SOP-1200-01-AI_Development
Title: Development
Document ID: SOP-1200-01-AI
Effective Date: (Date to be inserted)
Supersedes: None
Owner: Development Department
Approved By: (Name/Signature/Date)
Objective
This Standard Operating Procedure (SOP) defines the process, responsibilities, and controls for designing, implementing, and testing system components during the Development phase of the AI-SDLC. The Development phase ensures all business and technical requirements are satisfied and ready for subsequent Testing, Validation, and Deployment.
Scope
- Applies to all AI-related software/product development activities, including prototypes, enhancements, patches, bug fixes, and major releases.
- Covers code and associated documents from the time detail designs are approved to the point where a final, production-ready build is handed over to Quality Assurance.
- Includes required compliance steps involving the AI-IRB Liaison if any changes or additions have regulatory or ethical implications.
Definitions
| Term | Definition |
|---|---|
| AI-IRB Liaison | The individual or committee representative responsible for overseeing compliance with AI risk management, alignment with ethical/regulatory standards, etc. |
| Implementation Unit (IU) | A distinct chunk of functionality, code, or script that can be developed, tested, and integrated independently, e.g., a class or module. |
| VOB | Versioned Object Base. Central source control repository that maintains versioned code, documentation, and other development artifacts. |
Roles and Responsibilities
| Role | Responsibility |
|---|---|
| Project Manager | Orchestrates project tasks, resource planning, timeline updates, and cross-team communication. |
| Development Team Leader | Oversees coding standards, assignment of Implementation Units (IUs), code review sessions, and ensures developer adherence to technical design. |
| Developer | Writes, integrates, and unit-tests code for assigned IUs, addresses assigned defects, and updates associated documentation in the VOB. |
| Quality Assurance (QA) | Reviews deliverables for compliance and completeness, performs acceptance of code prior to QA environment. Tests fixes for defects and ensures test coverage is achieved. |
| Operations | Prepares or reviews environment configurations, ensures successful builds for integration testing, and readies staging or production as needed. |
| AI-IRB Liaison | Conducts or coordinates AI risk assessment if new or changed AI-related functionality is introduced, providing sign-off or requiring additional compliance steps. |
| Product Group | Collaborates on design input, ensures final product meets business and user needs. |
References
- SOP-1040-01-AI (Requirements Definition)
- SOP-1041-01-AI (Detail Design)
- SOP-1210-01-AI (Quality Function & Testing)
- SOP-1003-01-AI (Configuration Management)
- AI-IRB (Ethical and regulatory compliance guidelines for AI-enabled functionality)
Procedure Activities
1. Commence Development
- Pre-Development Validation
- Once Detail Design (SOP-1041-01-AI) is approved by QA and relevant stakeholders, the Development Team Leader allocates Implementation Units (IUs) to each Developer.
- If new AI functionalities are introduced, the AI-IRB Liaison must be notified for possible additional compliance steps.
- Set Up VOB and Environment
- Operations or Configuration Management sets up a VOB branch or similar structure for the new development.
- Developers ensure local dev environments match project specs.
2. Coding and Documentation
- Follow Approved Technical Design
- Developers create or modify source code adhering to coding standards.
- Code changes must reference relevant requirements and design documents.
- If AI changes require updated data usage approach or model updates, the AI-IRB Liaison steps in for re-approval, if needed.
- Unit Testing
- Developers write and execute unit tests for each IU.
- If tests fail, code is revised and re-tested.
- If a showstopper or unforeseen AI compliance issue arises, the Developer escalates to the Development Team Leader or AI-IRB Liaison, as appropriate.
3. Code Review / Peer Walk-Through
- Walk-Through Preparations
- Development Team Leader schedules code review sessions weekly or per milestone.
- Code authors and relevant peers (including QA if needed) attend.
- Session Execution
- The code author presents logic, functionality, any new AI modules.
- Attendees note findings, ensure coding style and design compliance.
- The recording secretary compiles any discovered defects or improvement requests.
4. Build and Merge for Integration
- Build IU Code
- Developers produce compiled executables or scripts for the assigned IU.
- Merge into VOB
- With the Team Leader’s approval, code merges into the shared integration branch.
- The Developer rechecks merges for conflicts, ensuring no overwritten changes.
- Integration Smoke Test
- The Developer performs a quick smoke test in the integration environment.
- Defects discovered are either resolved immediately or recorded for triage.
5. QA Handover
- Documentation Update
- Developer updates IU documentation, verifying references to new or changed code.
