In the interest of Food Safety, compliance with the FDA Bioterrorism Act of 2002 and the FDA Food Safety Modernization Act of 2011, DPI is requesting the completion of this document as part of your food safety management system evaluation. All audits submitted for consideration must have been completed within the last 12 months.
Scenario 1:If your company or manufacturing site(s) is/are currently audited by a GFSI (Global Food Safety Initiative) recognized auditing scheme, please complete Sections 1, 2, 3 and 13. Also provide a copy of your certification, proof of FDA registration and HACCP Flow Chart.
Scenario 2:If your company or manufacturing site(s) is/are currently audited by a second or third-party auditing program, please complete Sections 1, 2, 3 and 13. Also provide the third-party audit’s executive summary page(s) including any corrective action statements. Also submit proof of FDA registration and HACCP Flow Chart. If your auditing company is not listed below, contact your DPI representative for guidance.
Scenario 3:If your company or manufacturing site(s) does not participate in a second or third party audit program, please complete all sections of theDPI Supplier Quality Assurance Questionnaire – Product; except Section 3. Also submit proof of FDA registration and HACCP Flow Chart.
Listed below are accepted auditing bodies.
Scenario 1 / Scenario 2 / Scenario 3GSFI / cGMP-HACCP / No Third-Party Audit
Global Aquaculture Alliance Seafood Processing Standard Issue 2 - August 2012
/ AIB International / DPI Supplier Quality Assurance Questionnaire - ProductASI Food Safety Consultants
Bureau Veritas Certification
Cert ID LC
Food Safety System Certification 22000 -FSSC 22000 - October 2011 Issue
/ Complete IntegratedCertification Services, Inc.
Global Red Meat Standard - (GRMS) 4th Edition Version 4.1 / Det Norske Veritas- DNV
Eagle Food Registrations, Inc.
Eurofins Certification
Safe Quality Food - SQF Code 7th Edition Level 2 / Guelph Food Technology
Centre (GFTC)
British Retail Consortium- BRC Global Standard for Food Safety Issue 6
/ Intertek Labtest Ltd.NCS International Pty. Ltd.
NSF International
International Featured Standards - IFS Food Standard Version 6
/ Perry Johnson Registrars, Inc.ProCert SA
SAI Global Certification Services
Scientific Certification Systems
SGS Societe Generale De
Surveillance SA
Silliker Global Certification
Services Pty. Ltd.
STR-Registrar, LLC
The Steritech Group, Inc.
TUV SUD America Inc.
Validus
SECTION 1SUPPLIER DETAILS
Name of SupplierAddress
Telephone
Fax
Commercial Contact / Name / Phone
Technical Contact (QA) / Name / Phone
Recall/Trace Back Contact
(24 Hour) / Name / Phone
Product(s) Supplied
SECTION 2SUPPLYING SITE(S) - MANUFACTURING DETAILS
Please complete Sections 2-13 for each supplying or manufacturingfacility (domestic or foreign):
Make additional copies as needed to address each manufacturing facility or site.
Name of Facility or SiteAddress
Telephone
Fax
Commercial Contact / Name / Phone
Technical Contact (QA) / Name / Phone
Recall/Trace Back Contact
(24 Hour) / Name / Phone
Product(s) Supplied
Question / YES / NO / Details/Further Information
1 / Is this facility registered with the FDA under Bioterrorism Regulations? / Please list the facility registration number
2 / Is this facility under the USDA Federal Meat Inspection Actauthority? / If Yes, please answer Question 3.
3 / What is the facility Establishment Number and Grant Date? / Please list the Plant NumberGrant Date
SECTION 3GFSI CERTIFYING AGENCY FOOD SAFETY SYSTEM COMPLIANCE
Is this manufacturing site accredited to a recognized GFSI Standard (SQF, BRC etc.)? / YES / NOA cGMP, GMP or HACCP audit does not meet the requirements of the Global Food Safety InitiativeStandard. Review chart on page 1 for guidance.
If YES, please indicate the following:Certificating Body
Date of Last Audit
Audit Standard
Level or Score Achieved
Please enclose a copy of your certification
If NO, what plans are in place to gain accreditation?
