METHOD 4

Method 4: Item/Supplier Performance Record

The performance history (good or bad) of the item and supplier is a consideration when determining the use of
the other acceptance methods and the rigor with which they are used on a case-by-case basis. Specific regulatory
expectations for the use of a suppliers or items performance record are included in NRC GL 89-02 [10]. The
item/supplier performance record is typically used as a factor in the selection of sampling plans when verifying
physical and performance characteristics associated with hardware. Section 10 of this report covers item/supplier
performance in more detail.
Method 4: Item/Supplier Performance Record
The use of an item/supplier performance record involves a documented record of historical evidence indicating
acceptable results as a basis for accepting an item or supplier. Method 4 is typically used in combination with
another acceptance method to reduce the sample size or frequency of oversight activities. Using an item/supplier
performance record is typically appropriate in the following situations:
Documented indication of the suppliers past performance can be used as a basis for selecting an appropriate
sampling plan.
Documented indication of an items past performance can be used as a basis for selecting an appropriate
sampling plan.
Broad industry or other industry feedback is available to develop a documented basis for accepting certain
characteristics based on successful performance in the past.
The dedicating entity is not able to obtain rights of access to the suppliers facilities.

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METHOD 4
Step 5.7.20: Gather Industrywide Performance Data
In order to establish a performance record for a supplier or item, it is necessary to gather industrywide
performance data.
Methodology
For the particular critical characteristic for which Method 4 is being considered, sufficient performance data over
a sufficient length of time must be collected to facilitate an evaluation of the acceptability of the item, service, or
suppliers performance history. Based on the critical characteristic and/or manufacturer in question, perform the
necessary research to identify and acquire the historical data necessary to be able to evaluate the historical
performance record. The three typical categories of historical performance are as follows:
Historical performance of an item while in service
Historical dedication results from the use of Methods 1, 2, and/or 3 for the item, service, or
supplier/manufacturer
Industrywide performance of the item, service, or supplier/manufacturer
Depending on the category of performance history to be used, applicable data must be collected to support an
evaluation and determination of whether the performance history is sufficient to justify the use of Method 4 to
accept the critical characteristic in question. See Section 10 for more details.
Unless the item is a widely used commodity, collection of industrywide performance data may be the most
challenging, particularly when other organizations in the industry have not had reason or occasion to mine or
produce data or records pertaining to the item, service, or supplier in question. For a widely used commodity,
there may be extensive performance data; however, the information may not be public, and acquiring the data
may present a challenge.
In any event, sufficient data must be collected in order to evaluate the performance history to potentially take
advantage of a proven favorable performance record. If sufficient data cannot be acquired to support historical
performance, Method 4 cannot be used, and another acceptance method must be selected (return to Step 5.7.8 in
the flow chart in Figure 5-10).
Precautions/Lessons Learned
Performance data must be specific and applicable to the item, service, or supplier/manufacturer and critical
characteristic(s) being accepted.
The dedicating entitys historical experience from applying Method 1, 2, or 3 for acceptance of a particular
critical characteristic often yields the most readily available and directly applicable historical performance data.
Step 5.7.21: Document Performance for the Applicable Critical Characteristics
Description
The performance record for each applicable critical characteristic to be accepted by Method 4 must be clearly
documented and justified.
Methodology
The items/suppliers performance record, supporting data, and applicable justification must be documented to
support use of Method 4. An acceptable item, service, or supplier performance record shall include the item and
critical characteristic being evaluated, the supporting data, the basis for determining the acceptable performance
history, the adequacy of the performance record, limits or stipulations, and the applicable procurement document
requirements. See Section 10 for more details. Additionally, a continued application of Method 4 shall include a
documented periodic update and review to ensure that the item, service, or supplier maintains an acceptable
performance record.
For Method 4 to be employed alone as the sole method of acceptance for all of the critical characteristics of a
particular item or service, two conditions must be satisfied. First, the established historical record must be based
on industrywide performance data that are directly applicable to the critical characteristics and the intended
safety-related application. Second, the item manufacturers measures (or the service suppliers measures) for the

