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Argonne PR No.
G6-140013
Quality Assurance Procurement Requirements – Pressure Vessels, Manufactured Items, and Structural Items
PURPOSE AND SCOPE
This document, when invoked by purchase order or contract, establishes the quality assurance requirements to which suppliers to Argonne National Laboratory shall conform during the work performance required.
This document contains the following sections:
1. Purpose and Scope
2. Definitions
3. General Requirements Related to the Supplier’s Quality System
4. Specific Requirements and Acceptance Criteria Applicable to Purchase Order
DEFINITIONS
Purchase Order: the purchase order, contract, Blanket Agreement, subcontract or other written agreement with the supplier in which the requirements of this document are incorporated by reference.
Buyer/Laboratory: UChicago Argonne LLC, acting by and through its Procurement Department issuing the purchase order.
Supplier: the legal entity which is the contracting party with the buyer in respect to the purchase order.
PAAA: (Price Anderson Amendments Act) compliance with the requirements of 10 CFR 820, 824, 830, 835, and 708 or any compliance order pursuant to 10 CFR 820.41.
Suspect/Counterfeit Item: An item which is suspect when inspection or testing indicates that it may not conform to established Government or industry-accepted specifications or national consensus standards or whose documentation, appearance, performance, material, or other characteristics may have been misrepresented by the vendor, supplier, distributor, or manufacturer. A counterfeit item is one that has been copied or substituted without legal right or authority or whose material, performance, or characteristics have been misrepresented by the vendor, supplier, distributor, or manufacturer. Items that do not conform to established requirements are not normally considered S/CIs if non-conformity results from one or more of the following conditions (which must be controlled by site procedures as nonconforming items): defects resulting from inadequate design or production quality control; damage during shipping, handling, or storage; improper installation; deterioration during service; degradation during removal; failure resulting from aging or misapplication; or, other controllable causes.
Sub-tier Supplier: a member of a supplier’s direct or indirect sub-tier supply base (including, without limitation, subcontractors and vendors of a supplier, and of a supplier’s subcontractors and vendors) that provides goods and/or services in connection with item(s) being procured.
GENERAL REQUIREMENTS RELATED TO THE SUPPLIER’S QUALITY SYSTEM
SUPPLIER’s Quality Assurance Program/Inspection System Basis (Selected items apply – documented as part of supplier evaluation) |_| DOE O414.1D-based QA Program (Government order) |_| ASME NQA-1-2008 (including 2009 Addenda) Compliant QA Program (Nuclear and Radiological) |_| ISO 9001:2015 Certified and/or Compliant QA Program (General Quality System Standard) |_| ISO 17025:2017 Certified and/or Compliant QA Program (Calibration and Test Laboratory Quality System Standard) |_| QA Program based on: Specify Other Quality Assurance requirements:
Unless otherwise specified in the purchase order or statement of work, the following General Requirements apply:
Audit by Argonne: The supplier’s Quality Assurance Program is subject to audit(s) by the Laboratory for conformance with the requirements of the purchase order.
Conformance to Requirements: All items or services furnished to the Laboratory shall conform to the requirements of the purchase order. No change(s) shall be made without prior written approval of the Laboratory. This can be requested by submitting form ANL-1318, Supplier Disposition Request.
Responsibility for Conformance: Audits, surveillance, inspection, source verification, and/or tests made by the Laboratory or its representative(s) at the supplier’s or buyer’s facility shall not relieve the supplier of the responsibility to furnish items or services which conform to the requirements of the purchase order/contract.
Rights of Access: Argonne or its authorized representatives shall be afforded Rights of Access to the supplier (including sub-tier suppliers) for the purpose of record review, surveillance, inspection, source verification, or audit associated with this procurement.
Protection of Material and Equipment: The supplier shall ensure adequate protection of material and equipment during shipment/storage, and shall include special environmental packaging, as necessary.
Suspect/Counterfeit Items: The supplier warrants that all items provided to Argonne are genuine, new and unused unless otherwise specified in writing. The supplier further warrants that all items used by the supplier during the performance of work at Argonne, include genuine, original, and new components, or are otherwise suitable for the intended purpose. Furthermore, the supplier shall indemnify Argonne, its agents, and third parties for any financial loss, injury, or property damage resulting directly or indirectly from material, components, or parts that are not genuine, original, and unused, or not otherwise suitable for the intended purpose. This includes, but is not limited to, materials that are defective, suspect, or counterfeit; materials that have been provided under false pretenses; and materials or items that are materially altered, damaged, deteriorated, degraded, or result in product failure.
