ANL-407 Quality Assurance Procurement Requirements.docx

Argonne PR No.

G6-103057

Quality Assurance Procurement Requirements

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) |_| ASTM F496 and F1236 Certified Testing Program (Electrical Safety Gloves) |_| QA Program compliant with Argonne National Laboratory Project QA Plan |_| 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.

Government Industry Data Exchange Program (GIDEP): Argonne reserves the right to notify GIDEP as required per United States Federal Acquisition Register (FAR) 52.246-26, Reporting Nonconforming Items. This includes items defined by FAR 52.246-26 as “Critical nonconformance”, “Major nonconformance”, and “Suspect/counterfeit item”.

SPECIFIC REQUIREMENTS APPLICABLE TO PURCHASE ORDER

Supplier will be subject to the reporting requirements of FAR clause 52.246-26, Reporting Nonconforming Items.

Exceptions include:

· Commercial items

· Medical devices that are subject to the Food and Drum Administration reporting requirements at 21 CFR 803

· Contractors that are a foreign corporation or partnership that do not have an office, place of business, or fiscal paying agent in the United States

Specified Shipment Location:

SPECIFIC REQUIREMENTS APPLICABLE TO PURCHASE ORDER PER SCOPE OF SUPPLY SELECTED BELOW

|_| GENERAL ITEMS, MANUFACTURED ITEMS, STRUCTURAL ITEMS

Part Identification

Traceability requirements: Manufacturing Lot, Batch, or Serial Number Identification:

Configuration control requirements (manufactured parts, structural parts, electrical items):

Documentation Requirements

1. Identify the purchased material or equipment, such as the purchase order.

Identify the specific procurement requirements met by the purchased material or equipment (e.g., codes, standards, specifications).

Identify any procurement requirements that have not been met, together with an explanation and the means for resolving the nonconformances.

Certificate signed or otherwise authenticated by an individual responsible for this QA function, as described in the suppliers QA program.

Documented certification system, as described in the suppliers or Argonne’s QA program.

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.

|_| ELECTRICAL ITEMS

Part Identification

Traceability requirements: Manufacturing Lot, Batch, or Serial Number Identification:

Configuration control requirements (manufactured parts, structural parts, electrical items):

Documentation Requirements

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.

Identify the specific procurement requirements met by the purchased material or equipment (e.g., codes, standards, specifications).

Identify any procurement requirements that have not been met, together with an explanation and the means for resolving the nonconformances.

Certificate signed or otherwise authenticated by an individual responsible for this QA function, as described in the suppliers QA program.

Documented certification system, as described in the suppliers or Argonne’s QA program.

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.

|_| Nationally Recognized Test Laboratory (NRTL) listed equipment being procured for use in accordance with the listing or labeling for its intended purpose by the manufacturer, A list of typical registered certification markings can be found at the Electrical Safety Committee sharepoint site under reference materials.

|_| Unlisted equipment must meet the following requirements identified in consultation with electrical SME:

|_| CALIBRATIONS

Part Identification and Traceability requirements

Documentation Requirements

1. Title (e.g., "Test Report" or "Calibration Certificate") The name and address of the laboratory, and the location where the tests and/or calibrations were carried out, if different from the address of the laboratory Unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate The name and address of the customer Identification of the method used A description of, the condition of, and unambiguous identification of the item(s) tested or calibrated The date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration.

Reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results The test or calibration results with, where appropriate, the units of measurement The name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate Where relevant, a statement to the effect that the results relate only to the items tested or calibrated

|_| MATERIAL TESTING

Part Identification, Traceability, and Documentation Requirements

1. Title (e.g., “Test Report”) The name and address of the laboratory and the location where the tests was performed (if different from the address of the laboratory).

Note: When testing is subcontracted the certification shall clearly indicate this fact. The laboratory that performed the actual testing shall issue a certificate to the contracting laboratory, who in turn shall issue a certificate to Argonne with the subcontractor certification as an identified attachment. This prevents the testing results improperly being misrepresented as being performed by the contractor.

A unique identifier of the test report (e.g., certificate number); each page shall be paginated including a clear identification of the end of the test report.

The name and address of Argonne National Laboratory must be referenced, along with the Argonne Procurement Document number.

Identification of the test method used.

A description of the item(s) tested.

