Pacific Gas and Electric Company

Transcription

1 Pacific Gas and Electric Company

2 Supplier Quality Assurance Mission Statement Our mission is to assure that PG&E has a robust quality program that quantitatively measures supplier performance and drives continuous supplier improvement. We will work with our suppliers to assure delivery of safe, reliable and affordable products that meet or exceed our Customer s expectations.

3 Table of Contents 1.0 SCOPE APPLICABLE DOCUMENTS GENERAL DEFINITIONS QUALITY SYSTEM REQUIREMENTS PG&E PART QUALIFICATION PROCESS (PPQP) ADDITIONAL PG&E REQUIREMENTS Change Management Process Special Process Control Unexpected Visual Conditions Inspections and Product Acceptance Post-Qualification Reporting Requirements APPENDIX A I. QUALIFICATION PROCESS TERMINOLOGY II. QUALIFICATION WORK ELEMENT DEFINITIONS III. QUALIFICATION ELEMENT WORKSHEETS Revision Notes... 44

4 1.0 SCOPE 1.1 This manual establishes qualification requirements for direct material suppliers to PG&E for products and custom tools used in power generation (excluding nuclear) and the transmission and distribution of natural gas and electricity. It includes verification of a supplier s quality management system by audit and describes the process for product qualification to establish supplier capability to meet PG&E contract requirements. This manual applies to conditions identified in section 5.3 below. 2.0 APPLICABLE DOCUMENTS 2.1 The following documents form a part of this specification to the extent specified herein. Additional requirements, applicable item drawings, and specifications will be communicated by PG&E as necessary (examples, ASME, API, AWS, and ASTM). Unless otherwise indicated, the latest document revision shall apply ISO 9001, Quality Management System International Standard ISO 17025, General Requirements for the Competence of Testing and Calibration Laboratories Recommended Practice Number ASNT-TC-1A, Personnel Qualification and Certification for Non-Destructive Testing (or equivalent) 2.2 Hierarchy The Purchase Order (PO) is the formal document transmitting PG&E requirements to a supplier. Changes to a design drawing or specification cannot be made by PO revision alone without the accompanying revised drawing or specification In the event of a conflict between the PO, specifications and the requirements stated therein, the order of precedence (highest to lowest) shall be: Part Drawings (unless they defer to specifications as the overriding documents) Specifications SCM-2105M Purchase Order It is the responsibility of the supplier to review requirements transmitted by PG&E contract or purchase orders and document the results of the review. Any conflict between PO requirements including documents identified in the PO shall be brought to the attention of PG&E Supplier Quality Assurance for resolution prior to initiating work. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 1 of 42

5 3.0 GENERAL DEFINITIONS 3.1 Shall or Must indicate a mandatory requirement. Should or May indicate a recommended or desirable but not mandatory requirement. 3.2 Vendor - The entity to which PG&E issues a purchase order. The vendor is responsible for transmitting PG&E s part requirements to the supplier. 3.3 Supplier - Unless noted otherwise, refers to the corporation, company, partnership, sole proprietorship, or individual that is responsible for manufacturing the part subject to this qualification process. Suppliers of components or services to the manufacturer which enable manufacture of the final product are called sub-suppliers. 3.4 Supplier Quality Engineer (SQE) PG&E representative who communicates qualification and production quality requirements, and is the key contact with the supplier relative to qualifications, process improvements, non-conforming material dispositions, corrective actions, surveillances and auditing. 3.5 Sourcing PG&E representative who negotiates price, delivery, terms and conditions, and places purchase orders for qualification and production. This individual is the official contact between the supplier and PG&E for all commercial issues and conditions. 3.6 Responsible Engineer (RE) PG&E Engineering representative, typically a Standards Engineer, who together with the SQE is responsible for actions and approvals within the qualification process, and/ or reviewing nonconforming issues for engineering approval. This individual also coordinates disposition with the SQE for return response to the Supplier. The RE definition may apply to various functions at PG&E such as the Standards Engineer, Subject Matter Experts or other technical specialist assigned to review a qualification document or nonconformance. Any communication with the RE must be done with prior notification and knowledge of the SQE and Sourcing. 4.0 QUALITY SYSTEM REQUIREMENTS 4.1 The supplier should have a third-party certification to ISO 9001 or a quality management system that complies with ISO 9001 requirements. In cases where the supplier does not meet this requirement, PG&E will document deficiencies of the QMS per ISO guidelines as part of the audit process. The supplier shall submit a corrective action plan to PG&E for approval which addresses all documented deficiencies New suppliers to PG&E shall be audited and conditionally approved by PG&E before being allowed to begin product or process qualification activities. Approval requires the supplier to take corrective action on all audit nonconformance s to PG&E s satisfaction, or to have an approved corrective action plan in place to resolve the QMS deficiencies to PG&E s satisfaction Prior to the audit, suppliers shall submit at the minimum the following to the PG&E SQE for review: PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 2 of 44

6 Completed PG&E pre-audit questionnaire Current QMS Certification or evidence of Conformity to the ISO standard or equivalent Copy of the current QMS manual. Recent Organization Chart Accreditation of testing laboratories and the scope of their accreditation List of Special Processes List of key sub- suppliers who may be used to satisfy PG&E requirement and copies of their 3 rd party Certifications, if any. Refer to Appendix II for a definition of a key sub-supplier Pending a successful audit, the supplier will be placed on the PG&E Qualified Suppliers List as conditionally approved pending successful completion of PG&E Part Qualification. 4.2 Record Retention Records required by applicable industry product standards shall be retained for not less than the period of time specified by any applicable industry standards or five years, whichever is longer. Records required to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be retained for a minimum of five years. PG&E must be notified prior to the disposal of any quality records. 4.3 Right of Access PG&E reserves the right to visit suppliers and sub-suppliers for audits or business meetings during the normal course of business or to perform source inspection and surveillance. PG&E will use reasonable efforts to provide at least five (5) days advance notice and work with the suppliers to ensure adequate preparation for audit and business visits. Suppliers will provide advance notice to PG&E for planned surveillance or source inspection activities consistent with manufacturing schedules or as required for key hold points or witness points as defined in section 4.5 below. 4.4 Control of Sub-tier Suppliers If a supplier chooses to outsource a process, product component or final product, the supplier is responsible for qualification and surveillance of the sub-supplier to PG&E requirements and notifying PG&E of this qualification. PG&E reserves the right to (1) Review the supplier s process for selection, qualification and surveillance of its sub-suppliers; (2) To approve or disapprove the sub-supplier s qualification; and (3) Audit and monitor the sub-supplier s processes and facilities when deemed necessary The supplier shall perform routine quality audits and inspection of its key subsuppliers to ensure oversight, knowledge and control of critical or special processes PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 3 of 44

7 as well as changes enacted by the sub-supplier. In addition, the supplier shall have a documented system in place to inspect custom incoming components from subsuppliers for adherence to drawings or specifications The supplier shall conduct requalification to validate any major changes to processes or product provided by the sub-suppliers, including First Article inspections Key sub-suppliers, sub-supplier processes, or sub-supplier manufacturing locations or critical components that affect form, fit, or function that are approved as part of the PG&E qualification are considered frozen and cannot be changed without resubmittal and approval of the required documents by PG&E 4.5 Hold Points and Witness Points Hold Points are mandatory verification points identified by the PG&E SQE beyond which work may not proceed until a PG&E representative performs verification or surveillance and provides notice to proceed. Source inspection prior to product release and PG&E surveillance of a manufacturing step, special process test or inspection are examples of Hold Points. Hold points or witness points, when required, will normally be communicated through purchase order notes Witness Points require the Supplier to notify the SQE in writing prior to completion of those steps. After notification, work may proceed beyond a Witness Point with or without action by the SQE The supplier shall notify the SQE of Hold Points or Witness Points in the manufacturing or qualification process schedule a minimum of ten (10) days in advance (unless otherwise agreed upon with the SQE). 4.6 Design Control The supplier s quality management system shall implement controls to: Ensure that PG&E design, specification, functional and quality requirements are correctly translated into drawings, specifications, procedures, and instructions. Ensure that Supplier designs and specifications, including any revisions, for products being procured by PG&E are reviewed and accepted by PG&E Engineering to confirm that they meet PG&E requirements prior to initiating manufacturing. Assure that design reviews and approvals are documented. 4.7 Preventive Maintenance The supplier shall identify key process equipment and tooling, develop and document a Preventive Maintenance program. PG&E may verify that such programs are documented and effectively implemented during supplier audits. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 4 of 44

