GE Power Electronics Business Total Quality Author: Reviewers: Contributors: Alessandro A. Cervone Technical Manager Component & Reliability Engineering Alicia Scott Title Erika Nannis Title Robert Roessler Custom Components Technical Leader 601 Shiloh Road Plano, Texas 75074 601 Shiloh Road Plano, Texas 75074 601 Shiloh Road Plano, Texas 75074 Page 1 of 12
Table of Contents 1.0 PURPOSE... 3 2.0 SCOPE... 3 3.0 DEFINITIONS AND ACRONYMS... 3 4.0 REFERENCE DOCUMENTS... 3 5.0 ROLES AND RESPONSIBILITIES... 4 6.0 PROCEDURE... 4 6.1 RECORD RETENTION... 12 6.2 IMPLEMENTATION PLAN... ERROR! BOOKMARK NOT DEFINED. Document Issue History Issue Reason for changes Date 1.0 Initial Release Rewrite of Tyco Electronics Power Systems 12/06/2012 102-47 GE Power Electronics reserves the right to make changes to this specification and specifications referenced herein from time to time upon written notice to the supplier. GE Power Electronics retains the right to change its definitions of acceptability as to on-time delivery, count, compliance with specifications, etc., upon written notice to the supplier. Page 2 of 12
Purpose This specification defines the minimum quality management system requirements, for suppliers to GE Power Electronics. 1.0 Scope GE Power Electronics quality policy and quality management system requirements are documented in Quality Specification QPxxxxx, Total Quality Management Process. A copy of this document can be provided to suppliers upon request for their awareness and utilization in meeting Power Electronics supplier requirements. 2.0 Definitions and Acronyms Terminology or Acronyms Definition 3.0 Reference Documents The following documents and forms constitute a part of this specification to the extent specified herein. Unless otherwise specified, the latest edition of the document applies. Document ID ISO Guide 25 ISO 9001 ISO 10012-1 ISO/IEC 17025 ISO/TS 16949 Document Title Total Quality Management Process Procedure for Processing Deviation Requests QP8.5.A - General Requirements for Suppliers of Production Materials QP8.5.2+3 - Corrective and Preventive Action Process Form - Inspection Rejection Report Form - Request For Quotation Form - Deviation Request For Known Nonconformance Form - Power Electronics Supplier Profile, Classification/Certification, Questionnaire, and Environmental Indemnification White Paper Form - MNDA Form Supplier Integrity Letter Form Appropriate tax documents (W8/W9/FPD) Form EHS Prescreen Form Supplier Quality Self Survey Form - Supplier Corrective Action 8-D Worksheet General Guide for the Competence of Calibration and Testing Laboratories Quality Management Systems Requirements Quality Assurance Requirements for Measuring Equipment General Requirements For The Competence Of Testing And Calibration Laboratories Quality Management Systems Particular Requirements for the Application of ISO 9001:2000 for Automotive Production and Page 3 of 12
QS-9000 TL 9000 SAE AS 9100 Relevant Service Part Organizations Quality System Requirements Quality System Requirements Quality Systems Aerospace Model for Quality Assurance in Design, Develop Production, Installation and Servicing 4.0 Roles and Responsibilities Role Responsibility 5.0 Procedure 5.1. Quality Policy It is the policy of GE Power Electronics to deliver error-free products and services on time. Processes and controls shall be implemented such that tasks are performed properly the first time and to ensure that all products and services provided to our customers and to internal operations meet established requirements. Quality, continual improvement and customer satisfaction are the personal responsibility of each employee. 5.2. Supplier Support As an extension of our internal operations, suppliers are expected to commit to providing this same, high level of commitment to quality, (Zero Defects), delivery (100% on Time), continual improvement and customer satisfaction. A supplier shall specify any exceptions to the requirements of this document, drawing, request for quote or purchase order. Exceptions shall be stated on the quotation or acknowledgement of the confirming order. 5.3. SUPPLY BASE 5.3.1. Supplier Evaluation A. Suppliers of production materials, components and assemblies, that could impact product quality or delivery shall be evaluated prior to classification as an approved supplier. Suppliers are required to complete Form White Paper. B. Other evaluations may be required within 30 days after addition of a supplier to the approved supply base and may be repeated periodically to ensure that the supplier s quality management processes are maintained or enhanced. C. The supplier will be formally notified of the results of these evaluations by the Supplier Quality Engineer (SQE). Corrective action shall be required when the result of an onsite assessment fails to meet the established minimum requirements of this Specification. D. Suppliers are encouraged to earn third party registration to ISO 9001, ISO 14001, TL 9000, QS-9000, ISO/TS 16949 or SAE AS 9100 or equivalent national standard. Page 4 of 12
