N-UREGICR-6314

MiNEL--951"li

Quality Assurance
Inspections for Shipping and
Storage Containers

Prepared by
H. M. Strombcrg, G. D. Roberts, J. H. Bryce

Idaho National Engineering Laboratory

Lockheed Idaho Technologies Company

Prepared for
U.S. Nuclear Regulatory Commission
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 NUREG/CR-6314
INEL,-95/0061

Quality Assurance
Inspections for Shipping and
Storage Containers

Manuscript Completed: March 1996

Date Published: April 1996

Prepared by
H. M. Stromberg. G. D. Roberts, J. H. Bryce

Idaho National Engineering Laboratory

Lockheed Idaho Technologies Company
Idaho Fz.lls, ID 83415

D. G. Reid. NRC Technical Monitor

Prepared for
Spent Fuel Project Office
Office of Nuclear Material Safety and Safeguards
U.S. Nuclear Regulatory Commission
Washington, DC 20555-0001
NRC Job Code L1179
 "ABSTRACT

This document is a guide. for conducting quality assurance inspections of

transportation packaging and dry spent fuel storage system suppliers.
Suppliers are dermed as designers, fabricators, distributors, users, or owners
of transportation packagings and dry storagesystems for radioactive materials.
This document may be used during an inspection to determine regulatory
compliance with Ttle 10 of the Code of Federal Regulations, Part 71, Subpart
H; Title 10 of the Code of Federal Regulations, Part 72, Subpart G; Title 10
of the Code of Federal Regulations Part 21; and suppliers quality assurance
program commitments. This guide was dcvcloped to provide a structured and
consistent approach to inspections. The guidance described in this document
provides a framework for the evaluation of transportation packaging and dry
spent fuel storage systems quality assurance programs. Inspectors are
provided with the flexibility to adapt the methods and concepts to meet the
inspection requirements for the particular facility. The method used in "
document treats each activity at a facility as a separate performance element,
and combines the activities within the framework of an 'inspection tree." The
method separates each performance element into several areas for inspection
and identifies guidelines, based on regulatory requirements, to qualitatively
evaluate each area. This document also serves as a field manual to facilitate
the quality assurance inspection activities. This document replaces an earlier
document, NUREG/CR-5717 PackagingSupplrInspecdonGuide. NUREG
/CR-5717 contains a methodology for the quality assurance inspection
activities of transportation packagings. This replacement document enhances
the inspection activities for transportation packagingis and adds the dry spent
fuel storage system quality assurance inspection activities.

UW NUREGiCR-6314
 CONTENTS
ABSTRACT ..
EXECUTIVE SUMMARY" ................................ vii
1. INTRODUCTION ................... 1
2. INSPECTION AND EVALUATION METHODOLOGY ............................... 3
2.1 Information Collection ........................................................... 3
2.2 Tailoring the Guide to Match the Licensee ...................................... 3
2.3 Evaluation of Results . ............................ ........ ................ 3
3. USE OF THE QUALITY ASSURANCE INSPECTION TREE ........................... 5
3.1 General Description ............ ........................................... 5
3.2 Color Coding ............................................................. 5
3.3 Assessment Process .. ............................. 8
4. INSPECTION EVALUATION GUIDELINES ....................................... 11
4.1 Management Controls (I.) .......................... 1
4.1.1 Quality Assurance Policy (1.1) ........................................... 11
4.1.2 Nonconformance Controls (1.2) .......................................... 12
4.1.3 Documentation Contros (1.3) ........................................... 13
4.1.4 Audit Program (1.4) ................................................... 14
4.2 Design Controls (2.) ....................................................... 14
4.2.1 Design Development (2.1) .............................................. 15
4.2.2 Modifications (2.2) .................................................... 15
4.3 Fabrication Controls (3.) ................................................... 16
4.3.1 Material Procurement (3.1) ............................................. 16
4.3.2 Fabrication and Assembly (3.2) ......................................... 17
4.3.2.1 Fabrication Processes (3.2.1) ....................................... 17
4.3.2.1.1 Cleaning (3.2.1.1) ............. ............. 17
4.3.2.1.2 Special Processes (3.2.1.2) ..................................... 18
4.3.2.1.3 Machining (3.2.1.3) ........................................... 19
4.3.2.1.4 Assembly (3.2.1A)............................................ 19
4.3.2.2 Handling and Storage (3.2.2) ........................................ 19
4.3.2.2.1 Handling and Storage Process (3.2.2.1) ............................. 19
4.3.2.2.2 Protective Environment (3.2.2.2). ............................... 19
4.3.3 Test and Inspection (3.3) ............................................... 19
4.3.4 Tools and Equipment (3.4) .............................................. 21
4.4 Maintenance Controls (4.) ............................................... . 21
4.4.1 Maintenance Activities (4.1y ............................................. 21
4.4.1.1 Requirements (4.1.1) .......................................... . . 21
4.4.1.2 Procedures (4.1.2) ................................................ 22
4.4.1.3 Maintenance Personnel (4.1.3) ...................................... 22
4.4.1.4 Maintenance Materials (4.1.4) ....................................... 22
4.4.2 Tools and Equipment (4.2) .............................................. 22

5. REFERENCES ....... ....................................................... 25

V NUREG/CR-6314
 APPENDICES

Appendix A Inspection Element 1- Management Controls ............................. 27

Appendix B Inspection Elemcent 2- Design Controls .................................. 39
Appendix C Inspection Elemcnt 3- Fabrication Controls ............................... 45
Appendix D Inspection Elemcnt 4- Maintenance Controls .............................. 61

TABLES

1. Performance Color Code ...................................................... 8

FIGURES

1. Inspection tree major clements .................................................. 6

2. Inspection tree subtier elements ............................................. 7
3. Quality assurance inspection tree ................................................ 69
4. Quality assurance performance inspection summary tree ............................... 71

NUREG/CR-6314 vi
 EXECUTIVE SUMMARY

This document outlines a standardized method The evaluation method presented in this docu
for inspections conducted by the U.S. Nuclear ment (a) uses an analytical tree to standardize
Regulatory Commission's (NRCs) Office of Nucle inspections, (b) provides a basic structured evalua
ar Materials Safety and Safeguards. Such inspec tion technique, and (c) establishes a method for the
tions evaluate the quality assurance (QA) activities overall evaluation of a licensee's compliance with
of transportation packaging and dry spent fuel regulatory requirements and GA Program commit
storage system suppliers. Suppliers are defined as ments. The evaluation method addresses the
designers, fabricators, distributors, users, or owners regulatory requirements and QA Program commit
of transportation and dry spWat fuel storage system ments in four performance elements: management
containers for radioactive materials. The guidelines controls, design controls, fbricati controls, and
are de-igned to facilitate the work of inspectors in maintenance controls.
assessing the licensee's level of compliance with
regulatory icquirements and QA program commit This document presents the regulatory require
ments. ments and licensee commitments for inspection in
a format that is suitable for use in the field. it
The term licensee is used in this guide to presents each performance element and lists the
include all entities for whom the NRC QA require applicable inspection elements that should be used
ments apply, for example: designers, fabricators, and to evaluate them. The performance elements are
users of transportation packagings, fabricators, and connected and structured through the use of an
operators of dry spent fuel storage sy-tems ap "inspectioa tree." Each element is evaluazed and
proved by NRC through the issuance of a certificate results are summarized using a color coding
of compliance. scheme.

%ii NUREG/CR-6314
 QUALITY ASSURANCE INSPECTIONS FOR
SHIPPING AND STORAGE CONTAINERS
1. INTRODUCrION
This inspection guide was developed as an W Use of the systematic methodology establishes
for performing quality assurance (OA) inspections an overall summary of compliance with regulatory
of fabricators of transportation packaging or dry requirements and a licensee's OA program commit
spent fuel storage systems for the Nuclear Regulato ments. These summaries are obtained by examining
ry Commission's (NRC's) Office of Nuclear Materi all of the inspection elements (the bulleted criteria
al Safety and Safeguards. In earlier efforts, Refer under each block in rigure 3) pertaining to a
ence 1 was the method used for inspecting and iens•'s OA process. An assessment of each
documenting transportation packagings vendor inspection clement for adequacy is based on obser
inspections. This report enhances the original vations, isco activities, inspecti reports, past
report and adds the inspection of dry spent furl evaluations, and documentation in areas specific for
storage systems. each element. Once each inspection clement is
assessed, the results are summarized for the subtler
The term licensee as used in this guide includes performance elements (the blocked criteria num
all entities for whom the NRC GA requirements bered 1. through 4.2). The summaries for the
apply, for example: holders of NRC approved OA subtier performance elements are used to summa
programs for transportation packagings and dry rize the major performance elements (the blocks
spent fuel storage systems. numbered 1, 2., 3., and 4.). Using the summaries
of the major performanc elements, the GA Pro
The regulatory requirements specified in this gram asscisment is then summarized.
document are identified in Title 10 of the Code of
Federal Regulations (10 CFR) or are commitments For example, if an inspector assesses the effec
specified in licensees' QA programs. The require. tiveness of the fabrication processes, an evaluation
ments are specified in 10 CFR, Part 71, Subpart H, would be performed by examining the subtler
and 10 CFR, Part 72, Subpart G. The requirements performance elements of cleaning. special processes,
from these two subparts of the code are similar with machninig and assembly and determine which
the exception of the period of record retention. 10 elements are applicable based on the licensee's
CFR, Part 71 requires that QA records be retained activities. For the applicable subtier performance
for the entire time that a licensee engages in the elements, the inspection elements listed below those
activity for which a license was obtained plus three blocks are assessed. Expanding the above example,
years. 10 CFR, Part 72 requires that QA records when assessing the subtler performance element for
be maintained until the NRC terminates the license. cleaning. it is summarized by evaluating fluid con
In addition to the requirements specified in the OA trols, cleaning guidelines, and cle. ing processe.
portions of the code referenced above, 10 CFR, Using the summaries from the assessment of these
Part 21 specifies requirements for reporting defec inspection elements, the effectiveness of the licensee
tive materials. meeting the regulatory requirements and licensee
GA Program commitments for cleaning is assessed
This inspection guide uses a Management Over and summarized. Following this method, the
sight R•sk Tree (MORT), Reference 2. The inspection elements for each subtier element are
MORT methodology provides an effective approach assessed and summarized.
to perform GA inspections, and provides a means
for systematically presenting the inspection findings From an assessment of the inspection elements,
by displaying the effectiveness of the licensees' QA all applicable subtier elcments are summarized.
practices.

I NUREG/CR-6314
Introduction
I

Once applicable elements below a major perfor Methodology, Use of the Quality Assurance Inspec
mance elements are assessed, the summaries for the tion Tree, and Inspection Evalhation Guidelines.
subtlier performance elements are used to assess the Inspection EMements I through 4, in the appendices
adequacy of the major performance elements. contain the guidelines in checklist form. The
checklists are provided in a format such that they
The inspection guide presents the inspection can be removed from the document and be used
process In three sections: Inspection and Evaluation during an inspection.

