080415 Regulation Safety Quality
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Transcript of 080415 Regulation Safety Quality
Science-Based, Business-Ready Information for the Food Entrepreneur
News, Search, Links, Glossary
http://www.northwestfoods.net
Getting Your Recipe to MarketNorthwestFoods.net
Getting Your Recipe to MarketNorthwest Entrepreneur Development Seris
Safety, Perception, Demand:Better Names for Quality
John Henry WellsFood Systems Engineer
Foods Must be Safe
Safety before
Quality
Regulatory Definitions
Federal Food Drug & Cosmetic Act
"Food " means
(1)articles used for food or drink for man or other animals,
(2)chewing gum, and
(3)articles used for components of any such article.
OAR 603-025-0010
Adulterated Food (FD&C Act SEC. 402)
• Intentional or Unintentionally Added• Unintentional or Intentionally Not Added
Misbranded Food (FD&C Act SEC 403)
• Misleading Label or Container• Contents-Label Mismatched• Label Incorrect Format
Federal Food Drug & Cosmetic Acthttp://www.fda.gov/opacom/laws/fdcact/fdcact1.htm
Regulatory Definitions
"Food Processing" means the cooking, baking, heating, drying, mixing, grinding, churning, separating, extracting, cutting, freezing or otherwise manufacturing a food or changing the physical characteristics of a food, and the packaging, canning or otherwise enclosing of such food in a container, but does not mean the sorting, cleaning or water-rinsing of a food.
OAR 603-025-0010
Regulatory Definitions
"Potentially Hazardous Food" means any food that consists whole or in part of milk or milk products, eggs, meat, poultry, fish, shellfish, edible crustacia or other ingredients, including synthetic ingredients, in a form capable of supporting rapid and progressive growth of infectious or toxigenic microorganisms, but does not include food which has a pH level of 4.6 or below or a water activity (Aw) value of 0.85 or less
. OAR 603-025-0010
Food Science Food Microbiology
• Characteristics of Microorganisms– They are everywhere (ubiquitous)
• Assume your food has one or more pathogens– They live under extreme conditions
• Temperature– Psychrotrophic (refergiration temperatures) – Mesophilic (normal room temperatures)– Thermophilic (high temperatures)
• Atmosphere– Aerobic (live in presence of oxygen)– Anaerobic (live in absence of oxygen)– Facultative (live by adapting to what is available)
Food Science Food Microbiology
• You Can’t See Microorganisms (microscopic)
• Spoilage Microorganisms (impact quality change)– Slime, Mold, Yeast (undesirable sensory experience)– Beneficial Microorganisms (fermented foods)
• Pathogenic Bacteria (impact human health) – Foodborne Illness can result from:
• Toxins Production (past microbial activity)• Microflora Ingestion (present growth conditions)• Heat Resistant Spores (future contamination opportunity)
THEY MIGHT KILL YOU
We are the microbes …
Food Safety AnalysisRegulatory Definitions
• Code of Federal RegulationsTitle 21 – Food and Drugs
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200521
Part 1-99 Food and Drug AdministrationPart 100-169 Food (Labeling, GMP, HACCP, etc.)Part 170-199 Food Additives
(Title 21 CFR Section 101.9 - Nutrition labeling of food )
Food Science Physical Food Preservation
• pH Control - measurement of the acidity or alkalinity of a solution (pH meter)
• Aw Control - measurement of the amount of water available to microorganisms and chemical reactions (water activity)
• Temperature Control– Heating – elevated temperature to kill selected microorganisms
(thermal processing – heating followed by cooling)– Refrigeration – lowering temperature to slow microbial growth
(cooling)– Freezing – lowering of temperature to create biologically inert
water (formation of ice crystals)
Food Science Physical Food Preservation
• Combination Techniques– Multiple microbial hurdles
Controls on one or morepH + Aw + temperature
– Package microenvironment• Moisture barriers to maintain correct Aw
• Headspace gas composition to suppress microbesModified atmosphere packaging (MAP)
Food Safety before Food Quality
Food Safety AnalysisCross Contamination
• Post-process contamination – product that is heated to reduce the number of microorganisms and comes in contact with unheated materials.
– Avoid mixing of finished product and raw materials.
