**NRC INSPECTION MANUAL** NMSS/RII

INSPECTION PROCEDURE 88109

QUALITY ASSURANCE: INSPECTION, TEST CONTROL, AND

CONTROL OF MEASURING AND TEST EQUIPMENT

(PRE-LICENSING AND CONSTRUCTION)

PROGRAM APPLICABILITY: 2630

88109‑01 INSPECTION OBJECTIVES

01.01 To determine whether inspections and tests verifying conformance
of an item or activity to specified requirements are planned and
executed in accordance with U.S. Nuclear Regulatory Commission
(NRC)-approved Quality Assurance (QA) program requirements.

01.02 To determine whether the applicant=s control for tools, gages,
instruments, and other measuring and test equipment (M&TE) for
quality-affecting activities is in accordance with NRC-approved QA
program requirements.

01.03 To verify that the applicant has established a process to identify
the status of inspection and test activities to assure that required
inspections and tests are performed and to assure that items that have
not passed the required inspections and tests are not inadvertently
installed, used, or operated.

88109-02 INSPECTION REQUIREMENTS

Verify that selected elements associated with the applicant=s program
for inspection, test control, and control of M&TE (as identified in an
approved inspection plan) are in accordance with the applicant=s
approved QA Plan. Elements chosen for inspection may include three or
more of the following:

02.01 Verify that inspection requirements and acceptance criteria are
contained in the applicable design documents approved by the responsible
design organization. Verify that inspection activities are documented
and controlled by instructions, procedures, drawings, checklists,
travelers, or other appropriate means.

02.02 Verify that tests required to verify conformance of an item to
specified requirements, and to demonstrate satisfactory performance for
service, are planned and executed. Verify that the characteristics to be
tested and test methods to be employed are specified. Verify that test
results are documented and their conformance with acceptance criteria
are evaluated.

02.03 Verify that the applicant has established controls for tools,
instruments, gauges, and other M&TE used for quality-affecting
activities. Verify that M&TE is controlled, calibrated (at specified
periods), and adjusted to maintain accuracy within necessary limits.

02.04 Verify that the applicant has established the requirements to
identify the status of inspection and test activities. Verify that the
status is indicated either on the items or in documents traceable to the
items, where it is necessary to assure that required inspections and
tests are performed, and to assure that items that have not passed the
required inspections and tests are not inadvertently installed, used, or
operated. Verify that the status is maintained through indicators (i.e.,
physical location and tags, markings, shop travelers, stamps, inspection
records, computerized logs, or other suitable means). Verify that
authority for application and removal of tags, markings, labels, and
stamps is specified. Verify that status indicators provide for
indicating the operating status of systems and components of the
facility (i.e., tagging valves and switches) to prevent inadvertent
operation.

88109-03 INSPECTION GUIDANCE

The inspector should refer to the applicant=s approved QA Plan for
specific requirements and commitments.

1.  Verify that the following inspection activities are documented and
    controlled by instructions, procedures, drawings, checklists,
    travelers, or other appropriate means:

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a.  [Inspection Planning]{.underline}. Verify that documented inspection
    planning includes the following:

    1.  Identification of each work operation where inspection is
        necessary to ensure quality;

    2.  Identification of documents that are used to perform the
        inspections;

    3.  Identification of the characteristics for inspection and the
        identification of when, during the work process, inspections are
        to be performed for those characteristics;

    4.  Identification of inspection or process-monitoring methods
        employed;

    5.  Sufficient information from the final inspection, to provide a
        conclusion regarding conformance of the item to specified
        requirements;

    6.  Identification of the functional-qualification level (category
        or class) of personnel performing inspections;

    7.  Identification of acceptance criteria;

    8.  Identification of sampling requirements;

    9.  Methods to record inspection results; and

    10. Selection and identification of the M&TE to be used to perform
        the inspection to ensure that the equipment is calibrated and is
        of the proper type, range, accuracy, and tolerance to accomplish
        the intended function.

b.  [Selecting Inspection Personnel to Perform Inspections]{.underline}.

    1.  Determine that the individual who performs an inspection to
        verify conformance of an item to specified acceptance criteria
        is qualified to the requirements specified in the applicant=s
        approved QA Plan.

