AIFI Supplier Food Safety and Quality Questionnaire

8066 Fulton Street E

Ada, MI 49301

Phone: 616-974-9093

Fax: 616.974.9618

AIFI – Supplier Food Safety and Quality Questionnaire

Supplier Name: / Click here to enter text.
Contact Name: / Click here to enter text. / Title: / Click here to enter text.
Address: / Click here to enter text.
Telephone: / Click here to enter text. / Fax: / Click here to enter text. / E-Mail: / Click here to enter text.
Manufacturer Name (If different from above): Click here to enter text.
Contact Name: / Click here to enter text. / Title: / Click here to enter text.
Address: / Click here to enter text.
Telephone: / Click here to enter text. / Fax: / Click here to enter text. / E-mail: / Click here to enter text.
Please list all products manufactured at this location: / Click here to enter text.

A. FOOD SECURITY COMPLIANCE

1.  Does the manufacturing facility comply with the following?
·  FDA Registered Food Facility / ☐Yes / ☐No / ☐N/A
·  Kosher Certified / ☐Yes / ☐No / ☐N/A
·  Halal Certified / ☐Yes / ☐No / ☐N/A
·  HACCP / ☐Yes / ☐No / ☐N/A
·  FCC Standard / ☐Yes / ☐No / ☐N/A
·  USP Standard / ☐Yes / ☐No / ☐N/A
·  SGS/AIB/BRC Certified / ☐Yes / ☐No / ☐N/A
·  ISO 9000 Quality Management / ☐Yes / ☐No / ☐N/A
·  ISO 14000 Environmental Management / ☐Yes / ☐No / ☐N/A
·  ISO 22000 Food Safety Management/ HACCP / ☐Yes / ☐No / ☐N/A
·  FSSC 22000 Food Safety Management/ HACCP / ☐Yes / ☐No / ☐N/A
·  Other: / ☐Yes / ☐No / ☐N/A
2.  Independent Inspections/Audits
·  Which independent organization audited the facility in the past 12 months? Click here to enter text.
·  Was the audit announced or unannounced? Click here to enter text. / ☐Yes / ☐No / ☐N/A
·  Date of last audit: Click here to enter text.
·  Grade of last audit: Click here to enter text.
·  Please include a copy if the grade is less than 85%

B. REGULATORY REQUIREMENTS

1.  Does the facility comply with the Bioterrorism Act 2002?
·  If yes, please provide date of most recent registration with the FDA: Click here to enter text.
·  Please attach statement of registration. / ☐Yes / ☐No / ☐N/A
2.  Has this facility received any Regulatory Noncompliance Actions or 483 forms in the last 3 years?
·  If yes, please provide details or 483 form, as applicable: Click here to enter text. / ☐Yes / ☐No / ☐N/A
3.  Please provide date of the last state or federal agency inspection: Click here to enter text.
4.  Are programs in place to assure that all products meet applicable local, state and federal regulations? / ☐Yes / ☐No / ☐N/A
5.  Are programs in place to ensure proper labeling of materials? / ☐Yes / ☐No / ☐N/A
6.  Is background check performed on all employees? / ☐Yes / ☐No / ☐N/A
7.  Can you provide the following documents?
·  Kosher Certificate / ☐Yes / ☐No / ☐N/A
·  Halal Certificate / ☐Yes / ☐No / ☐N/A
·  Ingredient Statement / ☐Yes / ☐No / ☐N/A
·  Allergen Statement / ☐Yes / ☐No / ☐N/A
·  Nutritional Statement / ☐Yes / ☐No / ☐N/A
·  SDS / ☐Yes / ☐No / ☐N/A
·  Organic Certificate / ☐Yes / ☐No / ☐N/A
·  Certificate of Origin / ☐Yes / ☐No / ☐N/A
·  Health Certificate / ☐Yes / ☐No / ☐N/A
·  Fumigation Certificate for pallets / ☐Yes / ☐No / ☐N/A
·  Natural Statement / ☐Yes / ☐No / ☐N/A
·  Lot Code Explanation / ☐Yes / ☐No / ☐N/A
·  GMO Statement / ☐Yes / ☐No / ☐N/A
·  Picture of the packaging and product label / ☐Yes / ☐No / ☐N/A
·  Letter of Guarantee / ☐Yes / ☐No / ☐N/A
·  Warranty Statement / ☐Yes / ☐No / ☐N/A
·  Liability Insurance / ☐Yes / ☐No / ☐N/A
8.  Do all employees receive Food Security training annually? / ☐Yes / ☐No / ☐N/A

