Good Manufacturing Practices (GMPs)
What is the primary objective of GMP training for employees?
Ensure competency in FMP procedures
When is our 2024 Safe Quality Food Audit? Who is our certification body (CB).
July 22-23, 2024. It's a two day audit.
SCS Global Services
What does HACCP stand for? What is HACCP?
1. Hazard Analysis Critical Control Point (system)
2. HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.
What's the difference between Food Safety and Food Defense?
Food defense means the effort to protect food from intentional acts of adulteration.
Food safety is concerned with the unintentional adulteration of the food supply.
What is the purpose of Standard Operating Procedure (SOP)?
Document step-by-step instructions for tasks
List five things that are not allowed on the GMP floor (warehouse and production room).
Jewelry, gum, sleeveless shirts or blouses, no clothing with sequins or other decorative attachments, false lashes or fingernails, excessive cosmetics, etc.
What does GFSI stand for? What is the purpose of it?
1. Global Food Safety Initiative
2. The Global Food Safety Initiative (GFSI) is a non-profit association of industry experts committed to improving food safety along the value chain. The GFSI approves a number of food safety standards covering farming, packaging, storage and distribution.
Who's on our HACCP team? How often is the HACCP team suppose to meet?
Cierra, Lenny, Juliet, Michael, and Myron! (We're open to more employees joining :) )
A minimum, once a year. Meet whenever there's been a change to the HACCP Plan.
How many official entrance/exit doors do we have at our Canvasback facility?
1!!
Where do we store our records?
On our shared-drive (digital) and in our storage room (physical).
True or False. Full time employees are the only people who have to follow all GMP?
FALSE! All personnel are required to follow our GMPs in order to ensure product quality and safety. GMP's are a set of guidelines and regulations that apply to all individuals involved in the manufacturing process, including full-time, part-time, and temporary employees.
What is SQF? What is the purpose of SQF?
It is a food safety management system.
SQF certification provides an independent and external verification that a product, process, or service complies with international, regulatory, and other specified standard(s) and enables a food producer to give assurances that food has been produced, prepared, and handled according to the highest possible standards.
Yes or No. Do we have any Critical Control Points (CCPs)? Explain your answer.
No, we do not have any CCPs. The raw material is further processed once it leaves our facility.
What is a front-line employee?
The front-line employees from farm-to-fork are the "hands-on" people who actually have contact with the food, and are familiar with the proper measures to safeguard the food for food safety and food defense purposes. If you see something unusual or suspicious, it is your responsibility to report the incident.
What are the rules for records?
(1) Read instructions (SOPs and SSOPs), (2) Use black or blue ink only, (3) Handwriting must be legible, (4) Mistakes--cross them out with a single line and initial next to it (no white out!), (5) If something doesn't make sense or is not applicable to our process, talk to your supervisor or FSQA, (6) Do not worry about keeping the documents clean and free of wrinkles
Which organization provides guidelines for GMPs? (Hint: it's three organizations).
FDA (U.S. Food and Drug Administration), WHO (World Health Organization), ISO (International Organization for Standardization)
What does an SQF auditor do?
He/she examines our SQF system to determine: (1) If the system has been implemented effectively, (2) If there is evidence of Management Commitment to maintenance and improvement of the system, (3) If the activities comply with regulatory, customer, and SQF requirements.
There are three hazards that have the potential to cause an adverse health effect. What are the three hazards? Give an example for each.
1. Biological, chemical, and physical
2. (B): Mold, pathogenic bacteria (Salmonella, E-Coli, Listeria), Parasites, viruses
(C) Allergens, pesticides, toxic metals, cleaning chemicals
(P): Glass, metal fragments, hair, wood, etc.
Give an example of suspicious activity.
Suspicious activities may include an employee being in an area where they don't belong, acting anxious, bringing prohibited personal items into the processing area, or handling/opening containers in a suspicious way. An inside attacker who has access to the food facility and processes is one of the most difficult types of threats to prevent. In your work area you should be aware of who belongs where and their responsibilities.
During a mock recall/traceability exercise, what documents are needed?
CoAs, Blending instructions, sales/purchase orders, inbound/outbound reports, shipping/receiving reports, customer complains (if applicable), inventory sheet.
Describe what Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 117), Subparts A through F, is about.
PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
(A) General Provisions, (B) Building and Facilities, (C) Equipment, (D) Reserved, (E) Production and Process Controls, (F) Reserved
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-110
We received nine nonconformances (1 major and 8 minors). Describe 3 of the non-conformances and the corrective actions implemented.
Use Green Shutter Corrective Action Form
Do we have any control measures in place? If so, name three.
Yes, we do. We have multiple prerequisite programs in place to prevent or eliminate a food safety hazard or to reduce it to acceptable levels.
Cleaning program, GMPs, Pest Control, Chemical Control, Product Recall/Traceability, Supplier Approval, Food Defense, Glass, Brittle, Plastic, etc.
What does the "FIRST" acronym stand for?
FDA has developed an initiative for front-line employees, which emphasizes that employees are the FIRST line of food defense. The FIRST acronym makes it easy to remember your role as a front-line employee in food defense.
Follow company food defense plan and measures
Inspect your work area and surrounding areas
Recognize anything out of the ordinary
Secure all ingredients, supplies, and finishes product
Tell management or FSQA if you notice anything unusual or suspicious
What is the definition of traceability?
The ability to track food through all stages of production, processing and distribution. Traceability movements should be traced one step backwards and one step forward at any point in the supply chain.
Recalls are often voluntary; however in some instances regulatory agencies may mandate a recall. In some countries, withdrawal is used as recall. They may be conducted – on your own initiative, – By request of your buyer, – by FDA request, or – by FDA order under court order. Types of Recalls I, II, III (1 worst, 2 potentially dangerous, 3 least dangerous)