IP 43004
https://www.nrc.gov/docs/ML1328/ML13280A478.pdf
text
Issue Date: 11/29/13 1 43004
NRC INSPECTION MANUAL DCIP/EVIB
INSPECTION PROCEDURE 43004
INSPECTION OF COMMERCIAL-GRADE DEDICATION PROGRAMS
PROGRAM APPLICABILITY: 2504, 2507, 2515C
43004-01 INSPECTION OBJECTIVES
01.01 To verify that the dedicating entity’s commercial-grade dedication program satisfies the
requirements of Appendix B to 10 CFR Part 50 (Appendix B) with regard to the procurement
and acceptance of commercial-grade items (CGIs) for use as basic components in accordance
with 10 CFR Part 21.
01.02 To verify that the dedicating entity’s process for dedicating CGIs, as implemented,
meets the applicable portions of Appendix B and provides reasonable assurance that CGIs will
perform their intended safety function.
01.03 To verify that the licensee's process for dedicating CGIs, as implemented, meets the
applicable portions of Appendix B to 10 CFR Part 50 and provides reasonable assurance that
CGIs will perform their intended safety function.
43004-02 INSPECTION REQUIREMENTS
02.01 Verify that the dedicating entity has established adequate controls for performing
technical evaluations of items or services to be dedicated. This includes the review of materials,
parts, equipment, and processes for suitability of application as established in Criterion III of
Appendix B.
02.02 Verify that the dedicating entity has established adequate controls for the acceptance of
a CGI using the criteria established in Criterion VII of Appendix B.
02.03 Verify that the dedicating entity has properly developed and implemented a plan for
commercial-grade dedications.
02.04 Verify that there are adequate controls for the acceptance of items procured that were
dedicated by a third party.
02.05 Inspection of failed safety-related CGI
a. Initial Evaluation. After reviewing the dedicating entity’s evaluation of the failed item,
determine if the failed item was procured as a CGI and dedicated for safety-related
applications. If the failed item was dedicated, review the complete procurement and
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dedication records to determine if the commercial grade dedication process was
sufficiently thorough.
b. Further Assessments. If it is determined that the dedicated item failed as the result of
certain critical characteristics not being identified and/or properly verified, perform the
following assessments:
1. Determine if other CGIs from the same accepted lot or batch as the failed
dedicated CGI have been similarly dedicated and installed in other safety-related
applications. If yes, determine if the licensee has evaluated the operability of the
systems or components where these CGIs are installed. The inspector also
should review dedicating entity provided data, if available, for some CGIs (nondedicated) that failed in applications that were not safety-related. Explore the
possibility that the same CGIs also may have been used (following dedication) in
a safety-related application and may have the potential to affect the safe
operation of a safety-related structure, system or component (SSC).
If possible select and evaluate, as in step 1 above, at least three other dedicated
CGIs having similar applications and critical characteristics as the CGI(s) that
resulted in the identified failures.
2. If, after performing step 1 above, it is determined that there were weaknesses in
the commercial grade dedication process, the inspector should perform a more
comprehensive inspection of the dedicating entity’s dedication process in
accordance with the inspection requirements in Section 02.01, 2.02, and 2.03
above.
43004-03 INSPECTION GUIDANCE
The inspector should verify that the entity inspected has a dedication program that meets the
applicable portions of Appendix B and 10 CFR Part 21.
03.01 Verify that the dedicating entity has established adequate controls for the technical
evaluation of the items or services to be dedicated.
a. Technical Evaluations. Technical evaluations are conducted and documented by the
responsible engineering organization. Technical evaluations identify the necessary
technical and quality requirements that ensure the item will meet the intended design
conditions. These requirements should include:
1. Determination of the item’s safety function, performance requirements,
component/part functional classification, and application requirements (e.g.,
service conditions).
2. Review of the vendor’s technical data as well as industry operating experience,
including feedback from previous dedication activities, NRC bulletins and
information notices, supplier information letters, available industry data, and
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customer feedback to identify relevant technical information that may affect the
suitability of the item.
3. Performance of a Failure Modes and Effects Analyses (FMEA), if necessary to
identify the credible failure mechanisms of the item in the specific application
under consideration.
4. The identification of the item’s critical characteristics based on the information
developed above that will assure the suitability of all parts, materials, and
services for their intended safety-related applications. Factors that should be
considered include:
(a) The important design, material, and performance characteristics that have
a direct effect on the item's ability to accomplish its intended safety
function.
(b) Active/passive safety-related functions, system safety/non-safety
interfaces, and system compatibility under all design basis conditions.
(c) Any changes in design, material, or manufacturing process that could
impact the functional characteristics of the item.
