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Supplier Evaluation.Number 2

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Supplier Evaluation.Number 2

  1. 1. Company Name Supplier Evaluation Edition: 1.00 Page 1 of 9 Instruction Supplier evaluationReferences :ISOXXXXXXX Guidelines for Supplier Qualification.Prepared by department no:XXXValidation Improvement Specialist (date) Fatima Grangeiro Landim (FGL)Reviewed and Approved by:Quality Control Labs Manager (date) QC ManagerQuality Assurance (date) Quality Assurance Officer (Initial) (date)
  2. 2. Company NameSupplier EvaluationEdition: 1.00Page 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. 3. Company Name Supplier Evaluation Edition: 1.00 Page 3 of 91 Purpose and ScopeThis Quality instruction describes all the requirements for how to perform a supplierevaluation. Quality requirements and expectations are important points in choosing asupplier. 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 continuousimprovements, timely and effective actions in the event of non conformances, best costsare 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. 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 thepast 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. 5. Company Name Supplier Evaluation Edition: 1.00 Page 5 of 9Does 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/ADo Quality personnel review purchases orders to your make sure quality requirement areincorporate into the purchase?Does your company perform customer purchase order/contract reviews? NODoes your oganization have a Quality ManuaI describing the QMS (Quality managementsystem) ?Does your company periodically review quality documentation to ensure effectiveness ofthe quality system?How often is the Quality Manual reviewed and by whom?_________________________________________________________What actions does your company take for Customer notification of product becomingobsolete?________________________________________________________
  6. 6. Company Name Supplier Evaluation Edition: 1.00 Page 6 of 9Does your company document and maintain product traceability and identification (eg.lotnumber, serial number, ID number)?Is your company able to provide proof of traceability for materials/or products uponrequest?When product does not meet acceptance criteria after being quality inspected, what methoddoes 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 allnecessary quality inspections have been accomplished? Please describe:_________________________________________________________Do you have a procedure in place to initiate, investigate and provide solutions for customercomplaints?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 andshipped in accordance with purchase order, and that certificate of conformance, inspectionor tests data is also delivered to the customer with shipment?
  7. 7. Company Name Supplier Evaluation Edition: 1.00 Page 7 of 9Are non conforming materials/products removed from the production areas andpermanently 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 haveallowed 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 ofyour facility if required?Are obsolete and/or outdated drawings, SOPs, Work instructions, and specificationsrecalled 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 acalibration schedule for maintenance and re-calibration?Are calibration done under controlled conditions using national traceable standards and/orother independent reproducible standards?If calibration are done by “contract calibrations laboratories”’ Does your company ifrequired, audit the contract laboratory for verification of proper calibration procedures?
  8. 8. Company Name Supplier Evaluation Edition: 1.00 Page 8 of 9Are 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/ADoes your company have a procedure for internal quality auditing?Does your company have a procedure for personnel training program? N/ADoes your company have a procedure for Servicing? N/AAre control samples of each batch retained? N/ADoes your company have a shelf-life program for items in the supply system? N/ADoes each shelf life item have the expiration limit displayed on the item? N/A
  9. 9. Company Name Supplier Evaluation Edition: 1.00 Page 9 of 9Are storage facilities appropriate for environmental conditions such as temperature andhumidity?Does your company have a recall procedure that allows your company to recall any producteffectively from distributions points or market? N/A 5 Questionnaires DeadlineQuestionnaire shall be returned prior to any commercial business is done with supplier. Incase of any issues is rises due to supplier non compliance a clarification from the supplier isrequired 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 atsupplier premises to confirm the questionnaire responses, and if required documentationshall 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 thesupplier, and if suppliers have prepared the action plan for the negative responses, actionplan should be attached to questionnaires, and dates of implemented actions should bestated.In case of continued refusal to improve standards and if the supplier is a strategicallyimportant supplier for the company, the issue must be brought to the Quality Assurance andSupplier Evaluation Committee.
  10. 10. Company NameSupplier evaluationEdition: 1.00Page 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. 11. Company NameSupplier evaluationEdition: 1.00Page 2 of 3 Conclusion: Reviewed/signed Date: Init: by: QA Approved by: Date: Init:
  12. 12. Company NameSupplier evaluationEdition: 1.00Page 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. 13. Company nameSupplier evaluationEdition: 1.00Page 1 of 1 Change HistoryEdition Effective date Description of change Revised without changes Date / Sign.1.0 January 2011 Initial version

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