• Proper process planning – product flow should consider minimize risk of cross-contamination
– Incoming materials and finished product should be on opposite ends – Waste flow countercurrent to product flow
. • Proper facilities planning - HVAC (heating, ventilation and air
conditioning) system should be designed so that the highest air pressure is in the finished product area.
– Reduce the risk of cross-contamination by air-born particles.
HACCP References
• U.S. Department of AgricultureFood Safety Inspection Service
http://www.fsis.usda.gov/Science/Hazard_Analysis_&_Pathogen_Reduction/index.asp
• U.S. Food and Drug AdministrationCenter for Food Safety and Applied Nutritionhttp://www.cfsan.fda.gov/~lrd/haccp.html
Foods Must be Safe
Safety before
Quality
“Fitness for Use” Food Hazard
• Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
21 CFR 120.3 (g)
• Food Safety is most important (period) SAFETY BEFORE QUALITY
Food Safety Management SystemHazards and Controls
HazardsBiological Risks
Microbial Contamination(naturally occurring)
Chemical RisksChemical Adulteration(anything not on the
ingredient label)Physical Risks
Foreign Matter(glass shards, equipment
parts, etc.)
ControlsReduce Hazard
Sanitation Plan(GMP, SSOP, etc.)
Avoid HazardProcess Control(Measure, record, etc.)
Eliminate HazardCorrective Action(Change and verify)
Describe Your ProductClass Activity
• Describe the “Controls” for your product– How do you reduce, avoid, and/or eliminate
potential hazards?
~ 10 minutes!
QualitySearch for Meaning
A subjective term for which each person or sector has its own definition.
http://www.asq.org/glossary/q.html
QualitySearch for Meaning
the extent to which a product fulfills consumer needs and wants
an aesthetic standard for a product usually set by experienced users
the sum of those attributes that govern product acceptability to the buyer or consumer
Critical Reviews in Food Science and Nutrition, 2000
there are many incomprehensible, official definitions.
think of quality as "we keep our promises“
http://www.iso9001help.co.uk/ISO_9000_history.htm
QualitySearch for Meaning
QualitySearch for Meaning
in technical usage, quality can have two meanings: 1. the characteristics of a product or service that
bear on its ability to satisfy stated or implied needs; “fitness for use”
2. a product or service free of deficiencies; “conformance to requirements”
http://www.asq.org/glossary/q.html
“Fitness for Use” Food Hazard
• Food hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.
21 CFR 120.3 (g)
• Food Safety is most important (period) SAFETY BEFORE QUALITY
Quality Management SystemHazards and Controls
HazardsBiological Risks
Microbial Contamination(naturally occurring)
Chemical RisksChemical Adulteration(anything not on the
ingredient label)Physical Risks
Foreign Matter(glass shards, equipment
parts, etc.)
ControlsReduce Hazard
Sanitation Plan(GMP, SSOP, etc.)
Avoid HazardProcess Control(Measure, record, etc.)
Eliminate HazardCorrective Action(Change and verify)
“Conformance to Requirements” Food Standards
• Codex Alimentarius (FAO/WHO Standards)http://www.codexalimentarius.net/
Standard for Olive Oils and Olive Pomace Oils (33)Standard for Raisins (67)
• Standards of Identity (FDA/USDA Standards)http://www.gpoaccess.gov/cfr/
Cereal Flours and Related Products (21 CFR 137)Catsup (21 CFR 155.194)
Quality Grade StandardsAbsence of Something Bad
Quality (subjective concept)degree to which a set of inherent characteristics fulfils requirements
Defect – non-fulfillment of the needs and expectations
Grade (objective concept)category or rank given to different quality requirements for the items having the same functional use
Nonconformity – non-fulfillment of the stated requirement specifications
Quality Integration, March 23, 2005http://qiblog.blogspot.com/2005_03_01_archive.html
Perceptions of QualityPerishable Nature of Food
• Quality is an individual consumer’s expectations or preferences toward – Specific characteristics– Predominate attributes
• Foods perish by developing undesirable combinations of quality attribute– All foods perish – shelf-life expectation
Quality Attributes
Food ScienceFood Safety, Deterioration and Spoilage
• Microorganisms • Enzymes• Pests• Contamination• Inefficient Use
• Moisture• Temperature• Time• Oxygen• Light
Quality Perceptions Sensory and Consumer Science
A complicated, complex and chaotic interaction of:– Compliant factors– Product composition– Physical properties– Chemical reactions– Enzymatic activity– Microbial interaction/growth– Nutritional value– Aesthetic appeal
Quality Perceptions Sensory and Consumer Science
A complicated, complex and chaotic interaction of:– Compliant factors– Product composition– Physical properties– Chemical reactions– Enzymatic activity– Microbial interaction/growth– Nutritional value– Aesthetic appeal
SensoryCharacterics
hasvery few
SCIENTIFICSTANDARDS
Sensory Science Consumer Science
Perceptions and PreferencesSensory Science
• Sensory Perception– Taste– Smell– Vision– Touch/Hearing
• Sensory Preference– Flavor– Aroma– Appearance– Texture
• Taste (Tongue)– Palate, oral cavity
• Smell (Nose)– Oral-nasal region
• Vision (Eyes)– Scale/Dimension– Light
wavelength, intensity, purity
• Flavor– Salty, sweet, sour, etc
• Aroma– Fruity, floral, musty, etc.
