Quality Assurance Requirements.pdf

1.0 Applicability: <Diamond Window WN0200 and WN0300 for 20ID HEXM beamline>

1.1 Scope: This document, when included in the Laboratory purchase order, establishes the quality assurance requirements that the supplier must provide. The quality requirements in this document can be modified by contacting the Laboratory Procurement Department prior to the award of the Laboratory purchase order.

2.0 DEFINITIONS:

4.13 Supplier Measuring and Test Equipment List: The supplier shall provide a list of measuring and test equipment it intends to use for acceptance testing. The list shall contain the name and model number, and the date the equipment was last calibrated. The supplier shall include the list with its proposal.

4.14 Hold Points: The Laboratory reserves the right to specify hold points in the manufacturing process for the verification of quality requirements, delivery schedule, or other supplier activities. The supplier shall notify the Laboratory at least 72 hour (or other time frames stipulated by the Laboratory) in advance of reaching such points during the manufacturing process. The supplier shall not proceed past the hold point(s) without prior authorization from the Laboratory.

4.12 Supplier Proposed Changes: Prior to a change in a Laboratory’s approved design, workmanship standards, or manufacturing processes, the supplier shall submit the changes for Laboratory approval using a Supplier Disposition Request form included with the purchase order.

3.3 Audit by Argonne: The supplier is subject to audit(s) by the Laboratory for conformance with the requirements of the purchase order. The Laboratory will will be responsible for notifying the supplier at least 72 hours in advance of the audit.

3.4 Responsibility for Conformance: Audits, surveillances verifications, inspections and/or tests made by the Laboratory, or its representative(s), shall not relieve the supplier of the responsibility to furnish items or services which conform to the requirements of the purchase order

3.5 Suspect/Counterfeit items: The supplier shall have a process for preventing the delivery of suspect/counterfeit items to the Laboratory or its designated delivery locations.

4.1 Supplier Quality Management System: The supplier shall provide items and services in accordance with a documented quality management system that is compliant with ISO 9001:2008 or 2015.

4.2 Supplier Quality Program for Partner Laboratories: The supplier shall provide items and services in accordance with a documented quality assurance program that complies with DOE Order 414.1 D.

4.5 Supplier Quality Assurance Plan: The suppler shall provide a copy of its quality assurance plan with its proposal.

4.9 Supplier Key Personnel: The supplier shall provide the names and titles of the key personnel necessary for meeting the requirements Laboratory's purchase order. The supplier shall provide the information with its proposal.

4.10 Supplier Subcontractors: The supplier shall provide the names and addresses of the subcontractors it intends to use for meeting the requirements of the Laboratory purchase order. The supplier shall provide the information with its proposal.

4.11 Supplier Manufacturing Plan: The supplier shall submit a manufacturing plan identifying the manufacturing and inspection activities necessary for ensuring that quality will be achieved. The plan shall be submitted for the Laboratory's approval at least ten (10) working days prior to the start of manufacturing.

2.2 Laboratory: UChicago Argonne LLC, acting by and through its Procurement Department issuing the purchase order.

2.3 Supplier: The legal entity which is the contracting party with the Laboratory in respect to the purchase order.

2.4 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.

2.5 Suspect/Counterfeit Item: An item where inspection or testing indicates 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. The types of items known to have been misrepresented include 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.

3.1 Conformance to Requirements: All items or services furnished shall conform with the requirements of the Laboratory's purchase order. No change(s) shall be made without prior written approval of the Laboratory.

2.1 Purchase Order: The Argonne purchase order, contract, Blanket Agreement, subcontract or other written agreement with the supplier in which the requirements of this document are incorporated by reference.

3.0 GENERAL QUALITY REQUIREMENTS:

4.0 ADDITIONAL QUALITY REQUIREMENTS: The following requirements apply unless otherwise specified in the purchase order or statement of work.

