ML20058C664

Forwards Responses to Requesting NRC Guidance for Commercial Grade Dedication of Metallic Products to Be Used in Commercial Nuclear safety-related Applications.Nrc Insp Procedure 38703 Also Encl

ML20058C664
Person / Time
Issue date:	11/18/1993
From:	Norrholm L Office of Nuclear Reactor Regulation
To:	Anfrews S CONSOLIDATING POWER SUPPLY, INC. (CPSI)
References
REF-QA-99901263 NUDOCS 9312020524
Download: ML20058C664 (37)

Text

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UNITED STATES ag5Q f

NUCLEAR REGULATORY COMMISSION gs-j wassiucios, o c. rosswono, November 18, 1993 Docket No. 99901263 Mr. Steven W. Andrews Quality Assurance Manager Consolidated Power Supply 3556 Mary Taylor Road Birmingham, Alabama 35235

SUBJECT:

REQUEST FOR INTERPRETATION ON COMMERCIAL GRADE DEDICATION PRACTICES By letter dated March 18, 1993, you requested the U. S. Nuclear Regulatory Commission to provide guidance for the commercial grade dedication of metallic products to be used in commercial nuclear safety-related applications.

You also stated in your letter that your request is focused on vendors / distributors that primarily dedicate and supply (but do not manufacture) products such as structural steel, flanges, fittings, tubular products without filler metal, reinforcing bars, and other similar non-nuclear unique material to recognized industry standards.

Five examples, each with a descriptive text for its unique perchasing and quality conditions, were attached to your letter along with dedication questions for each example.

The five examples, related dedication questions, and our responses are discussed in Enclosure 1 to this letter. to this letter is a copy of NRC Inspection Procedure 38703, " Commercial Grade Dedication," dated November 8, 1993. This NRC procedure is applicable for performing inspections at NRC licensed facilities and Appendix A, " Dedication Issues," to this procedure provides for a graded approach in selecting critical characteristics to be verified.

For example, the A 36 steel plate,-in Enclosure 1, Example No. 4, could be used to fabricate a cut and drilled base plate for a heat exchanger in a mild environment, or, the plate could be used to fabricate a welded critical seismic pipe support. Depending on the specific application, all of the A 36 specification requirements may be essential for the item to perform its safety function and may have to be verified, sir, in the case of the A 36 plate being used as a base plate, only a portion of the A 36 requirements may be essential for the item to perform its safety function.

Generally, vendors such as Consolidated Power Supply receive purchase orders for metallic products that invoke the requirements of: (1) Appendix B to Title 10 of the Code of Federal Reaulations (10 CFR), or an equivalent 9312O20524 931110 PDR GA999 EEC*****

. A' i 99901263 PDR

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Mr. Steven U. Andrews November 18, 1993

' customer approved vendor Quality Assurance Program, (2) 10 CFR Part 21, (3) t technical requirements such as the governing material specification and any additional / supplementary requirements, and (4) documentation and/or certification requirements. When the product is certified by the vendor to be supplied in accordance with these or similar requirements, the customer generally considers that the product meets all of the technical requirements f

specified in its purchase order and, therefore, can be used in any safety-related application where design documents specifically identify the use of such products.

Because vendors certify that the requirements of its customer's purchase order have been met and, generally, do not know the intended safety-related applications for its proriucts, the vendor should dedicate these products by confirming that all of the technical requirements specified by the customer have been met.

For example, in the case where a supplier's material traceability controls have not been confirmed by the vendor as adequate and effectively implemented or where the vendor has not validated its supplier's test reports, each piece of material may have to be destructively and nondestructively tested, as discussed in the Enclosure 1 examples, in order for the vendor to determine that the material supplied meets specification requirements.

Unless a vendor knows the specific use of the metallic products it is supplying and has the capability to determine all of the attributes (critical characteristics) that should be verified to ensure that the product will perform its safety function, the vendor should not attempt to use the graded approach, discussed in Enclosure 2, for selecting critical characteristics.

Should you have any further questions, please contact Mr. Larry L. Campbell of my staff at (301) 504-2976 or Mr. Uldis Potapovs at (301) 504-2959.

Sincerely, Leif J. Norrholm, Chief Vendor Inspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation

Enclosures:

1.

NRC Responses to Consolidated Power Supply Questions 2.

NRC Inspection Procedure 38703 DISTRIBUTION:

GZech RGramm V1B R/F DRIL R/F Docket Files / Central Files /PDR OfflCE VIB/DRll VIB/DRIL VIB/DRIL DRIL/NRR NAME LLCampbell UPotapovs LNorrholm CERossi DATE 11/10/93*

11/10/93*

11/16/93*

11/18/93*

-COPY YES xx YES xx YES XX XXX NO YES NO DOC g

OFFICIAL SECORD COPY D'OCUMENT NAME: A:\\ QUEST.ANS 23* 1' D

l Mr. Steven W. Andrews customer approved vendor Quality Assurance Program, (2) 10 CFR Part 21, (3) technical requirements such as the governing material specification and any additional / supplementary requirements, and (4) documentation and/or certification requirements. When the product is certified by the vendor to be supplied in accordance with these or similar requirements, the customer generally considers that the product meets all of the technical requirements specified in its purchase order and, therefore, can be used in any safety-related application where design documents specifically identify the use of such products.

Because vendors certify that the requirements of its customer's purchase order have been met and, generally, do not know the intended safety-related applications for its products, the vendor should dedicate these products by confirming that all of the technical requirements specified by the customer have been met.

For example, in the case where a supplier's material traceability controls have not been confirmed by the vendor as adequate and effectively implemented or where the vendor has not validated its supplier's i

test reports, each piece of material may have to be destructively and nondestrcctively tested, as discussed in the Enclosure 1 examples, in order for the vendor to determine that the material supplied meets specification requirements.

Unless a vendor knows the specific use of the metallic products it is supplying and has the capability to determine all of the attributes (critical characteristics) that should be verified to ensure that the product will perform its safety function, the vendor should not attempt to use the graded approach, discussed in Enclosure 2, for selecting critical characteristics.

Should you have any further questions, please contact Mr. Larry L. Campbell of my staff at (301) 504-2976 or Mr. Uldis Potapovs at (301) 504-2959.

Sincerely,

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Leif J. fNorrholm," Chief Vendor lnspection Branch Division of Reactor Inspection and Licensee Performance Office of Nuclear Reactor Regulation

Enclosures:

1.

NRC Responses to Consolidated Power Supply Questions 2.

NRC Inspection Procedure 38703 i

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NRC RESPONSES TO CONSOLIDATED POWER SUPPLY (CPS)

REQUEST FOR INTERPRETATION ON COMMERCIAL GRADE DEDICATION PRACTICES

(

Reference:

Letter to Charles E. Rossi (NRC) from Steven W. Andrews (CPS), " Request for Interpretation on Commercial Grade Dedication Practices," dated March 18, 1993)

Example No. 1 A vendor procures ASTM A 36 angle directly from a melt facility (mill). The melt facility is surveyed on an annual basis for the scope of material traceability.