(d) Appropriate interface with the vendor to identify and characterize the
design and functional parameters of specific parts.
(e) The number and nature of the critical characteristics are to be based on
the intended safety function, application requirements, complexity, credible
failure modes and effects, and performance requirements of the item.
(f) Those critical characteristics that cannot be effectively verified during postreceipt inspection and testing should be identified in order to apply an
appropriate verification method during the manufacturing process.
The identified critical characteristics that are important for the item to perform its
safety function, as determined in the technical evaluation, are to be verified. Not
all design requirements need to be considered critical characteristics; however,
dedicating entities must assure the suitability of all parts, materials, and services
for their intended safety-related applications. This may involve the performance
of surveys, special tests and/or inspections, or source verification on commercialgrade vendors as part of the vendor selection process to verify the adequacy of
the vendor controls (see Acceptance Methods section below).
Determination of the appropriate verification methods for each critical
characteristic.
Identification of the acceptance criteria for the verification method used
consistent with the plant-specific application.
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Additional considerations for dedication of CGI for applications requiring
environmental or seismic qualification:
(a) Utilization of non-destructive methods to verify the critical characteristics of
the item to provide reasonable assurance that each individual commercialgrade item will perform in the design-basis accident/event harsh
environment (e.g., loss of coolant accident, high-energy line break,
Operating basis earthquake or safe-shutdown earthquake). Like-for-like
replacements should demonstrate performance equal to or better than the
qualified prototype.
(b) The commercial-grade item’s safety function(s), functional performance
requirements, and acceptance criteria determinations should include
design service conditions (harsh environment, seismic).
(c) Seismic and environmental qualification should be treated as critical
characteristics to be verified, as necessary.
b. Like-for-Like Commercial-Grade Item Replacements. A like-for-like replacement is a
replacement of an item with one that is identical. Characteristics of like-for-like items
are described below. A like-for-like replacement may be considered identical if:
The replacement item was purchased from the same vendor (successor
companies may be accepted), provided all design, materials, or manufacturing
processes are kept the same, or
The replacement item was purchased at the same time and from the same
vendor as the item it is replacing. For example, the item has the same
manufacturing time frame as determined by the date purchased or date shipped
from factory, date code, same batch or lot number.
A like-for-like determination should not be based solely on the selection of a
commercial-grade vendor with items manufactured to meet the same industry
standards of the item that was originally supplied. Meeting the same industry
standards may be a necessary condition, but is not a sufficient condition for a like-forlike determination.
An equivalency evaluation is needed if:
Differences from the original item are identified in the replacement item, then the item is
not identical, but similar to the item being replaced, and an equivalency evaluation is
necessary to determine if any changes in design, material, manufacturing process,
safety, form, fit, function or interchangeability could impact the alternate replacement
item’s ability to function under all design conditions (including design-basis event
conditions) and ultimately the component's ability to perform its required safety
function.
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1. Equivalency evaluations should not be used as the sole basis to accept a CGI for
safety-related use. The identified critical characteristics should still be verified for
acceptance of the item.
2. If the dedicating entity can demonstrate that the replacement item is identical in
its equivalency evaluation, then the safety function, design requirements and
critical characteristics need not be redetermined. However, item acceptance,
qualification of vendors and examination of products is still required.
03.02 Verify that the dedicating entity inspected has established adequate controls for the
acceptance of a CGI. The following are the four acceptance methods:
a. Method 1: Special Test and Inspections. Special test and inspections should be used
after the CGI is received for verification of critical characteristics to assure that the
purchased material, equipment, or service, whether purchased directly or through
contractors and subcontractors, meet the technical and quality requirements.
Tests and inspections specified for acceptance are to be documented in a plan or
checklist that should include:
- The tests and inspections to be performed
- The test methods and inspection techniques to be utilized
- Verification of the identified critical characteristics consistent with the
acceptance criteria determined in the technical evaluation
- Documentation of the inspection and test results
Receipt inspection activities should be used to establish and maintain traceability of
CGIs.
Inspections should include verification of objective evidence and performance of visual,
dimensional, electrical, and mechanical inspections, or tests (as necessary) to assure
product and material quality.
1. Functional tests before installation and/or operational tests after installation may
be performed to verify critical characteristics of the CGI.
Measuring and test equipment should be properly calibrated. Qualified
personnel should be used to perform the tests.
2. Sampling plans for testing should be used in accordance with nationally
recognized industry standards, and should have an adequate documented
technical basis. This technical basis includes homogeneity, complexity of the
item, lot/batch control for items, heat traceability for materials, and adequacy of
the vendor’s controls as confirmed by a survey. Other means of demonstrating
adequate lot/batch control may include satisfactory performance history and the
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3. Results of receipt inspections/testing. When such methods are used as a basis
for developing product sampling strategy, they should be supported by
documented objective evidence. The CGI sampling process should be
documented to develop the necessary objective evidence of the vendor’s ability
to consistently provide acceptable items.