5.3.2. Supplier Responsibilities A. General Requirements General requirements for suppliers of production material are defined in Quality Specification QP8.5.A. B. Purchase Order Conditions All purchase orders will be governed by the GE Terms of Purchase GE Terms of Purchase can be reviewed at: C. Requirements for Quoting GE site http://www.lineagepower.com/?page_id=427 Requests for quotation shall be provided by the GE Power Electronics buyer. Drawings and all related specifications shall accompany any Request for Quotation. Suppliers are to respond to the request for quote within the allocated time to the appropriate buyer. All requests for exceptions to the requirements shall be documented; otherwise, full compliance with these requirements is expected. D. Confidentiality The Supplier understands and agrees to hold in strict confidence all confidential information derived from GE Power Electronics. When requested by Sourcing, the supplier shall return all documents provided by GE Power Electronics. E. Specification and Document Review 1. Prior to acceptance of the purchase order, the supplier shall review all drawings and documents to ascertain that they are to the engineering revision level specified on the purchase order. The supplier shall notify the appropriate buyer of any errors or omissions. GE Power Electronics will either correct the error or arrange for a temporary deviation until correction can be made. The supplier shall not implement changes to any GE Power Electronics document without prior approval having been issued in writing by the GE Power Electronics buyer. 2. The supplier will establish a process to ensure the timely review, distribution and implementation of authorized drawing and document changes. F. Policy on Subcontract Jobs The Supplier is not to subcontract any work related to any given purchase order or place any GE Power Electronics tooling with subcontractors without notification and written permission from Power Electronics. G. Notification of Product or Process Changes GE Power Electronics must ensure that its customers receive product that is consistent with drawings, product specifications, and inherent performance requirements. To facilitate this requirement for Page 5 of 12
consistency, GE Power Electronics requires that the supplier provide prior written notice to the Sourcing and/or GE Power Electronics business unit when product, process or location changes occur (refer to Quality Procedure QP7.4.4). If there are any questions regarding the potential impact of a product or process change, contact the responsible buyer for direction. H. Raw Material Verification It is the responsibility of the supplier to only use materials that comply to the GE Power Electronics Material Specifications and drawing requirements when manufacturing components to a GE Power Electronics purchase order. When a purchase order states a requirement for raw material verification, the verification shall be provided by the supplier to GE Power Electronics receiving inspection. 1. Suppliers of raw material shall complete laboratory analysis to confirm that the material meets the requirements of the Material Specification referenced in the purchase order. In accordance with the purchase order, suppliers may be required to submit a Certificate of Analysis (C of A) with the raw material. 2. Suppliers of components shall use raw materials that conform to the applicable Material Specification identified on the manufacturing drawing or on the purchase order. In accordance with the purchase order, suppliers may be required to submit inspection data or a Certificate of Conformance (C of C) with the product. I. Laboratory Accreditation Suppliers of base metals and polymeric compounds must provide raw material test data from a laboratory that is currently accredited through a 3 rd party firm to ISO Guide 25 or ISO/IEC 17025 or national equivalent. J. Verification of Quality 1. GE Power Electronics and its customers reserve the right to perform any testing or inspection that may be necessary to determine that the purchase order requirements have been met, including verification at the supplier s location if required. The supplier may be required to submit test or inspection data corresponding to the lot(s) being tested or inspected for comparison or correlation purposes. 2. Product accepted at receiving inspection may be found to be nonconforming during the manufacturing process. The supplier is liable for such product unless specified shelf life has been exceeded. K. Continual Improvement GE Power Electronics expects that each of its Strategic and Preferred suppliers support continual quality and delivery improvement by formulating and implementing continual quality and delivery improvement plans. Continual improvement methods are described in QP8.5.1_Supplier_Continual_Improvement. Page 6 of 12
L. Design Review/Early Involvement 1. A Design Review is conducted for each new marketable product and/or application tooling under development or whenever a change affecting form, fit, or function is to be made to an existing product. There are three phases to a Design Review: Concept, Development, and Introduction. 2. Before any discussion of information, the supplier may be requested to sign a Nondisclosure Agreement initiated by operations and Sourcing to ensure complete confidentiality. 3. The supplier may be involved in the Concept and Development phases. GE Power Electronics will work with the supplier to ensure the supplier s ability to manufacture the product to meet requirements at the lowest total cost. At this time all applicable specifications are developed and implemented for the manufacture of the product. Communications and a good working relationship are welcomed and imperative to maximize the efficiency of the Concept and Development phases. 5.3.4. Quality Assurance System A. Additional Requirements The supplier is responsible for the quality of any process that affects the configuration, assembly, heat treatment, plating, and/or metallurgical properties of GE Power Electronics consigned or stocked material. B. Traceability and Material Identification Evidence of the GE Power Electronics raw material part number (base metal and polymeric compounds) as used in the particular part is necessary for each purchase order. With the exception of commercial items, specific traceability of these raw materials to final item lot is required through the use of a material trace number. Identification of the tool, tester, operator, etc., associated with the processing of a given lot shall be available for review in the event a recall is required. C. Process Controls The supplier is responsible for adopting the necessary techniques and controls during all phases of manufacturing to ensure that the quality of the product being produced is both known and controlled. As a measure of continued process improvement, a capability study shall be conducted on key characteristics, as agreed to by GE Power Electronics and the supplier. The supplier shall submit data or evidence of performance when required by GE Power Electronics Sourcing. In the absence of specified capability requirements, a minimum Cpk value of 1.33 is considered standard. D. Inspection When indicated on the purchase order, first article inspection approval shall be obtained from the supplier prior to initiation of full production. The supplier is responsible for notifying CEPI when first article samples and inspection data are available. SQE reviews the first article data and samples, with the supplier, as required. First article approval does not Page 7 of 12
relieve the supplier of the responsibility of assuring that subsequent production is in accordance with documented requirements. The supplier is responsible for all inspection and testing activities from incoming raw material through finished product. E. Calibration System 1. Responsibility for the supply, maintenance, and calibration of standard measurement and test equipment, such as pin gages, thread gages, micrometers, comparators, multimeters, etc. shall rest with the supplier. 2. Provision for special measurement and test equipment, unique to a specific purchase order or product, shall be negotiated at time of contract placement. Calibration and maintenance of such special equipment shall rest with the supplier, unless otherwise specified in the contract. 3. Gages, measuring devices, and testing equipment used to determine the acceptability of materials and tooling used in production shall be controlled and calibrated in accordance with the current revision of ISO 10012-1 or equivalent national standard. F. Nonconformance - Request for Deviation 1. The supplier is responsible for meeting all the requirements of the purchase order, drawings, and GE Power Electronics Specifications or Industry Standards or Specifications (e.g., EIA, ASTM, etc.) when specified or applicable. Material that does not conform to these requirements shall not be shipped to GE Power Electronics, its customers or other suppliers without prior written approval having been given in the form of an approved Deviation Request for Known Nonconformance, SPCN-QP7-4-4-SPCR_Form-GE(2-2).doc. 2. Request for deviation from requirements shall be brought to the attention of the GE Power Electronics SQE. Approval or disapproval of supplier deviation requests will be documented and communicated to the supplier by the buyer in accordance with (Quality Procedure QP7.4.4). 3. Each request for deviation shall include a statement of corrective action, person responsible for the corrective action, and estimated date of implementation of corrective action to prevent recurrence of the nonconformance. 4. Supplier shall identify, store, and ship deviated nonconforming material in such a manner as to keep it separate from conforming material. The deviation number is to be noted on the packing slip, and when requested, on all shipping containers. Page 8 of 12
G. Resubmitted Product 1. Rejected shipments may be resubmitted only after the supplier has reworked or removed all defective items and has re-inspected the product to determine that all requirements have been met. 2. Resubmitted shipments shall be accompanied by a copy of the GE Power Electronics Inspection Rejection Report or equivalent showing the rework/sorting performance results and should be preceded by notification to the GE Power Electronics buyer and/or appropriate GE Power Electronics Supplier Quality Assurance function of the course of action taken. 3. GE Power Electronics retains all rights with respect to resubmitted shipment same as with the original lots. H. Corrective Action 1. SQE shall assist the suppliers in eliminating all situations that, based on status and importance, could cause delays, rejections, rework, deviations, excessive scrap, or any condition that impairs the supplier s ability to meet established requirements. When requested, the supplier will submit a corrective action plan that provides the details of how the nonconformity will be resolved. The Supplier Corrective Action 8- Discipline Worksheet Form 4725-4 is the preferred format for supplier corrective action responses. Also see GE Power Electronics 8-D Problem Solving Checklist Form 4725-6. Supplier Quality Assurance and CE shall track these corrective action plans until closed. 2. Should that corrective action be ineffective, untimely, or performance not be restored, GE Power Electronics may exercise all rights available under contracts or purchase orders. I. Packaging and Labeling Unless otherwise specifically defined, packaging and labeling are the responsibility of the supplier and shall be adequate to prevent damage or deterioration during shipment. Packaging shall conform to all packaging specifications documented on the purchase order, production prints, material specifications and Packaging Specification PKG 2008. J. Handling and Storage Requirements The supplier is responsible for the proper handling and storage of all raw material and components supplied or consigned to GE Power Electronics per GE Power Electronics Component Shelf Life Policy. Special handling, packaging, and storage requirements will be documented on the purchase order. K. Unit Count Accuracy Unless otherwise specified, unit count accuracy of supplied materials shall be within the following limits: Page 9 of 12
1. Reeled Material +1.0%/-0.0% 2. Weigh Count +0.2%/-0.0% 3. Machine Count Bulk +0.5%/-0.0% 4. (Tube/Tray) Packaging +/-0.0% 5. Base Metals +/-15% (Qty. Shipped vs. Qty. Received) 6. Resins +/-2% (Qty. Shipped vs. Qty. Received) L. Quality Records The supplier is responsible for maintaining the following records for each part number manufactured or provided, as applicable: a. Inspection records (1) first article inspection results (2) set up inspection records (3) in process inspection records (4) final inspection records (5) dock audit results b. certificates of analysis c. certificates of compliance d. laboratory analysis test results e. SPC data (if applicable) f. purchase orders g. change orders h. approved deviations i. calibration records j. nonconforming material records k. corrective action responses l. shipping records m. PPAP (if applicable) Page 10 of 12
These records shall be maintained for a minimum of 7 years. 5.4 PERFORMANCE REQUIREMENTS/MEASUREMENTS 5.4.1. Performance Goals for Suppliers are defined in QP7.4.2 These performance measures shall be measured and regularly reported to suppliers. 5.5. SUPPLIER DEVELOPMENT Supplier development may be achieved through a variety of endeavors. It can be brought about through Supplier Performance Enhancement (SPE) meetings (Appendix A), workshops, surveys, corrective/preventive actions, training, or one on one meetings. These development actions may be implemented with suppliers on a selected basis. 5.6. Supplier Forecasting (Supplier Managed Inventory/Demand Pull) A. To control inventory levels and ensure on time delivery of raw materials and components, finished product and packaging materials, GE Power Electronics has developed and implemented a system for supplier forecasting and supplier management of inventory. Under this system, suppliers are provided with requirement forecast information at regular intervals and asked to hold fixed amounts of inventory (generally 2-4 weeks). In return, GE Power Electronics accepts some liability for a negotiated period of time to allow the supplier to procure raw materials and build inventory. There is also a negotiated time period during which scheduled quantities and delivery dates will not be changed. 1. Forecasts: There are two major components of this system: These are provided to suppliers weekly and contain a rolling twelve month requirements window. 2. Blanket Orders They are purchase orders issued in conjunction with forecasts. They are for a fixed quantity and/or duration and are based upon production schedules. Upon placement of the blanket purchase order, computer generated shipping schedules are transmitted weekly to the supplier. 5.5.4. Automated Sourcing System A. License Tag Barcode Labeling System The License Tag Barcode Labeling System enables Suppliers to create customized (to GE Power Electronics specifications) labels for their shipments to GE Power Electronics. The reference License Tag refers to the unique (as in an automobile license tag) serial numbers barcoded onto these labels. The License Tag process then automates the materials receiving process at GE Power Electronics, through enabling the creation, communication, and processing of shipping and receiving information and documentation. The License Tag process generates a labor savings at the receiving location, through reducing the number of personnel required to manage the receipt and stocking of inbound Page 11 of 12
shipments. Currently, GE Power Electronics has two versions of the License Tag Barcoding System: 1. EDI License Tag, the older version, which uses standard Electronic Data Interchange business documents to transmit the supporting information required for the labels and the process. 2. Internet License Tag, the newer version, which uses the Internet to transmit the supporting information required for the labels and the process (eliminating the more costly EDI). The license tag label itself is an individual label, (typically one per container), each having a unique serial number, like an automobile license tag, and incorporating barcode technology to contain that unique serial reference number. The number enables the identification of the package contents, and references traceability information. When assembling a shipment of outbound material, the supplier creates and applies barcoded license tag labels to the cartons/containers. The supplier then scans those labels, or alternatively manipulates carton data, to create a data model of the actual shipment of cartons and pallets, from which the license tag application software generates Advance Ship Notices (ASN s). These ASNs are then transmitted to GE Power Electronics. Upon arrival of the actual product shipment at GE Power Electronics, the incoming material can be automatically received when the receiving clerk scans any single box on the shipment, which automatically references the ASN data for the whole shipment. The purchasing system then uses that data to enable the receiving process, and electronically generates the necessary receiving documents. 5.5.5. Supplier Training & Development Plan The Training and Development planning process is a critical activity for every organization. An effective training and development program can help to fulfill the organizational goals and objectives, improve productivity and provide quality products and services. This training and development plan should be reviewed during the GE Power Electronics - Supplier feedback meetings to track and report progress to goals. (Refer to Appendix A). 6 Record Retention Document / Record Retention period Storage location Responsible (if applicable) Supplier Quality 7 Suppliers system Supplier Records Per 5.3.4 (L) Non Conformance 7 Windchill SQE Page 12 of 12