NUREG/CR-6314 2
 2. INSPECTION AND EVALUATION METHODOLOGY
The inspecion and evaluation methodology special data collection punued. When the quantity
requires that three tasks be performed: (a) informa
of data are determined to be adequate for evalua
tion collection, (b) tailoring the guide to match the
licensee, and (c) evaluation of inspection results. tion, the guidelines outlined in Section 3 are used.
Each effort is discussed separately.
2.2 Tailoring the Guide to Match
2.1 Information Collection the Licensee

The inspection begins with information collec Licensees differ in activity, siz, and orapniza
tion. Examples of a number of available sources tion. Many component suppiers, contractors, and
that may be utilized are: vendors haw a major role in the production or
distrution of the container. When contractors or
. Certificates of Compliance vendors are used to perform any of the major or
- Previous Inspection Reports subder performance elements presented in ti
- Previous Evaluations guide, they may be inspected for compliance with
- Safety Evaluation Reports (SERs) the regulatory requirements and OA Program
- Quality Assurance Program Applications to commitments as detailed for their specific elements
NRC (i.e., management, design, fabrication, or mainte
- Safety Analysis Reports (SARs) nance, controls).
. U.S. NRC Enforcement Actions
- Organization Charts When inspecting a licensee with a small orni
- General Correspondence zation, this guide may still be used. Howeve, in
. Procedures small orga-izations, many elements may be per
- Quality Assurance Plan formed by one individual. In these cases the
. Quality Assurance Records inspection tree and guide are used to aid the spec
tor in asking the appropriate questions to ensure
Procurement documents full coverage of all applicable performance ckment
0
Test Reports and their associated inspection elements.
Analysis Reports
0 Audit Reports This guide is intended to provide a framework
S Inspection Reports for GA inspections. Inspectors have the flexibility
S etc. to adapt the methods and concepts prsnted in this
guide to meet the needs of the particular licensee
The inspectors examine the information collect being inspected. It is up to the individual inspector
ed and analyze it against the applicable inspection to use his/her own judgement to properly apply the
elements. Due to the large quantity of documents guidelines to the situation.
at a facility, it is sometimes difficult to examine all
of them and identify all inspection elements to 2.3 Evaluation of Results
which each piece of information is applicable.
Because of this, an inspector may inspect by sample During the inspection, the inspectors determine
and by researching noteworthy areas. the adequacy of each applicable element based on
the regulatory requirements and an assestment of
There are times when information for a perfor compliance to these requirements. After the major
mance element does not exist, the quantity of data performance elements have been evaluated within
is insufficient for an evaluation, or the data are the framework of the guidelines, an overall assess
inconclusive and an adequate evaluation cannot be ment of the licensee's QA program performance is
performed. When this situation occurs, the sig made. A further description of the method for
nificance of the perfurmar~ce element or inspection determining the adequacy and assessment of the
element should be evaluated and the possibility of QA Program is provided in Section 3.

3 NUREG/CR.6314
 3. USE OF THE QUALITY ASSURANCE INSPECTION TREE

OA inspections are performed to determine for presenting overall inspection findin Figures
compliance with NRC regulatory requirements and 3 and 4 are attached at the end of this document so
QA Program commitments.' In the process, an they can be separated during the inspcction.
assessment is made of each applicable clement of
the Quality Assurance Inspection Tree. The results It is proposed that one of two methods be
of these assessments are used to determine a licens utiized for applying the inspection tree. The first
ec's compliance with applicable regulatory require method begins once information collection has been
mcnts and QA Program commitments. initiated. As information is collected and reviewed.
applicable performanc elements of the tree arc
Use of standardized inspection methods permit identified. The information is compared to the
objective comparison of observations made by inspection element criteria. Each subtler perfor
different inspectors. A summary of the licensee's mance element is evaluated for compliance with the
OA Program is developed by combining and assess. applicable codes, standards, regulstocy equire
ing performance element findings, which are ob ments, and OA program commitments.
tained using inspection elements. The inspection
elements are listed in Section 4 (Inspection Evalua The second method for entering the inspection
tion Guidelines), on the inspection tree diagram, tree is to select a performance element and thea
and in the appendices. locate information applicable to that elmet.. The
information is then used to determine the adequacy
3.1 General Description of performa clement documentation and imple
mnutation.
A MORT based inspection tree was developed
to organize the inspection process. The inspection 3.2 Color Coding
tree graphically depicts basic licensee activities and
the way they are examined during an inspection. During the inspection process. all mor perfor.
Figure 1, Inspection tree major elements, provides mance clcmentz, thkir associated subtler perfor
a presentation of the major performance elements. mance elements, and inspection elemunts are re
Subtier performance elements are presented in viewed for adequacy based on their significance to
Figure 2. safety. Data selected during the information collec
tion process are assessed against fth inspection
From Figure 1, it can be seen that there are elements for each applicable performance and
four major performance clcmcnts: Management inspection element. Following that review, a color
Controls, Design Controls, Fabrication Controls, code is assigned that indicates the level of perfor
and Maintenance Controls. As can be seen in mance found by the inspectors.
Figure 2, each major performance clcmer-t is
divided into subtier performance clements. Below The blocks on the inspection tree are separated
the subtier performance elements arc additional diagonally into two parts. The parl above the
subtier performance elcments or inspection ele diagonal line shows the adequacy with which the
ments. The inspection elcmcnts listed below each performance area is documented procedurally. The
subtier performance clement arc used to assess the part below the diagonal line shows the adequacy of
subtier performance clcmcnt. The inspection licensee's implementation of the approved proce.
elements are listed in Figure 3, Quality assurance dures. The color coding system consists of coloring
inspection tree. Figure 3 provides a complete the ue•pr and lower areas of the boxes either green,
graphical depiction of a QA Program. Figure 4 yellow, red, or blue. Each block's coding can be a
(Quality assurance performance inspection summary combination of any two of those coltrs depending
tree) is a performance summary of the inspection on the adequacy of established procedures and their
showing the inspection tree through the major implementation. As an example, green/green shows
performance elements. The summary tree is used that a performance element has excellent procedural
control and excellent implementation of the proce-

5 NUREG/CR-6314
 Inspection Tree Major Elements

I 2.

AA
ULU'

U-4

Figure I. Inspection tree major elements.

 Inspection afee Subtier Elements

fa FMoW

Major L
Elements I~ UCO

LI UI I*.US.)UI

ft~taflNmWWNOUN a

311.1~
1.2IL 14 1.2. it-II

Subtier
Elements
&.I. . .. t- -MM .
Use of Inspection Tree

dures, while red/red indicates that fhe element has elements (the items that have bullets o Frme
inadequate procedures and unsatisfactory implemen 3) for all subtier performance elements (shown
tation. Table I below, lists, the 4:oors used for as enclosed blocks an Figure 2). Ths is done
coding and the assessment criteria. for each inspection element ideatied in Sec
tion 4 and as presente in the appendices.
Each major performance element on the sum
mary tree is coded accordingly, based on the assess 2. Coasider the teria tha are sed to assms the
ments of the subtler performance and inspection subtier performanuce eements. Con•er docu
elements. After all major perfonnance elements mentatlon and implementatio where appropi
are evaluated, the overall QA program performance ate. The workdng copy of the inspection tree,
is summarized and color coded based on an assess Figure3 is used during the inspection as a
ment of its major performance ecinents. worksbee to document ad dispby the lindism
Molowing an evaluation of the data, each sub
3.3 Assessment Prc-ess tier elemenat is assessed and colk coded.

The inspection assessment is summarized using 3. Consder the assessment criteria for each nujor
the following steps. performan clement (Fi•re 1). Combine the
assessment for all subter elements into a single
1. Evaluate the inrormation gathered during the decisioa for the major performance element.
inspection against the applicable inspection

Table 1. Performance Color Code:

Assessment Cilteria

Green Indicates that overall performance istEXCELLENI. Overall performance surpass

es rcgulatory requircments and applicable commitment. Guidelines are fully
documented and implemented.

Yellow Indicates that overall performance Is SATISFACTORY. Applicable elements of

this program have been developed, documented, and implemented so that the
regulatory rcquircracnts and applicable commitments are met. Some areas may
require improvement.

Red Indicates that overall performance is .UNSATISFACTORY. Inadequate or no

cffort has been made in this specific aream and does not meet regulatory re
quir-mcnts or applicable commitments. Documentation or implementation is
missing or inadequate.

Blue Indicates that the clcmcnt was not inspected, data arc insufficient for evaluation,
or the elcmcnt is not applicable.

NUREG/CR-6314 8
 Use of Inspection Tree
4. After each major performance element lhas of the licenwe's ov•aU OA Program with
been valuated, the process of assessing the reVgulatoY requirements and (A Program
performance, elements is repeated for caub
level of the tree until the top element is deter. - -mkments.
mined. It should be noted that some major S. The results of the asessment ar transer"d
performance elements may be considered more from the Quality Assurance Inspectim Tree
important than others based on their importan. to the Oualky Assurace Performance Is
cc to safety and the licensee's operatio in the spection Summary Tree. The Ouality Aun
analysis, these elements may be considered and ance Performance Inspection Summary Tree
weighted more heavly. The color coding of the (figur 4) is used for Ohe Fresetatios of the
top element is a measure of compHiance
Inpcto findings

9 NUREG/CR-6314
 4. INSPECTION EVALUATION GUIDELINES

The Quality Assurance Inspection Tree provides 1. Ensure QA policies he been documented,
a means to systemsaically assess a licensee's compli approved, and implemented. (71I01.1c
ance with regulatory requirements and licensee GA and
71.103), (72.140(cj and 72.142)
Program commitments. To provide a correlation
between the text and the numbering scheme on the
2. Ensure that OA program authorities and respon
Quality Assurance Inspection Tree, the numbers sibilitics have been clearly defined and doo.
shown in the parentheses behind the section ttles
mented. (7L103), (72.142)
below correspond to the inspection element num.
bers in the Quality Assurance Inspection Tree.
Also included at the end of each inspection clement
3. Enurae the OA organization functions as an
independcnt group. (71.103), (72.142)
description is a reference to the applicable section
of the 10 CFR, Part 21, Part 71, or Part 72. 4. Ensure the organistiotaA chart indicate OA
organization independence from cost and sched
4.1 Management Controls (1.) ule influences. (71.103), (72.142)

Evaluation of management controls covers the 5. Ensure a graded approach to OA is applied

OA policy, nonconformance controls, documenta. consistent with importanc to safety. Ensure
tioa controls, and audit program. QA policy effec. controls arc placed on identified materials,
tiveness is verified through personnel interviews, structures, systems, and componems. Consider
review of control documents, working document the following: (71.10l[bi. 71.103, and 72.105(a,).
reviews (including procedures, purchase orders" (72.140[b), 72.142. and 72.144(la)
specifications, drawings, manuals, etc.), and a review
of OA inspections and audit reports and findings. a. The impact of malfunction or failure of the
item to safety,
The guidelines provided below are used to
evaluate the adequacy of management controls. b. The design and fabri•cating complexity or
The inspection checklist is provided in Appendix A. uniqueness of the item;

4.1.1 Quality Assurance Policy (1.1) c. The need for special controls and surveil
lane applications to Process and equip.
The OA policy consists of the philosophies and ment;
procedures that are established to ensure effective
OA Program implementation. d. The degree to which functional compliance
can be demonstrated by inspection or test;
The OA policy is assessed based on the empha and
sis and controls it places on ensuring that the
highest level of QA standards are met. OA policy e. The quality history and degree of standard
is used to verify whether all aspects of the OA ization of the item.
system are verifiable and traceable while being
applied to the design, purchase, fabrication, han 6. Ensure OA personnel have sufficient freedom
dling, shipping, storing, cleaning. assembly, inspec and authority to identify and resolve quality
tion, testing. operation, maintenance, repair, modifi problems. (71.103), (72.142)
cation of structures, systems, and components, and
decommissioning of packaging and dry storage 7. Ensure the materials, structure, systems, ard
systems that are important to safety. The following components covered by the GA Program have
guidclints are used to assess OA Policy:. been identified and documented. (71.105[a]),
72.144[a])

11 NUREG/CR-6314
ispection G e
trolled periodically reviewed, and updated.
8. In cases where a parts de&catiou program is (71T.1 and 71.33), (77.170 and 72.172)
used, ensure that the following are documented
and implemeantd (2L0(cD a. Ensure that - omc are Identifi
"ae and traceable.
a. A safety-related compoient identaitios
program. Incuded art The following: b. Ensure that orm mterials •re
I Component safety-rlated Levels docu. adequately identified and segregated to
prevent inadvetent use.
mented and Implemented;
2 Safety-related components for each
container docimentad and evaluated c. Ensure nosconformances are dispositioned
in aordance with documented procedure.
and
3 An inspection program that meets the
rcqtoirements of the safety-related Level d. Ensure soncounnfor mac dispositions are
rating appropriately reviewod and approved.
e. Ensure safety-related oonformances are
b. Material speciacation identification program reported to appropriate Management levels.
for safety-related compeents is identified,
documented, and implemented.
2. Ensure the deficienc and deViaMo COWtro
program identiies, tracks and resolves minor
c. Sources for safety-related equipment, mate
rias and commercial grade alternates arm quality discrepancies. The deficiency and devia
identified and placed on approved vesdo, tion control program is documeted controlld
reviewed, and updated (71133). (72.172)

d. A program for identifyixg and ensurin that 3. mnure the corrective action trackn programs
hame been developed, docmented. and imple
commercial grade alternates meet or exceed mented to follow deficikne, deviations. nooco
the specifcations for the safety-related com aformances, and audit and inspection findings.
ponents has been developed, documented, (71.31.7LL33, and 71.M7). (72.170,72.172, and
and implemented. This program should in 72.176)
clude the lowing:
1 Sample testing metlods; and 4. Ensure a root cause analysis program has been
2 Substituted materi•s are tracea"le to developed and implemented for determining the
toot causes of failures or rework events.
technica justfifcations in program docu (71.133). (72.172)
meats and specifi: containers having
substtutions are id.Atified.
S. Ensure the provisions of Part 21 arm identified
on procurement documents for safety-related
4.1.2 Nonconformance Controls (1.2) components purchased after January 6, 197.
(2131)
Control of materials, parts, or components that
do not conformt to requiremenaL is verUfed usg the 6. Easure that the required Part 21 documents are
fllowng guielies posted consp*cuously. (21.6)
L Ensure that a nonconformsnse control program a. 10 CFP Part 21,
identifies, tracks, and resowls major quality dis
crepancies. Ensure the nonconformance control b. Section 206 of Energy Reorganizat"o Act of
programs and procedures o'e documented, con- 1974, and

NUREG/CR-6314 12
 I Guidelmes
c. Procedures adopted pursuant to 10 CM authorized personne and avaable at locations
Part 21. where the presrked activities are performed. The
following are sed to asuss the adequacy of docu
7. In the cases of failures to comply with the mentation contreo
license or the eitence of a defect, the follow.
ing criteria must be addressed to be in compli L Ensure documeati atrolling the fabrica.
ance with Part 21 (21.21): tdn, maintenance and procurement processes is
approwd, with prosions in place for peiodic
a. Ensure appropriate procedures have been revw and updates. (7111, 1..71SaJ, and
documented and implemented to accom 7L.15) (72.15M, 72-.., and 72•.174)
push the following:
2. Ensur a procedure development progra is
1- Evaluation of deiations and failures to establithed and documented. Thi progam
comply with the license, and identify Specifies the various renews and approvals
defects ass.ciated with substantial safety required during procedure development, with
hazards as soon as practicable. provisions in place for periodic reviews ad up.
dates. (71.111 and 7U113). (72.150 and 72.1.2)
2- Ensure that if an evaluation of a devia
tion or failure to comply can not be 3. Ensure the contractor control program is docu
completed within 60 days, an interim mented and all materials and services supplied
rcport is prepared and submitted to by contractors are cvered by adequate QA
NRC within 60 days of discovery. procedures. This indudes specification of appro
prie inspections and audits. (71.109 and
I. Ensure that the responsible licensee 7MIN5AD, (72.148 and 72.154jaJ
officer is informed within rf working
days after completion of the evaluation 4. Ensure the quality recocds are Wdetrie, retriev
if the component faIl to comply with able, controlled, stored, and periodicaly review
the Atomic Energy Act, or any applica ed and update. Ensure qualky records are
ble rule, regulation order, or NRC retrievable for the life of the packaging and three
license. Years after ceasing activitks for P&ck&giP
licensed under Parn 71. Emure quality records
b. When there are cases of failure to comply are retrivab until the NRC terminates a
with the license or the existence of a defect, license for dry storage systems licensed unde
appropriate procedures have been devel Part 72. (71.35). (72.174)
opcd, reviewed, and approved to ensure
NRC reporting requirements are met. 5. Ensure a completed document close-out review
(21.21) program is documented and implemented.
(71.123 and 71.35), (72.162 and 72.174)
c. Records that document accomplishing Part
21 are prcparcd and maintained. (2131) 6. Ensure the appropriate procedures are available
at job locations. (71.113). (72.152)
4.1.3 Documentation Controls (1.3)
7. Ensure changes to controlled documents are
The documentation controls are evaluated based reviewed and approved. (71.113), 72.l52)
on the ability of the OA Program to control its
quality documentation. During the inspection, the 8. Ensure measures arc established for the issuance
instructions, procedures, and drawings, including of controlled documentation. Control documen
changes are reviewed for adequacy, released by tation should ensure that only the most current
documents are used. (71.113). (72.15Z)

13 NUREG/CR-6314
Inspection GuidliCa

41.4 Audit Progm (1.4) compte3t. and quantity of product (71137).

(72.176):
The QA audit program emaiines the porkies,
procedures, and historical documentatio demon. a. Internal operations
strating that high OA standards are implmented b. Contractors;
and practiced When inspecirq; the audit program, C. Vendors; and
consider whether the followiN; attribues are aid. d. Supplers.
dreewA:
12. Contractors, Wedos or sspprws if seJ are
1. The audit program covenrs a applkbl aspects approved. and tha an approved vendor fis is
of the OA Pwram. (71.137), (72.176) maintsaied and compled with. (7L115 laD.

2. Audits are scheduled and conducted periodi

cally. Included are audim to cesure confor 13. Cowactors orvendors, if se, adhere to a
manet with documented Instructions, proce Vendor Control program th is InPIa= The
dures, and drawings for accomplishing the program should ensure that aln mateals and
activity. (71.121 and 71.137), (72.160 azJ 72.176) svces supled by contractors or vndo
ar covesed by adequate OA pwrams as
3. Audits are performed in i-ecordance with ap fred throgh appropriate inspecLm an audit,.
proved procedures or checklists. (71.137). (71.109 and 7L1IS&D. (72.148 aSd 72.14(aD
(72.176)
4.2 MDesg Coatrfis (2.)
4. Audit personnel are appropritecly trained to
perform audits. (71.137). (72.176) AM Phase Of the desig processes are required
to be controld and traceabe 6m the ons od
S. Audit personnel do nad have direct reponsi. design through the compleio of testing and detiv.
bility in the areas being audited. (71,137). cry. A review of this a•ea ennsue that the desig
(72.176) And any 4aanges hawe been gwen adequate consider.
atlon in accordaice with rtifcate of complince
6. Audit results are documentcd. (71.137), (72.1IAS) Spedfic areas to be considered during the design
ar criticality physics, radiation sielding, stress,
7. Audit records are rcviewed and approved by thu therml, hydraulic, and accide alyses; opa
appropriate levels of maragement. (71.137). bilt of materials; accessblityfor Invice inspec
(72-176) ton, maintenan• and repair. feAurcs to facilitate
decotminatiom and dellneatim of acceptance
8. Appropriate follow.up actions ar taken for criteria for Inspection$ and tests.
dcficient areas. (71.t37), 172.176)
The types of documents reviewed indude design
9. An audit discrepancy restlution program has documents. procurement documents. procedures,
been dcvcloped, documented, and implemented. test documents, nondestructive examation (NDE)
Resolutions are implemented in a timely man records, and managemen control documents.
ner. (71.137), (72.176) Inspect a sample of several fabrication and modffs.
cati actiitkies to ensure adequate deign review
10. Corrective action follow-up programs have been has been completed, particularly in the areas or
identified and implementux. (71.133), (72.172) design basis cal~ans. criticalty metro% and
thermal design. The areas considered a discused
It. Audits are performed on the following, as in greater detail belo. The design control cheek
appropriate, based on importance to safety, lists are prtwted in Appendix B.

NUREG/CR-6314 14
 Inspectioa Guidelnes
4.2.1 Design Development (2.1) 4.2.2 Modirseations (2.2)
The design development program consists of Examie the controls MW the de4pn modification
measures .esablishedto ensure that high standaris process that ensure any changes m=a
of design onutrol are implemented and practiced. to the design
are reflected in the design documeAs Consider the
When inspecting and evaluating the design develop.
ment, consider the fcUomunW
L Weight and center of gravity are changed to
1. Ensure the measures that cmtrol the design support any modifcations. (71.33 and 7LIOTIcD
process are documented and implemented.
(71.1071a) and 71.111), (72.146(a] and 72.150) 241(b and 72'-4•cD
2. Material property changes wr reflected in design
2. Ensure th'.the regulatory and license applica. document. (71M and 7L07c1D. (72241b) and
tion requirements arc reflected in the specirca. 72.14cD
tions, drawings, procedures, and insLructiort
(71.107[a&). (72.146{a) 3. Gahanik and chemical property changes are
3. Ensure that the appropriate quality standards reflected in the design documents. (71.43(d1 and
71.1071c1), (72.2qb and 72.146)cD
are specified and inchudcd in the des4gn
(71.107[a]), (72.146{al) 4. Modifrcatonm to dosum dcvices are reflected in
the design documents. (71.43[cI and 71.1047c])
4. Ensure that any deviations from standards arm (7.241b and 7 2.-14IcD
adequately controlled. (71.1071a1), (72.1461a])
S. Modification to lifting device ar reflected in
5. Ensure measures have been established to the design documents. (7L45a&mad 71.1071c%)
determine the suitability of materials, parts, (72.24(bj and 72.146(cD
cquipment, and processes that are hnportant to
safety. ( 7 1.107laD, (72.1461aj) 6. Modltcaiomitotie-down devices are reflected in
the design documenmtL.45[bI and 71.10qcl).
6. Ensure that the design control interfaces are (72.2[b1 and 72.146[cD
established and implemented. (71.107IbD,
(72.146[b],
7. Type B packaging items (load resistance and
7. Ensure interface activitics between participating
exernal pressure) and potenwl changes in
environmental coditions are ghie adequate
organizations are controlled by approved and consideration during the design and modification
documented procedures. (71.1Z7IbI). process. Consider the following (71.71. 71.73,
(72.1461b1) and 71.107icl)
8. Ensure that desi&,; control meatures provide
independent verireation of design accuraces, - temperature compression
- immersion load resistance
(e&, design review, calculatLons, prototype test
- vibration percussion
ing, etc.). (71.1071b1). (72.1461b]) - water spray
rae
9. Ensure that design changes reccive similar - drops externa pressure
design controls as the original design. - internal pressure penetration pressue
(71.107"cl). (72.146[c])
&.Evaluate the document review process used
10. Ensure design changes have NRC approval. during the deve ment1 modification, and
(71.1071cl), (72-1t461c)) closeout of procedures and documents. Ensure
the review process is documented and imple.

