**NRC INSPECTION MANUAL** CQV

INSPECTION PROCEDURE 43002

ROUTINE INSPECTIONS OF NUCLEAR VENDORS

PROGRAM APPLICABILITY: 2507

43002‑01 INSPECTION OBJECTIVES

To verify that vendors supplying basic components have implemented
effective quality assurance (QA) procedures, policies, instructions, and
plans in accordance with a QA program that complies with the
requirements of Appendix B to 10 CFR Part 50 (Appendix B).

This procedure is to be used in combination with the following
inspection procedures, when applicable: Inspection Procedure (IP) 36100,
AInspection of 10 CFR Part 21 and 50.55(e) Programs for Reporting
Defects and Nonconformance,@ and IP 43004, AInspection of
Commercial-Grade Dedication Programs.@

43002‑02 INSPECTION REQUIREMENTS

02.01 The inspector reviews the QA program and instructions, procedures,
plans, and policies and verifies, by observing vendor activities,
document reviews, and interviewing vendor staff, that the selected
vendor has implemented effective QA controls for safety-related
activities. The facility=s QA program should be based on the appropriate
criteria contained in Appendix B.

02.02 The lead inspector will prepare an inspection plan in accordance
with established guidelines. The inspection plan should provide the
scope and basis for the inspection; describe the proposed evaluation of
the vendor=s activities, including the QA program procedures and its
implementation, and identify the work assignments for each inspector.
The inspection plan shall consider inspection of the critical and
quality attributes associated with inspections, test, analyses, and
acceptance criteria (ITAAC) family groups. The purpose of including
these in the plan is to provide input into the ITAAC closure
verification process. Guidance on inspection plans is contained in
IMC-0613, A10 CFR Part 52 Licensed Power Reactor Construction and Test
Inspection Reports.@

43002‑03 INSPECTION GUIDANCE

The vendor=s QA program should contain procedures, policies, and
instructions to address the following areas, as appropriate to the
vendor=s safety-related activities:

-   Organization

-   Quality Assurance Program

-   Design Control

-   Procurement Document Control

-   Instructions, Procedures, and Drawings

-   Document Control

-   Control of Purchased Material, Equipment, and Services

-   Identification and Control of Materials, Parts, and Components

-   Control of Special Processes

-   Inspection

-   Test Control

-   Control of Measuring and Test Equipment (M&TE)

-   Handling, Storage, and Shipping

-   Inspection, Test, and Operating Status

-   Nonconforming Materials, Parts, or Components

-   Corrective Action

-   Records

-   Audits

[Specific Guidance]{.underline}. The lead inspector will focus the
inspection effort on those Appendix B criteria most relevant to the
activities that the vendor performs.

After the inspector becomes familiar with the vendor=s QA program and
implementing procedures, the inspector will select a sample of QA
activities for review. For the selected activities, the inspector will
request that the vendor provide (or make available for review) a
complete package of the pertinent records. The review should include
procurement documents, engineering specifications, analyses, audit
reports, calibration reports, and associated documentation pertinent to
the area of review. The verification is accomplished by reviewing the
vendor\'s program/procedures, controlling processes and activities, and
evaluating the actual implementation of these controls.

The inspector will evaluate the effectiveness of the vendor\'s
implementation of the QA program and procedures using the guidance
below.

03.01 [Organization]{.underline}. Assess the organizational structure
and QA personnel by performing the following:

a.  Review the organizational structure and functional relationships.
    Identify the individuals or the organization responsible for
    defining the overall effectiveness of the QA program. Verify that
    the organizational description addresses the organizational
    structure, functional responsibilities, levels of authority, and
    interfaces.

b.  Verify qualifications, responsibilities, and duties of personnel
    performing activities affecting quality. Verify that personnel or
    organizations performing QA program implementation and verification
    activities have the authority, independence, and organizational
    freedom (independent from cost or schedule considerations) to
    identify quality problems, recommend solutions, and verify
    implementation of solutions.

c.  Verify that an individual has been designated to issue stop work
    orders.

