Jntg natlonalu Is peI In c

February 09, 2011

ATTN: Document-Control Desk

U.S. Nuclear Regulatory Commission

Washington, DC 20555-0001

Subject: Submittal of Responses to Requests for Additional Information (RAI)

TAC L32739

To Whom it May Concern,

The following document is provided as a response to the US Nuclear Regulatory Commission

RAIs pertaining to the International Isotopes Fluorine Products Inc. December 30, 2009

application to license a depleted uranium hexafluoride de-conversion and fluorine extraction

process facility.

(1) Quality Assurance (Management Measures)

Please contact me by phone at (208) 524-5300 or by email at iimiller@intisoid.com if you have

questions regarding these responses.

Sincerely,

John J. Miller, CHP

Radiation Safety Officer

(1) Enclosure as stated

JJM-201 1-11

cc: Dr. Matthew Bartlett, Project Manager

Mail Stop E2C40M

Executive Boulevard Building

6003 Executive Boulevard

Rockville, MD 20852

4137 Commerce Circle, Idaho Falls, Idaho 83401

Phone: 208-524-5300, 800-699-3108 Fax: 208-424-1411

Website: www.intisoid.com
Enclosure (1) JJM-201 1-11

Quality Assurance (Management Measures)

QA-1 (QA-2) In the fourth paragraph of the introduction of Section 11, "Management

Measures" the application states, "The provisions contained in this QA Program Description

are applicable during design and construction of the IIFP Facility for design activities taking

place beginning on the date the DB contactor assumes the detailed design and engineering role

and establishes the design organization and controls during design and construction phase of

the IIFP Facility beginning on the date the DB contactor assumes the detailed design and

engineering role and establishes the design organization and controls. " Consistent with 10 CFR

70.64, "Safety program and integrated safety analysis" clarify this sentence and its intent, and

correct the editorial errors. In addition, clarify if the provisions in Chapter 11 or QAPD are just

applicable to design and construction? What documents will be applicable to operations?

RESPONSE: All management measures are considered and addressed accordingly during all

phases of the IIFP Project, from the design and construction phase through the operations of the

IIFP Facility. Two sentences will be added to the subject paragraph explaining the evaluation of

the QA programs of prospective DB contractors.

Management measures also apply throughout the operations and maintenance of the facility. The

next paragraph (fifth paragraph) deals with the startup and operation of the facility. It is stated

that "The COO/PM (IIFP Chief Operations Officer/Plant Manager) (COO/PM will be changed

to "COO" and IIFP Chief Operations Officer) is responsible for implementing and maintaining

the management systems ("systems" will be changed to "measures" as shown below) for the

operating facility. The FEP/DUP facility line managers are responsible, with commensurate

delegated authority, for implementing and maintaining the management measures policies and

procedures in accordance with the approved facility safety design basis, licenses and permit

requirements and the QAP." QAP will be changed to QA program as shown below. A clarifying

statement will be added that the management measures also apply to operations.

A new paragraph will be added as the sixth paragraph on documents applicable to operations.

Figure 11-2 "IIFP Plant Organization during Operations of the FEP/DUP Facility" will be

removed and replaced with Figure 11-2 "Plant Operation Organization" depicting the

organizational structure of the Facility, in response to RAI OA-7A.

License Documentation Impact: Revisions will be made to the 4th and 5th paragraphs of the

IIFP License Application, Revision A, Chapter 11 introduction, and a new 6th paragraph will be

inserted (subsequent paragraphs will be shifted down, accordingly) and the revisions will read as

follows:

(Note: Former subsection of 11.8.4 "Graded Application" will become Subsection 11.8.2.2 due to revision.)

IIFP is a wholly owned subsidiary of International Isotopes, Inc. (INIS). The President-and-Ghi

E-ee.tit.V. Offie• r (CEO) of IIFP is the highest level of management responsible for IIFP's

corporate QA policies, goals, and objectives. The IIFP project is currently in its development,

initial conceptual design and licensing application phase. Management measureS described in

this Chapter bec.me effcotive and appli.able The IFP projeet is currently in its develcpment,

initial e.neeptual design and li.ensing applic•ie. n phase. During the selection of the

design/build (DB) contractor, the QA programs of the respective bidders will be evaluated to

ensure the prospective DB contractors have mature OA programs and to ensure that the

organization has all the controls and methodologies in place for design and change control

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Quality Assurance (Management Measures)

processes. The design must be developed and implemented in accordance with IIFP management

measures to ensure that the critical components and the items relied on for safety will be

available and reliable to perform their function when needed. The provisions contained in this

the QA Program Description are applicable during design and construction of the IIFP Facility

for design activities taking place beginning on the date the DB contactor assumes the detailed

design and engineering role and establishes the design organization and controls during the

design and construction phase of the IIFP Facility. beginning on the date the DB eentaetor

assumes the detailed designi and engineering roele and establishes the design erganiZation and

eenfrels Once the design, engineering and construction phase (r-eferred to as desig"'Uild (DB))

of the FEP/DUP pf --Facility_begins, the IIFP Chief Operations Officerl Commercial Faeility

P-jeet Direetef-(COO/GFPD), to be appointed by the President and CEO and reporting to the

NIS-IIFP President/G9O, is responsible for assuring implementingation of the management

measures necessary for safe design and construction in accordance with the graded QA Program.

(See Figure 11-1, _IIFP Project Organization during Design and Construction Organization"-of

the FEP/DUP Facility).

Management measures not only apply during the design and construction of the IIFP Facility but

throughout the operations and maintenance of the facility. Upon completion of construction, the

Plant Ooperations Oorganization takes responsibility for startup and operation of the facility; led

by the IIFP Chief Operations Officerplaat- Manager- (COOARM) who reports to the No-l-IIFP

PresidentL -EO. The COO WPM-is responsible for implementing and maintaining the

management systems-measures for the operating facility. The FEP/DUP Ffacility line managers

are responsible, with commensurate delegated authority, for implementing and maintaining the

management measures policies and procedures in accordance with the approved facility safety

design basis, licenses and permit requirements and the QAt program requirements. The

FEP/DUP Ffacility operating organization is shown in Figure 11-2. In the operating

organization, the Plant Manager and the Engineering EngineeringMaintenan.e Manager and..he

Pr-eductieo-iTeehnieal Manager have key roles in ensuring the safe design and operation of the

facility is maintained.

Critical documents applicable to operations include procedures. All activities involving IROFS

and QA Level 1 and 2 items (see subsection 11.8.2.2) are conducted in accordance with

approved procedures. As noted throughout this document, procedures are used to control IROFS

activities to ensure the activities are carried out in a safe manner and in accordance with

regulatory requirements. Applicable safety limits and IROFS are clearly identified in the

procedures. IIFP will incorporate a methodology for identifying, developing, approving,

implementing, and controlling operating procedures. Identifying needed procedures will include

consideration of ISA results.

License Documentation Impact: Remove Figure 11-2 and title and replace with revised Figure

11-2 "Plant Operations Organization" in the Chapter 11 of HFP License Application, Revision

A, (also in response to RAI OA-7) the revised Figure and will appear as follows:

Quality Assurance (Management Measures) RAIs Page 2
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Figure 11-2 Plant Operation Organization

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Enclosure (1) JJM-201 1-11

Quality Assurance (Management Measures)

QA-2 (QA-4) In the fifth paragraph of the introduction of Section 11, "Management Measures" the

application states, "The CO0/PM is responsible for implementing and maintaining the

management systems for the operating facility." Consistent with the acceptance criteria in

NUREG 1520 Revision 1, Section 11.4.3.1, in the first three bullets, clarify the wording

management systems.

RESPONSE: As stated above in the response to RAI QA-1, "management systems" was

changed to "management measures". Also in response to RAI QA- 1, the COO/PM was changed

to Chief Operations Officer (COO).

The first bullet of NUREG 1520 Revision 1, Section 11.4.3.1 states that "The application

describes the CM program, design requirements, document control, change control, assessments,

and design reconstitution (for existing facilities only)." The text will be revised to show where

the management measures are described in Chapter 11.

The second bullet of NUREG 1520 Revision 1, Section 11.4.3.1 states that "The application

describes the CM program and defines the specific attributes of the levels of CM that will be

applied to select IROFS." The text will be revised to show where these attributes are described

in Chapter 11.

The third bullet of NUREG 1520 Revision 1, Section 11.4.3.1 states that "The ISA Summary

clearly defines the IROFS to be listed under CM along with the assignment of any grades or

quality levels." The applicant should indicate in the ISA Summary the level of CM attributes

that is applied to a particular IROFS. However, in the ISA Summary, this indication may consist

of only an index or category designation." The text will be revised to show where these

attributes are described in Chapter 11.

License Documentation Impact: To define the location of management measures identified in

the first bullet of NUREG 1520, Revision 1, the following text will be added to the License

Application, Rev A, introduction section of Chapter 11 below former paragraph 7:

Management measures include the Configuration Management program which is fully described

in License Application Section 11.1 through 11.1.6. The Configuration Management Policy is

described in Section 11.1.1, Design Requirements in Section 11.1.2, Configuration Management

Controls on the Design Requirements in Section 11.1.3, Document Control in Section 11.1.4,

Change Control in Section 11L1.5, and Assessments in Section 11.1.6.

License Documentation Impact: To define the location of the specific attributes of the levels

of CM that will be applied to select IROFS identified in the second bullet of NUREG 1520,

Revision 1, the following text will be added to LA Rev A, Chapter 11, below the new paragraph

above:

(Note: Former subsection of 11.8.4 "Graded Application" will become Subsection 11.8.2.2 due to revision.)

License Application Section 11.1.2, provides details on "Design Requirements," IROFS and any

items that affect the function of the IROFS are designated as QA Level 1 or QA Level 2 (see

subsection 11.8.2.2).

Quality Assurance (Management Measures) RAIs Page 4
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Quality Assurance (Management Measures)

License Documentation Impact: To define the location of the ISA Summary which defines the

IROFS to be listed under CM along with the assignment of any grades or quality levels as

identified in the third bullet of NUREG 1520, Revision 1, the following text will be added to the

LA Rev A, Section 11 below the new paragraph above:

In Section 6 of the ISA Summary, Table 6-1 provides a list of IROFS in the identified high and

intermediate accident sequences. Table 6-1 identifies the control type, the management

measures, the initiatina event failure frequency index, the IROFS failure probability index, and

the failure frequency/probability index basis. A small number of sole IROFS are identified in

Table 8-1 of Section 8 of the ISA Summary. Table 8-1 identifies the type of IROFS and the

safety function of each sole IROFS.