8 5.0 PG&E PART QUALIFICATION PROCESS (PPQP) 5.1 General Terminology General terms applicable to the qualification process used by PG&E are listed below. Appendix A contains a glossary of additional terminology related to different work elements of the qualification process Qualification: A specific effort to demonstrate that a supplier s production facility, processes, equipment, tooling, software and/or inspection systems are capable of producing and discriminating acceptable product within the extremes of the defined process, to a defined confidence level as required by drawings, specifications or other documents PG&E Part Qualification Process (PPQP): A structured, approach to conduct supplier qualifications, establish basic manufacturing documentation requirements and assess that products meet PG&E requirements. The process may define effort in 2 Phases and include the following Phase 1 requirements: Part description including drawings and applicable specifications The actual tests and inspections to be performed. Where the tests and/or inspections are to be performed, i.e., at the Supplier or a PG&E facility. Minimum size of a First Article Production run, sampling plans and part test quantities, key characteristics and/or parameters to be evaluated. Acceptance Criteria Required completion of Qualification Process Work Elements. PG&E Hold or Witness Points Phase 2 deals with additional functional and environmental testing which may be required if Phase 1 is successfully completed. The need for such testing will be established by PG&E in conjunction with conversations with the supplier. A completed qualification package prepared by the supplier and submitted to PG&E will consist of a summary cover letter, documented completion of up to 15 different Qualification Work Elements plus an approved Part Warrant. A Work Element Submission Requirements and Status Checklist is also provided to the supplier to facilitate tracking the completion of the various work elements. The Work Elements are listed in Figure and the corresponding work sheets are included in Appendix A Part Qualification Plan (PQP): Documents the qualification and re-submittal requirements that are identified by PG&E for the product that the supplier will be manufacturing. Design drawings and applicable specifications are defined in the PQP Part Warrant (PW): The Part Warrant is the official document prepared by the Supplier and is used to track the status of the PPQP document package. When completed, it will also contain the official PG&E approval and final sign-off of the PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 5 of 44

9 5.2 PPQP Objectives qualification. It must be resubmitted when any approved qualification documents are revised. If the part warrant is rejected, a reason for the rejection will be provided. This process is based on elements of the Automotive Industry Action Groups (AIAG) Production Part Approval Process (PPAP) Standard Revision 4 March, The objectives of this process are: To provide evidence that engineering design and specification requirements are properly understood and fulfilled by the supplier. To demonstrate that the supplier s manufacturing and inspection processes provide products that meet PG&E requirements during an actual production run. An additional benefit includes establishing a baseline of supplier process documentation to facilitate Change Management and Control. 5.3 Applicability This process is required for the following situations: A new product manufactured by a new supplier. A new product manufactured by an existing supplier. A new supplier manufacturing an existing product. After a break of production for at least 2 years After a major factory disturbance such movement of key machines or product lines, a major restructuring of the work force or a factory change of ownership. A new product is defined as one that PG&E has never used or that a supplier may not have ever produced. The design or specification for the new or existing product may be provided by the supplier or PG&E. New product and/or new supplier qualification require submittal of all assigned Work Elements upon completion of Phase 1 by the supplier. This is identified as a Level 1 Qualification in Figure A Level 2 Qualification where most submittal requirements are defined by the SQE, and at PG&E discretion may be used for qualifying long-lead, one-of complex products or limited requalification activities. After an initial qualification, there are situations where some requalification and First Article testing may be required. These situations include but are not limited to: Changes in key sub-suppliers or the manufacturing location of the supplier and critical product sub-suppliers Changes in product design, specifications or processes, or a sub-supplier process, including critical integral software, such that product form, fit or function may be affected Change of a custom component or material PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 6 of 44

10 Quality issues such that existing qualifications are called into question. The scope of the required requalification effort will be determined by the SQE. Section 6.1 of this procedure entitled Change Management Process provides more guidance on when requalification would be necessary. Change Request requirements are also described. 5.4 General Requirements By successfully completing a qualification (Phase 1 and Phase 2 as required), the supplier demonstrates the ability to provide parts that meet PG&E requirements. The supplier is required to perform the qualification using the documented instructions in the Plan communicated by PG&E. Once the qualification is completed and deemed acceptable by PG&E, PG&E will sign the supplier provided Part Warrant. After approval, the supplier will be considered qualified to supply a specific part or part family The approved process, including those for supplier designed items, will be considered frozen. Any changes to the approved processes, procedures or supplier designed items will require resubmittal and approval by PG&E before they can be implemented. This also includes changes to the Bill of Materials for supplier designed hardware generally for parts defined to be key parts. 5.5 Communication The supplier shall appoint a Project Manager for the Qualification effort. This individual will be responsible for communicating with the SQE (or other identified PG&E Project Lead) on a mutually agreed upon schedule to report project item status, discuss issues (current or unforeseen) that could affect successful completion of the qualification, potential solutions, and SCARs. The Project Manager is responsible for developing schedules and assuring that commitments and milestones are met to satisfy PG&E requirements. 5.6 PG&E Qualification Process Requirements PG&E, with supplier input, will establish the scope of the qualification which is then documented in the Part Qualification Plan (PQP). The qualification process will consist of one or two Phases (depending on various factors that will be addressed by PG&E Supplier Quality Engineering with the Supplier): Phase 1: First Article Tests and Inspections. This Phase is performed by the supplier in compliance with the qualification test plan provided by PG&E. This testing may include dimensional inspection, material testing and/or functional tests to demonstrate that the product is acceptable. The First Articles must be taken from an actual production run in the facility intended to manufacture the product for PG&E using production tooling, PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 7 of 44

