ANY TISSUE BANK USA. Revision: 3

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1 1 of 5 1. Scope 1.1. This work instruction provides specific direction for qualifying vendors as required in SOP-5, Purchasing Components. 2. Definitions and Acronyms 2.1. Definitions for terms used in this procedure can be located in SOP-10, Definitions Vendor Management Team (VMT) A group with representation from Purchasing, Quality Assurance, and Operations to evaluate vendor qualifications and criticality of supplies. 2.. Component This term shall include supplies, reagents, chemicals, components, subassemblies, and services to cover the scope of input to all operations of TB Critical - A component used in the processing or storage of human tissue or medical devices, that can directly affect the suitability, usage or safety of the tissue/device for transplant if order criteria/quality are not met Grandfathering The process of allowing a vendor continuation of qualified status to the QVL based on historical performance or level Qualified Vendor List - QVL. Responsibility.1. It is the responsibility of the Director of Quality Assurance and the Purchasing Manager to ensure the requirements of this program are established..2. It is the responsibility of the Purchasing Staff to comply with the requirements of this procedure... It is the responsibility of Quality Assurance to schedule and perform on-site audits of vendors, as specified..4. It is the responsibility of the VMT to identify critical components; to qualify vendors, their level, status and continuing suitability; and to ensure information is communicated to the QA Dept. for audits and survey reviews of vendors and to Purchasing for updating the Qualified Vendor List. 4. Related Documents, Materials, or Equipment 4.1. Form-5.1.0, Purchase Requisition Form 4.2. Form-5-.1, Vendor Assessment Survey 4.. Form-5-4.2, VMT Vendor Evaluation Form 4.4. Controlled Database for Purchasing Form-5-4.1, Initial Vendor Report Form-5-5.1, Vendor Status Report Form-5-5.2, Vendor Monitoring Report Form-5-6.1, Qualified Vendor List 4.5. SOP-16, Component Receipt and Inspection 4.6. Form , Raw Material Inspection and Receiving 4.7. SOP-7, Recovery Partners Qualification Program.

2 2 of SOP-10, Definitions 4.9. SOP-50, Performance of Quality Audits 5. Qualification of Vendors 5.1. Vendors prior to December 1, 2005 may be grandfathered to the QVL Existing vendors of critical components prior to December 1, 2005 shall be placed on the QVL providing they had no more than nonconforming incidents Suppliers of non-critical components shall be automatically qualified New vendors shall be qualified according to the criteria listed in this instruction. The degree to which the qualification is done shall be based on criticality of the components being provided. The qualification shall be documented using Form-5-4.2, VMT Vendor Evaluation Form. 5.. Vendors shall be regularly evaluated to verify their status based upon assigned levels All vendors shall have Form-5-5.1, Vendor Status Report completed. 6. Categorizing Vendor Levels 6.1. Vendors will be categorized within levels Level 1 is assigned to vendors providing components that are defined as non-critical. Examples: Office letterhead, bubble wrap, janitorial services not associated with cleanroom operations Vendors identified as Level 1 vendor are evaluated by: Receiving inspections based on the purchase records Form-5-5.2, Vendor Monitoring Report is initiated when supplier has not met TB requirements including. Example: late deliveries, incorrect quantity. Completion of the form is self-explanatory VMT performs an annual review of the vendor s performance using the Vendor Monitoring Report results VMT has the discretion to remove Level 1 vendors determined to be unsuitable for qualification. 6.. Level 2 is assigned to vendors providing components that are defined as critical. Example: sterile gloves, SporKlenz, preventive maintenance services The vendors identified as Level 2 are evaluated by: Minimal to rigorous inspection based on appropriate specifications VMT performs an annual review of the vendor s performance A baseline on-site audit is required. Future audits are done as needed, based on performance Form-5-.1, Vendor Assessment Survey is sent every two years to vendors concerning their quality system. The first page to the survey, along with the Quality Manual, ISO cert, or other documentation may be substituted, when found acceptable.