4. When the verification of one or more critical characteristics is based on vendorcertified material test reports or certificates of conformance/compliance, the
validity of these documents should be verified (see Method 2 below). The
purchaser should verify that the vendor has established adequate traceability
controls and that these controls are effectively implemented. When distributors
are included in the supply chain, the activities of these distributors may need to
be surveyed to ensure that traceability and proper storage conditions are
maintained. Acceptance of an item using this method will be completed by
performing a receipt inspection that includes the accompanying vendor’s
certificate of conformance/compliance or certified material test report.
5. Reliance on part number verification and certification documentation alone on
receipt is insufficient to ensure the quality and suitability of commercially
procured products.
b. Method 2: Commercial-Grade Survey of Supplier. Commercial-grade surveys should
be used when the purchaser desires to verify one or more critical characteristics based
on the merits of a vendor’s commercial quality controls.
Commercial-grade surveys should be conducted at a sufficient frequency to ensure that
the process controls applicable to the critical characteristics of the procured item
continue to be effectively implemented. Factors to be considered in determining the
frequency of commercial-grade surveys include the complexity of the item, frequency of
procurement, receipt inspection, item performance history, and knowledge of changes
in the vendor's controls.
Acceptance Method 2 should not be employed as the sole basis for accepting items
from vendors with undocumented commercial quality control programs or with
programs that do not effectively implement their own necessary controls.
The entity should have a documented and effectively implemented program and/or
procedures to control the critical characteristics of the item(s) being procured.
1. The survey should be conducted by an individual(s) that is also trained in
auditing and knowledgeable in the operation of the item(s) and the associated
critical characteristics to be verified. The verification is accomplished by
reviewing the vendor's program/procedures controlling these characteristics and
observing the actual implementation of these controls in the manufacture of items
identical or similar to the items being purchased.
2. Critical characteristics that are not adequately controlled should be addressed by
the contract requiring the vendor to institute additional controls or by utilizing
other verification methods.
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3. If the vendor's controls are determined to be satisfactory, purchase orders for
these items should invoke these controls as contract requirements by referencing
the applicable program/procedure(s) and revision. Specific controls reviewed
and accepted during the survey should be implemented during the manufacturing
process.
4. Commercial-grade survey plans should include the identification of the item or
items for which the vendor is being surveyed, identification of the critical
characteristics of these items that the vendor is expected to control, identification
of the controls to be applied (program/procedure and revision), and a description
of the verification activities performed.
5. For survey reports prepared by third parties (e.g., a Nuclear Procurement Issues
Committee (NUPIC) joint or member survey), the following factors should be
considered:
(a) Review and acceptance of the surveyors’ procedure(s), checklists, and
personnel (e.g., the NUPIC commercial-grade survey procedure and
checklist).
(b) Ensure that the survey is critical characteristic-specific and plant
application-specific.
(c) The survey report should demonstrate that the critical characteristics
required for the purchaser's own application are in fact verified to be
controlled by the vendor.
6. Actual handling of the item by a distributor should be addressed in terms of the
distributor's controls (e.g., segregation of customer returns). However, other
factors may be taken into account that may warrant the need for a distributor
survey, such as:
(a) The need for documented, verifiable traceability to the original equipment
manufacturer.
(b) Presence and integrity of original equipment manufacturer
packaging/markings, etc.
(c) The susceptibility of the item to undetectable damage or tampering.
(d) History or experience with the particular vendor and distributor(s).
A survey of the distributor may not be necessary if there is a low probability of a
distributor being able to have any effect on the condition of an item merely by
having it in its physical possession, and where the distributor has rigorous
controls on items during possession.
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Acceptance Method 2 should not be employed as the basis for accepting items
from distributors unless the survey includes the part manufacturer(s) and the
survey confirms adequate controls by both the distributor and the part
manufacturer(s).
7. The dedicating entity is responsible for the control of subsuppliers of parts,
materials, or services. The dedicating entity is required to impose the necessary
controls on subsuppliers consistent with the importance of the subcontracted
item or service. Control of subsuppliers should also be adequately addressed by
survey so that the supplier has an adequate basis to accept test results and
certifications.