The condition of, and unambiguous identification of the item(s) or materials tested such as serial number, manufacturing lot or batch number, or other identifier.

The date of receipt of the test item(s) where this is critical to the validity and application of the results, and the date(s) the test(s) was performed.

Reference to the sampling plan and procedures used by the laboratory or other bodies where these are relevant to the validity or application of the results.

The test results with appropriate units of measurement.

The name(s), function(s), and signature(s) or equivalent identification of person(s) authorizing the test report.

Where relevant, a statement to the effect that the results relate only to the items tested.

If applicable, has the following been notated:

The deviation from the specific test method Any exclusions from the test method taken A clear description of the environmental conditions present during the testing Where relevant, a statement of compliance/non-compliance with the requirements and/or specifications A statement on the estimated uncertainty of measurement; information on uncertainty is needed in test reports

|_| HOISTING AND RIGGING ITEMS

Part Identification Requirements

a. Rated load on hoist or load block

b. Controls to indicate function or direction of motion

c. Name of manufacturer

d. Manufacturer model or serial number

e. Safety information affixed to hoist or load block

f. A signal word such as “WARNING” — ** Cautionary language against:

g. Lifting more than the rated load

h. Operating the hoist when it is restricted from forming a straight line

i. with the direction of loading

j. Operating the hoist with a twisted, kinked or damaged chain

k. Operating a damaged or malfunctioning hoist

l. Lifting people

m. Lifting loads over people

n. Operating a hoist with lever extension

o. Removing or obscuring warning labels

a. Name or trademark of manufacturer

b. Rated load

c. Size

d. Grade for alloy (eye bolts)

e. Torque value (Swivel Hoist Ring)

a. Rated load

b. Identification:

i. Manufacturer’s name and address

ii. Serial number

iii. Lifter weight if over 100 pounds

iv. Cold current amps, when applicable

v. Rated voltage, when applicable

vi. Rated load

vii. ASME BTH-1 Design Category (A-Normal Service or B-Severe Service)

viii. ASME BTH-1 Service Class

c. Product Safety Labels

i. Where size and shape of the lifter allow all lifters must have labels to include cautionary language to provide danger, warning, or caution notice to operators and others against:

1. Exceeding the rated load, or lifting loads not specified in the instruction manual

2. Operating a damaged or malfunctioning unit, or a unit with missing parts

3. Lifting people

4. Lifting suspended loads over people

5. Leaving suspended loads unattended

6. Removing or obscuring warning labels

7. Operating without having read and understood the operating manual

8. Not staying clear of the suspended load

9. Lifting loads higher than necessary

10. Making alterations to lifter

a. Marked by manufacturer with a tag or stamped to include:

b. Rated load for the types of hitches (single-leg vertical, choker, and basket

c. Dimensions of the part

d. Name & Trademark of manufacturer

e. Number of legs, if more than one

f. Alloy Steel Chain only

i. Material grade

ii. Nominal chain size

g. Metal Mesh only Individual sling identification (serial number)

1. Manufacturer Marking Rated Capacity Serial Number (assigned to the device by the manufacturer) Lifting Device Weight (if over 100 lbs.)

Rated Capacity UL Certification (or equivalent) for Electric Power Vacuum Lifting Devices Procured rigging shall not have suspect indicators (i.e., lack of the following: Crosby MFG Mark and/or Red Paint on Latching Hook and Shackle Pin, etc.).

Documentation Requirements

|_| RESPIRATORY EQUIPMENT

Part Identification

Note: If needed, visit http://knowits.niosh.gov to verify validity of manufacturer and confirm manufacturer has not had NIOSH certification revoked by visiting: http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/RespSource2RevokedTable.html Each respirator shall be packaged and certified as meeting the appropriate NIOSH Standard. The following shall be listed as a minimum

Traceability requirements: Manufacturing Lot, Batch, or Serial Number Identification

|_| CERTIFIED REFERENCE MATERIALS

Part Identification, Traceability, and Documentation Requirements

|_| ELECTRICAL SAFETY GLOVES

Part Identification, Traceability, and Documentation Requirements

Associated Documents: LMS-MNL-7 ANL-407 (03/17/2025) Page 1 of 6 Associated Documents: LMS-MNL-7 ANL-407 (03/17/2025) Page 1 of 10 image1.png