![](media/image1.jpeg){width="1.3333333333333333in"
height="0.4986111111111111in"} Argonne PR No.
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Argonne Award No. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**ARGONNE NATIONAL LABORATORY**

> *ANL-407 (March 1, 2000)*

**QUALITY ASSURANCE PROCUREMENT REQUIREMENTS**

1.0 [SCOPE]{.underline}

1.1 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.

1.2 This document contains three main sections. Section 3.0 covers the
general requirements that are applicable to all suppliers. Section 4.0
contains special quality assurance requirements that are applicable when
invoked by the purchase order/contract. Section 5.0 relates to computer
software; additional requirements, if any, will be stated in Section 6.0

2.0 [DEFINITIONS]{.underline}

2.1 **"Purchase Order"** means 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.

2.2 **"Buyer"/"Laboratory"** means Argonne National Laboratory, acting
by and through its Procurement Department issuing the purchase order.

2.3 **"Supplier"** means the legal entity which is the contracting party
with the buyer in respect to the purchase order.

2.4 "**PAAA**" means (Price Anderson and Amendments Act) compliance with
the requirements of 10 CFR 820 and all specified requirements of these
procurement documents.

3.0 [GENERAL REQUIREMENTS]{.underline}

Unless otherwise specified in the purchase order or statement of work,
the following General Requirements apply:

3.1 [Supplier's Quality Assurance Program/Inspection System]{.underline}

3.1.1 Quality Assurance Program (e.g. DOE 5700. 6C, MIL-Q-9858A, ASME
NQA-1.)

3.1.2 Calibration System (e.g. DOE [414.1A)]{.underline}

3.1.3 Dimensional Inspection/Sampling Plan (e.g. [414.1A)]{.underline}

3.2 [Audit by Argonne]{.underline}

The supplier's Quality Assurance Program or Inspection System is subject
to audit(s) by the Laboratory for conformance with the requirements of
the purchase order.

3.3. [Conformance to Requirements]{.underline}

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

3.4 [Responsibility for Conformance]{.underline}

Audits, surveillance, inspection 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.

3.5 [Protection of Material and Equipment]{.underline}

The supplier shall ensure adequate protection of material and equipment
during shipment/storage, and shall included special environmental
packaging, as necessary.

6.  PRICE ANDERSON AND AMENDMENTS ACT (PAAA)

> The goods or services being provided by the supplier will be subject
> to the requirements of 10 CFR 820.

4.0 [SPECIAL REQUIREMENTS]{.underline}

The following special requirements are applicable when invoked by
purchase order, or as indicated (check marked):

4.1 [QA Manual]{.underline}: The supplier shall submit to the Laboratory
for review and approval, a copy of the organization's quality assurance
manual or other appropriate documents which describe their quality
assurance program.

4.2 [QA Plan]{.underline}: The supplier shall submit to the Laboratory
for review and approval, a quality assurance plan describing those
procedures and activities used to assure the quality required for the
purchase order.

4.3 [Configuration Control System]{.underline}: To assure that all end
items (including spares) are of the proper configuration, and all
approved changes are incorporated at specified effectivity points,
records shall be maintained verifying the configuration of each item.

4.4 [Manufacturing/Inspection/Test Plan]{.underline}: 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:

4.4.1. Identification of critical manufacturing operations including
inspection and test checkpoints.

4.4.2 Identification of parts and/or subassemblies showing integrated
flow into end item(s).

4.4.3 Revisions or deviations from the approved plan shall be submitted
to the Laboratory for review and approval prior to implementation.

4.5 [Process Sheets, Travelers, etc]{.underline}.: A system defining the
sequence of manufacturing/inspection/test activities shall be
incorporated to assure completion and proper sequencing of required
operations (operations, types of inspection, and tests shall be
identified).

4.6 ["Witness" Points]{.underline}: The Laboratory reserves the right to
designate manufacturing, inspection, and/or test operations as "witness"
points. 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.

4.7 [Test and Inspection Procedures]{.underline}: 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.

4.8 [Qualification of Special Process Personnel, Procedures, Facilities
and Equipment]{.underline}: 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.

4.8.1 [Qualification and Certification of Personnel for Special
Processes]{.underline}: 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.

4.8.2 [Special Process Procedures]{.underline}: 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.

4.8.3 [Special Process Certification]{.underline}: 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.

4.9 [Welding Procedures and Specimens]{.underline}:

4.9.1 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 AWS DI.I. These procedures are subject to approval by
the Laboratory. Qualification tests shall be performed and documented by
the supplier prior to fabrication.

4.9.2 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.

4.10 [Nondestructive Test Reports]{.underline}: 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-TC-IA. 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.

[NDT required by purchase order/contract]{.underline}:

4.10.1 Penetrant

4.10.2 Magnetic Particle

4.10.3 Eddy Current

4.10.4 Ultrasonics

4.10.5 Leak or Pressure

4.10.6 Radiography

4.10.6.1 [Radiographic Requirements]{.underline}: 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. Personnel interpreting film shall have
been subjected to examination and certification. Responsibility for
certification shall rest with the supplier, whether the supplier does
the work or subcontracts to a specialized laboratory.

