FSC3010 - Food Quality Assurance: Test One Review

Quality

*An Integrated business plan includes long term targets and means for achieving goals in____ Defects, Failures, Customer Complaints & Satisfaction

Delivery

*An Integrated business plan includes long term targets and means for achieving goals in____ New product development, on-time deliveries, response time, distribution

Costs

*An Integrated business plan includes long term targets and means for achieving goals in____ Production costs, money strategies, sale revenue, market share

Morale

*An Integrated business plan includes long term targets and means for achieving goals in____ Satisfaction of stakeholders, employee satisfaction, # of educated employees and training programs

A Product Manufacturing Audit Describes

-Any observed deviation from prescribed manufacturing instructions -Any potential situation for deviation -Lack of effectiveness or relevance of any step

Reasons for Conducting a Product Manufacturing Audit

-Assurance that actual practices reflect required procedures -Uncovering deviations, so they may be corrected -Conforming consistency

Organism Perpetuation

-Bacterial & some yeasts multiply by binary fission -Mother cell increases in size and divides into 2 daughter cells -Most yeast multiply by budding -Generation time average 30 minutes for bacteria -Lag phase: Dormant / slow growth -Log phase: Rapid growth (Temperature dependent) -Molds reproduce by spores, increase size by fungal hyphae (long, branching threadlike tubes, multicellular filaments) -Viruses replicate inside host cells -Parasites do not proliferate in foods, usually require more than one host for life cycle

Three Categories of Microorganisms

-Beneficial -Pathogenic (Bad, Get rid of or control) -Spoilage (Fine, cause little to no harm)

Cause & Effect Diagram

-Causes are arranged according to level of importance or detail -Interrelationship Diagrams -Depicts relationships and hierarchy of events -Causes typically arranged into 4 common categories: ---Manpower, methods, materials, & machinery (for manufacturing) ---Equipment, policies, procedures, and people (for administration and planning)

Classifications of Recalls

-Class I : Products which could cause serious injury or death, such as not labeling an allergen -Class II : Products which might cause serious injury or temporary illness, such as microbial contamination or mislabeling -Class III : Products which are unlikely to cause injury or illness, but that violate FDA regulations, such as faulty closure/sealing of a product or missing a batch number

Major Functions of the Quality Assurance Department

-Compliance with specifications: Legal, industry, company internal, shelf-life testing, customer specifications -Test procedures: Testing raw materials, in process and finished product -Sampling procedures and schedules: maximize the probability of detecting while maximizing workload -Record keeping and reporting -Troubleshooting -Special problems: customer complaints, production issues, employee training -Food plant sanitary practices -Establishes criteria for acceptable food plant -Federal regulations 21 CFR 110 - current good manufacturing practices

Observation Classes

-Critical: Any condition of actual product or container adulteration or condition in which adulteration is imminent or inevitable such as rust, peeling paint, mold, oils, dirt, lubricants, condensation, or use of unapproved chemicals. Stop production and fix immediately -Major: Any condition or practice that is a source of potential product or container adulteration such as eating, smoking, exposed light bulbs, inadequate pest control, inadequate employee hygiene, or unprotected openings to the outside. Fix as soon as possible -Minor: Any other observation from GMP's such as poor housekeeping, log/paperwork left too close to the line, foreign material on exterior of seamers, or inadequate ground maintenance. Not imminent, address when seen

Best By Date Label

-Date of ideal quality, best if consumed by -Mark of ID, batch, code, or lot number must be on the food so it can be traced -Same code = same quality -Date label must list Sell by, Use by, OR Best by date, manufactures choice as to which

Use By Date Label

-Date to be consumed OR discarded -Date label must list Sell by, Use by, OR Best by date, manufactures choice as to which

Sell By Date Label

-Date to be sold OR frozen -Still usable after date, but not manufacturer quality -Typically 1/3rd of products shelf life -Date label must list Sell by, Use by, OR Best by date, manufactures choice as to which

Quality Evaluation

-Describing or appraising the worth of a product -Means taking measurements to evaluate : ---Performance of incoming (raw) materials ---Products in process ---Finished products

