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SOP-QMS-08 — Operational Planning & Control

Defines how UBC plans, executes, and controls operational processes to meet service and regulatory requirements (ISO 9001 §8).

Owner: Operations DirectorApprover: Quality DirectorVersion: 3.5Updated: 11/22/1969

1. Purpose

Establish the requirements for planning, executing, and controlling the operational processes that deliver UBC services.

2. Scope

All operational processes across Hub Services, AI Platform, Pharmacovigilance, and Platform Engineering.

3. Definitions

  • Service requirement — A documented client, regulatory, statutory, or organizational need the service must satisfy.
  • Control — A means of managing a risk or ensuring a requirement is met.

4. Roles & Responsibilities (RACI)

ActivityRACICadence
Capture service requirementsProduct OwnerOperations DirectorClient, LegalDelivery teamPer engagement
Plan operational controlsProcess ownerOperations DirectorGRC, SecurityDelivery teamPer engagement
Monitor operational performanceProcess ownerOperations DirectorQualityQuality CouncilContinuous

5. Procedure

  1. For each new service or major change, document requirements, acceptance criteria, and applicable controls.
  2. Confirm resources, roles, tools, and information needed to deliver the service.
  3. Establish operational metrics and thresholds; wire them into the observability stack.
  4. Perform planned changes under SOP-SDLC-06 (Change & Configuration Management).
  5. Manage outsourced processes via SOP-PM-08 (Vendor Management).
  6. Review operational performance monthly with process owners and quarterly at Management Review.

6. Inputs & Outputs

Inputs

  • Client contracts
  • Regulatory requirements
  • Risk register
  • Prior audit findings

Outputs

  • Service delivery plans
  • Operational dashboards
  • Change records

7. Controls & Metrics

MetricTarget
SLA attainment≥ 99%
Unapproved production changes0

8. Exceptions & Escalation

  • Emergency changes follow the Emergency Change subsection of SOP-SDLC-06.

9. Records & Retention

RecordRetention
Service delivery plansLife of service + 7 years
Change records7 years
Operational KPIs7 years

10. Related Documents

  • SOP-SDLC-06
  • SOP-PM-08
  • Access Control Policy

11. References

  • ISO 9001:2015 §8
  • CMMI-DEV v2.0 PP, PMC
  • SOC 2 CC7.x

12. Revision History

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

Document code: SOP-QMS-08 · Aligned to ISO 9001:2015 §8. Controlled document — reproduction outside the UBC QMS requires the Quality Manager's approval.

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Frameworks
ISO 9001
CMMI-DEV
SOC 2