840 Control of Externally Provided Processes, Products, Services 7.15 Control of Measuring Equip.

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1 Page 1 of 8 Purchasing 7.4 Define a Requirement Use an Approved Vendor Check Approved Vendor List Standard Vendor Shop Vendor Brokered Vendors A vendor is conditional approved if they can deliver of perform the service Once the vendor successfully complete an order, they are qualified. Do I Have a qualified Vendor? Yes No Do I need to qequalify this Vendors? Yes Qaulification/Re- Qualification No Generate a Purchase Order Define the product to be procured Fulfill Requirement Confirm details with Vendor, as needed Process Purchase Order Evaluate Supplier Evaluate Service Non-conforming Product Delivery Receive Products Check Receiver against the PO or Work Order Verify T/R and C of C against Industry/Customer/EFI standards. Release material to stock, by returning Ticket with efi heat # to shop. Receive Prodict and/or Service efi Ed Fagan Incorporated /15/2013

2 Page 2 of 8 1. Objectives 1.1. To determine and apply criteria for the evaluation, selection, monitoring, and periodic re-evaluation of external providers to ensure that provided processes, products and services conform to requirements, including process, product and service conformity, and on-time delivery performance To define the requirements for controlling documented information created by and/or retained by external providers To maintain a register of external providers that incorporates approval status (e.g. approved, conditional, disapproved) and the scope of the approval (e.g. product type, process family, ) 1.4. To define the controls to be applied to an external provider and those to be applied to the resulting output; 1.5. To ensure the adequacy and the clear communication of requirements to external providers To determine verification or other activities, if needed, to ensure that externally provided processes, products, and services meet requirements To confirm that data in test reports provided by external providers meet requirements To validate the accuracy of external providers test reports, if a customer or relevant organization has identified raw material as a significant risk To ensure, when required, that customer-designated or approved external providers, including process sources (e.g., special processes), are used To accept the responsibility for the conformity of all externally provided processes, products, and services, including those from sources designated by the customer To require that external providers apply appropriate controls to their external providers, to ensure that requirements are met. 2. Responsibilities 2.1. The Materials Manger is responsible for selection and approval of suppliers for stock material The Sales department is responsible for selection and approval of suppliers for brokered material The Operations Manager and the Warehouse Manager are responsible for selection and approval of suppliers for critical plant supplies and for calibration services of inspection and testing equipment The Sales department is responsible for determining if and when customer approval of a supplier/subcontractor is needed to fulfill the customers need Sales and Inventory Control are responsible for selection and approval of suppliers for subcontracted processing and testing The President is responsible for maintaining the approved supplier list.

3 Page 3 of Persons placing an order are responsible for: ensuring that the selected supplier is approved for the item or service being ordered, or that a person listed in this Procedure as responsible for supplier selection for that item or service approves the order ensuring that information given to the supplier is accurate and complete, and for initiating the proper documentation, reviews and/or approvals as described in this procedure for the item or service All members of management are responsible for evaluating supplier performance problems that may affect the supplier's approved status. 3. Definitions 3.1. Supplier: Provider of materials, parts, processing, or other products or services which have, or can have a direct or significant impact on the quality of products or services provided to customers. 4. Procedures 4.1. Supplier Approval The responsible person for the applicable product or service reviews and approves suppliers, based upon one or more key criteria such as: a) If required, to use customer designated or approved externally provided processes, products or services a) Specifications, customer requirements, customer approval or customer designation b) past performance on the same or similar purchases c) delivery, price, responsiveness, other terms and conditions d) Evaluation of initial trial order(s) e) If an unusual and/or critical risk is identified at a supplier: - the appropriate efi person evaluates the risk and - determines how to mitigate the risk. - Modifies the system, where appropriate, to insure mitigation actions are taken (e.g. - note on the suppliers purchase order to perform extra checks on incoming material) The responsible person records approvals on Supplier Approval forms and forwards them to President. The President adds the online document to system and update the approved supplier list. (Exception: for brokered materials, sales selects the supplier at the time of each order based on the supplier's ability to meet order requirements. The record of broker approval for brokered orders is the Purchase Order.)

4 Page 4 of Control and Reevaluation of Suppliers Critical items are inspected at incoming (see Quality System Procedure QSP 850) At quality system management reviews, management discusses unfavorable supplier performance and initiates Corrective and Preventive Action Requests as needed (QSP 930) If it is determined that a supplier should no longer be considered acceptable for future consideration, the responsible person lists the supplier as "Disapproved", and notes the reason and date of disapproval on the supplier's Supplier Approval form, and signs or initials it Beginning in 2005 the President, with the responsible person for the applicable product or service: a. reviews all approved suppliers, within 3 years of latest approval/re-approval, for evidence of their continued ability to meet customer requirements, specifications, delivery needs, price, and other terms and conditions. b. if performance is satisfactory, the President or the person responsible for that supplier notes the re-approval on the Supplier Approval form and signs or initials and dates it. c. if performance is unsatisfactory, the President or the person responsible for the supplier notes the reason and date of disapproval on the supplier's Supplier Approval form and signs or initials and dates it. d. Records the approval/dis-approval on Form 406.1(new version) or 310-2(Old version). 4.3 General Purchasing Procedure for items other than brokered materials, the orderer determines that the supplier is approved for the product or service requested or obtains approval for the order from the responsible person The orderer ensures that any purchasing document clearly describes what is to be provided, including: a) for materials, where appropriate: - Applicable association, industry, customer or government specification number - Certs of Conformance and Test report to accompany the shipment. - Clearly defined parameters if they are more restrictive than or in addition to the listed specification - physical dimensions and/or quantity - requirements for controlling documented information created and/or retained by the supplier - delivery, packing and shipping instructions - Requirements for approval of products, procedures, processes, and/or equipment - Requirements for qualification of personnel - Quality management system requirements