Quality Assurance (Management Measures) RAIs Page 5
Enclosure (1) JJM-201 1-11

Quality Assurance (Management Measures)

QA-3 (QA-5) In the second paragraph of Section 11.1.1, "Configuration Management Policy, "the

application states, "In addition, the applicant will identify design documents that provide design

input, analysis and results specifically for IROFS with the appropriate QA level. "Consistent

with the acceptance criteria in NUREG 1520 Revision 1, Section 11.4.3.8 in the third bullet,

describe the intent of this sentence and provide a description of the QA Levels.

RESPONSE: The above quote comes from the NUREG 1520, Revision 1 document. The

acceptance criteria in NUREG 1520 Section 11.4.3.8, in the third bullet, deals with Design

Control and states: "The applicant should define, control, and verify its design controls. The

applicant should specify and correctly translate design inputs to design documents. Controlled

measures, commensurate with those applied to the original design, should govern the adequacy

of design and design changes.".

Configuration Management Policy will be revised to provide a reference to the description of the

QA Levels. In addition, LA Rev A, Sections 11.8.2, 11.8.3, and 11.8.4 are revised to show that

each IROFS receives a QA Level 1 or 2 classification and to better define those levels. Sections

and subsection will be renumbered in sequence, accordingly

NRC Follow-up Question (1): In Response to Question QA-3, the licensee revised the

second paragraph of the LA to read as follows:

"Configuration management provides the means to establish and maintain a technical baseline

for the facility based on clearly defined requirements. During the design phase of the project,

CM is based on the design control provisions and associated procedural control of the design

documents to establish and maintain the technical baseline. Design documents are identified

that provide design input, design analysis, or design results specifically for IROFS. are

id-nt led with the appr.priate Q6A kevel. Each IROFS receives a classification of QA Level 1 or

Level 2 that applies throughout the life of the facility. Those Quality Assurance (QA) levels are

defined in subsection 11.8.2.2. These design documents undergo interdisciplinary review during

the initial issue and during each subsequent revision. See Figure 11-1, "IIFP Project Design

and Construction Organization. ". dr-i.g Design and Co.s..ruetion .f the FEP/DUP Facility

Please clarify the intent of the following sentence: "Design documents are identified that

provide design input, design analysis, or design results specifically for IROFS.

NRC FOLLOW-UP QUESTION RESPONSE (1): The subject sentence could be better

stated that "Design documents are 4deff4iie4.those that provide design input, design analysis, or

design results specifically for IROFS." The subject sentence has been revised in the license

documentation impact.

NRC Follow-up Question (2). In Response to Question QA-1, the applicant stated that QAP was

going to be changed to QA Program. In Response to Question, QA-3, QAP appears in two

different instances, however, it was changed to QA Program in the first instance and QA

Procedures in the second. Please clarify if the intent is to change QAP to QA Program

throughout the document and this was a misunderstanding.

Quality Assurance (Management Measures) RAls Page 6
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NRC FOLLOW-UP QUESTION RESPONSE (2): For those cases where "QA procedures"

were used for the QAP acronym in the RAI response, the license application has been changed

to "QA program" for the acronym.

NRC Follow-up Question (3): Also in Response to Question QA-3, the applicant added some

paragraphs explaining the different QA levels and the requirements. The new second paragraph

for the QA Level 2 requirements states. "The following QA elements are applied equally to QL-1

and QL-2 IROFS: design control, procurement control; document control; control ofpurchased

items and services; identification and control of materials, parts, and components; control of

measuring and test equipment, control of nonconforming items, corrective actions; and quality

assurance records. "Please clarify ifprocurement control means procurement document

control. In addition, please clarify why audits and assessments will not be applied equally to

QLJ and QL-2 IROFS.

NRC FOLLOW-UP QUESTION RESPONSE (3): Procurement control does indeed refer to

procurement document control since control of purchased items and services is already included

in that listing. The subject listing above has been revised to state "procurement document

control" instead of "procurement control."

IIFP intends to apply a basic level of audits and assessments to all IROFS (QL-I and QL-2).

However, as identified in Section 11.5.5, the frequencies are commensurate with the status and

importance of the activity, and the twelve bulleted areas of consideration presented in Section

11.8.2.2 would be used in developing these frequencies.

License Documentation Impact: The second paragraph of the License Application, Revision

A, Section 11.1.1 will be revised to read as follows.

(Note: Subsection 11.8. 2.2 was formerly subsection of 11.8. 4 "Graded Application".)

Configuration management provides the means to establish and maintain a technical baseline for

the facility based on clearly defined requirements. During the design phase of the project, CM is

based on the design control provisions and associated procedural control of the design

documents to establish and maintain the technical baseline. Design documents are those that

provide design input, design analysis, or design results specifically for IROFS.raFeidentified

with the app.OP.iatO QA level. Each IROFS receives a classification of QA Level I or Level 2

that applies throughout the life of the facility. Those Quality Assurance (QA) levels are defined

in subsection 11.8.2.2. These design documents undergo interdisciplinary review during the

initial issue and during each subsequent revision. See Figure 11-1 -' "IIFP Project Design and

Construction Organization.". during Design ....and t.u.tion..f the F-EPDUP Facilit"...

License Documentation Impact: The IIFP License Application, Revision A, Sections 11.8.2,

11.8.3, and 11.8.4 will be revised in their entirety with additional paragraphs added and existing

paragraphs revised as follows. Sections and subsections will be renumbered in sequence,

accordingly.

Quality Assurance (Management Measures) RAIs Page 7
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Quality Assurance (Management Measures)

11.8.2 Quality Assurance Program Basis

IIFP is committed to ensuring a safe facility operation and to providing the best quality products

possible. It is IIFP policy that its activities will comply fully with all applicable regulations,

codes and standards to which the work is subject.

NIS-IIFP has developed a Q(APQA program that applies to the design, construction, operation,

and decommissioning of the IIFP Ffacility. The QA program is applied to the design,

fabrication, testing, operation, procurement, inspection, maintenance, and modification of

IROFS and activities affectin2 those IROFS. The OA orogram is anolied in a graded anoroach

based on an item's importance to safety.

Appl ieatiefn of the QAP is mandatcry fOr lROFS9 in acceOrdance with 10 CER 70.4, "Definitionsn

(CFR, 2009a), 10 CFR 70.6,1, "Perfo.man.e Re.uir-.m.nts" (CFR, 2009b), and 10 .FR 70.64

(CF-R, 2009d). The QAP, in eenjunction with the other mfanlagement mneasur-es, ensures IROFS8

are av'ailable and reliable to p04rFoM the requirOEd safet funcstions when needed.

The QAP-QA pro -am specifies mandatory requirements for performing activities affecting

quality and is set forth in procedures which are distributed on a controlled basis to organizations

and individuals responsible for quality. When work cannot be accomplished as specified in

implementing OA procedures, or accomplishment of such work would result in an unsafe

condition, work is stopped until proper corrective action is taken. If procedures cannot be used

as written, then work is stopped until the procedures are modified. Revisions to these procedures

are also distributed on a controlled basis. Applicable portions of the QAP--QA program are

documented, approved and implemented prior to undertaking an activity.

11.8.3 Applicability

11.8.2.1 Applicability

The IIFP QA program applies to IIFP workers at all levels of the organization, including

contractor personnel, who perform quality-affecting activities associated with safety-related

aspects of the IIFP Facility. The QA program is risk-based and utilizes only those elements and

principles appropriate for assuring the quality-related aspects (management measures) of the

facility.

IIFP contractors may work under the IIFP QA program or their respective QA programs per

approved written procurement procedures. Contractor QA programs shall be consistent with the

requirements of the IIFP QA program for quality-affecting activities. The interfaces between

contractors and IIFP shall be documented. IIFP and contracted personnel have the responsibility

to identify quality problems.

The QA••QA program is a management system established to ensure that IIFP products are safe

and reliable and that those products and IIFP services meet or exceed customers' requirements,

needs, and expectations. The QAP-QA program applies to all products and services using a

graded approach as described in the QA Program Description of the IIFP LA Appendix A (and

in the summary Section 11.8.4-2.2 below). The establishment of the program shall include

Quality Assurance (Management Measures) RAIs Page 8
Enclosure (1) JJM-2011 -11

Quality Assurance (Management Measures)

consideration of the technical aspects of the activities affecting quality. The QAP-QA program

sets forth the minimum requirements for those items, activities, and services and is established,

maintained, and executed as described in Appendix A of the LA.

The QAP-QA program for design, construction, and pre-operational testing continues

simultaneously with the QAP-QA program for the operational phase when construction activities

are in progress during plant operation.

11.8.4 Graded Applicat ion

11.8.2.2 Graded Application

This section is a summary of the graded application of the IIFP QAP-QA program. Detailed

description is proevided in the IIFP LA as Appendix A, Quality Assurannc Program~ Description

Risk is the fundamental consideration in determining to what extent the requirements of the

QAP QA program apply. Certain activities, items, or processes may require extensive control

measures while others may require only a limited degree of control. The control measures that

are to be considered include procedural coverage, qualification and training, peer reviews,

surveillances, audits, and assessments. The application and degree to which these control

measures are employed for an activity, item, or process is established through the risk

assessment decision process.

The risk assessment decision process shall take int÷ accouant suc-h facto as

" Risk significanHec;

" Relative imHportance to safet, sa1feguards, and secur~ity,;

CoGnsequenees of failur.;•"

Prbability P ,f failure;

*Applicable r-egulations, industry eodes, and standards;,

CoGmplexity or uniqueness Of anR item/actiNvity and the cnvir-enment in which it has to

funetien -3

0 Quality history of.the item iln S....e or acfiVit'y;

*Degree to which functienal compliance can be demonstrFated or assessed by test-,

inspection, Or mfaintenance methods;,

*Anticipated life span;

* Degree of standardizatfion;

*importance of data gener-ated; and

*Reproeducibility Of results-.

Facility components and processes are assigned a QA level if they are determined to be IROFS

based on their safety significance. Each IROFS component will receive a classification of QA

Level 1 or Level 2 that applies throughout the life of the facility and is based on the following

definitions:

QA Level 1 Requirements The QA Level I Program shall conform to the criteria established in

10 CFR 70, Subpart H. The QA Level I QA program shall be applied to a single item relied on

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for safety (sole IROFS) preventing or mitigating a high consequence event. All QAP-QA

program requirements are applied to QA Level-I (OL-1).IROFS.