3 of Level is assigned to vendors providing components that are defined as critical and would be highly suspect in the physical failure, quality or safety of the tissue/devices. Examples: sterilization services, laboratory services The vendors assigned to Level are evaluated by: Vendor certifications, accreditations or licenses, as applicable Initial on-site inspection and biennial inspections thereafter by QA Multiple deviations or major nonconformances may necessitate on-site evaluation prior to scheduled audit VMT performs an annual review of the vendor s performance, which is reported to QA and the Quality Review Board for the management review Annually, Form-5-.1, Vendor Assessment Survey is sent to vendors concerning their quality system. The first page to the survey, along with the Quality Manual, ISO cert, or other documentation may be substituted, when found acceptable Vendors incorrectly assigned to a level initially, may be reassigned after further evaluation. Documentation of this change shall be made with justification by VMT The VMT shall assign the qualified vendor status based upon one or more of the following: A review of the receiving inspection records for similar components or services from the vendor in question is done to demonstrate quality and acceptability References checks Acceptable on-site audit is performed of the vendor s facility Industry certifications to evidence control of quality systems and operations, e.g. ISO certification, AATB accreditation, are received Documented responses to surveys are evaluated Grand fathering, which requires evaluation of documented historical dealings with the vendor to evidence future component suitability Special condition: If the vendor is the sole source of the component, other controls will be needed. The VMT will consult with QA Management for these criteria Other methods, which are deemed appropriate by the VMT, may also be used Qualification of vendors shall include capacity and capability of a vendor to meet purchasing criteria When a vendor review is completed, the results shall be documented using Form-5-4.2, VMT Vendor Evaluation Form. The status of the vendor shall be assigned as one of the following: Qualified The vendor has received Satisfactory in all areas. Purchasing may order components from this supplier and they will be placed on the QVL Not Qualified - The vendor cannot furnish critical components to TB due to major regulatory or technical difficulties, or unsatisfactory ratings documented in their

4 4 of 5 evaluation. The vendor is removed from the QVL. A vendor in this category may submit corrective actions for consideration and re-evaluation Not Applicable The components are not considered critical and the vendor can be used based simply on their ability to provide the item at a time and price agreeable to the Buyer The completed Vendor Evaluation Form shall be placed in the vendor performance file for reference VMT Vendor Evaluation Form will be completed annually for Level 2 & Level vendors VMT Vendor Evaluation Form will be completed for Level 1 vendors at the time of the initial evaluation. Level 1 vendors will be reviewed annually but VMT Vendor Evaluation Form will only be completed again if the VMT changes the level or status of the vendor Purchasing shall control and maintain the QVL (Form 5-6.1) in the supplier database, which includes each vendor level and the list or category of components they provide. This list shall be made available to all TB personnel authorized to request purchases The Qualified Vendors List can be found on the S drive. Open the folder Qualified Vendors List. Choose the file stating Qualified Vendors List. The vendor name, level and criticality information, and the component listing will be provided, along with the vendor address, phone number and last review date. 7. Requalification of Vendors 7.1. Vendors will be requalified based upon their Level by the VMT The process will be similar to the initial qualification process for survey Performance will be evaluated Audit will be determined based on level and performance Level 1 vendors will be reviewed annually. If performance is satisfactory, they will continue on the QVL. If their performance is unsatisfactory, the VMT will remove them from the QVL and communicate the action to the vendor Level 2 vendors will be reviewed annually. On site audits may be required as determined by the VMT and will be identified in the vendor file. A survey will be sent to these vendors at least every two years Level vendors will be reviewed annually. A survey is required every year and an on site audit will be done at least biennially Special vendors, who are sole suppliers of a component, will be evaluated with consideration to effect on TB operations Vendor performance will be reviewed based upon purchase order, agreement and contract fulfillment The Vendor Monitoring Reports shall be reviewed for the requalification time period. The number of reports shall be evaluated for significance to the vendor meeting their contractual obligations The nonconformance system shall also be searched for NCR s issued to the vendor. Severity and number of Nonconformance Reports will be rated to determine if the vendor s performance is unsatisfactory.

5 5 of Unsatisfactory performance will require the vendor to implement corrective action. If the vendor has implemented corrective actions to resolve previous issues, the VMT will evaluate if the actions were effective based on consecutive performance. 7.. On site audits will be required if a Level 2 vendor s performance is unsatisfactory, and will be performed more frequently if a Level vendor is not performing as expected Corrective actions will be evaluated at the vendor s site. If found acceptable, the vendor will be considered for continuing on the QVL if all other criteria are satisfactory Ineffective corrective actions will be evaluated and a determination will be made by QA to allow additional opportunities to better correct the vendor s performance. If the additional opportunities for improvement are not acceptable, QA will advise the VMT to remove the vendor from the QVL Vendors rated as satisfactory for all criteria will remain on the QVL The Purchasing Dept. will notify the vendor in writing of their continuing status and maintain a copy in their file The vendor database will be updated to show the most current evaluation.

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