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Argonne PR No.
G6-068006
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 must 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 must conform to the requirements of the purchase order. No change(s) must be made without prior written approval of the Laboratory. This may 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 must 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 must 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 must confirm adequate protection of material and equipment during shipment/storage and must include special environmental packaging, as needed.
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 must 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 must 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 must be controlled pending an approved disposition by the Laboratory. Copies of the Argonne approval document must accompany each affected shipment or in the case of a service, a copy must be included in a final buy-off release.
Government Industry Data Exchange Program (GIDEP): Argonne reserves the right to notify GIDEP as required according to 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
| 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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| For Quality Level A only |
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 Drug 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
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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 must 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 must 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 must 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 must 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 must accompany the shipment. Also, one copy must 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) must be given by the supplier for scheduling of source verification or surveillance. |
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| Direct Shipment: Material procured from distributors must 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. Documentation or labelling should confirm that items were shipped from specified shipment location. |
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 must be resubmitted accompanied by a copy of the report of non-conformance (NCR) (Form ANL-626). A notation must be made on the packing list identifying the resubmittal and the NCR number. |
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| Argonne/Government Supplied Material: Must be completely accounted for. Scrap or waste generated through machining or fabrication must 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) must 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 must be produced using the same design, materials, processes and tooling used to manufacture the approved first article(s). Any changes must 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 must be burned-in for a continuous 96-hour period at nominal operating power and specified maximum temperatures. At completion, each item must be tested to determine conformance with requirements. In the event of failure during or after test, the faulty item(s) must be repaired or replaced and be subjected to 96-hour burn-in period. Records of burn-in tests along with repairs must be maintained by the supplier and made available to the Laboratory upon request. |
SPECIFIC REQUIREMENTS APPLICABLE TO PURCHASE ORDER PER SCOPE OF SUPPLY SELECTED BELOW
|_| GENERAL ITEMS, MANUFACTURED ITEMS, STRUCTURAL ITEMS
| Applicable |
| Acceptance Criteria |
Part Identification
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| Each drawing or specification for parts, components, subassemblies, or end items must 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 must bear the appropriate identification according to 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 |
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, must 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 must assign a separate and distinct serial number to each end item. Where impractical due to size or shape, the serial number must be marked on identifying tags or the smallest unit package. Two items having the same part number must not be identified with the same serial number. Records of serial numbers for each part number must be maintained by the supplier. |
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| Identification of Age Control Items: Material identification must 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, and quantity must be provided. |
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| Material Traceability: All items must be traceable to the raw materials. Methods of identifying materials, parts and components must be submitted to the Laboratory for approval before 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 must be furnished by the supplier. |
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| Special Heat Treat Identification – for manufactured or structural: Heat treated items must be legibly identified. Methods of identification must be submitted to the Laboratory prior to application. Heat treat furnace charts must be provided showing material lot, quantity, atmosphere, temperature and time. |
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| Material Marking – for manufactured, structural, or pressure vessels: Materials must be marked with specifications and heat numbers. Marking methods must be submitted to the Laboratory for written approval prior to application. |
Configuration control requirements (manufactured parts, structural parts, electrical items):
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| Supplier Controlled Products: Copies of applicable specifications, drawings, installation, operation and maintenance instructions or catalogues must accompany the initial shipment of material. No changes must be made in later 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 must obtain the Laboratory’s written approval (Supplier Disposition Request). Changes must be identified in shipping documents. |
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| Proprietary Designs and Processes: The supplier must notify the Laboratory before changing proprietary processing or design of products to be shipped. |
Documentation Requirements
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| Certificate of Conformance: With each shipment of items or services covered by the purchase order, a Certificate of Conformance must be submitted. Objective evidence must be retained by the supplier, including records of inspections/tests, preservation/packaging, and preparation shipment. These records must be made available to the Laboratory for review, if requested. |
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| When a Certificate of Conformance is used the following minimum criteria must 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 (for example, 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 (for example, 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.
