GMP Audit v14.09 Scope Outline - PrimusLabs

1 Audit #: _____Start Time: _____Date: _____End Time: _____Facility Name: _____FDA Registration #: _____Season Duration: _____Approximate Size of the Facility (ft or m ): _____GPS: _____Location: _____GMP Audit Scope OutlineAuditor Name: _____Supervisor: _____Audit Scope (& any exclusion): _____Lines Audited: _____Cooling Equipment Audited: _____Wet/High Humidity Storage: _____Product washed or hydrovaced: _____# of Employees: _____Customer: _____Additional Commodities: _____Commodities Observed: _____PrimusLabs GMP Audit ChecklistPage 1 of 17 good manufacturing practices - SECTION 1 Category#QuestionTotal was no significant threat to the safety of the product that may be considered critical and warrants an automatic failure? Explain. ANY DOWN SCORE IN THIS QUESTION RESULTS IN AUTOMATIC FAILURE OF THE Areas & Packaging all chemicals (pesticides, sanitizers, detergents, lubricants, etc.)

2 Stored securely, safely and are they labeled correctly?15 Storage Areas & Packaging "food grade" and "non-food grade" chemicals used appropriately, according to label and stored in a controlled manner? 10 Storage Areas & Packaging ingredients (including ice), products, and packaging stored to prevent cross contamination (this includes iced product pallets stored above pallets of product without adequate protection as well any allergen cross contamination issues)?15 Storage Areas & Packaging the storage area completely enclosed? 10 Storage Areas & Packaging the facility's use restricted to the storage of food products?5 Storage Areas & Packaging rejected or on hold materials clearly identified and separated from other materials?10 Storage Areas & Packaging raw materials, work in progress, ingredients (including water and ice), finished goods and food contact packaging within accepted tolerances for spoilage and free from adulteration?

3 ANY DOWN SCORE IN THIS QUESTION RESULTS IN AUTOMATIC FAILURE OF THE Areas & Packaging all storage areas clean, especially the racking structures, lights, ceilings, floor areas by the walls and other hard to reach areas?10 Storage Areas & Packaging materials (commodities, packaging, ingredients, processing aids, work in progress, etc.) properly marked with rotation codes (receipt dates, manufacture dates, etc)?5 ChecklistPRIMUSLABS GMP AUDITP rimusLabs GMP Audit ChecklistPage 2 of 17 Storage Areas & Packaging materials (commodities, packaging, ingredients, processing aids, work in progress, etc.) rotated using FIFO policy?5 Storage Areas & Packaging storage areas at the appropriate temperatures for the specific products being stored?10 Operational the process flow, facility layout, employee control, utensil control, internal vehicle use, etc. ensure that finished goods are not contaminated by raw materials?

4 15 Operational all exposed materials (product, packaging, etc.) protected from overhead contamination ( ladders, motors, condensation, lubricants, walkways, loose panels, degrading insulation, etc.)?15 Operational packing and/or processing areas completely enclosed?15 Operational storage areas clean and well maintained; especially lights, floor areas by the wall and equipment, and other hard to reach areas? 15 Operational all re-work / re-packaging handled correctly?10 Operational raw materials examined before use?5 Operational finished products coded (carton and unit packaging) for the day of production?10 Operational finished product coding clearly link to supplier(s) of incoming materials? (Auditor performs a live traceback test to verify documentation reviewed for )10 Operational foreign material control methods ( metal detectors, metal traps, visual inspection, etc.)

5 In place? Are these systems regularly tested (where relevant) to ensure proper operation?10 Operational the facility use the appropriate test strips, test kits or test probes for verifying the concentrations of anti-microbial chemicals (product washing water, terminal sanitizers, dip stations, etc) being used and are they in operational condition?10 Operational Are hand washing stations adequate in number, appropriate in location, in working order, have warm water, adequately stocked ( disposable towels, soap, etc.) and restricted to hand washing purposes only? 15 Operational toilet facilities adequate in number and location and are they adequately stocked ( toilet paper, disposable towels, soap, etc.)?15 Operational secondary hand sanitation stations ( , touch-free dispensers) adequate in number and location? Are the stations maintained properly?5 PrimusLabs GMP Audit ChecklistPage 3 of 17 Operational foot dip stations adequate in number and location?