03.02 [QA Program]{.underline}. Verify QA program implementation by
performing the following:

a.  Verify that the QA program identifies the items and activities to
    which it applies.

b.  Verify that activities affecting quality are accomplished under
    suitably controlled conditions.

c.  Verify that management of those organizations implementing the QA
    program, or portions thereof, assess the adequacy of that part of
    the program for which they are responsible and assure its effective
    implementation in accordance with established procedures.

d.  Verify that programs are implemented for the indoctrination and
    training of personnel performing activities affecting quality.
    Verify that qualification records and certifications exist for
    inspection/test personnel, auditors, calibration, repair personnel,
    and similar specialists performing activities affecting quality.
    Verify that qualification records of personnel are certified in
    accordance with industry and/or vendor=s program requirements.

e.  In order to verify that personnel have been adequately trained, the
    inspector may conduct interviews with the personnel to ensure they
    have an understanding of the activities they are performing
    commensurate with their responsibilities.

03.03 [Design Control]{.underline}. Assess implementation of design
controls and design configuration controls by performing the following:

a.  Review the vendor=s design control process and verify that the
    procedures delineate design activities in a planned, controlled, and
    orderly manner. Verify that procedures provide controls for design
    inputs, outputs, design analyses (e.g., physics, stress, thermal,
    hydraulic, etc.), records, and organizational interfaces. Verify
    that design activities are accomplished in accordance with
    procedures.

b.  Verify that provisions in the design process permit the selection
    and review for suitability of application of materials, parts,
    equipment and processes that are essential to the safety-related
    function of the product. When required, assessment of
    commercial-grade dedication activities is done in accordance with IP
    43004, AInspection of Commercial-Grade Dedication Programs.@

c.  Verify that applicable design inputs are correctly translated into
    specifications, drawings, procedures, or instructions. Verify that
    the design translation is supported by engineering data (i.e.,
    calculations, performance test, etc.), including verification that
    design inputs are satisfied. The final design (approved design
    output documents and approved changes) is relatable to the design
    input and identifies assemblies and/or components that are part of
    the item being designed.

d.  Verify that procedures identify the interfaces between design
    organizations, including criteria designs, specifications, changes,
    technical direction, and approvals.

e.  Verify that procedures are implemented to control design changes.
    Verify that design changes are subject to design control measures
    commensurate with those applied to the original design. Ensure that
    design verification is performed by individuals or groups other than
    those who performed the original design, but who may be from the
    same organization.

03.04 [Procurement Document Control]{.underline}. Select a sample of
procurement documents and verify the implementation of procurement
document controls by performing the following:

a.  Verify that procedures are established and implemented for the
    control and release of procurement documents and subsequent changes.

b.  Verify that quality requirements, including technical,
    administrative, regulatory, and reporting requirements (such as
    specifications, codes, standards, tests, inspections, special
    processes, witness and hold points, and applicability of 10 CFR
    Part 21) are specified in procurement documents. Verify that these
    requirements are extended to lower tier suppliers, where necessary.

c.  Verify that, as appropriate to the circumstances of procurement,
    procurement of basic components require a documented QA program that
    is implemented and meets the applicable regulatory requirements.

d.  Verify that deviations from previously established requirements,
    including design changes, are adequately controlled and reviewed.
    These deviations are documented to provide objective evidence of the
    review. Verify that procurement document changes are subject to the
    same degree of control as utilized in the preparation of the
    original documents.

03.05 [Instructions, Procedures, and Drawings]{.underline}. Verify the
implementation of work and quality instructions, procedures, and
drawings by performing the following:

a.  Verify that work and inspection procedures have been established and
    implemented, including those related to sub-vendor activities.

b.  Verify that instructions, procedures, and drawings are reviewed,
    approved, and controlled. Verify that individuals performing
    activities related to quality have available to them the most
    recently approved specifications, procedures, and instructions
    pertinent to activities.

c.  Verify that instructions, procedures, and drawings include
    quantitative and qualitative acceptance criteria for determining
    that activities have been satisfactorily accomplished.

