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Differences Between Regulatory Differences Between Regulatory & Customer Driven Audits & Customer Driven Audits

for for Preventive Controls for Human Preventive Controls for Human

FoodsFoods

ByByMas HoriMas Hori

Retired CA DHS Food & Drug BranchRetired CA DHS Food & Drug Branch

Differences Between Regulatory & Customer Driven Differences 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)


• 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


• 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


• 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)


• 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


Activity Record Needed

Regulatory Required

Customer Required

Training Y Y Y

GMP Compliance Facility Construction

Y Y Y

GMP ComplianceEquipment

Y Y Y

GMP CompliancePest Control

Y Y Y

GMP ComplianceEmployee Practices

Y Y Y



Regulatory Required

Customer Required

GMP ComplianceSanitary Facilities

Y Y Y

GMP Compliance Manufacturing Practices

Y Y Y

GMP ComplianceWarehousing

Y Y Y

Food Security Y Y Y

Quality Control Y Y Y



Regulatory Required

Customer Required

HACCP Y Y Y

SSOP Monitoring Y Y Y

Written SSOP Y Y Y

SOPs Reg – YTP - Y

Y Y



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



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



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


• 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

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