is NUREGICR-6314
Inspection Guidelines
mented. Ensure that any charges to procedures 4.3.1 Material Procurement (3.1)
and control documents are limplemented into Materials are to be controlled, verifiable, and
the design. Consider the following: (71.10[c)), traceable from the time of purchase through the life
(72.146[cD of the packaging or dry storage system. Specific
areas are discussed below.
a. Drawing changes
b. Fabrication and manufacturing procedures. 1. Ensure measures that control material procure
ment are documented and implemented. (71.109
9. Evaluate the engineering chnge notice (ECN) and 71.135), (72.148 and 72.174)
control process. , Ensure W ECN process is
proceduralized. approved, and traceable. 2. Ensure procurement documents are controlled
(71.107[c)), (72-146[c)) and retrievable. Also ensure that the applicable
codes, standards, and regulations are referenced.
10. Evaluate the drawing change control process. (71.109, 71.1151b], and 71.135), (72.148, 72.154[b],
Ensure the drawing control process is procedur and 72.174)
alized, approved, and traceable. (71.107[c]),
(72.146[c)) 3. Ensure material traceability documentation is
available and auditable. (71.115[b] and 71.117),
11. Assess the design modification review process. (72.154(b] and 72.156)
Ensure the design modification review process
is documented, prccedurali2cd, approved, and 4. Ensure drawings and procedures used for pro
traceable. Ensure the design modification re curement are identified and consistent with
specifications. Ensure procurement is made in
view is as comprehensive as the original design
review. (71.107[c]), (72.1461[c]) accordance with approved specification changes.
Ensure any changes made to specifications axad
design basis analyses are incorporated in these
4.3 Fabrication Controls (3.) ,.4cuments. (71.111), (72.150)
The insprction and evaluation of this perform 5. Ensure suitable materials arc specified and used
ance element verifies that all phases of the fabrica in accordance with design specifications, calcu
tion process are properly contro:Lled and implement lations, and models. Ensure substituted materi
ed. The fabrication process is required to be als are as good or better than the original. Con
controlled and verifiable from the onset of design sider tlc following specifically but others may be
through the completion of the manufacturing considered: (71.115[a]), (72.154[al)
process. The areas include material procurement,
fabrication and assembly, test and inspection, and . seals gaskets
equipment. Inhouse, contractor, or vendor supplied . foam.
fabrication controls are evalui'tcd using identical
criteria. 6. Ensure material shelf life for safety-related
components has been considered. (71.117),
The types of documents to be reviewed include (72.156)
design documents, procurement documents, fabrica
tion documents (e.g., travelers), process documents 7. Ensure there is a reccipt inspection program to
(e.g., machining and welding), procedures, test address compliance with procurement docu
documents, NDE records, and management control ments. Also ensure that the results of the
documents. The fabrication controls checklists are receipt inspections are documented and retriev
provided in Appendix C. able. (71.115[bl), (72.154[bl)

NUREG/CR-6314 16
 Inspection Geidelinea
8. Ensure measures have been established that b. Specifications are identified and compliance
assure each item is identified by hbe number, ensured. (71.105t1b] and 71.119), (72.144b]
part number, or other appropriate means, either and 72.158)
on the item or on records traceable to the item.
The measurs are required throughout fabrica. c. Applicable drawings are identified and refer
tion, installation, and use of the item. (71.117), enced. (71.111), (72.150)
(72.156)
d. Are hold points identified?
4.3.2 Fabrication and Assembly (3.2)
e. Are hold points appropriately released?
The fabricaion and assembly performance
clement consist* of procedures that ensure high 2. Ensure process control measures for QA inspec
standards of fabrication and assembly controls are tions, hold points, program reviews, documenta
implemented and practiced. tion reviews, and onsite controls for contractor
work performed onsite are established and func
The fabrication and assembly process controls tional. Consider the following questions: (71.111,
are inspected through personnel interviews, reviews 71.113, and 71.121), (72.150, 72.152, and 72.160)
of control documents (including purchase orders,
specifications, drawings, manuals, etc.) review of a. Were the control measures performed when
work control documents (design, procurement, required?
procedures, test records, NDE records, and man
agement control documents), and a review of QA b. Were the operational steps signed off when
inspections and audits. performed?
432.1 Fabrication Processes (3.2.1). The c. Were obsersations of the control measures
fabrication process is separated into four areas within the specifications?
during an inspection. These areas, discussed sepa
rately below, are examples of major processes that d. Were noncompliances handled in accordance
may be applicable to a particular facility. with the noncompliance control program?
Some areas may not be applicable, the non 3. Ensure the tools, equipment, and measurement
applicable areas may be dropped from the evalua instruments required by each procedure are
tion. The inspector has the flexibility to inspect the identified in fabrication control documents.
fabrication process as it is performed at each Verify that calibration requirements and sensitiv
facility. When inspecting fabrication activities, as ity ranges are adhered to during use. (71.125),
appropriate, consider the following: (72.164)
I. Ensure the fabrication procedures are docu 4.3.2.1.1 Cleaning (3.2.1.1). Ensure that
mented, approved, and implemented for each procedures controlling the cleaning processes have
applicable step of a process. Ensure the follow. been documented and implemented. Observe the
ing are addressed where appropriate: (71.111), cleaning process and review completed documents
(72.150) to ensure that: (71.119), (72.158)
a. Appropriate codes, standards, and drawings 1. Appropriate cleaning fluids are identified and
are idcntified and implemented. (71.1051b) specified, along with any cleanliness and/or
and 71.119), (72.144[b] and 72.158) chemistry controls. (71.111 and 71.127), (72.150
and 72.166)

17 NUREG/CR-6314
Inspection Guidelines

2. Guidelines for any cleaning process are speci b. Uranium shield processes:
fied. (71.111 and 71.127), (72.1L0 and 72.166)
. oxidizing and hydriding controls
3. That the exact cleaning process to be used is - heat treatment guidelines
specified. Consider the following: (71.111 and . welding criteria and procedures
71.127), (72.150 and 72.166): - cladding procedures
. stainless steel sensitizing controls
- NDE processes - acid baths . personnel requirements.
. solvents.
5. Ensure the controls implemented for NDE
4.3.2.1.2 Special Proesses (3.2.1.2). including radiography, ultrasonic inspection,
Ensure procedures involving special processes are penetrant inspection, and magnetic particle in
documented, approved, and implemented. Special spection are documented, approved, and imple
processes include welding, NDE, brazing. lead pour, mented. Ensure the following: (71.119), (72.158)
foam pour, heat treating. stress r:lieving. forging,
casting, rolling. and others. Ensusre the controls a. The personnel that perform NDE activities
that have been established are documented, imple are qualified and certified per procedures.
mented, and approved by appropriate personnel.
b. The equipment used in NDE activities are
1. Ensure procedures for controlling and perform suitable for the application.
ing special processes have keen documented,
approved, and implemented. ,Also ensure that c. The NDE activities are performed satisfacto
the procedures are in compliance with the rily and per a written procedure. This
applicable codes, standards, specifications, should include:
criteria, and other special rcquirements.
(71.119), (72.158) 1 Through observations ensure that NDE
activities are performed satisfactorily.
2. Ensure acceptance criteria and hold points for 2 Second person verification of NDE activ
special processes and inspections arc document ities are performed by qualified and
cd and implemented. (71.121), (72.160) certified individuals.
3 The personnel used in NDE activities
3. Ensure special process personnel controls have are qualified and certified.
been documented and implemented. Ensure 4 The equipment used in NDE activities
training requirements and qualifications.arc re are suitable for the application.
viewed and documented. Ensure special pro 5 The personnel testing requirements are
cess procedures are qualificd prior to use. current.
(71.119), (72.158)
6. Ensure the controls implemented on welding
4. For shiclding, consider: (71.111), (72.150) activities are documented, approved, and imple
mented. Ensure the following: (71.119), (72.158)
a. Lead shield processes:
a. Personnel used in welding activities are
ambient temperature qualified and certified.
pour
heating and cooling b. Equipment used in welding activities are
support suitable for the application.
wall thickness guidclines
acceptance criteria. c. Personnel testing requirements are current.

NUREG/CR-6314 18
 Inspection Guidelines
d. WeldinMmterials are adequately controlled pleted documents and stored products are reviewed
to prevent unauthorized use. Also welding
materials are stored appropriately. to ensure acceptance criteria are met, steps are per
formed in the proper order, the correct revision of
43=.13 the procedure has been used, spare parts and
Mwbln (32.13). Ensure
procedures controlling the machining processes have materials are controlled, and packagings and dry
been documented, approved, and implemented. storage container systems are traceable to OA
Machining controls should be verified by observa. standards. (71.111 and 71.127), (72.150 and 72.166)
tion of the machining processes or by reviewing
completed documents. Consider: (71.111), (72.150) 1. Ensure measures that control the handling and
storage process are documented and implement.
- ed. (71.111), (72.150)
feed rates cutting depths
- cutting rates cooling fluids
. hold points 2. Ensure spare part inventories are identified in
surface finish criteria the procurement documents. (71.117), (72.156)
- personnel acceptance criteria.
3. Ensure the spare part procurement and inven
4.3.2.1.4 Assembly (3.2.1.4). Ensure mea
sures have been implemented for controlling the tories are controlled by the OA Program.
assembly process. The measures should insure the (71.109 and 71.117), (72.148 and 72.156)
assembly is controlled and traceable.
4. Ensure material issuance and storage arc docu
1. Ensure procedures have been documented, mented, approved, and implemented. (71.117),
approved, and implemented. (71,111), (72.150) (72.156)

2. Ensure preparations for assembly have been 5. Ensure the safcty-related component shelf life
identified and completed prior to commencing has been assessed. Also ensure the shelf life is
assembly. (71.111), (72.150) controlled so that material is not used after the
shelf life is exceeded. (71.117), (72.156)
3. Ensure that the finished packagings and dry
storage containers have been assembled per 43.2.2.2 Protective Environment (322.2).
certified drawings. (71.111), (72.150)
If a protective environment is requircd, ensure any
protective environmental controls required to
4.32.2 Handling and Storage (3.2). The protect the product have been documented and
inspection ensures that adequate controls are implemented. Consider the following: (71.127),
implemented so that the handling and storage (72.166)
processes are controlled, and traceable from the
start of the packaging and dry storage container - inert gas - moisture content
assembly process through following fabrication, . humidity temperature.
testing, inspection, and final acceptance. The types
of documents reviewed include procedures, storage 4.3.3 Test and Inspection (3.3).
records, and traceability documents. The areas
considered include the handling and storage, and Ensure tests and inspections are controlled,
protective environment. These areas are discussed verifiable, and traceable, from the design phase
in greater detail below. through testing and inspections up to and including
the review of closed-out procedures and inspection
43.2.2.1 Handling and Storage Process reports. Documents considered for review should
(3.2.2.1). The handling and storage process consists include design documents, procedures, test docu
of procedures that ensure high standards of storage ments, NDE records, and management control
and handling are implemented and practiced. Corn- documents.

