PURCHASING SUPPLIER QUESTIONNAIRE

Vendor Company Name:

Supplier Site Address: Supplier Business Address (if different):

Phone No: Phone No:

Fax No: Fax No:
E Mail: E Mail:
Material or Service supplied to Integrated DNA Technologies, covered by this questionnaire:

Is the Company a division/subsidiary of another corporation? Yes No N/A

☐ ☐ ☐
If Yes, Please Specify:

This questionnaire was completed by:

Name:
Job Title:
Date:
Signature:

For “Yes” / “No” answers; Please tick the box for the one which applies, or select “N/A” (Not Applicable)
Management Responsibility

Is an organization chart available? If yes, please enclose a copy. f Yes No N/A

☐ ☐ ☐
Are there any written job descriptions defining each individuals responsibilities? Yes No N/A
☐ ☐ ☐
How many shifts of operation are there in the Production Area? How many shifts of operation are there in QC Laboratory?
Approximately how many employees do you have?
-Site total:
-QA/QC:
-Production:
To whom does the QA/QC Manager report?
Does the company have a policy on EHS (Environmental, Health & Safety)? Yes No N/A
☐ ☐ ☐
Does the company have a policy on Quality? Yes No N/A
☐ ☐ ☐
Who is responsible for contacts with Integrated DNA Technologies with regards to the following areas:
Quality:

Technical:

Commercial:

PUR-002 Page 1 of 9
Are subcontractors (if used), used for significant steps or components in Preparation of Yes No N/A
IDT’s products? The term subcontractors includes both contracted operations within ☐ ☐ ☐
Production and the Laboratory
If “Yes”, please list and explain:

Can you please provide full Supply chain(s) for the referenced material(s) (i.e. Yes No N/A
Manufacturer, Testers, Providers of C of A / C of C, Packers / Re-packers and Storage & ☐ ☐ ☐
Distribution)
If “Yes”, please list & explain:

Quality Management System

Does your company have a documented Quality Management System? Yes No N/A
If your company has a Quality Manual, please provide a copy. ☐ ☐ ☐
Is your company ISO 9001 registered (or equivalent)? Yes No N/A
If “Yes”, please enclose a copy of the certificate. ☐ ☐ ☐
If “No”, does your company intend on pursuing registration within the next 12 months? Yes No N/A
☐ ☐ ☐
Is your company registered with the FDA? Yes No N/A
If “Yes”, please provide the registration number: ☐ ☐ ☒
Have any regulatory agencies inspected your facility in the last five years? Yes No N/A
☐ ☐ ☐
If “Yes”, by whom, when and what were the results?

Is formal document control utilized in your company processes that includes revision level Yes No N/A
controls and date affectivity? ☐ ☐ ☐
Are there approved product specifications that include materials, packaging and label Yes No N/A
requirements, and manufacturing and inspection instructions? ☐ ☐ ☐
Are procedures in place that control changes/deviations to material, manufacturing Yes No N/A
processes, test methods, and/or product specifications? ☐ ☐ ☐
Are QA/QC responsibilities well defined and independent? Yes No N/A
☐ ☐ ☐
Is your company capable of identifying changes/deviations that may impact IDT’s use of the Yes No N/A
product, and subsequently provide notification to IDT prior to implementation and ☐ ☐ ☐
shipment?
How is a batch (standard quantity) defined?

What is the batch numbering system? (Please explain in detail)

Do you assign shelf/expiry/retest-lives for all materials (incoming & produced)? Yes No N/A
☐ ☐ ☐

PUR-002 Page 2 of 9
If “Yes”, please provide details.

Which department reviews and approves production procedures?

Are reference samples retained? Yes No N/A

☐ ☐ ☐
If “Yes”, for how long?

For how long are records retained?

Is there a self-audit program? Yes No N/A

☐ ☐ ☐

Exclusively Service companies may proceed directly to

The ‘Social Responsibility’ section, found on page 7.
Incoming Goods

Is a list of approved suppliers used? Yes No N/A

☐ ☐ ☐
Is there a documented procedure for approval of suppliers? Yes No N/A
☐ ☐ ☐
Does this include the auditing of suppliers? Yes No N/A
☐ ☐ ☐
If bulk tankers are used, are they dedicated? Yes No N/A
☐ ☐ ☐
If not, is a cleaning certificate required? Yes No N/A
☐ ☐ ☐
Is there a system for monitoring or reviewing suppliers’ performance? Yes No N/A
☐ ☐ ☐
Are there documented procedures for: Yes No N/A
-Inspecting material ☐ ☐ ☐
-Testing material Yes No N/A
☐ ☐ ☐
Are established Purchase Specifications used? Yes No N/A
☐ ☐ ☐
What is the basis for acceptance of raw materials, i.e. testing, receipt of suppliers C of A or both?

Is a sampling plan in place? Yes No N/A

☐ ☐ ☐
Is a testing plan in place? Yes No N/A
☐ ☐ ☐
Warehouse

Are storage facilities/equipment/ rented or personnel contracted? Yes No N/A

☐ ☐ ☐
If “Yes”, please provide details.

