commercial grade item dedication guidance revision · 2014-06-02 · marc tannenbaum principle...

Marc Tannenbaum

Principle Technical Leader, EPRI

NRC Workshop on Vendor Oversight

June 12, 2014

Commercial Grade Item Dedication

Guidance Revision

2 © 2014 Electric Power Research Institute, Inc. All rights reserved.

Revision to EPRI Dedication Guidance

• 3002002982 will supersede NP-5652 and TR-102260

• Will reference other associated documents

– Computer Program Dedication

• 3002002289 (12/2013)

– Sampling

• TR-017218-R1

– Acceptance of digital devices

• TR-106439 (11/1996)

• TR-107339 (12/1997)

• 1009659 (3/2005)

• 1001452 (9/2001)


Revision to EPRI Dedication Guidance

• Will reference other associated

documents:

– Use of Laboratory Accreditation

in lieu of Commercial Grade

Survey

• NEI 14-05, Rev. 0


Diverse Technical Team

• Licensee, supplier, regulator and construction perspectives

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Key Points

• The document summarizes and discusses important updates to

dedication methodology that reflect key additions as well as differences

between the original guidelines and this update to the guidance.

– Supplier as well as utility perspectives

– Discussion related to the two paths a supplier can use to provide a

basic component.

– Clarification that a completed and accepted design is required prior

to beginning the commercial grade dedication process

– A shift in focus from “identifiable and measurable characteristics” to

characteristics necessary to perform safety function.

– Clarification that a failure modes and effects analysis (FMEA) is an

effective tool to determine critical characteristics when complete

design information is not available.


Key Points

• Continued

– Clarification that product identification attributes are not necessarily

“critical characteristics” as defined in 10CFR, Part 21

• However, product identification attributes such as part and model

number, nameplate data, and so forth are important and should

always be verified as part of the receipt inspection process.

– Use of the term “critical characteristics” in place of “critical

characteristics for acceptance” and “design characteristics” in place

of “critical characteristics for design”

– References to applicable content in ASME NQA-1 (in addition to

ANSI N42.2-1978)


Contents:


Appendices


Legacy

Basic

Process 4.2

Does item program

perform a safety

function?

NoProcure item non-

safety related

4.3

Is program

being procured as a

basic component?

Yes

4.3.1

Procure item as a

basic componentBasic

Component

4.4

Document Safety Function(s)

and FMEA

4.5

Identify and Document

Critical Characteristics

4.6

Select Acceptance Method(s)

4.6.1

Method 1

Special Tests

and

Inspections

4.6.4

Method 4 -

Item/Vendor

Performance*

4.6.3

Method 3

Source

Verification

4.6.2

Method 2

Survey of

Commercial

Supplier

Commercial grade item

4.7

Conduct acceptance

activities. Evaluate and

document results

Te

ch

nic

al E

va

lua

tio

n

Acce

pta

nce

4.1

Identify item program being

procured

Combination

of two or

more

methods

*Note restrictions on use of

Method 4 in GL 89-02 [27]


Detailed Process & Expanded Sub-processes

Figure Content Major

Step

Expanded

Steps

5-2 Overview of commercial grade Item dedication

process

5.1-5.6

5-3 Overview of commercial grade Item dedication

process

5.7-

5.13

5-4 Screen for Eligibility 5.2 5.2.1 – 5.2.6

5-5 Identification of safety function 5.3 5.3.1 – 5.3.3

5-7 Failure Modes and Effects Analysis 5.4 5.4.1 – 5.4.2

5-8 Identification of critical characteristics 5.5 5.5.1 – 5.5.4

5-9 Establishing dedication boundaries when safety

function is unknown

5.6 5.6.1 – 5.6.5

5-10 Identification of acceptance methods – Method 1,

special tests and Inspections

5.7 5.7.1 – 5.7.7

5-11 Method 2 – Commercial grade survey 5.7 5.7.8 – 5.7.14

5-12 Method 3 – Source verification 5.7 5.7.15 – 5.7.19

5-13 Method 4 – Item / supplier performance 5.7 5.7.20 –5.7.22


How the diagrams work

Item Identified

for

Procurement

as CGI5.1

..

Screen for

Eligibility

5.2

...

Not eligible

for dedication

Output / Input (green Lines)

Feedback / Return (red lines)

5.3 Indicates number of next step

Document

Acceptance

Requirements

5.7.14

..

....

Description of Step

Step number

Color fill indicates a sub-process diagram

with more detail is included. Step

numbers correspond to primary step.

Sub-process step numbers for primary

step 5.4 are 5.4.1, 5.4.2, and so forth

Perform FMEA

5.4

....

FMEA based

upon Item

Function(s)

5.4.1

..

....

Document

Failure Modes/

Mechanisms

5.4.2

..

....

Identified

failure modes

& effects

Known failure modes

and mechanisms5.5

© 2014 Copyright Electric Power Research

Institute – All Rights Reserved


Detailed Basic Process – Steps 5.1-5.6

Pursue Means

Other than

Dedication

A

..

....

Item Identified

for

Procurement

as CGI5.1

..

Screen for

Eligibility

5.2

...

Not eligible

for dedication

Identify Safety

Functions

5.3

....

Item is

Eligible

for

Dedication

Bound Eval

Functions /

Uses

5.6

....

Dedication

Limitations

And

Applications

Safety

Function

Information

Identify Critical

Characteristics

5.5

....

5.7

Safety Function

Information Not

Available

Perform FMEA

5.4

....

Failure Modes

Mechanisms

Dedicate based upon

design criteria

© 2014 Copyright Electric Power

Research Institute

All Rights Reserved


Detailed Basic Process – Steps 5.7-5.13

© 2014 Copyright Electric

Power Research Institute

All Rights Reserved

Identify

Acceptance

Methods &

Criteria5.7

.

....

Conduct

Acceptance

Activities

5.9

.

....

Pass

Acceptance

Document

actual results

of Acceptance

5.10

.

....

Documented Record of

Acceptance Failure

Discrepancy

Evaluation

5.11

..

....

Initiate NCR or

Corrective

Action

5.13

..

....

Remove from

CGID Process

5.12

..

....

Acceptable

Additional

Evaluation/Action

Remove from

CGID Process

Establish

sample plans

(as applicable)

5.8

..

....


Detailed Sub-process for Step 5.6 (includes

steps 5.6.1 – 5.6.5

Gather Original

Requirements

& Design Info

5.6.1

..

....

Analyze

Available

Design Info

5.6.2

..

....

Available design information

Is sufficient to determine functions

& critical characteristics

Submit for

Purchaser

Review

5.6.5

..

....

Insufficient

information

Request Info

from

Purchaser

5.6.3

..

..3

Information

Provided

Information

Not provided

Establish

Boundaries of

Dedication

5.6.4

..

....End Uses,

Safety Functions.

Qualifications

ApprovedNot Approved

5.3

© 2014 Copyright Electric Power Research Institute

All Rights Reserved

5.5


Step Dialog – Description, Methodology,

Precautions & Lessons Learned


Step Dialog – Precautions / Lessons Learned


Commercial Grade Survey Planning Tool


Example Technical

Evaluation Forms


Example Technical Evaluation Forms


Dedication Technical

Evaluation Review

Checklist



Evaluation Review

Checklist


August 19-21, 2014

Sandpearl Resort

Clearwater Beach, Florida

More detail and

discussion at JUTG

Content will be focused on the commercial grade dedication guidance

revision


Questions?

commercial grade item dedication guidance revision · 2014-06-02 · marc tannenbaum principle...

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