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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)

Differences Between Regulatory & Customer Driven Differences 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

Differences Between Regulatory & Customer Driven Differences 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

Differences Between Regulatory & Customer Driven Differences 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)

Differences Between Regulatory & Customer Driven Differences 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

Differences Between Regulatory & Customer Driven Differences 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 ComplianceEquipment

Y Y Y

GMP CompliancePest Control

Y Y Y

GMP ComplianceEmployee Practices

Y Y Y

Differences Between Regulatory & Customer Driven Differences 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 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

Differences Between Regulatory & Customer Driven Differences 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 – YTP - Y

Y Y

Differences Between Regulatory & Customer Driven Differences 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

Differences Between Regulatory & Customer Driven Differences 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

Differences Between Regulatory & Customer Driven Differences 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

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

Differences Between Regulatory & Customer Driven Differences 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