Quality Assurance.pdf

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

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.

1.0 Applicability: High Energy, Small Pixel, Pixel Array Detector for 28-ID

2.0 DEFINITIONS:

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.

2.1 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.

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.

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

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

the supplier shall submit the changes for Laboratory approval using a Supplier Disposition Request form included with the purchase order.

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.

4.16 Supplier Progress Reports: The supplier shall submit progress reports during the execution of the purchase order. The progress reports shall include a summary of work that has been completed, work scheduled to be completed, and problems that may impact delivery.

Advanced Photon Source Upgrade Project Procurement Quality Requirements form

ANL-407-APSU ( ) Page 1 of 2 (APS_2016776)

5.0 SHIPMENT:

6.0 LABORATORY ACCEPTANCE CRITERIA:

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.

4.19 Electrical Items: The Supplier should provide electrical items that operate above 50 Volts AC that are listed by a Nationally Recognized Testing Laboratory (NRTL) shown at https://www.osha.gov/dts/otpca/nrtl/nrtllist.html. The Laboratory will inspect electrical items for the application of a NRTL label. Electrical items that do not have an NRTL label will be inspected by a Laboratory Designated Electrical Equipment Inspector.

4.20 Electronic Components and Printed Circuit Boards: The supplier shall provide electronic components and printed circuit boards that are designed and manufactured in accordance with the current version of the following standards.

- IPC-A-610D Class 2. Acceptability of Electronic Assemblies

- IPC-A-620 Class 2, Requirements and Acceptance for Cable and Wire Harness Assemblies

- IPC-A-600F Class 2, Acceptability of Printed Boards

- IPC-2221 Class 2, Generic Standard on Printed Board Design

- IPC-2222 Class 2, Sectional Design Standard for Rigid Organic Printed Boards

- IPC-CM-770E Class 2, Guidelines for Printed Board Component Mounting

- IPC-SM-780 Component Packaging and Interconnecting with Emphasis on Surface Mounting

4.21 US Grade 5,8 or Metric Grade 8.8-12.9 Fasteners: High strength fasteners shall be manufactured in accordance with an applicable national or international standard and under the control of a certified quality management system. The fasteners shall not have Head Markings shown on the Suspect/Counterfeit Bolt Head mark List included in the Laboratory Terms and Conditions Document.

4.22 Lifting Devices: The supplier shall provide lifting devices that are designed and manufactured in accordance with ASME B30.20 or equivalent standards. When used, the equivalent standards shall be submitted for approval by the Laboratory. Lifting Hooks shall be marked with Manufacturer Marking, Rated Capacity, Serial Number, Lifting Device Weight (if over 100 lbs.), and Rated Capacity. Elecrtically powered lifting devices shall be listed by a Nationally Recognized Testing Laboratory (NRTL) shown at https://www.osha.gov/dts/otpca/nrtl/nrtlmrk.html by a (or equivalent).

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.

4.39 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.

4.40 Burn-in Testing: The supplier shall perform a burn in test is on electrical items or systems prior to delivery. The burn-in shall consist of a continuous 96-hour period at nominal operating power and specified maximum temperatures. At completion, each item shall be tested to determine conformance with its requirements. In the event of failure during or after test, faulty items shall be repaired or replaced and subjected to an additional 96-hour burn-in Burn-in Test. The supplier shall provide a documented test report shall be provided when required by section 4.53 of this document.

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.

4.58 Calibration Records: The supplier shall provide records for the measurement and test equipment used to determine the acceptability of the product being provided to the Laboratory. The records shall contain the equipment name, model number and serial number if applicable, the calibration date, the applicable calibration procedures, and the serial numbers of the calibration standards. The calibration standards shall be traceable to the U.S. National Institute of Standards and Technology or equivalent standards laboratory.

5.4 Shipment to the Laboratory: Items shall be shipped to the Laboratory as specified in the purchase order.

4.61 Supplier Software Quality Assurance Plan: The supplier shall apply a software quality assurance plan based on IEEE-Std-730-2014 or equivalent software consensus standard.

4.64 Documentation to be provided to the Laboratory: The supplier shall provide the documents specified in this document or the purchase order to the Technical Representative identified on the Laboratory purchase order. The documents should be sent by email in pdf format.

ANL-407-APSU ( ) Page 2 of 2 (APS_2016776)