Definitions Flashcards
History of the Alliance
The FSPCA was established in 2011 as part of a grant from FDA to the Illinois Institute of Technology’s Institute of Food Safety and Health The purpose of this broad-based alliance is to develop and maintain a cost-effective education and training program to assist the food industry with understanding and achieving compliance with the Preventive Controls regulation requirements applicable to their facilities
the responsibilities of a “preventive controls qualified individual” include
perform or oversee
- preparation of the Food Safety Plan
- validation of the preventive controls
- records review
- reanalysis of the Food Safety Plan
Acid or Acidified foods
Foods that have an equilibrium pH of 4.6 or below
acid foods = natural pH of 4.6 or below
acidified foods = acid added to reduce the pH
Adequate
That which is needed to accomplish the intended purpose in keeping with good public health practice
Allergen cross-contact
The unintentional incorporation of a food allergen into a food crosscontact
Audit
means the systematic, independent, and documented examination through observation. investigation records review discussions with employees of the audited entity and as appropriate sampling and laboratory analysis to assess an entity’s food safety
processes and procedures
aW
Water activity
CCP
Critical Control Point
cGMPs
Current Good Manufacturing Practices
Cleaning
The removal of soil food residue dirt grease or other objectionable matter
Correction
means an action to identify and correct a problem that occurred during the production of food without other actions associated with a corrective action procedure such as actions to reduce the likelihood that the problem will recur evaluate all affected food for safety and prevent affected food from entering commerce
Corrective action
Procedures that must be taken if preventive controls are not properly implemented
Critical Control Point CCP
A point step or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level
Critical limit
The maximum or minimum value or combination of values to which any biological chemical or physical parameter must be controlled to significantly minimize or prevent a hazard requiring a process preventive control
Cross-contamination
The unintentional transfer of a foodborne pathogen from a food where it may occur naturally or insanitary object to another food where it may present a hazard
Defect action level
means a level of a non-hazardous naturally occurring unavoidable defect at which FDA may regard a food product “adulterated” and subject to enforcement action under section 402a3 of the Federal Food Drug and Cosmetic Act
Deviation
Failure to meet a critical limit
Environmental pathogen
A pathogen capable of surviving and persisting within the manufacturing processing packing or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogens for the purposes of this part include Listeria monocytogenes and Salmonella spp but do not include the spores of pathogenic sporeforming bacteria
Facility
A domestic facility or foreign facility that is required to register under section 415 of the Federal Food Drug and Cosmetic Act in accordance with the requirements of 21 CFR part 1 subpart H
Food
Includes
1. articles used for food or drink for man or other animals
2. chewing gum
3. articles used for components of any such article
Examples of food include fruits, vegetables, fish, dairy products, eggs, raw agricultural commodities used for food or as components of food, animal feed including pet food, food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages including alcoholic beverages and bottled water, live food animals, bakery goods, snack foods, candy, and canned foods. Does not include pesticides or food contact substances not intended to have any technical effect in the food
Food allergen
Any of the following
1) Milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, and soybeans.
2) A food ingredient that contains protein derived from a food specified in 1
Food-contact surface
Those surfaces that contact human food and those surfaces from which drainage or other transfer onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operation “Food contact surfaces” includes utensils and food-contact surfaces of equipment
Food Safety Plan
A set of written documents that is based on food safety principles incorporates hazard analysis preventive controls supply-chain programs and a recall plan and delineates the procedures to be followed for monitoring corrective actions and verification
Food safety system
The outcome of implementing the Food Safety Plan and its supporting elements
GMPs (Good Manufacturing Practices)
The regulation that outlines the conditions and practices the regulated food industry must follow for processing safe food under sanitary conditions including personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, warehousing and distribution, and defect action levels considerations
HACCP
Hazard Analysis and Critical Control Point
Hazard
Any biological chemical including radiological or physical agent that has the potential to cause illness or injury
Hazard analysis
The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore must be addressed in the HACCP or Food Safety Plan
Hazard Analysis and Critical Control Point
A system which identifies evaluates and controls hazards which are significant for food safety
Hazard requiring a preventive control
means a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing processing packing or holding of food would based on the outcome of a hazard analysis which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls such as monitoring corrections or corrective actions verification and records as appropriate to the food the facility and the nature of the preventive control and its role in the facility’s food safety system
Known or reasonably foreseeable hazard
A biological chemical including radiological or physical hazard that is known to be or has the potential to be associated with the facility or the food
Lot
The food produced during a period of time and identified by an establishment’s specific code
Microorganisms