The vendor's procurement document reflects invocation of the current mill quality program manual, and requires a conformance/ compliance statement to such program on the mill certification document.

The mill's quality manual does not meet all elements of 10 CFR 50 Appendix B.

10 CFR 21 is not invoked in the vendor's procurement document. Upon receipt by the vendor, the mill test report is reviewed by the inspector. Upon acceptance by i

the inspector, one piece from each heat of material is provided to a testing facility to conduct the destructive and nondestructive testing identified in the critical characteristic listing for the type and grade of material. A tension test and full cherical analysis is performed using equipment qualified under the vendor's 10 CFR 50 Appendix B quality program. No additional-destructive or nondestructive testing is performed on the balance of the material.

All pieces receive a dimensional inspection as the mill was not qualified for its control over measuring and test equipment, based on the fact that the mill does not conduct any type of qualification of calibration suppliers.

Question 1:

Is it possible to perform a sampling (10% for example) of the material received for conducting the dimensional inspection activities?

NRC Response:

Since the mill was not qualified for its control over measuring and test equipment (M&TE), verification of the A 36 angle's dimensions should not be based on dimensional inspections performed by the mill.

For standard products having a simple design such as the A 36 angle, inspection to verify dimensions may be performed on a sample basis. Sample plans used for the performance of the dimensional inspection should consider lot / batch control' as discussed in Appendix A, " Dedication Issues," to Enclosure 2, NRC Inspection Procedure No. 38703, " Commercial Grade Dedication," dated November 8, 1993.,

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Also, if a manufacturer has been producing a particular standard item for a long period of time, using essentially the same controls, and if the quality i

history of the item indicates that its significant characteristics performed satisfactorily, this satisfactory performance history could be used to support a general product homogeneity over the years and the use of standard statistical sampling methods to accept certain product characteristics. When i

this philosophy is used, it should be documented and substantiated by objective evidence.

Question 2:

Is it acceptable to perform destructive testing on only one piece from each heat as the mill was surveyed for traceability of material?

NRC Response:

t When heat traceability of the material has been established (for this example material traceability was reviewed during the annual survey) and each piece of i

material (or container of material where permitted by code or specification and applicable implementing procedures) is marked with the material heat i

number, all chemical analysis and mechanical tests required to verify the critical characteristics identified by the material specification may be performed on one piece of this material. Other critical characteristics such as dimensions and surface finish would have to be verified either by sampling i

as discussed in the NRC response to Question No. I or by inspecting each it m where sampling is not appropriate.

Question 3:

Is it necessary to perform destructive testing, such as tension tests and i

chemical analysis on the material, or only perfeem nondestructive testing such as hardness and/or alloy verification?

1 NRC Response:

l Since the vendor does not know the specific safety-related application (s) for the A 36 angle, the vendor should verify that the angle has the chemical and t

mechanical properties required by the material specification.

j Question 4:

Is it necessary to even perform a survey of the mill if the vendor's purchase order is placed directly with the mill? The material and certification would be provided directly to the vendor without the use of a distributor, and the j

material reflects appropriate mill identification (heat / lot number) to enable traceability of the material to the test report.

j NRC Response:

When the dedication of a commercial grade item is based partially or entirely on certification and material identification by the mill, it is necessary to t

establish the validity of documents such as the mill test reports by survey.

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i If a vendor places a purchase order directly to the mill and the mill supplies products directly to the vendor and the vendor does not audit or survey the mill, the controls that the mill has in place for activities such as material manufacturing, traceability, testing, marking, and certification have not been confirmed as being adequate and effectively implemented.

If a survey or audit is not performed, the vendor must implement alternate measures to validate that such activities affecting the quality of the product being supplied are adequate and are being effectively implemented by the mill.

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Example No. 2 l

A vendor procures ASTM A 240 type 304 plate from a distributor who implements a quality program that does not meet 10 CFR 50 Appendix B requirements. The program is invoked by the vendor's procurement document without 10 CFR 21 requirements.

The distributor's program is surveyed by the vendor on an annual basis and found to be satisfactory for maintaining traceability of material within their surveyed facility. Also, the distributor has a documented section in its quality program that addresses surveys of their suppliers. As the distributor does a large volume of commercial business, all material is procured directly from the mills that have been surveyed.

The distributor does not invoke the quality program in its procurement documents utilized by the mill.

In addition, the distributor may segregate the material i

within its surveyed facility, but does implement satisfactory controls for maintaining traceability for the subdivision of material as evaluated during the vendor's survey at the distributor's facility. The distributor provides certification that reflects a conformance/ compliance statement to the program invoked in the vendor's procurement document, in addition to a copy of the material manufacturer's test report.

Upon receipt by the vendor, one piece from each heat is tested in accordance with the critical characteristics reflected for this specification and type of material.

This includes tension testing and chemical analysis, which is destructive.

No other destructive or nondestructive testing is conducted on the balance of the material received by the vendor.

All pieces receive a dimensional inspection as the distributor's program has not been qualified for appropriate measuring and test equipment control.

Question 1:

Is it possible to perform a sampling (10% for example) by heat or lot of material received to perform dimensional inspection activities?

NRC Response:

Since the example indicates that the distributor and its subsuppliers, the mills, do not have controls in place for dimensional inspection activities, any sample plan used by a vendor for accepting dimensions on A 240, type 304, plate needs to provide a high confidence level that dimensions are correct.

A tightened sample plan, with a sample size exceeding that required by standard statistical sampling methods which are based on sampling homogenous product lots, should be used for a lot of items, such as the plate, from multiple mills.

Question 2:

Is it acceptable to conduct the testing on one piece from each heat or lot if traceability to the melt facility is documented and verified?

4 a

I NRC Response:

Yes, provided that the distributor's surveys of the mills confirmed that controls for maintaining traceability are being effectively implemented.

However, if the heat or lot subdivided by the distributor consists of pieces i

of plate from more than one mill, one piece from each mill heat or lot should be tested.

f Question 3:

Is the distributor's procurement document required to invoke the mill's controlling quality program manual to accomplish testing of one piece per heat?

If so, should there be a statement of conformance/ compliance to the mill's program on their certification document?

NRC Response:

The quality assurance requirements and the elements of the quality assurance program applicable to the item being purchased should be included or invoked by reference in the procurement document.

Prior to the distributor invoking or referencing quality requirements in its procurement documents to the mills, the mills should be surveyed to ensure that their commercial or quality control for the applicable critical characteristics are being effectively implemented. The mill's compliance to the distributor's purchase order requirements should be documented on the certification document.

y Question 4.:

Do the material markings have to be those of the original material manufacturer (mill) to conduct any sampling process?

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NRC Response:

No, provided that each distributor's lot markings are traceable to each of the mill heats forming the lot and one piece from each mill heat is sampled for physical and chemical properties. However, for verifying critical characteristics such as dimensions, as discussed in NRC responses to Questions 1 and 2 of this example, if the mill's marking have been supplemented during the heat or lot subdivision by the distributor and the distributor's lot contains pieces from several mills, a tightened sampic plan should be used.

