Documentation
Documentation, SOP
Objective
Develop comprehensive Standard Operating Procedures (SOPs) for cosmetic manufacturing companies. Ensure regulatory compliance, operational consistency, maintenance standards, and quality assurance across departments.
Cosmetic manufacturing facilities require rigorous documentation systems to meet cGMP, ISO 22716, and FDA regulations. I've designed systems that ensure employees are trained well and warehouse functions can be replicated without fear of changes in staffing or location.
What I deliver
1. Regulatory Compliance Framework
2. Warehouse Operations Documentation
3. Quality Control Laboratory Procedures
4. Safety & Training Documentation
5. Process Control & Documentation Systems
6. Validation & Verification Protocols
Process
Research:Conduct thorough assessments of any existing documentation systems, analyze regulatory requirements across multiple jurisdictions.
Framework Development:Create standardized SOP templates, document hierarchies, review cycles, and user-friendly formats for implementation.
Content Creation & Documentation:Write detailed step-by-step procedures for all critical operations, including visual aids, forms, and monitoring criteria .
Review & Validation:Conduct technical reviews with subject matter experts, test procedures through user feedback and dry runs.
Implementation & Training:Deploy SOPs company-wide, including training programs for personnel and systems for continuous improvement/revision management.
Results
A comprehensive SOP documentation system ensures full regulatory compliance across all manufacturing operations. Companies I've done this for report successful regulatory audits with zero critical findings, improved operational consistency and reduced training time for new employees.
Conclusion
Documentation is an overlooked resource that a lot of companies don't put the time in to get right. They'll rely on "tribal knowledge" to get a project done and then will be on the hook if something happens to a staff member integral to the process.
I started out my career writing these SOPs for startups and I still write them. During COVID, I created a guide for SOP emergency protocols that was downloaded hundreds of times under the (now defunct) website, Routinelines.com.
Please reach out for a free template SOP, or if there's something you would like to create!