OA Level 2 Requirements The QA Level 2 program is applied where two or more IROFS are

credited to prevent or mitigate a high consequence event, or any single IROFS (sole IROFS)

preventing or mitigating an intermediate consequence event. QAP requirements are applied to

QA .ROFS Level 2 using a graded appro.ach. The grraded approach is implemented through

approved wri Men precedures taking inte onsideration the fact(r-s delineated above-.

By appropriately balancing eensidcraitions of importanee and proceess eapability, an approepriat

level of qualiRO is ashieved commensurate with the item's impotacee to safaty. The results he

caplieion o th gaded aprOae.ll to quality are incorporeated into design requaiemdnt

documents, spccifications, proeedUres, inStructions, drawings, inpection plans, test plans,

procurement doeuments, and other documfents that establish the requir-emfents for itemfs Or

aetiv~ities. Management measures are applied to OA Level 2 (OL-2) IROFS consistent with the

type of IROFS to assure that the IROFS remains reliable at its credited failure frequency when

called upon to be available. All applicable OA program requirements are also applied to OL-2

IROFS in a manner necessary to achieve this goal.

The extent that attributes of management measures and OA program elements are applied to QL1 and OL-2 IROFS will be determined by evaluating the factors that contribute to reliability of

each IROFS. The following QA elements are applied equally to OL-J and QL-2 IROFS: design

control, procurement document control: document control: control of purchased items and

services; identification and control of materials, parts, and components; control of measuring

and test equipment: control of nonconforming items; corrective actions: and quality assurance

records. For the QA elements listed above, the management measures that flow from these

elements will be the same, regardless of whether the IROFS is OL-1 or OL-2.

For the remaining QA elements, the management measure(s) applied to those aspects of the

activity that influence reliability of the IROFS will be determined by evaluating the design,

function, and task analyses associated with operating and maintaining the IROFS and by

assigning the characteristic to the attribute taking into consideration the following:

* Risk significance;

" Relative importance to safety, safeguards, and security;

* Consequences of failure:

* Probability of failure;

" Applicable regulations, industry codes, and standards:

* Coi~nplexity or uniqueness of an item/activity and the environment in which it has to

function-,

* Quality history of the item in service or activity:

* Degree to which functional compliance can be demonstrated or assessed by test,

inspection, or maintenance methods;

* Anticipated life span;

* Degree of standardization;

* Importance of data generated; and

* Reproducibility of results.

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QA Level 3 Requirements The QA Level 3 program is defimed as standard commercial

practice. A documented QA Level 3 program is not required. QA Level 3 components or

processes do not require a Quality Level 3 designation on any documentation or system

requirements. QA Level 3 governs all activities that are not designated as QA Level I or QA

Level 2.

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QA-4 (QA-7) In Section 11.1.1.4, "Organizational Structure and Staffing Intetfaces, "the applicant

states, "The various IIFP departments and contractors of IIFP perform quality-related

activities." Consistent with the acceptance criteria in NUREG 1520 Revision 1, Section 11.4.3.8,

clarify the meaning of this sentence and provide a description of these quality related activities..

RESPONSE: "Quality-related activities" will be revised to "management measures." In the

License Application, the next paragraph of the subject paragraph states "Configuration

management is implemented through or otherwise related to other management measures. Key

interfaces and relationships to other management measures are described below.

" Quality Assurance - The QA program establishes the framework for CM and other

management measures for IROFS and items that affect the function of the IROFS.

" Records Management - Records associated with IROFS and items affecting IROFS are

generated and processed in accordance with the applicable requirements of the QA

Program and provide evidence of the conduct of activities associated with the CM of

those IROFS.

* Maintenance - The maintenance requirements are established as part of the design basis,

which is controlled under CM. Maintenance records for IROFS and items affecting

IROFS shall provide evidence of compliance with preventive and corrective

maintenance schedules.

* Training and Qualifications - Training and qualifications are controlled in accordance

with the applicable provisions of the QA Program. Personnel qualifications and/or

training to specific processes and procedures are management measures that support the

safe operation, maintenance, or testing of IROFS. Also, work activities that are

themselves IROFS, (i.e., administrative controls) are included in procedures; and

personnel shall be trained and qualified to these procedures. Training and qualification

requirements and documentation of training may be considered part of the design basis

controlled under CM.

" Incident Investigation/Audits and Assessments -Audits, assessments, and incident

investigations are described in Sections 11.5, "Audits and Assessments," and 11.6,

"Incident Investigations and Corrective Action Process." Corrective actions identified as

a result of these management measures may result in changes to design features,

administrative controls, or other management measures (e.g., operating procedures). The

Corrective Action Program is described in Section 11.6, Incident Investigations and

Corrective Action Process. Changes are evaluated under the provisions of CM through

the QA Program and procedures. Periodic assessments of the CM program are also

conducted in accordance with the audit and assessment program described in Section

11.5.

* Procedures - Operating, administrative, maintenance, and emergency procedures are

used to conduct various operations associated with IROFS and items affecting IROFS

and are reviewed for potential impacts to the design basis. Also, work activities that are

themselves IROFS, (i.e., administrative controls) are contained in procedures."

NUREG 1520 Revision 1, Section 11.4.3.8, addresses the other QA elements as Organization;

QA Program; Design Control; Procurement Document Control; Instructions, Procedures, and

Drawing Control; Document Control; Control of Purchased Items; Identification and Control of

Items; Control of Processes; Inspection; Test Control; Control of Measuring and Test

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Equipment; Handling, Storage, and Shipping; Inspection, Test, and Operating Status; Control of

Nonconforming Items; Corrective Action; Quality Assurance Records; and Audits.

NRC Follow-up Question (4): In Question QA-4, please clarify if the text explaining the

relationships and interfaces will be added to the license application.

NRC FOLLOW-UP QUESTION RESPONSE (4): The subject relationships and interfaces

are already stated in the license application in section 11.1.1.4 referred to in question QA-4.

License Documentation Impact: The first sentence of the second paragraph of the License

Application, Revision A, Section 11.1.1.4 will be revised as follows to clarify the meaning of the

subject sentence:

The various IIFP departments and contractors of IIFP perform la lity-eI-teda•aefvit-es

management measures as those summarized below. The primary IIFP contractors are responsible

for development of their respective QA Programs and CM elements, which are consistent with

the requirements of the IIFP QA Program for those activities determined to be within the scope

of the IIFP QA Program. The interfaces between contractors and IIFP or among contractors are

documented. IIFP and contractor personnel have the responsibility to identify quality problems.

If a member of another area disagrees, that individual is instructed to take the matter to

appropriate management. The disagreement may either be resolved at this level or at any level

up to and including the 4NIS-IIFP President.

License Documentation Impact: A final paragraph will be added to LA Rev A, Section

11.1.1.4, subsection "Procedures" to provide a reference to the description of these management

measures as follows

(Note: QAPD Section numbering may have changed in response to RAI-QAPD-I.)

A description of the QA elements is provided in the Appendix A of the License Application,

"Quality Assurance Program Description." The location of each QA element described in the

QAPD is shown below.

Ouality Assurance Elements

Organization Section A. 1

Quality Assurance Program Section A.2

Design Control Section A.3

Procurement Document Control Section A.4

Instructions, Procedures, and Drawings Section A.5

Document Control Section A.6

Control of Purchased Items and Services Section A.7

Identification and Control of Materials, Parts, and Components Section A.8

Control of Special Processes Section A.9

Inspection Section A. 10

Test Control Section A. 11

Control of Measuring and Test Equipment Section A. 12

Inspection, Test, and Operating Status Section A. 13

Control of Nonconforming Items Section A. 14

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Corrective Action

Quality Assurance Records

Audits

Section A. 15

Section A. 16

Section A. 17

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QA-5 (QA-8) Consistent with the acceptance criteria in NUREG 1520 Revision 1, Section 11.4.3.1

and Section 11.5.1.3, provide the following information.

A. In Section 11.1.2, "Design Requirements, " the application states, "The associated design

documents are subject to interdisciplinary reviews and design verification. Changes to the

design are evaluated to ensure consistency with the design basis. " Clarify if these sentences

are referring to IROFS or QL- I or QL-2 items.

RESPONSE: The entire paragraph from the License Application reads as follows: "IROFS and

any items that affect the function of the IROFS are designated as QA Level I or QA Level 2 (see

Section 11.8). The associated design documents are subject to interdisciplinary reviews and

design verification. Changes to the design are evaluated to ensure consistency with the design

basis. Computer codes used in the design of IROFS are also subject to these design control

measures, with additional requirements as appropriate for software control, verification, and

validation." Thus, these sentences are referring to IROFS and the QL-1 or QL-2 items

comprising the IROFS. Revisions are made to the subject sentence in LA, Revision A, Section

11.1.2 to clarify the meaning of that statement.

License Documentation Impact: The IIFP License Application, Revision A, Section 11.1.2,

paragraph three will be revised as follows:

(Note: Section 11.8 reference changed to new subsection 11.8.2.2 to more specifically identify location.)

IROFS and any items that affect the function of the IROFS are designated as QA Level I or QA

Level 2 (see Seetiefi-subsection 11.8.2.2). The asseeiated design documents associated with

IROFS are subject to interdisciplinary reviews and design verification. Changes to the design are

evaluated to ensure consistency with the design basis. Computer codes used in the design of

IROFS are also subject to these design control measures, with additional requirements as

appropriate for software control, verification, and validation.

B. (QA-9) In Section 11.1.2, "Design Requirements," the application states, "During the check

and review, emphasis is placed on assuring conformance with applicable codes, standards

and LA design commitments. " Clarify what is "check and review" and to which documents

the sentence is referring.

RESPONSE: In the previous paragraph to the one in question, the following is found which

provides clarification for "check and review" process: "A qualified individual who specifies and

includes the appropriate codes, standards, and licensing commitments within the design

documents prepares each design document, such as a calculation, specification, procedure, or

drawing. This individual also notes any deviations or changes from such standards within the

design documentation package. Each design document is then checked by another individual

qualified in the same discipline and is reviewed for concept and conformity with the design

inputs. These design inputs are in sufficient detail to permit verification of the document. The

manager having overall responsibility for the design function approves the document. The

Configuration Manager ensures that the designated engineering organization documents the

entire review process in accordance with approved procedures."

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Earlier in License Application Section 11.1.2, "Design Requirements," the following is found to

clarify the documents to which this process is applied: "Design requirements are documented in

design requirement documents i.e. calculations, safety analysis, design criteria, engineering

drawings, system descriptions, technical documents, and specifications. The design requirements

and basis of design documents are controlled under the design control provisions of the CM

program as described above and are subject to the same change control as analysis,

specifications, and drawings.

Modifications are made to the subject statements in Section 11.1.2 to provide clarification of the

"check and review" process and to clarify which documents the sentence is referring.

License Documentation Impact: Paragraph six of the License Application, Revision A,

Section 11.1.2 will be revised as follows:

During the check and review, process described above, emphasis is placed on assuring

conformance with applicable codes, standards and LA design commitments. The individuals in

engineering assigned to perform the check and review of a-design requirements documents

(calculations, safety analysis, design criteria, engineering drawings, system description,

technical documents specifications, etc.) have full and independent authority to withhold

approval until questions concerning the work have been resolved. Design reviews, alternative

calculations, or qualification testing accomplishes verification of design. The basis for a design,

such as analytical models, theories, examples, tables, codes and computer programs must be

referenced in the design document and their application verified during check and review. Model

tests, when required to prove the adequacy of a concept or a design, are reviewed and approved

by the responsible qualified individual. Testing used for design verification shall demonstrate

adequacy of performance under conditions that simulate the most adverse design conditions. The

tests used for design verification must meet all the design requirements.

C. (QA-JO) In Section 11.1.2, "Design Requirements," the application states, "In accordance

with these procedures, the report is forwarded for appropriate review to the responsible

manager... "Clarify to which report the sentence refers.

Response: The report refers to nonconformance reports. To assist in clarifying that, the first two

statements of the paragraph in question read: "When deficiencies are identified which affect the

design of IROFS, such deficiencies are documented and resolved in accordance with approved

Corrective Actions procedures. In accordance with these procedures, the report is forwarded for

appropriate review to the responsible manager, who coordinates further review of the problem

and revises all design documents affected by the deficiency as necessary." The subject statement

in the LA Section 11.1.2 will be revised to clarify to which report the sentence refers.

License Documentation Impact: Paragraph 10 of the IIFP License Application, Revision A,

Section 11.1.2, will be revised as follows:

When deficiencies are identified which affect the design of IROFS, such deficiencies are

documented and resolved in accordance with approved Corrective Actions procedures. In

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accordance with these procedures, the nonconformance report (NCR) is forwarded for

appropriate review to the responsible manager, who coordinates further review of the problem

and revises all design documents affected by the deficiency as necessary. Where required, the

responsible manager forwards the report to the engineers in other areas, who coordinate

necessary revisions to their affected documents.

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QA-6 (QA-14) In Section 11.2.2.4, "Functional Testing - Post-Maintenance Testing, "the application

states, "This test is performed, with acceptable results, prior to returning the equipment into

service. "Consistent with the acceptance criteria in NUREG 1520 Revision 1, Section 11.4.3.2,

clarify the intent of this sentence. (i.e. what happens if the test fails or the results are not

acceptable?)

RESPONSE: Section 11.2.2.4, "Functional Testing - Post-Maintenance Testing" will be

modified to include revisions to clarify that if acceptable results are not obtained during testing,

equipment cannot be returned to service and corrective action is taken.

License Documentation Impact: The subject statement and former paragraph one in License

Application, Revision A, Section 11.2.2.4, will be revised to read as follows:

Pos.t .a.itenaiie Testing Post-maintenance testing-(PM-T) is established to provide assurance

that IROFS will perform their intended function following maintenance activities. 4h4is4e-tPostmaintenance testing confirms that the maintenance performed was satisfactory, the identified

deficiency has been corrected, and the maintenance activity did not adversely affect the

reliability of the item. This-testPost-maintenance testing is performed,-,vith until acceptable

results are obtained, prior to returning the equipment to service. If acceptable results are not

obtained, corrective action is taken and documented via the nonconformance report (NCR)

process. The engineering discipline will dictate the path forward in the NCR process. See

Sections 11.2.2.2 and 11.2.2.3 for additional information on actions taken prior to returning the

IROFS to service.

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QA-7 (QA-21) Section 11.3.8, "Evaluation of Training Effectiveness," includes the statement,

"Unacceptable individual performance is transmitted to the appropriate line manager. "

Consistent with the requirements in NUREG 1520 Revision 1, Section 11.4.3.3, clarify if this

statement is misplaced in this section instead that in Section 11.3.10, "Periodic Personnel

Evaluations/Needs for Retraining."

RESPONSE: NUREG 1520, Section 11.4.3.3 covers all aspects of "Training and

Qualifications." The subject statement could indeed provide further clarification for the

"Periodic Personnel Evaluaiions/Needs for Retraining" section in the License Application which

presently reads in part as follows: "When the results of the evaluation dictate, retraining or other

appropriate actions are provided. Continuing training is also required due to plant modifications,

procedure changes, and QAP changes that result in new or revised information." However, the

subject statements provides appropriate clarification in the present location within the

"Evaluation of Training Effectiveness" section providing information on the evaluation of the

overall training program effectiveness. If the trainee does not meet the evaluation criteria

provided in that section, line management is notified.

License Documentation Impact: The subject statement will be retained in LA Rev A, Section

11.3.8; and LA Rev A, Section 11.3.10 (paragraph two) will be revised to add the subject

statement as follows:

Personnel performing activities related to IROFS are evaluated periodically to determine

whether they are capable of continuing their activities that are related to IROFS. The evaluation

may be by written test, oral test, or on-the-job performance observation by the supervisor. The

results of the evaluation are documented. Unacceptable individual performance is transmitted to

the appropriate line manager for investigation and corrective action where appropriate. When the

results of the evaluation dictate, retraining or other appropriate actions are provided. Continuing

training is also required due to plant modifications, procedure changes, and QA taram

changes that result in new or revised information.

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QA-8 (QA-25) Section 11.5.3 of the application, "Conduct ofAudits and Assessments, "states,

"Audits are conducted on an annual basis." Section 11.5.5, "Scheduling ofAudits and

Assessments, "states "The frequency of audits and assessments is based upon the status and

safety importance of the activities being performed and upon work history. "Consistent with the

requirements in NUREG 1520 Revision 1, Section 11.4.3.5, modify sections as necessary to

make them consistent with each other.

RESPONSE: The subject paragraph in LA Rev A, Section 11.5.3 is modified to ensure

consistency with NUREG 1520 Revision 1, Section 11.4.3.5 and IIFP Section 11.5.5.

License Documentation Impact: The IIFP License Application, Revision A, Section 11.5.3,

paragraph three will be revised as follows:

Audits are performed in accordance with a written plan that identifies and schedules audits to be

performed. Audit team members shall not have direct responsibility for the function and area

being audited. Team members shall have technical expertise or experience in the area being

audited and are indoctrinated in audit techniques. Audits are conducted en an anlnual basis. The

frequency of audits is based upon the status and safety importance of the activities being

performed and upon work history. Maior activities, as described in Section 11.5.4, are audited or

assessed on a periodic basis.

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QA-9 (QA-2 7) Section 11.7 of the application, "Records Management and Document Control, "states,

"The principal elements of each of the records management and document control programs

and a brief description of the manner in which the functions associated with each element shall

be performed along with a list of the types of records that are retained for the duration of the

NRC License at the site. " Consistent with the requirements in NUREG 1520 Revision 1, Section

11.4.3.7, clarify what was meant by this sentence.

RESPONSE: The subject sentence should have read as follows: "The principal elements of each

of the records management and document control programs and a brief description of the

manner in which the functions associated with each element are performed are provided below,

along with a list of the types of records that are retained at the site for the duration of the NRC

License." The applicable statement and paragraph in the LA is modified to clarify the meaning

of the sentence and to specify the location in the LA of (1) lists and descriptions principal

elements of the records management and document control programs, and (2) the types of

records.

License Documentation Impact: In response, paragraph one of the HFP License Application,

Revision A, Section 11.7 will be revised as follows:

Records management and document control programs are established to ensure records and

documents required by the QA_.Prram are appropriately managed and controlled. These

programs provide administrative controls that establish standard methods and requirements for

collecting, maintaining, and disposing of records. These programs also ensure that documents

are controlled and distributed in accordance with identified written requirements and

authorizations. The administrative controls for the generation and revision of records and

documents are contained in site implementing procedures. The principal elements of each of the

records management and document control programs and a brief description of the manner in

which the functions associated with each element shall be performed are provided below along

with a list of the types of records that are retained at the site for the duration of the NRC License

at-the site. The principal elements with the brief description are listed and described in Sections

11.7.1.1 through 11.7.1.14, and the types of records are identified in Section 11.7.1.12. The

principal elements for Document Control are described in Sections 11.7.2.1 through 11.7.2.13.

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QA-I O (QA-6) In Section H.]. 1. 1, "Scope of Structures, Systems, and Components," the application

states, "These documents include documentation related to IROFS that is generated through

functional interface with QA, maintenance, and training and qualifications ofpersonnel.

Consistent with 70.62(d) clarify why other management measures (e.g. procedures, incident

investigations, audits and assessments, and records management) are not mentioned

RESPONSE: The functional interface with QA would include the other management measures

as procedures, incident investigations, audits and assessments. Section 11.1.1.4, "Organizational

Structure and Staffing Interfaces," states, "Configuration management is implemented through

or otherwise related to other management measures. Key interfaces and relationships to other

management measures are described below." Those interfaces identified and described included

Quality Assurance, Records Management, Maintenance, Training and Qualifications, Incident

Investigations, Audits and Assessments, and Procedures.

License Documentation Impact: License Application, Revision A, Section 11.1.1.1, final

paragraph will be revised as follows to include those interfaces identified in Section 11.1.1.4:

These documents include documentation related to IROFS that is generated through functional

interface with QA (procedures, incident investigations, audits and assessments, etc.),

maintenance, records management and document control, and training and qualifications of

personnel. Configuration management procedures will provide for evaluation, implementation,

and tracking of changes to IROFS, mnd-processes, equipment, computer programs, and activities

of personnel that impact IROFS.

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QA-11 (QA-11) In Section 11,1.4, "Document Control, " the application states, "Procedures are

established which control the preparation and issuance of documents such as manuals,

instructions, drawings, procedures, specifications, design documents, procurement documents,

and supplier-supplied documents, including any changes. " Consistent with Section 11.4.3.1 of

NUREG-1520, "Configuration Management, "clarify that the following documents are included

in this description: ISAs, all procedures that are IROFS, procedures involving training, QA,

maintenance, audits and assessments, emergency operating procedures, emergency response

plans, system modification documents, assessment reports, and others that the applicant deems

part of CM.

RESPONSE: This stated documentation is included in the IIFP Configuration Management

program. Within the Configuration Management Policy (License Application Section 11.1.1)

under Section 11 .1.1.1, "Scope of Structures, Systems, and Components," the following is

stated:

"The scope of Structures, Systems, and Components (SSCs) under CM includes all IROFS

identified by the ISA of the design basis and any items which may affect the function of the

IROFS. Design documents subject to CM include calculations, safety analyses, design criteria,

engineering drawings, system descriptions, technical documents, and specifications that

establish design requirements for IROFS. During the design phase, these design documents are

maintained under CM when initially approved.

The scope of documents included in the CM program expands throughout the design process. As

drawings and specification sections related to IROFS or items affecting the functions of IROFS

are prepared and issued for procurement, fabrication, or construction, these documents are

included in CM.

During construction, initial startup, and operations, the scope of documents under CM similarly

expands to include, as appropriate:

* vendor data;

" test data;

" inspection data; and

* initial startup, test, operating and administrative procedures as applicable to IROFS

These documents include documentation related to IROFS that is generated through functional

interface with QA, maintenance, and training and qualifications of personnel. Configuration

management procedures will provide for evaluation, implementation, and tracking of changes to

IROFS, and processes, equipment, computer programs, and activities of personnel that impact

IROFS."

Section 11.1.1.4 further clarifies the following. "Operating, administrative, maintenance, and

emergency procedures are used to conduct various operations associated with IROFS and items

affecting IROFS and are reviewed for potential impacts to the design basis. Also, work activities

that are themselves IROFS, (i.e., administrative controls) are contained in procedures."

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Section 11.4 states the following: "All activities involving IROFS and QA level 1 and 2 items

(See Section 11.8.2.2) are conducted in accordance with approved procedures. As noted

throughout this document, procedures are used to control IROFS activities to ensure the

activities are carried out in a safe manner and in accordance with regulatory requirements."

Section 11.4.2.1 states: "Site managers have the responsibility for identifying which tasks are

included in procedures within their areas of control. Procedures are required where actions are

taken necessary to prevent or mitigate the consequences of accidents described in the ISA. As a

minimum, a procedure is required for any task or activity that affects QA Level 1 and QA Level

2 SSCs."

License Documentation Impact: License Application, Revision A, Section 11.1.4 will be

revised to add a final paragraph as follows to add subject clarification.

Document control encompasses those documents that are relied on for safety, e.g. the ISA, all

procedures that pertain to IROFS, procedures involving training, OA, maintenance, audits and

assessments, emergency operating procedures, emergency response plans, system modification

documents, assessment reports, and others that the applicant deems part of CM. See Section

11.1.1.1, "Scope of Structures, Systems, and Components," for a general accounting of the

documents subiect to configuration management during design, construction, and operations of

the IIFP Facility. A more detailed listing of documents under configuration control during

design is provided in Section 11.1.2, "Design Requirement" and Section 11.1.3, "Configuration

Management Controls on the Design Requirements." Documentation under CM during

construction is delineated in Section 11.1.5.2 below. Similarly, Section 11.1.5.3 provides a

discussion of documentation under CM during the operations phase.

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QA-12 (QA-15) Section 11.2.2.4, "Functional Testing, " includes the requirements for functional

testing, preoperational testing and post maintenance testing. Consistent with the acceptance

criteria in NUREG 1520 Revision 1, Section 11.4.3.2, clarify if there will be any periodic or

special testing as part of the maintenance program.

RESPONSE: The Functional Testing Section is revised to address functional testing

requirements during pre-operational testing and operational testing. Presently pre-operational

testing is adequately addressed. Operational testing includes periodic testing and special testing.

Post-maintenance testing is being incorporated into operational testing.

License Documentation Impact: The subject section in License Application, Revision A,

Section 11.2.2.4, "Functional Testing", subsection "Post-Maintenance Testing" will be revised.

The "Post-Maintenance Testing" heading will be changed to "Operational Testing." New

paragraphs will be added to address operational testing and special testing. Former paragraphs

will be revised to address post-maintenance testing and to clarify the operational testing

requirements of IROFS. The Operational Testing subsection will read as follows:

Post Ma.ntenanec Operational Testing

Operational testing consists of periodic testing and special testing. Periodic testing is conducted

to monitor various facility parameters and to verify the continuing integrity and capability of

facility IROFS. Special testing which may be conducted at the facility is testing which does not

fall under any other testing program and is of a non-recurring nature.

The periodic testing program at the facility consists of testing conducted on a periodic basis to

verify the continuing capability of IROFS to meet performance requirements. The facility

periodic testing program begins during the pre-operational testing stage and continues

throughout the facility's life. A schedule is established to ensure that all required testing is

performed and properly evaluated on a timely basis. The schedule is revised periodically, as

necessary, to reflect changes in periodic testing requirements and experience gained during plant

operations. An integral part of the operational testing program is post-maintenance testing.

Post-maintenance testing (P-MT)-is established to provide assurance that IROFS will perform

their intended function following maintenance activities. Thistest-Post-maintenance testing

confirms that the maintenance performed was satisfactory, the identified deficiency has been

corrected, and the maintenance activity did not adversely affect the reliability of the item._Thtis

test-Post-maintenance testing is performed-witA- until acceptable results are obtained, prior to

returning the equipment to service. If acceptable results are not obtained, corrective action is

taken and documented via the nonconformance report (NCR) process. Engineering will dictate

the path forward in the NCR process. See Sections 11.2.2.2 and 11.2.2.3 for additional

information on actions taken prior returning the IROFS to service.

Special testing is testing conducted at the facility that is not a facility pre-operational test,

periodic test, or post-maintenance test. Special testing is of a non-recurring nature and is

conducted to determine facility parameters and/or to verify the capability of IROFS to meet

performance requirements. The determination that a certain plant activity is a special test is

intended to exclude those plant activities which are routine surveillances, normal operational

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evolutions, and activities for which there is previous experience in the conduct and performance

of the activity.

P-MT-Operationa0 testing requirements of IROFS are developed and included in work packages,

where -ROF -or-during the work planning process. The Plant Manager organization Preduetion

O.ganizatien may provide support to the Plant Engineering and Maintenance oOrganization in

identifying P-MT-operational testing requirements.jPM-T-Operational testing meets applicable

codes and technical requirements and is conducted with specified acceptance criteria. The results

of theP-MT-operational testing are documented and retained in the work package with other

documentation generated during the maintenance evolution.

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QA-13 Section 11.2, "Maintenance, " outlines the maintenance program to be implemented in the

operations phase of the facility. Consistent with Section 11.4.3.2 of NUREG-1520,

"Maintenance,"

A. (QA-16) Clarify how the maintenance function uses, interfaces with, or is linked to the

various management measures.

RESPONSE: Various management measures are found throughout License Application Section

11.2. Examples of these management measures include:

" Establishment of Performance Criteria.

* Trending/Corrective Actions.

* Incident Investigations/Root Cause Determination.

" Lessons Learned

* Procedures.

* Records.

* Assessments.

* Feedback.

* Procedures/Control of M&TE

* Documented Management Measures within Procedures.

Section 11.2.1 of the LA will be modified to clarify how the maintenance function uses,

interfaces with, or is linked to the various management measures.

Section 11.2.2.1, "Surveillance/Monitoring," will be modified to clarify how

surveillance/monitoring uses, interfaces with, or is linked to the various management measures:

License Documentation Impact: The IUFP License Application, Revision A, Chapter 11,

Section 11.2.1, "Maintenance Program," will be amended (1) to introduce the use of

management measures to all IROFS (new paragraph one) and (2) to clarify how the maintenance

function uses, interfaces with, or is linked to the various management measures. New paragraphs

will be added and existing paragraphs the Section will be revised to read as follows:

A comprehensive Process Hazard Analysis was conducted as part of the ISA. Four types of

IROFS controls were used to maintain an acceptable risk level. These included Passive

Engineered Controls, Active Engineered Controls, Enhanced Administrative Controls, and

Administrative Controls. The ISA identified management measures for IROFS. where

applicable. See the ISA Summary (IIFP, 2009b) for additional details.

To provide for the continued safe and reliable operation of the facility IROFS, these

management measures are implemented to ensure that the quality of these IROFS is not

compromised by planned changes (modifications) or maintenance activities. Change

*aagement-Control for modifications is described in Section 11.1.5 above. In maintenance of

the facility, IWFP utilizes a systems-based program for planning, scheduling, tracking and

maintaining records for maintenance activities whem -affectin_ IROFS. Use of approved

maintenance procedures for IROFS--related maintenance is a vital part of that program. The

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details of maintenance procedure acceptance criteria, reviews, and approval are provided in

Section 11.4, "Procedures Development and Implementation."

As applicable, contractors that work on or near IROFS identified in the ISA Summary will be

required by IWFP to follow the same maintenance procedures described for the corrective,

preventive, functional testing, or surveillance/monitoring activities listed abovebelow for the

maintenance function.

Maintenance supervisors or Maintenance Planners provide the planning function in accordance

with the work control process. Maintenance supervisors or Maintenance Planners are responsible

for the planning of maintenance work activities and for maintaining a record of work

accomplished. Listed below are methods or practices that will be incorporated into the work

control process for the corrective, preventative, and functional-test maintenance elements. IIFP

will prepare written procedures for performance of these methods and practices. These methods

and practices include, as applicable:

" Authorized work instructions with detailed steps and a reminder of the importance of the

IROFS identified in the ISA Summary:

* Parts lists:

" As-built drawings;

" A notification step to the Plant Manager organizationeeii function before

conducting repairs and removing an IROFS from service;

* Radiation Work Permits;

" Replacement with like-kind parts and the control of new or replacement parts to ensure

compliance with 10 CFR 21 (CFR, 2003a);

• Compensatory measures while performing work on IROFS;

* Procedural control of removal of components from service for maintenance and for

return to service;

* Ensuring safe operations during the removal of IROFS from service: and

* Notification to the Plant Manager organization personnel that repairs have been

completed.