Question 5:

Is nondestructive testing required on additional pieces of material to correlate to the destructive testing performed from the same heat of material?

NRC Response:

No, provided that heat traceability of the material has been established and each piece of A 240, type 304, plate is marked with the same mill heat number.

Question 6:

i Is destructive testing, such as chemical analysis and/or tension testing, even required to dedicate the material, or could hardness testing or an alloy verification be conducted to reasonably assure the material is what was ordered?

NRC Response:

Because the vendor is certifying that the A 240, type 304, plate meets the req tirements of Specification A-240, under its Appendix B quality assurance program, and does not know for what safety-related application (s) the plate will be used in at the nuclear power plant, the dedication of the plate must provide a high level of confidence that the requirements of Specification A 240 are met.

The performance of tension testing, hardness checks, chemical analysis, and verification of selected requirements of Specification A 480/A-480M will provide reasonable assurance that the plate meets the requirements of Specification A 240 (type 304).

Performance of a hardness test and/or an alloy verification using an alloy separator would not provide reasonable assurance that the plate is A 240, type 304.

For example, a hardness of 92 Rockwell B or 202 Brinell would be acceptable for A 240, types (304, 316, and 347) plate and an alloy separator, as a rule, could not separate these 300 series materials.

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Examole No. 3 i

A vendor procures ASTM A 234 fittings from an un-surveyed distributor as commercial material.

No program or programmatic controls are invoked in the vendor's procurement document.

A material test report is required which must be traceable by heat or lot number to the fittings supplied. The material may or may not reflect the original material manufacturer's markings. The actual mill test report may or may not be supplied with the fitting manufacturer's-test report.

Upon receipt, the vendor verifies that all fittings reflect the heat or lot number which is traceable to the fitting manufacturer's test report. One fitting from each heat is destructively tested using tension testing and chemical analysis as reflected on the critical characteristics form, with no cther destructive or nondestructive testing being performed on the balance of the material.

Jimensional inspections would be performed on i

all fittings not destroyed by the testing for compliance to the applicable American National Standards Institute specifications.

NRC Discussion:

i Since there are no requirements for the distributor to audit or survey its suppliers or to invoke specific quality assurance requirements in purchase orders to its suppliers, the distributor may not have performed these activities.

Even if the distributor did perform audits or surveys of its suppliers and did invoke quality assurance requirements in purchase orders to its suppliers, the vendor could not take credit for these activities because the vendor did not perform any reviews or evaluate the distributor's control over these activities.

Based on the above discussion, if (1) the A 234 fittings do not reflect the i

original material manufacturer's marking, and (2) the actual manufacturer's test reports are not provided with the fittings, and (3) the actual mill certified material test reports are not provided, dedication would require, as a minimum, verification of all physical and chemical properties of each fitting, and dimensional inspections such as wall thickness and end preparations.

Even with these dedication activities being performed, without the mill certified material test reports and the forger's product analyses, the vendor could not certify that the fittings meet all of the requirements of A 234 (e.g. Section 4, " Materials," Section 5, " Manufacture," Section 6, " Heat Treatment").

With the exception of the NRC Response to Question 4, the following responses are based on having manufacturer's and distributor's (if applicable) markings on the A 234 fittings and actual manufacturer (forger) test reports for each heat and actual miis test reports for each heat, and the fittings are not intended for use in critical safety applications (see NRC Comment I for this example).

Question No. 1:

Is it necessary to perform destructive testing, or could nondestructive testing such as hardness testing and/or alloy verification be utilized?,

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f NRC Response:

Destructive testing to verify the physical properties specified by A 234 and any supplemental properties specified in the customer's purchase order, such as impact properties, should be performed on at least one fitting from each heat. Because the vendor purchased the A 234 fittings from an un-surveyed distributor as commercial grade, chemical analysis and hardness testing should be performed on each fitting to verify compliance to A 234 physical and chemical requirements.

Question 2:

In response to Question 1, if only nondestructive testing is required, could a sampling (10% for example) be tested, or should all fittings be testes, or could only one fitting be tested?

NRC Response:

l Destructive testing of one fitting, from each of the distributor's heat or lot of fittings, should be performed as discussed in the NRC response to Question 1.

Additionally, since material traceability has not been established, nondestructive testing should be performed on each fitting to verify that its chemical composition and hardness meet the requirements of A 234.

t Question 3:

Is it possible to perform dimensional inspection activities on a sampling (10%

for example) of the fittings?

NRC Response:

i Since the example indicates that the vendor purchased the fittings from an un-surveyed distributor and no program controls were invoked in the vendor's procurement documents, there do not appear to be any validated controls in place for dimensional inspection activities performed by the distributor or its suppliers.

Any sample plan used by a vendor for accepting dimensions on these A 234 fittings needs to provide a high confidence level that dimensions are correct.

Since material traceability has not been established, a tightened sample plan, with a sample size exceeding that required by standard statistical sampling methods which are based on sampling homogenous product lots, should be used i

for each of the distributor's heat or lot of items.

Question 4:

Is there a difference if the mill test report accompanies the fitting manufacturer's test report, and the fittings reflect the actual fitting manufacturer's marking as opposed to the distributor's marking of the material?

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NRC Response:

Yes, the tightened sample plan for dimensional inspection should be adjusted accordingly to consider cases in which (1) the distributor is the sole source in maintaining the fitting identification markings and (2) identification markings by both the distributor and manufacturer are on the fittings.

However, it is noted that, because material traceability has not been established, the responses to Questions 1 and 2 would still apply as previously discussed.

Question 5:

Is it acceptable to perform destructive testing on one fitting and then perform nondestructive testing such as hardness testing on the balance or a sampling (10% for example) of the balance.

NRC Response:

Because material traceability has not been established, nondestructive testing as described in the response to Questions 1 and 2 should be performed.

NRC Comments for Example No. 3 1.

The above responses may not be adequate for ensuring that A 234 fittings in certain applications will perform their safety function.

For critical nuclear safety-related applications (e.g. fittings in high pressure, high temperature, steam or water applications) where failure modes include fatigue, deformation, burst, wall thinning (caused by corrosion / erosion), and propagation of manufacturing defects, the following requirements would apply:

a.

Tensile tests and other physical tests (e.g., impact) should be performed using a prolongation obtained from the end of the fitting or using a fitting from the same heat. Material traceability of the test specimen and, if used, a fitting from the same heat, to the fitting being dedicated should be established by audit, survey, or source surveillance regardless of where the test specimens were obtained.

b.

Chemical analysis should also be performed on the actual fitting or specimen where material traceability to the fitting has been established as discussed in (a) above.

2.

The vendor should exercise caution in preparing its certification statement addressing conformance to A 234.

If the vendor only confirmed during dedication that the physical, chemical, and dimensional requirements of A 234 had been met, its certification should so state. The end user of the fittings would then determine if the fittings were acceptable for their intended safety-related applications.

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[xample No. 4 A vendor procures ASTM A 36 plate from a distributor that has nota been surveyed.

No program or programmatic controls are invoked in the vendor's procurement document. A material test report is required with the material.

