msc-pro-qa-259 - hanford.govjan 15, 2018 · rev. 7, chg. 1 msc -pro qa 259 page 1 of 13 graded...

Procedures

MSC-PRO-QA-259Graded Approach

Revision 7, Change 2

Published: 01/15/2018 Effective: 01/15/2018

Program: Quality and Performance OversightTopic: Quality Assurance

Subject Matter Expert : Mata, GeorgeAlternate Subject Matter Expert : Chafin, HenryFunctional Manager: Mata, George

Use Type: Administrative

*MSAPS.MSC-PRO-QA-259*

JHA: Administrative Periodic Review Due Date: 12/19/2022 Rev. 7, Chg. 2 USQ Screen Number:

not required : Excluded from USQExclusion Reason: USQ screening not required for MSA facilities.

CHANGE SUMMARY

Description of Change

Corrected links to appendixes in Sec. 4.2

Before each use, ensure this copy is the most current version. Administrative Use

Rev. 7, Chg. 2 MSC-PRO-QA-259 Page i of i

Graded Approach Published Date: 01/15/18 MSC-PRO-QA-259 Effective Date: 01/15/18

Rev. 7, Chg. 1 MSC-PRO-QA-259 Page 1 of 13

Graded Approach Published Date: 01/15/2018 Effective Date: 01/15/2018

NOTE: Employees may print off this document for reference purposes but are responsible to check MSA PS to ensure the

most current version is used to prevent unintended use of obsolete versions.

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Table of Contents

1.0 PURPOSE ............................................................................................................................ 2

2.0 SCOPE ................................................................................................................................. 2

3.0 RESPONSIBLITIES ............................................................................................................ 2

4.0 INSTRUCTIONS ................................................................................................................. 3

4.1 Incorporation of Grading Into Applicable Process Procedures and Other

Documents .............................................................................................................. 3

4.2 Grading Process ...................................................................................................... 3

5.0 RECORD IDENTIFICATION ............................................................................................ 7

6.0 SOURCES............................................................................................................................ 7

6.1 Requirements .......................................................................................................... 7

6.2 References ............................................................................................................... 7

Attachment 1. Requirements ........................................................................................................... 8

Attachment 2A. Grading Process Flow Chart............................................................................... 10

Attachment 2B. SSC Grading Guide ............................................................................................ 11

Attachment 2C. Software Grading Categoriztion Guide .............................................................. 12

Attachment 3. Electrical Boundary Rules ..................................................................................... 13





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1.0 PURPOSE

The scope, depth and rigor of the Mission Support Alliance (MSA) Quality Assurance

(QA) Program application of requirements to a specific activity are determined by using a

grading process. The purpose of grading is to select the controls and verifications to be

applied to various items, activities, and services consistent with their importance to

safety, environment, cost, schedule and success of the activity/mission. The MSA graded

approach is integrated into processes through procurement documents, internal plans,

procedures, and other working level documents by defining levels of rigor and detail

appropriate to the prescribed tasks/activities.

This procedure establishes the minimum requirements for the graded application of the

MSA QA Program. It implements portions of the requirements of MSC-PLN-QA-599,

Quality Assurance Program Description (QAPD). Furthermore, procedure MSC-PRO-

QA-8635, Review and Approval of Technical Documents should be used in conjunction

with this procedure for determining review and approval requirements of applicable

documents.

NOTE: The graded approach may not be used to implement the Unreviewed Safety

Question (USQ) process or in implementing technical safety requirements necessary to

ensure the safe operation of a nuclear facility. Also the graded approach process shall

not be used to gain relief from the requirements of 10 CFR 830 or DOE O 414.1D which

apply to the scope of work performed, rather it shall be used to determine the scope and

degree of rigor in the application of those requirements.

2.0 SCOPE

This Level 1 Management Control Procedure is applicable to MSA employees and

subcontractors, who conduct activities (including providing items and services) requiring

the use of a graded approach.

This document partially implements the following ISMS Guiding Principles:

Core Function No. 1, Defining the Scope of Work

Core Function No. 4, Performing Work within Controls

Guiding Principle No. 4, Balanced Priorities.

3.0 RESPONSIBLITIES

The Design Authority, Subject Matter Expert, Functional Area Manager, and Cognizant

QA Representative are responsible for the application of a graded approach.

MSA Organizations with service contracts for equipment and labor resources with other

Hanford Prime Contractors (OHC) shall work and apply a graded approach in accordance

with the QA program and Safety envelope requirements specified in the governing Inter-

http://msc.ms.rl.gov/msaps/procedure.cfm/MSC-PLN-QA-599





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Hanford Contractor Work Orders (ICWO) and Statements of Work, as applicable when

performing work activities outside of the MSA confines.

4.0 INSTRUCTIONS

NOTE: for definitions of terms, refer to MSC-PRO-QA-8635.

4.1 Incorporation of Grading Into Applicable Process Procedures

and Other Documents

Actionee Step Action

Design

Authority

Subject Matter

Expert,

Functional

Area

Manager,

Cognizant QA

Representative

1. Review the implementing procedures, plans, manuals and other working level

documents to ensure the requirements relative to MSC-PLN-QA-599, Quality

Assurance Program Description are not being negated, but are being

implemented in a graded approach commensurate with importance to safety

and project risk associated with the process/application.

2. Considering risk, importance to safety, and quality requirements associated

with the activity, ensure the graded approach is incorporated into procurement

documents and applicable internal process procedures, plans, manuals and

other working level documents.

4.2 Grading Process

The following attachments provide guidance relative to the Grading Process and Safety

Classifications/Quality Levels:

Attachment 2A, Grading Process Flow for Self-performed and Procured Items and

Services: The flow chart adds detail to the grading process based on Safety, Project,

and other associated Risks.

Attachment 2B, SSC Grading Guide: This example provides grading guidance for

SSC’s and Construction Projects based on Nuclear Safety and Project/SSC risk.

Refer to MSC-PRO-QA-42390, Risk Analysis, Processing, and Reporting, where

required by procedure.

Attachment 2C, Software Grading Categorization Guide: This example provides a

Software Safety Categorization Classification breakdown guide. The procedure for

software implementation and documentation requirements is MSC-PRO-IS-309,

Controlled Software Management.

MSA also performs work on Structures, Systems, and Components (SSC’s), such as Fire

Protection, Electrical and Water Utilities, that have the potential to affect Other Hanford

Contractor’s (OHC’s) Safety Basis documents, etc. Before proceeding with these types

http://msc.ms.rl.gov/msaps/procedure.cfm/MSC-PRO-QA-42390

http://msc.ms.rl.gov/msaps/procedure.cfm/MSC-PRO-IS-309





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of activities, an USQ by an OHC may be required, see Nuclear Safety Protocols for Work

Performed by the Mission Support Contractor in Nuclear Facilities Managed by Other

Hanford Site Prime Contractor’s for additional guidance.

NOTE: Determination of the depth, extent and degree of rigor, including evaluation of

nuclear safety and project risk, applies to new work/activities where quality levels have

not been previously established.


Design

Authority

with support

from the

Cognizant

SME, QAE,

etc.

1. Identify scope of work and specific actions to be taken to assure the

items, activities, or service under consideration meets its intended

purpose, function, and requirements.

NOTE: While application of a safety class designator is not always

applicable to environmental activities, the graded approach for

environmental activities will vary according to specific needs and

objectives for the activity. The environmental graded approach shall

be documented in project documents such as Quality Assurance

Project Plans (QAPPs) or Sampling and Analysis Plans (SAPs) as

appropriate and as required by the governing standard(s) (e.g., EPA

QA/R-5).

2. Identify the potential consequences of failure, considering both nuclear

safety and project risk impacts in accordance with either

MSC-PRO-QA-42390, or Attachment 2B, SSC Grading Guide.

3. Assign an applicable Quality Level in accordance with the following

criteria:

Quality Level (QL)-1 shall be assigned to Safety Class (SC)

items and associated activities or services that are high Nuclear

Safety Risk based on the Documented Safety Analysis

(DSA)/Safety Basis Documentation. The Quality Assurance

program shall be utilized either internally or specified in

procurement documents for items and providers of services.

The specific QA program requirements are important to the

acceptability and suitability of the item, activity, or service to

perform its intended function to specified acceptance criteria.

Internal grading processes are established in working level

procedures, plans, and manuals.

Suppliers of QL-1 items and services are required to have their

quality assurance program evaluated as part of the Bid

Evaluation process, unless the item or service is to be dedicated

utilizing the Commercial Grade Item Dedication process.

Acceptance methods shall be specified including acceptance






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and other applicable performance criteria and shall be

documented and verified before use of the item or service.

QL 2 shall be assigned to Safety Significant (SS) items,

activities, and services not designated as QL 1. These are

items, activities and associated services posing a moderately

high Nuclear Safety Risk. Internal grading processes are

established in working level procedures, plans, and manuals.

Suppliers of QL-2 services are required to have their quality

assurance program evaluated as part of the Bid Evaluation

process, unless the item or service is to be dedicated utilizing

the Commercial Grade Item Dedication process. Acceptance

methods shall be specified including acceptance and other

applicable performance criteria and documented and verified

before use of the item or service. Some of the required

characteristics may be examined less rigorously than for QL 1.

QL 3 shall be assigned to GS items, activities, and services that

are important to project mission and represent sufficient risk

that controls beyond standard commercial practices are

considered necessary to ensure the item, activity or service is

suitable for its intended purpose.

NOTE: As discussed below, GS items, activities, and services may be

graded as QL 1, 2, or 3 depending if the project risk dictates the higher

level of rigor. Furthermore, these GS, QL-1, -2, -3 procurements do

not have to be procured from a vendor/supplier listed on the MSA

Evaluated Suppliers List (ESL)

(See Attachment-2, A, B, or C).

4. Determine the depth, extent, and degree of rigor necessary in the

application of the appropriate controls for the item, service, or process.

Project risk shall be determined using structured guidance provided in

MSC-GD-ENG-33553, Engineering Implementation of the Graded

Approach for Procurement of Materials and Services, or Attachment 2,

(A, B, or C) as applicable. Through the evaluation of project risk, it

may be determined that although the items/services are categorized as

GS, the projects risks may warrant an incremental increase in the risk

designation (low, medium, high) commensurate with the identified

risks. That is, a risk category of medium or high may result from the

evaluation causing the quality level to be re-designated to QL 2 or

QL 1.

Suppliers of QL-3 items or services typically have commercial quality

assurance programs. These commercial quality assurance programs do

http://msc.ms.rl.gov/msaps/procedure.cfm/MSC-GD-ENG-33553





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not require supplier evaluation in accordance with MSC-PRO-QA-

3144, Supplier Quality Assurance Program Evaluation as part of the

Bid Evaluation process. However, procurement documents shall

describe the method/s of acceptance to establish confidence that the

item/service is suitable for its intended purpose. If post installation

testing is specified as acceptance criteria the verification activity is the

post installation test.

Examples where the Quality Level for internal processes and

procurement activities would be assigned are as follows:

a. Utilizing any quality clauses for procurement activities is

considered controls beyond standard commercial practices.

Below are some examples:

B-32, Identification of items with part number/model

number.

B-33, Identification of items with Product Data Sheets.

B-34, Identification of Items.

B-76, Procurement of Potentially Suspect or Counterfeit

Items.

b. Internal work processes or services with the potential to cause

radiological harm, in the present or future, by:

Affecting the integrity of a radiological barrier.

Increasing the extent, level, or duration of radiological

exposure during routine operations and/or reasonably

anticipated off-normal events.

Affecting the effectivity of radiological detection,

monitoring, or alarming capability (except for properly

functioning, calibrated detection instrumentation).

c. Internal work activities and services where national consensus

industrial code, special processes, or regulatory code (welding

specialty coatings, and special permitting), are called out and

where independent verification is required by a

national consensus standard (e.g., AWS D1.1; ANSI B31.3;

ASME Section VIII), which have not been designated as QL 1

or 2.

d. The following are examples of GS internal work activities and

services, which may be graded as QL 3, based on an

engineering evaluation:

Items or services performing a safety function (defense-in-

depth), but does not meet the criteria of SC or SS.

Items or services performing a function to minimize

impact to the environment.





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Items or services performing a function to minimize

damage to the facility or its critical equipment.

NRTL-compliant electrical equipment must be procured as

General Service, Quality Level 3, as a minimum if it meets

the Electrical Boundary Rules (see Attachment 3).

5. QL 0 shall be assigned to GS items and services procurements not

designated as QL 1, 2 or 3. The controls inherent in standard

commercial practices are acceptable and no QA input/review is

applicable in accordance with MSC-PRO-QA-8635.

5.0 RECORD IDENTIFICATION

None

6.0 SOURCES

6.1 Requirements

MSC-PLN-QA-599, Quality Assurance Program Description

10 CFR 830, Subpart A, Quality Assurance Requirements

CRD O 414.1D, Quality Assurance

Enforcement Guidance Supplement 99-01: Enforcement of 10 CFR Part 830.120,

Quality Assurance Rule for Facilities below Hazard Category III

6.2 References

MSC-GD-ENG-33553, Engineering Implementation of the Graded Approach for

Procurement of Materials and Services

MSC-PRO-QA-42390, Risk Analysis, Processing, and Reporting

MSC-PRO-IS-309, Controlled Software Management

MSC-PRO-QA-3144, Supplier Quality Assurance Program Evaluation

MSC-PRO-QA-8635, Review and Approval of Technical Documents



http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title10/10cfr830_main_02.tpl

http://msc.ms.rl.gov/msaps/procedure.cfm/MSC-GD-ENG-33553


http://msc.ms.rl.gov/msaps/procedure.cfm/MSC-PRO-IS-309







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Attachment 1. Requirements

NOTE: Under the requirement "type" column, “V” means verbatim and “I” means interpreted.

# REQUIREMENT TYPE

SOURCE V or I

1. The QA Rule (10 CFR 830, Subpart A) applies in a graded

approach to all Department of Energy (DOE) Reactor and

nonreactor nuclear facilities. The QA Rule includes those

activities related to design, manufacture, and assembly of items

for use with radioactive materials in such form or quantity that

a nuclear hazard potentially exists even when no nuclear

material is present. The QA Rule does not specify any

minimum for such a hazard. (Reference Enforcement

Guidance Supplement 99-01: Enforcement of 10 CFR Part

830.120 [Quality Assurance Rule] for Facilities below Hazard

Category III).

Nuclear facilities shall comply with 10 CFR 830 criteria; other

activities not regulated by 10 CFR 830, shall comply with DOE

O 414.1D CRD.

I MSC-PLN-QA-599,

Foreword, and

Section 1.0,

Para: 2.2.2

2. The application of the QA Program requirements to a specified

item, service, or process shall be determined by the use of a

grading process.

I MSC-PLN-QA-599,

Foreword,

Para: 1.0

3. The graded approach shall be based on an assessment of risk,

including the consideration of function, complexity,

consequence of failure, reliability, repeatability of results, and

economic considerations. Fundamental considerations shall

include:

a. Relative importance to safety, safeguards and security.

b. Magnitude of any hazard involved.

c. Life-cycle stage of a facility.

d. Impact/consequences on the programmatic mission of a

facility.

e. Particular characteristics of a facility or activity.

f. Nuclear safety classification or hazard category of the

item or activity.

g. Adequacy of existing safety documentation.

h. The relative importance of radiological and non-

radiological hazards.

I MSC-PLN-QA-599,

Section 1.0,

Para: 2.9.3








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i. Complexity of products or services involved.

j. Performance history of a facility or activity, and

k. Any other relevant factor (e.g., cost, schedule).

4. The Design Authority, engineer, or qualified personnel for non-

design-related activities (e.g., Scientist), with the assistance

from QA representative, as appropriate, shall determine and

document the extent, depth, and rigor applied to the process.

I MSC-PLN-QA-599,

Section 1.0,

Para: 2.9.6

5. The graded application process shall not be used to circumvent

applicable QA, legal or contractual requirements. Rather,

grading determines the scope and degree of rigor applied.

I MSC-PLN-QA-599,

Section 1.0,

Para: 2.9.10

6. Items, services and processes that do not have an engineered

safety function are classified as General Service (GS). The

graded approach for GS items and activities consists of:

a. Using the administrative processes established in Mission

Support Contract (MSC) documents and project or

facility specific procedures to manage, perform, and

assess the work being performed (e.g., document control,

work control, records and data management).

b. The design authority may determine, on a case-by-case

basis, a need to apply additional QA controls (e.g.,

inspection, testing, sample custody controls) to mitigate

the risk associated with failure of an item or performance

of a task. When additional controls are necessary,

drawings, specifications, plans or other work instructions

will be prepared that identify the characteristics and

functions to be verified, inspected, or tested and the

necessary acceptance criteria to measure conformance.

Implementing documents shall include the following

information as appropriate on the work to be performed.

Quantitative or qualitative acceptance criteria sufficient for

determining that activities were satisfactorily accomplished.

I MSC-PLN-QA-599,

Section 1.0,

Para: 2.9.7








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Attachment 2A. Grading Process Flow Chart

Start

Determine Safety

Classification (Note 1)

Determine reviewers and approvers

per MSC-PRO-QA-8635 (Note 1)

SC or SS?

(Note 2)

Yes

(SC or SS)

(Note 6)

Assign QL 1 or

QL2 as

appropriate

No

(GS?)

Determine other potential

safety implications (Note 3)

Notes:

1. DA/TA with QA assistance

2. Safety Class (SC) or Safety Significance (SS)

3. Consider other Hanford contractors (OHC) Safety Basis (SB).

4. High risk for schedule, cost, Industrial Safety, etc. Risk may be

determined by the following considerations in a teaming forum lead by

DA:

Administrative Risk: Risk related to accomplishment of MSA or OHC

contract objectives

Safety Risk: Risk to personnel for Near Miss, First Aid, Recordable, Lost

Time, or Fatality

Environmental Risk: Risk to environment if failure occurs

Schedule Risk: Risk to project or facility performance to schedule

Cost Risk: Risk to project or facility budget

Financial Risk: Risk to MSA or OHC performance to financial goals

Operational Risk: Risk Related to facility and operations complexity

5. National consensus industrial code or special processes (welding,

specialty coatings, independent third party inspection requirements,

special permitting, etc).

