Audit Checklist For Food Industry Page 3
Sections 5, 6, and 7
Please read disclaimer and instructions on page 1.
| Sec. |
Question |
Yes, No, or NA |
5.0
|
Material/Component Control
|
|
| 5.1 |
Material/Component Specification and Purchasing Control |
|
| 5.101 |
§110.80(a)(2) Do raw materials or other ingredients
contain levels of microorganisms that may produce food poisoning or other
disease? |
|
| 5.102 |
§110.80(a)(3)(4) Do raw materials and other
ingredients comply with FDA regulations, guidelines, and action levels for
poisonous or deleterious substances? |
|
| 5.103 |
§110.80(a)(2)(3)(4) Is there a supplier's guarantee or
certificate to verify compliance with the requirements in 5.101 and 5.102? |
|
| 5.2 |
Material Component Receipt, Inspection, Sampling, and
Laboratory Testing |
|
| 5.201 |
§110.80(a)(1) Are raw materials inspected to
ascertain that they are clean and suitable for processing into food? |
|
| 5.202 |
§110.80(a)(1) Are raw materials washed or cleaned as
necessary to remove soil or other contamination? |
|
| 5.203 |
§110.80(a)(1) Are containers and carriers of raw
materials inspected upon receipt? |
|
| 5.204 |
Are ingredients dated upon receipt with the date placed on
the bottom unit of pallet? |
|
| 5.205 |
Do receiving records indicate lot codes on all incoming
material? |
|
| 5.3 |
Material Component Storage and Handling |
|
| 5.301 |
§110.80(a)(1) Are raw materials segregated or otherwise
handled as necessary to ascertain that they are clean and ready for use? |
|
| 5.302 |
§110.80(a)(5) Are raw materials and other
ingredients, including rework, held in bulk or in containers designed to
protect against contamination? |
|
| 5.303 |
§110.80(a)(5) Are raw materials held at temperature
and humidity levels that prevent food from being adulterated? |
|
| 5.304 |
§110.80(a)(6) Are frozen raw materials and other ingredients
kept frozen? |
|
| 5.305 |
§110.80(a)(7) Are liquid or dry materials and other
ingredients received and stored in bulk held in a manner to protect
against contamination? |
|
| 5.306 |
Are pallets and skids kept clean and in good repair? |
|
| 5.307 |
Are raw materials stored off the floor and away from walls
and ceilings? |
|
| 5.4 |
Inventory Control Program |
|
| 5.401 |
Are ingredients, packaging supplies, and other materials
rotated on a FIFO basis? |
|
| 5.402 |
Are inventories maintained at a reasonable level to avoid
excessive age and insect infestation? |
|
| 5.5 |
Vendor Control Program |
|
| |
No requirements |
|
6.0
|
Operational Control
|
|
| 6.1 |
Material/Component/Label Verification, Storage, and Handling |
|
| 6.101 |
§110.80(b)(3) Are refrigerated foods kept
at 45°F (7.2°C) or below as appropriate? |
|
| 6.102 |
§110.80(b)(3) Are hot foods maintained at
140°F (60°C) or above? |
|
| 6.103 |
§110.80(b)(3) Are acid or acidified foods
held in hermitically sealed containers at ambient temperatures heat
treated? |
|
| 6.104 |
§110.80(b)(13) Are filling, assembling, and
packaging operations protected against contamination by use of safe and
suitable material for food containers and packaging materials? |
|
| 6.105 |
Are containers kept off the floor when not in
use? |
|
| 6.106 |
Are all ingredient storage containers properly
identified? |
|
| 6.107 |
Are materials selected for transport to
processing areas visually inspected and containers wiped clean? |
|
| 6.108 |
Is insect susceptible material that is over
three weeks old inspected according to random sampling method? |
|
| 6.2 |
Equipment/Line/Area Cleaning, Preparation, and
Clearance |
|
| 6.201 |
§110.80(b)(1) Is equipment taken apart
for thorough cleaning as necessary? |
|
| 6.202 |
§110.80(b)(17) Are food manufacturing
areas or equipment used for manufacturing non-human grade food or inedible
products? |
|
| 6.3
| Operational Process Validation and Production
Change Order Control |
|
| 6.301 |
§110.80(b)(13) Are critical control
points identified and controlled for filling, assembling, and packaging
operations? |
|
| 6.302 |
§110.80(b)(2) Is there careful monitoring of
physical factors such as time, temperature, humidity, pH, pressure, and
manufacturing operations such as freezing, dehydration, heat processing,
etc.? |
|
| 6.303 |
§110.80(b)(4) Are measures such as sterilizing,
irradiating, pasteurizing, freezing, refrigerating, control of pH or water
activity adequate to prevent the growth of undesirable microorganisms? |
|
| 6.304 |
Is there a formalized program for control of
bacteria, yeast, and mold? |
|
| 6.305 |
Are dry ingredients sifted with: a 16 mesh
screen; a 30 mesh screen for finely milled material? |
|
| 6.4 |
In-Process Inspection, Sampling, and Laboratory
Control |
|
| 6.401 |
§110.80 Is appropriate chemical,
microbial, or extraneous material testing conducted to identify sanitation
failures or possible food contamination? |
|
| 6.402 |
§110.80(b)(8) Are traps, sieves, metal
detectors, magnets, etc. used to detect the inclusion of metal or other
extraneous material? |
|
| 6.403 |
§113.60(a) For LACF products, are regular
observations maintained during production for gross closure defects? |
|
| 6.404 |
§113.60(a)(1) Are tear down
examinations for double seamed cans (LACF products) performed with
sufficient frequency on enough containers to ensure maintenance of seam
integrity? |
|
| 6.5 |
Reprocessing/Disposition of Material |
|
| 6.501 |
§110.80(b)(9) Are food, raw materials and
other ingredients that are adulterated disposed of in a manner to
protect other food from contamination? |
|
| 6.502 |
§110.80(b)(9 When reconditioning of adulterated food is done,
is a proven effective method used? |
|
| 6.503 |
§110.80(b)(9) Is reconditioned food
examined and found free of contamination before being incorporated with
other food? |
|
| 6.504 |
§110.110(d) Is food containing defects
above current defect action levels mixed with other lots of food? |
|
7.0
|
Finished Product Control
|
|
| 7.1 |
Finished Product Verification, Storage, and
Handling |
|
| 7.101 |
§110.80(b)(6) Are effective measures
taken to protect finished food from contamination by raw materials, other ingredients
or refuse? |
|
| 7.102 |
§110.80 Is all adulterated food (within
the meaning of the FD&C Act) either rejected or treated/processed to
eliminate contamination? |
|
| 7.103 |
§110.93 Is the storage and transportation
of finished food under conditions that protect against physical, chemical,
or microbial contamination? |
|
| 7.2 |
Finished Product Inspection, Sampling, Testing
and Release for Distribution |
|
| 7.201 |
§110.110(a) Does the finished product
contain natural or unavoidable defects at low, non-hazardous levels? |
|
| 7.202 |
§110.110(c) Have Good Manufacturing
Practices been followed in producing the food? |
|
| 7.3 |
Distribution Controls |
|
| 7.301 |
Are vehicles used to transport food visually
examined, cleaned, and maintained? |
|
| 7.302 |
Are distribution records maintained to identify
initial distribution? |
|
| 7.4 |
Marketing Controls |
|
|
No requirements |
|
| 7.5 |
Complaint Handling and Customer Satisfaction
Program |
|
|
No requirements |
|
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