Internal & External Audit:
Auditing performed internally or at the raw
materials supplier sites. The audit provides a benchmark baseline and
determines FDA, USDA or USDC/NMFS compliance, and level of control in the
operations. The areas of audit include:
Federal Documentation, Good Manufacturing Practices, Sanitation Program, Hazard
Analysis and Critical Control Point, Process Flow and Control, Quality Costs
Systems, Incoming Inspection, Quality Management Programs, Vendor Certification
Systems, Metrology, Laboratory Operations, Systems, Process and Products
overview, and Record Keeping.
Co-Packer Auditing and Process Monitoring:
Based on the initial audit findings, an audit
schedule is set up to monitor the co-packer’s operations on an ongoing basis.
Programs are proposed to develop the areas shown to be deficient or needing
improvement. Development includes design and implementation of product processing
and packaging specifications, parameters for internal auditing of quality and
production operations, daily inspection programs to ensure compliance to FDA or
USDA guidelines. Setup of methods for reporting implementation of quality
systems, critical processing and finished product data.