Vendor Audit Questionnaire

Vendor Audit 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 supplied to Sydco, 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:

All information contained within this document will be treated as confidential between the Supplier and Buyer.

For ³Yes´ / ³No´ answers; Please tick the box for the one which applies, or select ³N/A´ (Not Applicable)
Management Responsibility
Is an organization chart available?  If yes, please enclose a copy.	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 Sydco with regards to the following areas: Quality: Technical: Commercial:
Are subcontractors (if used), used for significant steps or components in Preparation of Sydco¶s products? The term subcontractors includes both contracted operations within Production and the Laboratory	Yes	No	N/A
If ³Yes´, please list and explain:

Can you please provide full Supply chain(s) for the referenced material(s) (i.e. Manufacturer, Testers, Providers of C of A / C of C, Packers / Repackers and Storage & Distribution)	Yes	No	N/A
If ³Yes´, please list & explain:

Quality Management System
What is the basis of your quality system, i.e. ISO?
Please state your Certificate/Registration reference and appropriate dates:
Have any regulatory agencies inspected your facility in the last five years?	Yes	No	N/A
If µYes¶, by whom, when and what were the results?
Are all procedures documented and approved?	Yes	No	N/A
Are there change control procedures in place?	Yes	No	N/A
Is there a procedure to notify customers of change?	Yes	No	N/A
Are QA/QC  responsibilities well defined and independent?	Yes	No	N/A
Does QA/QC approve all analytical specifications and methods?	Yes	No	N/A
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
If ³Yes´, please provide details.
Which department reviews and approves production procedures?
Are reference samples retained?	Yes	No	N/A
If ³Yes´, for how long?
For how long are records retained?
Is there a self-audit program?	Yes	No	N/A

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 audit 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: - Inspecting material	Yes	No	N/A
- 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 ³Yes´, 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 labelling)
How is rejected material controlled?  (i.e. Physical, system or labelling)
Is there an identified sampling area?	Yes	No	N/A
Are all containers identified?	Yes	No	N/A
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
Is Temperature (T ), controlled and documented?	Yes	No	N/A
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 ³Yes´, please provide details.
Is plant equipment labelled as to its status and contents?	Yes	No	N/A
Is Pipe work labelled?	Yes	No	N/A
Are critical processes validated?	Yes	No	N/A
Does process documentation include: Process instructions	Yes	No	N/A
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 µYes¶, 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)?
Please list any hazardous materials that are manufactured on your site (whether in dedicated or multi purpose facilities). E.g. herbicides.
If available, please enclose a brief process flow, and if possible include where in-process controls are performed.

Packing
Are packing operations segregated from production?	Yes	No	N/A
Are barcode readers in use?	Yes	No	N/A
Are areas labelled 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 labelling?	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 labelled, 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 ³Yes´, do you identify the Computerized systems that are considered to have an impact on Quality of Product, or Service offered?	Yes	No	N/A
If ³Yes´, 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

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: Sampling	Yes	No	N/A
Sample handling	Yes	No	N/A
Sample labelling	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
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

Material Release
Is the decision to release/reject product made by a person or function independent from production?	Yes	No	N/A
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 ³C of A ³ OR ³C of C¶s´	Yes	No	N/A
Is there a documented recall procedure?	Yes	No	N/A

Transport
Is a list of approved hauliers in use?	Yes	No	N/A
Is temperature controlled transports used?	Yes	No	N/A
If ³Yes´, are temperature records reviewed and retained?	Yes	No	N/A
If bulk tankers are used, is a cleaning certificate required?	Yes	No	N/A
If bulk tankers are used, are they dedicated?	Yes	No	N/A
If not, what other substances could be transported in the tankers?

If Agent/Distributor involved, is the pipe work used on delivery to the agent/distributor dedicated?	Yes	No	N/A
Are the Agent/Distributor storage facilities dedicated?	Yes	No	N/A
If ³No´, what other substances are stored in the facilities?
Does the Agent/Distributor use dedicated filling lines?	Yes	No	N/A
What instructions are given to the haulier for delivery to a Sydco site e.g. dedicated hoses, dedicated tanks, dedicated pumps, temperature control, and paperwork to accompany delivery?

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 pest 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

Questionnaire reviewed for Buyer lead audit site by:

Name:

Title:

Date: