| • Quality management systemo Parts made from ISO9001 certified companies only
 o Material origin is tracked by Bar code attached to each part
 o Torreyvac holds regular reviews to ensure continual improvement of these processes
 
 • Corrective Action Request (CAR)
 o Customer requested corrective actions are logged, numbered and owner assigned
 o Assigned owner to report resolution within 1 week.  If the process should take longer, estimated completion date is specified in the CAR
 o Engineering is responsible and has the sole authority to approve CAR resolution
 o CAR meeting is held every Wednesday and Friday.  Status is logged in the CAR
 
 • Revision Change by Engineering Change Order (ECO)
 o ECR (engineering Change Request) is required prior to any design change
 o Engineering to make disposition of overall effect of the change
 o Final disposition is written into an ECO (Engineering Change Order)
 o Engineering signature is required for final approval
 o Manufacturing to incorporate revised SOP into production and QC
 
 • First article
 First article is provided when a customer specifically requests for it.  In a rare case if first article is rejected, manufacturing has 10 working days to implement corrective action or customer has the option to cancel order
 
 • Internal Audit
 Torreyvac’s contract manufacturing is required to go through internal audits in order to maintain ISO9001 certification.  Audit report will be presented upon customer’s request.
 
 • Control of nonconforming product
 Torreyvac ensures that product which does not conform to requirement is identified and returned in one of the following ways.
 o Take action to correct the detected nonconformity (such as reworking the part).
 o Accept under concession by relevant authority and/or by customer. Record of nonconformity shall be maintained.
 
 • RMA
 When a part is rejected by customer, Torreyvac issues RMA # along with credit memo to credit the amount back to customer.
 
 • Inspection at receiving
 Standard parts are inspected by QC at the manufacturing facility to ensure quality is maintained.   Inspection report and/or certificate of performance will be provided at the request by customer.
 
 Torreyvac performs random inspection at visual level such as cosmetics, label and packaging.
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