Are receipt and release procedures documented? Yes No N/A

☐ ☐ ☐
Is the supply chain documented? Yes No N/A
☐ ☐ ☐
How is material status controlled? (i.e. Physical, system or labeling)

How is rejected material controlled? (i.e. Physical, system or labeling)

Is there an identified sampling area? Yes No N/A

☐ ☐ ☐
Are all containers identified? Yes No N/A

PUR-002 Page 3 of 9
 ☐ ☐ ☐
Is a First-In-First-Out or First-Expiry-First-Out system in use? (Identify) Yes No N/A
☐ ☐ ☐
Are shelf life/expiration dates used? Yes No N/A
☐ ☐ ☐
Yes No N/A
Is Temperature (T°), controlled and documented?
☐ ☐ ☐
Comments:

Is Relative humidity (RH %), controlled and documented? Yes No N/A

☐ ☐ ☐
Comments:

Production

Is there more than one site or plant used for the manufacture of the specified material(s)? Yes No N/A
☐ ☐ ☐
If “Yes”, please provide details.

Is there a formal product release procedure that includes review of batch records? Yes No N/A
☐ ☐ ☐
Does your company have non-conforming materials & process deviation controls? Yes No N/A
☐ ☐ ☐
Are critical processes validated? Yes No N/A
☐ ☐ ☐
Does process documentation include: Yes No N/A
-Process instructions ☐ ☐ ☐
-Cleaning instructions Yes No N/A
☐ ☐ ☐
-Cleaning records Yes No N/A
☐ ☐ ☐
-Area clearance Yes No N/A
☐ ☐ ☐
Are cleaning processes validated? Yes No N/A
☐ ☐ ☐
Is there traceability throughout the process? Yes No N/A
☐ ☐ ☐
Is there an in-process monitoring system? Yes No N/A
☐ ☐ ☐
Is there an equipment use log? Yes No N/A
☐ ☐ ☐
Are all critical instruments calibrated? Yes No N/A
☐ ☐ ☐
Is there a preventative maintenance program? Yes No N/A
☐ ☐ ☐
Is reprocessing allowed? Yes No N/A
☐ ☐ ☐
Is there a non-conformance procedure? Yes No N/A
☐ ☐ ☐
Is the yield checked against defined limits? Yes No N/A
☐ ☐ ☐
Are different grades of material produced? Yes No N/A
☐ ☐ ☐
If “Yes”, how and at what stage are these differentiated/selected?

Is the plant dedicated or multi-purpose?

If the plant is multi-purpose, what other types of materials are produced in the unit(s)?

PUR-002 Page 4 of 9
Please list any hazardous materials that are manufactured on your site, e.g. herbicides.

Packing

Are packing operations segregated from production? Yes No N/A

☐ ☐ ☐
Are barcode readers in use? Yes No N/A
☐ ☐ ☐
Are areas labeled with the product being packed? Yes No N/A
☐ ☐ ☐
Are re-usable containers used? Yes No N/A
☐ ☐ ☐
Are cleaning procedures in place? Yes No N/A
☐ ☐ ☐
Are controlled procedures used for issuing labels and labeling? Yes No N/A
☐ ☐ ☐
Are label details checked? Yes No N/A
☐ ☐ ☐
Are there label reconciliation procedures? Yes No N/A
☐ ☐ ☐
Are there label disposal procedures? Yes No N/A
☐ ☐ ☐
How are containers security sealed?

Is material clearly labeled, including waste and reject material? Yes No N/A
☐ ☐ ☐
Computerized Systems

Do you have a list of the Computerized systems used by this facility? Yes No N/A
☐ ☐ ☐
If “Yes”, do you identify the Computerized systems that are considered to have an impact Yes No N/A
on Quality of Product, or Service offered? ☐ ☐ ☐
If “Yes”, how is this documented?

Does your Quality system cover the quality of Computerized systems? Yes No N/A
☐ ☐ ☐
Do you have procedures in place for disaster recovery and restoring of data archives? Yes No N/A
☐ ☐ ☐
Do you have access security levels for the Computerized systems? Yes No N/A
☐ ☐ ☐
Do your procedures for validation cover the Computerized systems? Yes No N/A
☐ ☐ ☐
Do you have anti-virus protection? Yes No N/A
☐ ☐ ☐
Does the Change Control procedure include Computerized systems? Yes No N/A
☐ ☐ ☐

