Ch 8 Current GMPs And Hazard Analysis Flashcards
What 5 areas are covered by the Preventative Controls for Human Food Production?
- Process control
- Food allergens
- Sanitation control
- Supply chain control
- Recall plan
What is HARPC?
Hazard Analysis and Risk-Based Preventative Controls
How is a HARPC program different from a HACCP?
It includes the elements that would be in a HACCP program and prerequisite programs. Gives it a much broader approach to all parts of food production and safety.
In short, producers will need more documentation throughout the process
If it is a qualified facility, what are the two attestations that are required by the FDA?
- That they meet the requirements to be considered a qualified facility
- That they have a food safety program in place OR that they have all of the documentation from local/state/federal authorities to be in compliance with current law
Who must sign and accept responsibility for the food safety plan at a facility?
The qualified individual (plant owner, agent, operator)
Is the qualified individual required to be an employee of the establishment?
No
What should be included in an employee hygiene plan?
- procedures
- training
- records
- monitoring and follow-up
What health issues should you monitor your employees for to prevent food borne illness?
- jaundice
- diarrhea
- vomiting
- fever
- sore throat w/fever
- visible skin infection or sores
- discharge from ears, eyes, nose
When is training needed at a facility?
- when hired
- when job duties change
- when policies/procedures change
- to reinforce current policies
According to 21 CFR 117, what should Process Controls include?
- parameters associated with control of the hazard
- the max or min value needed to prevent or control any biological, physical or chemical hazard to prevent a hazard requiring control
What is required for food allergen controls?
- ensuring protection of food from cross contact during production, storage, handling, use
- labeling of finished food and ensuring it is not mislabeled
What should never be used to clean drains?
High pressure hoses
Where should floor drains never be located?
Not located under or near production, filing or packing equipment
In work rooms where dairy products are packaged or manufactured, what is the candle foot measurement required?
30 foot candles
In areas where dairy products will be graded or examined for quality, how many foot candle are required?
50
How should dairy waste be disposed of?
Must be consistent with the EPA regulations
When storing cheese, how far should it be away from walls?
18” from walls and stored on pallets or dunnage
What should be included in a master sanitation schedule?
- daily, weekly and monthly cleaning and sanitizing tasks
- who is responsible for each task
On foot baths, what is the ppm if using QUATS? Chlorine?
Quats: 400-800ppm
Chlorine: 200ppm
What are the Top Food Allergens?
Wheat
Fish
Milk
Shellfish
Tree Nuts
Eggs
Peanuts
Sesame
Soy
What is ACP?
Allergen Control Plan
What falls under the definition of “product contact water”?
Any water used for:
- ingredient water
- water used for flushing product
- water used for washing and sanitizing
Can the water used in heat exchangers be potable or non potable?
Must be potable water source
In regards to HVAC, how should the production facility be designed?
Should have positive air pressure zones. The highest pressure area should be where the product is exposed to open air
HVAC air intakes should never be located in which locations?
Near feed mills, livestock operations, etc
What 4 elements are required in the 2016 Sanitary Transportation of Human and Animal Food?
- proper vehicles and equipment
- transportation operations (temp controls, proper loading/handling, etc)
- training
- records
When calibrating pH meters, what are the levels you test for calibration?
4.0 and 7.0 (sometimes 10.0 if needing to test for that level of alkalinity)
For quality control purposes, what information should be included on the make sheet for a product?
- date and batch/lot code
- ingredients
- lot codes of ingredients (for traceability)
- amount of each ingredient used
- vat number
If not using all of an ingredient and it’s disposed of, should it be logged?
Yes! In the event of a recall, 100% of the ingredient should be traceable
What is the difference in a recall and a market withdrawal?
Market withdrawal: Voluntary withdrawal of a product that does not warrant legal action by regulatory agencies or no violations of state/federal/local regulations or health hazard
What event should trigger an internal investigation regarding food safety
Two reported incidents/complaints from customers about a product with the same code date
If notified of a recall, what information should be documented?
What the action is (recall; no recall)
The manufacturer/importer/distributors instructions of what to do with the affected product
Should testing as part of an Environmental monitoring and testing program be completed at in-plant laboratories?
No! Too high of a risk
Use verified third party off-site laboratories
What are the two types of environmental monitoring samples?
Swabs for smaller, hard to reach areas; sterile sponges for larger areas
What is “foreign matter“?
Anything that does not belong in the product. Can include:
- wood
- plastic
- metal
- glass
- unwanted chemicals
What is involved in a glass Breakage Policy?
Required in areas that either use glass containers or have glass or glass substitutes in manufacturing areas.
Plan for cleanup, evaluation after cleaning, why it happened, ways to prevent it from happening again and documentation
What are the 2 Preventative Controls for allergens as a part of FSMA?
- Protection of allergen cross contact
- Labeling of the food correctly
What should a good traceability program encompass?
Create codes and document all product movement from suppliers through production and to customers
What is the time goal for completing a finished product recall?
Completed within 2 to 4 hours
How often should a mock trace recall be performed?
At least once a year
What does the Foreign Supplier Verification Program part of FSMA require?
That importers conduct risk based activities that ensure food imported has been produced in a manner that meets all US food standards