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METHOD 4
control of applicable design, process, and material changes have been adequately implemented, as verified by a
commercial-grade survey and the survey results accepted by the dedicating entity.
If the intent is to base acceptance solely on the documented item, service, or supplier history, proceed to Step
5.7.22 to determine if the suppliers controls have been adequately verified. If the intent is to use Method 4 in
combination with Method 1 and/or Method 3, the historical performance data can be considered as input when
establishing sampling plans in Step 5.8.
Precautions/Lessons Learned
The performance record for each critical characteristic should be documented in enough detail to ensure that it
can be successfully understood and that a reviewer would concur with the conclusions.
If the supplier or manufacturers controls require verification and they are not going to be verified though a
survey (Method 2) or source verification (Method 3)or if the performance does not warrant acceptance based
solely on the item, service, or supplier/manufacturer historical experienceconsider using the performance
record to help determine the sample size (Step 5.8).
Step 5.7.22: Determine If Manufacturer Controls Have Been Verified
Description
For Method 4 to be employed alone as the sole method of acceptance for all of the critical characteristics of a
particular item or service, the item manufacturers measures (or the service suppliers measures) for the control
of applicable design, process, and material changes must have been adequately implemented as verified by a
commercial-grade survey (or source verification) and the results accepted by the dedicating entity.
Methodology
If Method 4 is to be employed alone as the sole method of acceptance for all of the critical characteristics of a
particular item or service, obtain the survey or source verification report of the item manufacturer or service
supplier. Review the report, and verify that a recent commercial-grade survey or source verification concluded
that the item manufacturers measures (or the service suppliers measures) for the control of applicable design,
process, and material changes were adequately implemented.
If a commercial-grade survey or source verification is necessary to verify these controls, initiate these activities
in Steps 5.7.10 or 5.7.15, respectively. If the manufacturers controls have been verified by a commercial-grade
survey, the purchase order and certification requirements are developed according to Step 5.7.13.
Precautions/Lessons Learned
The commercial-grade survey or source verification evaluating the manufacturer or suppliers controls must have
been performed recently (that is, within the last three years) to be valid.
If Method 4 is being evaluated for application to only a subset of the total critical characteristics of the item or
service, verification of the manufacturers or suppliers controls is not necessarily required. See Section 10 for
more information.

METHOD 4: ITEM/SUPPLIER PERFORMANCE RECORD

Description of Method 4
A documented item or supplier performance record is a method of acceptance that may be used under certain
stipulations to verify acceptability of one or more of the identified critical characteristics of a commercial-grade
item or service. This may require evaluation of the suppliers performance record for identical or similar items or
services. Use of Method 4 to confirm the acceptability of one or more critical characteristics can provide the
dedicating entity with the capability to establish reasonable assurance of the items or suppliers performance
based on historical performance gained from the successful utilization of other acceptance methods and/or
pertinent industrywide performance data. Acceptable data for historical performance may be compiled using
monitored performance of the item, industry product tests, compliance with national codes and standards (nonnuclear-specific), and other industry records or databases. The item or supplier performance record (or data)
shall be from service conditions, environmental conditions, failure modes, maintenance program, testing, or

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METHOD 4
other applicable conditions equivalent to the intended safety-related application of the commercial-grade item or
service being dedicated.
If the documented performance record provides reasonable assurance that the critical characteristic satisfactorily
meets applicable acceptance criteria, Method 4 can be used for acceptance of that critical characteristic. After the
establishment of an acceptable performance record, acceptance of the item using Method 4 is completed by
performing a receipt inspection. The supporting information is periodically updated and reviewed to ensure that
the item/supplier maintains an acceptable performance record.

Application of Method 4
Figure 10-1 is a standard flow chart for accepting a commercial-grade item by relying on a documented
acceptable item/supplier performance record.

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METHOD 4
Although it was originally envisioned that Method 4 could be used as the sole basis for accepting some
commercial-grade items, experience has proven that Method 4 is best suited for use in the following two
situations: as a basis for reducing the sample size for one or more critical characteristics associated with the use
of another acceptance method and as a basis for accepting a particular critical characteristic while the other
critical characteristics are verified by the use of another acceptance method.
The objective in considering Method 4 is to use a sufficiently broad spectrum and volume of data over a period
long enough to provide the objective evidence necessary to establish a sound technical basis for determining
acceptable performance. As stated in NRC Generic Letter 89-02:
Method 4 should not be employed alone unless:
The established historical record is based on industry-wide performance data that is directly applicable to the items
critical characteristics and the intended safety-related application and
The manufacturers measures for the control of design, process, and material changes have been adequately
implemented as verified by audit (multi-licensee team audits are acceptable). [10]

Care should be taken in application of this method to ensure that the performance data are directly applicable to
the verification of the critical characteristic specific to the intended safety- related application. Method 4 should
not be used as the sole method of acceptance for all of the critical characteristics of an item or service, unless
specific measures are implemented to ensure the validity of this method of acceptance.

