Issue Date: 02/07/07 88108 1

NRC INSPECTION MANUAL NMSS/RII

INSPECTION PROCEDURE 88108

QUALITY ASSURANCE: CONTROL OF MATERIALS, EQUIPMENT, AND SERVICES

(PRE-LICENSING AND CONSTRUCTION)

PROGRAM APPLICABILITY: 2630

88108-01 INSPECTION OBJECTIVES

01.01 To determine whether the procurement of Quality Level 1 (QL-1) and QL-2 material,

equipment and services are controlled to assure conformance with specified technical and

Quality Assurance (QA) requirements.

01.02 To determine whether the necessary controls have been established for QL-1 and

QL-2, to ensure that only correct and accepted material, parts, and components are used

or installed.

01.03 To determine that special processes that control or verify quality are controlled in

accordance with U.S. Nuclear Regulatory Commission (NRC)-approved QA program

requirements.

01.04 To determine that the handling, storage, cleaning, packaging, shipping, and

preservation of items are controlled in accordance with requirements of the NRC-approved

QA program, to prevent damage or loss and to minimize deterioration.

01.05 To determine that a process has been established for controlling items that do not

conform to specified requirements and to prevent inadvertent installation or use. To

determine that established controls provide for: (1) identification; (2) documentation; (3)

evaluation; (4) segregation; when practical; (5) disposition of nonconforming items; and (6)

for notification to affected organizations.

01.06 To determine if commercial-grade item dedication is appropriately defined and

implemented to provide the necessary assurance of quality.

88108-02 INSPECTION REQUIREMENTS

Verify that selected elements associated with the applicant’s systems for controlling

purchased material, equipment, and services (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 Procurement Control System. Determine if the procurement of QL-1 and QL-2

material, equipment, and services are controlled to assure conformance with specified

technical and committed QA Program and associated QA procedural requirements.

02.02 Identification and Control of Material, Parts, and Components. Determine if the QA

program, and associated QA procedures, implement the necessary controls for QL-1 and

QL-2, to assure that only correct and accepted material, parts, and components are used

or installed. In addition, for QL-1, verify that procedures require that identification is
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maintained on the items, or in documents traceable to the items, in a manner that assures

that adequate identification and controls are established and maintained.

02.03 Control of Special Processes. Determine if the QA program and associated QA

procedures establish the necessary requirements for the control of special processes, such

as welding, heat treating, chemical cleaning, and nondestructive examination. Verify that

these requirements include: (1) personnel qualification; (2) certification; (3) acceptable

equipment; (4) environmental conditions; and (5) applicable codes, design specifications,

and other established standards.

02.04 Handling, Storage, and Shipping. Determine if the QA program and associated QA

procedures establish the necessary requirements to control the handling, storage, cleaning,

packaging, shipping, and preservation of items, to prevent damage or loss and to minimize

deterioration. 

02.05 Nonconforming Materials, Parts, or Components. Determine if the QA program and

associated QA procedures provide a process for controlling items that do not conform to

specified requirements. Verify that these items are controlled to prevent inadvertent

installation or use. Verify that the process for controlling items provides for: (1)

identification; (2) documentation; (3) evaluation; (4) segregation when practical; (5)

disposition of nonconforming items; and (6) notification to affected organizations.

02.06 Programmatic Review of Commercial-Grade Item Dedication.

a. Commercial-Grade Item Dedication Program Definitions. Determine if commercialgrade item program definitions are established and described, consistent with

regulatory and QA plan requirements.

b. Dedication Activity Inspection. Determine if commercial-grade item dedication is

appropriately performed in accordance with the QA plan.

