As we all know, the devil is in the details. Are you going to create numerous new and complex policies, plans, procedures and check sheets for compliance or are you going to streamline your approach to compliance with added data analysis abilities to constantly improve your programs. As you read through the basic summary of changes relative to Preventive Measures for Human Foods below, think about the number of redundant data bases and processes you have or will have to manage compliance.
What if your specifications could directly drive your CoA compliance? Product Quality Assurance? Ingredient Hazard Identification and Supply Chain Risk Assessment? Compliance to the need for your customer to understand what hazards may be present in ingredients? Document and verify that your customers do have preventive measure in place for any Hazards communicated to them? Directly cross reference customer complaints to specifications and Hazard Analysis Data Bases.
While we do need to be careful when developing programs for FSMA Compliance as they relate directly to Food Safety, Quality compliance would be is necessary to assure that the ” Safe” products that are manufactured meets the customers quality expectations. Some may question why I would even mention quality within the context of food safety, the reason is that many Quality Systems have overlapping data bases which can be leveraged to streamline operations with the correct data types identified.
For fun, I threw in some of the other FSMA regulations that are coming to illustrate how different new regulation need to work together to assure overall food safety.
The FDA’s Food Safety Modernization Act”s Preventive Measures for Human Foods is one of several new regulations to be released for compliance this year. The final rule was released on September 10, 2015. For Major Manufacturing companies, compliance is expected in one year. Affects facilities that manufacture, process, pack or hold human foods.
1.Smaller companies will have more time based upon size.
2.Applies to companies registered with the FDA.
3.Applies to both Imported and Domestic Food. (in conjunction with Foreign Supplier Verification)
4.Does not apply to Farms or Retail Food Establishments (these entities are covered in conjunction with Produce Safety Rule and FDA Food Code. )
5.Prevention of allergen cross contamination mandated.
6.Food Safety Education and Training is mandated.
7.Hazard Analysis, Monitoring Procedures, Preventive Measures, Corrective Action Procedures, and Verification Procedures are mandated.
Ingredients and unintentional/intentional adulteration are included in Hazard Analysis.
Evaluation of environmental pathogens for ready to eat foods included in Hazard Analysis.
Calibration, Process Control and Sanitation Control Procedures documented and verified.
8.Recall Plan is mandated.
9.Risk Based Supply Chain program mandated.
Approved Supplier Verification – audits/material testing (in conjunction with Third Party Verification Rule)
Communication to customer of hazards and verification the customer has preventive measures.
In conjunction with Sanitary Transportation Rule. (need to assure food safety during transit)