03.06 [Document Control]{.underline}. Select a sample of documents
prescribing activities affecting quality for review. Assess the control
of documents by performing the following:

a.  Verify that a program to control the issuance of documents is
    implemented. Examples of controlled documents include design
    drawings, as-built drawings, engineering calculations, design
    specifications, material analysis records, purchase orders and
    related documents, audit and surveillance procedures, technical
    specifications, nonconformance reports, corrective action reports,
    work instructions and procedures, calibration procedures, quality
    verification procedures, and inspection and test reports.

b.  Verify that a document control system identifies the documents to be
    controlled; identifies the individuals responsible for the review,
    approval, issuance, and distribution of documents, and controls
    changes or revisions to such documents.

c.  Verify that documents attesting to the quality of components used in
    the manufacturing process, including material certifications, test
    reports, receiving inspections, evaluations, and audit results are
    maintained to indicate that quality requirements have been met.

d.  Verify that quality-related documents sampled are reviewed for
    adequacy by qualified personnel.

03.07 [Control of Purchased Materials, Equipment, and
Services]{.underline}. Assess the controls implemented on purchased
items and services by performing the following:

a.  Verify that procedures have been established and implemented to
    select and qualify vendors supplying basic components. Examples of
    procured services include calibration, non-destructive examination
    (NDE), testing laboratories, software codes/programs, heat
    treatment, third-party inspections, engineering and consulting
    services, installation, repair, or maintenance work.

b.  Verify that appropriate methods are used to accept a basic component
    from a supplier, such as certificates of conformance, source
    verifications, audits, surveillances, receiving inspections, or a
    combination thereof.

c.  Verify that vendors implementing an Appendix B QA program conduct
    audits and surveys of commercial-grade suppliers. These activities
    should be based upon the suppliers= capability to supply the
    commodity desired in accordance with applicable codes/regulations.

d.  Verify that the effectiveness of the control of quality is assessed
    at intervals consistent with the importance, complexity, and
    quantity of the product or service (i.e., approved suppliers list).
    See the Audits section of this inspection procedure for additional
    guidance.

e.  Verify that there are provisions in the procedures to verify the
    validity of certificates and determine the effectiveness of the
    certification system when desired, such as during the performance of
    audits. Verify that certificates of conformance/compliance identify
    the material, equipment, or service supplied; identify specific
    procurement requirements (codes, standards, certificates, or other
    specifications) that have been met as well as those that have not
    been met, together with an explanation and the means for resolving
    the nonconformance; and identify the supplier=s QA individual
    responsible for authenticating such certificates. If any criteria
    have not been met, verify if a nonconformance report was initiated
    and follow up on its resolution.

f.  Verify that receiving inspections examine objective evidence of
    purchased items by verifying attributes specified in procurement
    documents. Receiving inspections should verify, as a minimum, item
    configuration, dimensions, physical characteristics, and
    identification and traceability of material and equipment, including
    status of inspection or tests performed, as required.

g.  Verify that the vendor has a documented method for the
    identification and control of nonconforming material and components,
    including fraudulent parts, to preclude inadvertent use.

h.  When possible, observe and assess actual techniques being used and
    their acceptability relative to contract/procedural requirements.

03.08 [Identification and Control of Materials, Parts, and
Components]{.underline}. Assess the identification and control of
purchased items by performing the following:

a.  Verify that procedures have been established and implemented for the
    identification and control of items to ensure that only specified
    and accepted items are used.

b.  Verify that identification markings, when used, are applied using
    materials and methods that provide a clear and legible
    identification and do not adversely affect the function or service
    life of the item. Verify that markings are maintained on the item or
    in documents traceable to the item.

c.  Verify that physical identification is used to the maximum extent
    possible. Ensure that, where physical identification on the item is
    either impractical or insufficient, physical separation, procedural
    control, or other appropriate means are employed.