88108-03 INSPECTION GUIDANCE

03.01 Procurement Control System.

a. Review the applicant’s system for evaluating and selecting suppliers/subcontractors

and their proposals/offers. Verify that evaluations are performed before

subcontracts and/or purchase orders are awarded. Verify that the measures used

for evaluating and selecting procurement sources are as specified in QA

procedures and meet the requirements of the approved QA Plan. Verify that

suppliers/subcontractors for QL-1 items have been placed on the approved supplier

list and are periodically evaluated in accordance with the approved QA Plan.

b. Review the applicant’s measures for evaluating supplier/subcontractor performance

after contracts are awarded. Verify that such measures have been established and

are in accordance with the approved QA Plan. Review a variety of procurement

contractors (at least one each for materials, equipment, and services) associated

with a QL-1 (SSCs) and verify that established evaluation measures are being

followed.

c. Review the applicant’s methods for accepting supplier-subcontractor-furnished

material, equipment, or services. Verify that the supplier/subcontractor with an

approved QA program has been placed on the applicant’s Approved Suppliers List

before the award of the subcontract. Verify that any certificate of conformance,
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source verifications, receipt inspections, or post-installation testing (or other

approved methods) used to accept QL-1, affecting materials, equipment, or

services, have been performed per the approved QA Plan and associated

implementing procedures.

d. Select two to three examples of purchased material, equipment, or services, to

verify that the procurement process has been performed per the approved QA Plan

and associated implementing procedures.

e. Review any reports of nonconformance from suppliers/subcontractors, and verify

that the applicants have properly evaluated their effect on QL-1 safety controls.

f. Review the applicant’s system for specifying, accepting, and receiving commercialgrade items. Verify that this system meets the requirements in the approved QA

Plan and implementing procedures.

03.02 Identification and Control of Material, Parts, and Components.

a. Verify that the applicant has established and maintained an identification system

on QL-1 items.

b. Verify that item identification methods make use of physical markings and ensure

that traceability is established and maintained in a manner that allows an item to

be traced to applicable design or other specifying documents. Verify that item

traceability documentation ensures that the item can be traced from its source

through installation or end use.

03.03 Control of Special Processes.

a. Verify that the applicant has established and maintained a list of special processes

that each organization will perform, or will be responsible for performing.

b. Verify that special processes (such as welding, heat treating, chemical cleaning and

nondestructive examination) that control or verify quality are controlled in

accordance with the approved QA Plan and implementing procedures.

03.04 Handling, Storage, and Shipping.

a. Verify that the applicant controls the handling, storage, cleaning, packaging,

shipping, and preservation of items, in accordance with established work and

inspection procedures, shipping instructions, or other specified documents, as

required by the approved QA Plan.

b. If required for particular items, verify that the applicant has specified and provided

special equipment (such as containers, shock absorbers, and accelerometers) and

special protective environments (such as inert gas and specific moisture and/or

temperature levels). Verify that the applicant adequately maintains the tools and

equipment in accordance with the approved QA Plan and implementing procedures.

03.05 Nonconforming Materials, Parts, or Components.

a. Verify that the applicant has an established process for controlling items that do

not conform to specified requirements. Verify that nonconforming materials, parts,

or components are controlled to prevent inadvertent installation or use.
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b . Verify that the process for controlling nonconforming items includes the following

requirements, as specified in the approved QA Plan: 

1. Identification - Verify that nonconforming items are identified by marking,

tagging, or other methods that do not adversely affect their end uses.

2. Documentation and evaluation - Verify that nonconformance documentation

clearly identifies and describes the characteristics that do not conform to

specified criteria. Verify that the responsibility and authority for reviewing,

evaluating, approving the disposition, and closing nonconformances is

specified.

3. Segregation - Verify that the applicant has made provisions to segregate

nonconforming items by placing them in a clearly identified and designated

hold area, until properly dispositioned, or if segregation is impractical, employ

other precautions to preclude inadvertent use.

4. Disposition - Verify that the disposition of “use-as-is,” “reject,” “repair,” or

“rework,” for nonconforming materials, parts, or components, is clearly

identified and documented. Verify that items that do not meet the original

design requirements and are dispositioned “use-as-is” or “repair” are subject

to design control measures commensurate with those applied to the original

design. Determine that the disposition of an item to be reworked or repaired

includes a requirement to reexamine the item, to verify acceptability.

03.06 Programmatic Review of Commercial Grade Item Dedication. Selection of areas

for evaluation during inspections shall be based on the risk significance of the SSCs, related

activities, and past performance. The scope of inspections also should consider the

cumulative effect of failures related to low-risk-significant SSCs, regarding their potential

effects on overall system performance and reliability.