8. A certificate of conformance or certified material test report by the original
equipment manufacturer/vendor or material supplier may be acceptable,
provided:
(a) Documented, verified traceability to the original equipment manufacturer
has been established, and
(b) The purchaser has verified that the original equipment manufacturer or
material supplier has implemented adequate quality controls for the activity
being certified.
c. Method 3: Source Verification. Method 3 involves witnessing quality-related activities
before releasing the CGI from the vendor or test laboratory facility to confirm by direct
observation that the selected critical characteristics of the item being procured are
satisfactorily controlled by the vendor. Source verification could also be used when
specialized tests and/or inspections are required to verify selected critical
characteristics and the equipment to perform these tests is available only at the
vendor’s facilities.
1. Source verifications should be controlled by a documented plan. Factors to be
considered in the plan include:
(a) The identification of a specific process of interest that may be correlated
with a manufacturing or testing phase.
(b) The verification method utilized to verify the critical characteristics for
acceptance.
(c) Appropriate hold points to verify design, material, and performance
characteristics during manufacture and/or testing relevant to the safety
function of the item when those characteristics cannot be verified after the
item has been completely manufactured.
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(d) A dedicating entity inspector(s) who performs direct observations of the
verification of a commercial-grade item’s critical characteristics and
manufacture at the supplier facility. The inspector(s) should be a technical
specialist skilled in audit practice and knowledgeable in operation of the
item(s) and the associated critical characteristics to be verified.
(e) Documentation of the source verification results. This includes the critical
characteristics for acceptance and the actual results obtained during
verification. Deficiencies observed should be corrected by the supplier
before shipping.
2. The dedicating entity inspector authorizes shipping and establishes initial
traceability.
d. Method 4: Acceptable Supplier/Item Performance Record. This method could be used
to demonstrate one or more critical characteristics based upon documented acceptable
item performance.
1. Examples of such documented performance records include: acceptable quality
control of critical characteristics, or acceptable industry-wide performance. The
use of industry-wide performance should not be employed alone unless the
established documented performance record is based on industry-wide
performance data that is directly applicable to the item's critical characteristics
and the intended safety-related application.
Information pertinent to the commercial-grade item’s quality of performance
obtained from outside sources (e.g., operational event reports, NRC, vendor
equipment technical information program, and Institute of Nuclear Power
Operations) and from commercial-grade surveys, source verifications, receipt
inspections, previous dedication or qualification, and operational history is
factored into the dedication process.
2. This method should be used in combination with one or more of the methods
explained above to collect the objective evidence necessary to ensure
acceptable historical performance of the supplier.
03.03 Review a representative sample of dedication packages to assess whether procedures
for dedication activities have been adequately planned and implemented.
a. Verify that the dedication process identifies those design, material, and performance
characteristics relevant to the safety function as described in Section 03.01 of this
procedure.
b. Verify that the dedicating entity demonstrated that the critical characteristics are met
using appropriate acceptance methods as described in Section 03.02 of this procedure.
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03.04 Review a representative sample of procurement documents for items dedicated by a
third party.
a. Verify that the procurement documents have adequate controls for the dedicating entity
and the proper critical characteristics and acceptance methods were used for the
dedication.
b. Verify that receipt inspections performed adequately check for the acceptance of the
dedicated item.
c. Verify that upon receipt any restrictions to the use of the dedicated item are clearly
documented so that the item is only used in an application that is prescribed in the
procurement documents.
03.05 As needed Inspection of licensee’s CGD
a. Initial Evaluation. A failure resulting from general weaknesses in the commercial grade
dedication program may occur when the important design, material, and performance
characteristics that are necessary to provide reasonable assurance that the dedicated CGI will
perform its intended safety function are not addressed during dedication.
1. Review and discuss with dedicating entity personnel the failure/root-cause analysis
when required or applicable for the failed CGI. Look for failures due to weaknesses in the
commercial grade dedication process.
2. Review the dedication package as described in Section 03.01 to determine if
appropriate critical characteristics had been identified by the licensee. Appendix A to this
inspection procedure should not be interpreted as inspection requirements but only as a
discussion of dedication issues including guidance on selection and verification of critical
characteristics.
b. Further Assessments
1. From the list of dedicated items provided by the licensee, the inspector should select
for review other dedication packages having similar applications and critical characteristics as
the CGI(s) that resulted in the identified failures.
2. Request that the dedicating entity compile a complete package of all the procurement
and dedication records for each item. Typical contents of a dedication package are described in
Appendix C of this inspection procedure. Review the dedication packages as described in
Appendix B of this inspection procedure.
03.06 Definitions.
a. Basic component: A structure, system, component, or part thereof that affects its safety
function necessary to assure:
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The integrity of the reactor coolant pressure boundary;
The capability to shut down the reactor and maintain it in a safe shutdown
condition; or
The capability to prevent or mitigate the consequences of accidents which could
result in potential offsite exposures comparable to those referred to in 10 CFR 50.34(a)(1), 10 CFR 50.67(b)(2), or 10 CFR 100.11, as applicable.
