Design and Development Planning
ISO 9001:2015 – Section 8.3.2
Our consultancy ensures that organizations plan and control design and development in a structured manner. This includes determining stages, responsibilities, and resources to ensure outputs meet requirements for subsequent processes and effective delivery.
Scope of Work
1. Design Stages and Milestones
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• Define design phases from concept to release.
• Establish review, verification, and validation checkpoints.
• Document approval mechanisms at each stage.
2. Responsibilities and Authorities
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• Assign clear roles for design, review, and approval.
• Define escalation paths for design-related issues.
• Ensure top management oversight and accountability.
3. Resource and Competence Planning
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• Identify required resources, tools, and technologies.
• Plan for competent personnel and training needs.
• Ensure external providers are integrated into planning where applicable.
4. Interfaces and Communication
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• Define how different functions (design, production, quality, customer service) interact.
• Establish channels for stakeholder input and feedback.
• Document communication flows within the design process.
Deliverables
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• Documented design and development plan.
• Responsibility matrix for design and review activities.
• Resource allocation and competence assurance plan.
• Defined process map for interfaces and communication.
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 Planning Workshop | Interactive facilitation to map out design stages, responsibilities, and resource requirements. | $1,400/session |
| Competency & Resource Mapping Package | Structured plan to ensure skilled resources and adequate tools for design. | $1,250/project |
| Design Interface and Communication Toolkit | Templates and guidance for managing cross-functional design communication. | $1,050/project |
| Ongoing Planning Advisory | Continuous support in monitoring and updating design planning processes. | Starting at $130/month |