Specific Guidance:

a. Commercial-Grade Item Dedication Program Definitions.

Verify that definition of “commercial-grade item” meets the requirements of 10 CFR Part 21.

1. Verify that preferred definitions of critical characteristics, dedicating entity,

and dedication are adopted.

2. Verify that the licensee commits to comply with all provisions associated with

the commercial-grade-item dedication definitions.

3. Verify that the QA program describes the responsibilities and requires

instructions and procedures for commercial-grade item dedication.

b. Dedication Activity Inspection.

1. Verify that commercial-grade items are identified as such in approved design

output documents.

2. Verify that the original intended function and design requirements are met for

substituted commercial-grade items.
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3. Verify that commercial-grade item supplier evaluation and selection are based

on the complexity and importance to safety, when applicable.

4. Verify that the basis for sampling plans used for commercial-grade-item

dedication activities are documented; and

(a) Sampling plans for high-safety-risk-significant activities use criteria that

provide a 95-percent confidence that only 5 percent of the items in a

lot are defective (95/5).

(b) Lots sampled are essentially homogeneous.

5. Verify that commercial-grade items are identified in the procurement

documents by the manufacturer's published product descriptions.

6. Verify that, after receipt of a commercial-grade item, the purchaser confirmed

the following:

(a) Damage was not sustained during shipment.

(b) The item received was the item ordered.

88108-04 INSPECTION RESOURCES

Inspection resources necessary to complete this inspection procedure are estimated to be

24-36 hours of inspection per facility visit. Once the construction authorization is issued,

the basics of this inspection procedure should be conducted annually, during the

construction phase.

04.01 Procurement Control System. This section should be inspected once per year or

when significant design control changes occur. Estimated effort is 16 to 20 hours per

occurrence.

04.02 Identification and Control of Material, Parts, and Components. This section should

be inspected once per year or when significant additions or changes occur. The resource

estimate for this section is 2 to 4 hours per occurrence.

04.03 Control of Special Processes. This section should be inspected once per year or

when significant additions or changes occur. The resource estimate for this section is 2

to 4 hours per occurrence.

04.04 Handling, Storage, and Shipping. This section should be inspected once per year

or when significant additions or changes occur. The resource estimate for this section is

2 to 4 hours per occurrence.

04.05 Nonconforming Materials, Parts, or Components. This section should be inspected

once per year or when significant additions or changes occur. The resource estimate for

this section is 2 to 4 hours per occurrence.

04.06 Programmatic Review of Commercial Grade Item Dedication. This section should

be inspected once per year or when significant additions or changes occur. The resource

estimate for this section is 2 to 4 hours per occurrence.
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8108-05 REFERENCES

U.S. Code of Federal Regulations, Title 10, Part 70, “Domestic Licensing of Special Nuclear

Material.”

Duke, Cogema, Stone and Webster, “Mixed Oxide Fuel Fabrication Facility, MOX Project

Quality Assurance Plan (MPQAP),” Docket Number 070-03098, under US Department of

Energy Contract DE-AC02-99-CH10888, latest revision accepted by NRC (Sections 7, 8,

9, 13, and 15).

Duke, Cogema, Stone and Webster, “Mixed-Oxide Fuel Fabrication Facility Construction

Authorization Request,” latest revision accepted by NRC.

U.S. Nuclear Regulatory Commission, NUREG-1718, “Standard Review Plan for the Review

of an Application for a Mixed Oxide Fuel Fabrication Facility,” August 2000.

END
ATTACHMENT 1

Revision History for IP 88108

CommitmentTrackingNumber

Issue Date Description of Change Training

Needed

TrainingCompletionDate

ComAcce

02/07/07CN 07-006

IP 88108 is a newly issuedprocedure. Issued for MOX inspection program to improve effectivenessand efficiency by incorporating andconsolidating quality assurance requirements for the control of materials, services, and equipment and theassociated inspection requirements.

None N/A ML 0

Issue Date: 02/07/07 A-1-1