4.10.7 Other
[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.underline}

4.11 [Chemical or Physical Test Reports]{.underline}: 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.

4.11.1 Chemical 4.11.2 Physical

4.12 [Functional Test Report]{.underline}: 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

-   Schedule One

-   Specifications

-   Procedures

-   Drawings

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.

4.13 [Part Identification]{.underline}

a\. 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.

-   Drawing Number, including revisions

-   Part Number

-   Part Number, revision letter

-   Serial Number (when applicable)

b\. Each part, component or subassembly shall bear the appropriate
identification in accordance with drawings and specifications .

4.13.1 [Manufacturing Lot or Batch Number Identification]{.underline}:
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.

4.13.2 [Serial Numbers]{.underline}: 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.

4.13.3 [Identification of Age Control Items]{.underline}: 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.

4.13.4 [Material Traceability]{.underline}: 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.

4.13.5 [Assembly and Parts List]{.underline}: An assembly parts list
designating the part number, serial or lot control number for each part
incorporated, including an Laboratory furnished components or
subassemblies shall be furnished by the supplier.

4.14 [Material Certification]{.underline}: 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.

4.15 [Certificate of Conformance]{.underline}: 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 for shipment. These records
shall be made available to the Laboratory for review, if requested. The
certificate shall be signed by an officer of the company, and shall
constitute representation by the supplier that:

4.15.1 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.

4.15.2 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.

4.15.3 Items or services as delivered comply with specifications or
other purchase order requirements.

4.15.4 Items in this contract have been produced from material supplied
by the Laboratory on Argonne Shipper No. \_\_\_\_\_\_\_\_\_\_\_\_\_.

4.16 [First Article Acceptance]{.underline}: 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:

4.16.1 Submit the first article(s) for inspection or test by the
Laboratory.

4.16.2 Submit a record of results of supplier's first article(s)
inspection or test, including the actual dimensions or value of each
specified characteristic.

4.16.3 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.

4.17 [Source Inspection or Surveillance]{.underline}: Items or services
to be delivered under this purchase order require inspection, tests or
surveillance by the Laboratory's representative 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
inspection or surveillance.

4.18 [Nonconformance Report]{.underline}: Any nonconformance to
drawings, specifications or other contract requirements shall be
recorded as found and submitted to the Laboratory for disposition.
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. Nonconformances shall be reported on Form
ANL-311, "Supplier Disposition Request" (SDR).

4.19 [End Item Documentation Package]{.underline}: 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.

4.19.1 Reports for required inspections, examinations and tests,
properly validated by the supplier's authorized personnel.

4.19.2 Record of the as-built configuration for each delivered item
(including drawing number and revisions, parts list or other means of
positive identification).

4.19.3 "Supplier Disposition Requests" properly dispositioned with
Laboratory approvals (Ref. 4.18).

4.19.4 Material test reports with actual physical and/or chemical
properties (Ref. 4.11).

4.19.5 A certificate of Conformance (Ref. 4.15).

4.20 [Shipment]{.underline}: The supplier shall be responsible for
providing the documentation package as required in 4.19 for review by
the Laboratory. Three (3) copies shall be shipped to the Laboratory with
or prior to shipment.

4.20.1 [Shipment Destination Other than the Laboratory]{.underline}: 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.

4.21 [Resubmittal of Items]{.underline}: 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-267). A notation shall be made on the
packing list identifying the resubmittal and the NCR number.

4.22 [Supplier Controlled Products]{.underline}: 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.

4.23 [Changes Proposed by the Supplier]{.underline}: 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, Ref 4.18).
Changes shall be identified in shipping documents.

4.24 [Proprietary Designs and Processes]{.underline}: The supplier shall
notify the Laboratory prior to changing proprietary processing or design
of products to be shipped.

4.25 [Special Heat Treat Identification]{.underline}: 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 (4.13.1), quantity,
atmosphere, temperature and time.

4.26 [Material Marking]{.underline}: Materials shall be marked with
specifications and heat numbers. Marking methods shall be submitted to
the Laboratory for written approval prior to application.

4.27 [Argonne/Government Supplied Material]{.underline}: Shall be
completely accounted for. Scrap or waste generated through
machining/fabrication shall be dispositioned as stipulated in the
purchase order/contract.

4.28 [Cleaning Certification]{.underline}: 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.

4.29 [Certification of Instrumentation Calibration]{.underline}: The
certification shall contain, as a minimum: the identify 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.

4.30 [Burn-in Test]{.underline}: 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.

4.31 [Operating Manual(s):]{.underline} For off-the-shelf items, which
includes additions, changes and/or modifications.

5.0 [SOFTWARE]{.underline}

> 5.1 Documentation
>
> 5.2 Test Run Data
>
> 5.3 Limitations of Application
>
> 5.4 Limitations of Argonne Development of Purchased Programs

6.0 [OTHER REQUIREMENTS]{.underline}