Supplier Evaluation.Number 2
- 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