The distributor provides a test report from the mill and marks the plate with the heat / lot number corresponding to the test report received with the plate.

The vendor then performs tension testing and chemical analysis on each piece of plate. Also, each piece receives a dimensional inspection.

Test reports from the qualified test facility confirm that the material meets the requirements of A 36, however review of the results against the manufacturer's test report reflects the material may be from another heat or even another plate manufacturer.

Question 1:

Is the product acceptable?

NRC Response:

In order to certify that the plate meets the requirements of A 36, the vendor would have to confirm that all of the requirements of A 36 have been met including the applicable requirements of A 6 (Specification for Structural Steel) as required by Section 4 of A 36.

Because the vendor has determined that the documentation supplied with the plate is not for the plate received, the vendor should identify the test results and any other inspections it performed on each piece of plate and document these on its certification for the plates.

Question 2:

{

Is it possible to conduct the aforementioned destructive testing on only one piece of plate and perform nondestructive testing such as hardness on the balance or sampling of the balanced?

NRC Response:

No.

The conditions described above clearly indicate that the distributor and/or his supplier have not maintained material traceability for the plates, therefore each plate has to be evaluated for compliance to A 36 requirements.

Question 3:

Is destructive testing necessary or could one piece, all pieces, or a sampling of the pieces be tested nondestructively?

NRC Response:

i A.

Because material traceability has not been maintained, each piece of plate should be destructively and nondestructively tested as previously discussed.

h B.

If the test reports from the qualified test facility had confirmed that the plate met the requirements of A 36 and the results were consistent with the manufacturer's test report, it would be acceptable to perform destructive testing on one piece of plate from each heat and to perform nondestructive testing on the balance of plate from each heat. Since the vendor does not know what applications the plate will be used in, nondestructive tests such as a hardness and/or alloy verification would not be sufficient to determine that the pieces of plate meet all of the requirements of A 36.

Question 4:

Is it possible to perform dimensional inspection on a sampling of material?

NRC Response:

Because evidence exists to question the material traceability and marking of the plates as well as the material certification supplied by the distributor, the vendor should not sample the material dimensions. However, as stated in previous NRC responses, sampling of product dimensions is acceptable under certain circumstances.

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4 Example No. 5 l

t A vendor procures ASTM A 569 sheet from a distributor.

No quality program is invoked and no mill or material test report is available. The material may or may not reflect the manufacturer's markings, and may not even reflect a heat or lot number.

The vendor tests each piece of sheet and verifies by testing all of the requirements of the material specification.

The test results, which comply with A 569, are provided to the customer as the only verification that the material meets the specification. The vendor will mark the material with appropriate trace codes to tie the material to the test reports and other applicable certification.

Question 1:

Is the above practice acceptable?

NRC Response:

If the vendor has confirmed by test and inspection that all of the requirements of A 569, as required by the vendor's customer purchase order, as l

well as the applicable requirements of A 568/568M have been met, the above practice appears to be acceptable. However, the vendor should note on its certification that certain requirements such as the marking on the material is by the vendor and that the manufacturer's product marking requirements, Section 14 of A 568/568M, have not been met.

Question 2:

Is it possible to perform destructive testing on one piece only?

NRC Response:

When no mill / material test reports are provided (and in this case the material has no markings), material traceability has not be established.

Therefore, a piece of steel from each A 569 sheet should be destructively tested.

Question 3:

Is it possible to perform destructive testing on one piece and perform nondestructive testing on the balance or sampling of the balance, to correlate to the destructive testing performed?

NRC Response:

If the A 569 sheets were properly marked with the manufacturer's heat or lot number and one piece from each heat or lot was destructively tested (e.g.,

physical and chemical properties tested) and the test results were confirmed to be consistent with those on the manufacturer's test report, the remaining pieces could be nondestructively tested to verify compliance with the material specification requirements, i.

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i Question 4:

Could only nondestructive testing be performed, such as hardness, provided the material specification had either hardness values to check against, or tensile values that could be approximated by the hardness?

NRC Response:

If the material specification or customer purchase order identifies required tensile / yield values and the A 569 sheets are properly marked by the manufacturer and the manufacturer has provided test reports, only one piece from each heat or lot needs to be destructively tested by the vendor to verify the material's tensile / yield strength. The remaining sheets of A 569 material (from each heat or lot) should be tested and inspected to confirm that other requirements (e.g. chemistry) of A 569 have been met.

In addition, since adequate material control / marking by the distributor and manufacturer have not b2en confirmed by survey or audit, a hardness check on the remaining pieces should be performed to verify that the other sheets have the (approximate) required tensile / yield strength.

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l NRC

GENERAL COMMENT

S 1.

Dedication of commercial grade items for use as basic components is a quality related activity and needs to be performed and controlled in accordance with the requirements of Appendix B to Title 10 of the C2df i

of federal Heaulations (10 CFR) Part 50.

2.

There are requirements in material specifications such as performance of hydrostatic tests, welding, and nondestructive examination of welds and weld repair areas that were not specifically discussed in these examples. When applicable, these and other specification requirements need to be confirmed during the dedication process or the failure to perform these tests noted on the material certification.

3.

When the customer's purchase order invokes supplementary specification requirements or additional requirements not addressed in the material i

specification, care should be exercised during the dedication process to ensure that these additional requirements have been met.

4 If the dedication process only confirms that a portion of the applicable material specification requirements have been met, the vendor should so inform its customer.

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ENCLOSURE 2 Y

UNITED STATES y[\\

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NUCLEAR REGULATORY COMMISSION

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1 NRC INSPECTION MANUAL RviB INSPECTION PRDCEDURE 38703 COMMERCIAL GRADE DEDICATION I

PROGRAM APPLICABILITY:

2515 SALP FUNCTIONAL AREA: ENGINEERING (50ETS-0) o 3B703-01 INSPECTION OBJECTIVES 01.01 To detemine whether the failure of a safety-related system, structure, l

componer.1 (SSC), or part to perform its intended safety function was the result of a deficient comercial grade item (CGI) dedication process.

01.02 To verify that the licensee's process for dedicating CG!s, as implemented, meets the applicable portions of Appendix B to 10 CFR Part 50 and provides reasonable assurance that CG!s will perfarm their intended safety function.

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38703-02

. INSPECTION REQUIREMENTS 02.01 Reactive inspection Recuirements i

a.

Initial Evaluation.

Af ter reviewing the. licensee's evaluation of the j

f ailed 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 dedication records to determine if the comercial grade dedication process was sufficiently t

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 accepted, the inspector should perform the following assessments:

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1.

Deternine if other CG]s from the same accepted lot or batch as the.

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failed dedicated CGI have been similar.ly dedicated and. installed in i

other safety-related applications.

If yes, detemine if the licensee has evaluated the operability of the systems or components.

where these CG]s are installed.

The inspector also should review licensee-provided data, if available, for some CG!s (non-dedicated) that failed in applications that were not safety-related.

Explore the possibility that the same CG!s also may have been used (following dedication) in a safety-related application and may have the potential to affect the safe operation of a SSC.