    2.  Verify that inspections are performed by personnel other than
        those who performed or directly supervised the work being
        inspected. Verify that inspection personnel do not report
        directly to the immediate supervisor responsible for the work
        being inspected.

c.  [Inspection Hold Points]{.underline}.

    1.  If mandatory inspection hold points are used to control work,
        then verify that specific hold points are indicated in
        documents.

    2.  When applicable, verify that consent to waive hold points are
        documented and approved before to continuing work beyond the
        designated hold point.

d.  [Statistical Sampling]{.underline}. If statistical sampling is used
    to verify the acceptability of a group of items, then verify that
    the statistical sampling method used is based on recognized standard
    practices.

e.  [In-Process Inspections and Monitoring]{.underline}.

    1.  If inspection of processed items is not practicable, then verify
        that indirect control is provided by the monitoring of
        processing methods, equipment, and personnel.

    2.  Verify that both inspection and process monitoring are
        conducted, when control is inadequate with only one method.

    3.  Verify that controls are established and documented for the
        coordination and sequencing of the work at established
        inspection points during successive stages of the process.

f.  [Final Inspection]{.underline}.

    1.  Verify that finished items are inspected for completeness,
        markings, calibration, adjustments, protection from damage, or
        other characteristics, as required to verify the quality and
        conformance of the item to specified requirements.

    2.  Verify that final inspections include a review of the results
        and resolution of nonconformances identified by earlier
        inspections.

    3.  If modifications, repairs, or replacements of items are
        performed subsequent to the final inspection, then verify that
        appropriate re-tests or re-inspections are performed.

g.  [Accepting Items]{.underline}. Verify that the acceptance of an item
    is documented and approved by qualified and authorized personnel.

h.  [Inspection Documentation]{.underline}. Verify that inspection
    documentation includes the following:

    1.  The item inspected, date of inspection, the name of the
        inspector, or the inspector=s unique identifier, who documented,
        evaluated, and determined acceptability;

    2.  The name of the data recorder, as applicable, and the type of
        observation or method of inspection;

    3.  The inspection criteria, sampling plan, or reference documents
        used to determine acceptance;

    4.  Results indicating acceptability of characteristics inspected;

    5.  M&TE used during the inspection, including the identification
        number and the most recent calibration date; and

    6.  Reference to information on actions taken in connection with
        nonconformance.

03.02 Verify that the following test control activities are conducted
and documented in accordance with the applicant=s approved QA Plan:

a.  [Test Planning]{.underline}. Verify that test planning includes the
    following:

    1.  Identification of documents to be developed to control and
        perform tests;

    2.  Identification of items to be tested, test requirements, and
        acceptance limits, including required levels of precision and
        accuracy;

    3.  Identification of test methods to be employed and instructions
        for performing the test;

    4.  Identification of test prerequisites addressing, calibration for
        instrumentation, adequacy of test equipment and instrumentation,
        qualifications of personnel, condition of test equipment and the
        item to be tested, suitably controlled environmental conditions,
        and provisions for data acquisition;

    5.  Identification of mandatory hold points and methods to record
        data and results; and

    6.  Selection and identification of the M&TE to be used to perform
        the test to ensure that the equipment is of the proper type,
        range, accuracy, and tolerance to accomplish the intended
        function.

b.  [Performing Tests]{.underline}. Verify that tests are performed in
    accordance with the applicant=s QA procedures, and, as applicable,
    include the following:

    1.  Provisions for determining when a test is required, describing
        how tests are performed, and ensuring that testing is conducted
        by trained and appropriately qualified personnel.

    2.  Test objectives and provisions for ensuring that prerequisites
        for the given test have been met, adequate calibrated
        instrumentation is available and used, necessary monitoring is
        performed, and suitable environmental conditions are maintained.

    3.  Test requirements and acceptance criteria provided or approved
        by the organization responsible for the design of the item to be
        tested, unless otherwise designated.

    4.  Test requirements and acceptance criteria based on specified
        requirements contained in applicable design or other pertinent
        technical documents.

