Information
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Audit 750-FRM-0024 rev 1 March 28th, 2011 Quality Audit - Raw Materials
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Client / Site
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Conducted on
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Audited by
Administration
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Contact Name
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Number of employees
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Number of work quarters
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Building age. If extension, please specify dates
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Is there a union? If yes, which is the agreement convention due date?
150-HRS HUMAN RESOURCES
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1- Is there a training program for new employees?
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2- Is there a training program specific to certain tasks (For example: maintenance, cleaning, quality control)? See some employee's forms.
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3- Do all employees have been trained in accordance with good manufacturing practices?
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4- Are subcontractors also trained in accordance with good manufacturing practices?
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5-Is there a continue training program for all employees? Specify the themes.
450-MMS GOODS / PURCHASES MANAGEMENT
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1-Is there an approval system for suppliers?
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2- Is there an approval process for new ingredients? (Allergen, Kosher, Technical sheet)
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3- Are certificates of analysis required from suppliers?
550-PMS ENGINEERING AND MAINTENANCE
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1- Are the outside of the building and the field well maintained? ?
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2- Is the inside of the building well maintained and designed to ensure food safety of products?
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3- Are the equipments well designed and positioned properly (to facilitate cleaning and maintenance and thus reduce the risk of contamination)?
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4- Are maintenance chemicals food grade at production areas?
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5-Does the company have a management program for maintenance with a risk of foreign material?
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6- Do you have a preventive maintenance program?
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7- Are the water, steam and compressed air systems appropriate to prevent product and environment contamination?
650-PPS PRODUCTION PROCESS
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1- Does the company have a traceability system (describe the process)?
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2- Does the company make measurements and analysis during production?
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3- Does the company make controls at product packaging (sealing, identification)?
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4- Does the company have a weight control system?
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5- Is there a procedure in place for the management of rework?
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6- Is there a system in place for the management of containers, utensils and tools (identification, color coding)?
750-QMS QUALITY MANAGEMENT
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1- Does the company have an accreditation to a quality standard? If yes, please specify (attach a copy of the certificate).
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2- Is the company audited by external agencies or third party? If yes, please specify.
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3- Does the company perform internal facility audits (minimum once per month)?
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4- Is the effectiveness of the quality system reviewed regularly?
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5- Is there a documentary managment system?
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6- Is there any HACCP plan in place for each product family? If yes, specify the product families and the CCP's.
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7- Are the CCP control responsible persons adequately trained and are able to make good decisions in case of critical limit deviation ?
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8- Audit at least 3 control registers for each CCP.
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9- Are the protection mechanisms against foreign bodies appropriate (magnets, sieves, filters, metal detectors, X-Ray detectors, optical sorters)?
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10- Are the protection mechanisms frequently verified. (See registers).
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11- Are the flour sifter tailings checked frequently?
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12- Does the company conduct an investigation when a foreign body is found inside the facility (See registers).
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13- Is there a calibrations program for equipments (lab and production)?
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14- Does the company conduct microbiological and chemical analysis of raw materials and/or finished products?
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15- Is there a specification management system of finished products?
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16- Is there a product recall procedure?
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17- Does the company conduct a mock recall at least once a year? (See the last simulation and describe the results)
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18- Does the company have a complaint management system?
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19- Is there a mechanism for identifying non-compliant products? If yes, describe the mechanism.
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20- Is there a master cleaning schedule (including frequency and methodology for all building components and equipments)?
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21- Is the cleaning program effective? Please see documentation for at least 3 items).
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22- Are the cleaning products approved for food?
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23- Does the company conducts pre-operational inspection of the surfaces in contact with food?
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24- Is there a program to validate the effectiveness of cleaning?
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25- Does the company have a pest control program?
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26- Does the company uses a contractor for this service? If yes, what is the name of the company?
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27- Is the pest control program adequate?
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28- Is there any evidence of contamination by insects, rodents or other?
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29- Is there a documented procedures for handling glass, brittle or hard plastic?
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30- Are all the lighting system adequately protected to prevent risk for the products?
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31- Is there a zone to isolate the nonconforming or quarantined products?
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32- Is there an allergen management program in place?
820-WMS LOGISTICS / WAREHOUSE - RECEIVING
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1- Does the company ensure stock rotation according to the FIFO (first in, first out) or other principle?
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2- Does the company has a location management system?
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3- Are the raw materials and the packaging goods stored, handled and properly identified to insure their integrity and their traceability?
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4- Are there any designated areas for raw materials versus finished products?
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5- Is the warehouse temperature controlled? If yes, what are the normal or programmed temperatures?
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6- Is the warehouse humidity controlled? If yes, what are the normal or programmed humidity levels?
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7- Is the racking system at a minimum distance of 18 inches from the walls?
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8- Is there a visual inspection of the trucks before loading? If yes, is it documented?
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9- Is there a visual inspection of the products before loading? If yes, is it documented?
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10- Is the security system adequate to fight against bioterrorism? Note FDA number
Appendix 1 - Allergens
ALLERGENS IN THE PLANT
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PEANUTS AND DERIVED PRODUCTS (example: PEANUT OIL)
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NUTS AND DERIVED PRODUCTS
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SESAME SEEDS
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DAIRY PRODUCTS - SPECIFY: MILK, LACTOSE, CASEIN, WHEY
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EGGS
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FISH
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<br>MOLLUSCS
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SOYA AND DERIVED PRODUCTS (example: SOY PROTEINS, LECITHIN, OIL)
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WHEAT / GLUTEN (eg SEASONING, FLAVOR, OATS, BARLEY, TRITICAL, ETC.)
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SULFITES AND DERIVED PRODUCTS
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MUSTRAD
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OTHER (SPECIFY)
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Comments
Appendix 2 - COMMENTS
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Indicate the unsatisfactory elements to be improved
Appendix 3 - STATUS
SUPPLIER
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Quality VP validation
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Select date
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IN CAS OF CONDITION - VALIDATION
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Auditor Signature
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Select date