The work control process includes provisions for

* Planning tasks to ready-to-work status;

* Ensuring that safety, safeguards, quality, and configuration management are properly

and effectively implemented in performance of maintenance; and

* Closing out, including final validation of work performed and review of the acceptance

tests.

Maintenance procedures involving IROFS commit to the epies- management measures listed

below for corrective and preventive maintenance, post-maintenance testing, and

surveillance/monitoring maintenance activities:

* Pre-maintenance activities require reviews of the work to be performed, including

procedure reviews for accuracy and completeness.

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Steps , that require a n.tificatio Notification of all affected parties (Plant Manager's

organization prfductin perfn*nel and other appropriate managers) is required before

performing work and on completion of maintenance work. The discussion includes

potential degradation of IROFS during the planned maintenance.

* Control of work described above is accomplished by maintenance personnel following

comprehensive procedures to be followed by maintenanee t.. hnician.

* Radiation Protection, Industrial Hygiene, Environment and Industrial Safety

representatives provide personnel safety and radiological control requirements needed to

perform work safely.

* Procedures address the qualifications of personnel authorized to perform the

maintenance or surveillance.

" Procedures also address controls on and specifications of any replacement components

or materials to be used as well as post-maintenance testing to verify operability of the

equipment.

" Procedures address tracking and records management of maintenance activities.

* Quality Assurance performs inspections that are specified in work packages and

procurement documents.

Written procedures for the performance of maintenance activities include the steps listed above.

The details of maintenance procedure acceptance criteria, reviews, and approval are provided in

Section 11.4.1.3, "Procedures Development and Implementation."

License Documentation Impact: Section 11.2.2.1, "Surveillance/Monitoring," will be

modified to clarify how surveillance/monitoring uses, interfaces with, or is linked to the various

management measures. Section 11.2.2.1 of the LA, Rev A will read as follows:

Surveillance/monitoring activities are utilized to detect degradation and adverse trends of IROFS

so that action may be taken prior to component failure. The monitored parameters are selected

based upon their ability to detect predominate failure modes of the critical components. Data

sources include the following:

* surveillance,

* periodic and diagnostic test results,

* plant computer information,

* operator rounds,

* walk downs,

" as-found conditions,

" failure trending, and

* predictive maintenance

IIFP utilizes active engineered controls that are integrated into routine operations to the degree

practical. The IROFS are monitored as a routine part of the operating process. IROFS associated

with passive engineered systems are typically fixed physical design features to maintain safe

process conditions. Availability and reliability of IROFS are maintained through pre-operational

audits and periodic verifications as prescribed in the ISA, and includes consideration of the

importance of the IROFS as well as available quality and reliability information.

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Surveillance/monitoring and reporting are required for IROFS and any administrative controls

that could impact the functions of an IROFS. During surveillance/monitoring, maintenance

utilizes the management measures delineated in the paragraphs below.

Plant performance criteria are established to monitor plant performance and to monitor IROFS

functions and component parameters. These criteria are established by industry experience,

operating data, surveillance data, and plant equipment operating experience. These criteria

ensure the reliability and availability of IROFS. The performance criteria are also used to

demonstrate that the performance or condition of an IROFS is being effectively controlled

through appropriate predictive and repetitive maintenance strategies so that IROFS remain

capable of performing their intended function.

Surveillances are included in the work control process to permit timely planning, scheduling,

establishment of system or facility conditions, execution of the activity, and creation of

documentation that identifies the results of the surveillance. The established frequencies are

based on the IROFS degree of safety importance. Surveillance of IROFS is performed at

specified intervals. The purpose of the surveillance program is to measure the degree to which

IROFS meet performance specifications. The results of surveillances are trended, and when the

trend indicates potential IROFS performance degradation, preventive maintenance frequencies

are adjusted or other appropriate corrective action is taken.

Incident investigations may identify root causes of failures that are related to the type or

frequency of maintenance. The investigation is to determine their specific or generic root

cause(s) and generic implications, to recommend corrective actions, and to report to the NRC as

required by 10 CFR 70.74 (CFR, 2009f) or to other regulatory agencies, accordingly. The record

of IROFS failures required by 10 CFR 70.62(a)(3) (CFR, 2009c) for IROFS is reviewed as part

of the investigation. See Section 11.6, "Incident Investigations and Corrective Action Process,"

for further details. The lessons learned from such investigations are factored into the

surveillance/monitoring and preventive maintenance programs as appropriate.

Maintenance procedures prescribe compensatory measures, if appropriate, for surveillance tests

of IROFS that can be performed only while equipment is out of service.

Records showing the current surveillance schedule, performance criteria, and test results for all

IROFS will be maintained in accordance with the Record Management System.

Results of surveillance/monitoring activities related to IROFS via the CM program is-are

evaluated by the appropriate safety disciplines to determine any impact on the ISA and any

updates needed.

B. (QA-17) Provide justifications for assignment of differing degrees of maintenance to

individual IROFS, based on the item's contribution to the reduction ofrisk.

RESPONSE: A comprehensive Process Hazard Analysis was conducted as part of the ISA.

Four types of IROFS controls were used to maintain an acceptable risk level. (See RAI-QA-13A

for new paragraph one to be inserted in LA, Section 11.2.1). Integration of those types of IROFS

controls is shown in Section 11.2.2.4 "Functional Testing," this text provides is an excellent

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example of how the maintenance function uses, interfaces with, or is linked to the various

management measures (RAI QA- 13A above):

License Documentation Impact: As stated above, the new first paragraph of LA Rev A,

Section 11.2.1 will be revised as follows to provide justifications for assignment of differing

degrees of maintenance to individual IROFS (See RAI-13A):

A comprehensive Process Hazard Analysis was conducted as part of the ISA. Four types of

IROFS controls were used to maintain an acceptable risk level. These included Passive

Engineered Controls, Active Engineered Controls, Enhanced Administrative Control, and

Administrative Control. The ISA identified general high-quality management measures to all

IROFS. See the ISA Summary (IIFP, 2009b) for additional details.

License Documentation Impact: The following will be added LA Rev A, Section 11.2.2.1 as a

new second paragraph for this Surveillance/Monitoring section (Management measures applied

to this maintenance function are provided above in the License Documentation Impact for RAI

QA- 13A. above.):

IIFP utilizes active engineered controls that are integrated into routine operations to the degree

practical. The IROFS are monitored as a routine part of the operating process. IROFS associated

with passive engineered systems are typically fixed physical design features to maintain safe

process conditions. Availability and reliability of IROFS are maintained through pre-operational

audits and periodic verifications as prescribed in the ISA, and includes consideration of the

importance of the IROFS as well as available quality and reliability information.

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QA-14 (QA-19) Section 11.3.1, "Organization and Management of Training, "states, "Training

records are maintained to support management information needs associated with personnel

training, job performance, and qualification. " Consistent with Section 11.4.3.3 of NUREG-1520,

"Maintenance, " clarify ifprogrammatic and individual training records will be maintained.

RESPONSE: Programmatic and individual training records are maintained as stated in License

Application Section 11.3.1: "Records are maintained on each employee's qualifications,

experience, and training. The employee training file shall include records of all general initial

site training, safety training, technical training, and employee development training conducted at

the facility. The employee training file shall also contain records of special company sponsored

training conducted by others. The training records for each individual are maintained so that they

are accurate and retrievable. Training records are retained in accordance with the records

management procedures." The subject paragraph in LA, Section 11.3.1 will be revised to clarify

that programmatic and individual training records will be maintained:

License Documentation Impact: The subject paragraph (four) in LA Rev A, Section 11.3.1

will be revised as follows:

Training programs and training records at the facility are the responsibility of the Training

organization-Lead. Training attendance records, examinations, employee qualification records,

and program needs are maintained in an accurate, auditable manner to document each

employee's training. Training records are maintained to support management information needs

associated with programmatic and individualpetsefs e training, job performance, and

qualification. Records are maintained on each employee's qualifications, experience, and

training. The employee training file shall include records of all general initial site training, safety

training, technical training, and employee development training conducted at the facility. The

employee training file shall also contain records of special company sponsored training

conducted by others. The training records for each individual are maintained so that they are

accurate and retrievable. Training records are retained in accordance with the records

management procedures.

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QA-15 (QA-22) Section 11.4.1.2, "Administrative Procedures "provides a list of the activities that will

be covered by administrative procedures. Consistent with Section 11.4.3.4 ofNUREG-1520,

"Maintenance, " clarify if existing or planned procedures will direct the following activities:

construction, radiation safety, and criticality safety.

RESPONSE: Procedures for construction are not addressed in Chapter 11. The Design and

Build (BD) contractor chosen by IIFP must possess existing construction procedures. The DB

contractor would use those procedures during the construction phases of the IIFP Facility.

Radiation safety procedures are identified in the referenced listing in Section 11.4.1.2.

Radiological Safety Training on these procedures is discussed in Section 11.3.7.2.

Criticality Safety procedures will not be applicable for the IIFP Facility since the facility will

only process depleted uranium.

NRC Follow-up Ouestion (5): In Response to Question QA-15, please clarify if the procedures

chosen by the DB contractor for the construction phases will be reviewed and approved by IIFP.

NRC FOLLOW-UP QUESTION RESPONSE (5): During the selection process of the DB

contractor, review of contractor QA procedures is integral in the evaluation of the prospective

bidders. The DB contractor field procedures will not be approved by HFP since the DB

contractor is more knowledgeable in those areas than IIFP personnel.

License Documentation Impact: License Application, Revision A, Section 11.4.1.2, (revised

paragraph one and add two additional paragraphs) will be amended, including a heading title

change to modify the listing of subject activities and to address the need for construction and

criticality safety procedures:

11.4.1.2 Management Control (Administrativel Procedures

A• .nilitFave-Management control procedures deal with policy or programs and administrative

systems, provide programmatic requirements, and do not normally involve manipulation of

equipment. AdminliStrativc Management control procedures are used to perform activities that

support productions and control process with IROFS and/or hazardous chemicals incident to the

processing of licensed material. Site-wide safe work practices (such as lockout/tagout, confined

space entry, exclusion area requirements, radiation or hot work permits, industrial safety, and

environmental issues) apply to workers, visitors, contractors, and vendors. These management

control procedures includeimg management measures such as the following:

* Configuration management;

* Industrial Sa4e-,safetv, radiation safety, chemical safety, and fire safety;

* Quality _aAssurance;

* Design control;

* Facilit P-let personnel training and qualification;

* Audits and assessments;

* Incident investigations;

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* Record keeping and document control;

* Reporting; and

" Procurement

Procedures for construction will be an integral part of the procedures of the Design and Build

(DB) contractor chosen by IIFP. The DB contractor will use those procedures during the

construction phases of the IIFP Facility.