    5.  Potential sources of uncertainty and error.

c.  [Use of Other Testing Documents]{.underline}. Other testing
    documents (e.g., American Society for Testing and Materials
    specifications, vendor manuals, or other related documents
    containing acceptance criteria) may be used instead of preparing
    special test procedures. If the applicant uses other documents, then
    verify that the information is incorporated directly into the
    approved test procedure, or incorporated by reference in the
    approved test procedure.

d.  [Tests Results]{.underline}. Verify that test results are documented
    and their conformance with acceptance criteria evaluated by a
    qualified individual within the responsible organization, to ensure
    that the test requirements have been satisfied.

e.  [Test Documentation]{.underline}. Verify that test documentation
    includes the following:

    1.  Item or work product tested, date of test, names of tester and
        data recorders, type of observation, and method of testing;

    2.  Test criteria or reference documents used to determine
        acceptance;

    3.  Results and acceptability of the test;

    4.  Actions taken in connection with any nonconformances noted;

    5.  The individual evaluating the test results; and

    6.  M&TE used during the test, including the identification number
        and the most recent calibration date.

f.  [Qualification of Test Personnel]{.underline}. Verify that the
    individual who directs a test to verify conformance of an item to
    specified acceptance criteria is qualified in accordance with the
    applicant=s approved QA Plan. Verify that tests are directed by
    personnel other than those who performed or directly supervised the
    work being tested. Verify that test directors do not report directly
    to the immediate supervisor responsible for the work being tested.

03.03 Verify that the program for the control of M&TE is conducted and
documented in accordance with the applicant=s approved QA Plan. The
following elements should be verified:

a.  [Calibration]{.underline}.

    1.  Verify that M&TE is calibrated, adjusted, and maintained at
        prescribed intervals, or before use, against reference
        calibration standards having traceability to nationally
        recognized standards. If no nationally recognized standards or
        physical constants exist, verify that the basis for calibration
        is documented.

    2.  Verify that calibration standards have a greater accuracy than
        the required accuracy of the M&TE being calibrated.

    3.  Verify that the method and interval of calibration, for each
        device, are defined, based on the type of equipment, stability
        characteristics, required accuracy, intended use, and other
        conditions affecting measurement control. For M&TE used in
        one-time-only applications, verify the calibration is performed
        both before and after use, when practicable.

    4.  Verify that the calibration is performed when the accuracy of
        calibrated M&TE is suspect.

    5.  Verify that calibrated M&TE is labeled, tagged, or suitably
        marked or documented to indicate a due date or interval of the
        next calibration and uniquely identified to provide traceability
        to its calibration data.

b.  [Documenting Use of Measuring and Test Equipment]{.underline}.
    Verify that the use of M&TE is properly documented and, as
    appropriate to equipment use and calibration schedule, verify that
    the documentation identifies the processes monitored, data
    collected, or items inspected or tested since the last calibration.

c.  [Out-of-Calibration Measuring and Test Equipment]{.underline}.

    1.  If the calibration due date or interval has passed without
        recalibration, or the device produces results known or suspected
        to be in error, then verify that the applicant has considered
        the M&TE to be out of calibration and not used until calibrated.

    2.  Verify that out-of-calibration M&TE is controlled (tagged,
        segregated, etc.).

    3.  If any M&TE is consistently found out of calibration during the
        recalibration process, then verify that the M&TE is repaired,
        replaced, or the calibration interval shortened.

d.  [Lost or Damaged Measuring and Test Equipment]{.underline}. If M&TE
    is lost or damaged, then verify it is documented as a nonconforming
    item in accordance with the applicant=s approved QA Plan. Verify
    that the evaluation of the nonconformance addresses the validity of
    results obtained using that equipment, since its last valid
    calibration, to determine acceptability of previously collected
    data, processes monitored, or items previously inspected or tested.

e.  [Handling and Storage]{.underline}. Verify that M&TE is properly
    handled and stored to maintain accuracy.

f.  [Commercial Devices]{.underline}. No specific guidance is provided;
    however, inspectors should recognize that calibration and control
    are not required for rulers, tape measures, levels, and other normal
    commercial equipment that provide adequate accuracy.

g.  [Measuring and Test Equipment Documentation]{.underline}. Verify
    that M&TE calibration documentation includes the following:

    1.  Identification of the measuring or test equipment calibrated;

    2.  Traceability to the calibration standard used for calibration;

    3.  Calibration data, including the results of the calibration and
        statement of acceptability;

    4.  Identification of the date of calibration and the recalibration
        due date or interval;

    5.  Identification of the individual performing the calibration;

    6.  Identification of the document and revision number used in
        performing the calibration; and

    7.  Reference to any actions taken in connection with
        out-of-calibration or nonconforming M&TE including evaluation
        results.

