A. Purchasing
B. Supplier certification
C. Ingredient specification
D. First aid materials

A.  Purchasing.  Whenever possible, supplies shall be purchased from suppliers who have registered HACCP programs and provide HACCP-based certification of all supplies and materials.  If not, suppliers must provide information on probable levels of pathogen contamination.  Suppliers of chemical products must furnish Material Safety Data Sheets.  Suppliers of food containers must provide information on leaching of substances from the container or provide proof that the food container surfaces are constructed of FDA-approved materials.  Equipment suppliers must provide simple cleaning and maintenance instructions for their equipment and how the equipment must be used to achieve FDA safety standards.

B.  Supplier certification.  A summary list shall be maintained, showing supplier, items supplied, presence of a supplier HACCP certification program.

 The following forms can be used for supplier certification records.
            (a)  Supplier HACCP Qualification Standards.  (See Section V, encl. 1.)  This form requires the supplier to provide information about the supply company's HACCP-TQM program.  The supplier's information should be kept on hand to verify performance when you periodically visit the supplier.
            (b)  Supplier HACCP/QA Qualification List by Ingredients Purchased.  (See Section V, encl. 2.)  This form provides a summary list of the suppliers that have provided HACCP-TQM information.  Each year, when the supplier HACCP forms are updated, it is appropriate to check to see if supplier(s) are improving, and if the hazard levels/sizes (of hard foreign objects) have been reduced.

C.  Ingredient specification.  Ingredient specification shall be supplied for each ingredient by the supplier.

Compliance with the above shall be achieved by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or by analyzing these materials and ingredients for aflatoxins, other natural toxins, and contamination. When a supplier does not have a HACCP certification program, there can be random hazard contamination of raw food.  If the food supplier provides no microbiological data, assume the following pathogenic microbial levels:

Expected Contamination Levels
(Number / ml or gram of food)

Salmonella spp., Vibrio spp., Hepatitis A, Listeria monocytogenes 
   10 CFU / g
Campylobacter jejuni (on meat, poultry, and milk) 
 100 CFU / g
Clostridium botulinum 
     1 CFU / g
Clostridium perfringens (in meat and poultry) 
100 CFU / g
Bacillus cereus (in grains, cereals and legumes) 
100 CFU / g
Mold toxins, bacterial toxins  Below government tolerances
Below government tolerances
D.  First aid materials.  First aid materials shall be stored so that these materials cannot contaminate food.  First aid supplies shall be checked weekly by the PICs and shall be replenished.

Encl. 1

Vendor ________________________________________________________________  Date  _____________

Address  _____________________________________

Since you are one of our current / potential vendors, we would like to know about your quality assurance program.  If you have a HACCP program, we consider this to be part of your QA program.  It is very costly for us to receive a product or service from a vendor that does not meet our expectations.  Please answer the following questions and provide the material as appropriate concerning your quality assurance plan and program to achieve each requirement.  When we visit with you, we will expect that you be able to demonstrate that you do each item effectively and are continually improving.

  1. Who developed your HACCP / Quality Assurance program?

         Who validated your program as effective?

         Who are the members of your HACCP / QA team?

         How often do they meet?

         Describe your pre-ship verification program.

  2. Have you taught each employee who works with food the hazards associated with the task he/she performs and how to perform the necessary controls?

  3. What do you require of your suppliers in terms of ingredient HACCP controls?

  4. Please tell us about your recall and emergency action program.

  5. Describe the responsibilities of your Quality Assurance / Quality Control department.

         What ingredient testing do you do?

         What product testing do you do?

  6. What are the critical limits, if you have them, for the biological, chemical, and physical hazards that are reasonably likely to be in the products you provide to use?

 In addition to the above, please provide specifications to us for the products we purchase from you.

We will appreciate your prompt response.



Encl. 2

 Food Item(s)
 HACCP Yes/No:
  Date Expected Hazards and Levels

To Table of Contents
To Section IV
To Section VI