11 procedures and equipment. Exceptions may be made with written release by PG&E. The minimum size of the production run and sampling plan for selection of the First Articles to be tested and submitted to PG&E will be established by PG&E. If the Phase 1 results of First Article tests and inspections meet PG&E Acceptance Criteria, the complete PPQP package including a cover letter summary prepared by the supplier, the completed Work Elements, and the signed Part Warrant shall be submitted to PG&E for review and approval. If Phase 1 results do not meet PG&E requirements, Corrective Actions would be required and Phase 1 repeated or amended. Prior to initiating Phase 1, if a product, new to PG&E, has been manufactured by either a new or existing supplier, information on product characteristics and performance will be requested to allow PG&E to perform an initial product assessment. This request will be documented using the Supplemental Requirements Work Sheet of the Qualification Plan and address the following topics: Design Record including Drawings (Minimum), Material and Technical Specifications Electrical Characteristics Utility References Design test results Safety test results Product maintenance & operating procedures and/or requirements Installation instructions Weather proofing characteristics and requirements Samples or Prototypes (if available) for PG&E evaluation Conformance with National Standards Lab test results and certifications Environmental and life testing Production test results Durability (Accelerated life or age test results) Product demonstration results Product In-service experience Material Problem Report History Production history and Capacity For supplier designed products, design records must be provided by the Supplier. Key product and process characteristics should be identified by the supplier in the design record. Key characteristics may be product specification requirements or in-process product characteristics identified by the supplier as being necessary to assure that final product meets requirements. If a product requested by PG&E has never been produced by a supplier, PG&E may take the lead responsibility and/or work with the supplier to populate the Design Record. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 8 of 44

12 If parts requiring qualification are already in production at a new or existing supplier, samples should be submitted to PG&E for evaluation. The results of this evaluation may influence the scope of the later Phase 1 or Phase 2 qualification work. All required Qualification Work Elements shall be submitted to PG&E prior to fabricating First Articles unless specified otherwise by the SQE. Phase 2: Functional and/or Environmental Testing. If deemed necessary by PG&E, this Phase will include additional tests or inspections that may be required to demonstrate functional capability of the product; confirm that installation and maintenance requirements are met; and / or prove that the product will perform in the environment that it is intended to be used. These tests may be performed by the Supplier or PG&E as defined in the PQP. A successful Phase 1 is a pre-requisite for conducting Phase 2 testing. If both Phase 1 and 2 are successfully completed to PG&E s satisfaction, the Part Warrant will be signed by PG&E and returned to the supplier. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 9 of 44

13 Figure : Qualification Work Elements Work Element Level 1 Level 2 -- Part Qualification Plan (PQP) PG&E PG&E _ Work Element Requirements and Submission Status Checklist* PG&E PG&E -- Supplemental Qualification Requirements PG&E PG&E -- Product Marking, Packaging & Labeling Requirements PG&E PG&E 1 Special Process List 2 Special Process Qualification Documentation Key Sub-supplier List Qualified Laboratory Documentation Process & Inspection Flow Chart (PFO) Software Control Applicable Document List Visual Standards and Part Checking Fixtures Certificate of Conformance (C of C) 10 Dimensional and Visual Inspection Report Supplier Test Report Exceptions Identified During Qualification Part Warrant 14 Change Assessment Questionnaire S S 15 Supplier Change Request (2 pages) 16 Part Warrant Revision History S= Required supplier submittal; the Part Warrant is required upon completion of Phase 1. PG&E = PG&E submittal AR = As Required supplier submittal * = Provided by PG&E to the supplier to track the status of the required Work Elements S S S S S S S S S S S S S AR AR AR AR AR AR S AR S AR S AR AR AR S AR AR PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 10 of 44