Other Audits

-Document control audits -Supplier audits -QC instrument calibration and maintenance audits -Product batch prep/ formulation audits

Flow Charts

-Excellent for process operations -Records steps, decisions, & actions for manufacturing -Usually presented in blocks: Round = start/stop, Diamond = decision, Square = result

Plant Sanitation / GMP Audit

-Federal regulations 21 CFR part 110 -Acceptability of plant facilities ---Warehouse and storage: Storage conditions, code dating, separation of allergen-containing ingredients, proper label declarations, specifications and certificates of analysis on file ---Building and facility construction ---Plant and ground maintenance ---Sanitary facilities ---Employee hygiene: Personal hygienic practices, personal health conditions, use of gloves, outer garments ---In-Process control: Review of sanitation SOP's, sanitation control records, water quality, cleanliness of food contact surfaces and equipment, prevention of cross contamination, color coding allergens ---Contamination and adulteration: protect ingredients, raw materials, and packaging from adulteration with lubricants, fuel, pesticides, cleaning agents, sanitizers, etc. ---Proper labeling of cans, boxes, bags ---Proper storage & use of toxic compounds ---Records of plant pest control and outside firm

Legal Standards of Quality

-Federal, State, Municipal -Mandatory: set up through law or regulation

Viruses Consist of

-Genetic material (RNA/ DNA) -Protein coat (capsid) -Envelope of lipids (sometimes, helps avoid immune system) -Glycoprotein (protein containing oligosaccharide chain) on surface to help identify and bind to receptor sites on host cell membrane

Product Manufacturing Audit

-Helps verify manufacturing is carried out in a suitable environment, under acceptable manufacturing conditions, and under sanitary conditions -In accordance with manufacturing documents: ---Documented work instructions ---Suitable environment ---Samples for criteria for workmanship ---Compliance with standards -Quality product dependent on quality of raw materials ---Control of purchasing ingredients ---Properly identifying ---Tracing raw materials

Viruses are Classified by

-Host group infected (animals, plants, bacteria, fungi) -Type of disease caused -Type of nucleic acid present -Structure of the protein coat -If the virus has an envelope or is naked

A TQM Mission should state:

-How to achieve the corporate vision within a certain time frame -Stakeholder submitted activities to achieve the corporate vision -Simple statement understood by all levels of employees as well as the public, suppliers, and customers

Food Contamination Sources

-Humans: Largest contamination source besides from food itself -Equipment: Contamination occurs during use as well as idle time -Air and Water: Airborne microorganisms, water used to clean and/or as an ingredient -Sewage: From humans, in fields, entering potable water lines -Insects, Rodents, and Birds: Flies and roaches transfer filth from contaminated areas to food through their waste and body parts

Hazard Analysis Critical Control Points (HACCP) Audit

-Internationally recognized as means of assuring food safety from harvest to consumption -Verified that plan complies with the 7 principals of HACCP: Analyze hazards, determine critical control points, establish limits for critical control points, establish monitoring procedures for critical control points, establish corrective actions, establish verification procedures -Detailed observation to ensure hazards have been identified and are effectively controlled and limits are validated or proven effective

Control of Bacterial Growth in Food

-Intrinsic: Inherent to the food itself such as pH, oxidation reduction, water activity, nutrient content, naturally occurring preservatives and antimicrobials, and natural barriers such as shells and peels -Extrinsic: Controlled and modified factors such as temperature of storage, relative humidity of environment, presence and contamination of gases, and presence and activities of other microorganisms -Combined: Hurdle concept meaning to combine multiple preservation methods

X-Bar and R Chart

-Most commonly used of control charts -Ideal for improving product quality and process control - Help reduce scrap/rework -Used for control of variables expressed in discrete number such as inches, pounds, pH, percent solids, or temperature *X-Bar -Average value of several measurements *R Chart -Range of each subgroup of data -Subtract maximum and minimum values from subgroup

Audit Worksheets Include

-Observation -Classification -Type (i.e. ingredient handling, equipment) -Area of program