Use of Method 4
Method 4 allows the dedicating entity to accept commercial-grade items based on a confidence in the supplied
item achieved through proven performance of the item. It also allows the dedicating entity to take credit for
demonstrated item performance based on historical verification gained from the successful utilization of
Methods 1, 2, or 3 or pertinent industrywide performance data.
When properly used, Method 4 can be a valuable means to accept certain critical characteristics of a commercialgrade item because it relies on proven historical performance and thereby negates the need for costly timeconsuming or repetitive activities, which, because of the proven history, do not add value to the verification of
quality or performance of the item. Similarly, Method 4 could be used to reduce the sample size for a particular
critical characteristic of an item.
In using Method 4, the results of historical performance can be objectively compiled and documented using
sources such as the following:
The monitored performance of or certain critical characteristics of the item
Industry standard product tests
National codes and standards (not specific to the nuclear industry) governing the manufacture or performance
of the item
Industry or government databases (military, aerospace, and so on)
The dedicating entity could establish a documented item/supplier performance record using the following
sources of information. Although individual sources of information may be adequate to adjust sample sizes or to
support acceptance of a particular characteristic, they are not intended to stand alone and may not be adequate as
the sole means of verifying critical characteristics of the item or service.
With regard to supplier performance, for dedication of commercial-grade items, the historical performance
record should be focused on the actual manufacturer (or production source) of the item. However, for dedication
of commercial-grade services, the historical performance record should be focused on the supplier actually
performing the service activities.
For Method 4 to be employed as the sole method of acceptance for all of the critical characteristics of a particular
item or service, two conditions must be satisfied. First, the established historical record must be based on

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METHOD 4
industrywide performance data that are directly applicable to the critical characteristics and the intended safetyrelated application (that is, single sources of information are not adequate to demonstrate satisfactory
performance without the use of other methods of acceptance). Second, the item manufacturers measures (or the
service suppliers measures) for the control of applicable design, process, and material changes have been
adequately implemented as verified by a commercial-grade survey and the survey results accepted by the
dedicating entity.
Historical Performance
Results of Monitored Performance
An items performance record can be determined by monitoring the performance of the items manufacturer.
Depending on the nature of the item, this could also include monitoring the performance of the parent component
in which the item was installed. Component performance data are normally available from maintenance records,
failure history, or ongoing product proof tests. Once documented, performance and failure history data provide
an acceptable source for establishing a record for a given commercial-grade item. The objective basis to support
the satisfactory performance of the commercia1-grade item in service will vary with the application, but it could
simply be the lack of failures during a suitably long in-service period under applicable operating conditions.
In this sense, failure refers to a malfunction caused by some deficiency in a critical characteristic of the item that
prevents it from performing its intended safety function. Failure in this context is not intended to mean failure of
a part or parent component because of misuse or normal wear/deterioration or failure induced from the failures
or malfunctions of other items.
Results of Maintenance, Production, or Periodic Surveillance Tests
The dedicating entity could have (or acquire) documented records of the results of routine maintenance tests,
production tests, and/or periodic operational surveillance test results over a sufficient length of time. Acceptable
and repeatable test results could be used to demonstrate that a particular critical characteristic of the item (or the
item itself) satisfactorily performed (or was capable of performing) its intended safety function for a sufficient
period.
Historical Dedication Results
The successful acceptance of a critical characteristic of an item or service using Methods 1, 2, or 3 or a
combination thereof over a sufficient period could be used to establish reasonable assurance of acceptability of
that critical characteristic based on its proven history. An update and review of the supporting performance
information is required to ensure that an acceptable performance record is maintained. Periodic confirmatory
testing, a limited-scope commercial-grade survey, or an occasional source verification should be considered to
maintain ongoing confidence in the established performance history.
Industrywide Performance
Industrywide performance data must be specific and applicable to the item and critical characteristics being
accepted if they are to be used to establish an acceptable item or manufacturer/supplier performance record. In
this case, industrywide refers to a cross-section of users of the item or service.
Depending on the nature of the item and its applications, industrywide may or may not include data sources
outside the field of nuclear facilities. For the manufacturer of an item or a supplier with direct access to
manufacturer data, industrywide could include the manufacturers customer base, both foreign and domestic.
Product Performance Test Results
The manufacturer of an item may routinely test production samples or periodically send product samples to an
independent test laboratory. The results of these tests could be used as a basis to establish acceptable
performance history to accept certain critical characteristics. Other information that supports the items
performance history (such as reliability data from operating nuclear plants, suppliers, or industrial users) may
also be considered.