• Appearance– Physical shape and size– Color
hue, brightness, saturation
Perceptions and PreferencesSensory Science
• Hearing (Ears)– Sound of biting/chewing
• Touch (Kinesthesis)– Muscles, tendons, joints
• Touch (Somethesis)– Pressure, pain, temperature
• Vision– Light
transmitted, absorbed, reflected
• Texture– Crispness, hardness, etc
• Texture– Sticky, chewy, gummy, etc.
• Texture/Taste (mouth feel)– Fizzy, melt, etc.
• Texture/Appearance– Structure, thickness
shine, polish, turbity
Perceptions and PreferencesSensory Science
Sensation and IntensityPerceptions and Preferences
• Sensory stimulus in context and experience– Perception expressed as a sensation (+ or -)
• Presence of desirable product attributes• Absence of undesirable product attributes
– Preference expressed as intensity (relative)• Greater degree of desirable attribute is perceived
– higher intensity (more preferred ~ higher quality)• Lesser degree of the desirable attribute is perceived
– lower intensity (less preferred ~ lower quality)
Sensory Testing
• Sensory Rating Methods– Panelists are trained to recognize specific quality attribute
that are defined in advance• Intensity Scaling• Quality Loss Monitoring
• Sensory Difference Methods– Panelists are asked to compare product samples and
determine if there are “noticeable charges”• Deviation from Reference• Shelf-Life Determination
Sample A
Sample B
Sample C
Not Hot Very Hot
Not Hot Very Hot
Not Hot Very Hot
Intensity Scaling
Sample A
Sample B
Sample C
R
R
R
Reference
Deviation from Reference
Sensory Science Consumer Science
Consumer Testing
• Focus Groups– Open discussion within a group guided by a moderator
• Use and Brand Studies• Market Drivers
• Hedonic Scaling– Rating question about non-specific character
• Overall Liking
Emotions and BehaviorsConsumer Science
• Affective Measures (agreement)– Emotional state elicited by a food item prior to ‘action’
(sensory acceptance or avoidance level)• Acceptor Set Size - Percentage of customers who like the
product (as acceptable)
• Consumptive Measures (certainty)– End-point ‘action’ is the behavior of selection or
consumption of a food item• Direct Weight Measurement – Weight of each food item
before and after serving (least uneaten portion)
Describe Your ProductClass Activity
• Describe the “Sensation and Intensity”– What are the most prominent characteristics of
your product?– How will the consumer know it is there?
• Describe the “Emotions and Behaviors”– What are the feelings and actions that you want
consumers’ to experience from your product?
~ 10 minutes!