03.09 [Control of Special Processes]{.underline}. Assess the control of
special processes by performing the following:

a.  Verify that procedures have been established and implemented for the
    control of special processes. Examples of special processes include
    welding, nondestructive examinations (NDE), heat treatment,
    soldering, painting, and electroplating.

b.  Verify that procedures provide measures for the generation of
    special process control documents such as travelers, process sheets,
    instructions, checklists, or other appropriate means.

c.  Verify that process control documents include, as a minimum,
    personnel and equipment qualification requirements; conditions
    necessary for accomplishing the process; acceptance criteria;
    results of completion of specific operations at checkpoints of
    fabrication, manufacture, or installation, and signature, initials,
    or stamp and date of the authorized representative for the
    activities witnessed.

d.  Verify that special processes are performed by qualified personnel
    using qualified procedures in accordance with applicable codes,
    standards, specifications, criteria, and other special requirements.

e.  Verify that qualification records are maintained as appropriate for
    the currently qualified personnel, processes, and equipment for each
    special process.

f.  When possible, observe and assess actual techniques being used and
    their acceptability relative to contract/procedural requirements.

03.10 [Inspection]{.underline}. Assess inspection controls by performing
the following:

a.  Verify that procedures are established and implemented for the
    inspection of items and activities affecting quality. Examples of
    inspections include source, receipt, in-process, in-service, final,
    operations, modification, maintenance, and third-party oversight.

b.  Verify that procedures provide measures for the generation of
    inspection control documents such as travelers, process sheets,
    instructions, checklists, or other appropriate means.

c.  Verify that inspection control documents include, as a minimum, the
    item inspected, inspection date, type of observation, results of
    examination and tests, and the signature, initials, or stamp and
    date of the authorized representative (e.g., authorized nuclear
    inspector) for the activities witnessed. Verify that mandatory hold
    points are indicated in the controlling documents and that work does
    not proceed without appropriate approval.

d.  Verify that inspections are performed by qualified persons other
    than those who performed or directly supervised the work being
    inspected.

e.  Verify that inspection results are documented by the inspector and
    reviewed by authorized personnel qualified to evaluate the technical
    adequacy of the inspection results.

f.  When possible, observe and assess actual techniques being used and
    their acceptability relative to contract/procedural requirements.

03.11 [Test Control]{.underline}. Assess test controls by performing the
following:

a.  Verify that procedures are established and implemented for the test
    of items. Examples of tests include prototype qualification,
    production, construction, pre-operational, operational,
    post-maintenance, post-modification, computer program/software, and
    proof tests prior to installation.

b.  Verify that test procedures include or reference test objectives,
    test requirements, applicable prerequisites, and acceptance criteria
    contained in the applicable design or technical documents.

c.  Verify that test results are documented and evaluated by a qualified
    individual to ensure the test requirements have been satisfied. Test
    records, as a minimum, should identify the item tested, date of
    test, tester or data recorder, type of observation, instruments used
    and the validity of their calibration, results and acceptability,
    action taken in connection with any deviations noted, and the
    individual evaluating test results.

d.  When possible, observe and assess actual techniques being used and
    their acceptability relative to contract/procedural requirements.

03.12 [Control of Measuring & Test Equipment (M&TE)]{.underline}. Assess
M&TE controls by performing the following:

a.  Verify that procedures have been established and implemented to
    ensure adequate control, calibration, and adjustment of measuring
    and test equipment. Examples of M&TE include instruments, tools,
    gages, and nondestructive examination equipment.

b.  Verify equipment calibration history. Check for dates calibrated,
    the individual who performed the calibration, results, due date,
    primary standard, and purchase order number, if a vendor calibrated
    the instruments.

c.  Verify that M&TE is calibrated, adjusted, and maintained at
    prescribed intervals prior to use. Verify that the method of
    calibration for each device is defined.

d.  Verify that M&TE is labeled, tagged, handled and stored, or
    otherwise controlled to indicate the calibration status of the
    instrument and ensure its traceability to calibration test data.

e.  Verify that calibration is against certified equipment having known
    valid relationships to nationally recognized standards. For domestic
    applications, procurement of commercial-grade calibration services
    for safety-related applications using laboratory accreditation
    programs administered by the National Institute of Standards and
    Technology (NIST) and by the American Association for Laboratory
    Accreditation (A2LA) are acceptable. If no nationally recognized
    standards exist, the basis for calibration is documented.

f.  When M&TE is found to be out of calibration, provisions in the
    procedures should require an evaluation to verify if previous
    inspection or test results are affected. Verify that there are
    provisions to notify affected customers, where appropriate.

g.  Verify that records are maintained to indicate calibration status.
    Review these records and check calibration logs for As Found/As Left
    information.

h.  Verify that out-of-calibration devices are tagged or segregated.

i.  Verify that devices consistently found out of calibration are
    repaired or replaced.

j.  When possible, observe and assess actual techniques being used and
    their acceptability relative to contract/procedural requirements.

