Presented by: Commercial Food Sanitation, LLC MOM Brands Heinz McCain Foods Limited General Mills, Inc. Nestle USA & Canada Kraft Foods Ocean Spray Cranberries, Inc. Kellogg Company Quaker (PepsiCo) Equipment & Plant Design For Allergen/Pathogen Control in Low Moisture Foods
Charles M Moder, Environmental Hygiene Controls Manager, MOM Brands
Part 7: Hygienic Zoning Controls in a
Low-moisture Food Plant
Sanitary design is integral to food safety.
Hygienic Zoning Controls in a Low-Moisture Food Plant: Agenda
• Why Hygienic Zoning?
• Concepts of Hygienic Zoning • Acceptance of Hygienic Zoning implementation • Q&A
Sanitary design is integral to food safety.
Why Hygienic Zoning? •Fact or fiction:
•Studies prove raw flours and grains
contain low levels of Salmonella
Sanitary design is integral to food safety.
Why Hygienic Zoning? Many Raw Ingredients Have No Heat Step Prior to Receipt
FACT: Studies prove raw flours and grains contain low levels of Salmonella. Sanitary design is integral to food safety. Why Hygienic Zoning? In addition to raw grains and flours, there are other sources that may potentially be contaminated
• Dust (airborne) • Floor sweepings from facility cleaning or maintenance / construction activities
Sanitary design is integral to food safety.
6 Why Hygienic Zoning? In addition to raw grains and flours, there are other sources that may potentially be contaminated
• Exterior materials from the
outside including dirt, airborne dust, water, filth, animals and insects.
Sanitary design is integral to food safety.
7 Why Hygienic Zoning? In addition to raw grains and flours, there are other sources that may potentially be contaminated
• Floor drains • Air flow
Sanitary design is integral to food safety.
8 Why Hygienic Zoning? •Fact or fiction:
•Product recalls have been attributed to
water leaks
Sanitary design is integral to food safety.
Why Hygienic Zoning? In addition to raw grains and flours, there are other sources that may potentially be contaminated
• Water leaks
• Construction debris / floor sweepings
FACT: Food borne illness outbreaks in the food industry have been caused by poorly controlled contamination sources which spread from construction activity or building leaks to the product stream. Sanitary design is integral to food safety. 10 Concepts of Hygienic Zoning
•Objective: Prevent transfer of potentially
contaminated materials associated with risk to food product safety
• Conduct hazard analysis
• Determine boundaries for control / Barriers to sources of contamination • Hygienic Zones different from Product Zones • Establish physical controls • Establish procedural controls
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Conduct Hazard Analysis – Identify Risks (FMEA Potential Failure Modes and Potential Failure Effects)
• Location, line, process step
• Potential contamination type • Origin of potential contamination • Possible Transfer method(s) • Areas that may be affected • Product stream affected • Risk score Failure Mode Potential Contamination Type Areas that may (raw grain dust, Transfer Method Product Stream Origin of Potential Potentially become nonsanitary dust, (airborne, Potentially at Risk Contamination and Contaminated contaminated humans, waterborne, (location, description, How it Occurs (room, hallway, contaminated footwear, post cook, post kill, (specific equipment, portion of room, equipment, hands/arms, etc.) environmental site, equipment, etc.) contaminated materials, clothing, (in order of most at humans, etc.) (in order of most at wet equipment, wet equipment, etc.) risk to least at risk) risk to least at risk) facilities, outside water, etc.)
• Current controls • Potential additional controls • Responsibility for implementing additional controls
• Reassess, recalculate RPN with additional
controls
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Barriers to Sources of Contamination
• Barriers to outside sources
• Pest control • Security • Physical barrier to water • Physical barrier to air • Physical barrier to other materials
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Barriers to Sources of Contamination
• Barriers to potentially contaminated materials
brought in • Pallets: wooden, plastic • New manufacturing equipment: hygienic condition • Other equipment: hygienic condition • Construction materials: contain • People: captive footwear, uniforms, visitor smocks & shoe covers • Ingredients: sourcing Sanitary design is integral to food safety. Concepts of Hygienic Zoning: Boundaries for Control - Employee Entrance
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Boundaries for Control - Employee Entrance
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Boundaries for Control - Employee Entrance
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Hygienic Zones Within the Plant
• Barriers to contamination by materials, people, and equipment
• GMP Support Zones: employee welfare areas, offices,
maintenance shop, inner docks • GMP Zones - High Sensitivity GMP Zone: exposed to High Sensitivity Materials (HSMs) - General GMP Zone - High Hygiene GMP Zone: protect post kill product • Hygienic Zones are different from Product Zones
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Hygienic Zones Within the Plant
High General High
Sensitivity GMP GMP Hygiene GMP Zones Zones Zones
Some form of decontaminating: Hands, feet, clothing, materials & Keep Keep equipment contaminants contaminants from getting into from leaving here here
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Control of Contaminants
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Stressed in the past; Now more frequent
Additional protocols when moving between hygienic
zones: Does everyone understand what, how and why?
