Supplier evaluation example only.

1. Company Name
Supplier Evaluation
Edition: 1.00
Page 1 of 9
Instruction
Supplier evaluation
References :
ISOXXXX
XXX Guidelines for Supplier Qualification.
Prepared by department no:XXX
Validation Improvement Specialist
(date) Fatima Grangeiro Landim (FGL)
Reviewed and Approved by:
Quality Control Labs Manager
(date) QC Manager
Quality Assurance
(date) Quality Assurance Officer (Initial)
(date)

2. Company Name
Supplier Evaluation
Edition: 1.00
Page 2 of 9
Table of Contents
1 Purpose and Scope ............................................................................. 3
2 Responsibilities .................................................................................... 3
3 Definitions and/or Abbreviations ........................................................... 3
4 Procedure – Questionnaires:................................................................ 4
4.1 Commercial and Quality Technical Questionnaire: ........................ 4
5 Questionnaires Deadline ...................................................................... 9
5.1 Required actions if supplier is recommended for use: ................... 9
5.2 Required actions if supplier is not recommended for use: ............. 9
6 Non conformances/deviation report ...................................................... 1
7 Supplier attachment documentation ..................................................... 3

3. Company Name
Supplier Evaluation
Edition: 1.00
Page 3 of 9
1 Purpose and Scope
This Quality instruction describes all the requirements for how to perform a supplier
evaluation. Quality requirements and expectations are important points in choosing a
supplier. Open communication channels, technical and manufacturing data, zero defects,
conformances to regulatory bodies and policies, production or shipping concerns,
certification and licensing as a pharmaceutical supplier, commitments to continuous
improvements, timely and effective actions in the event of non conformances, best costs
are points that a customer anticipates from a supplier.
2 Responsibilities
Person responsi- Responsibilities Final action
ble
Procurement de- Initiate registration and evaluation Approve/sign and date
partment of pharmaceutical supplier. Yearly evaluation report
evaluation of Product Suppliers
through a questionnaire.
Quality Assurance QA is responsible for evaluating Approve/sign and date
and approving the supplier regard- evaluation report
ing quality issues (e.g. Facilities
Quality control).
3 Definitions and/or Abbreviations
Definition/Abbreviation Full text/ Explanation
Policy A document that typically describe principles or rules to guide
decisions and achieve final and conscientious outcome(s).
Shelf-life The length of time that products are given before they are
considered unsuitable for use.
Obsolete product State of a being which occurs when an object, service or
practice is no longer wanted or necessary.
Quality audit Evaluation that verifies the effectiveness of a quality man-
agement system.

4. Company Name
Supplier Evaluation
Edition: 1.00
Page 4 of 9
Definition/Abbreviation Full text/ Explanation
PO Purchase order is a commercial document issued by a buyer
to a seller indicating prices, product type, quantities, etc.
SOP Standard Operating Procedure.
QMS Quality Management system.
4 Procedure – Questionnaires:
4.1 Commercial and Quality Technical Questionnaire:
Which is the type of products manufactured/ supplied by your company?
___________________________________________________________________
List principal customers for whom your company have supplied product /materials in the
past two (2) years?
___________________________________________________________________
How long has your company been in business?
_____________________________________________________________
Does your company export products manufactured in house to other countries?
Are all manufacturing operations (processing, packaging) carried out internally?
Did any another company/customer/government initiate a quality audit in your company?
_____________________________________________________________
Does your company subcontract any processes? Describe:
_____________________________________________________________

5. Company Name
Supplier Evaluation
Edition: 1.00
Page 5 of 9
Does your company have a documented organisational structure, outlining name, position,
and contact details for its key people?
Does your organisation have a written policy for Customer Service?
Does your organization have an approved procedure for purchasing?
Does your company dispose of a material loss or damage insurance policy?
N/A
Do Quality personnel review purchases orders to your make sure quality requirement are
incorporate into the purchase?
Does your company perform customer purchase order/contract reviews?
NO
Does your oganization have a Quality ManuaI describing the QMS (Quality management
system) ?
Does your company periodically review quality documentation to ensure effectiveness of
the quality system?
How often is the Quality Manual reviewed and by whom?
_________________________________________________________
What actions does your company take for Customer notification of product becoming
obsolete?
________________________________________________________

6. Company Name
Supplier Evaluation
Edition: 1.00
Page 6 of 9
Does your company document and maintain product traceability and identification (eg.lot
number, serial number, ID number)?
Is your company able to provide proof of traceability for materials/or products upon
request?
When product does not meet acceptance criteria after being quality inspected, what method
does your company use to assure product will not be shipped to customer? Please,
describe:
_________________________________________________________
How does your company control and guarantee that, a product is only released when all
necessary quality inspections have been accomplished? Please describe:
_________________________________________________________
Do you have a procedure in place to initiate, investigate and provide solutions for customer
complaints?
Are all manufacturing operations (processing, packaging) carried out internally?
Is there a packaging procedure that prevents product against damage?
Does your company dispose of procedure to assure product/material is packaged and
shipped in accordance with purchase order, and that certificate of conformance, inspection
or tests data is also delivered to the customer with shipment?