Issue Date:

11/08/93 38703 I

h h

2.

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.

j 3.

If, after performing step 2 above, it is determined that there were weaknesses in the comercial grade dedication process, the inspector should perform a more comprehensive inspection of the licensee's dedication process in accordance with the inspection requirements in Section 02.02 below.

02.02 Proaramatic Inscettion Reovirements a.

Review of Procram and Procedures.

Using the inspection guidance contained in Section 03.02 and Appendix A to this procedure, review the licensee's program and procedures for the procurement and dedication of CG!s in order to understand the basic operation of the licensee's program.

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b.

Selection of Dedication Packaoes.

Select approximately 20 dedication packages for evaluation from a list of comercially dedicated items provided by the licensee.

Request that the licensee provide (or make available for review) a complete package of the pertinent procurement and dedication records for each item.

c.

Evaluation of Dedication Packeaes.

Using the inspection guidance contained in Section 03.01 of this procedure, perform a detailed evaluation of the dedication packages selected in item b above.

d.

Evaluation of Trainina Effectiveness.

If the inspector's evaluation of comercial grade dedication activities indicates there are weaknesses in the way these activities are being performed, the inspector should investigate further to determine if weaknesses within the licensee's training program may have contributed to the cause. The inspector should determine if the licensee is implementing an effective training program.

38703-03 INSPECTION GUIDANCE GENERAL GUIDcNCE Backaround. Licensees are required to ensure the quality of items purchased and installed in safety-related applications. In the past, licensees procured major assemblies from approved vendors who maintained quality assurance (QA) programs pursuant to Appendix B to 10 CFR Part 50. Because of the decrease in the number of qualified nuclear-grade vendors, licensees are increasing the numbers of comercial grade replacement parts that they procure and dedicate for use in safety-related applications.

Since comercial grade dedications have increased in number, the Nuclear Regulatory Comission (NRC) has developed this inspection procedure to provide guidance to assist the inspector in assessing the effectiveness of the implementation of the licensee's comercial grade procurement practices and provide for early identification of any adverse trends or emerging problems.

The Vendor Inspection Branch, of the NRC's Office of Nuclear Reactor hgulatian, is available to assist with specific questions that arise during the performance of this procedure.

38703 Issue Date:

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l i

Schedulina the Inspection. This inspectir, procedure should be considered for implementation when there is reason t:, believe that the failure of a SSC or part to perform its intended safety. function was the result of weaknesses in CGI dedication. This inspection procedure may be implemented independently or it may be used as a supplement to other major team inspections.

Such inspections may include maintenance, modification, or system-specific inspections where review of failed SSCs or parts is appropriate, or an augmented inspection team investigating failures.

i The NRC should contact the appropriate NRC and licensee personnel to schedule the

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inspection.

When practical, inform the licensee of the objectives of the inspection 4-6 weeks before the inspection is to begin and advise them of information that will be needed, such as a list of items that the licensee purchased as comercial grade after July 1990 and subsequently dedicated for use in safety-related applications. Before the beginning of the onsite inspection, the inspector should request and review the licensee's program and procedures to become familiar with the licensee's procurement and dedication process.

Also 1

explore with the licensee the possibility of obtaining a list of recent component failures. Request this list only if the licensee states this type of information would be easily retrievable. The list of component failures can be used by the inspector during the selection of dedication packages for review described in Section 02.02 of this inspection procedure.

This inspection procedure is consistent with the Nuclear Management and Resources Council (NUMARC) initiative for improving the utilization of CGIs in nuclear safety-related applications that was implemented in July 1990. The methods used to comercially dedicate items procured by licensees before that date will not necessarily meet the guidance contained in this inspection procedure.

If the inspector encounters a significant failure of a commercially dedicated item, which was dedicated before July 1990, the inspector may review the dedication of that item with the understanding that the licensee was not expected to meet the i

current guidelines.

SPECIFIC GUIDANCE 03.01 Reactive Inspection a.

Initial Evaluation. A failure resulting from general weaknesses in the comercial 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.

For example, f ailures of safety-related bolting have occurred when the dedication process did not verify that the material composition and/or mechanical properties met the specified requirements and nonconforming material was j

supplied.

Review and discuss with licensee personnel the failure / root-cause analysis when required or applicable for the failed CGl. The inspector i

should attempt to determine if the failure was due to a design deficiency, f ailure unrelated to the item's safety function, or normal wear, and eliminate these from further review.

The inspector should focus on the inspection of failures that appear to be due to weaknesses in the comercial grade dedication process.

If none of the failures are due to weaknesses in the comercial grade dedication process, then the inspector should not continue using this inspection procedure.

If the inspector decides to change the focus of the inspection to examine other i

issues related to the failures, such as the adequacy of corrective issue Date:

11/08/93 3870'

actions,- other procedures should be used, such as NRC Inspection i

Procedure 92720, " Corrective Action." Once the failure mode and cause of failure have been postulated or determined, review the dedication package as described in Section 03.01a(1) 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. Appendix A, if properly implemented, represents an acceptable means of complying with regulatory requirements.

Individual licensee's may develop alternate methods of achieving Appendix B compliance.

Appendix B provides definitions of terms used for commercial grade dedication activities, and Appendix C provides the typical contents of a dedication package.

The goal of the review of the dedication packages is to provide reasonable assurance that the CGIs dedicated for safety-related applications will perform their intended safety functions.

Inspection effort should be directed towards the identification of weaknesses in the dedication process that could potentially render SSCs or parts inoperable.

When reviewing licensee's operability determinations for dedication of CGIs, the inspector should refer to the " Technical Guidance

• section of NRC Inspection Manual, Part 9900, for further guidance.

a(1)

Review of Dedication Packaaes.

After becoming familiar with the licensee's procurement and dedication program and procedures, perform a detailed review of the dedication package as described below.

Determine if the safety function of the item for its intended use has been identified by reviewing the documents associated with the technical evaluation including, as applicable:

- classification of the item

- consideration of credible failure modes item equivalency / substitution evaluations Determine if the important design, material, and performance characteristics relevant to the safety function have been identified.

Determine whether the licensee verified the characteristics necessary to provide reasonable assurance that the item will perform its intended safety function.

If appropriate, take into account post-installation testing and periodic surveillance testing and inspection.

Review the basis for engineering judgment when it is used as the basis for selection or verification of critical characteristics.

Determine whether the item is an equivalent replacement or a new item replacement of an obsolete item.

Determine if the item is or may be used in a different safety-related application than previously evaluated in which different design, material, and performance characteristics say be applicable.

This is especially applicable f)r generic dedications of bulk iters and stock material.

Determine if the dedication ensures those design, material, and performance characteristics relevant to the safety function.

38703 Issue Date:

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Determine why the item is being replaced. Have there been repeated failures 7 Is the degraded performance a result of adverse environment? Did it fail because it was a refurbished or fraudulent item? General information on similar activities subject to Appendix B to 10 CFR Part 50 is provided in American National Standards institute (ANSI) ANSI N45.2-1977,

" Quality Assurance Program Requirements for Nuclear Power Plants," Section 17, ' Corrective Action."