14 6.0 ADDITIONAL PG&E REQUIREMENTS 6.1 Change Management Process This process implements a formal PG&E policy requiring approval for all supplier changes. It provides a formal system for assessing, tracking & documenting changes, thereby improving PG&E awareness to prepare and support the change. It also forces pre-approval to avoid the adverse effect of random changes. The supplier is required to implement a Configuration Management System to ensure the control of documentation and the definition of product manufactured and / or designed for PG&E by the supplier or its sub-suppliers When changes are contemplated, a Change Assessment Questionnaire shall be completed by the supplier. Depending on the Yes/No evaluation, the supplier is required to elaborate on the change using the Change Request Form. The Change Assessment Questionnaire along with the Change Request Template for reporting a Change to PG&E are included in Appendix A The Questionnaire and a completed Change Request must be submitted to PG&E for review. They should be submitted at least 6 weeks in advance of when the change is contemplated to be implemented to allow time for PG&E review At a minimum and to facilitate PG&E review or final acceptance of the proposed change, First Articles and first article inspection results may be required for the following: Revisions to drawings and specifications Product manufacturing or equipment changes Manufacturing location changes for the supplier or sub-suppliers Changes in Sub-tier suppliers of product. Changes in the manufacturing environment shown to have no impact on form, fit or function of the product Changes to improve product performance (process yield, scrap, defect rates, customer return rates, etc.) Changes in QC inspection methods or procedures Changes in product packaging or shipping details Qualified product which has had a production lapse of two years or more. Factory change of ownership that affects process or personnel significantly or other major changes in the workforce not related to a change of ownership If the change is to a part designed by the supplier, a Revised Design Record and a revised Bill of Materials for the proposed part should be submitted along with the Change Request The SQE, RE, and others at PG&E will review the Change Request in a timely fashion and determine what actions and PQP resubmittal requirements are PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 11 of 44

15 needed, if any, before the Change can be implemented. The signed form and determination will be returned to the supplier. NOTE: A qualified process or design cannot be changed without first receiving approval from PG&E. 6.2 Special Process Control A Special Process is one in which the results are highly dependent on the control of the process or skill of the operator or both and where the required quality characteristic cannot be readily determined by inspection and test of the product Specific documented and controlled procedures shall be developed and implemented for each special process. The procedures shall include identification and monitoring of critical to process (CTPs) or critical to quality (CTQs) attributes for each special process. The procedures, and related qualification reports, shall be submitted to PG&E for review and approval Only qualified or certified personnel shall be assigned to perform a special process. The supplier shall develop and document specific training plans, check and document the performance of the qualified individual on a regular basis. Personnel performing non-destructive testing shall meet the requirements of Reference Sub-suppliers performing special processes shall meet the same requirements as imposed on suppliers Special processes include but are not limited to: Non-destructive testing and examinations (NDT & NDE) Hydrostatic testing Joining methods such as Welding, Brazing, Soldering Heat treating Melting (raw material production) Pickling, Etching and Chemical Cleaning Passivation Plating Painting or Coating and surface preparation Forging and Hot forming Casting Compositional testing or check methods The following conditions require a qualification or re-qualification of a special process: New special processes or new suppliers performing the special process. Equipment changes that affect Set Points or key parameters of a currently qualified special process PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 12 of 44

16 Non-conservative changes to previously qualified key parameters or Set Points outside of the previously qualified limits New or revised PG&E Specification requirements 6.3 Unexpected Visual Conditions Visual standards often are developed during qualification. Such standards may represent unusual or unexpected conditions observed during qualification of a new product or new process If an unexpected visual condition (UVC) is observed or anticipated on a component, the condition must be clearly identified as such and communicated in writing to the SQE. A UVC will be considered a non-conforming condition unless the SQE is notified in advance early in the manufacturing process, not at final inspection... The notification shall include at a minimum: Photographs of the UVC and description contrasted to a typical or conforming condition. The reason for the UVC Justification for use if the supplier considers the UVC acceptable or as a Minimum Acceptable visual standard. The submittal will be reviewed by PG&E, the result documented and the supplier notified in writing. 6.4 Inspections and Product Acceptance As part of the Qualification Plan, products may be subject to inspection and test by PG&E (source inspection) at the Supplier, PG&E facility or both as determined by PG&E. Acceptance of product at source inspection at the Supplier does not relieve the Supplier of its obligation to provide products that meet drawing, specification and purchase order requirements. Final acceptance (notwithstanding warranty issues discovered during use) shall be based on incoming inspection of Phase 1 parts at PG&E facilities and successful Phase 2 testing results if Phase 2 testing is required. There may be some exceptions, for example transmission and substation class products (including such items as large oil filled electrical products, transmission class pipe, valves and fittings, underground cable and fabricated structures), where final inspection ordinarily occurs at the Supplier s plant or the authorized distributor if there are no Phase 2 tests required. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 13 of 44