03.13 [Handling, Storage, and Shipping]{.underline}. Assess handling,
storage, and shipping controls by performing the following:

a.  Verify that procedures have been established and implemented for the
    control of shipping activities, which include packaging,
    marking/labeling, storing, status and shipment of items and
    components, and control of limited shelf life materials.

b.  Verify that special equipment and protective environments are
    specified, provided, and verified when required. Examples of special
    equipment include containers, shock absorbers, and accelerometers.
    Examples of protected environments include humidity and temperature
    controls, specific moisture content levels, and inert gas
    atmospheres.

c.  Verify that operators of special handling equipment are experienced
    or trained in the use of the equipment.

d.  When possible, observe and assess actual techniques being used and
    their acceptability relative to contract/procedural requirements.

03.14 [Inspection, Test, and Operating Status]{.underline}. Assess
inspection, test, and operating status controls by performing the
following:

a.  Verify that the status of inspections and tests performed on
    individual items are indicated either on the item or on
    documentation traceable to the item.

b.  Verify that procedures specify the authority for application and
    removal of status indicators.

c.  When possible, observe and assess actual techniques being used and
    their acceptability relative to procedural requirements.

03.15 [Nonconforming Materials, Parts, or Components]{.underline}.
Assess nonconforming item controls by performing the following:

a.  Verify that procedures are established and implemented to control
    items that do not conform to specified requirements.

b.  Verify that written procedures provide for identification,
    documentation, evaluation, segregation (when practical), disposition
    (along with technical justifications), reference to instructions or
    procedures for repair and rework activities (where required),
    re-inspection of repaired and reworked items (where required), and
    notification to affected organizations of nonconforming conditions.

c.  Verify that procedures identify the responsibility and authority for
    review and disposition of nonconforming items, and controls further
    processing, delivery, and installation of nonconforming items until
    disposition is completed.

d.  Review and verify that the vendor has taken adequate actions
    regarding nonconforming materials or items.

e.  Verify that nonconforming items are reviewed and dispositioned in
    accordance with documented procedures. Nonconforming items are
    dispositioned as accepted, rejected, repair, rework, or use-as-is.

f.  Verify that technical justifications are documented to verify the
    acceptability of nonconforming items dispositioned as repair or
    use-as-is.

g.  Verify that nonconformance(s) to design requirements dispositioned
    as use-as-is or repair are subject to design control measures
    commensurate with those applied to the original design.

h.  Verify that the process to control nonconformance(s) provides a
    connection to the 10 CFR Part 21 procedures. Assessment of the
    evaluation and reporting of deviations or failures to comply is done
    in accordance with IP 36100, AInspection of 10 CFR Part 21 and
    50.55(e) Programs for Reporting Defects and Nonconformance.@

03.16 [Corrective Action]{.underline}. Select a sample of corrective
action reports and related documents for review. Assess corrective
action controls by performing the following:

a.  Verify that procedures have been established and implemented for
    correcting conditions adverse to quality.

b.  Verify that corrective action reports provide for documentation and
    description of the condition adverse to quality, the cause and
    corrective action taken to prevent recurrence, review and approval
    by the responsible authority, status of corrective actions reviewed,
    and follow-up action taken to verify timely and effective
    implementation of corrective action.

c.  Verify that the corrective action process provides a connection to
    the 10 CFR Part 21 procedures. Assessment of the evaluation and
    reporting of deviations or failures to comply is done in accordance
    with IP 36100.

d.  Verify if subcontractors are required to submit nonconforming
    reports and proposed corrective action for approval before
    implementing corrective action.

e.  Verify that deficiencies identified or reported by customers (e.g.,
    receipt inspection rejections, nonconformances, etc.) are adequately
    assessed and entered into either the nonconformance or corrective
    action program.

f.  Verify that a management system is established for overview of
    trends for conditions adverse to quality.