If the answer to Question 1 is YES, go to the end of the questionnaire (Section 13) and sign,
If NO, please continue and fill in the remaining sections; Sections 4-13 should be duplicated and completed for each manufacturing facility or site.
SELF-AUDIT QUESTIONNAIRE
SECTION 4PREMISES (Outside Facility)
Question / YES / NO / Details/Further Information1 / Are the surrounding grounds well maintained, landscaped and debris free?
2 / Is standing water present on the grounds or property that could provide a breading ground for insects?
3 / Are buildings in a good state of repair with no open holes or cracks?
4 / Are pipe and wire holes sealed to prevent rodents and insects from entering building?
5 / Are doors self-closing and close fitting?
6 / Are exterior warehouse doors ‘fast action’ or fitted with strip curtains?
7 / Are windows that open to outside fitted with screens?
8 / Is there evidence of roof leaks into the interior of the building?
9 / Is a 12-inch perimeter around the building foundation free from plant growth?
10 / Are outside storage areas located away from the building?
SECTION 5PLANT AND EQUIPMENT (Inside of Facility)
Question / YES / NO / Details/Further Information1 / Are walls floors and ceilings maintained to prevent harbourages for bacteria?
2 / Is all processing equipment designed and maintained to facilitate wash down and prevent contamination?
3 / Are there documented cleaning procedures, cleaning schedules and records of cleaning?
4 / Are all contact surfaces of equipment and tools suitable for the intended purpose?
5 / How is cleaning validated?
6 / Is ATP used to validate cleaning?
7 / Is there an effective planned maintenance program?
8 / Are lights protected from breakage?
9 / Is equipment routinely serviced and calibrated?
10 / Is the processing compressed air filtered?
If so, to what standard?
11 / What type of thermometer(s) is/are used in processing?
How often and how are thermometers calibrated?
12 / Is the production room/facility under positive air pressure?
13 / Is the air supply to the room filtered?
If so, to what standard?
14 / How often is the water supply tested for potability?
15 / Do you have a written backed-up drain policy?
16 / If scales are used in production, how often are they calibrated?
17 / If scales are used in production, how often are they checked?
18 / During excessive rain, does water flood into the facility?
19 / Is there evidence of roof leaks into the interior of the building?
20 / What procedures are in place should the roof leak?
SECTION 6PEST/INFESTATION CONTROL
Question / YES / NO / Details/Further Information1 / Who operates your pest control program?
2 / How many visits per year?
3 / What is the scope of the service?
4 / Do you have copies of the Pest Control Operator’s (PCO) current license or certificate?
5 / How often is a trend analysis performed?
6 / What is the spacing of the exterior bait stations?
7 / Are pesticides stored on site?
If so, where?
8 / Do you have current copies of all Safety Data Sheets for all pest control chemicals?
9 / Is waste material stored to prevent infestation?
10 / Do you have a written pest control policy?
SECTION 7PERSONNEL HYGIENE AND FACILITIES
Question / YES / NO / Details/Further Information1 / Are toilets and changing facilities available?
2 / Are these separate from production areas?
3 / Are employee break rooms available?
4 / Are protective aprons, frocks etc. provided?
If yes, what is provided and how many changes per week?
5 / Is there a written dress code policy?
6 / Are lockers provided for personal belongings?
7 / What controls are there on eating and drinking?
8 / Is there a written locker inspection policy?
9 / Is smoking permitted?
If yes, where?
10 / Are handwashing facilities used prior to entering production areas?
11 / Are blue, detectable dressings used on cuts?
12 / Does staff undergo any medical screening e.g. health questionnaire?
13 / Does staff receive any formal hygiene (cGMP) training?
14 / Are there regular hygiene (cGMP) audits?
15 / Is there a jewellery policy? Please describe.
16 / Is there a cell phone use policy in the facility?
17 / Is there a sick worker policy?
If yes, please describe.
18 / Is there a captive footwear policy in place?
19 / Where do employees store their lunches?
20 / If visitors or guests are allowed in production areas, what precautions are in place to prevent a visitor or guest from contaminating products?
SECTION 8SUPPLIER CONTROLS
Question / YES / NO / Details/Further Information1 / Do you have a list of your approved suppliers?
2 / Do you have specifications for all raw materials or ingredients you use?