Basic components are items designed and manufactured under a QA program
complying with Appendix B to 10 CFR Part 50, or commercial-grade items which have
successfully completed the dedication process.
In all cases, a basic component includes safety-related design, analysis, inspection,
testing, fabrication, replacement of parts, or consulting services that are associated with
the component hardware whether these services are performed by the component
supplier or others.
b. Certificate of Compliance: A document attesting that the materials are in accordance
with specified requirements.
c. Certified Material Test Report (CMTR): A document attesting that the material is in
accordance with specified requirements, including the actual results of all required
chemical analyses, treatments, tests, and examinations.
d. Commercial-grade item: A structure, system, or component, or part thereof that affects
its safety function that was not designed and manufactured as a basic component.
e. Commercial-grade survey: Activities conducted by the purchaser or its agent to verify
that a supplier of commercial-grade items controls, through quality activities, some or all
of the critical characteristics of the designated commercial-grade items to be
purchased. The verification can be used as a method to accept those characteristics.
The commercial grade survey should include verification of the supplementary
documentation and the effective implementation of the commercial-grade quality
program.
f. Commercial-grade dedication package: An auditable collection of documents that is the
result of the commercial-grade dedication process for a specific item and specific safety
function. These documents contain the technical and quality basis for satisfying the
commercial-grade item dedication process, and provide the objective evidence to
reasonably assure that the dedicated commercial-grade item will perform its required
safety function.
g. Critical characteristics: Those important design, material, and performance
characteristics of a commercial-grade item that, once verified, will provide reasonable
assurance that the item will perform its intended safety function.
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h. Dedicating entity: The organization that performs the dedication process. Dedication
may be performed by the manufacturer of the item, a third-party dedicating entity,
and/or the licensee itself. The dedicating entity is responsible for identifying and
evaluating deviations, reporting defects and failures to comply for the dedicated item,
and maintaining auditable records of the dedication process. (10 CFR Part 21)
i. Dedication: An acceptance process undertaken to provide reasonable assurance that a
commercial-grade item to be used as a basic component will perform its intended safety
function and, in this respect, is deemed equivalent to an item designed and
manufactured under an Appendix B, quality assurance program. This assurance is
achieved by identifying the critical characteristics of the item (not required in like-for-like
replacements) and verifying its acceptability by inspections, tests, or analyses
performed by the purchaser or third-party dedicating entity after delivery (Method 1),
supplemented as necessary by one or more of the following: commercial-grade surveys
(Method 2), product inspections or witness at holdpoints at the manufacturer's facility
(Method 3), and analysis of historical records for acceptable performance (Method 4).
In all cases, the dedication process must be conducted in accordance with the
applicable provisions of Appendix B. (10 CFR Part 21).
j. Engineering Judgment: A process of logical reasoning performed by a qualified
individual that leads from stated premises to a conclusion. This process should be
supported by sufficient documentation to permit verification by a qualified individual.
k. Like-for-like Replacement: Replacement of an item with one that is identical.
l. Procurement Document: A contract that defines the technical and quality requirements
that must be met in order to be considered acceptable by the purchaser.
m. Source Verification: Activities witnessed at the supplier's facilities by the purchaser or
its agent before releasing the CGI from the vendor or test laboratory facility to confirm
by direct observation that the selected critical characteristics are verified by the vendor.
n. Traceability: The ability to verify the history, location, or application of an item by
means of recorded identification. Traceability to the manufacturer is required when the
manufacturer is relied upon to verify one or more critical characteristics.
43004-04 RESOURCE ESTIMATE
Inspection resources necessary to complete this inspection procedure are estimated to be 160
hours of direct inspection per facility.
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43004-05 REFERENCES
10 CFR Part 21, "Reporting of Defects and Noncompliance."
10 CFR Part 50, Appendix B, "Quality Assurance Criteria for Nuclear Power Plants and Fuel
Reprocessing Plants."
U.S. Nuclear Regulatory Commission, Generic Letter 89-02, Actions to Improve the Detection of
Counterfeit and Fraudulently Marketed Products.@ NRC: Washington, DC. March 21, 1989.
(ADAMS Accession No. ML031140060)
U.S. Nuclear Regulatory Commission, Generic Letter 91-05, Licensee Commercial-Grade
Procurement and Dedication Programs. NRC: Washington, DC. April 9, 1991. (ADAMS
Accession No. ML031140508)
ANSI/ASME NQA-1, "Quality Assurance Program Requirements for Nuclear Facility
Applications."
EPRI NP-5652, "Guideline for the Utilization of Commercial - Grade Items in Nuclear SafetyRelated Applications (NCIG-07)."