6 Are the stations maintained properly?3 Operational single service containers used for their intended purpose only so that potential cross contamination is prevented?5 Operational re-usable containers clean and clearly designated for the specific purpose (raw product, finished product, re-work, ice, trash, etc.) such that cross contamination is prevented?10 Operational food safety measuring devices working properly and calibrated (where applicable)? 3 Employee employees washing and sanitizing their hands before starting work each day, after using the restroom, after breaks and whenever hands may be contaminated?15 Employee employees fingernails clean, short and free of nail polish?5 Employee there no sign of any employees with boils, sores, open wounds or exhibiting signs of foodborne illness working in indirect or direct contact with food?10 Employee first aid kits adequately stocked and readily available?

7 Are blue metal detectable waterproof band aids used? 5 Employee employees wearing effective hair restraints?10 Employee jewelry confined to a plain wedding band and watches are not worn?3 Employee all employees wearing outer garments suitable for the operation ( smocks, aprons, sleeves and non-latex gloves)?10 Employee employees remove protective outer garments smocks, aprons, sleeves and gloves when on break, before using the toilets and when going home at the end of their shift?5 Employee there a designated area for employees to leave protective outer garments smocks, aprons, sleeves and gloves when on break and before using the toilets?5 Employee personal items are not being stored in the production or material storage areas? 5 Employee smoking, eating, chewing and drinking confined to designated areas; spitting is prohibited in all areas?10 Employee all items removed from garment (smock, shirt, blouse, etc) top pockets?

8 Food contact equipment surfaces free of flaking paint, corrosion, rust and other unhygienic materials ( tape, string, cardboard, etc.)?15 PrimusLabs GMP Audit ChecklistPage 4 of non-food contact equipment surfaces free of flaking paint, corrosion, rust and other unhygienic materials ( tape, string, cardboard, etc.)? equipment design and condition ( smooth surfaces, smooth weld seams, non-toxic materials, no wood, or other absorbant materials) facilitate effective cleaning and maintenance? thermometers (independent of thermostat probes) present in all coolers and freezers? all thermometers non-glass and non-mercury?10 Equipment food contact equipment surfaces clean?15 Equipment non-food contact equipment surfaces clean?10 Equipment cleaning are foods and packaging protected from contamination?15 Equipment cooling units including coils in coolers and freezers clean and free of aged, dirty ice?

9 5 Equipment all fan guards dust-free and the ceiling in front of the fans free of excessive black deposits?5 Equipment stored equipment that is not used on a daily basis stored in a clean condition with food-contact surfaces protected and/or are they retained on cleaning schedules in some manner, even though they are not in use?10 Equipment all utensils, hoses, and other items not being used stored clean and in a manner to prevent contamination?10 Equipment maintenance tools that are used in the production and storage areas of the facility clean, sanitary and corrosion free?3 Equipment excess lubricants removed from the equipment and are lubricant catch pans fitted where needed? 5 General spills cleaned up immediately?10 General waste and garbage frequently removed from packing and storage areas?5 General floor drains appear clean, free from odors and well maintained?5 General high level areas including overhead pipes, ducts, fans, etc.

10 Appear clean?10 General plastic strip curtains maintained in a good condition, kept clean and mounted so that the tips are not touching the floor?5 PrimusLabs GMP Audit ChecklistPage 5 of 17 General personal protection equipment (PPE) for the sanitation crew meet label requirements of chemicals used; is it in good condition and stored to prevent cross contamination to raw materials, work in progress, ingredients, finished goods and packaging?3 General cleaning equipment maintained clean and stored properly?10 General cleaning equipment identified in order to prevent potential cross contamination issues production, maintenance, outside, restroom equipment?10 General all items used for sanitation appropriate for their designated purpose? (no steel wool, metal bristles, etc.)5 General toilet facilities and hand-wash stations clean?15 General employee break facilities clean, including microwaves and refrigerators?