How To Ensure Quality Assurance
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1 1001 Robb Hill Road Oakdale, PA / PROCUREMENT SPECIFICATION: SUPPLIER QUALITY MANAGEMENT SYSTEM REQUIREMENTS Specification Number: ATI-QA-703, Rev 4 Date: 11/12/13 Page: 1 of 7 Written by: Ross E. Snowden Date: 11/8/13 Approved by: Brian G. Drummond Date: 11/10/13 Approved by: Rocco A. Longo, Jr. Date: 11/12/13 Approved by: Ross E. Snowden Date: 11/9/13 (Signatures on file.) Italic Text Indicates Latest Revision 1.0 PURPOSE The purpose of this standard is to define the minimum Quality Assurance requirements for suppliers of material and processing to ATI Powder Metals (ATIPM). The quality management system of the supplier shall be based on the type and complexity of material or process as well as the reliability requirements of the final product. 2.0 SCOPE 2.1 This standard applies to suppliers of material and processing when specified in the Purchase Order or other procurement document. The supplier s system shall assure that adequate control of quality is maintained throughout the entire process of purchasing, manufacturing and processing, and testing. Additional requirements may be contained in other documents. 2.2 Right of Entry The supplier shall grant ATIPM, our customers, and/or regulatory agencies the right of entry to the supplier s facility and to their entire supply chain to determine and verify the quality of work performed, records and material. 2.3 The order of precedence for procurement documents referenced is as follows: a) Purchase Order b) Supplier Instruction Sheet containing additional requirements c) Referenced Drawings d) Specifications referenced on drawings Any conflict discovered by the supplier shall be reported to the ATIPM purchasing personnel. 2.4 The supplier's quality system shall be subject to initial and periodic review and acceptance by ATIPM. The purpose of the review is to evaluate the supplier's quality system and the continued capability to provide conforming material and services. 2.5 In addition, suppliers of Special Processes may be subject to an on-site evaluation of quality systems and process capability. 2.6 These evaluations shall be performed using ATIPM Supplier Capability and Quality Systems Questionnaires. Registration to ISO9001, AS9100, ISO17025 or other recognized standards may be
2 Specification Number: ATI-QA-703, Rev 4 Date: 11/8/13 Page 2 of 7 accepted as proof of compliance with the requirements of this Standard, as determined by the ATIPM Manager of Quality Assurance. 2.7 Special Process Suppliers may be subject to approval by ATIPM customers or other designated accreditation agencies. 3.0 ASSOCIATED MATERIALS 3.1 AS Quality Management Systems Aerospace Requirements 3.2 ISO Quality Management Systems Requirements 3.3 QS Qualification and Control of Suppliers 3.4 QA ATIPM Supplier Capability Questionnaire 3.5 ISO Measurement management systems - Requirements for measurement processes and measuring equipment 3.6 ISO/IEC General requirements for the competence of testing and calibration laboratories 3.7 ANSI/NCSL Z Requirements for the Calibration of Measuring and Test Equipment 4.0 GENERAL QUALITY ASSURANCE REQUIREMENTS The following provisions apply to all ATIPM Purchase Orders that reference this specification. 4.1 Organization The responsibility for control of quality shall be clearly defined within the Supplier's organization. The relationship between Quality Assurance and other departments shall be indicated, and the Quality Assurance function shall have sufficient authority to assure that quality requirements are maintained. 4.2 Initial Quality Planning The supplier shall, at the earliest possible time, review the requirements of the order to assure that the requirements can be satisfactorily met The supplier's Quality Assurance function shall participate in the review of orders prior to release to production use in order to identify special requirements of materials, fixtures, equipment and qualifications necessary to assure product quality. 4.3 Work Instructions The supplier shall determine the need for written work instructions for processing and inspection. The work instructions shall be prepared or approved by authorized and qualified personnel and changes shall be controlled and documented Procedures shall be readily available to personnel requiring them and in sufficient detail that properly trained personnel can effectively perform operations that affect quality. The instructions shall include acceptance criteria. 4.4 Document Control The supplier shall have a system to assure that drawings, specifications and instruction required by the purchase order, as well as authorized changes, are utilized in the manufacture of processing of
3 Specification Number: ATI-QA-703, Rev 4 Date: 11/8/13 Page 3 of 7 material. Unless otherwise specified, the revision in effect at the time of contract acceptance shall be applicable The system shall include provisions to determine the adequacy of documents with respect to the requirements of the order as well as the compatibility with the intended use of the product The system shall provide for timely review and implementation of authorized changes and for documentation of effective date of any changes The supplier shall be responsible for obtaining supplemental documents, such as Government and Industry standards, referenced but not controlled or provided by ATIPM. 4.5 Control of Purchases The supplier shall have a means for controlling the selection of sub-contract suppliers. The program shall provide for the selection of sub-contract suppliers based on their ability to perform satisfactorily The supplier shall maintain a list of approved sub-contract suppliers and collect quality performance data in order to assure that the material and services obtained from sub-contract suppliers meet the purchase order requirements The supplier shall provide for inspection and surveillance sufficient to effectively control the quality of material or services procured for sub-contract suppliers The supplier's purchase order for sub-contract supplied material or services shall contain the pertinent information (drawings, specifications, instructions), including key characteristics, necessary to successfully fulfill the order requirements Sub-contracting of services is not allowed without the approval of ATIPM No product substitution is permitted. 4.6 Customer Supplied Material The supplier shall provide for the inspection of ATIPM supplied material, including material supplied by a ATIPM customer, to detect transit damage and to assure that the proper material has been allocated and is properly identified. The supplier shall maintain identity of the supplied material throughout the manufacturing cycle ATIPM supplied material shall be protected from damage or improper use or application while under the control of the supplier The supplier shall provide for immediate notification of damage, loss, or improper use or application of ATIPM supplied material. 4.7 Quality Assurance Planning A system shall be in place to assure that operations are accomplished under controlled conditions, including a documented sequence of manufacturing, acceptance, and process operations The sequence of operations or work instructions shall identify specific methods, tooling and equipment, and proper environmental conditions The planning shall include criteria for acceptance and rejection for product acceptance operations and the supplier shall have a means for documenting the completion of each pertinent operation.