7. Company Name
Supplier Evaluation
Edition: 1.00
Page 7 of 9
Are non conforming materials/products removed from the production areas and
permanently identified or destroyed? Is there a non-conformance report policy in place?
Does your company notify the customer when an out-of-calibration condition may have
allowed faulty product to be shipped? Please describe in few words the procedure in place:
________________________________________________________
Is it your company willing a representative of our organization to perform an onsite audit of
your facility if required?
Are obsolete and/or outdated drawings, SOPs, Work instructions, and specifications
recalled and removed from files to prevent further use?
Quality system has been certified to an ISO Standard? If yes, please specify:
________________________________________________________
Does your company dispose of in-plant corrective actions procedures?
Are calibrations performed within your facility? If yes, does your company dispose of a
calibration schedule for maintenance and re-calibration?
Are calibration done under controlled conditions using national traceable standards and/or
other independent reproducible standards?
If calibration are done by “contract calibrations laboratories”’ Does your company if
required, audit the contract laboratory for verification of proper calibration procedures?

8. Company Name
Supplier Evaluation
Edition: 1.00
Page 8 of 9
Are the calibration procedures reviewed and approved by the Quality personnel?
Is there a documented procedure for in-process inspection and testing?
Are all inspection records being kept and maintained?
Is there an approved procedure to control revision of technical data?
N/A
Does your company have a procedure for internal quality auditing?
Does your company have a procedure for personnel training program?
N/A
Does your company have a procedure for Servicing?
N/A
Are control samples of each batch retained?
N/A
Does your company have a shelf-life program for items in the supply system?
N/A
Does each shelf life item have the expiration limit displayed on the item?
N/A

9. Company Name
Supplier Evaluation
Edition: 1.00
Page 9 of 9
Are storage facilities appropriate for environmental conditions such as temperature and
humidity?
Does your company have a recall procedure that allows your company to recall any product
effectively from distributions points or market?
N/A
5 Questionnaires Deadline
Questionnaire shall be returned prior to any commercial business is done with supplier. In
case of any issues is rises due to supplier non compliance a clarification from the supplier is
required and if applicable an action plan is required.
5.1 Required actions if supplier is recommended for use:
Prior to finalising the approval for the relevant supplier, it is recommended an audit at
supplier premises to confirm the questionnaire responses, and if required documentation
shall be attached to final questionnaire.
5.2 Required actions if supplier is not recommended for use:
If the supplier is not recommended for use, a mitigation plan would be an advice for the
supplier, and if suppliers have prepared the action plan for the negative responses, action
plan should be attached to questionnaires, and dates of implemented actions should be
stated.
In case of continued refusal to improve standards and if the supplier is a strategically
important supplier for the company, the issue must be brought to the Quality Assurance and
Supplier Evaluation Committee.

10. Company Name
Supplier evaluation
Edition: 1.00
Page 1 of 3
6 Non conformances/deviation report
Non conformance/Deviation Report
Supplier name and/or number :
Number of deviation:
Deviation description :
Reviewed/signed Date: Init:
by:
Reason and proposal of corrective and/or preventive action(s) :
Reviewed/signed Date: Init:
by:

11. Company Name
Supplier evaluation
Edition: 1.00
Page 2 of 3
Conclusion:
Reviewed/signed Date: Init:
by:
QA Approved by: Date: Init:

12. Company Name
Supplier evaluation
Edition: 1.00
Page 3 of 3
7 Supplier attachment documentation
Supplier documentation (if required) shall be attached to final
evaluation questionnaire
Attachment Number of Initial & date
Description
number : pages
Quality Manual (first page
1.
only)
Calibration certification for
2.
instruments
Calibration information for
3.
test equipment
Calibration Procedures (first
4. page only)
Training Procedures (first
5.
page only)
Insurance Policy (first page
6.
only)
Product list
7.
8.
9.
10.
11.
12.

13. Company name
Supplier evaluation
Edition: 1.00
Page 1 of 1
Change History
Edition Effective date Description of change Revised without
changes
Date / Sign.
1.0 January 2011 Initial version