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| Operating Manual(s): For off-the-shelf items, which includes additions, changes, and/or modifications |
|_| ELECTRICAL ITEMS
| Applicable |
| Acceptance Criteria |
Part Identification
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| Each drawing or specification for parts, components, subassemblies, or end items must 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 must bear the appropriate identification according to 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 |
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, must 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 must assign a separate and distinct serial number to each end item. Where impractical due to size or shape, the serial number must be marked on identifying tags or the smallest unit package. Two items having the same part number must not be identified with the same serial number. Records of serial numbers for each part number must be maintained by the supplier. |
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| Identification of Age Control Items: Material identification must 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, and quantity must be provided. |
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| Material Traceability: All items must be traceable to the raw materials. Methods of identifying materials, parts and components must 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 must be furnished by the supplier. |
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| Special Heat Treat Identification – for manufactured or structural: Heat treated items must be legibly identified. Methods of identification must be submitted to the Laboratory prior to application. Heat treat furnace charts must be provided showing material lot, quantity, atmosphere, temperature, and time. |
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| Material Marking – for manufactured, structural, or pressure vessels: Materials must be marked with specifications and heat numbers. Marking methods must be submitted to the Laboratory for written approval prior to application. |
Configuration control requirements (manufactured parts, structural parts, electrical items):
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| Supplier Controlled Products: Copies of applicable specifications, drawings, installation, operation and maintenance instructions or catalogues must accompany the initial shipment of material. No changes must be made in later 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 must obtain the Laboratory’s written approval (Supplier Disposition Request). Changes must be identified in shipping documents. |
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| Proprietary Designs and Processes: The supplier must notify the Laboratory prior to changing proprietary processing or design of products to be shipped. |
Documentation Requirements
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| Certificate of Conformance: With each shipment of items or services covered by the purchase order, a Certificate of Conformance must be submitted. Objective evidence must be retained by the supplier, including records of inspections/tests, preservation/packaging, and preparation shipment. These records must be made available to the Laboratory for review, if requested. |
When a Certificate of Conformance is used, the following minimum criteria must 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 (for example, 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 (for example, 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.
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| Approval/Listing of Electrical equipment. The equipment being procured is either: |
|_| Nationally Recognized Test Laboratory (NRTL) listed equipment being procured for use according to 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:
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| Certification of Instrumentation Calibration: The certification must contain, as a minimum: the identity of the instrument(s), the calibration procedure used, the S/Ns of the standards or equipment used along with the date of calibration and traceability to NIST or other approved standards. Detailed support data must remain on file with the supplier. Certification(s) must be signed by an authorized representative. |
|_| CALIBRATIONS
| Applicable |
| Acceptance Criteria |
Part Identification and Traceability requirements
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| Identification and use of NIST or Internationally traceable Calibration standards, including description, serial number or other identifier, and last calibrated and calibration due dates for the standards used. |
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| As-Found Results: Report the as-found values. |
Documentation Requirements
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| ANSI/ISO/IEC 17025:2017 Certificate of Calibration: Each calibrated piece of Measuring and Test Equipment must be performed according to the supplier Quality Program and the Argonne Procurement Document. The use of sub-tier suppliers is prohibited. The following, as a minimum, must be identified on the test report or calibration certification. |
1. Title (for example, 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 to confirm 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
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| Certificate of Calibration other than ISO/IEC 17025:2017: Each calibrated piece of Measuring and Test Equipment must be performed according to the supplier quality program and the Argonne Procurement Document. The following, as a minimum, must be identified on the test report or calibration certification (select those that apply). |
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| Title (for example, Test Report or Calibration Certificate) |
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| 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 |
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| Unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification to confirm 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 |
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| The name and address of the customer |
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| Identification of the method used |
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| A description of, the condition of, and unambiguous identification of the item(s) tested or calibrated |
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| 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. |
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| 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 |
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| The test or calibration results with, where appropriate, the units of measurement |
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| The name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate |
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| Where relevant, a statement to the effect that the results relate only to the items tested or calibrated |
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| As found data to be included on certificate |
|_| MATERIAL TESTING
| Applicable |
| Acceptance Criteria |
Part Identification, Traceability, and Documentation Requirements