19 NUREG/CR-6314
Inspecti Guidelines
5. Ensure the controls implemented for NDE
The testing and Inspection program ensures the activities (including radiography, ultrasonic,
procedures controlling testing and inspections are penetrant, and magnetic particle) are document
docmented, approve, and implemented. When ed, approved, and implemented. (71.119 and
inspecting this element, consider both the controls 71.123) (72.158 and 72.162)
placed on the testing and inspection program and
the controls placed on the analysis of the results. 6. Ensure controls placed ,on the tools and equi
Testin and inspection effectliveness is verified by pment required for implementation of the testing
personnel intcervw,' review of control documents, and inspection processes are documented and
working document reviews (inclu4ing procedures, implemented. Consider: (71.125), (72.164)
purchase orders specifications, drawings, manuals,
etc.), and a review of OA insplctions and hold a. Tools and equipment are identified and
points. Documents that should be considered for controlled. Items to be considered include
review include design documents%procedures, test meters, gauges, calipers, micrometers, torque
documents, NDE records, and management control wrenches, relief valves, dial indicators,
documents. cranes, etc. (71.125), (72.164)

Consider the following attributes: b. Tool and equipment calibration requirements

are identified and controlled. (71.125),
1. Ensure testing and inspection requirements, (72.164)
when appropriate, are identifiad for: hydrostat
ic/le.ak tests, shielding. thermal loads, heavy c. Tool and equipment rated measurement ca
lifts, and NDE. Ensure measures have been pacities and sensitivities are identified, and
established so that prerequistes arc met prior actions taken to ensure they are complied
to initiating a test. (71.123), (72.162) with. (71.125), (72.164)
. Are tests performed using written and ap d. Tools and equipment used in test and in
proved procedures? spections can be identified by test. Also
ensure that the tools and equipment are
. Are the test procedures reviewed an ap compatible with the test and inspection
proved by appropriate pclrsonncl? needs (i.e., instrument ranges are compatible
with the test acceptance criteria).
. Are measures established that ensure pre (71.123), (72.162)
requisites are mdt prior to beginning the
testing? 7. Ensure measures for specifying quality control
hold points have been documented and imple
2. Ensure acceptance criteria are identified and mented, with provisions in place for periodic
compliance ensured. (71.123), (72.162) reviews and updates. (71.111 and 71.121),
(72.150 and 72.160)
3. Ensure tVst conditions are suitable. (71.123)
(72.162) 8. Ensure that a procedure controlling the opera
tion of pac kaging and dry storage systems has
* Were tests performed to the appropriate been documented and implemented. The proce
procedure revision? dure should consider the status of inspections or
tests. (71.129), (72.168)
4. Ensure a completed document dose-out review
program has been implemented, documented, 9. Ensure measures have been established and
and approved. Ensure the acceptance criteria implemented to control the operating status of
are met, all steps were completed, and the packagings and dry storage systems. The mea-
procedures are acceptable. (71.123), (72.162)

NuREG/cR.6314 20
 Inspection Guidelines
sures should pmreat inadveent operation. 4.4 Maintenance Controls (4.)
(71.129), (72.168)
The goas of the maintenance process are to
10. Ensure inspection arc performed by individuals Identiy and perform maintenance on the packaginp
other than those who performed the activity. and dry storage systems to ensure each will meet its
(71.21). (72.160) design task, ensure suitable spare parts are used,
and ensure that adequate tood and equipment
4.3.4 Tools and Equipment (3.4). controls are established. To expedite the effort, the
maintenance program has been separated into two
Ensure procedure controls have been document. areas (maintenance activities and tools and equip
ed, approved, and Implemented for the tools and ment), each of which is discussed below. The main
equipment. The types of equipment of concern are tenance inspection chcrklist is presented in Appen
meters, gauges, regulators transmitters, sensors. dixD.
torque wrenches, relief valves, cranes, etc.
Maintenance controls are verified through
Consider the foowwi personnel interviews, document rcviews, and obser
vations. The types of documents that should be
L Ensure the tools and equipment are identified, reviewed include: vendor manuals, operating
spefled, and controlled. (71.125, (72.164) manuals, procurement documents, reports, test
documents, letters of correspondence, procedures,
2. Ensure that a testing and calibration program and maintenance orders.
has been documented, approved, and imple
mented. Ensure calibration and testing stan 4.4.1 Maintenance Actlvltds (4.1).
dards are traceable to national standards.
(71.125), (72.164) Maintenance activities consist of procedures and
programs established to ensure that maintenance
3. Ensure the tool and equipment measurement requirements are identified and performed properly.
ranges and sensitivities have been identified, the When inspecting and evaluating this element, four
equipment used accordingly, and actions taken areas arc addressed requirements, procedurcs,
to ensure the ranges and sensitivities are met. maintenance personnel, and maintenance materials.
(71.125), (721.64)
4A.1.1 Requlrcie ts (41.1). The maintenance
4. Ensure the tools mad equipment are traceable to requirements section assesses the controls and
specific jobs and date of use. Traceability guidelines that ensure applicable maintenance is
should include documentation showing where identified, performed, and documented. The follow
and when used. (71.123), (72.162) ing are used to evaluate maintenance requirement
identification.
5. Ensure that in cases where instruments are
found to be out of calibration, there is a proce 1. Ensure a program for the identification of re
dure for justifying product quality for the tests quired maintenance has been developed and
or inspection performed using the out of cali implemented. (71.1051b] and 71.127), (72.144[b]
bration instruments. (71.123), (72.162) and M2.166)

21 NUREG/CR-6314
inspect . Guidelines

2. Ensure acceptance criteria governing mainte 4A.IA Maintenance Materials (4.1A). The
nanc ctivities are identificd. These include inspection assesses the materials control process,
tolerances, frequency of replacements, and fre including the effectiveness of identifying materials,
quency of performance. (71.i1), (72.150) materials receipt inspection., controls for storage
and handling before use, and materials traceability.
3. Ensure a trending'progr•in for component Consider whether the following areas are addressed:
failures and maintenance has been developed
and implemented. (71.105[b] and 71.133), 1. Documentation necessary to demonstrate appro
(72.144[bl and 72.172) priate materials have been used and is available
for maintenance is available and traceable.
4. Ensure hold points for maintenance inspections Consider procurement documents, specifications,
and verifications are Identificd and follow sped design documents, tests, and past maintenance
Bed guideline (71.121), (72.160) actions. (71.109, 71.111, and 71.115[a]), (72.148,
72.150, and 72.154{a))
4A.1.2 Procedures (4.1.2). Procedures are
established to control required maintenance. 2. Shipping, handling, and receiving requirements
Consider the following during the inspectlon: are identified and compliance ensured. (71.
105[b] and 71.1151b]), (72.144[b] and 72.154[b])
1. Ensure procedures have 'been documented,
approved, and implemented for the perfor 3. Matcrial specifications, part substitutions, and
mance of all maintenance activities. Include shelf life requirements for degradable materials
consideration for the manufacturers and sup are identified. (71.109, 71.115[b], and 71.135),
pliers providing any changes to the maintenance (72.148, 72.154[b], and 72.174)
program when deemed eccessary. (71.111),
(72.150) 4. Spare parts inventories have been addressed
whcre appropriate. (71.105[bl), (72.144[b))
2. Ensure a root cause analysis program has been
developed and implemented for determining the 5. The matcrial procurement process is adequately
root causes of failures or rework events. controlled and documented. Consider the fol
(71.133). (72.172) lowing:

3. Ensure the adequate maintcnance requirements a. Procedures for control of materials have
arc provided. (71.105[bl), (72.144[bD) been documented, approved, and implement
ed. (71.111), (72.150)
4.4.1.3 Maintenance Personnel (4.13). Evalu
ate maintenance personnel, taking into account b. Material traceability has been assured.
management controls. The guidelines for inspecting (71.115[b), 71.117, and 71.135), (72.154[b],
maintenance personnel arc dis:ussed below. 72.156, and 72.174)

1. Ensure personnel qualificatilon requirements are c. Material storage, handling, and issuing have
identified and compliance assured. Ensure been addressed. (71.115(b], 71.117, and
qualification exams and/or rcquired ed'icational 71.127), (72.154[b], 72.156, and 72.166)
and experience levels are appropriate.
(71.105[d]), (72.144[d1) 4.4.2 Tools and Equipment (4.2).

2. Ensure training rcquirements for personnel are The tool and equipment area is established for
identified for staff in quality control, shipping the identification of tools and equipment necessary
and receiving, and maintenance activities. for packaging and dry storage system maintenance.
(71.105[d1), (72.144(dl) The types of equipment that should be considered

NUREG/CR-6314 22
 Inspection Guidelines
include meteas puge, calipers, reguators, trans gram has been documented, approved, and im.
mitters, r micrometers, torque wrenches, plemented. Ensure traceability of the calibration
relief valves, dial Indckors, crazes, etc. and testing standards to national standards.
(71.125), (72.164)
Verify tool and equipment controls through
personnel interviews, reviews of control procedures% 3. Ensure the tools and equipment rated measuring
review of work control documents, calibration ranges and sensitivities are identified and actions
sheCts, caliuations records, etc. taken to ensure compliance. (71.125), (72.164)
The review should consider the following areas: 4. Ensure the tools and equipment are traceable to
specific jobs and date of each use. Traceability
1. Ensure tools and equipment necemury for safe should include documentation showing where
and controlled maintenance are identified and and when used. (71.123), (72.162)
specifed (71.125), (72.164)
5. Ensure that when instruments are found to be
2. Ensure tools and equipment for calibration and out of calibration, there is a procedure for
testing requirements are identified and con justifying product quality for the tests or inspec
trolled. Ensure a testing and calibration pro- tions performed using the out of calibration
instruments. (71.123), (72.162)

23 NUREG/CR-6314
 S. REFERENCES
1. U-S. Nudwm Iegdator Commission, Packaging Suplier Inspection Guide, NUREG/CR-5717, April
199L
2. W. G. (Bill) JOhnson, MORT - The Managemen Oversight and Risk Tree, SAN 821-2, February 12,1973.

25 25
NUREG/CR-6314
 APPENDIX A
INSPECTION ELEMENT 1
MANAGEMENT CONTROLS

27 NUREG/CR-6314
 Element Inspection Criteria T Acceptable Remarks and Observations .
I. Management Controls
Verify that adequate measures have been implemented to ensure that all aspects of the facility are adequately controlled to
ensure compliance with regulatory requirements and QA program commitments. Management controls include a quality
assurance policy, nonconformance controls, documentation controls, and an audit program.
1.1 Quality Assurance Policy

Verify that all aspects of quality assurance are controlled and traceable while being applied to the design, purchase, fabrication,
handling, shipping, storing, cleaning, assembly, inspection, testing, operation, maintenance, repair, modification of structures,
systems, and components, and decommissioning of packaging and dry storage systems that are important to safety.
Verify QA policies are documented, approved, and imple
mented. (71.101[c] and 71.103) (72.140(c] and 72.142)

Verify that QA program authorities and responsibilities are

clearly defined and documented. (71.103) (72.142)
Verify that the QA organization functions as an independent
group. (71.103) (72.142) L
Comments:

'I.

I
I
S.-..

a
I
zC Inspection Criteria Acceptable Remarks and Observations
Element
t•i
0 1.1 Verify that the organizational charts demonstrate QA organi )I.I

zation independence from cost and schedule influences.

I
(cont.)
(71.103) (72.142) e

Verify that a graded approach to QA is applied consistent

with importance to safety. Verify controls are placed on
identified materials, structures, systems, and components
commensurate with their importance to safety. Consider the
following: (71.101[b]. 71.103, and 71.105[a]) (72.140(b),
i Z142- and 72.144ra])
I
The impact of malfunction or failure of the item to
safety.

The design and fabrication complexity or uniqueness of

the item.

The need for special controls and surveillance applica

tion to processes and equipment.

The degree to which functional compliance can be dem

onstrated by inspection or test.