Determine how the identity of the item is controlled from the tiine it is receipt inspected until the time it is installed.

General information on similar activities subject to Appendix B to 10 CFR Part 50 is provided in ANSI N45.2-1977, Section 9, ' Control of Parts and Components."

Determine if information learned during the dedication process is fed back to the appropriate persons to evaluate existing stock items, or installed items, and for future use in surveys and source verifications. This information could include positive and adverse findings obtained during surveys and source verifications. General information on similar activities subject to Appendix B to 10 CFR Part 50 is provided in ANSI N45.2.13-1976, " Quality Assurance Requirernents for Control of Procurement of Items and Services for Nuclear Power Plants,' Section 9, ' Corrective Action."

Refer to the discussion of significant dedication issues in Appendix A for guidance during the review of dedication packages. Also refer to the specific guidance for each of the four dedication methods provided below.

Focus should be on those activities that are likely to affect the performance of the items being dedicated.

It is not necessary to review the licensee's programmatic compliance to the 18 criteria of Appendix B to 10 CFR Part 50 as they may not apply to the activities reviewed.

Appendix B to 10 CFR 50 does not apply to comercial grade activities which occur prior to dedication for use in a safety-related system. It also should be recognized that this appendix provides for the application of QA to safety-related systems and components consistent with their irwortance to safety (graded quality approach).

Although guidance concerning the application of graded quality assurance is discussed in the first paragraph of Appendix A to this inspection procedure, it is expected that the inspector will need to exercise considerable judgment in deternining the adequacy of controls applied to a specific activity.

The following are the four acceptance methods that can be used to accept CGIs.

These methods provide, either individually or in combination, a means to reasonably ensure that a CGI that is received meets the requirements of the item specified. The results of employing each method should be documented.

i Method 1 - Special Tests and Inspections General information on similar activities subject to Appendix B to 10 CFR Part 50 is provided in ANSI N45.2.13-1976, Section 10, ' Acceptance of Item or Service."

Use the following approach to review packages that were dedicated using this method:

i Issue Date:

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To the extent practicable, attempt to witness receipt _ inspections and tests of in-process dedication of CGIs that are similar to that of the failed item to verify the identified critical characteristics.

Review receiving records and associated tests and inspections.

Review post-installation test records.

Verify that the tests and inspections specified for acceptance adequately verify the identified critical characteristics.

Verify that sampling plans are controlled and have adequate technical basis, considering lot traceability and homogeneity, complexity of the item, and adequacy of supplier controls.

Verify that CGI receiving inspection activities are adequately controlled under a quality program regardless of whether they are being performed in conjunction with other plant receipt inspection activities.

Verify that receipt inspection activities et,tablish and maintain traceability of CGIs by capturing and appropriately relating traceability documents through identification and monitoring of CGls.

Verify that measuring and test equipment was properly calibrated, that approved vendors were used to perform tests, and that personnel were qualified to perform the tests.

Method 2 - Comercial Grade Survev i

Use the following guidance to review packages that were dedicated using this method:

Deternine if the guidance of Generic Letter 89-02, or an appropriate alternate, is included in the appropriate procedures. Specifically, confirm that (1) the documented commercial quality program was effectively implemented and (2) the surveys were conducted at the location necessary to verify that adequate controls were exercised on distributors as well as manufacturers.

Through interview, determine if the persons who perform vendor surveys are knowledgeable in the following:

the use of performance-based surveys screening third-party surveys processing and evaluating adverse findings resulting from the review of third-party surveys to ascertain if those findings affect CGIs already installed or stored in the warehouse awaiting future installation General information on similar activities subject to Appendix B to 10 CFR Part 50 is provided in ANSI N45.2.12-1977, ' Requirements for Auditing of Quality Assurance Programs for Nuclear Power Plants," and ANSI N45.2.23-1978, *0ualification of Quality Assur4nce Program Audit Personnel for Nuclear Power Plants.*

38703 Issue Date:

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~

1 Verify that the-supplier's comercial quality controls are imposed in the procurement documents.

Determine if the critical characteristics that are to be verified by.

I the survey team are accurately and completely incorporated in the survey plans.

\\

Determine if the validity of supplier documentation, relied on in i

the dedication of the item, is verified during the survey.

i Determine if surveys of comercial grade suppliers are performance based as opposed to programmatic.

Specifically, verify that the critical characteristics for the CGls being surveyed are controlled by the supplier's quality activities.

j Deternine if survey teams include technical and quality personnel,

=

as appropriate, that are knowledgeable -in the operation of the item (s) and the associated critical characteristics to be verified, including any special processes such as welding and heat treatment that are specific to the critical characteristics.

i Detemine if surveys are conducted at appropriate times relative to the procurement.

Are surveys required to be updated on a regular 1

basis to support dedication?

Determine if the control of subvendors is adequately addressed by the surveys so that the supplier has an adequate basis to accept test results and certifications from the subvendor.

I Determine if pertinent information about a supplier or its products i

is used to plan, cor, duct, and report results of surveys and source verifications.

Such information could have been available from source verifications, receiving inspections, the dedication process, supplier / product performance history, or outside sources such as NRC information notices and bulletins, nuclear plant reliability data system reports, or Nuclear Utility Procurement Issues Comittee i

(NUPlt) comercial grade survey reports.

Method 3 - Source Verification General information on similar activities subject to Appendix B to 10 CFR r

Part 50 is provided in ANSI N45.2.13-1976 Section 10.3.2,

• Acceptance by Source Verification.* Use the following approach to review packages that were dedicated using this method:

Deternine if source verifications involve witnessing the supplier-performing quality activities on the actual items being procured and adequately verify the item's critical characteristics.

Determine if personnel who participated in the. source verification surveys were qualified for their specific assignment.

Determine if appropriate hold points are imposed in the purchase orders. This would include a hold point to verify design, material, and performance characteristics relevant to the safety. function i

that cannot be verified after the item - has been completely manufactured.

Issue Date:

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g

,n w

t-Determine if the results of the source verifications were adequately documented.

Method 4 - Acceptable Sueolier/ Item Performance Record Use the following guidance to review packages that were dedicated using this method:

Deterwine if the guidance of Generic Letter 89-02, or an appropriate alternate, has been incorporated. Specifically, (I) the established i

historical record is based on industry-wide performance data that is directly applicable to the item's critical characteristics and the intended safety-related application and (2) the manufacturer's measures for the control of design, process, and material changes have been adequately implemented as verified by survey (multi-i licensee team surveys are acceptable).

Determine if information pertinent to the CGl's quality of performance, obtained from outside sources (e.g., operational event reports, NRC, vendor equipment and technical inforzation 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.

Deternine if the item or manufacturer is included in the licensee's perforvance trending program.

b.

Further Assessments 1.

No inspection guidance.

2.

From the list of dedicated items provided by the licensee, the inspector should select for review approximately three other dedication packages having similar applications and critical characteristics as the CGl(s) that resulted in the identified failures.

After the selections have been made, the inspector should request that the licensee 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.

The inspector should review the dedication packages as described in Section 03.01a(1) of this inspection procedure.