03.04 Verify that the program for identifying the status of inspection
and test activities is conducted and documented in accordance with the
applicant=s approved QA Plan. The following elements should be verified:

a.  [Identifying Items]{.underline}.

    1.  Verify that items that have satisfactorily passed the required
        inspections have been identified.

    2.  Verify that identification methods preclude the inadvertent
        installation, use, or operation of items that have not passed
        the required inspections and tests.

b.  [Indicating Status]{.underline}.

    1.  Verify that the statuses of required inspections and tests of
        items are indicated, when necessary to preclude inadvertent
        bypassing of such inspections and tests.

    2.  Verify that the statuses of inspections and tests are identified
        either on the items or in documents traceable to the items.

    3.  Verify that the statuses are maintained through the use of
        status indicators (e.g., tags, markings, labels, and stamps), or
        other means (travelers, logs, inspection or test records).

    4.  Verify that the authority for applying and removing status
        indicators is specified.

    5.  Verify that the status indicator is used to provide indications
        of the tests or operating statuses of items or facilities to
        prevent inadvertent changes in operating statuses.

88109-04 RESOURCE ESTIMATE

Inspection resources necessary to complete this inspection procedure are
estimated to be 24-32 hours of inspection per facility visit. The basics
of this inspection procedure should be conducted annually, during the
construction phase, or when significant changes occur to the M&TE
program.

88109-05 REFERENCES

Code of Federal Regulations, 10 CFR Part 50, Appendix B, AQuality
Assurance Requirements for Nuclear Power Plants and Fuel Reprocessing
Plants.@

Code of Federal Regulations,10 CFR Part 70, ADomestic Licensing of
Special Nuclear Material.@

U.S. Nuclear Regulatory Commission, NUREG-1718, AStandard Review Plan
for the Review of an Application for a Mixed Oxide Fuel Fabrication
Facility,@ August 2000.

U.S. Nuclear Regulatory Commission, Regulatory Guide 1.28, AQuality
Assurance Program Requirements (Design and Construction),@ (Rev. 3).

Duke, Cogema, Stone and Webster, AMixed-Oxide Fuel Fabrication Facility,
MOX Project Quality Assurance Plan (MPQAP),@ Docket Number 070-03098,
under U.S. Department of Energy Contract DE-AC02-99-CH10888, latest
revision accepted by NRC (Sections 10, 11, 12, and 14).

Duke, Cogema, Stone and Webster, AMixed-Oxide Fuel Fabrication Facility
Construction Authorization Request,@ latest revision accepted by NRC.

American Society of Mechanical Engineers, (ASME) NQA-1-1994 Edition,
with NQA‑1a‑1995 Addenda.

END

ATTACHMENT 1

Revision History for IP 88109

+--------+--------+------------------------+-----+-------+-------------+
| Comm   | Issue  | Description of Change  | Tr  | Tra   | Comment     |
| itment | Date   |                        | ain | ining | Resolution  |
| Tr     |        |                        | ing | Compl | Accession   |
| acking |        |                        | Nee | etion | Number      |
| Number |        |                        | ded | Date  |             |
+--------+--------+------------------------+-----+-------+-------------+
| N/A    | 06     | IP 88109 is a newly    | N   | N/A   | ML071570221 |
|        | /20/07 | issued procedure.      | one |       |             |
|        |        | Issued for MOX         |     |       |             |
|        | CN     | inspection program to  |     |       |             |
|        | 07-020 | improve effectiveness  |     |       |             |
|        |        | and efficiency by      |     |       |             |
|        |        | incorporating and      |     |       |             |
|        |        | consolidating controls |     |       |             |
|        |        | for measuring and test |     |       |             |
|        |        | equipment inspection   |     |       |             |
|        |        | requirements.          |     |       |             |
+--------+--------+------------------------+-----+-------+-------------+
|        |        |                        |     |       |             |
+--------+--------+------------------------+-----+-------+-------------+
|        |        |                        |     |       |             |
+--------+--------+------------------------+-----+-------+-------------+