The quality history and degree of standardization of the

item. .1_______ 1

Comments:
 Element Inspection Criteria 'Acceptable Remarks and Observations
1.1 Verify that the QA personnel hive sufficient freedom and
(cont.) authority to identify and resolve quality problems. (71.103)
(72.142)
Verify that the materials, structure, systems, and components
covered by the QA Program have been identified and docu
mented. (71.105(a)) (72.144[a])
Verify that when a parts dedication programs is used, the
following are documented and implemented. (21.3[c)

A safety-related component identification program has

been developed, documented, and implemented. Verify
that the program includes the following:

a. Component safety-related levels identified, docu

mented, and implemented.

b. Safety-related components for each container iden

tified, documented, and evaluated.

c. Inspection program meets the requirements of the

safety-related level ratings.

Material specification identification program for safety

related components identified, documented, and imple
mented.
Comments:

I
A.-

t.
z Element
1.1
(cont.)
Inspection Criteria

Sources for safety-related equipment materials and

commercial grade alternates identified and placed on
Acceptable Remarks and Observations
I
II
approved vendor lists.
0-

Verify that a program for identifying and ensuring

commercial grade alternates meets or exceeds the speci
fications for the applicable safety-related components
has been developed, documented, and implemented.
Verify the following:

a. Sample testing methods are appropriate.

b. Substituted materials are traceable to technical jus

tifications in program documents and packaging or
dry storage systems having substitutions are identi
fiable.

1.2 Nonconformance Controls

Verify all nonconformances are identifiable, traceable, and the disposition of nonconformances are clear.
Comments:
 Element Inspection Criteria Acceptable I Remarks and Observations
1.2 Verify that the nonconformance control program is docu
(cont.) mented, controlled, periodically reviewed, and updated.
Also verify the nonconformance control program considers
the following (71.131 and 71.133) (72.170 and 72.172):

Verify nonconformances are identifiable and traceable.

Are nonconforming materials adequately identified and

segregated to prevent inadvertent use?
Are nonconformances dispositioned in accordance with
documented procedures?

Are dispositions appropriately reviewed and approved?

Are safety-related nonconformances reported to appro

priate management levels?
Verify that the deficiency and deviation control program
identifies, tracks, and resolves minor quality discrepancies.
Also verify that the deficiency and deviation control program
is documented, controlled, periodically reviewed, and updat
ed. (71.133) (72.172)
Verify corrective action tracking programs have been devel
oped, documented, and implemented to follow deficiencies,
deviations, nonconformances, and audit and inspection find V>
ings. (71.131, 71.133, and 71.137) (72.170, 72.172, and
72.176)
Verify that a root cause analysis program has been developed
and implemented for determining the root causes of failures
or rework events. (71.133) (72.172)
Verify the provisions of Part 21 are identified on procure
ment documents for safety-related components purchased
0
after January 6, 1978. (21.31)
_______ & L

p.. Comments:
 Element
Ele en

1.2
Inspectio
tht
1.2
inspection Criteria
teeriy folowng 1
C
CF
Itei IIIIIII
Par 21docuentIar
Verify that the following 10 CFR Part 21 documents are
Acceptable Remarks and Observations
II:
0
(cont.) posted conspicuously. (21.6)
C)
10 CFR Part 21,

Section 206 of Energy Reorganization Act of 1974, and

Procedures adopted pursuant to 10 CFR fart 21. _____ ,mIiI

Ia
In the cases of failures to comply with the licunse or the
£ c-etant- of a Ap-fat vprifv the fOOllawing for compliance: w[
(21.21)

The appropriate procedures have been documented and

implemented to accomplish the following:

a. Evaluate deviations and failures to comply, and

identify defects associated with substantial safety
hazards as soon as practicable.

b. Ensure that if evaluation of a deviation or failure to

comply can not be completed within 60 days, an
interim report is prepared and submitted to the
NRC within 60 days of discovery.

c. Ensure the responsible licensee officer is informed

within 5 working days after completion of the eval
uation if the component fails to comply with the
Atomic Energy Act, or any applicable rule, regula
tion order, or NRC license, or contains a defect. ____________________ 4.
In cases of failures to comply with the license or the
existence of a defect, appropriate procedures have been
developed and approved to ensure NRC reporting re
quirements are met. (21.21) ________________ I

Records that document accomplishing 10 CFR 21 are

prepared and maintained. (21.51) I _ _ __ _ __ _ I

Comments:
 Element Inspection Criteria Acceptable Remarks and Observations
1.3 Documentation Controls
Verify that all aspects of the document controls are verifiable, controlled, and traceable. Verify instructions, procedures, and
drawings, including changes are reviewed for adequacy. Verify instructions, procedures, and drawings are released by
authorized personnel. Verify instructions, procedures, and drawings are used at locations where prescribed activities are
performed.
Verify the fabrication plans, maintenance, and procurement
documents are approved. Are they reviewed and updated
periodically? (71.111, 71.115[a], and 71.135) (72.150,
72.154-I.], and 72.174)
Verify a procedure development program is established and
documented. Also verify that this program specifies the
various reviews and approvals required during procedure
development, with provisions in place for periodic reviews
and updates. (71.111 and 71.113) (72.150 and 72.152)
Verify that a contractor control program is documented and
ensures that all materials and services supplied by contractors
are covered by an adequate QA Program. This includes -,
specification of appropriate inspections and audits. (71.109
and 71.115[a]) (72.148 and 72.154[a])
Verify that quality records are identified, retrievable, con
trolled, stored, and periodically reviewed and updated. Veri
fy that the quality records are retrievable for the life of the
packaging and three years after ceasing activities for packag
ings licensed under Part 71. Ensure quality records are
retrievable until the NRC terminates a license for dry storage
I
systems licensed under Part 72. (71.135) (72.174)

z Comments:
eli
03
Ii
C,
b
 l " "

I
., m i

Element jInspection e, el
Criteria Acceptable Renmaks and Obiervatiom

1.3 Verify that a completed document close-out review program

(cont.) is documented and implemented. (71.123 and 71.135) (72.162 9

I
0.- and 72.174)
Verify that appropriate procedures are available at job loca
tions. (71.113) (72.152)
Verify that changes to controlled documents are reviewed
and approved. (71.113) (72.152)
Verify that measures have been established that control the
is' of
-Ce ntrFo!!edb4 11,_,mlntatifnn Veruiv that the mea

sures ensure only the most current documents are used.

(71.113) (72.152)

1.4 Audit Program

Verify that all aspects of the QA audit program are verifiable, controlled, and traceable.
Verify that the audit program covers all applicable aspects of
the QA Program. (71.137) (72.176)
Verify that audits are scheduled and conducted periodically.
Verify audits to ensure conformance with documented in
structions, procedures, and drawings. (71.121 and 71.137)
(72.160 and 72.176)
Verify that audits are performed in accordance with ap
proved procedures or checklists. (71.137) (72.176)
Verify that audit personnel are appropriately trained to
perform audits. (71.137) (72.176)

Comments:
 -1 I
Eleme ,nt Inspection Criteria
Acceptable I IRemarksnd Observations
1.4 Verify that audit personnel do not have direct responsibility
(cont.) in the areas being audited. (71.137) (72.176)
Verify that audit results are documented. (71.137) (72.176)
Verify that audit records are reviewed and approved by
appropriate levels of management. (71.137) (72.176)
Verify appropriate follow-up actions are taken for deficient
areas. (71.137) (72.176)
Verify an audit discrepancy resolution program has been
developed, documented, and implemented. Verify that
I II...
resolutions are implemented in a timely manner. (71.137)
(72.176)
Verify corrective action follow-up programs have been
identified and implemented. (71.133) (72.172)
Verify that the following areas are audited as appropriate,
based on importance to safety, complexity, and quantity of
product. (71.137) (72.176)
a. Internal operations;
b. Contractors;
c. Vedors; and
d. Suppliers.
Contractors, vendors, and suppliers, if used are approved and
an approved vendor list is maintained and compliance en
sured. (71.1 1 5(a]) (72.154(a[)
Contractor or vendor if used adhere to a vendor control
program that ensures all materials and services supplied by
contractors or vendors are covered by adequate QA Programs
as demonstrated through appropriate inspections and audits.
Io Comments:
(71.109 and 71.1 15[aJ) (72.148 and 72.154fa])
A

V0
 APPENDIX B
INSPECTION ELEMENT 2
DESIGN CONTROLS

39 NUREG/CR-6314
 Element Inspection Criteria 7 Acceptable Remarks and Observations
2. Design Controls

Verify thpt all phases of the design processes are controlled, retrievable, and traceable from the onset of design through the
completion of testing and delivery. Specific areas to be considered during the design are: criticality physics, radiation shield
ing, stress, thermal, hydraulic, and accident analyses; compatibility of materials; accessibility for inservice inspection, mainte
nance, and repair; features to facilitate decontamination; and delineation of acceptance criteria for inspections and tests.
2.1 Design Development

Verify that all aspects of the design development process are verifiable, controlled, and traceable from the onset of the design
through the completion of testing and delivery.
Verify measures that control the design process are properly
documented and implemented. (71.107[a) and 71.111)
(72.146[a) and 72.150) _

Verify that regulatory and license application requirements

are reflected in the specifications, drawings, procedures, and
Ab instructions. (71.107(a]) (72.146(a))
Verify appropriate quality standards are specified and in
cluded in the design. (71.107[a)) (72.146(a])
Verify that deviations from established standards are ade
quately controlled. (71.107iaJ) (72.146(a]) .....
Comments:

z ,
r:
ffI.
- 0
 Inspection Criteria Acceptable Remarks and Observations |

I
Element
z
rTl 2.1 Verify that measures have been established to determine the 0
C., (cont.) suitability of materials, parts, equipment, and processes that
C., are important to safety. (71.107[a]) (72.146(a[)
Verify that design control interfaces are established and
implemented. (7 I.!07[b]) (72.1 46(b]) ...... _________________ I
Verify that interface activities between participating organi
zations are controlled by approved and documented proce
dures. (71.107([b) (72.146(b)) ,,),

Verify that design control measures provide independent

reviews, calcu
verification of design accuracies (eg., design(72.146(b))
lations, prototype testing. etc.). (71.1071b))

Verify that design changes are subjected to similar design

control measures as the original design. (71.107[c]) (72.146[c))
Verify that design changes have received NRC approval.
(71.107(c]) (72.146(c])

2.2 Modifications

Verify that all aspects of the design modification process are controlled and traceable.
Comments:
 -__ _____I I
Element Inspection Criteria Acceptable
I I 'IJ Remarks and Observations
II II
2.2 Verify whether weight and center of gravity changes have
(cont.) been accounted for in any modifications. (71.33 and
71.107[c]) (72.24(b] and 72.146([c)
4
Verify that material property changes are reflected in design
documents. (71.33 and 71.107[c]) (72.24(bj and
72.146(c))
Verify that galvanic and chemical property changes are
reflected into the design documents. (71.43(d] and 71.107[c))
(72.24(b) and 72.146[c])
Verify whether modifications to closure devices are reflected
into the design documents. (71.43[c] and 71.107[c)) (72.24(a)
and 72.146[c])
Determine whether modifications to lifting devices are re
flected into the design documents. (71.45[a) and 71.107(c))
(72.24[a) and 72.146(c))
t
Determine whether modifications to tie-down devices are re
flected into the design documents. (71.45[b) and 71.107[c])
(72.24(a] and 72.146(c])
9
Type B items (load resistance and external pressure) and
potential changes in environmental conditions are given
adequate consideration during the design and modification
process. Consider the following items (71.71, 71.73 and
71. 107[c])

temperature compression
immersion load resistance
vibration percussion w
water spray fire

Comments:
drops
internal pressure
external pressure
penetration pressure. I.9
a.
z Element inspection Criteria Acceptable Remarks and Observatioms

2.2
(cont.)
Verify that a document review process for use during the
development, modification, and closeout of procedures and
to
documents has been documented and implemented. Verify
that all changes to procedures and control documents are
implemented in the design. Consider drawings and fabri
cation and manufacturing procedures. (71..107[c]) (72.146(c))
Verify the engineering change notice (ECN) control process.
Verify that the ECN process is proceduralized, approved,
and traceable. (71.107[c]) (72.146[c]) . .......

