HARDWARE DEFECTIVE PARTS PROCESS Quality System Document 000034

Important Information Purpose The purpose of the procedure is to establish a procedure for handling of defective parts to identify parts that are under OEM warranty, and return them for repairs or replacement promptly. This procedure covers new parts from inventory, and parts returned from customers for repair. Important Information This procedure applies to all products and materials shipped from the Jacksonville warehouse, whether obtained from vendors, produced in-house, or in company stock and whether shipped to dealers, customers, or inter-company. For the FDA regulated products (Fusion EMM and CMM) a Defect Tracking Log will be maintained to track all product failures, and root cause analysis information. The Tracking Log will be maintained in the Jacksonville office.

Spok Template v2 Agenda After reviewing QSD000034 and related training materials, you will be quizzed on the following questions in your SpokAcademy Learning path: Who, What, Where, When… Who will adjust the item out of inventory (if it’s an inventoried item)? What Products and materials do these procedures apply to? What step does NOT happen when a new part of a unit is found to be damaged or defective during Acceptance Testing? Where is the tracking log maintained? When a new part or unit is found to be damaged or defective during incoming inspection, or during Acceptance Testing and the part is an FDA device (Fusion EMM or CMM) then_________. For the FDA regulated products a ______________ will be maintained to track all product failures, and root cause analysis information. True or False: The processes outlined in QSD000034 covers new parts from inventory, and parts returned from customer.  

DEFECTIVE PART CATEGORIZATION AND WORKFLOW Quality System Document 000034

DEFECTIVE PART CATEGORIZATION & WORK FLOW: NEW FROM INVENTORY Spok Template v2 DEFECTIVE PART CATEGORIZATION & WORK FLOW: NEW FROM INVENTORY When a new part or unit is found to be damaged or defective during incoming inspection, or during Acceptance Testing the… Technician will: Complete both sections of the repair tag and attach it to the defective part or unit. Note the date, item name and serial number, description of defect, and technician name. Place the defective part in the designated location and give the lower section of the tag to the Office Administrator VINCE, respecting our history The Office Administrator will: Adjust the item out of inventory (if an inventoried item). The Defective Parts will: Be shipped back to the manufacturer for warranty repair/replacement on a quarterly basis.

DEFECTIVE PART CATEGORIZATION & WORK FLOW: NEW FROM INVENTORY Spok Template v2 DEFECTIVE PART CATEGORIZATION & WORK FLOW: NEW FROM INVENTORY When a new part or unit is found to be damaged or defective during incoming inspection, or during Acceptance Testing…. If the Part is an FDA device (Fusion EMM or CMM): The failure data will be recorded of the EMM/CMM Defect Tracker form. VINCE, respecting our history When the Parts are Shipped for Repair: A copy of the EMM/CMM Defect Tracker will be shipped to the vendor for Root Cause Analysis input, and returned to the Head of Fulfillment when completed. The EMM/CMM Defect Tracking Log will: Be maintained in the Jacksonville Office.

DEFECTIVE PART CATEGORIZATION & WORK FLOW: USED-RETURNED FOR REPAIRS Spok Template v2 DEFECTIVE PART CATEGORIZATION & WORK FLOW: USED-RETURNED FOR REPAIRS A part or unit that has been sent in for repair. The part or unit may or may not be covered under 12 month manufacturer’s warranty, or an active maintenance contract. Defective parts in this category will be inspected by the Technician to determine if the part or unit is repairable If the part or IS STILL UNDER THE 12 MONTH OEM LIMITED WARRANTY the Technician will give the lower section of the tag to the Office Administrator. The Office Administrator will contact the vendor for a RMA to return the part or unit for warranty repairs If the part or unit is NOT COVERED under the OEM limited warranty, but is repairable, the Technician will place the part in the designated location If the part or unit IS REPAIRABLE is repairable the Technician will repair the unit per the Repair Procedures If the part or unit is NOT REPAIRABLE the Technician will complete both sections of the Repair Tag and attach the tag to the part or unit If the part is an FDA Device, the Technician will notify the Head of Fulfillment, and the failure data will be recorded on the EMM/CMM Defect Tracker When the parts are shipped for repair, a copy of the EMM/CMM Defect Tracker will be shipped to the vendor for Root Cause Analysis input, and returned to the Head of Fulfillment when completed The EMM/CMM Defect Tracking Log will be maintained in the Jacksonville office. VINCE, respecting our history

ITEMS TO BE COMPLETED IN LEARNING PATH: REVIEW QUALITY SYSTEM DOCUMENT 000034 QUIZ / KNOWLEDGE CHECK