17 6.5 Post-Qualification Reporting Requirements A Supplier Scorecard is the basis for rating supplier performance. PG&E will create a Scorecard tailored to the work being performed by the supplier. The Scorecard will allow both parties to track performance and success. It will also provide a basis for both parties to work together on areas that need of improvement. Topics that are typically addressed in PG&E Scorecards include: Product Quality (e.g., Defective Part Rate, DPPM). On-time Delivery. Qualifications and Change Control: adequacy, timeliness and transparency. Quality System audits and SCAR status: are SCAR responses adequate, timely with no repeat issues? Status and timeliness of Improvement Initiatives Communication: proactive notification of quality events and issues. Proactive Contract Support: Cooperation, product design & development support Performance metrics and Key Performance Indicators (KPIs) used in the Scorecard will be established. The Supplier Scorecard will be issued by PG&E on at least a quarterly basis. If the metric objectives are not met, the supplier s product allocation can be reallocated to other suppliers who meet the requirements Reports of process performance capability for qualified products may be requested periodically by PG&E for tracking purposes. Details will be determined with the Supplier after completion of the qualification work A 4-Panel dashboard report format or an equivalent alternative will be employed for suppliers in need of improvement to add performance visibility and track performance. The 4-Panel Report typically contains the following information: Chart trending total inspection rejects over time Pareto trending observed condition leading to the rejects Details of number of parts rejected as a function of time and part type Corrective Action Plans and Status It is expected that the identified supplier(s) will provide frequent performance reports (e.g., bi-weekly) using the 4-Panel Dashboard as agreed upon, or in connection with each delivery to PG&E depending on performance and delivery requirements. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 14 of 44

18 APPENDIX A Elements of the PG&E Part Qualification Process (PPQP) I. Process Qualification Terminology II. Qualification Element Definitions III. Qualification Element Work Sheets PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 15 of 44

19 I. QUALIFICATION PROCESS TERMINOLOGY The following definitions will facilitate understanding of the different elements of the PG&E Part Qualification Process that are presented and described later in this Appendix: Critical to Process (CTP) These may also be referred to as KCC or Key Control Characteristics. They are the critical parameters or set points for controlling a process to ensure that the results of the process meet specifications or a CTQ characteristic. Examples include tool profiles, machine settings, annealing furnace settings, etc. Critical To Quality (CTQ): A characteristic that is identified as critical to the form, fit or function of the final component. This may be a drawing characteristic for a piece or hardware for example or a specification requirement in the case of bulk material. Design Record is the part drawing, specifications, math calculations, and /or electronic CAD data that conveys the information necessary to produce a product. This Record is provided by the supplier for supplier designed products in which case a Design Risk Analysis (FMEA) compliant to PG&E requirements should also be included if available. A single Design FMEA may apply to a family of similar parts or materials. Catalog parts: the design record may only consist of a functional specification or reference to a recognized industry standard. Bulk Materials: the design record may consist of identification of raw materials, formulations, processing steps and parameters, final product specifications and acceptance criteria. Bulk material can also be input to other production processes. Black Box Parts: Are those that may be supplier designed, produced and considered Proprietary. For this type of part, the design record may be limited to an outline drawing or identification of characteristics or items required for customer interface connections and verification of functional requirements. The Design Record, including drawings and specifications, must be revision controlled. There is no specific worksheet requirement for the Design Record format since design files and information may vary from supplier to supplier. First Article (FA) Inspection (FAI): Samples selected for FAI are taken from actual manufacturing and inspection processes being qualified in the supplier facility that will be used for production. The number of FA samples to be sent to PG&E for testing and inspection will be determined based on a sampling plan and specified in the Qualification Plan instructions. Depending on the inspection results, a qualification may have more than one set of first article samples. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 16 of 44

20 Integral Software: (also known as dedicated software) Software, which is dedicated to equipment or a process to the extent, it is inoperable without that software. Integrated System Testing: Integrated System Testing provides increased assurance that new or modified process or inspection equipment has been installed correctly and coordinated to work properly with other facility equipment. This testing is performed in as part of the actual production process. Product or surrogate material may be used to demonstrate the integrated operation of the process equipment and software. Qualification Process (QP): A structured approach to supplier qualifications and manufacturing control. A QP package contains a cover letter prepared by the supplier, up to 15 different elements (depending on PQP requirements) and an approved Part Warrant. Set Points: Settings that control equipment or processes within defined parameters. Significant Production Run: For mass-production type processes: This is sometimes referred to as serial production. The Phase 1 qualification run requires using production equipment, tooling, procedures and production employees operating at normal production rate under normal production conditions. This typically is 300 parts or more. The intent is to assure that all data from the production qualification run reflect the actual production process. For bulk materials: First Article samples for qualification shall be taken in such a manner such that they represent steady-state process operation since it may not be possible to identify a specific number of discrete parts. Production and inspection histories of similar products can be used to estimate initial process capabilities. Supplier Correction Action Report (SCAR): A document that is used to identify, track and correct supplier quality deficiencies as part of a Corrective Action Process. Verification: A work effort to confirm that the range of previously qualified parameters, set points and/or process monitoring produces product that meets specifications or to demonstrate that the process does not adversely affect physical/chemical material properties, quality records, product traceability and inspection sensitivity or reliability. II. QUALIFICATION WORK ELEMENT DEFINITIONS The elements of the Qualification Process are defined below and corresponding templates or worksheet examples follow. Alternate formats to record and present the results of the qualification work requirements may be substituted with prior PG&E SQE agreement. Part Qualification Plan (PQP) Documents the requirements for Phase 1 and/or 2 qualification efforts that will be controlled by the PPQP package and this Manual. Requirements that will be identified will include but are not limited to: item description PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 17 of 44