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METHOD 4
Equipment Performance Data
Operating experience and customer feedback databases can be used to obtain information on component failures
that can be used to compile data on component failure history.
Seismic and Environmental Equipment Qualification Databases
The nuclear industry, as a result of empirical studies of earthquake-induced failures, has developed a seismic
experience database for EPRI members called Seismic Qualification Reporting and Testing Standardization
(SQURTS) that could be used to acquire historical data. Similarity by item, category, or general type should be
established to demonstrate an items inherent seismic sensitivity or ruggedness. EPRI members or members of
programs such as SQURTS also have access to qualification data and reports developed by those organizations.
Another useful source of information is the Equipment Qualification Data Bank (EQDB). Originally established
by EPRI, the EQDB was commercialized and is currently a product maintained by the Scientech Division of
Curtiss-Wright. The database includes several libraries of information related to equipment qualification. One
library lists summarized equipment qualification parameters for Class 1E equipment in operating nuclear plants.
Other libraries contain seismic qualification data as well as thermal and radiation properties of nonmetallic
materials that commonly appear in electrical and mechanical equipment of nuclear power plants.
Care should be exercised to ensure that the use of these databases is acceptable under plant-specific conditions
relative to the particular critical characteristic under evaluation.
Audits or Surveys Conducted by Industry Groups
An audit or survey conducted by an industry group on the manufacturer of an item or the supplier of a service
could be used to support justification of an acceptable supplier performance history. To take credit for this type
of information, the dedicating entity should ensure that the audit or survey addressed the supplier quality controls
applicable to the specific commercial-grade item and critical characteristic(s) in question and that those quality
controls were employed by the manufacturer or supplier when the supplied item was produced or the service
performed.
Supplier Responses to the Commercial-Grade Program Controls Questionnaire
The dedicating entity may determine by questionnaire those controls established, previously verified, and
currently maintained by the manufacturer that reasonably ensure that the critical characteristic in question for the
commercial-grade item to be furnished is the same as the commercial-grade item provided with the original
equipment. The most important information to be obtained is as follows:
Identification of changes that would result in a part number or design change to the item
Material, configuration, interface, or mounting changes
Changes to the manufacturing processes that could impact the acceptability of a critical characteristic
Utilization of National Codes and Standards
The credit a dedicating entity can take for a product manufactured to a national code or standard must be
investigated on a case-by-case basis for the critical characteristic in question. To take credit for an item being
manufactured to a recognized code or standard, the dedicating entity shall ensure that the item was actually
manufactured in accordance with the specified code or standard. This assurance can be obtained as follows:
Invoking the applicable code or standard in the purchase order
Requiring and receiving certification from the supplier as delineated in the applicable code or standard
Researching and documenting that it is standard industry practice to manufacture the product to this code or
standard
Verifying manufacturer testing or independent agency testing with certification or documentation as delineated
in the code or standard (including the product listing in an agency certification registry similar to the U.S.
Defense Logistics Agencys Qualified Product List and Qualified Manufacturer List)
Verifying by inspection at receipt that the item is marked or tagged as conforming to the specified code or
standard

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METHOD 4
The manufacture of a product to a recognized code or standard provides some degree of confidence in the
uniformity and quality of the item. This is particularly true if an independent endorsement is given based on
testing. Production to a recognized code or standard helps to justify continual acceptance of a commercial-grade
item by Method 4.
For example, certain electrical items are manufactured to a UL product specification. The UL product
specifications require tests or controls of certain attributes, some of which could also be a critical characteristic
of the item. If the commercial-grade item is listed by UL, UL will periodically test a product specimen to ensure
continued product conformance, that the manufacturer is authorized by UL to label the product with the
applicable UL mark, and that the item is listed in the applicable UL product directory. The UL labeling and
directory listing should be verified at receipt.
Ongoing Assurance of Performance
The historical performance of an item or a supplier does not guarantee future results. Therefore, when employing
Method 4, measures must be established and implemented to verify continued satisfactory performance for
recurring use of Method 4 for acceptance of a particular critical characteristic of a particular item or service. For
example, if Method 4 is used based on the historically successful acceptance of a critical characteristic of an item
by a Methods 1 test, the Method 1 test should be performed at an appropriate periodicity, either time-based or
event-based (such as annually or every X purchases), to verify that the performance history of the critical
characteristic in question is still valid.

Documentation to Support Method 4

The item/supplier performance record, supporting data, and applicable justification must be documented to
support use of Method 4. An acceptable item, service, or supplier performance record shall include the
following:
Identification of the item, service, or supplier being evaluated
Identification of the critical characteristic(s) being evaluated specific to the item, service, or supplier
Identification of the data examined to evaluate the item, service, or supplier performance
Identification of the basis for determining that the performance data substantiate the acceptability of the
applicable critical characteristic(s) for the item, service, or supplier
Documentation of the adequacy and acceptance of the item, supplier, or service performance record
Any limits or stipulations on the application of Method 4 for acceptance of the applicable critical characteristic
Procurement document requirements and any supplier submittals necessary to support the Method 4 acceptance
Continued application of Method 4 shall include a documented periodic update and review to ensure that the
item, service, or supplier maintains an acceptable performance record. Alternatively, measures can be
implemented to verify continued performance with each receipt (see the UL example in Section 10.3.3.6).

Use of Items/Suppliers Performance Record to Support Sample Size

The processes and methodologies described for use of Method 4 as a means to accept a particular critical
characteristic of a commercial-grade item can also be used as input to determine the sample size for a Method 1
test or inspection.

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