EPRI TR-102260, “Supplemental Guidance for the Application of EPRI Report 5652 on the
Utilization of Commercial Grade Items.”
EPRI NP-6406, "Guidelines for the Technical Evaluation of Replacement Items in Nuclear
Power Plants (NCIG-11)."
EPRI NP-6629, "Guidelines for the Procurement and Receipt of Items for Nuclear Power Plants
(NCIG-15)."
EPRI NP-6630, "Guidelines for Performance - Based Supplier Audits (NCIG-16)."
EPRI NP-6895, "Guidelines for the Safety Classification of Systems, Components, and Parts
Used in Nuclear Power Plant Applications (NCIG-17)."
EPRI NP-7218, "Guideline for the Utilization of Sampling Plans for Commercial - Grade Item
Acceptance (NCIG-19)."
EPRI TR-1019163, “Plant Support Engineering: Counterfeit, Fraudulent and Substandard ItemsMitigating the Increasing Risk.”
EPRI TR-017218-R1, “Guideline for Sampling in the Commercial-Grade Item Acceptance
Process."
Manual Chapter 2504, “Construction Inspection Program Inspection of Construction and
Operational Programs.”
Manual Chapter 2507, “Vendor Inspections.”
END
Issue Date: 11/29/13 14 43004
Appendices:
A. Dedication Issues
B. Contents of Dedication Packages
Attachment:
Revision History for IP 43004
Issue Date: 11/29/13 AppA-1 43004
APPENDIX A DEDICATION ISSUES BASIS FOR THE SELECTION AND VERIFICATION OF CRITICAL CHARACTERISTICS
1. Consideration of Item's Safety Function
Critical characteristics of a commercial grade item (CGI) should be based on the item's safety
function. The licensee is responsible for (a) identifying the important design, material, and
performance characteristics that have a direct effect on the item's ability to accomplish its
intended safety function and (b) selecting from these characteristics a set of critical (or
acceptance) characteristics that, once verified, will provide reasonable assurance that the item
will perform its intended safety function. The selection of critical characteristics for verification
can be based on a graded approach consistent with the item's importance to safety. When an
existing equipment specification is available that contains adequate technical requirements for
the item being purchased, that specification can be used to select the critical characteristics for
this item.
2. Graded Quality Assurance
Criterion II of Appendix B to 10 CFR Part 50 provides for the application of quality assurance
over activities affecting the quality of structures, systems, and components to an extent
consistent with their importance to safety. The application of graded quality assurance to the
CGI dedication process should include consideration of the item's importance to safety and
other factors specific to the item being procured. Certain items and services may require
extensive controls throughout all stages of development while others may require only a limited
quality assurance involvement in selected phases of development. The following factors should
be considered in determining the extent of quality assurance to be applied: (a) The importance
of malfunction or failure of the item to plant safety, (b) the complexity or uniqueness of the item,
(c) the need for special controls and surveillance over process and equipment, (d) the degree to
which functional compliance can be demonstrated by inspection and test, and (e) the quality
history and degree of standardization of the item. Additional guidance on the use of graded
quality assurance can be found in the non-mandatory appendix to ANSI N45.2.13-1976.
3. Consideration of Failure Modes
An evaluation of credible failure modes of an item in its operating environment and the effects of
these failure modes on the item's safety function may be used in the safety classification of an
item and as a basis for the selection of critical characteristics.
4. Reasonable Assurance
The dedication process represents an acceptable method of achieving compliance with
Appendix B to 10 CFR Part 50 with the purchaser assuming many of the responsibilities for
ensuring quality and functionality of an item that had previously been the responsibility of the
vendor. In this context, reasonable assurance consists of the purchaser controlling or verifying
the activities affecting the item's quality to an extent consistent with the item's importance to
safety or ensuring that these activities are adequately controlled by the supplier.
Issue Date: 11/29/13 AppA-2 43004
For more complex items, dialogue with the original equipment manufacturer may be necessary
to identify the design and functional parameters of specific piece parts. Once the dedication
process is completed, the quality assurance and/or other measures applied to those aspects of
the item that directly affect its safety function should result in the same level of performance as
for a like item manufactured or purchased under a quality assurance program of Appendix B to
5. Engineering Judgment
Engineering judgment can be used in selecting those important design, material, and
performance characteristics that are identified as the item's critical characteristics. The bases
for engineering judgment utilized in the selection process should be documented.