Types of material, parts, and components known to have been misrepresented include (but are not limited to) fasteners; hoisting, rigging, and lifting equipment; cranes; hoists; valves; pipe and fittings; electrical equipment and devices; plate, bar, shapes, channel members, and other heat treated materials and structural items; welding rod and electrodes; and computer memory modules. The supplier’s warranty also extends to labels and/or trademarks or logos affixed, or designed to be affixed, to items supplied or delivered to the Contractor. In addition, because falsification of information or documentation may constitute criminal conduct, the Contractor may reject and retain such information or items, at no cost, and identify, segregate, and report such information or activities to cognizant Department of Energy officials.
Nonconformance Report: Any nonconforming condition to drawings, specifications or other contract requirements shall be recorded as found and submitted to the Laboratory for disposition using the form ANL-1318, Supplier Disposition Request (SDR). Further processing, delivery, installation, or use of nonconforming items shall be controlled pending an approved disposition by the Laboratory. Copies of the Argonne approval document shall accompany each affected shipment or in the case of a service, a copy shall be included in a final buy-off release.
SPECIFIC REQUIREMENTS APPLICABLE TO PURCHASE ORDER
| Applicable |
| Acceptance Criteria |
| The following special requirements are applicable when invoked by purchase order, or as indicated (selected items apply) |
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| Price Anderson Amendments Act (PAAA): The goods or services being provided by the supplier will be subject to the requirements of 10 CFR 820, 824, 830, 835, and 708 or any compliance order pursuant to 10 CFR 820.41 |
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| Government Industry Data Exchange Program (GIDEP) reporting per Federal Acquisition Regulation (FAR): The goods or services being provided by the supplier will be subject to the reporting requirements of FAR clause 52.246-26, Reporting Nonconforming Items, in accordance with FAR clause 46.317 Reporting Nonconforming items. |
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| “Witness” Points: The Laboratory reserves the right to identify “witness” points for the performance of Source Verifications at the supplier facilities. The supplier shall provide the Laboratory with 72 hours’ notice (or other time frames stipulated by Argonne) before reaching such points during the manufacturing and test cycle. |
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| “Hold” Points: The Laboratory reserves the right to identify “hold” points for the performance of Source Verifications at the supplier facilities. The supplier shall provide the Laboratory with 72 hours’ notice (or other time frames stipulated by Argonne) before reaching such points during the manufacturing and test cycle. The supplier shall not proceed past the identified hold point(s) without authorization and approval from Argonne. |
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| Test and Inspection Procedures: These procedures are required to meet purchase order/contract requirements. They shall be prepared by the supplier and submitted to the Laboratory for review and approval thirty (30) days prior to use. |
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| Shipment Destination Other than the Laboratory: If items are shipped to a destination other than the Laboratory, copies of the required quality assurance data shall accompany the shipment. In addition, one copy shall be mailed to the Laboratory on the day of shipment. |
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| Source Verification or Surveillance: Items or services to be delivered under this purchase order require inspection, tests or surveillance by the Laboratory’s representative at Argonne National Laboratory or the supplier’s facility. If the source verification is performed at the supplier’s facility, a minimum of 72 hours’ notice (or other time frames stipulated by Argonne) shall be given by the supplier for scheduling of source verification or surveillance. |
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| Direct Shipment: Material procured from Distributors shall ship direct to Argonne from the Original Equipment Manufacturer (OEM) or the location specified below. The chain of custody must remain intact from the OEM or specified location to Argonne. |
Specified Shipment Location:
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| Resubmittal of Items: Items which have been returned to the supplier by the Laboratory for rework, repair or replacement shall be resubmitted accompanied by a copy of the report of non-conformance (NCR) (Form ANL-626). A notation shall be made on the packing list identifying the resubmittal and the NCR number. |
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| Argonne/Government Supplied Material: Shall be completely accounted for. Scrap or waste generated through machining/fabrication shall be dispositioned as stipulated in the purchase order/contract. |
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| First Article Acceptance – General items, Electrical items: Laboratory acceptance of first article(s) is required prior to the production run. The first article(s) shall be identified, including the purchase order number, part number and name. The supplier is required to: |
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| · Submit the first article(s) for inspection or test by the Laboratory. |
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| · Submit a record of results of supplier’s first article(s) inspection or test, including the actual dimensions or value of each specified characteristic. |
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| · After the Laboratory’s acceptance all remaining units required by the purchase order shall be produced using the same design, materials, processes and tooling utilized to manufacture the approved first article(s). Any changes shall have written prior approval from the Laboratory. |
