ByHeart, I have a few Questions

Say, food safety people, what questions do you have?

• Food safety plan/HACCP plan for each manufacturing facility
  • Processing flow diagram – role and processes of all manufacturing plants under control of ByHeart
  • Employee qualified training records
  • Food safety plan audits
  • Food Safety Plan Implementation records
  • Food Safety Plan Reanalysis Documentation
  • Process Preventive controls
  • Allergen Preventive Controls
  • Sanitation Preventive Controls
  • Supply-Chain Preventive Controls
  • Supply Chain Preventive Controls Program (See below)
  • Recall Plan
  • Monitoring and corrective actions records
  • Process validation records
  • Verification methods and records
    • Calibration of instruments
    • Product testing 
    • Environmental monitoring
• Good Manufacturing Program (GMP) Prerequisite program
  • Employee Training records
• Supply Chain Preventive Controls/Supply Chain Program 
  • Disclosure Documents (from Suppliers) – When a receiving facility (manufacturer/processor) identifies a hazard requiring a preventive control (C. botulinum spores), does not control the identified hazard (pasteurization ineffective at inactivating spores) and relies on an entity in its distribution chain to address the hazard, they much disclose information to their customers about foods that need control downstream to manage the identified hazard (C. botulinum spores)
  • Supplier approval documentation
    • Supplier performance
      • Supplier’s food safety practices related to the safety of the raw material and other ingredients (Suppliers Food Safety Plan)
        • Process Preventive control records, pathogen environmental monitoring, sanitation and allergen preventive control records
      • Supplier’s compliance with regulatory requirements (e. g. warning letters, recalls, inspection results)
      • Supplier’s food safety history relevant to the raw material or other ingredients form that supplier including (supplier’s ingredient test results for hazard, suppliers third-party audit results)
    • Supplier Storage and transportation practices
    • Appropriate Supplier Verification Activities
      • Documentation of audits, Sampling and testing of the raw material or ingredients
        • Supplier name and location; audit procedures, audit dates, audit conclusions, corrective actions, documentation that the audit was conducted by a qualified auditor
        • Identification of the raw material or other ingredients including lot number, and number of samples tested; tests conducted and method used; date and test conducted and date of the report; results of the tests; corrective actions; name of laboratory conducting the tests. 
      • Review of Supplier’s relevant food safety records (pasteurization)
        • Name of the supplier, date of review, nature of the records reviewed, conclusions, corrective actions taken
      • Other appropriate supplier verification activities base don the risk associated with the ingredient and the supplier
  • Written procedures for receiving raw ingredients or other ingredients
  • Receiving records
  • Documentation of other supplier verification activities
  • Pasteurization records 
  • Certificate of analysis for all ingredients
• Environmental monitoring program records
• Finished product testing results
  • Results of Cronobacter and Salmonella testing
• Records from control release program
• Diverted product records
• Traceability records
• Nutrient Testing records
  • Testing records for all four points in the production process
  • Each nutrient premix, testing no later than the final product stage, before distribution for an indicator nutrient from each nutrient premix; testing at final product stage for vitamin A, C, E and thiamin and at the final product stage, testing for all required nutrients and all nutrients added by the manufacturer for which the manufacturer has not previously tested the production aggregate
• Stability Testing Records
• Level of nutrients present throughout the shelf life of the product
• Shelf life as determined by stability testing records

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.