Additionally, criticality safety procedures will not be applicable for the IIFP Facility since the

facility will only process depleted uranium.

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QA-16 (QA-23) Section 11.4.1.3, "Maintenance Procedures" describes the controls for the

maintenance procedures. Consistent with Section 11.4.3.4 of NUREG-1520, "Maintenance,"

A. Clarify Wfpre-maintenance activities will involve reviews of the work to be performed,

including procedure reviews for accuracy and completeness.

RESPONSE: The first sentence of the first paragraph of License Application Section 11.4.1.3

"Maintenance procedures," states: "Maintenance, including testing, and calibration, of facility

IROFS is performed in accordance with approved written procedures, documented instructions,

checklists, or drawings that conform to applicable codes, standards, specifications, and other

appropriate criteria." Pre-maintenance activities would include review of those procedures.

License Documentation Impact: LA Rev A, Section 11.4.1.3 will be revised to clarify that premaintenance activities involve reviews of the work to be performed, including procedure

reviews for accuracy and completeness. The fourth paragraph of the subject section reads as

follows:

Maintenance procedures address:

* Preventive and corrective maintenance of IROFS;

* Surveillance (includes calibration, inspection, and other surveillance testing);

SPost maifntnanoeFunctional testing of IROFS; and

* Requirements for pre-maintenance activity involving reviews of the work to be performed

and reviews of procedures for accuracy and completeness.

B. Clarify if the maintenance procedures will include steps that will require notification of all

affected parties before performance of work and on completion of maintenance of work,

including the discussion ofpotential degradation of JROFS during planned maintenance.

RESPONSE: Section 11.4.3.4 of NUREG 1520, "Procedures," specifies for maintenance

procedures that "Steps require notification of all affected parties (operators and supervisors)

before performance of work and on completion of maintenance work. The discussion includes

potential degradation of IROFS during the planned maintenance." The IIFP License Application,

Revision A, Section 11.4.1.3, fifth paragraph states the following: "The administrative control of

maintenance is maintained as follows:

" A comprehensive maintenance program for the facility's IROFS is established to assure

safe, reliable, and efficient operation.

" Personnel performing maintenance activities are qualified in accordance with applicable

codes and standards and procedures.

* Maintenance is performed with written procedures that conform to applicable codes,

standards, specifications, and other appropriate criteria.

" Maintenance is scheduled so as not to jeopardize facility operation or the safety of

facility personnel.

" Maintenance histories are maintained on facility 1ROFS.

" The administrative control of facility modifications is maintained as in Section 11.1.5,

"Change Control".

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The last bullet in paragraph five formerly referenced Section 11. 1, "Configuration Management"

and will be modified in license documentation impact

The sixth paragraph Section 11.4.1.3 is modified to include the requirements of subject

notification of all affected parties before performance of work and on completion of

maintenance of work and an additional paragraph is added to identify the location of additional

information on requirements for maintenance procedures.

License Documentation Impact: IIFP LA, Rev A, Section 11.4.1.3, the fifth paragraph, last

bullet will be revised to reflect reference to Section 11.1.5 "Change Control and the sixth

paragraph will be revised and an additional paragraph will added. These paragraphs will read as

follows.

The administrative control of maintenance is maintained as follows:

* A comprehensive maintenance program for the facility's IROFS is established to assure

safe, reliable, and efficient operation.

* Personnel performing maintenance activities are qualified in accordance with applicable

codes and standards and procedures.

* Maintenance is performed with written procedures that conform to applicable codes,

standards, specifications, and other appropriate criteria.

* Maintenance is scheduled so as not to jeopardize facility operation or the safety of

facility personnel.

* Maintenance histories are maintained on facility IROFS.

* The administrative control of facility modifications is maintained as in Section 11 .1.5,

"Cf.fig•r..i..n Manag.me..RChan-e Control."

Maintenance procedures are reviewed by the various safety disciplines, including fire, radiation,

and industrial and chemical process safety. The procedures describe, as a minimum, the

following:

" Pre-maintenance activities will involve reviews of the work to be performed including

procedure reviews for accuracy and completeness:

* Steps that require notification of all affected parties (operators and appropriate

supervisors) before performing work on completion of maintenance work (The

discussion includes potential degradation of IROFS during the planned maintenance.);

* Controls on and specification of any replacement components or materials to be used, to

ensure like-kind replacement;

* Post-maintenance testing to verify operability of the equipment;

" Tracking and records management of maintenance activities; and

* Safe work practices (e. g., lockout/tag-out, confined space entry, control of exclusion

area, radiation or hot work permits, and fire, chemical, and environmental

requirements).

See Section 11.2.1 for additional information on requirements for maintenance procedures.

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QA-17 (QA-28) Section 11.7.1. "Records Management, "establishes the elements and requirements of

the records management program applicable to QA Level 1 and QA Level 2 SSCs and activities;

or to ESH, financial, quality, emergency response or investigation related records as required

by regulations or approved procedures. In accordance with Section 11.4.3.7 of NUREG-1520,

"Records Management, "

A. Please clarify if there are implementing procedures that (1) assign responsibilities for

records management, (2) specify the authority needed for records retention or disposal, (3)

specify which records must have controlled access and provide the controls needed, (4)

provide for the protection of records from loss, damage, tampering, and theft or during an

emergency, and (5) specify procedures for ensuring that the records management system

remains effective.

RESPONSE: License Application Section 11.7.1 states: "The Records functional organization

is responsible for the administration of the records management program. The managers and

functional organizations that generate the records are responsible for ensuring compliance with

the records management program. This program is implemented through procedures that provide

guidance for the program elements.

The IIFP License Application, Revision A, Section 11.7.1 is modified to re-affirm records

requirements are included in implementing procedures:

License Documentation Impact: The first paragraph will split into two paragraphs will

additional wording added to the new second paragraph of LA Rev A. Section 11.7.1 will be

revised as below:

The following elements and requirements of the records management program shall be applied

to QA Level 1 and QA Level 2 SSCs and activities; or to ESH, financial, quality assurance,

emergency response or investigation related records as required by regulations or approved

procedures. These elements may be also applied to commercial quality and other plant activities

where determined by facility management or required by procedure. The records management

program provides direction for the handling, transmittal, storage, and retrieval of records.

Records media may include microfilm, electronic (magnetic or optical), or hard copy. Records

are categorized and handled in accordance with their relative importance to safety and storage

needs. The Record functional organization is responsible for the administration of the records

management program. The managers and functional organizations that generate the records are

responsible for ensuring compliance with the records management program. Th perogram . -is

imip!.l...mentcd th..Ugh ..... dures that pr..vid. guidance for- the fell wing program elements.

The HUP QA Program Description requires procedures for reviewing, approving, handling,

identifying, retention, retrieval and maintenance of quality assurance records. These records

include the results of tests and inspections required by applicable codes and standards,

construction, procurement and receiving records, personnel certification records, design

calculations, purchase orders, specifications and amendments, procedures, incident investigation

results and approvals or corrective action taken, various certification forms, source surveillance

and audit reports, component data packages, and any other OA documentation required by

specification and procedures. Implementing procedures assign responsibilities for records

management, specify the authority needed for records retention or disposal, specify which

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Quality Assurance (Management Measures)

records must have controlled access and provide the controls needed, provide for the protection

of records from loss, damage, tampering, and theft or during an emergency, and specify

procedures for ensuring that the records management system remains effective. Implementing

procedures will include:

" Assign responsibilities for records management,

* Specify the authority needed for records retention or disposal,

" Specify which records must have controlled access and provide the controls needed,

* Provide for the protection of records from loss, damage, tampering, and theft or during

an emergency, and

* Specify procedures for ensuring that the records management system remains effective.

Records management This -pFegFaral-is implemented through procedures that provide guidance

for the following program elements.

B. Please clarify if records of IROFS failures will be maintained and updated in accordance

with 10 CFR 70.62(a)(3).

RESPONSE: Records of IROFS failures will be maintained and updated in accordance with 10

CFR 70.62(a)(3). Section 11.7.1.12 is revised to clarify records of IROFS failures are

maintained and updated in accordance with 10 CFR 70.62(a)(3) and to show the linkage to

Section 11.6.1.

License Documentation Impact: LA Rev A, Section 11.7.1.12 will be revised, inserting a new

paragraph two to read as follows:

Records of IROFS failures will be maintained and updated in accordance with 10 CFR

70.62(a)(3). See Section 11.6.1 on incident investigations for additional records requirements.

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QAPD-1 The QAPD does not address requirements for criteria such as Control of Special Processes;

Test Control; and Inspection, Test, and Operating Status. Consistent with NUREG-1520

Revision 1, Section 11.4.3.8, please clarify if the application of these measures to IROFS are

appropriate.

RESPONSE: The application of Control of Special Processes; Test Control; and Inspection,

Test, and Operating Status to IROFS are appropriate for the QAPD for the IIFP Facility. In

response the IIFP License Application, Revision A and the License Application, Revision A,

Appendix A will be amended to include these topics. Due to revisions, Sections and

subsections will be renumbered in sequence, accordingly.

License Documentation Impact: "Control of Special Processes" will be added as a new

paragraph to LA, Rev A, as new Section 11.8.9 (to be inserted before formerl 1.8.15,

"Inspection") and to the LA, Rev A, Appendix A as new Section A.9, (to be. inserted before

former A.9.1, "Inspection") each will read as follows:

11.8.9 Control of Special Processes

Special processes affecting quality of items and services are controlled. Procedures,

instructions, drawings, checklists, travelers, work orders, or other appropriate means are used

to control special processes. These means assure that special process parameters are controlled

and that specified environmental conditions are maintained.