Yeast, molds, bacteria, viruses, protozoa, and microscopic parasites and includes species that are pathogens. The term “undesirable microorganisms” includes those microorganisms that are pathogens that subject food to decomposition that indicate that food is contaminated with filth or that otherwise may cause food to be adulterated
Monitor
To conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended
NACMCF (National Advisory Committee on Microbiological Criteria for Foods)
Chartered under USDA to provide impartial scientific advice to US Federal food safety agencies for use in the development of an integrated national food safety systems approach from farm to final consumption to assure the safety of domestic imported and exported foods
Non-food-contact surface
Those surfaces that do not contact human food and from which drainage or other transfer onto the food or onto surfaces that contact the food ordinarily does not occur during the normal course of operation
Operating limits
Criteria that are more stringent than critical limits and that are used by an operator to reduce the risk of a deviation
Parameter
a characteristic feature or measurable factor that can help in defining a particular system
Pathogen
A microorganism of public health significance
Pest
Any objectionable animals or insects including birds rodents flies and larvae
Potable water
Water that meets the standards for drinking purposes of the State or local authority having jurisdiction or water that meets the standards prescribed by the US Environmental Protection Agency’s National Primary Drinking Water Regulations 40 CFR 141
Prerequisite programs
Procedures including GMPs that provide the basic environmental and operating conditions necessary to support the Food Safety Plan
Preventive controls
Those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding at the time of the analysis
Preventive controls qualified individual
A qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system
Qualified auditor
A person who is a qualified individual as defined below and has technical expertise obtained through education training or experience or combination thereof necessary to perform the auditing function as required by 117180c2
Examples of potential qualified auditors include
1) A government employee including a foreign government employee
2) An audit agent of a certification body that is accredited in accordance with regulations
Qualified individual
a person who has the education training or experience or a combination thereof necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment
RTE Ready-to-eat food
Any food that is normally eaten in its raw state or any other food including a processed food for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards
Reanalysis
A verification procedure to assure that the Food Safety Plan remains valid and the food safety system is operating according to the plan
Receiving facility
A facility that is subject to subpart C [Hazard Analysis and Risk-based Preventive Controls] and subpart G [Supply Chain Program] of this part and that manufactures/processes a raw material or ingredient that it receives from a supplier
Rework
Clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food
Risk
A function of the probability of an adverse health effect and the severity of that effect consequential to a hazards in food
Safe-moisture level
A level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, processing m, packing, and holding. The safe moisture level for a food is related to its water activity. An aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms
Sanitize
To adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens and in substantially reducing numbers of other undesirable microorganisms but without adversely affecting the product or its safety for the consumer
Sanitary conditions
The result of a combination of cleaning and sanitizing as appropriate for the environment that prevents the adulteration of food
Severity
The seriousness of the effects of a hazard
Significantly minimize
To reduce to an acceptable level including to eliminate
Small business
A business including any subsidiaries and affiliates employing fewer than 500 full-time equivalent employees
Supplier
The establishment that manufactures/processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment except for further manufacturing/processing that consists solely of the addition of labeling or similar activity of a de minimis nature
Supply?chain?applied control
A preventive control for a hazard in a raw material or other ingredient when the hazard in the raw material or other ingredient is controlled before its receipt
Unexposed packaged food
Packaged food that is not exposed to the environment
Validation
Obtaining and evaluating scientific and technical evidence that a control measure combination of control measures or the food safety plan as a whole when properly implemented is capable of effectively controlling the identified hazards
Verification
The application of methods procedures tests and other evaluations in addition to monitoring to determine whether a control measure or combination of control measures is or has been operating as intended and to establish the validity of the food safety plan
Very small business
A business including any subsidiaries and affiliates averaging less than $1000000 adjusted for inflation per year during the 3?year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured processed packed or held without sale eg held for a fee
Water activity3 aW
A measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature
Written procedures for receiving raw materials and other
ingredients
Written procedures to ensure that raw materials and other ingredients are received only from suppliers approved by the receiving facility or when necessary and appropriate on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subjected to adequate verification activities before acceptance for use
Contents of a Food Safety Plan Required
Hazard Analysis Preventive Controls Procedures for monitoring corrective action and verification
Contents of a Food Safety Plan Useful
Food Safety Team Facility overview product description flow disgrams process description
