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FST408 Final

List the stages and gates for new product development and commercialization. Stage: Project Initiation Gate: Brief Finalized Stage: Development Gate: Final Formula Locked Stage: Commercialization Gate: Ready to Launch Stage: Production
What are some important aspects of project planning? Identify risk areas and communicate in writing, contingency plan, identify time for R&D
What are some important aspects of product/process testing? Compare product to known stable control, remember scaling up can cause problems, accelerated shelf life testing early on, real time shelf life testing monthly, include a plant trial (!) and record everything
What should you do if there is a problem in processing? Gather data, organize, look for trends; ignore anecdotal thoughts
What three factors contribute to NPD success? Consumer need, business strategy, trends
Food producers must comply with ______, _______, and ______ city policies. federal, state, city
Many states adopt the _______ policy. FDA Food Code
What does the FTC (Federal Trade Commission) do? Shares jurisdiction with FDA and USDA to ensure truthfulness of nutrient content/health claims.
What are the steps of the rule making process? 1. Proposed rule is published in the Federal Register explaining reason behind 2. Comment period (minimum 30 days) 3. Modification of proposed rule 4. Final rule published in Federal Register/Code of Federal Regulations
All rules promulgated or amended by the FDA are published in _______. Title 21 CFR (Code of Federal Regulations)
All rules regulated by USDA are published in _______. Title 9 CFR (Code of Federal Regulations)
True or False: The FDA can file criminal charges. False
What are the FDAs options in enforcement of laws? -warning letters -injunctions -seizures -recalls
True or False: The FDA is only able to inspect a given food processing operation on the average of once every 8 years. True
What are the steps of a factory inspection? 1. Review of file 2. Presentation of credentials 3. Inspection 4. Summary meeting with management 5. Establishment Inspection Report (EIR)
What is the Food, Drug, and Cosmetic Act of 1938? The primary law to prevent adulteration and misbranding of the American food supply (includes imports)
Which act made it possible for the FDA to mandate recalls? Food Safety and Modernization Act
What must a hazard analysis plan include? -corrective action measures -verification procedures -recordkeeping activities
True or false: The FDA (via FSMA) has the right to take products into custody if there is reason to believe that they could cause harm. True
Food companies must register their company with the FDA ________. bianually
What are pre-requisite programs? The components of an operation that set up basic grounds for environmental and operational conditions to produce safe products.
What do good manufacturing practices (GMPs) account for? -employees -equipment -processing -environmental considerations
True or False: Buildings and facilities should be designed so that people flow from raw product to finished product to prevent cross contamination. False
What are standard operating procedures (SOPs)? Descriptions of specific tasks to be carried out in a particular operation.
What should SOPs include? Who, Why, What, How Frequent, Critical Time Limits, Corrective Action
What does HACCP stand for? Hazard Analysis Critical Control Points
What are the three types of hazards? Biological, chemical, physical
HACCP was originally developed for ______. NASA; safe food for astronauts
List the seven principles of HACCP. 1. Conduct hazard analysis 2. Identify critical control points 3. Establish critical limits for CCP 4. Establish monitoring procedures 5. Establish corrective actions 6. Establish verification procedures 7. Establish recordkeeping procedures
What are the three types of HACCP? Scientific, regulatory, pragmatic
What is a CCP? A point or step in procedure where control can be applied and a food safety hazard can be prevented or eliminated.
______, _______, and ______ are factors of critical limits. Time, temperature, aw
What are the three stages of quality control? 1. Control of raw materials 2. Control at the processing line 3. Inspection of the finished product
What is quality assurance? Assures that processes and products are acceptable and in compliance with requirements or specifications
What are the three methods of quality assurance? -quality control -quality evaluation -quality audit
What does quality evaluation consist of? 1. Establish a set of criteria 2. Develop criteria by physical, chemical, sensory, and microbial tests 3. Write everything down; accept/reject criteria 4. List potential causes for deviations from acceptable standards; corrective actions
What does a quality audit consist of? 1. Shelf life 2. Market review 3. Consumer complaints 4. Plant/independent audits
List the three main functions of business. Marketing, operations, finance
______ is concerned with creating and the delivery of the product or service to the consumer Operations
_______ is defined as Performance/Cost Value
True or false: To be successful, operations must have processed that are highly unpredictable. False
What is Murphy's law? Anything that can go wrong will go wrong.
List the roles of management. -Produce results -Create a positive environment -Set and manage standards -Evaluate processes -Develop people
True or false: Business to business sales makes up the highest percentage of sales transactions. True
What is the role of operation's management? To create systems that enable each function to work in harmony with each other to assure that intended performance is realized without interruption.
What is a business strategy? The long-range plan of how the company intends to create and keep its customers.
What are the important aspects of process control in the food industry? attractive product, priced competitively, available, consistency
What are the four stages of quality? 1. Quality is a necessary evil. 2. Quality costs real money. 3. Quality is the responsibility of every function. 4. Prevention of quality problems becomes a way of life.
True or false: The main objective of a business is profit. False
What is the PDCA (Plan Do Check Act) cycle? It aids to reduce the difference between customer need and process performance as well as incorporate feedback from customers back into the process.
What are the two types of data utilized in quality management? Variable and attribute data
What does Statistical Processing Control (SPC) do? Used process data to confirm the variation is under control or create alarms when data indicate an out-of-control situation.
What is a sampling plan and how is it used to determined acceptable quality levels? A sampling plan is used in evaluating the quality of raw material and product lots. It gives an accurate view of the characteristics of the food being made. Statistical samples are taken at specified times and stages of processing.
What actions would be taken if a specification for a product was outside of range? The control chart would be consulted to determine if this was the first outlier or if a corrective action was required.
True or false: Control of raw materials is important from a food quality standpoint. True
True or false: Fast methods for determination of food quality are not important. False
Created by: goberoi



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