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| · First Article/ Electrical Burn-in Test: To be performed by the supplier on electrical items or systems prior to delivery. Items shall be burned-in for a continuous 96-hour period at nominal operating power and specified maximum temperatures. At completion, each item shall be tested to determine conformance with requirements. In the event of failure during or after test, the faulty item(s) shall be repaired or replaced and be subjected to 96-hour burn-in period. Records of burn-in tests along with repairs shall be maintained by the supplier and made available to the Laboratory upon request. |
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| Part Identification, Traceability, and Configuration control requirements (selected items apply depending on the scope of supply): |
| Applicable |
| Acceptance Criteria |
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| Each drawing or specification for parts, components, subassemblies, or end items shall specify the location and methods of applying the appropriate identification which included the following. |
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| Drawing Number, including revisions |
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| Part Revision Level |
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| Serial Number (when applicable) |
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| Each part, component or subassembly shall bear the appropriate identification in accordance with drawings and specifications |
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| · Identification required for end items only |
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| · Identification required for End items and subassemblies |
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| · Identification required for End items, subassemblies, components |
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| Traceability requirements: Manufacturing Lot, Batch, or Serial Number Identification: |
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| Manufacturing Lot or Batch Number Identification: All parts and materials, plus applicable documents, shall be identified by a manufacturing lot batch number stamped on the smallest unit packaged by the supplier. |
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| Serial Numbers: The supplier shall assign a separate and distinct serial number to each end item. Where impractical due to size or shape, the serial number shall be marked on identifying tags or the smallest unit package. No two items having the same part number are to be identified with the same serial number. Records of serial numbers for each part number shall be maintained by the supplier. |
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| Identification of Age Control Items: Material identification shall be supplied for each item, package or container having limited shelf life. The cure date, date of manufacture, shelf life, storage temperature, humidity, and special handling conditions in addition to required identification, such as name, part number, type size, quantity, etc., shall be provided. |
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| Material Traceability: All items shall be traceable to the raw materials. Methods of identifying materials, parts and components shall be submitted to the Laboratory for approval prior to use. |
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| Assembly and Parts List: An assembly parts list designating the part number, serial or lot control number for each part incorporated, including any Laboratory furnished components or subassemblies shall be furnished by the supplier. |
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| Special Heat Treat Identification – for manufactured, structural, or pressure vessels: Heat treated items shall be legibly identified. Methods of identification shall be submitted to the Laboratory prior to application. Heat treat furnace charts shall be provided showing material lot, quantity, atmosphere, temperature and time. |
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| Material Marking – for manufactured, structural, or pressure vessels: Materials shall be marked with specifications and heat numbers. Marking methods shall be submitted to the Laboratory for written approval prior to application. |
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| Configuration control requirements (manufactured parts, structural parts, pressure vessels, electrical items): |
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| Supplier Controlled Products: Copies of applicable specifications, drawings, installation, operation and maintenance instructions or catalogues shall accompany the initial shipment of material. No changes shall be made in subsequent shipments unless approved by the Laboratory. |
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| Changes Proposed by the Supplier: Prior to a supplier’s change in the Laboratory’s approved design, workmanship standards, or manufacturing processes, the supplier shall obtain the Laboratory’s written approval (Supplier Disposition Request). Changes shall be identified in shipping documents. |
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| Proprietary Designs and Processes: The supplier shall notify the Laboratory prior to changing proprietary processing or design of products to be shipped. |
|_| Pressure Vessels, Manufactured Items, Structural Items
| Applicable |
| Acceptance Criteria |
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| Qualification of Special Process Personnel, Procedures, Facilities and Equipment: Prior to use, personnel, procedures, facilities and equipment used for performance of special processes shall be qualified. Records of qualification shall be available to the Laboratory upon request. |
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| Qualification and Certification of Personnel for Special Processes: Supplier’s personnel responsible for performing or verifying processes requiring special skills shall be qualified and certified. Qualifications for these processes shall be by formal test to assure the proficiency of each individual. Personnel satisfactorily passing the required tests shall have objective evidence of certification. |
Records of qualification shall be available to the Laboratory upon request. Only those personnel who have been qualified shall be used in performance of these processes.
