Control of Production and Service Provision
ISO 9001:2015 – Section 8.5.1
Our consultancy approach ensures that organizations implement strict controls over production and service provision. This guarantees that all processes are carried out under planned conditions, ensuring conformity of outputs with requirements while maintaining consistency, traceability, and reliability.
Scope of Work
1. Planning and Documentation
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• Define documented work instructions and standard operating procedures.
• Ensure availability of drawings, specifications, monitoring equipment, and acceptance criteria.
• Plan production/service activities with defined process parameters.
2. Provision of Resources
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• Ensure required equipment, facilities, and calibrated measurement tools are available.
• Verify that infrastructure and environment for operation are suitable.
• Provide adequate human resources with demonstrated competencies.
3. Process Control and Monitoring
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• Implement in-process monitoring, inspection, and testing activities.
• Maintain records of conformity and verification activities.
• Apply mistake-proofing methods (where feasible) to minimize human error.
4. Identification and Traceability
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• Identify product/service status throughout the operation.
• Use labels, batch numbers, or system-based tracking mechanisms.
• Ensure traceability when required by standards, regulation, or customer requirements.
5. Output Preservation and Handling
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• Apply proper handling, packaging, and storage to prevent damage or deterioration.
• Establish procedures for safe transportation and delivery.
• Implement post-delivery activities when required by customer agreements.
Deliverables
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• Documented production/service control procedures.
• Resource allocation and monitoring checklists.
• Competency verification and training records.
• Product/service traceability registers.
• Preservation and handling instructions.
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 |
|---|---|---|
| Production & Service Control Package | Comprehensive framework for documenting and monitoring production/service provision. | $2,200/system |
| Traceability & Identification Toolkit | Templates and tools for product/service identification and status tracking. | $1,600/system |
| Process Monitoring & Inspection Kit | Checklists and records for in-process verification and acceptance criteria. | $1,450/project |
| Preservation & Handling Protocols | Structured procedures for storage, packaging, and delivery requirements. | $1,250/project |
