Regulatory audits enforce food safety regulations and ensure compliance, while customer-driven audits are conducted by third parties to meet customer requirements. Regulatory audits require more documentation and adherence to preventive controls, HACCP, SSOP, and GMP regulations. Customer audits also require documentation of food safety programs but may not require all the same preventive controls and hazard analyses as regulatory audits. Food companies will need both types of audits to comply with regulations and meet customer food safety standards.

1. Differences Between RegulatoryDifferences Between Regulatory
& Customer Driven Audits& Customer Driven Audits
forfor
Preventive Controls for HumanPreventive Controls for Human
FoodsFoods
ByBy
Mas HoriMas Hori
Retired CA DHS Food & Drug BranchRetired CA DHS Food & Drug Branch

2. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
• Regulatory
– Federal
• United States Food & Drug Administration (USFDA)
• United States Department of Agriculture (USDA)
– State
• California Department of Health Services Food & Drug
Branch (CA FDB)
• California Department of Food & Agriculture (CDFA)
– Local
• County Health Departments (LA, Orange, SB, Riverside, SD,
Ventura, Vernon, Pasadena, Long Beach)

3. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
• Regulatory enforces:
– Federal
• Preventive Controls for Human Foods (CFR 21 Part 117)
• Seafood Products HACCP (CFR 21 Part 123)
• Fresh Juices HACCP (CFR 21 Part 120)
• Meat Product HACCP (CFR Tittle 9 Part 417.4)
• Sanitation (Meat) (CFR Title 9 Part 416)
– State
• California Sherman Food, Drug & Cosmetic Law (CA H&S)
• California Food & Agriculture Code (CA F&A)
– Local
• County or City Ordinances
– Cannot enforce the federal GMPs

4. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
• Regulatory enforces:
– Federal
• HACCP (Hazard Analysis Critical Control Point)
– Seafood Products (FDA)
– Meat Processors (USDA)
– Fresh Juice Processors (FDA)
• SSOP (Sanitation Standard Operating Procedures)
• Preventive Controls for Human Foods for All foods not seafood,
fresh juice or meat products
– State
• HACCP
– Seafood Products
– Fresh Juice Processors
• SSOP
• Preventive Controls for Human Foods
– Local
• HACCP
– Retail establishments only

5. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
• Customer Driven Audits (Third Party Audits)
– Various Contracted Companies that are hired by the customer
• NFPA (National Food Processors)
• Cook and Thurber
• Siliker Labs
• AIB (American Institute of Baking)
• Steritech
• Other private consultants
– Vendors
• Company Quality Assurance Auditors (ie. Marriot Group, Trader Joe’s)

6. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
• Third Party Auditors audit for firms now:
– Foods Safety Program
• GMPs
– Operational Conditions
– Facility Conditions
– Pest Control
• HACCP
• SSOPs
• Food Security
• Standard Operating Procedures (SOPs)
• Recall

7. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
Activity Record
Needed
Regulatory
Required
Customer
Required
Training Y Y Y
GMP Compliance
Facility Construction
Y Y Y
GMP Compliance
Equipment
Y Y Y
GMP Compliance
Pest Control
Y Y Y
GMP Compliance
Employee Practices
Y Y Y

8. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
Activity Record
Needed
Regulatory
Required
Customer
Required
GMP Compliance
Sanitary Facilities
Y Y Y
GMP Compliance
Manufacturing
Practices
Y Y Y
GMP Compliance
Warehousing
Y Y Y
Food Security Y Y Y
Quality Control Y Y Y

9. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
Activity Record
Needed
Regulatory
Required
Customer
Required
HACCP Y Y Y
SSOP Monitoring Y Y Y
Written SSOP Y Y Y
SOPs Reg – Y
TP - Y
Y Y

10. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
Activity Record
Needed
Regulatory
Required
Customer Required
Hazard Analysis for All Food
Products if preventive control
found the following is needed
through the Hazard Analysis
Y Y Y/N?
Preventive Controls for Process, if
needed
Y Y Y
Preventive Controls for Allergens,
if needed
Y Y Y
Preventive Controls for Sanitation,
if needed
Y Y Y
Preventive Controls for Supply
Chain, if needed
Y Y Y

11. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
Activity Record
Needed
Regulatory
Required
Customer
Required
Written Product
Description
Y Y Y/N?
Written Product Flow
Description and
Verification
Y Y Y/N?
Written Process
Narrative
Y Y Y/N?
Process Preventive
Controls, if needed
Y Y Y

12. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
Activity Record
Needed
Regulatory
Required
Customer
Required
Allergen Preventive
Controls, if needed
Y Y Y/N?
Sanitation Preventive
Controls, if needed
Y Y Y/N?
Supply Chain
Preventive Controls, if
Needed
Y Y Y/N?
Verification and
Validation Controls, if
needed
Y Y Y

13. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods

14. Differences Between Regulatory & Customer DrivenDifferences Between Regulatory & Customer Driven
Audits for Preventive Controls for Human FoodsAudits for Preventive Controls for Human Foods
• Summary
– Regulatory
• Alot More documentation required
– Third Party Audits
• More on documentation of SOPs and records
supporting the SOP when the Third Party Audits
starts the Preventive Controls for Human Foods
regulation later next year
– Food firms with Seafood and Non Seafood
products will need both programs in place for
FDA, that will be the same for Fresh Juice
firms