5 Page 5 of 8 - records retention requirements - If efi or our customer intends to perform verification at the supplier s premises, the intended verification arrangements and method of product release - Notification and/or required approval for disposition of any non-conformances - Notification and/or required approval of changes in product and/or process, product suppliers, or manufacturing facility location. - Flow down to the supply chain of all applicable requirements, including that external providers apply and flow down appropriate controls to their suppliers b) For other purchases, as appropriate: - the type, class, grade, part number, scope of work, and/or other precise identification of the product or service to be provided - the title, number, date, revision, and/or other positive identification of any applicable referenced documents, such as bills of materials, specifications, drawings, work instructions, standards, regulations, or other relevant technical data - quantities and dates required - where appropriate, requirements for approval of products, procedures, processes, and/or equipment - where appropriate, requirements for qualification of personnel - where appropriate, quality management system requirements - If EFI or our customer intends to perform verification at the supplier s premises, the intended verification arrangements and method of product release The orderer ensures review/approval of the order as defined in the next section If the supplier returns an acknowledgment, the orderer checks to ensure that it is in agreement with the specified requirements, and resolves any discrepancies with the supplier Ensures the conformity of all externally provided products, processes, and services including those designated by the customer. 4.4 Specific Purchasing Procedures Stock Materials a) Supplier Approval: Materials Manager b) Authorized to Order: Materials Manager, Operations Manager c) Ordering Process: - Orderer negotiates terms for item, places order, either verbally or in writing, and fills in and forwards requisition to Inventory Control - Inventory Control inputs order into computer, prints Purchase Order - Orderer reviews and approves Purchase Order

6 Page 6 of 8 - Inventory Control distributes Purchase Order copies to Supplier, Inventory Control, Operations Manager, and Purchase Order file Brokered Materials a) Supplier Approval: Sales b) Authorized to Order: Sales c) Approval/Ordering Process: - Sales determines that supplier is capable of meeting requirements, negotiates terms, places order verbally or in writing, fills in requisition, inputs order into computer, prints Purchase Order, reviews and approves Purchase Order, and distributes Purchase Order to: Supplier, Inventory Control, Sales Customer Order file, and Local Purchase Order file Critical Operating Supplies a) Supplier Approval: Operations Manager or Warehouse Manager b) Authorized to Order: Operations Manager or Warehouse Manager c) Ordering Process: - Orderer negotiates terms for item and places order, verbally or in writing, fills in requisition, reviews, approves and distributes to Inventory Control (1 for Invoicing, 1 for Stock Requisition file), and Operations Manager or Warehouse Manager Subcontracted processing, inspection/testing services a) Supplier Approval: Operations Manager, Warehouse Manager, Materials Manager, Sales b) Authorized to Order: Operations Manager, Warehouse Manager, Materials Manager, Sales c) Ordering Process: - Orderer negotiates terms and places order verbally or in writing. - If work is for a Shop Order, orderer fills out, reviews and approves Warehouse Work Order and distributes copies to Supplier, Sales Customer Order file, Inventory Control, and Purchase Order file Calibration of Inspection/Testing Equipment a) Supplier Approval: Operations Manager or Warehouse Manager b) Authorized to Order: Operations Manager or Warehouse Manager c) Ordering Process: - Orderer negotiates terms for item, places order verbally or in writing, fills in, reviews and approves requisition, attaches "Purchasing Specification - Calibration Services" (311.2) to supplier's copy and distributes to: Supplier, Inventory Control (2 copies - 1 for Invoicing, 1 for Stock Requisition file), and Operations Manager or Warehouse Manager

7 Page 7 of Quality Records (See QSP 753) 5.1 Record Description: Supplier Approval forms (items other than brokered materials) Maintained By: President Online Document 5.2 Record Description: Approved Purchase Orders (brokered materials) Maintained By: Sales 5.3 Record Description: Receiving Report (See QSP 850) Maintained By: inventory Control 5.4 Record Description: Record of supplier performance/problem reviews (CAPAR) (See QSP 1000) Maintained By: President 5.5 Record Description: Approved Supplier List Maintained by: President 6.0 Documents And Forms 6.1 Quality System Procedure QSP Leadership 6.2 Quality System Procedure QSP 850 Production and Service Provision 6.3 Quality System Procedure QSP 1000 Improvement and Corrective Action 6.4 Quality System Instruction Purchasing Specification - Calibration Services 6.5 Supplier Approval form (406.1) 6.6 F CorectiveActionRequest-CAR 6.7 Purchase Order (EF-113) 6.8 Purchase Order / Brokered Materials (406.2) 6.9 Approved Supplier List (406.3 online document) 6.10 Warehouse Work Order (Any Number?) 7.0 Revision History 7.1 Original: 10/13/ Revised: 05/16/05, 05/26/06, 02/17/10, 01/13/11, 12/01/11, 10/14/14, 11/2/15, 12/18/ Latest Revision Details: Changed language to Para to reflect current practice and simplify re-approvals of vendors 8.0 Document Owner 8.1 Operations Manager 8.2 Materials Manager 9.0 Approval 9.1 President

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