TRACEABILITY
Material/Items Purchased From Distributors
Traceability can be defined as the ability to verify the history, location, or application of an item
by means of recorded identification. Where the item's acceptance is based entirely or partially
on a certification by the manufacturer, the traceability must extend to the manufacturer. The
purchaser should ensure by survey or by other means that the manufacturer has established
adequate traceability controls and that these controls are effectively implemented. For
situations in which intermediaries (distributors) are included in the supply chain, the activities of
these organizations may need to be surveyed to ensure that traceability and proper storage
conditions are maintained. A survey of the distributor may not be necessary if the distributor
acts only as a broker and does not warehouse or repackage the items or in cases where
traceability can be established by other means such as verification of the manufacturer's
markings or shipping records. Inspectors should be mindful of potential Counterfeit, Fraudulent
or Suspect Items in the supply chain and can question the purchaser on their assurances and
best practices to avoid acceptance of those items.
SAMPLING
1. Established Heat Traceability (Materials)
When heat traceability of metallic material has been established and each piece of the material
is identified with the material heat number, chemical analysis and destructive testing required for
the acceptance of this material may be performed on one piece of the material. The same
rationale may be used for the acceptance of containers of nonmetallic materials such as
lubricants providing that traceability has been established and each container is identified with a
unique mix or batch number.
Issue Date: 11/29/13 AppA-3 43004
2. Established Lot/Batch Control (Items)
When lot/batch (defined as units of product of a single type, grade, class, size, and composition,
manufactured under essentially the same conditions and at essentially the same time) control is
established through a commercial grade survey, the party performing dedication of such items
can use sampling prescribed by standard statistical methods that are based on homogeneous
product lots. Such sample plans should be identified and should provide for the verification of
the critical characteristics with a confidence level consistent with the item's importance to safety.
Other means of demonstrating adequate lot/batch control may include satisfactory performance
history and the results of receipt inspection/testing. When such methods are used as a basis for
developing product sampling strategy, they should be supported by documented objective
evidence.
3. Material and Items with No Lot/Batch Control
When lot/batch control cannot be established, sampling plans need to be considered on
individual, item-specific basis and ensure that they are capable of providing a high level of
assurance of the item's suitability for service. There may be situations where each item needs
to be tested.
COMMERCIAL GRADE SURVEYS
1. Verification of Vendor's Control of Specific Characteristics
A commercial grade survey should be specific to the scope of the CGI(s) being purchased. The
vendor's controls of specific critical characteristics to be verified during the survey should be
identified in the survey plan. The verification should be accomplished by reviewing the vendor's
program/procedures controlling these characteristics and observing the actual implementation
of these controls in the manufacture of items identical or similar to the items being purchased.
2. Identification of Applicable Program/Procedures
The vendor must have a documented program and/or procedures to control the critical
characteristics of the item or items being procured that are to be verified during the survey.
When many items are being purchased, a survey of a representative group of similar items may
be sufficient to demonstrate that adequate controls exist. If the vendor's controls are
determined to be satisfactory, purchase orders for these items should invoke these controls as
contract requirements by referencing the applicable program/procedure(s) and revision. If
multiple working level procedures are applicable to the vendor's activities, which affect the
item's critical characteristics and these procedures, in turn, are controlled by a higher level
document, it may be appropriate to reference that document in the purchase order. It is
important to ensure that the specific controls reviewed and accepted during the survey be
applied during the manufacturing process. Upon completion of the work, the vendor should
certify compliance with the purchase order requirements.
Issue Date: 11/29/13 AppA-4 43004
3. Documentation of Survey Results
Commercial grade survey documentation should include the identification of the item or items
for which the vendor is being surveyed, identification of the critical characteristics of these items
that the vendor is expected to control, identification of the controls to be applied
(program/procedure and revision), and a description of the verification activities performed and
results obtained. Critical characteristics that are not adequately controlled should be addressed
by contractually requiring the vendor to institute additional controls or by utilizing other
verification and acceptance methods.
4. Survey Frequency
Commercial grade surveys should be conducted at sufficient frequency to ensure that the
process controls applicable to the critical characteristics of the item procured continue to be
effectively implemented. Factors to be considered in determining the frequency of commercial
grade surveys include the complexity of the item, frequency of procurement, receipt inspection,
item performance history, and knowledge of changes in the vendor's controls. The survey
frequency should not exceed the audit frequency established for 10 CFR Part 50, Appendix B,
suppliers.
ACCEPTANCE OF CERTIFIED MATERIAL TEST REPORTS (CMTRs) AND CERTIFICATES
OF COMPLIANCE (CoCs)
Validity Verified Through Vendor/Supplier Audit or Testing
When the verification of critical characteristics is based on vendor CMTRs or CoCs, the validity
of these documents should be ensured. This can be accomplished through a commercial grade
survey or, for simple items, periodic testing of the product on receipt. Such verifications should
be conducted at intervals commensurate with the vendor's past performance. If the item's
supply chain includes a distributor, a survey of the distributor's activities may be necessary (see
"Traceability").