3.

No inspection guidance.

03.02 Procrarrratic Inspection a.

Review of Proaram and Procedures.

The review of the program and procedures should be performed to familiarize the inspector with the i

licensee's CGI dedication process.

For cases in which problems are identified with the licensee's CGI dedication process, the inspector may decide to perform a more extensive review of the program and procedures to deternine if these problems are the result of inadequate procedures.

The inspector's review should include procedures that control:

procurement activities; material control; the dedication of CGIs, including receipt inspection and acceptance testing; surveys of 38703 Issue Date:

11/08/93

comercial grade suppliers; classification of components; traNng of personnel; trending of supplier performance; and equipment G A res.

Attempt to identify any apparent weak areas to concentrate on during the evaluation of the program implementation.

After arriving onsite, the inspector should request that the licensee explain its commercial grade dedication process and conduct a walkthrough of areas associated with it. Areas in the walkthrough could include the engineering, receipt insoection, component testing, and warehouse. The inspector should becoue familiar with key licensee personnel involved in the comercial grade dedication process.

These key personnel should include the responsible engineer (s) who developed the dedication package (s) and systems engineers, procurement engineers, receipt inspectors, quality assurance engineers and inspectors, and warehouse personnel. The inspector should discuss the commercial grade dedication

~

process with these key personnel to gain a better understanding of the process, including:

How processing of CGI procurement dccumts is controlled under the quality program and how they receive review and approval.

General information on similar activities subject to Appendix B to 10 CFR Part 50 is provided in ANSI N45.2.13-1976, Section 3, " Procurement 1

Document Preparation, Review, and Change Control."

How technical personnel participate in the preparation, review, and

=

approval proc 2ss of procurement documents.

How consistency and coordination is maintained between corporate level, engineering / support level, and site level programs and implementing procedures.

b.

Selection of Dedication Packaaes. As discussed in the general guidance section above, the NUMARC initiative for the utilization of CGIs in nuclear safety-related applications was not implemented until July 1990.

Therefore, the methods used ta perform comercial grade dedication of items p mcured or dedicated by licensees before that date will not necessarily meet '.he guidance contained in this inspection procedure.

The selection process should be performance oriented (e.g., weighted toward the review of dedication packages for equipment, components, or parts that have experienced failures). To accomplish this, the inspector should request from the licensee approximately 20 packages for review using the two-step approach described below.

The licensee should be given sufficient lead time to prepare the 20 packages and make them available for the first day of onsite inspection.

Sten 1: Review the licensee's records available at the plant site to identify recent failures (approximately the last 2 years) of equipment, components, or parts.

Review these failures to determine if any were CGIs dedicated for use in safety-related applications.

If available, select apprn.nately 75 percent of the total sample from CGI failures.

Step 2: From the list of dedication packages supplie6 by the licensee, under the " Inspection Guidance" section of this procedure, select the remainder of packages for review.

The total sample size including packages from steps 1 and 2 should be approximately 20 packages.

However, the inspector can select a larger or smaller sample depending on the complexity of the packages and the time available.

The inspector Issue Date:

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i l

I should select these packages on the basis of the following j

considerations:

1 The inspector should select packages for items whose failure would i

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have the most effect on the ability of the plant to safely operate, safely shutdown from an adverse condition, or maintain a safe i

shutdown condition.

If time permits, review the plant-specific i

probabilistic risk assessment, individual plant examination, and

~

risk-based inspection guides that provide information on the risk significance of safety-related plant equipment.

l The inspector should take a performance oriented approach to the

=

selection process by including in the sample packages those items that have been problems.in the past.

Review available sources of

{

information to identify any known failures of CG!s that were used in i

safety-related applications.

These sources of information could include:

5 component failure lists or lists of items requiring frequent maintenance or replacement as provided by the licensee misrepresented or fraudulent items reported in NRC information j

notices licensee trending of equipment and supplier performance previous history of component failures or malfunctions as reparted in licensee event reports or plant nonconformance reports L

The inspector should include both simple and complex packages in the

=

i sample as well as packages that include a variety of dedication methods (e.g., Methods I through 4) described in Section 03.01a(1) l above.

In addition to selecting packages based on the above considerations (safety significance, complexity, and failures), the inspector should attempt to select samples from each of the following areas:

1 electrical, instrumentation and control, mechanical equipment, and

}

materials.

r c.

Evaluation of Dedication Packaaes.

Perform a detailed review of the dedication packages as described above in Section 03.01a(1).

d.

Evaluation of Trainina Effectiveness.

Experience. gained during. the procurement assessments and pilot inspections suggested that training of personnel involved in CGI dedication activities was -a very important i

factor in the development of _a good CGI dedication program.

The CGI-dedication process generally requires more highly qualified / trained personnel than specified in Appendix B to 10 CFR Part 50 procurement. _

Personnel involved in this process need to be familiar with current.

industry and NRC guidance and have a strong interface with the licensee's

.i design / engineering organizations.

The training expectations, however, should not exceed what is required by the existing licensee's QA' program.

As applicable to their job function, select and review the training i

records for individuals involved in the following areas:

Determining the safety classification of an item. Training in_ this 1

=

area is appropriate when the job function includes reclassification 38703' Issue Date:

11/08/93 i

of items or estabitshing safety classification of piece parts of safety-related components.

Specifying design,

material, and perfomance characteristics relevant to the safety function and establishing the acceptance criteria for these characteristics.

Specifying or performing comercial grade

surveys, source verifications, and tests and inspections, including enhanced post-receipt verification testing or inspection.

The preparation and review of procurement documents.

Through observation, interviews, and a review of records of work performed by the individuals:

Detemine if the individuals selected have adequate knowledge to perform the specific tasks assigned to them.

Attend a training course, if available, or review the lesson plans for selected training courses.

Determine if training inadequacies contributed to any of the deficiencies that may be identified during the inspection.

Determine if the personnel are familiar with the program requirements and procedures and if they have been properly trained in the dedication process.

It should be noted that alternatives to a formal training pro adequate to ensure satisfactory program implementation (e.g., gram may be on the job training). Additional information in this area is provided -in NRC Inspection Procedure 41500, " Training and Qualification Effectiveness.*

38703-04 INSPECTION RESOURCE ESTIMATE The estimated number of onsite inspection hours required to complete all inspection requirements is 144 hours0.00167 days <br />0.04 hours <br />2.380952e-4 weeks <br />5.4792e-5 months <br /> when both the reactive and programatic options are implemented. This estimate is for broad resource planning and is not intended as a quota or standard for judging inspector or regional perfomance.

The on-site hours can be expected to vary significantly depending on the specific circumstance and scope of each inspection.

38703-05 REFERENCES The following documents'are listed for the inspector's infomation only and are not considered regulatory requirements unless the licensee has formally comitted to implementing any of these documents for application to safety-related activities. The inspector may wish to review these documents to become familiar with comercial grade dedication issues.

ANSI N45.2-1977, " Quality Assurance Program Requirements for Nuclear Power Plants

• as endorsed by NRC Regulatory Guide 1.28, Revision 2.