21 including reference to design drawings and applicable Specifications, Phase 1 testing requirements, identifying applicable PQP sections, number of pieces required for qualification, inspection frequency for qualification components and acceptance criteria. Work Element Requirements and Submission Status Checklist - This form is intended to be a useful tool for both the supplier and PG&E. It summarizes Work Element Submission Requirements identified by PG&E and the Completion Status of each. The planned completion dates for Work Elements originating from the Supplier are established by the Qualification Project Schedule as agreed upon by the Supplier and the SQE. Supplemental Qualification Requirements Additional requirements as part of the Phase 1 qualification effort are listed in this section. This could also contain special qualification requirements such as barcoding process methods as well as specifying witness or hold points or one-of performance test requirements. Marking, Packaging and Labeling Identifies the requirements for part marking, packaging and labeling for shipping to PG&E. These requirements may include industry standards and cover such details as: part marking / barcoding, final documentation package content, part and lot identification requirements, maximum packaging limitations (quantity, weight, number of lots), packing list and box label contents. Special Process List A list of the special processes used to manufacture the component. The specific qualification files or reports for these processes are to be listed in the Special Process Qualification Work Sheet. Qualified Laboratory Documentation This is a list of laboratories along with their accreditations and qualified test methods that will or may be used for inspecting or testing product samples for certification purposes. This does not preclude qualification of specific laboratory processes used for product testing, in which case an additional qualification plan and report for the particular process will be required to be submitted by the Supplier. Process and Inspection Flow Chart (PFO) Identifies the process flow for the component covering all manufacturing and inspection steps (on-line or off-line) from receipt of raw material to shipment of the final product. Any work outsourced to a subsupplier must be shown including the name and address of the sub-supplier and any receipt inspections performed by the supplier upon return of the subject parts. Flow of nonconforming parts or material, including rework or scrap loops must also be shown. Rework operations must be approved by PG&E before being used. PG&E Hold Points, Witness Points and Source Inspection points must also be identified in the Process Flow. There is a general format in the attached worksheets but any specific format used by the supplier may also be acceptable. The PFO shall be revision controlled. Special Process Qualifications Special processes will either be previously qualified or an additional special process qualification activity must be included with the part qualification. In each case the key parameters and qualified ranges will be documented PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 18 of 44

22 in this section. All non-destructive testing must be qualified and performed by qualified and certified non-destructive evaluation personnel. Key Sub-Suppliers A sub-supplier is one who performs special processes, inspections, or operations that affect form, fit, or function of the product. Software Control All software that will be used in the manufacture or inspection of the component (examples: OGP, CMM, etc.) must be under revision control and documented. Any changes that are made to the software must be updated and approved in this section. Applicable Document List Identifies all supplier documentation for the manufacture of the component (example: Procedures, supplier drawings, etc.). This list is to be revised and resubmitted along with any revised documents requiring PG&E approval. Visual Standards and Part Checking Fixtures A list of the supplier's visual standards and part checking fixtures, the identification number, a description of each, the PG&E requirement for the condition, the date submitted and approval status. For checking fixtures, a controlled copy of the drawing should be supplied. If the fixture is used to check part dimensions in final form, then evidence that the fixture conforms to its design drawing is required. This may be a gage study showing repeatability in assessing the required characteristics.. Supplier Test Report This report should identify inspection methods, related drawing dimensional characteristics and tolerance, inspection results for that characteristic, and frequency of inspection. Required visual characteristics should also be identified on this form along with the method, results and inspection frequency. This form is an example; alternates may be submitted to PG&E for approval prior to use. Supplier Testing (Material & Performance Test Results) Identifies any testing (and summarizes results) required for the supplier to complete in order to certify the component other than dimensional and visual inspection results which are recorded elsewhere. This section can also summarize any performance tests and results obtained by the supplier during the qualification process. Copies of the original test reports shall also be provided. Material composition / test results should be reported on a Certificate of Analysis (or testing) from an accredited laboratory. Confirmation by the supplier that the material meets all requirements is required for the qualification as well as for continued production. Certificate of Conformance (C of C) This is an example of a Certification that the supplier completes and submits with the components to certify the product. All individual test reports must be attached to this C of C. An alternate can be proposed by the Supplier. At a minimum, a C of C should include: Summary of results and Acceptability Product description and requirements such as applicable Drawings and Specifications PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 19 of 44