Consumers need < product name > because …
Consumers want < product name > because …
Consumers value < product name > because …
Consumer DemandEssential Market Understanding
Food and Agriculture EnterpriseConsumer Demand
Food Review 25(1): 2-9. USDA-ERS, May 2002
• Demand for Value-Added Products
• Demand for Quality-Differentiated Foods
Food and Agriculture EnterpriseConsumer Demand
Food Review 25(1): 2-9. USDA-ERS, May 2002
• Demand for Value-Added Products“Benefits” that Add Value
Benefits that Add ValueMultiple Perspectives
Purpose
Perception
Promotion
Process
Place
Food and Agriculture SystemBenefits that Add Value
Benefits that Add Value• Production – cultural practices and supply chain
– Managed by farmer producers and ingredient suppliers• Manufacturing – defined specifications
– Managed by food entrepreneurs • Consumption – customers and consumer
– Managed by distributors and retailers
Food and Agriculture EnterpriseConsumer Demand
Food Review 25(1): 2-9. USDA-ERS, May 2002
• Demand for Value-Added Products
• Demand for Quality-Differentiated Foods
“Benefits” that Add Value
“Distinctions” that Differentiate Quality
Food and Agriculture SystemConsumer Demand
Distinctions that Differentiate Quality• Needs• Wants• Values
Benefits that Add Value• Production - An economic livelihood for farmer producers• Manufacturing - A business opportunity for entrepreneurs • Consumption - A market source of nutrition for society
Distinctions that Differentiate Quality• Needs - I need food to live
Benefits that Add Value• Production - An economic livelihood for farmer producers• Manufacturing - A business opportunity for entrepreneurs • Consumption - A market source of nutrition for society
(my lifestyle experience)
Food and Agriculture SystemConsumer Demand
• By 2020 more than one-third of the American population will be over fifty
• Over 68 percent of the population is using vitamins and minerals
• Over 25 percent of the population are using herbs and related supplements
• American consumers are constructing new personal wellness regimes
Lifestyle ExperienceDistinct Needs
Natural Products Census, The Hartman Group
Food and Agriculture SystemConsumer Demand
Distinctions that Differentiate Quality• Needs - I need food to live (my lifestyle experience)• Wants - I want foods that are …
Benefits that Add Value• Production - An economic livelihood for farmer producers• Manufacturing - A business opportunity for entrepreneurs • Consumption - A market source of nutrition for society
Dashboard Dining Makes Tracks
Focused on the growing niche of mobile foods, Deli Dashers® Premium Meal Oriental Cups, with a decidedly regional Chinese influence, are hitting the mark.
http://www.preparedfoods.com/CDA/ArticleInformation/features/BNP__Features__Item/0,1231,113739,00.html
PreparedFoods.com
Convenience Products Distinct Foods
Stand-Up,
Zip-Lock,
Pop-Top,
Squeeze Bottle,
Surprise Inside
Products
Food and Agriculture SystemConsumer Demand
Distinctions that Differentiate Quality• Needs - I need food to live • Wants - I want foods that are … • Values - I appreciate (and benefit from) foods that are …
Benefits that Add Value• Production - An economic livelihood for farmer producers• Manufacturing - A business opportunity for entrepreneurs • Consumption - A market source of nutrition for society
Distinct ValuesCertifications
Quality-Differentiated ProductsIncreasing Distinction
Degree of Distinction:
Safety
Satisfaction
Sustainability
Social Responsible
Continuous Improvement: Programs:
ISO 22000 Food Safety Management SystemHACCP Microbial Food Safety Hazards
ISO 9000 Quality Management System
ISO 14000 Environmental Management System
ISO 26000 Guidance Standard on Social Responsibility SA 8000 Social Accountability Standard
International Standards Organization (ISO)
4-S Criterion for Food and Agricultural Enterprise
Quality-Differentiated ProductsHow is quality defined?
Continuous Improvement
in the
Degree of Distinction
Food and Agriculture SystemConsumer Demand
“Distinction Mix” that Differentiates Quality• Needs• Wants • Values
“Benefit Mix” that Adds Value• Production • Manufacturing • Consumption
Benefit
Increasing Value-AddedProducts
Increasing
Distinction
Quality-DifferentiatedFoods
Benefit
Increasing Value-AddedProducts
Increasing
Distinction
Quality-DifferentiatedFoods
Production
Manufacturing
Consumption
Benefit Mix
Needs
Values
Wants
Dis
tinct
ion
Mix
ConsumerDemand
Benefits + Distinctions
Cost
Production
Manufacturing
Consumption
Benefit Mix
Safety
Social Responsibility
SustainabilityDis
tinct
ion
Mix
DemandSpecifications
Satisfaction
Describe Your ProductClass Activity
• Describe the “Benefit Mix” for a product– How are production, manufacturing, and/or
consumption factors used to add-value to your product?
• Describe the “Distinction Mix” for a product– How are consumers’ needs, wants, and/or values
(4-S criterion) considered to quality-differentiate your product?
~ 10 minutes!