Verify that the drawing control process is proceduralized,

approved, and traceable. (71.107[c]) (72.146(c]) .....

Verify that the design modification review process is docu

mented, proceduralized, approved, and traceable. Verify
that the design modification review process is as comprehen
sive as the original design review. (71.107[c)) (72.146(c]))

Comments:
 APPENDIX C
INSPECTION ELEMENT 3
FABRICATION CONTROLS

45 NUREG/CR-6314
Element Inspection Criteria j Acceptable_ Remarks and Obsetvdons
3. Fabrication Controls

Verify that the fabrication process is controlled and verifiable from the onset of design through the completion of the assembly
process. Inhouse, contractor, or vendor supplied transportation packaging fabrication controls should be evaluated using
identical criteria.
3.1 Material Procurement

Verify that all aspects of the materials procurement are controlled, verifiable, and traceable from the time of purchase through
the life of the packaging or dry storage system.
Verify that the measures that control material procurement
are documented and implemented. (71.109 and 71.135X72.148
and 72.174)
Verify that procurement documents are controlled and re
trievable. Also verify that applicable codes, standards, and
regulations are referenced. (71.109, 71.115(b], and 71.135)
"(72.148, 72.154(b), and 72.174)
Verify that material traceability documentation is available
and auditable. (71.115[b) and 71.117) (72.154[b] and 72.156)
Verify that drawings and procedures used for procurement
are identified and consistent with specification. Verify that
any changes made to specifications are incorporated into
these documents.. (71.111) (72.150) . . ....
Comments:
rr,
Element
3.1
(cont.)
Inspection Criteria
Verify that procurments are made in accordance with these
latest approved specification changes? (71.111) (72.150)
Acceptable Remarks and Observations

..
I
C)
'U

I
C.,
Verify that suitable materials are specified and used in ac
cordance with design specifications, calculations, and models.
Verify that if materials are substituted, the new material is as
meet the same or higher quality requirements than the origi C)
nal material. Consider the following specifically but other
components may be considered: (71.115(a]) (72.154[al)
- seals - gaskets

Verify that rmaterial shelf life for safety related components

has been considered. (71.117) (72.156)
Verify that there is a receipt inspection program to ensure
compliance with procurement documents. Also ensure that
the results of the receipt inspections are documented and
retrievable. (71.11 5[b]) (72.154[b])
Verify that measures have been established that assure each
item is identified by heat number, part number, or other
appropriate means, either on the item or on records traceable
to the item. Verify the measures are required throughout 56
fabrication, installation, and use of the item.(71.117X72.1 )

3.2 Fabrication and Assembly

of fabrication and assembly
Verify that the fabrication and assembly process consists of procedures that ensure high standards
are implemented and practiced.
Comments:
 Element Inspection Criteria Acceptable Remarks and Observations
3.2. 1 Fabrication Processes

The fabrication process is separated into four areas, some of

which may not be applicable to a particular facility. Inspect only
the areas that are applicable.
Verify that fabrication and assembly procedures are docu
mented, approved, and implemented. Consider the follow
ing: (71.111) (72.150)
a. Verify that the appropriate codes, standards, and draw
ings, are identified and implemented. (71.105[b] and
71.119) (72.144[b] and 72.158)
b. Verify that the appropriate specifications are identified
and compliance ensured. (71.105[b] and 71.119)
(72.144[b) and 72.158)

'0
c. Verify that the applicable drawings are identified and
referenced. (71.111) (72.150)

d. Are hold points instituted?

e. Are hold points appropriately released?
Comment,^

0
z

I
 Inspection Criteria Acceptable "Remarks and Observations 'I
Ele-ent

3.2.1 Verify that process control measures for QA inspections and

(cont.) hold points, program reviews, documentation reviews, and 0
onsite controls for contractor work performed onsite are
established and functional. 'Consider the following: (71.111,
71.113, and 71.121) (72.150, 72.152, and 72.160)

a. Were the control measures performed when required?

b. Were the operational steps signed off when performed? E0

0.

c. Were the observations of the control measures within the

specifications?

d. Were noncompliances handled in accordance with the

noncomplianxe control program?
Verify that the tools, equipment, and measurement instru
ments required by each procedure are identified in fabrica
tion control documents. Verify that calibration requirements
and sensitivity ranges were adhered to at the time of each
use. (71.125) (72.164)
3.2.1.1 Cleaning

Verify that procedures involving cleaning processes are docu

mented, approved, and implemented. Verify that controls are
documented and implemented for the following: (71.119) (72.158)
Verify that appropriate cleaning fluids are identified and
specified, along with any cleanliness and/or chemistry con
trols. (71.111 and 71.127) (72.150 and 72.166)
Verify that guidelines for any cleaning process are specified.
(71.1.11 and 71.127) (72.150 and 72.166)
Comments:
 Element Inspection Criteria Acceptable Remarks and Observations
3.2.1.1 Verify the appropriate cleaning process is specified. Consid
(cont.) er the following cleaning processes: (71.111 and 71.127)
(72.150 and 72.166)
- NDE type processes - acid baths
- solvents.
3.2.1.2 Special Processes

Verify that the special process controls have been documented,

approved, and implemented. Special processes include welding,
NDE, brazing, lead pour, foam pour, heat treating, stress reliev
ing, forging, casting, rolling, and others. Verify that all proce
dures relating to special processes are reviewed and approved by
the appropriate personnel.
Verify that procedures for controlling and performing special
t processes are documented, approved, and implemented. Also
verify that the procedures are in compliance with the appli
cable codes, standards, specifications, criteria, and other
special requirements. (71.119) (72.158)
Verify that acceptance criteria and hold points for special
processes and inspections are documented, approvwd, and
implemented. (71.121) (72.160)

Verify that special process personnel controls have been

documented and implemented. Verify training requirements
and qualifications are reviewed and documented. Determine
if special process procedures are qualified prior to first use.
J_ (71.119) (72.158)
CL
Comments:
S"

,4., 0
z Element Inspection Criteria Acceptable Remarks and Observations
3...Io
Elmet___________I____________________
hedn rcse, osdrtefloigies
m
C.'
-S
0
3.2.1.2
(cont.)
For shielding processes, consider the following items:
(71.11i) (72.150)

a. For lead shield processes:

- ambient temperature
I
0I

- pour
- heating and cooling
- support
wall thickness guidelines
- acceptance criteria.

b. For uranium shield processes:

- oxidizing and hydriding controls

- heat treatment guidelines
- welding criteria and procedures
IJ - cladding procedures
- stainless steel sensitizing controls
- personnel requirements. - A

Verify that the controls implemented for NDE including

radiography, ultrasonic inspection, penetrant inspection, and
magnetic particle inspection are documented, approved, and
implemented. Verify the following: (71.119) (72.158)

The personnel used in NDE activities are qualified and

certified per written procedures.

The equipment used in NDE activities are suitable for

the application.

The NDE activities are performed satisfactorily and per

written procedures. The following are included:

Through observations ensure NDE activities are

performed satisfactorily. I a

Comments:. , ,
 Element Inspection Criteria Acceptable Remarks and Observatioes

3.2.1.2 - Second person verification of NDE activities are

(cont.) performed by qualified and certified individuals.
- The personnel used in NDE activities are qualified
and certifed.
- The personnel testing requirements are current
Verify that the controls implemented on welding activities
are documented, approved, and implemented. Verify the
following: (71.119) (72.158)

The personnel used in welding activities are qualified

and certified.
The equipment used in welding activities are suitable for
the application.

The personnel testing requirements are current.

The welding materials are adequately controlled so as to

prevent unauthorized use. Also the welding materials
are stored in compliance with storage requirements.
3.2.1.3 Machining

Verify that procedures involving machining processes are docu

mented and implemented.
Consider the following areas that may need to be addressed in the
machining procedures: (71.111) (72.150)
B.
Wy
- feed rates - cutting depths
Z - cutting rates - cooling fluids
- hold points - surface finish criteria 0
- personnel - acceptance criteria.

Comments:
4 Element
3.2.1.4 Assembly
Inspection Criteria

Verify the controls implemented for the assembly process. Con

Acceptable Remarks and Observations

'I
00

sider the following items.

Verify that assembly procedures have been documented,
approved, and implemented. (71.111) (72.150) .
Verify preparations for assembly are identified and com
pleted prior to commencing assembly. (71.111) (72.150)
verify that the iinished packag ns auduydi aonseStuz s ux
were assembled per the certified drawings. (71.111) (72.150) .......
3.2.2 Handling and Storage

Verify that adequate controls have been implemented to ensure

handling and storage processes are controlled, and traceable from
the start of the packaging and dry storage assembly processes to
storage.
Comments:

F
Element Inspection Criteria Acceptable Remarks and Observations
3.2.2.1 Handling and Storage Process
Review completed documents to verify whether acceptance
criteria are met, steps are performed in the proper order, correct
revisions of procedures were used, spare parts and materials are
controlled, and packagings and dry storage container systems are
traceable to the QA standards. (71.111 and 71.127) (72.150 and
72.166)
Determine whether the measures controlling the handling and
storage process are documented and implemented. (71.111)
(72.150)
Are the spare part inventories are identified in the procure
ment documents? (71.117) (72.156)
Are the spare part procurement and inventories controlled by
the QA Program? (71.109 and 71.117) (72.148 and 72.156)
Verify that material issuance and storage measures are docu
mented, approved, and implemented. (71.117) (72.156)
Verify that the material shelf life for safety-related compo
nents has been assessed. Verify whether material shelf life is
controlled so that material is not used after shelf life is ex
ceeded. (71.117) (72.156)
3.2.2.2 Protective Environment

Verify that the controls established to protect the product have

been documented and implemented..
Comments:

U C3

F,
 I
Inspection Criteria Acceptable Remarks and Observations
z Element

3.2.2.2 Consider the following environmental areas and their con

(cont.) trols: (7 1.127) (72.166) 0

3.3
inert gas
humidity

Test and Inspection

-
-
moisture content
temperature. .........
F
Verify that the tests and inspections are controlled and traceable, from the design basis events through testing and inspections up
to and including the review of closed-out procedures and inspection reports.

Verify that testing and inspection requirements are iden

I
tified, as appropriate, for hydrostatic/leak tests, shielding,
criticality, thermal loads, heavy lifts, and NDE. Consider the
following: (71.123) (72.162)

- Are tests performed using written and approved proce

dures?
- Are the test procedures reviewed an approved by appro
priate personnel?
- Are measures established that ensure prerequisites are
met prior to beginning the testing?