23 PG&E Purchase Order and Material Code information Mfg. history by reference to the applicable approved Part Warrant Material condition and Material Certification Reference Statement that products were manufactured, inspected, and tested to approved procedures and meet PO, specification, and design requirements Signature of approval by Supplier authority All test reports must be attached Exceptions Identified During Qualification - Exceptions encountered during qualification should be documented and explained on this Work Sheet. Examples to be documented include departures from the original qualification plan; unplanned or unforeseen processing issues; part outages or deviations noted during production or inspection of the First Article production run; part rework or scrap conditions. Corrective actions for the exceptions must be listed and actual completion dates identified. Corrective actions must be completed before Phase 1 can be considered complete. PG&E Part Warrant This is the official governing document to track the status and approval of the PPQP package. Change Assessment Questionnaire and Supplier Change Request Form - This process implements a formal policy requiring PG&E approval of supplier changes that may impact product quality. It provides a formal system for assessing, tracking & documenting changes: improves PG&E ability to be aware, prepare and support the change; forces pre-approval to avoid the adverse effect of random changes. The Change Assessment Questionnaire is to identify if any action is required to validate or verify potential changes to the existing PPQP. This questionnaire, along with the Change Request Form is to be filled out by the supplier and then submitted to the SQE for evaluation by PG&E to define requalification requirements, if any. In the case of changes to Supplier designed products, a revised Design Record must be submitted along with the Change Request. Part Warrant Revision History This is to documents all revisions and changes to a completed PPQP package. PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 20 of 44

24 III. QUALIFICATION ELEMENT WORKSHEETS Examples of the different Qualification Element Worksheets for each PPQP Element and page number locations follow below. Functional electronic worksheets for each element can be obtained from the PG&E Supplier Quality Engineer assigned to your qualification. The worksheets must be completed and returned to the PG&E Supplier Quality Engineer on a pre-agreed upon schedule. The method of transmission of the completed worksheets to PG&E is to be agreed upon with the Supplier Quality Engineer. Transmission via is preferred. Section III. Table of Contents Work Sheet Page Number Part Qualification Plan (PQP) 22 Work Element Requirements and Submission Status Checklist 23 Supplemental Qualification Requirements 24 Marking, Packaging & Labeling Requirements 25 Special Process List 26 Key Sub-supplier List 27 Special Process Qualification Documentation 28 Qualified Laboratory Documentation 29 Process & Inspection Flow Chart (PFO) 30 Software Control 31 Applicable Document List 32 Visual Standards and Part Checking Fixtures 33 Certificate of Conformance (C of C) 34 Dimensional and Visual Inspection Report 35 Supplier Test Report 36 Exceptions Identified During Qualification 37 Part Warrant 38 Change Assessment Questionnaire (2 pages) 39 Supplier Change Request (2 pages) 41 Part Warrant Revision History 43 PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 21 of 44

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33 PROCESS / INSPECTION FLOW CHART (PFO) Part/Drawing Number (Include Item #; MCN): Drawing Revision: Part Name: Legend: Manual Operation Decision Process Operation Any work outsourced to a sub-supplier must be shown including the name and address of the sub-supplier and any receipt inspection upon return of the subject parts. Flow of nonconforming parts or material, including rework or scrap loops must also be shown. Rework operations must be approved by PG&E before being used. PG&E Hold Points, Witness Points and Source Inspection points must also be identified in the Process Flow. The PFO shall be revision controlled. RE Approval: Date: SQE Approval: Date: PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 30 of 44

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38 DIMENSIONAL & VISUAL INSPECTION REPORT Drawing No. Item Rev. Material Code: Part Name and Serial Number(s) QC Procedure No. Rev. Specification Rev. Heat No. P.O. No. Rev. P.O. Item No. Material Supplier Lot Size Sample Size No. Pcs. Accepted No. Pcs Rejected Inspector Date Dim QC Ref. Drawing Acceptance No. Char Dimension LSL USL Accept Reject Results/Comments Remarks Frequency Verification Supplier QA/QC Manager: Approved Date SQE Approval: Date: Other PG&E Approval: Date: PG&E 2014 Pacific Gas and Electric Company. All rights reserved. Page 35 of 44

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