4 Specification Number: ATI-QA-703, Rev 4 Date: 11/8/13 Page 4 of Change Notice and Approval The supplier shall notify and obtain ATIPM approval prior to any change in the specified materials, product and/or process, approved suppliers and the manufacturing location. 4.9 Measurement and Test Equipment The supplier shall have a system to assure that measuring and test equipment necessary to verify compliance of product or processes to purchase order requirements are properly selected and maintained The supplier shall assure that calibration of measuring and test equipment is performed in accordance with ISO10012 or ANSI/NCSL Z Records and Retention The supplier shall assure that records generated as objective evidence of conformance to product and process compliance are complete and reliable and readily accessible to ATIPM or ATIPM customer The records of all inspections and tests shall be maintained and indicate the type and number of observations made, conformance or non-conformance, the number and description of nonconformances found and any corrective action taken The supplier shall maintain adequate records to cross reference material requiring lot, heat, or serial number traceability The supplier shall define in a written policy or procedure the retention period for records and the disposition of test material The supplier shall retain records based on purchase order and supplier instruction sheet requirements or for a minimum of seven (7) years (whichever is greater) Qualification and Certification When certification or qualification of equipment, processes, operators or inspectors is required, the supplier is responsible for implementing and documenting a certification and qualification program All qualifications for special processes controlled by ATIPM customers shall be the responsibility of the supplier. Evidence of this approval shall be made available to ATIPM upon request Individuals that inspect parts for final acceptance shall pass an annual eye examination, administered by a medically qualified person, for near vision and an annual examination for color vision. Individuals must meet the following minimum requirements in one eye, corrected or uncorrected: Near Vision: Snellen 14/18 or better, Jaeger type 2-20/25, Ortho-Rated or equivalent method Color Vision: Passing using one of the following methods: Pseudochromatic plates, Dvorine, Ishihara, Richmond, Farnsworth lantern, Keystone Orthoscope, Titmus Vision Tester, Titmus II Vision Tester 4.12 Handling and Storage The supplier shall provide and maintain equipment and facilities necessary for the safe handling and storage of material. The storage shall protect material from damage, loss, unauthorized withdrawal or contamination, and shall be in compliance regulatory requirements.
5 Specification Number: ATI-QA-703, Rev 4 Date: 11/8/13 Page 5 of Nonconforming Material The supplier shall have a system for the prompt identification, segregation, documentation, and disposition of nonconforming material or processes that do not comply with requirements The supplier shall promptly notify ATIPM of any material that is nonconforming or processing that does not comply with requirements. Material that is not in compliance with the procurement requirements may not be accepted as is by the supplier unless approved by ATIPM The system shall also include positive corrective action to prevent reoccurrence and follow-up to determine the effectiveness of corrective action Conformance Audits The supplier shall conduct audits of the quality management system sufficient to verify that the organization is complying with the written procedures, plans and operating practices The extent and frequency of audits shall be well defined and determined from the complexity of the operation and past performance Audit results and any corrective action shall be documented Preparation for Shipment Prior to shipment, the supplier shall assure that all material processing, tests and inspections are complete and acceptable The supplier shall assure that material has been packaged using proper methods and in compliance with any special requirements of the purchase order and any regulatory agencies The supplier shall assure that all required documentation, such as inspection reports, Certificates of Compliance, test reports, have been submitted prior to shipment or included with the shipment. 5.0 SPECIAL REQUIREMENTS The following provisions apply when specified in the Purchase Order or other ordering document. 5.1 Priority Rated Orders When a priority rating is specified in the Purchase Order, the order is certified for national defense use and the supplier is required to follow all provisions of the defense priorities and allocation system regulation (15 CFR 700). 5.2 Anti-Terrorism Supplier will adhere to the directions provided in Executive Order on terrorist financing - blocking property and prohibiting transactions with person who commit, threaten to commit or support terrorism, effective 09/24/2001 and any subsequent changes made to it. Supplier further agrees to include this requirement in lower-tier purchase orders and subcontracts hereunder. To view the contents of Executive Order 13224, please search the following website:
6 Specification Number: ATI-QA-703, Rev 4 Date: 11/8/13 Page 6 of Mercury Free Material The conditions of purchase forming a part of this order stipulate that materials furnished under this order shall be free from contamination by the presence of mercury. 5.4 General Electric S1000 Quality System Supplier's quality system shall comply with the latest revision of General Electric S Honeywell Engines & Systems Supplier's quality system shall comply with the latest revision of Honeywell SPOC Manual Section 1.0 General Requirements. 5.6 Calibration Service Requirements All measurement standards shall be traceable and supported by certificates, reports or data sheets including identification of the item; the calibration source; date of calibration; calibration assigned value; Statement of Uncertainty and Environmental or other conditions under which the calibration results were obtained. Supplier to provide a report including a description of the item, calibration interval, date calibrated, identification of the measurement standard, calibration procedure, calibration results and calibration actions taken. Supplier to affix a label to each item calibrated indicating the date calibrated, the next calibration due date and the person performing the calibration The supplier shall maintain an effective quality system to assure that the calibration system, procedure and services comply with the requirements of this contract. Suppliers of calibration services shall provide sufficient documentation to demonstrate compliance with ANSI/NCSL Z540.3, ISO/IEC 17025, or ISO10012 and ATI purchase order requirements. 5.7 Radiation All raw materials being delivered to ATI Powder Metals shall not emit radiation levels above background. Any raw material exceeding background levels of radiation may be considered nonconforming by ATI and may be returned to the supplier at the supplier's expense. All liabilities resulting from the delivery or return of the raw material will be the sole responsibility of the supplier specifically any liability relating to environmental liability or clean up. 5.8 Fraud and Falsification If the items being furnished by the Seller under this purchase order are produced or manufactured on an individual basis, identifying the customer (here the Buyer) to the deliverable item(s) at any stage prior to completion of manufacture, inspection, or test, then, at the point the individual deliverable item identified to the customer, the following clause applies. However, if the manufacture, inspection, or test of the deliverable items is completed before the issuance of the purchase order by the Buyer to the Seller for the deliverable item, only Paragraph (a) of the clause shall apply. "FRAUD OR FALSIFICATION" (a) This purchase order and activities hereunder are within the jurisdiction of the Department of Energy and/or the Department of the Navy. Any knowing and willful act to falsify, conceal, or alter a material fact, or any false, fraudulent or fictitious statement or representation in connection with the performance of work under this order may be punishable in accordance with applicable Federal statutes. (b) The Seller agrees that all employees engaged in the performance of this purchase order shall be, if they have not been previously, informed in writing prior to their commencing performance of work under this order that there is a risk of Federal criminal penalties associated with any falsification, concealment, or misrepresentation in connection with the performance of work under his order. The seller further
7 Specification Number: ATI-QA-703, Rev 4 Date: 11/8/13 Page 7 of 7 agrees that a signed statement shall be, if it has not been previously, obtained from said employees prior to their commencing performance of work under this purchase order that they have been so informed. Such statements shall be maintained by the seller for at least three years after final payment under this order. An acceptable form for such written statement is substantially as follows: "The company/division/department/branch performs work under contracts which are within the jurisdiction of the departments or agencies of the United States Government. Some of the work performed under these contracts affects the national security of the United States and the requirements of these contracts are designed to ensure that essential attributes of the work are carefully checked or inspected and that records accurately reflect the results of the work. Any falsification, concealment, or alteration of any material fact or any false, fraudulent, or fictitious statement or representation in connection with the work under any contract within the jurisdiction of the Government is not only prohibited by company policy, but may also be punishable under Federal Law. Please acknowledge by your signature that you have read and understand the above." (c) The seller agrees to include the following statement preprinted on each manufacturing, inspection, or test record used in conjunction with the purchase order: "NOTE: The recording of false, fictitious or fraudulent statements or entries on this document may be punishable as a felony under Federal Statutes." (d) The Seller agrees to include this article, including this Paragraph (d) in every subcontract or lowertier purchase order issued hereunder except those excluded by the head note of this clause. 5.9 Vision Requirements (a) Perform a vision assessment (eye examination) on commencement of employment and at two (2) year intervals for personnel engaged in product verification / inspection activities to ensure visual acuity. (b) Ensure that the vision assessment (optometric examination) is conducted by an optometrist who is trained / qualified to examine eyes, test sight and give advice on visual problems. (c) Ensure that optical aids used during the vision assessment to ensure visual acuity are also used during product verification / inspection activities (d) Perform a (one time only) color perception test to ensure that personnel are capable of distinguishing and differentiating colors where color perception is required for product verification / inspection activities (e) Maintain records of vision standards for the period that the relevant employee remains within the supplier s organization, plus three (3) years.
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