6. For SC/SS QL1 or QL2 SSCs, supplier evaluation is required prior to

award of contract/purchase order or CGI dedication for any of the

following:

Ø procurement of engineered equipment (i.e., design/build)

Ø procurement of services (engineering, construction, NDE, etc)

Ø procurement of items for self performed work (i.e., fasteners, steel

products, etc)

Credited in

OHC SB?

Yes

(GS?)

Perform USQ

No

(GS)

USQ Positive?No

(GS)

Yes

(SC/SS)

(Note 6)

Yes

(GS)

Determine project risk

High Risk

(Note 4)

Note 5 apply?

No

(GS)

Assign QL 3

Yes

(GS)

Assign QL 0

No

(GS)

Proceed with Work/

Procurement Planning

GSDefinitions pertaining to General Service (GS):

< Commercial practices +Low Risk = QL0

> Commercial Practices (National consensus industrial

code, special permitting, or special processes such as

welding, specialty coatings, independent third party

inspection requirements, special permitting, system testing

requirements, etc) + Medium = QL3

National Consensus Industrial Code: AWS, ASME,

AWWA, etc

Special Permitting: Discharge permits, etc (excludes simple

commercial construction (trailer placement, carports, etc)

GS

Hig

h R

isk

GS

Med

ium

Ris

k

GS

Low

/No R

isk





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Attachment 2B. SSC Grading Guide





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Attachment 2C. Software Grading Categoriztion Guide

NOTE: Software documentation requirements are specified in MSC-PRO-IS-309, Controlled

Software Management.

Definitions:

Item: an all-inclusive term used in place of any of the following: appurtenance,

assembly, component, equipment, material, module, part, product, structure,

subassembly, subsystem, system unit, or support systems.

Services: The performance of work, such as design, manufacturing, construction,

fabrication assembly, decontamination, environmental restoration, waste management,

laboratory sample analysis, inspection, nondestructive examination/testing,

environmental qualification, equipment qualification, repair, installation, or the like.





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Attachment 3. Electrical Boundary Rules

If any of the following conditions are met, electrical materials/equipment must be procured as

Quality Level 3 for Suspect/Counterfeit (S/CI), Nationally Recognized Testing Laboratory

(NRTL) listing, and part number verification, as a minimum:

1. Electrical equipment operating at greater than 240V and associated active control

components.

2. 3-Phase electrical equipment (to include HVAC units and shop equipment).

3. Active electrical equipment being used in safety systems.

4. Protective devices operating at greater than 50V (i.e., circuit breakers, fuses, etc.).

5. Active electrical equipment that will be used in NFPA 70 hazardous locations.

6. Custom built/assembled electrical equipment (included in the SOW).

7. Electrical equipment containing graded hex and heavy hex bolts/cap screws.

NOTE 1: Active equipment is considered electrical equipment that is capable of controlling

current flow in a circuit (Example – switches, relays, motors). Passive electrical equipment

includes conductors, conduit, and cover plates.

NOTE 2: Equipment under the exclusive control of Electrical Utilities is outside the scope of

DOE-0359, Hanford Site Electrical Safety Program and NFPA 70, National Electrical Code.

NOTE 3: Except as noted above, all other electrical equipment may be procured as Quality

Level 0. All electrical equipment (regardless of Quality Level) must be NRTL listed. Non-NRTL

conditions may exist and are reserved for use in unique situations or special needs that do not

satisfy the NRTL requirements from DOE-0359. When such conditions exist, contact the NFPA

70 Authority Having Jurisdiction (AHJ) for path forward (see Links Below).

NOTE 4: If there is a concern about the specific electrical equipment being procured, consult

the responsible Design Authority and raise the Quality Level. The Design Authority has the final

responsibility and authority to assign the appropriate Quality Level and can be consulted to

consider lower or higher Quality Levels for a specific installation.

The link to HSESP is:

http://msc.ms.rl.gov/ims/page.cfm/IntegratedSiteWideSafetySystems(ISWSS)/FSA/ESP

The link to the current AHJs is:

http://msasp.rl.gov/shq/bp/ISWSS/ESP%20Document%20Library/POCs/AHJ_List.pdf

http://msc.ms.rl.gov/ims/page.cfm/IntegratedSiteWideSafetySystems(ISWSS)/FSA/ESP

http://msasp.rl.gov/shq/bp/ISWSS/ESP%20Document%20Library/POCs/AHJ_List.pdf