The effectivity period for all certifications shall be specified. Individuals shall be recertified at the end of these periods through retesting.
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| Special Process Procedures: Thirty (30) days prior to use, copies of written detailed procedures or specifications describing each special process shall be submitted to the Laboratory for review and written approval. Revisions or changes to the Laboratory’s approved special process procedures or specifications shall be submitted for written approval prior to reimplementation. |
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| Special Process Certification: Each shipment shall be accompanied by a certification for the special processes covered by specifications/contract. Special processes include: Heat Treating, Welding/Brazing, Nondestructive Test (incl. Helium Leak, Hydro or Pneumatic Pressure Tests), Surface Prep/Treatment, etc. The certification shall list the applicable specifications including letters and numbers to which the processes conform, the name of the agency performing them (if other than the supplier), the date, and authorized signature of the responsible representative. When parts are serialized, serial numbers shall appear on the certification. |
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| Welding Procedures and Specimens: |
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| The supplier shall prepare detailed procedures for each type of weld and weld joint to be used in accordance to ASME Boiler and Pressure Code Section IX or American Welding Society Structural Code (D1.1, D1.2, D1.3, D1.4, D1.6, D1.7 or D1.8 as applicable). These procedures are subject to approval by the Laboratory. Qualification tests shall be performed and documented by the supplier prior to fabrication. |
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| The supplier shall prepare samples of typical weld joints using the same material required for the finished part. These samples are to be submitted the Laboratory for written approval prior to the start of welding operations. In the event of disapproval, the supplier will receive a written explanation of inadequacies. |
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| Nondestructive Test Reports: Nondestructive tests (NDT) shall be conducted in compliance with the applicable provisions of the contract and/or applicable specifications. Personnel and equipment utilized in performance of such tests shall be evaluated and certified in accordance with ASNT SNT-TC-1A or CP-189. The supplier shall furnish with or prior to each shipment reports and observed results. These reports shall be specified in the contract or specifications and be identifiable to the respective item or material. Reports shall contain the signature and title of the individual performing the tests. If parts are serialized, numbers shall appear on the reports. Reports are subject to review and acceptance by the Laboratory. |
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| NDT required by purchase order/contract: |
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| Magnetic Particle |
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| Visual (AWS QC1 CWI for Structural, ASNT SNT-TC-1A or CP-189 for Pressure Vessels) |
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| Leak or Pressure Testing |
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| Radiographic Requirements: Items requiring radiographic inspection shall be radiographed and processed in accordance with design specifications, standards and contract requirements. Findings shall be reported on an appropriate form, including the name of the interpreter and signature. The radiographic film and a copy of the report shall accompany each shipment. An adequate method of identifying and cross referencing each exposure, report, and item shall be provided. When parts are serialized, serial number shall appear on the report and film. Responsibility for certification shall rest with the supplier, whether the supplier does the work or subcontracts to a specialized laboratory. |
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| Radiographic Film: Radiographic film (exposed) shall be stored and shipped to Argonne in accordance with ASTM E1254-13, Standard Guide for Storage of Radiographs and Unexposed Industrial Radiographic Films. |
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| Chemical or Physical Test Reports: Reports shall be submitted to the Laboratory with or prior to each shipment; each report shall contain: actual test results or analysis obtained from the originating source of the material; and the signature of an authorized contract representative of the supplier or contract representative of the agency performing the test. The supplier shall be responsible for the validity of content. Reports shall be subject to review and acceptance by the Laboratory. |
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| Functional Test Report: Each shipment shall be accompanied by the reports of actual test results identifiable to the acceptance criteria designated in the procurement package and are listed in one or more of the following documents: |
· Purchase Order/Subcontract
· Statement of Work
· Specifications
· Procedures
· Drawings
· Results of Pressure Testing
· Appropriate ASME Data Report (if applicable) These reports shall contain the date, results or data and signature of the responsible representative and name of the organization performing the tests and shall be subject to review and acceptance by the Laboratory.