Eight Dimensions of Quality

-Performance -Features -Reliability -Conformance -Durability -Serviceability -Aesthetics -Perceived Quality

Three Levels of Cleanliness

-Physical Cleanliness: Absence of visual product waste, foreign matter, slime etc. -Chemical Cleanliness: Freedom from undesired chemicals, contamination could be from cleaning, germicides, or pesticides -Microbiological Cleanliness: Influenced by amount of microorganisms present on the product, the equipment, and the workers

Primary Objectives of Sanitation/ GMP Audits

-Plant facilities -Employee hygiene -Pest control -In-Process control

Keys to Quality

-Process must be managed and improved -Define the process -Measure process performance -Reviewing process performance -Identify process shortcomings -Analyzing process problems -Making process change -Measuring process change -Communicating between subordinates and supervisor

Employee Sanitation

-Proper handwashing -Toilet facilities away from food surfaces -Minimize potential for direct or indirect contact of fecal matter -Disposable glove use -Hair/ beard nets -Appropriate outer garments -Employee hygiene requirements

Primary Function of Quality Assurance

-Provide confidence for management and the ultimate customer -Customer is the management's guide to quality

Ten Steps to Total Quality Management (TQM)

-Pursue new strategic thinking -Know your customer -Set true customer requirements -Concentrate on prevention, not correction -Reduce chronic waste -Pursue a continuous improvement strategy -Use structured methodology for process improvement -Reduce variation -Use a balanced approach -Apply to all functions

Quality Control

-Regulate standards prescribed to food and beverage products -QC activities and standards are operators tools -Help maintain production line

Value of a Planned Sanitation Program

-Results in efficient operations, fewer accidents, increased productivity -Storage facilities benefit from appropriate control of dust, pests, insects -Litter and garbage disposed of in appropriate containers which are clean and disinfected -Toxic substance controlled, stored far away from food products

Scatter Diagram

-Similar to line graph except data points are plotted without connecting lines -Good at showing how data points compare to each other -Used to study possible relationship between two variables -Purpose is to display what happened to one variable when the other variable changed

Quality Audits

-Verify or examine a product or manufacture process over time -Allow for quality verification in manufacture warehousing, distribution, and market -Include: Manufacture QA, Product QA, HACCP audits, and Plant Sanitation / GMP Audits

A TQM Vision should state:

-What an Organization wants to be -Future Market Area -Simple statement understood by all levels of employees as well as the public, suppliers, and customers

Communicable Disease Transmission

-Wide range, may be transmitted by infected employee to consumers through food or utensils -Identify any worker showing symptoms of active cases of illnesses and exclude from work -Include: ---Hep. A ---Salmonella ---Shigella ---Norwalk ---Staphylococcus aureus ---Streptococcus pyogenes

Yeast Vs. Mold

-Yeast = Single-cell -Mold = Multi-cell

Viral Envelope

A lipid bilayer that envelops some viruses, protects the genetic material when travelling between hosts, some include glycoproteins (protein containing oligosaccharide chain) on surface to help identify and bind to receptor sites on host cell membrane

Physical Cleanliness

Absence of visual product waste, foreign matter, slime etc.

Primary Objective of Total Quality Management (TQM)

Achieve customer satisfaction by involving all in manufacturing

Company / Voluntary Label Standards

Additional labeling done by the company that is not required, such as making a product kosher or gluten free

Critical Observation

Any condition of actual product or container adulteration or condition in which adulteration is imminent or inevitable such as rust, peeling paint, mold, oils, dirt, lubricants, condensation, or use of unapproved chemicals. Stop production and fix immediately

Major Observation

Any condition or practice that is a source of potential product or container adulteration such as eating, smoking, exposed light bulbs, inadequate pest control, inadequate employee hygiene, or unprotected openings to the outside. Fix as soon as possible

Minor Observation

Any other observation from GMP's such as poor housekeeping, log/paperwork left too close to the line, foreign material on exterior of seamers, or inadequate ground maintenance. Not imminent, address when seen