C. QUALITY PROGRAMS

Are there documented programs for the following?
1.  Document and Records Management / ☐Yes / ☐No / ☐N/A
2.  Good Manufacturing Practices and Food Safety / ☐Yes / ☐No / ☐N/A
·  Is there a program in place for all new employees? / ☐Yes / ☐No / ☐N/A
·  Is there a documented re-training program of all employees on an annual basis?
·  Date of last training session: Click here to enter text. / ☐Yes / ☐No / ☐N/A
3.  Supplier Approval / ☐Yes / ☐No / ☐N/A
·  If so, does it include review of food safety and quality programs?
·  Please briefly describe the approval process: Click here to enter text. / ☐Yes / ☐No / ☐N/A
·  Are supplies and products obtained from approved suppliers only? / ☐Yes / ☐No / ☐N/A
·  Are there inspection procedures in place for incoming materials? / ☐Yes / ☐No / ☐N/A
·  Are the controls in place to ensure that raw and packaging materials comply with specification? / ☐Yes / ☐No / ☐N/A
4.  Products and Labeling / ☐Yes / ☐No / ☐N/A
5.  Product Traceability and recall / ☐Yes / ☐No / ☐N/A
6.  Weight Control / ☐Yes / ☐No / ☐N/A
7.  Storage and Shipping / ☐Yes / ☐No / ☐N/A
8.  Non-Conforming Material Control / ☐Yes / ☐No / ☐N/A
·  Are materials and ingredients tested and inspected for conformance to specifications? / ☐Yes / ☐No / ☐N/A
·  Are finished products tested for conformance to specifications?
·  Please explain how are non-conforming items identified and segregated: Click here to enter text. / ☐Yes / ☐No / ☐N/A
·  Is a Certificate of Analysis provided for every lot of product? / ☐Yes / ☐No / ☐N/A
·  Are internal laboratory procedures verified through comparison to an external lab?
·  If yes, briefly describe procedure and frequency: Click here to enter text. / ☐Yes / ☐No / ☐N/A
·  Are external accredited laboratories contracted for testing? / ☐Yes / ☐No / ☐N/A
9.  Rework Control / ☐Yes / ☐No / ☐N/A
·  If yes, how is rework material evaluated prior to use?
·  How is rework material traceability documented? Click here to enter text. / ☐Yes / ☐No / ☐N/A
10.  Returned Product Control / ☐Yes / ☐No / ☐N/A
11.  Customer Complaint Handling and Root Cause Analysis / ☐Yes / ☐No / ☐N/A
12.  Equipment Calibration / ☐Yes / ☐No / ☐N/A
13.  Preventative Maintenance / ☐Yes / ☐No / ☐N/A
14.  Vendor Management / ☐Yes / ☐No / ☐N/A
15.  Change Management / ☐Yes / ☐No / ☐N/A
·  Is there a process to notify customers of manufacturing process and product specification changes?
·  Please explain: Click here to enter text. / ☐Yes / ☐No / ☐N/A
16.  Internal Quality Audits / ☐Yes / ☐No / ☐N/A
17.  Crisis Management / ☐Yes / ☐No / ☐N/A
18.  Continuous Improvement / ☐Yes / ☐No / ☐N/A

D. HACCP AND FOOD SAFETY PROGRAMS

1.  Does the facility have a documented HACCP Program?
·  If yes, please attach the HACCP Program Summary and the HACCP Flowchart
·  If no, by what date do you plan to implement your HACCP Program? Click here to enter text. / ☐Yes / ☐No / ☐N/A
2.  Is there a multi-disciplinary HACCP Team in place? / ☐Yes / ☐No / ☐N/A
3.  Is there a flowchart for each manufacturing process that includes the identification of CCPs? / ☐Yes / ☐No / ☐N/A
4.  Does the HACCP Program address all products and processes within the facility? / ☐Yes / ☐No / ☐N/A
5.  Is the HACCP Program validated?
·  If so, by whom and what date? Click here to enter text. / ☐Yes / ☐No / ☐N/A
6.  Does the Hazard Analysis include evaluation of all ingredients, equipment, processing steps and packaging? / ☐Yes / ☐No / ☐N/A
7.  Is the HACCP Program reviewed at least once a year and when process changes occur? / ☐Yes / ☐No / ☐N/A
8.  Do all employees receive HACCP training at least annually? / ☐Yes / ☐No / ☐N/A
9.  Is your facility certified by a GFSI standard?
·  If yes, please attach the most recent certificate, audit report and corrective actions. / ☐Yes / ☐No / ☐N/A
·  If no, do you plan to become GFSI certified?
·  When? Click here to enter text. / ☐Yes / ☐No / ☐N/A
10.  Do all employees receive Blood Borne Pathogen training annually? / ☐Yes / ☐No / ☐N/A
11.  Do all employees receive Food Safety training annually? / ☐Yes / ☐No / ☐N/A
12.  Are periodic food safety inspections conducted and actions taken to address issues found? / ☐Yes / ☐No / ☐N/A
13.  Does your facility have an Environmental Monitoring Program in place? / ☐Yes / ☐No / ☐N/A