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| Material Certification: Shall be submitted with or prior to each shipment, indicating purchase order or contract number and identification of the specification to which the material conforms. Certifications shall include the signature and title of the authorized representative for the agency who verified the compliance. The supplier shall be responsible for certification validity. |
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| Certificate of Conformance: With each shipment of items or services covered by the purchase order, a Certificate of Conformance shall be submitted. Objective evidence shall be retained by the supplier, including records of inspections/tests, preservation/packaging, and preparation shipment. These records shall be made available to the Laboratory for review, if requested. |
When a Certificate of Conformance is used the following minimum criteria shall be followed:
1. Identify the purchased material or equipment, such as the purchase order.
1. Identify the specific procurement requirements met by the purchased material or equipment (e.g., codes, standards, specifications).
1. Identify any procurement requirements that have not been met, together with an explanation and the means for resolving the nonconformances.
1. Certificate signed or otherwise authenticated by an individual responsible for this QA function, as described in the suppliers QA program.
1. Documented certification system, as described in the suppliers or Argonne’s QA program.
1. Means will be provided to verify the validity of supplier certificates and the effectiveness of the certification system (e.g., audits of the supplier, independent inspection or test of the items). Verification will be conducted at intervals commensurate with the supplier’s past quality performance.
Additional provisions may include:
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| Materials used are those which have been specified by the Laboratory, and the items or services delivered were produced from materials for which the supplier has reports of chemical or physical analysis, or other equivalent evidence of conformance. |
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| Processes used in the fabrication were in compliance with applicable specifications required by the purchase order, and/or other Laboratory approved procedures. No significant process changes were made during manufacturing or since issued of the Laboratory’s purchase order/contract without written approval. |
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| Items or services in this contract have been produced from material supplied by the Laboratory on Argonne Shipper No. |
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| Shipment: The supplier shall be responsible for providing the documentation package as required for review by the Laboratory. Three (3) copies shall be shipped to the Laboratory with or prior to shipment. |
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| Special Heat Treat Identification: Heat treated items shall be legibly identified. Methods of identification shall be submitted to the Laboratory prior to application. Heat treat furnace charts shall be provided showing material lot, quantity, atmosphere, temperature and time. |
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| Material Marking: Materials shall be marked with specifications and heat numbers. Marking methods shall be submitted to the Laboratory for written approval prior to application. |
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| Cleaning Certification: A certification stating the process and specification used shall accompany each shipment. The section numbers to which the cleaning process applies shall be listed along with the name of the agency who performed the operation (if other than the supplier), the signature of the supplier’s authorized representative and the date. When parts are serialized, serial numbers shall appear on the certification. If restricted materials have been used, test results showing their removal shall be reported. |
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| Certification of Instrumentation Calibration: The certification shall contain, as a minimum: the identity of the instrument(s), the calibration procedure used, the S/Ns of the standards or equipment utilized along with the date of calibration and traceability to NIST or other approved standards. Detailed support data shall remain on file with the supplier. Certification(s) shall be signed by an authorized representative. |
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| Operating Manual(s): For off-the-shelf items, which includes additions, changes and/or modifications. |
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| End Item Documentation Package: Each item supplied shall have objective evidence that it complies with purchase order requirements. Documentation shall be complete, legible, indexed, and traceable to the item supplied, and contain the following, as applicable. |
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| Reports for required inspections, examinations and tests, properly validated by the supplier’s authorized personnel. |
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| Heat Treat certification indicating temperature, time and cooling media |
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| Record of the as-built configuration for each delivered item (including drawing number and revisions, parts list or other means of positive identification). |
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| “Supplier Disposition Requests” properly dispositioned with Laboratory approvals |
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| Material test reports with actual physical and/or chemical properties |
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| A Certificate of Conformance |
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| “As built” drawing(s), including mass |
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| Recommended list of priced spare parts for next 3 years of operation |
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| Base plate anchor bolt plan; torque values sequence |
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| Fasteners: Verify the procured Fasteners do not have Head Markings listed on the prohibited list (as applicable). |
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| Manufacturing/Inspection/Test Plan: At least ten (10) working days prior to fabrication, the supplier shall prepare and submit for the Laboratory’s review and written approval a manufacturing/inspection/test plan which satisfies the following: |
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| Identification of critical manufacturing operations including inspection and test checkpoints. |
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| Identification of parts and/or subassemblies showing integrated flow into end item(s). |
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| Revisions or deviations from the approved plan shall be submitted to the Laboratory for review and approval prior to implementation. |
Associated Documents: LMS-MNL-7 ANL-407 (12/21/2022) Page 1 of 6 Associated Documents: LMS-MNL-7 ANL-407 (12/21/2022) Page 1 of 11 image1.png
Department of Energy Office of Science