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Change Control

This document provides a change control template for deploying oxo-flow in regulated environments such as clinical laboratories, CLIA-certified labs, and facilities operating under ISO 15189 or CAP accreditation.

Purpose

To ensure that all changes to the oxo-flow pipeline system are documented, reviewed, assessed for risk, and approved before implementation in a production environment.

Scope

This change control process applies to:

  • Updates to the oxo-flow software version
  • Modifications to workflow definitions (.oxoflow files)
  • Changes to reference data (genomes, annotations, databases)
  • Changes to environment specifications (containers, conda envs)
  • Infrastructure changes (hardware, OS, cluster configuration)

Change Control Record

Change Information

Field Value
Change ID CC-YYYY-NNN
Date requested
Requested by
Change description
Reason for change
Affected systems
Priority Routine / Urgent / Emergency

Risk Assessment

Risk Factor Assessment
Patient impact None / Low / Medium / High
Data integrity risk None / Low / Medium / High
System downtime required Yes / No
Rollback complexity Simple / Moderate / Complex
Regulatory impact None / Notification / Re-validation

Impact Analysis

  • Affected workflows: List all pipelines and rules impacted by this change.
  • Affected outputs: Describe how results may differ.
  • Validation required: Specify whether IQ/OQ/PQ re-validation is needed (see VALIDATION_PROTOCOL.md).
  • Training required: Identify any user training needs.

Approval

Role Name Signature Date
Requester
Technical reviewer
Quality manager
Laboratory director

Implementation Plan

  1. Pre-implementation

    • Back up current configuration and workflow files
    • Document current software versions and checksums
    • Notify affected users

  2. Implementation

    • Apply the change in a staging environment
    • Run validation tests (see VALIDATION_PROTOCOL.md)
    • Compare outputs against expected results
    • Document any deviations

  3. Post-implementation

    • Verify the change in the production environment
    • Update documentation and SOPs
    • Archive the change control record
    • Monitor for unexpected behavior

Verification

Test Expected Result Actual Result Pass/Fail

Rollback Plan

Describe the steps to revert this change if issues are discovered:

  1. Restore previous oxo-flow version / workflow files from backup
  2. Verify rollback by running validation tests
  3. Notify affected users
  4. Document the rollback and initiate a new change request if needed

This template is provided as a starting point. Adapt it to your organization's quality management system and regulatory requirements.