CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA)
Clean Slate Representative: Chris Beyer
Report Started: 2025-09-01
Report Completed: 2025-09-02
Name: James Smith
Phone: 123-456-7894
Email: james.smtih@email.com
1. Immediate Corrective Actions (Taken)
- Implement a Digital Maintenance Management System (CMMS): This system will automate scheduling, send reminders, and create a clear audit trail for all equipment maintenance.
- Assign a Dedicated Maintenance Coordinator: A single point of contact will be responsible for overseeing the CMMS, ensuring all maintenance is performed on schedule, and reporting on the status of all equipment.
- Establish a Bi-Weekly Maintenance Log Audit: The newly appointed coordinator will conduct regular audits to cross-reference the digital system with physical logs, ensuring consistency and accuracy.
- Revise SOPs for Environmental Controls: Update our Standard Operating Procedures (SOPs) to include daily checks of all environmental control systems (e.g., HVAC, dehumidifiers) in production and packaging areas.
2. Root Cause CAPAs & Preventive Measures
Corrective Actions
Action: Mandatory Quarantining of Affected Product
Responsible: Inventory Manager
Due Date: 2025-04-25
Verification: Physical audit of the quarantine vault by the Quality Assurance Manager, cross-referenced with the batch production log and B2B sales records.
Action: Expedited Product Retrieval & Destruction
Responsible: Logistics Coordinator
Due Date: 2025-04-25
Verification: Signed manifest from the destruction facility confirming receipt and destruction of the exact quantity of recalled product, matched with original sales records.
Action: Contingent SOP for Environmental Malfunctions
Responsible: Operations Supervisor
Due Date: 2025-04-25
Verification: Supervisor sign-off on a daily checklist confirming a physical inspection of all environmental controls, reviewed by the Operations Manager weekly.
Action: Forensic Investigation of Cultivation & Drying Rooms
Responsible: Quality Assurance Manager
Due Date: N/A
Verification: Completion and submission of a detailed forensic report, reviewed and signed off by the Director of Cultivation and the Quality Assurance Manager.
Preventive Measures
Action: Implementation of a Digital CMMS
Responsible: IT Manager
Due Date: 2025-05-01
Verification: Audit of the new system's logs to confirm all planned maintenance tasks are entered, scheduled, and completed as per the new SOPs.
Action: Designated Maintenance Coordinator Role
Responsible: Director of Operations
Due Date: N/A
Verification: A new job description and role within the organizational chart with clearly defined responsibilities for equipment maintenance and log auditing.
Action: Revise and Formalize SOPs for Environmental Controls
Responsible: Operations Manager
Due Date: N/A
Verification: Review and approval of the updated SOPs by the legal and compliance teams, followed by formal distribution to all relevant personnel.
Action: Employee Training & Certification
Responsible: HR Manager
Due Date: 2025-05-01
Verification: A record of all employee training completions and signed certificates, maintained by the HR department.