Comments:
 Element Inspection Criteria Acceptable Remarks and Observations

3.3 Verify that acceptance criteria are defined and compliance

(cont.) ensured. (71.123) (72.162)
Verify the suitability of test conditions. (71.123) (72.162)

- Were tests performed to the appropriate procedure revi

sion?
Verify that a completed document close-out review program
has been documented, approved, and implemented. Verify
that acceptance criteria are met, the steps were completed
satisfactorily, and procedures are acceptable. (71.123)
(72.162)
Verify that NDE procedures are appropriately reviewed,
approved, and controlled. Consider radiography, ultrasonic
inspection, penetrant inspection, and magnetic particle in
spection. (71.119 and 71.123) (72.158 and 72.162)
-4
Verify that the controls placed on the tools and equipment
calibration required for implementation of the testing and
inspection process are documented and implemented. Con
sider the following: (71.125) (72.164)
Comments:

0
0

A,
0
 Element Inspection Criteria f Acceptable Remarks and Observations

3.3 a. Verify whether tools and equipment are identified and

(cont.) controlled. Items to be considered include meters, gaug In
0
es, calipers, micrometers, torque wrenches, relief valves,
dial indicators, cranes, etc. (71.125) (72.164)
&
b.

c.
Verify if tool and equipment calibration requirements
are identified and controlled. (71.125) (72.164)
Verify that tool and equipment rated capacities and
I
sensitivities are identified, and actions taken to ensure
compliance. (71.125) (72.164)
d. Verify that tools and equipment used in test and inspec
tions can be identified by test. Also verify that the tools
and equipment are compatible with the test and inspec
tion needs (i.e., instrument ranges are compatible with
the test acceptance criteria). (71.123) (72.162)
Verify that established quality control hold points were
appropriately released. (71.111 and 71.121) (72.150 and
72.160)
Verify that a procedure controlling the operation of packag
ing and dry storage systems has been documented and imple
mented. The procedure should consider the status of inspec
tions or tests. (71.129) (72.168)
Verify that the measures to control the operating status of
packagings and dry storage systems have been documented
and implemented. The measures should prevent inadvertent
operations. (71.129) (72.168)
Ensure inspections are performed by individuals other than
those who performed the activity. (71.121) (72.160)

Comments:
 Element Inspection Criteria Acceptable Remarks and Observations

3.4 Tools and Equipment

Verify that procedures have been documented, approved, and implemented for tool and equipment controls. Verify that the
tools and equipment are controlled and traceable. The types of equipment of concern are meters, gauges, regulators, transmit
ters, sensors, torque wrenches, relief valves, cranes, etc. When inspecting and assessing this area, consider controls placed on the
tools and equipment storage and handling, controls (procedures, acceptance criteria, use tracking, qualifications of personnel,
etc.) placed on the their use, and the controls placed on ensuring they are ready for use (calibration records and deficiency
control).
Comments:

0.

0
'11
0

i
0~ I.
:2.

0
z

Q
7'3
Element
3.4
(cont.)
Inspection Criteria

Verify that the tools and equipment are identified, specified,

and controlled. (71.125) (72.164)
Verify that a testing and calibration program has been docu
Acceptable Remarks and Observations

I
C,

mented, approved, and implemented. Verify that calibra

tion and testing standards are traceable to national standards.
(71.125) (72.164)
Verify that tool and equipment rated capacities and sensitivi
ties have been identified and actions taken to ensure the
I
ranges and sensitivities are met. (71.125) (72.164)
Verify that tools and equipment uses are documented and
traceable to where and when used. (71.123) (72.162) _

Verify that when instruments are found to be out of calibra

tion, there is a procedure for justifying product quality for
the tests or inspections performed using the out of calibration
instruments. (71.123) (72.162)

Comments:
 APPENDIX D
INSPECTION ELEMENT 4
MAINTENANCE CONTROLS

61 NUREG/CR-6314
 Element Inspection Criteria Acceptable Remarks and Observations

4. Maintenance Controls

The maintenance process identifies and performs maintenance on the packagings and dry storage systems to ensure each will
meet its design task.
4.1 Maintenance Activities

Verify that maintenance activities consist of procedures and programs established to ensure that maintenance requirements are
identified and performed so that the packagings and dry storage systems are capable of performing their designed tasks.
Comments:

C:,

X.

-- • a I -- .. . .. i i ii • IIIIII I III IlI2

 I
Element Inspection Criteria Acceptable Remarks and Observations

4.1.1 Requirements

Verify that controls and guidelines are in place that ensure main

II
tenance is ;dentified and documented as required. Use the fol
lowing to inspect maintenance requirement identification.

Verify that a program for the identification of required

maintenance has been developed and implemented. (71.105[b]
and 71.127) (72.144[b] and 72.166)
Verify that acceptance criteria governing maintenance activi
ties are identified. These include tolerances, frequency of
replacements, and frequency of performance. (71.111)
(72.150)
Verify that a trending program for component failures and
maintenance has been developed and implemented.
(71.105[b] and 71.133) (72.144[b] and 72.172)
Verify whether maintenance QA hold points and verifica
tions are identified and follow specified guidelines.
(71.121) (72.160)

Comments:
 Element Inspection Criteria Acceptable Remarks and Observations

4.1.2 Procedures

Verify that documentation and controls are established to control

maintenance adequately. Consider the following:
Verify that procedures have been documented, approved,
and implemented for the performance of all maintenance
activities. Include consideration for the manufacturers and
suppliers providing any changes to the maintenance'program
when deemed necessary. (71.111), (72.150)
Verify that a root cause analysis program is in placed for
determining the root causes of failures. (71.133) (72.172)
Verify that adequate maintenance requirements are provided.
(71.105[b)) (72.144[b]) ..

4.1.3 Maintenance Personnel

Verify maintenance personnel controls are documented and

implemented, consider management controls. The inspection
criteria are listed below.
Verify personnel qualification requirements are identified
and met. Verify qualification exams and/or required educa
tional and experience levels are appropriate as required.
(71.105[d)) (72.144[d])
Comments:

I
C,
0I
 Element Inspection Criteria Acceptable Remarks and Observations

P
0'
4.1.3
(cont.)
Verify that appropriate levels of personnel training are pro
vided for staff
maintenance in quality
activities control, shipping
as applicable. and receiving,
(71.105d]) (72.144(d])and _

4.1.4 Maintenance Materials

Verify that the materials control process, including the effec

tiveness of identifying materials, materials receipt inspections,
controls for storage and handling before use, and materials trace
ability. .....
Verify if appropriate materials have been used and are avail
able when maintenance is performed. Verify the materials
are traceable. Consider procurement documents, specifica
tions, design documents, test procedures, and past mainte
nance actions. (71.109, 71.111, and 71.115(a))(72.148,
72.150, and 72.154(a])
Verify that shipping, handling, and receiving requirements
are identified and followed if required. (71.105[b] and
71.115[b]) (72.144[b] and 72.154[b])
Verify material specifications and part substitutions. Deter
mine if shelf life requirements for degradable materials are
applicable. (71.109, 71.115[b], and 71.135) (72.148, 72.154(b],
and 72.174)
Has a spare parts inventories have been addressed where ap
propriate? (71.105[b]) (72.144[b])
Verify that the material procurement process is adequately
controlled and documented. Consider the following:
a. Verify procedures for control of materials have been
documented, approved, and implemented. (71.111)
(72.150)

Comments.

' I I I I Il II IIIl I

I
 Element Inspection Criteria Acceptable Remarks and Observations

4.1.4 b. Verify that material traceability has been assured.

(cont.) (71.115[b], 71.117, and 71.135) (72.154(b], 72.156,
72.174)
c. Verify that material storage, handling, and issuing have
been addressed. (71.115[b], 71.117, and 71.127)
(72.154[b], 72.156, and 72.166)
42 Tools and Equipment

Verify that controls that have been established and implemented for the identification and control of tools and equipment neces
sary for packaging maintenance. Consider meters, gauges, calipers, regulators, transmitters, sensors, micrometers, torque wren
ches, relief valves, dial indicators, cranes, etc.
Verify that the tools and equipment necessary for safe and
controlled maintenance are identified and specified. (71.125)
(72.164)
0', Verify that the tools and equipment for calibration and
testing requirements are identified and controlled. Verify
that a testing and calibration program has been documented,
approved, and implemented. Verify that the calibration and
testing standards are traceable to national standards. (71.125)
(72.164)
Comments:

I
W
73
-S
0
 -| iI i ii- ,=

Element Inspection Criteria Acceptable ,Remarks and Observations

P 4.2
(cont.)
Verify that tool and equipment are appropriately used within
their rated capacities and sensitivities. (71.125) (72.164)
Verify that tool and equipment uses are documented and
I?
traceable to where and when used. (71.123) (72.162)
Verify that when instruments are found to be out of calibra
tion, there is a procedure for justifying product quality for
the tests or inspections performed using the out of calibration
instruments. (7 1.123) (72.162)

Comments:
 69
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QUALITY ASSURANCE PEKFORMANCE
(Roed)
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B (vivo) - N.2 uPplicalblo, not awalustoed. or INSPECTION SUMMARY TREE

issuffloIoat data.

-J

U
C-,
Figure 4. Quality assurance performance inspection summary tree.
M•OFOsM U.S. NUCLEAR REGULATORY COMWION I. REPORT NUMBER
BIBLUOGRAPHIC DATA SHEET
(SW h~anicti"on gs)
OR tiW

2. TITLE ^ANSITITLE NUREG/CR-631 4

INEL-95/0061
iQuality Assurance Inspections for 3. DATE REPORT PUBLISHED

"Shipping and Storage Containers ONT64 j YEAR

April 1996
4. FIN OR GRANT NUMBER

L1179
6. TYPE OF REPORT
k, AUTHORIS;

H. M. Stromberg, G. D. Roberts, and J. H. Bryce Technical

7. PERIOD COVERED uo ,'.* r

I1 PE•R FORMING ORGAN IZAT ION - NAME AND ADDRESS I R , O O-. , .;N< lk€ ¢* •,•,, • .= #,m,,,.

Idaho National Engineering Laboratory

Lockheed Idaho Technologies Company
P. 0. Box 1625
Idaho Falls, ID 83415
e "Sbw. .
9. SPONSOR ING ORGANIZATION - NAME AND ADDRESS ItI NRC. tvyp' .w .1coMrAw. pwdd.. NRC DU•o, OaII., o• R.9ow. U .m.NM.• A9. JotO, Can.,awwo.,,

Spent Fuel Project Office

Office of Nuclear Material Safety and Safeguards
U. S. Nuclear Regulatory Commission
Washington, D. C. 20555-0001
I II
I I

10 SUPPLEMENTARY NOTES
D. G. Reid, NRC Technical Monitor
11. ABSTRACT f"0 wwo o in

This document is a guide for conducting quality assurance inspections of transportation during an
packaging and dry spent fuel storage system suppliers. This document is used Federal
inspection to determine regulatory compliance with Title 10 of the Code of
Part 72,
Regulations, Part 71, Subpart H; Title 10 of the Code of Federal Regulations,
21, and quality
Part
Subpart G; and Title 10 of the Code of Federal Regulations, for transportation
assurance program commitments. The guidance provides a framework
are provided
packaging and dry spent fuel storage system inspections. Inspectors
with the flexibility to adapt the methods and concepts to meet the inspection
a
requirements for the particular facility. This guide was developed to provide each
structured and consistent approach for inspections. The method separates
guidelines,
performance element into several areas for inspection and identifies area. This document
based on regulatory requirements, to qualitatively evaluate each
to facilitate the quality assurance
was also developed to serve as a field manual
inspection activities.

12 KEY ~ ~r''-P~. ~ " 3 AVAILA6ILiTV'StAtEkMENT

1OOfECP~Sf,,~"~

Supplier Unlimited
144ECURIIY CLASSII ON
Package Supplier
Container Supplier Inspection Guide IT.""
Uncl assified
Transportation Package "n"1"
Spent Fuel Dry Storage System Uncl assified
Packaging inspection and evaluation methodology 15 NUMBEROF PAGES

16 PRICE

INC # UA0 3JIAIJ)'8