Special processes that control or verify quality (such as, those used in welding, heat treating,

and nondestructive examination) are performed by qualified personnel using approved written

procedures in accordance with specified requirements, codes, or standards. Special process

procedures prescribe the necessary equipment, process parameters, calibration, and acceptance

criteria. Records are maintained of currently qualified personnel, processes, and equipment for

special processes. See LA Appendix A.9.

A.9 Control of Special Processes

A.9.1 General

A system is established for the control of special processes within the scope of the QA

Program Description. This system establishes the requirements for the control of special

processes.

A.9.2 Responsibilities

The engineering discipline is responsible for determining special processes, providing

technical requirements for identified special processes, and reviewing and concurring with all

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special process procedures including the utilization and application of nondestructive

examination (NDE) procedures.

The Quality Assurance Manager is responsible for the qualification on NDE personnel,

including welder/brazing qualifications.

Line Managers ensure that identified special processes are performed by qualified personnel,

using qualified and approved procedures or documents of a type appropriate to the

circumstances.

A.9.3 Requirements

Special processes affecting quality of items and services such as welding, heat treating, and

nondestructive examination are controlled.

Policies, plans, procedures, instructions, drawings, checklists, travelers, work orders, or other

appropriate means are used to control special processes.

These special processes ensure special process parameters are controlled and specified

environmental conditions are maintained.

Special processes that control or verif' quality (that is, those used in welding, heat treating,

and nondestructive examination) are performed by qualified personnel using approved written

policies, plans, and/or procedures in accordance with specified requirements, codes, or

standards.

When the outcome of the process is highly dependent on personal skills, such individuals are

certified in accordance with specified requirements.

When the outcome is highly dependent on control of process parameters, the process and

equipment are pre-qualified in accordance with specified requirements.

Special process policies, plans, and/or procedures prescribe the necessary equipment, process

parameters, calibration, and acceptance criteria.

Records are maintained of currently qualified personnel, processes, and equipment for special

processes.

License Documentation Impact: "Test Control" will be added as a new paragraph to LA,

Rev A, as new Section 11.8.11 (to be inserted after 11.8.15, "Inspection") and to the LA, Rev

A, Appendix A as new Section A. 11, (to be inserted after former Section and subsections for

A.9. 1, "Inspection") each will read as follows:

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11.8.11 Test Control

Tests required for conformance verification of an item or computer program to specified

requirements and to demonstrate satisfactory performance for service are planned and

executed. Characteristics to be tested and test methods to be employed are specified. Test

results are documented and their conformance with acceptance criteria is evaluated.

Tests include design verification tests, acceptance tests, pre-operational and operational tests,

post-maintenance, and special tests. Planning for tests may include mandatory hold points, as

required. Test procedures contain the following information, as appropriate:

* Test purpose or objectives, responsibilities, characteristics to be tested, hold points,

and test methods to be employed;

* References and related documents:

* Provisions for ensuring that prerequisites for a given test have been met, to include, as

applicable: calibrated instrumentation, appropriate equipment, trained personnel,

condition of test equipment and the item to be tested, and provisions for data

acquisition;

* Adequate instrumentation is available and suitable environmental conditions are

maintained,

* Provisions for documenting and evaluating the test results for conformance with

acceptance criteria; and

* Qualifications for test personnel.

Test records contain the following information: item tested, test date, tester or data recorder,

type of observation, test procedure or reference, results and acceptability, actions taken in

connection with any deviations noted, and person evaluating the results. See LA Appendix

A.11.

A.11 Test Control

A.11.1 General

A system is established for design verification testing, acceptance testing, pre-operational and

operational testing, post-maintenance testing, and special testing of IROFS. This system

provides measures to ensure that this testing is completed satisfactorily.

Requirements for the certification of personnel who perform design verification testing,

acceptance testing, pre-operational and operational testing, post-maintenance testing, and

special testing of IROFS are identified.

A. 11.2 Responsibilities

The Engineering organization is responsible for providing technical criteria for testing.

evaluation of test results, and resolution of deficiencies identified from these tests.

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Line managers are responsible for the conduct of testing activities under their cognizance

which are in accordance with procedures consistent with these requirements.

A 11 3 Upaivirpmpntia

Tests required for conformance verification of an item or computer program to specified

requirements and to demonstrate satisfactory performance for service are planned and

executed.

Characteristics to be tested and test methods to be employed are specified.

Test results are documented and their conformance with acceptance criteria is evaluated.

Tests required to collect data, such as for siting or design input, shall be planned, executed,

documented, and evaluated.

Tests include design verification tests, acceptance tests, pre-operational and operational tests,

post-maintenance tests and special tests. Planning for tests may include mandatory hold points,

as required.

Test policies, plans, and/or procedures contain the following information, as appropriate:

" Test purpose or objectives, responsibilities, characteristics to be tested, hold points,

and test methods to be employed;

* References and related documents:

* Provisions for ensuring prerequisites for a given test have been met, to include, as

applicable, calibrated instrumentation, appropriate equipment, trained personnel.

condition of test equipment and the item to be tested, and provisions for data

acquisition:

" Adequate instrumentation is available and suitable environmental conditions are

maintained-,

* Provisions for documenting and evaluating the test results for conformance with

acceptance criteria; and

* Qualifications for test personnel.

In lieu of test policies, plans, and procedures, appropriate methods of related documents rsuch

as American Society for Testing and Materials (ASTM), external manuals, maintenance

instructions, or approved drawings] may be used. Such documents must include adequate

instructions to ensure the required quality of work.

Test records contain the following information:

" Item tested: test date:

* Tester or data recorder:

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* Type of observation:

* Test policy, plan, procedure, or reference;

* Results and acceptability:

* Actions taken in connection with any deviations noted; and

* Person evaluating the results

License Documentation Impact: "Inspections, Test, and Operating Status" will be added as a

new Section to LA, Rev A, as Section 11.8.13 (to be inserted after former 11.8.16, "Control of

Measuring and Test Equipment") and to the LA, Rev A, Appendix A as new Section A. 13, (to

be inserted after former Section and Subsections for A. 10.1, "Control of Measuring and Test

Equipment") each will read as follows:

11.8.13 Inspection, Test, and Operating Status

Requirements are established for IIFP to identify the status of inspection and test activities.

Status indicators are also provided for indicating the operating status of IROFS systems and

components to prevent inadvertent operation. Policies, plans, and procedures are established to

ensure that the status of inspection and test activities are either marked or labeled on the item

or in documents traceable to the item.

Status indicators (for example, physical location and tags, markings, work controlling

documents, stamps, inspection records, or other suitable means) are utilized when required.

This includes indicating the operating status of systems and components to prevent inadvertent

operation. Authority for the application and removal of tags, markings, labels, and stamps is

specified. See LA Appendix A. 13.

A.13 Inspection, Test, and Operating Status

A.13.1 General

A system establishes requirements for HFP to identify the status of inspection and test

activities. Status indicators are also provided for indicating the operating status of IROFS

systems and components to prevent inadvertent operation.

A.13.2 Responsibilities

The Ouality Assurance Manager is responsible for providing a status-indicating system for

inspections performed in accordance with these requirements.

Line managers participating in testing and operational activities are responsible for the

development and implementation of status-indicating systems consistent with these

requirements.

A i 1V fl an uu.rnnton*c st. A*5 HltI hI llAlh SO

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Policies, plans, and procedures are established to ensure that the status of inspection and test

activities are either marked or labeled on the item or in documents traceable to the item. This

activity is required when it is necessary to ensure that required inspections and tests are

performed, and to ensure items that have not passed the required inspections and tests are not

inadvertently installed, used, or operated.

Status indicators (for example, physical location and tags, markings, work controlling

documents, stamps, inspection records, or other suitable means) are utilized when required.

This includes indicating the operating status of systems and components (for example, tagging

valves and switches) to prevent inadvertent operation. Authority for the application and

removal of tags, markings, labels, and stamps is specified.

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Quality Assurance (Management Measures)

OAPD-2 Section A. 7.1.3.3 of the Quality Assurance Program Description states that "The criteria and

methods shall identify the critical characteristics that are essential to ensure the item will

perform its intended IROFS function. "Consistent with 10 CFR Part 21, "Reporting of Defects

and Noncompliance, "dedication occurs after receipt when the item is designated for use as a

basic component. Please clearly describe the dedication process; and, if critical

characteristics will be verified, please identify those methods.

RESPONSE: The QAPD is revised to describe the dedication process and methods to verify

critical characteristics.

License Documentation Impact: Former Section A.7.1.3.3 of the Quality Assurance Program

Description (LA, Rev A, Appendix A) new Section number A.7.3.3 will be revised to add new

second and third paragraphs which will read as follows:

A.____ .4J.3A.7.3.3 Commercial Grade Items

Methods shall be established for determining whether an item can be purchased as commercial

grade and dedicated for use in an IROFS application. The criteria and methods shall identify

the critical characteristics that are essential to ensure that the item will perform its intended

IROFS function.

QL-1 and OL-2 items may be procured as commercially available items provided they are

subiected to a dedication process. Items and services that are not relied on for safety may be

designated as QL-2 or QL-3 and may be procured as commercially available items. The

dedication process is described below.

In accordance with 10 CFR 21 (CFR, 2009c), the procurement process procedures include

requirements that IIFP confirm each supplier/vendor approved to provide basic components

has an approved process in place that implements the requirements of 10 CFR 21. In cases

where commercial-grade items are to be procured and then dedicated for use as IROFS or

parts thereof, the procurement process procedures include requirements that IIFP define to the

supplier those elements of the supplier's process controls that are mandatory and any other

requirements necessary to ensure critical characteristics will be met. Those requirements for

verifying acceptability of critical characteristics could encompass inspection, tests, or analyses

after delivery, supplemented as necessary by one or more of the following:

* Commercial arade surveys,

* Product inspections or witness at hold-points at the manufacturer's facility, and

" Analysis of historical records for acceptable performance.

As a minimum for acceptance of commercial grade items, receipt inspection will be performed

to provide reasonable assurance that the item received is the item ordered. Receipt inspections

are performed:

* to determine that damage was not sustained during shipment,

* that the item received is the item ordered,

" that inspection and testing was performed by the supplier as required by Engineering,

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* to ensure conformance with manufacturer's published requirements, and

• to ensure that required documentation is received and is acceptable

Commercial grade items are identified in the contract or purchase order by the manufacturer's

published product description. Alternate commercial grade items are allowed provided

Engineering provides verification that the alternate commercial grade item will perform its

intended IROFS function.

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