3.2 Rights of Access: The Laboratory or its authorized representatives shall be afforded rights of access to the supplier and its sub-tier suppliers for the purpose of performing records reviews, surveillances, inspections, source verifications, or other activities associated with this procurement. The Laboratory will will be responsible for notifying the supplier at least 72 hours in advance of an activity.

Advanced Photon Source Upgrade Project Procurement Quality Requirements form

ANL-407-APSU (2/23/2024) Page 1 of 2 (APS_2016776)

4.53 Inspection and Test Reports: The supplier shall provide documented reports to the Laboratory for the inspection and testing activities specified above. The reports shall be traceable to the item provided and contain the date that the inspection or test was performed, and the signature and title of the individual that performed the inspection or test.

4.55 As-Built Drawings: The supplier shall provide drawings showing the as built condition of the items being provided to the Technical Representative identified in the purchase order following delivery.

4.41 Pressure Testing: The supplier shall perform pressure testing as specified in the purchase order or its associated documents. The supplier shall provide a certified test report when required by section 4.53 of this document.

4.42 Leak Testing: The supplier shall perform leak testing as specified in the purchase order or its associated documents. The supplier shall provide a documented test report when required by section 4.53 of this document.

4.36 Calibrated Measuring and Test Equipment: The supplier shall ensure that calibrated measuring and test equipment is used for acceptance testing. The calibration shall be in accordance with the equipment manufacturer's specifications, or other approved documents, and is traceable to the U.S. National Institute of Standards and Technology or equivalent standards laboratory.

4.37 Visual Inspection: The supplier shall perform visual inspection as specified in the purchase order or its associated documents. The supplier shall provide a documented inspection report when required by section 4.53 of this document.

4.38 Dimensional Inspection: The supplier shall perform dimensional inspection as specified in the purchase order or its associated documents. The inspection shall be performed using calibrated equipment and at a temperature of 20°C (68°F). Measurements performed at temperatures other than 20°C (68°F) shall be approriately compensated. The supplier shall provide a documented inspection report when required by section 4.53 of this document.

4.39 Functional Testing: The supplier shall perform functional testing as specified in the purchase order or its associated documents. The supplier shall provide a documented test report when required by section 4.53 of this document.

4.32 Qualification of Supplier Personnel: Supplier personnel, processes, and equipment used to perform special processes such as precision machining, welding, brazing, inspection, testing, or other specialized tasks shall be properly qualified. Records of the qualification shall be maintained by the supplier and provided to the Laboratory upon request.

4.31 Material Certifications: The supplier shall provide certifications for the raw materials used in manufacturing items provided to the Laboratory. The certifications shall contain the specification to which the material conforms, the supplier's purchase order number, the signature and title of the authorized representative that verified compliance, and the drawing or part number for which the material was used.

4.26 Serial Numbers: Each component or subassembly shall be identified with a unique serial number. 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.

4.30 Traceability: Each component being provided shall be traceable to the specifications, batch or lot number, and material from which it was made.

4.15 Progress Meetings. The supplier shall participate in meetings or teleconferences with Laboratory personnel for the purpose of reviewing the supplier's progress, and for the discussion of manufacturing and scheduling issues. The meetings shall be conducted on a bi-weekly basis or at other times agreed to by the Laboratory and the supplier.

4.17 Use of Advanced Photon Source Engineering Drawings: The supplier shall not manufacture to Advanced Photon Source engineering drawings unless the release level in the drawing title block is "Released" and the drawings are stamped "Construction".

6.1 Basic Acceptance Criteria: The items provided will be inspected for compliance to the Laboratory purchase order following delivery. Items that are found to be nonconforming may be returned at the supplier's expense. The basic criteria for Laboratory acceptance is shown below.

- No Shipping damage

- Correct quantity

- No Suspect/Counterfeit items

- Overall conformance to the purchase order

5.1 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.

5.0 SHIPMENT:

6.0 LABORATORY ACCEPTANCE CRITERIA:

ANL-407-APSU (2/23/2024) Page 2 of 2 (APS_2016776)