3 / Do you audit suppliers and is this to a schedule or program?
4 / If suppliers are not audited, how do you approve them?
5 / Are any of the products you supply to DPI manufactured or sub contracted out to other companies? If yes, please supply us with details
SECTION 9RAW - INGREDIENTS MATERIALS
Question / YES / NO / Details/Further Information1 / Are raw-ingredients materials sampled/tested before use?
2 / Are certificates of analysis or conformance reviewed at time of receiving?
3 / Are raw materials-ingredients stored in appropriate conditions to prevent deterioration or infestation?
4 / How is stock control maintained to ensure correct use and rotation?
5 / How are reject materials handled?
SECTION 10PROCESS CONTROLS
Question / YES / NO / Details/Further Information1 / Are process control records kept?
2 / What microbiological testing is carried out on finished product?
3 / Do you issue certificates of analysis?
Please enclose a sample.
4 / How is work in progress and non-conforming product identified?
5 / Is metal detection used on finished product?
Please describe.
SECTION 11QUALITY SYSTEMS/FOOD SAFETY
Question / YES / NO / Details/Further Information1 / Do you have a HACCP program in place? Provide copy of process flow diagram.
2 / Do you have a customer complaints procedure?
3 / Do you have a Crisis Management Plan/Procedure?
4 / Do you have a product withdrawal and recall plan?
5 / How many mock recalls do you perform per year?
6 / Can you trace back from finished product to raw materials used?
7 / Do you have a Glass/Plastic register and is this audited?
8 / Do you have a Glass/Plastic breakage procedure?
9 / Are dedicated cleaning supplies identified to be used only on broken glass, hard or brittle plastic?
10 / Do you have an Internal Audit program?
11 / Do you carry out regular hygiene (cGMP) audits?
What is the frequency?
12 / Do you handle any allergens on site?
13 / If yes to question 11, what segregation controls do you have in place?
14 / What allergens are on site?
15 / How is product shelf life determined?
SECTION 12FOOD DEFENSE
Question / YES / NO / Details/Further Information1 / Do you have a written food defense plan?
2 / Is the property perimeter secured to prevent entry by unauthorized persons? Explain.
3 / Does your facility have established emergency procedures, including procedures for responding to an intentional contamination?
4 / Are incoming shipments of raw materials, ingredients, and packaging materials required to be sealed with tamper-evident or numbered seals (and documented in the shipping documents)?
5 / Are basic background checks and/or reference checks with previous employers conducted for all new employees?
6 / Do all employees receive training on security procedures and food defense awareness as part of their orientation training?
7 / Is there a designated person or team to implement, manage, and update the Food Defense Plan?
8 / Does the Food Defense Plan have procedures to ensure that contaminated or potentially harmful products are held at the facility?
9 / Is the emergency contact information for local, state, and federal government regulatory authorities and public health officials included in the Food Defense Plan?
10 / Are employees encouraged to report signs of possible product contamination, unknown or suspicious persons in the facility, or breaks in the food defense system?
SECTION 13CERTIFYING SIGNATURES
Thank You for completing this form.
Completed By (Signature) / Position/Title / DateFOR DPI USE ONLY
Supplier Reference Number
Status / Approved / Approved Subject To Audit / Not Approved
Reviewed By / Title / Date
Page 1 of 10DF 190 2/28/14
Document Review & Approval Form
This page is a required component of the DPI Forms Management Policy.
DPISpecialty Foods / Supplier Quality Assurance Questionnaire - ProductPrepared by / R. Crompton / Department / DPI
Author / R. Crompton / Program Used / MS Word
Reviewed by / R. Crompton
Effective Date / 6/25/07 / Current Document Date / 12/28/12
Review Due
Document Number / DF 190
© DPI This document is supplied by DPI for use of the immediate recipient.
Document Log
Date / Section / Comments (optional) / Author
6/20/12 / Changed logo / R. Crompton
12/21/12 / Added sections on FDA & USDA Registrations, changed grammatical errors, and reworded various questions for clarity / R. Crompton
2/28/13 / Added Food Defense, clarified the opening paragraph and page. Added approved GSFI and cGMP audit companies. Expanded questions in various sections. / R. Crompton
DF 190