of name and date constitutes a binding electronic signature completed via DocuSign or equivalent 21 CFR Part 11-compliant workflow.

Reviewed By

Quality Approval

Department Manager

Is Containment and/or Correction Required? *

Yes

No

Rationale for No Containment *

0 / 1000

Description of Containment Activities *

0 / 2000

Expected Completion Date *

Actual Completion Date

Evidence of Containment Completion *

0 / 1200

Signatures — Phase 3

21 CFR Part 11 Notice: Entry of name and date constitutes a binding electronic signature completed via DocuSign or equivalent 21 CFR Part 11-compliant workflow.

Completed By

Quality Approval

Timing Requirement: Root cause investigation must be completed within 30 working days from the date of Phase 2 approval, unless a documented extension has been approved by Quality.

Lead Investigator *

Expected Completion Date *

Additional Investigators

Root Cause Investigation *

Document the investigation methodology, data gathered, and analysis performed. Address both the occurrence cause (why the problem happened) and the escape cause (why it was not detected). Focus on systemic / process-level causes, not individual attribution.

0 / 2000

Root Cause Summary *

0 / 1200

Signatures — Phase 4

21 CFR Part 11 Notice: Entry of name and date constitutes a binding electronic signature completed via DocuSign or equivalent 21 CFR Part 11-compliant workflow.

Completed By

Department Manager

Quality Approval

Corrective Action Required? *

Yes

No

Rationale — No Corrective Action *

0 / 1000

Corrective Action Plan *

0 / 2000

Preventive Action Required? *

Yes

No

Rationale — No Preventive Action *

0 / 1000

Preventive Action Plan *

0 / 2000

Impact Assessment

Impact Area	Applicable?	Details
Regulatory / QMS Impact	Yes No
Product Safety Impact	Yes No
Validation / Verification Required	Yes No

Additional Impact Assessment Notes

0 / 1000

Assigned Implementer *

Target Completion Date *

Additional Participants

Signatures — Phase 5

21 CFR Part 11 Notice: Entry of name and date constitutes a binding electronic signature completed via DocuSign or equivalent 21 CFR Part 11-compliant workflow.

Completed By

Department Manager

Quality Approval

🔒Phase 6 will be unlocked upon completion and approval of Phase 5.

🔒Phase 7 will be unlocked upon completion and approval of Phase 6.

🔒Phase 8 will be unlocked upon completion and approval of Phase 7.

🔒Phase 9 will be unlocked upon successful completion and approval of Phase 8.

Corrective & Preventive Action (CAPA)