Design and Development Changes
ISO 9001:2015 – Section 8.3.6
Our consultancy approach ensures that all design and development changes are systematically controlled, reviewed, and documented. This guarantees that modifications do not introduce new risks, compromise compliance, or negatively impact customer satisfaction.
Scope of Work
1. Change Identification and Documentation
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• Establish processes for formally identifying proposed design changes.
• Record reasons, scope, and expected impacts of each change.
• Maintain version control to ensure traceability of revisions.
2. Change Evaluation
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• Assess the effect of changes on customer requirements, regulatory compliance, and product/service performance.
• Evaluate risks and opportunities introduced by the change.
• Determine if re-validation or re-testing is required.
3. Approval and Authorization
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• Define roles and responsibilities for authorizing changes.
• Secure approval from relevant stakeholders before implementation.
• Ensure decisions are documented with accountability.
4. Implementation and Communication
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• Update design documents, records, and outputs accordingly.
• Communicate changes to production, operations, and affected parties.
• Provide training or awareness sessions if needed.
5. Monitoring and Verification
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• Track implementation of design changes for effectiveness.
• Conduct reviews to confirm conformity after modifications.
• Maintain evidence of monitoring, verification, and compliance.
Deliverables
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• Documented design change requests and records.
• Change impact assessment reports.
• Authorized approval forms and logs.
• Updated and version-controlled documentation.
• Verification records demonstrating compliance after change.
Pricing & Timeline
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• Fee: $3,150.00/month per facility (6-month engagement)
• Estimated Duration: 180 business days
Completion timeline may vary based on client responsiveness and documentation turnaround.
Sample Milestone Plan
| Phase | Key Activities | Core Deliverables |
|---|---|---|
| Month 1 – Planning | Kick-off, scope definition, project charter |
✓ Implementation Plan ✓ Scope Statement & Team Roles |
| Months 1–2 – Design | FSMS drafting, PRP setup, document control systems |
✓ SOPs, PRPs ✓ Controlled Document Framework |
| Months 2–3 – Execution | Competency training, system rollout, records logging |
✓ Training Logs ✓ First Cycle Recordkeeping Evidence |
| Months 3–6 – Validation | Internal audits, reviews, performance monitoring |
✓ Internal Audit Reports ✓ CAPA Logs ✓ Management Review |
| Month 6 – Readiness | Final system check, CB coordination, mock audit |
✓ Pre-Audit Summary ✓ Final CAPA Log ✓ Audit-Day Prep |
Certification Audit Support
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• On-site or remote audit-day presence
• Real-time response to auditor inquiries
• Post-audit support and non-conformance response drafting
Deliverables:
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✓ Audit Representation
✓ NC Response Support
✓ Audit Day Documentation
Project Closure
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• Final FSMS documentation handover
• Executive summary outlining system status and sustainability plan
• Option to transition into maintenance & continuous improvement support
Deliverables:
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✓ Final Document Handover
✓ Close-Out Report
✓ Maintenance Plan Proposal
Additional Compliance Support Options
| Service | Description | Fee |
|---|---|---|
| Design Change Request (DCR) Package | Standardized templates for initiating and documenting changes. | $1,200/project |
| Change Impact Assessment Toolkit | Structured evaluation tools for risks, opportunities, and compliance effects. | $1,400/system |
| Authorization & Approval Workflow | Configurable workflows for efficient approval and sign-off. | $1,100/project |
| Version Control & Documentation Update Service | Cloud-enabled system for managing controlled updates and revisions. | Starting at $99/month |