ANSI N/5.2.13-1976, " Quality Assurance Requirements for Control of Procurement of items and Services for Nuclear Power Plants," as endorsed by NRC Regulatory Guide 1.123, Revision 1.

Issue Date:

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-l 1

Electric Power Research Institute (EPRI) NP-5652, " Guidelines for the Utilization of Commercial-grade items in Nuclear Safety Related Applications (NCIG-07)," as conditionally endorsed in NRC Generic Letter 89-02.

Generic Letter 89-02, " Actions to Improve the Detection of Counterfeit and Fraudulently Marketed Products" (microfiche 48960-001).

i Generic Letter 91-05, " Licensee Commercial Grade Procurement and Dedication Programs * (microfiche 57468-264).

NRC Inspection Procedure 41500, " Training and Qualification Effectiveness."

SECY-90-304, "NUKARC Initiatives on Procurement" (microfiche 55277-049).

SECY-91-291,

" Status of NRC's Procurement Assessments and Resumption of Programmatic Inspection Activity" (microfiche 59490-079).

END Appendices:

A.

Dedication issues B.

Definitions C.

Contents of Dedication Packages i

1 P

i 38703 Issue Date:

11/08/93

APPENDIX A DEDICATION ISSUES BASIS FOR THE SELECTION AND VERIflCATION OF CRITICAL CHARACTERISTICS 1.

Consideration of item's Safety function Critical c!iaracteristics should be based on the item's safety function.

l 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. Criterion 11 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.

This graded quality approach can be used in the selection and verification of critical characteristics for commercial grade items (CGis).

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 Ouality Assurance 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 cmplexity or uniqueness of the item, (c) the need for special controls m i surveillance over process and equipment, (d) the degree to which fune.ional 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 nonmandatory 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.

ReasoNijle Assurante The dedication process represents an acceptable method of achieving 4

compliance with Appendix B to 10 CFR Part 50 with the purchaser assuming many of the responsibilitiet 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 issue Date:

11/08/93 A-1 38703, Appendix _A

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.

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 30 CFR Part 50.

5.

Encineerino Judoment Engineering judgment can be used in selecting those important design, material, and performance characteristics that are identified as the item's crit P.al characteristics. The bases for engineering judgment for this application 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.

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 heaf 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.

2.

Established Lcf/ 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 38703, Appendix A A-2 Issue Date:

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that are based on homogeneous product lots. Such sample plans should be identified and should provide for the verification of the critical characteristics with 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 Soecific Characteristics A comercial 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 L

observing the actual implementation of these controls in the manufacture of items identical or similar to the items being purchased.

2.

Identification of Acolicable procram/ 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 ara 'pplicable to the vendor's activities, which affect the item's criti; 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 'eviewed and accepted during the survey be applied during the manufac.sring process. Upon completion of the work, the vendor should certify compliance with the purchase order requirements.

3.

Documentation of Survey Results Comercial 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 entrol, identification of the controls to be applied (program / procedure and revision), and a description of the verification activities performed and results obtained.

Critical charatteristics that are not adequately controlled should be addressed by contrattually requ"ing the vendor to institute additional controls or by utilizing other verification and acceptance methods.

Issue Date:

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4.

Survey frecuency Comercial 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 comnercial 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 (Cots)

Validity Verified Throuch Vendor / Supplier Audit or Testina When the verification of critical characteristics is based on vendor CNTRs or Cots, the validity of these documents should be ensured.

This can be accomplished through a comercial grade survey or, for simple items, periodic testing of the product on receipt.

Such verifications should be conducted at intervals comensurate with the vendor's past performance. If the item's supply chain includes a distributor, a survey of the distributor's activities say be necessary (see " Traceability").

USE OF INDUSTRY GUIDANCE The Electric Power Research Institute (EPRI) NP-5652, ' Guideline for the Utilization of Comercial 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 charact... its the " item specified" encompassed those attributes that are essential for W 7erformance 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."

The EPRI NP-6406 definition of

" critical characteristics for design' includes those attributes that ensure the performance of the item's design function.

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 38703, Appendix A A-4 Issue Date:

11/08/93

l APPENDIX B DEFINITIONS The following terms are listed to provide the inspectors with working definitions of important terms used during the procurement and dedication of commercial grade items (CG!s). These terms are defined only in the context of the CGI dedication i

process and are solely to aid the inspector in the inspection process.

Bjsic Component - A plant structure, system, component, or part thereof necessary to ensure one of the following:

the integrity of the reactor coolant pressure boundary a

• capability to shut down the reactor and maintain it in a safe shutdown condition

• the capability to prevent or mitigate the consequences of accidents that could result in off site radiation exposures comparable to those referred to in 10 CFR Part 100.11

[ertificate of Coroliance - A written statement attesting that the materials are in accordance with specified requirements.

Certified Material Test Report - A document attesting that the material is in accordance with specified requirements, including the actual results of all required chemical analyses, tests, and examinations.

Comercial Grade item - An item satisfying All the following criteria:

• not subject to design or specification requirements that are unique to nuclear facilities

• used in applications other than nuclear facilities

• ordered from the manufacturer / supplier on the basis of specifications set forth in the manuf acturer's published product description (e.g., catalog)

Comercial Grade Survey - Activities conducted by the purchaser or its agent to verify that 4 Supplier of CGis controls, through quality activities, the critical i

characterist cs of specifically designated CGIs, as a method to accept those items for safety-related use.

Critical Characteristics - Those important design, material, and performance characteristics that, once verified, will provide reasonable assurance that the t

item will perform its intended safety function.

Dedication - The process. by which a CGI is designated for use as a basit component. This process includes the identification and verification of critical i

characteristics. (Also refer to definition in 10 CFR Part 21.3(4)(c-1))

Enaineerina Judament - A process of logical reasoning that leads from stated premises to a conclusion.

This process should be supported by sufficient documentation to permit verification by a qualified individual.

Issue Date:

11/08/93 B-1 38703, Appendix B l

I Source Verification - Activities witnessed at the suppliers' facilities by the purchaser or its agent for specific items to verify that a supplier of CGIs controls the critical characteristics of that item as a ethod to accept the item for safety-related use.

Traceability - Is the ability to verify the history, location, or application of an item by means of recorded identification.

END i

1 1

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l 38703, Appendix B B-2 Issue Date:

11/08/93

I APPENDIX C CONTENTS OF DEDICATION PACKAGES The dedication packages 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 Part 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 docu ents to trace the item from the time it was dedicated to the time it was insthlled, tested, and accepted.

• Certificates of conformance/ compliance / quality.

• Vendor test and inspection reports.

• Third-party or subvendor test and inspection reports.

• Shelf life information.

• Yendor dedication / partial dedication information.

• Design / material / process change history information.

• 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)

• Any deviation from design, material, and performance characteristics relevant Issue Date:

11/08/93 C-1 38703, Appendix C

I 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.

a

• Completed stock or material issue forms and installation work orders or reports.

• Historical performance information.

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l 38703, Appendix C C-2 Issue Date:

11/08/93

)