Objective Method for Determining Quality

Based on specific standards: -Physical methods: Size, texture, color, consistency, weights, etc. -Chemical methods: Aw (water activity), pH, salt, soluble solids, enzymes, moisture, etc. -Microscopy methods: Differentiation between cell types, tissue types & Microorganisms, adulteration and contamination (presence of yeasts, molds, foreign materials)

Consumer or Grade Standards

Consumer requirements, USDA grades

Data Sheet

Data from table, spreadsheet, forms

Lag phase of Bacterial Growth

Dormant / slow growth

Process Control

Essential Elements to quality programs: -Quality in production -Control of production Process control is critical for the successful operations of manufacturing -Ensures quality targets are consistently achieved

Doctrine of Total Accountability

Foresight and vigilance required, Chief Executives are also held responsible for a violation of the Food, Drug & Cosmetic Act (FD&C) -Public welfare takes precedence over any consideration of individual claims in the sensitive area of food safety

Chemical Cleanliness

Freedom from undesired chemicals, contamination could be from cleaning, germicides, or pesticides

Control Chart

Graphically displays measured characteristic vs. sample number of time -Center represents average -Upper Control Limit (UCL) -Lower Control Limit (LCL)

Histogram

Graphically summarizes and displays distribution of a data set process, also called a Bar Chart

Pareto Chart

Graphically summarizes and displays the relative importance of differences between groups of data

Industry Standards of Quality

Industry group gives quality limits for a given commodity

Microbiological Cleanliness

Influenced by amount of microorganisms present on the product, the equipment, and the workers

Product Quality Audit

Inspecting product that has previously been inspected and accepted to determine compliance and performance over time when available to consumer. Compare to: -QC specification limits -Quality of previous years -Quality of competitive brands -Products manufactures at different plants

Integrated Business Plan

Long term targets & means for achieving goals in quality, cost, delivery, and morale -Quality: Defects, Failures, Customer Complaints & Satisfaction -Costs: Production costs, money strategies, sale revenue, market share -Delivery: New product development, on-time deliveries, response time, distribution -Morale: Satisfaction of stakeholders, employee satisfaction, # of educated employees and training programs

Quality Assurance

Modern term for describing control, evaluation, and audit of food processing systems

Batch / Code / Lot Number

Must be listed on product

Control of Non-Conforming Product

Nonconforming product must be held until decision of the product can be: -Reworked (re-incorporated into new product) -Accepted by concession -Regraded for alternative application -Scrapped (last resort)

Subjective Method for Determining Quality

Organoleptic (uses the sense organs) : Flavor, odor, color, touch, appearance

Class III Recall

Products which are unlikely to cause injury or illness, but that violate FDA regulations, such as faulty closure/sealing of a product or missing a batch number

Class I Recall

Products which could cause serious injury or death, such as not labeling an allergen

Class II Recall

Products which might cause serious injury or temporary illness, such as microbial contamination or mislabeling

Log phase of Bacterial Growth

Rapid growth (Temperature dependent)

Management in Quality Programs

Responsible for ensuring: -Training -Communication of quality procedures -Supporting empowerment -Writing and enforcing quality standards and good manufacturing techniques

P-Chart

Shows percent of samples in manufacturing process being nonconforming or defective, 2 types: -P-Chart with constant lot size: used to determine control of percent of defective units and to establish if the process is in control for the day; constant means within 20% -P-Chart with variable lot size

Grantt Chart

Shows planned work and finished work in relation to time, key for project management

Doctrine of Strict Liability (Absolute/Vicarious Ability)

States that the president of any food company can be found guilty of a violation of the Food, Drug & Cosmetic Act (FD&C) -Does not require them to have been personally involved -Defendant is barred from relying on any assertion that he or she was ignorant of an offense

Generation Time

The time it takes the number of bacteria to double, average 30 minutes

Fundamental Functions of Quality Assurance

To provide confidence to management and the customer, 3 Fundamental Functions: -Quality Control -Quality Evaluation -Quality Audits

Audit Class by Program / Control Area

Typical program control areas: -Employee hygiene -Employee practices -Cleaning and sanitation -Pest control -Process equipment design and construction -Process equipment maintenance -Non-Process equipment maintenance -Building construction -Building maintenance