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| Test Certification: Test results must be certified attesting compliance with the supplier quality program and the Argonne Procurement Document. The following, as a minimum, must be identified on the test certification. |
1. Title (for example, 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 must clearly indicate this fact. The laboratory that performed the actual testing must issue a certificate to the contracting laboratory, who in turn must 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 (for example, certificate number); each page must 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
| Applicable |
| Acceptance Criteria |
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
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| 4.13.38 Hardware (shackles, turnbuckles, eye bolts, eye nut, swivel hoist ring, wire rope clips, links, rings, rigging blocks) |
a. Name or trademark of manufacturer
b. Rated load
c. Size
d. Grade for alloy (eye bolts only)
e. Torque value (swivel hoist ring only)
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| 4.13.39 Below-The-Hook (spreader beams, scrap and material handling grapples, beam clamps lifting magnets) |
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
| Service Class 0 |
| 0-20,000 cycles |
| Service Class 1 |
| 20,001 - 100,000 cycles |
| Service Class 2 |
| 100,001 - 500,000 cycles |
| Service Class 3 |
| 500,001 - 2,000,000 cycles |
| Service Class 4 |
| Over 2,000,000 cycles |
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| 4.13.40 Slings (alloy steel chain, wire rope, metal mesh, natural/synthetic fiber rope, synthetic webbing, polyester rounds) |
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 and 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
i. Individual sling identification (serial number)
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| 0. Lifting Hooks: Lifting Hooks must have the following markings according to (I.A.W. DOE-STD-1090-2007): |
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
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| Fasteners: Must have manufacturer head markings. Refer to the section titled Indicators for S/CI Hardware Items (Fasteners) in the DOE Suspect/Counterfeit Items Resource Handbook. |
Documentation Requirements
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| Either Certificates of Conformance or Proof Test Certifications to the applicable ASTM or ASME B30 standard: all lifting devices must be accompanied by a certificate of conformance or proof test certificate with serial numbers clearly identified that match the associated lifting component (for example, hooks, slings, lifting beams, vacuum lifting devices) as specified in DOE-STD-1090 |
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| 4.13.44 Original Equipment Manufacturer (OEM) Manual |
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| 4.13.45 Safety labelling according to the original equipment manufacturer (OEM) manual . |
|_| RESPIRATORY EQUIPMENT
| Applicable |
| Acceptance Criteria |
Part Identification
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| 0. NIOSH Compliance |
Each respirator must be packaged and certified as meeting the appropriate NIOSH Standard. The following must be listed at a minimum
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| NIOSH Logo (only listed on disposable respirators) |
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| NIOSH Filter Classification as applicable |
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| · Cartridge filters |
Traceability requirements: Manufacturing Lot, Batch, or Serial Number Identification
| |_| |
| |_| |
| · Test and certification number clearly listed on respirator or packaging (commonly listed as TC Number) |
| |_| |
| |_| |
| · Manufacturer symbol or trademark (for example, 3M or MSA, only applicable for disposable respirators) |
| |_| |
| |_| |
| Model or part number |
| |_| |
| |_| |
| Manufacturer lot number (applicable to cartridge filters) |
| |_| |
| |_| |
| Original, unaltered manufacturing packaging |
|_| CERTIFIED REFERENCE MATERIALS OR HIGH QUALITY/HIGH-COST RAW MATERIALS
| Applicable |
| Acceptance Criteria |
Part Identification, Traceability, and Documentation Requirements
| |_| |
| |_| |
| Certificate of Analysis or Measurement: The supplier must submit a certification report and/or a certificate of analysis or measurement for each standard. The supplied documentation must contain the following as recommended by ISO GUIDE 31:2000(E): |
| |_| |
| |_| |
| Name and address of certifying body |
| |_| |
| |_| |
| Name of the material |
| |_| |
| |_| |
| Reference material code and batch number |
| |_| |
| |_| |
| Description of certified reference material |
| |_| |
| |_| |
| Instructions for proper use |
| |_| |
| |_| |
| Instructions for appropriate conditions of storage |
| |_| |
| |_| |
| Hazard identification, if applicable |
| |_| |
| |_| |
| Level of homogeneity, if applicable |
| |_| |
| |_| |
| Certified property values along with a statement of uncertainty |
| |_| |
| |_| |
| Method used to obtain property values |
| |_| |
| |_| |
| Uncertified values |
| |_| |
| |_| |
| Date of certification |
| |_| |
| |_| |
| Period of validity, if appropriate |
| |_| |
| |_| |
| Names and signatures of certifying officers |
| |_| |
| |_| |
| Independent verification of validity/accuracy of very high quality/high-cost raw material – independently verify validity/accuracy of data. |
|_| ELECTRICAL SAFETY GLOVES
| Applicable |
| Acceptance Criteria |
Part Identification, Traceability, and Documentation Requirements
| |_| |
| |_| |
| Marking: Each glove must be clearly and permanently marked on the cuff with the following: |
| |_| |
| |_| |
| Name of the manufacturer or supplier |
| |_| |
| |_| |
| ASTM D120, type, class, and size |
| |_| |
| |_| |
| The marking must be color specific as follows: |
| |_| |
| |_| |
| Workmanship and finish: |
| |_| |
| |_| |
| · The gloves must have a smooth finish and the cuff edges must be finished with a roll or a reinforcing strip of rubber unless otherwise specified and must be produced by a seamless process; |
| |_| |
| |_| |
| · Gloves must be free on both inner and outer surfaces of physical irregularities |
| |_| |
| |_| |
| Guarantee: The manufacturer or supplier must replace, at no cost to the Laboratory, unused gloves, which, at any time within a period of nine (9) months from the date of initial delivery of shipment. |
| |_| |
| |_| |
| Packaging: Each pair of gloves must be packaged in an individual container or sufficient strength to properly protect the gloves from damage in transit. The end of packing/containers must be marked with the name of the manufacturer or supplier, type, class, length, size, color, and cuff design. |
| |_| |
| |_| |
| Certification: The supplier must provide the current testing certification with the gloves at the time of shipment. |
| |_| |
| |_| |
| Counterfeit indicators: Verify that the gloves do not exhibit counterfeit indicators listed below: |
| |_| |
| |_| |
| Illegible labeling |
| |_| |
| |_| |
| Marked with a country of origin besides USA (for example, Malaysia, China) |
Associated Documents: LMS-MNL-7 ANL-407 (05/02/2025) Page 1 of 6 Associated Documents: LMS-MNL-7 ANL-407 (05/02/2025) Page 1 of 10 image1.png
Department of Energy Office of Science