E. QUALITY MANAGEMENT

1.  Do you perform in-house inspections for compliance to FDA GMP’s local and state requirements… etc?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
2.  Are finished goods tested according to specified parameters?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
3.  Are test results completed prior to shipment?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
4.  Are CoA’s issued on a routine basis? / ☐Yes / ☐No / ☐N/A
5.  Is there an internal program that monitors pesticide levels of your finished material?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
6.  HOLD and RELEASE Program / ☐Yes / ☐No / ☐N/A
·  Is there a written program in place? / ☐Yes / ☐No / ☐N/A
·  Is there a separated storage area for held items?
·  Describe how held items are identified: Click here to enter text. / ☐Yes / ☐No / ☐N/A

F. FACILITY AND EQUIPMENT

1.  Is the facility constructed in such a way that it meets regulatory food safety and quality requirements? / ☐Yes / ☐No / ☐N/A
2.  Are structures, floors, walls, ceilings and equipment well maintained as not to compromise product safety? / ☐Yes / ☐No / ☐N/A
3.  Is the outside perimeter free from debris, trash, weeds or grass? / ☐Yes / ☐No / ☐N/A
4.  Is there an 18” vegetation kill zone around the building? / ☐Yes / ☐No / ☐N/A
5.  Are all doors, windows, intake air ducts and exhausts protected with self-closing devices, screens, air curtains, louvers, or gaskets to protect against entry of insects, birds and other vermin?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
6.  Are all equipment and internal structures free from rust or peeling paint? / ☐Yes / ☐No / ☐N/A
7.  Are roofs, walls and docks free from cracks and leaks? / ☐Yes / ☐No / ☐N/A
8.  Is the temperature and humidity recorded in controlled storage and/or food handling areas? / ☐Yes / ☐No / ☐N/A
9.  Is the production a closed operation? / ☐Yes / ☐No / ☐N/A
10.  Please describe your equipment sanitary design requirements: / ☐Yes / ☐No / ☐N/A
11.  Do facility and equipment repairs meet FDA sanitary requirements? / ☐Yes / ☐No / ☐N/A
12.  Are inspections on all repairs performed in the process before starting production?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
13.  Are temporary repairs using tape, cardboard and wire allowed while production is running until scheduled maintenance?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
14.  Are only food grade lubricants used in the facility? / ☐Yes / ☐No / ☐N/A
15.  Are all product zones adequately protected?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
16.  Are there accessible hand washing stations in the processing areas? / ☐Yes / ☐No / ☐N/A
17.  Does the facility have potable water which meets local regulatory requirements?
·  If yes, is potable water tested? Click here to enter text.
·  What frequency? Click here to enter text. / ☐Yes / ☐No / ☐N/A
18.  Does the facility use compressed air for equipment cleaning purposes? / ☐Yes / ☐No / ☐N/A
·  If so, is compressed air tested for purity? / ☐Yes / ☐No / ☐N/A
·  What frequency? Click here to enter text.
19.  Is the compressed air used in processing filtered and trapped?
·  If so, what is the filter size? Click here to enter text. / ☐Yes / ☐No / ☐N/A

G. SANITATION

1.  Does the facility have a Master Sanitation Schedule? / ☐Yes / ☐No / ☐N/A
·  Is it written?
·  Name of person responsible for maintaining it: Click here to enter text. / ☐Yes / ☐No / ☐N/A
·  Are all sanitation chemicals used approved for use by the appropriate regulatory authority? / ☐Yes / ☐No / ☐N/A
·  Does the program include post-sanitation audits by a different department?
·  Describe: Click here to enter text. / ☐Yes / ☐No / ☐N/A
·  Are all cleaning records maintained? / ☐Yes / ☐No / ☐N/A
2.  Does the facility have documented Sanitation Procedures (SOP’s) for:
·  Production/Processing equipment cleaning? / ☐Yes / ☐No / ☐N/A
·  Workshop and warehouse structural cleaning? / ☐Yes / ☐No / ☐N/A
3.  Are pre-operational inspections conducted to verify that areas and equipment are clean prior to starting production? / ☐Yes / ☐No / ☐N/A
4.  What monitoring methods are used? Check all that apply:
·  Visual Inspection ☐
·  ATP bioluminescence ☐
·  Micro swabs ☐
·  Allergen swabs ☐
·  Others ☐

H. PERSONNEL PRACTICES