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SOP-QMS-10 — Nonconformity, CAPA & Continual Improvement

Handles nonconformities, corrective and preventive actions, and continual improvement of the QMS (ISO 9001 §10).

Owner: Quality DirectorApprover: SVP OperationsVersion: 4.0Updated: 12/7/1969

1. Purpose

Provide a controlled process to react to nonconformities, determine root cause, implement corrective action, and drive continual improvement.

2. Scope

All UBC services, processes, and suppliers.

3. Definitions

Nonconformity — Non-fulfillment of a requirement.
CAPA — Corrective and Preventive Action.
Root cause — The underlying reason for a nonconformity, established via structured analysis.

4. Roles & Responsibilities (RACI)

Activity	R	A	C	I	Cadence
Log nonconformity	Any employee	Process owner	Quality	Owner	On detection
Contain immediate impact	Process owner	Operations Director	Quality	Affected clients	Within 24h
Root cause analysis	CAPA owner	Process owner	SME	Quality	Within 10 days
Implement corrective action	CAPA owner	Process owner	Quality	Affected teams	Per plan
Verify effectiveness	Quality Analyst	Quality Director	Process owner	Quality Council	≥ 30 days post-close

5. Procedure

Any employee may raise a nonconformity in the CAPA portal.
Categorize impact (Sev 1–3) within 4 business hours.
Perform containment; document actions and communication to affected parties.
Conduct root cause analysis (5 Whys, Fishbone, or FMEA as appropriate).
Define corrective and preventive actions with owners and due dates.
Track to completion; verify effectiveness after ≥ 30 days.
Feed themes and recurring root causes into continual improvement initiatives.

6. Inputs & Outputs

Inputs

Nonconformity report
Incident tickets
Audit findings
Client complaints

Outputs

CAPA record
Verified corrective actions
Improvement initiatives

7. Controls & Metrics

Metric	Target
CAPAs closed within committed date	≥ 90%
Recurring root causes	≤ 5%

8. Exceptions & Escalation

Regulatory-reportable nonconformities are reported per SOP-PV-Reg within statutory timelines.

9. Records & Retention

Record	Retention
CAPA records	10 years
Verification evidence	10 years

SOP-QMS-09
SOP-QMS-06 Risk
Incident Response Runbook

11. References

ISO 9001:2015 §10
CMMI-DEV CAR (Causal Analysis & Resolution)

12. Revision History

See the Versions tab for the full change history maintained by the Auto-Doc Engine.

Document code: SOP-QMS-10 · Aligned to ISO 9001:2015 §10. Controlled document — reproduction outside the UBC QMS requires the Quality Manager's approval.

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Frameworks

ISO 9001

CMMI-DEV