03.17 [QA Records]{.underline}. Select a sample of QA records for
review. Assess QA records controls by performing the following:

a.  Verify that the vendor implements a documented record system that
    provides measures for, as a minimum, the identification of records
    to be maintained; classification of records; validation of records;
    control of distribution, handling, maintenance, and storage, and
    procedures implementing configuration management requirements.

b.  Examples of QA records include inspection and test records; audit
    reports; quality-related procedures/instructions/drawings;
    qualifications and certifications; material analysis records;
    vendor-supplied documents; certifications of compliance/conformance;
    laboratory/engineering/manufacturing operating logs; calibration
    records; and nonconformance documents.

c.  Verify that procedures identify the designated person or
    organization responsible for records access, including receipt
    control, processing, corrections, and safekeeping.

d.  Verify that the records sampled are legible, adequate, retrievable,
    adequately protected, and traceable to markings, identification
    tags, or other means of identifying materials, components, and
    activities important to safety.

e.  Verify that records are stored in a manner that precludes
    deterioration, environmental effects, damage, and loss.

f.  Verify that QA records stored in electronic media are subject to the
    same controls described above. Electronic recordkeeping systems
    shall maintain the integrity, authenticity, and acceptability of QA
    records during their required retention period in accordance with
    NRC requirements. This includes management of software
    configuration, record migration/regeneration programs, and
    electronic media control.

g.  Verify that design records are stored and maintained in accordance
    with established procedures. Design records include, but are not
    limited to, the final design output, subsequent revisions, the
    important design steps (e.g., calculations, analyses, and computer
    programs), and the sources of input that support the final output.

03.18 [Audits]{.underline}. Select a sample of audit records for review.
Assess audit controls by performing the following:

a.  Verify that procedures have been established and implemented to
    provide a comprehensive independent audit of activities and
    procedures, including the status and adequacy of the QA program.

b.  Verify that procedures describe the scope and purpose of audits to
    be performed, frequency or schedule of audits (including
    supplemental audits to provide adequate coverage), audit criteria,
    basis for re-audit, documentation of audit results, management
    review and assessment, corrective action, and follow-up (where
    required).

c.  Verify that audit teams were selected using qualified auditors.
    Verify that selected auditors are not auditing their own work.

d.  Review a sample of audits and verify that scheduled audits were
    performed using checklists and/or procedures. These
    checklists/procedures include an audit plan, documented objective
    evidence, audit results, and a review of audit results by
    responsible management. Verify that audits were performed at the
    minimum frequency specified in the QA manual. Verify that follow-up
    action was taken where indicated.

e.  During inspections at ASME certificate holders, verify that the
    authorized nuclear inspector (ANI) is performing its third-party
    oversight as required. Verify that the ANI has reviewed and signed
    the ASME Section III code data report.

43002-04 RESOURCE ESTIMATE

This inspection procedure is used for routine inspections of vendors
providing basic components to licensees. The resource estimate for this
inspection procedure is approximately 200 hours of direct inspection
effort.

43002‑05 REFERENCES

Inspection Procedure 36100, AInspection of 10 CFR Part 21 and 50.55(e)
Programs for Reporting Defects and Nonconformance.@

Inspection Procedure 43003, AReactive Inspections of Nuclear Vendors.@

Inspection Procedure 43004, AInspection of Commercial-Grade Dedication
Programs.@

END

Attachments:

1\. Revision History

ATTACHMENT 1

[Revision History for IP 43002]{.underline}

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| Comm   | Issue  | Description of | Training | Training | Comment      |
| itment | Date   | Change         | Required |          | Resolution   |
| Tr     |        |                |          | Co       | Accession    |
| acking |        |                |          | mpletion | Number       |
| Number |        |                |          | Date     |              |
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| N/A    | 10     | Researched     | None     | N/A      | N/A          |
|        | /03/07 | commitments    |          |          |              |
|        |        | for 4 years    |          |          |              |
|        | CN     | and found      |          |          |              |
|        | 07-030 | none.          |          |          |              |
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