HANDS AND FEET: CLOTHING & PPE: EQUIPMENT:
FOREARMS: Dedicated shoes, Protection, Decontamination Sinks or sani shoe protection or dedicated uniform, for tools and wipes decontamination bump cap equipment decontamination Sanitary design is integral to food safety. Concepts of Hygienic Zoning: Hygienic Zone Map of Plant
Non GMP Zone
Non GMP Zone
High Hygiene Zone
General GMP Zone
Non GMP Zone
GMP Support GMP Zone High Sensitivity Support Zone Zone
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers Between Hygienic Zones
• GMP Support Zone into General GMP Zone
• Handwashing
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers Between Hygienic Zones
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers Between Hygienic Zones
• GMP Support Zone into General GMP Zone
• Handwashing • Footwear sanitation
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers Between Hygienic Zones
Sanitizer Spray Unit for Footwear
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers Between Hygienic Zones
• GMP Support Zone into General GMP Zone
• Footwear sanitation • Handwashing • Hairnet/beardnet • Safety items: glasses, hearing protection, bump cap • GMP policies for jewelry, no eating, etc
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers between Hygienic Zones
• High Sensitivity Zones: Contain high sensitivity
materials • Walls and doors • Limited access • Air balancing • HSM adverse event prevention/response • Hygienic Entrance Area (HEA) – for people • Hygienic Transfer Area (HTA) – for materials and equipment
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers between Hygienic Zones
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Example of Hygienic Entry Area Layout
Hand Supplies Vac Brown Smocks
Shoe wash Brush Sanitize sink Box
Mirror Bench Blue Smocks Mirror
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: HEA Procedure – Entering High Sensitivity Zone
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: HEA Procedure – Exiting High Sensitivity Zone
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers between Hygienic Zones
Vacuum Inspection Brush for Mirrors Uniform
Vacuum Brush Box
for Footwear Sanitary design is integral to food safety. Concepts of Hygienic Zoning: Physical & Procedural Barriers between Hygienic Zones
• Protect High Hygiene Zones to reduce
contamination risk • Walls and doors • Limited access • Air balancing • Hygienic Entry Area (HEA) • Hygienic Transition Area (HTA)
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Physical & Procedural Barriers between Hygienic Zones
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: HEA Procedure – Entering High Hygiene Zone
•“I have to wash my hands and spray my shoes
again?!?”
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Hygienic Transition Area Procedure – into High Sensitivity Zone
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Hygienic Transfer Area Procedure – into High Sensitivity Zone
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Hygienic Transfer Area Procedure – out of High Sensitivity Zone
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Hygienic Transition Zone (HTA) – Non GMP to GMP Support
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Hygienic Transition Area Procedure – into High Hygiene Zone
Sanitary design is integral to food safety.
Concepts of Hygienic Zoning: Not totally embraced by everyone!
Sanitary design is integral to food safety.
Acceptance of Hygienic Zoning Implementation:
•Fact or fiction:
•“…low numbers of Salmonella are not a
problem in low-moisture foods because these products do not support Salmonella growth.”
Sanitary design is integral to food safety.
Acceptance of Hygienic Zoning Implementation: Common misconception regarding low moisture foods…
• Fiction: “…low numbers of Salmonella are not a
problem in low-moisture foods because these products do not support Salmonella growth.” • Reality: “…low numbers of Salmonella in foods can cause illness, and the presence of the organism in low- moisture ready-to-eat foods must be prevented.” • GMA guidance document Control of Salmonella in Low-moisture Foods • Outlines elements needed to control Salmonella • Prepared by GMA and several manufacturing reps (Kellogg, General Mills) • Available at http://www.gmaonline.org/downloads/technical-guidance-and- tools/SalmonellaControlGuidance.pdf • Reprinted in Food Protection Trends
Sanitary design is integral to food safety.
Acceptance of Hygienic Zoning Implementation: Low Occurrence, High Severity
•Using Hygienic Zoning to prevent Bacterial
Contamination is similar to using Explosion Vents to prevent Explosions: The likelihood of either one occurring is very low but if either happens the consequences are very severe.
Sanitary design is integral to food safety.
Acceptance of Hygienic Zoning Implementation: Get buy-in…
• Safety #1 (Personnel and Food)
• Communicate need for HZ and risk mitigation: Must be understood and accepted by all • The “Why” is as critical as the “What” and “How” • Includes admission that things won’t be easier
• Minimize cost • “Make the easy way the right way” • Minimize disruption of manufacturing operations • Awareness & Training Sanitary design is integral to food safety. Acceptance of Hygienic Zoning Implementation: Make training fun!
• “Everybody must get zoned”
Sanitary design is integral to food safety.
Equipment & Plant Design For Allergen/Pathogen Control in Low Moisture Foods