- If AI models or code changes are included, relevant sections are documented in separate AI compliance notes.
- Integration Sign-Off
- Quality Assurance reviews integration test results.
- If results are acceptable, QA signals readiness for QA environment testing. Otherwise, code is returned for rework.
6. Post-Development Review
- Development Team Leader organizes final check to confirm readiness for formal QA testing (SOP-1210-01-AI).
- Project Manager updates the project plan if there’s scope or schedule deviation discovered.
- AI-IRB Liaison confirms final AI compliance sign-off if AI-related enhancements were introduced during development.
Acceptance Criteria
- All Implementation Units pass unit tests with recorded results, including AI compliance steps if relevant.
- Peer code reviews yield no critical design or compliance issues.
- Integration smoke test passes with no critical or blocking issues.
- Documentation is updated in the VOB or designated repository.
Records and Reports
- Unit Test results stored in the VOB or test management tool.
- Peer Review notes or logs compiled by the recording secretary.
- Integration test logs, including smoke test results.
- AI-IRB sign-off emails or forms if AI changes were introduced.
Change Management
- Any major re-scoping or additional AI compliance requirements discovered mid-development must follow SOP-1003-01-AI (Configuration Management) or relevant gating procedures.
Attachments/Appendices
None in this SOP version.
Revision History
| Version | Date | Changes | Approved By |
|---|---|---|---|
| 1.0 | (insert date) | Initial Release | Development Dept. |
End of SOP
@startuml
title SOP-1200-01 Development Sequence Diagram
actor PM as “Project Manager”
actor LDR as “DevTeamLeader”
actor DEV as “Developer”
actor QA as “Quality Assurance”
actor OPS as “Operations”
actor IRB as “AI-IRB Liaison”
actor PG as “Product Group”
PM -> LDR: Provide Approved Detail Design
note right
Commence Development
after final design sign-off
end note
LDR -> LDR: Plan Implementation Units (IUs)
LDR -> DEV: Assign IUs and Provide Code Standards
alt New AI Functionality Introduced?
LDR -> IRB: Notify AI-IRB for compliance check
IRB -> LDR: AI compliance guidance or approval
else No AI Changes
LDR -> LDR: Proceed without IRB involvement
end
OPS -> LDR: Confirm VOB branch & environment readiness
LDR -> DEV: Confirm Dev environment setup
DEV -> DEV: Code Implementation (following design specs)
DEV -> DEV: Execute Unit Tests
alt Unit Tests Pass?
DEV -> LDR: Unit test success, ready for peer review
else Unit Tests Fail
DEV -> DEV: Fix code and re-run unit tests
DEV -> LDR: Updated code with successful unit tests
end
LDR -> LDR: Schedule Code Walk-Through
LDR -> DEV: Present code in weekly walk-through
LDR -> LDR: Document review findings
DEV -> DEV: Update code per walk-through findings
DEV -> DEV: Build IU Code (executable)
DEV -> LDR: Request Merge to Integration Branch
LDR -> LDR: Approve code merging
DEV -> OPS: Merge to shared VOB branch
DEV -> DEV: Perform integration smoke test
alt Smoke Test Pass?
DEV -> QA: Notify readiness for QA environment
else Smoke Test Fail
DEV -> DEV: Fix integration issues
DEV -> LDR: Request additional check
DEV -> QA: Ready for QA after fix
end
QA -> DEV: Review final integration build
alt Accept or Return?
QA -> QA: If accepted, proceed
QA -> DEV: If not, rework needed
end
DEV -> DEV: Update Documentation
alt AI-IRB Impact Re-check?
DEV -> IRB: Provide final AI changes doc
IRB -> DEV: AI re-approval or no changes
else No AI Re-check needed
note over DEV
Standard process continues
end note
end
LDR -> PM: Final readiness for QA Testing
PM -> LDR: Adjust schedule/resources if needed
@enduml
Short textual explanation:
This sequence diagram shows the SOP-1200-01 Development process. The Project Manager hands off approved detail designs to the DevTeamLeader, who partitions tasks into Implementation Units. If new AI functionality is present, the AI-IRB Liaison reviews compliance aspects. Developers code, perform unit tests, and fix issues before merging to the integration branch. A smoke test checks basic integration readiness. After acceptance, Quality Assurance validates the final integration build. Documentation is updated, and any final AI re-check is done before the DevTeamLeader signals readiness for formal QA testing. The Project Manager may update schedules if needed.