USE OF INDUSTRY GUIDANCE
The Electric Power Research Institute (EPRI) NP-5652, "Guideline for the Utilization of
Commercial Grade Items in Nuclear Safety Related Applications (NCIG-07)," defines critical
characteristics as "identifiable and measurable attributes/variables of a CGI, which once
selected to be verified, provide reasonable assurance that the item received is the item
specified." NRC's conditional endorsement of EPRI NP-5652 by Generic Letter 89-02 was
based on interpreting that in the EPRI definition of critical characteristics the "item specified"
encompassed those attributes that are essential for the performance of the item's safety
function. This interpretation is consistent with the definition of "critical characteristics for
acceptance" found in EPRI NP-6406, "Guidelines for the Technical Evaluation of Replacement
Items in Nuclear Power Plants," which notes that critical characteristics for acceptance are a
subset of "critical characteristics for design."
Issue Date: 11/29/13 AppA-5 43004
The EPRI NP-6406 definition of "critical characteristics for design" includes those attributes that
ensure the performance of the item's design function.
EPRI TR-1019163, “Plant Support Engineering: Counterfeit, Fraudulent and Substandard
Items- Mitigating the Increasing Risk” describes best practices for avoiding entrance of
Counterfeit, Fraudulent or Suspect items into the commercial nuclear supply chain and can be
helpful to increase awareness of the potential.
Published NRC guidance does not differentiate between design and acceptance critical
characteristics and the CGI dedication guidance provided in Generic Letters 89-02 and 91-05
does not suggest that all design requirements of an item need to be verified during the
dedication process. Rather, the licensee is expected to identify the item's design, material, and
performance characteristics that have a direct effect on the item's ability to accomplish its
intended safety function and select from these characteristics a set of critical (or acceptance)
characteristics that, once verified, will provide reasonable assurance that the item will perform
that function. Consistency in the definition of critical characteristics can be improved by
equating the NRC's definition of critical characteristics to the EPRI definition of "critical
characteristics for acceptance."
END
Issue Date: 11/29/13 AppB-1 43004
APPENDIX B DEDICATION DOCUMENTS
The dedication documentation compiled by the licensee may contain the following items, as
applicable, depending on the item chosen and the dedication methods used.
Purchase requisitions and purchase orders.
Other pertinent vendor/licensee correspondence.
Design specifications - original and updated to verify certain important parameters, such
as original design pressure of a system or degraded pickup voltage of a solenoid or
relay.
Catalog specifications.
Procurement basis evaluation - like-for-like, equivalency, plant design change packages,
drawing and specification updates.
10 CFR 50.59 safety evaluation, if required.
Material receiving reports, packing lists/invoices, and other
shipping documents.
Receipt inspection reports and any related test reports.
Other documents to trace the item from the time it was
dedicated to the time it was installed, tested, and accepted.
Certificates of conformance/compliance/quality.
Vendor test and inspection reports.
Third-party or subvendor test and inspection reports.
Shelf life information.
Vendor dedication/partial dedication information.
Design/material/process change history information.
Issue Date: 11/29/13 AppB-2 43004
Completed commercial grade dedication document including:
- safety classification
- identification of safety functions/application requirements
- identification of critical characteristics
- identification of verification methods and acceptance criteria for the critical
characteristics
- evaluation of credible failure modes (if applicable)
- identification of the suppliers quality assurance program that meets 10 CFR 50,
Appendix B
Any deviation from design, material, and performance characteristics relevant to the
safety function (nonconformance dispositions).
Documents showing objective evidence:
- special test and inspection procedures and results
- commercial grade survey reports -item, design, material, and specific performance
characteristic (relevant to safety function)
- source inspection reports
Completed post-installation test procedure and results.
Completed stock or material issue forms and installation work orders or reports.
Historical performance information.
END
Issue Date: 11/29/13 Att1-1 43004
Attachment 1 - Revision History For 43004
Commitment
Tracking
Number
Issue Date Description of Change Description of
Training Required
and Completion Date
Comment and
Feedback Resolution
Accession Number
N/A 10/03/07
CN 07 030
Researched commitments for 4 years and found
none.
Initial issuance
N/A N/A
N/A ML110871957
04/25/11
CN 11-007
Revised Inspection Procedure to refer to the
applicable Manual Chapter. Added the
applicable Manual Chapters to the references.
This revision is in response to OIG audit (OIG10-A-02 (ML103020267)).
N/A N/A
N/A ML13280A478
11/29/13
CN 13-027
This revision is a complete re-write. IP 38703
has been integrated into this procedure to have
one CGD inspection procedure for the agency.
N/A ML13280A479