PUR-002 Page 5 of 9
Laboratories, QA & QC

Is an equipment use log in place? Yes No N/A

☐ ☐ ☐
Are all instruments qualified (IQ, OQ, PQ)? Yes No N/A
☐ ☐ ☐
Are all instruments calibrated? Yes No N/A
☐ ☐ ☐
Is there a preventative maintenance program? Yes No N/A
☐ ☐ ☐
Are there documented procedures for: Yes No N/A
-Sampling? ☐ ☐ ☐
-Sample handling? Yes No N/A
☐ ☐ ☐
-Sample labeling? Yes No N/A
☐ ☐ ☐
-Re-testing / Re-sampling? Yes No N/A
☐ ☐ ☐
-Specification generation? Yes No N/A
☐ ☐ ☐
-Analytical method generation? Yes No N/A
☐ ☐ ☐
-Control and review of analytical methods? Yes No N/A
☐ ☐ ☐
-Investigation of rejected material? Yes No N/A
☐ ☐ ☐
-Product complaints? Yes No N/A
☐ ☐ ☐
-Handling out of specification results? Yes No N/A
☐ ☐ ☐
Are manual calculations checked by a second person? Yes No N/A
☐ ☐ ☐
Are data transcriptions checked by a second person? Yes No N/A
☐ ☐ ☐
Is all raw-data retained? Yes No N/A
☐ ☐ ☐
Are all standards traceable to their preparation and the reagents used? Yes No N/A
☐ ☐ ☐
Are analytical methods validated? Yes No N/A
☐ ☐ ☐
Do you perform stability testing on materials and/or products? Yes No N/A
☐ ☐ ☐
Are all standards traceable to their preparation and the reagents used? Yes No N/A
☐ ☐ ☐
Are analytical methods validated? Yes No N/A
☐ ☐ ☐
Do you perform stability testing on materials and/or products? Yes No N/A
☐ ☐ ☐
If so, what shelf life / retest dates are available for the referenced product(s)?

Do you perform annual product reviews or campaign reviews on products? Yes No N/A
☐ ☐ ☐

PUR-002 Page 6 of 9
Material Release

Is the decision to release/reject product made by a person or function independent from Yes No N/A
production? ☐ ☐ ☐
Is the final status recorded? Yes No N/A
☐ ☐ ☐
Are certificates issued for each batch? Yes No N/A
☐ ☐ ☐
Are certificates signed by QA/QC? Yes No N/A
☐ ☐ ☐
If not, who signs certificates?

Is shelf life or retest dates or expiry date provided on the “C of A “ OR “C of C” Yes No N/A
☐ ☐ ☐
Is there a documented recall procedure? Yes No N/A
☐ ☐ ☐
Social Responsibility

Does your company have a sourcing policy with respect to Conflict minerals? Yes No N/A
☐ ☐ ☐
Has your company verified that minerals used in your product are from “Conflict free” Yes No N/A
mines? ☐ ☐ ☐
If “no”, to either of the two preceding questions, what steps are you taking to verify sourcing of the above mentioned minerals is “Conflict free”?

Does your company have a system to ensure compliance with the minimum working age Yes No N/A
prevailing standard(s)? ☐ ☐ ☐
Does the company’s site(s) have the accurate system to measure the hours worked by Yes No N/A
employees to ensure conformance with applicable wage and hour labor laws? ☐ ☐ ☐
Does the company have a process in place to ensure compliance with applicable laws Yes No N/A
concerning discrimination in hiring and employment practices? ☐ ☐ ☐

Facilities & Housekeeping

Are there procedures for health and hygiene? Yes No N/A

☐ ☐ ☐
Are rest/change/wash facilities separated from production areas? Yes No N/A
☐ ☐ ☐
Are access restrictions implemented as needed? Yes No N/A
☐ ☐ ☐
Do any production areas have special containment needs? Yes No N/A
☐ ☐ ☐
Are waste disposal systems in place? Yes No N/A
☐ ☐ ☐
Are there procedures documenting a control program? Yes No N/A
☐ ☐ ☐
Are material Safety Data Sheets maintained? Yes No N/A
☐ ☐ ☐
Training

Is there a written training program? Yes No N/A

☐ ☐ ☐
Are job-training needs evaluated? Yes No N/A
☐ ☐ ☐
Is completed training evaluated and approved? Yes No N/A
☐ ☐ ☐
Are there completed written training records for all employees? Yes No N/A
☐ ☐ ☐

PUR-002 Page 7 of 9
Comments:

PUR-002 Page 8 of 9
 The following sections are to be completed by Integrated DNA Technologies staff only

Method(s) of supplier assessment [check all that apply, explain in ‘Comments’ below and provide evidence in supplier file]:

□ IDT Supplier Self-Audit Questionnaire □ ISO 9001 registered (or equivalent standard)

□ On-site visit / audit by IDT □ QMS or process control documentation

□ Past job reference/performance analysis □ Other (specify):

□ First Article Submission (i.e. material sample(s)) □ Additional information required?

(product manufacturing/test plan specifications,
certificate of analysis, batch record/process history, etc.)
Comments:

Supplier Classification/Product Category: □ Class A □ Class B □ Class C

Supplier Accepted: □ Yes/Prequalified □ Yes/Approved □ Yes/Conditional □ No/Disqualified

Purchasing:
Printed Name Signature Date:

Quality Assurance:
Printed Name Signature Date:

Purchasing Approver:
Printed Name Signature Date:

PUR-002 Page 9 of 9