ML20058A071

Rev 0 to, QA Plan

ML20058A071
Person / Time
Issue date:	10/17/1990
From:	Bangart R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20058A075	List: ML20058A071 ML20059P097
References
REF-WM-3 NUDOCS 9010250241
Download: ML20058A071 (12)

Text

f 4

i

'?

3 1

4 m

9 ;(

! (;

1 u-QUALITY ASSURANCE PLAN

~ '

(

Division of Low-Level Waste Management and Deconnissioning Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Connission Washington, DC 20555-j t

i

-i i

- i i

-l, t

=s i

V Id L

l_

p 1

i l-a l.

9010250241 901019 m"

PDR WASTE WM-3 PDR I '..

r,

),i r

J;

'h, L

i..

.q i

j 2

POLICY It is the policy of the Division of Low-Level Waste Management and Decommissioning (LLWM) to perform prelicensing' licensing and regulation activities under a formal quality assurance program. The quality assurance (QA) program, as described in-j this document, establishes the principle'that all LLWM employees are responsible

'for assuring quality in their work, provides for planning work activities to meet agency goals, conducting activities by qualified employees according to' approved-procedures, and retaining documentation to provide objective evidence of licensing-and regulation activities performed. The program applies management controls

. consistent with the importance of;1icensing and regulation activities being-conducted. This QA plan supplements other NMSS and NRC procedures and practices, 1

such as the NRC Manual Chapters and the NMSS Policy and Procedures Letters, established to assure quality in NRC operation.

Each Division staff member who performs licensing and regulation activities should ensure that he/she accomplishes his/her work in a manner meeting the highest standards of performance. Each individual is expected to comply with the policies and procedures of the quality assurance program described in this

-l plan.

L' t

}

J

. f 5bm_u /-

/W2 E/k '

[ Rich'ardL.Bangart ['

Date li Director, Division of Low-Level Waste Management and Decommissioning 1

Revision 0, 10/17/90

y 3

J..

n

.p, o.

r c

3 i

T i

i UNITED STATES NUCLEAR REGULATORY COMISSION DIVISION OF LOW-LEVEL. WASTE MANAGEMENT' AND DECOMMISSIONING:

QUALITY ASSURANCE MANUAL..

CONTENTS Section~

. Division Revision.

Issue Date l1:

Division. Quality Assurance 0

Policy 10/17/90 l

- 11^

Contents 0

10/17/90-i

111 Introduction 0

10/17/90

-1.0 Organization 0

10/17/90 2.0.

Quality' Assurance Program-0 10/17/90.

-3.0:

Procurement-Document Control 0

10/17/90

4.0 Instructions and Procedures 0

"10/17/90

- 5.0

-Document Control 0-10/17/90 l

6.0 Control ~of Purchased Services 0

10/17/90_

.1 7.0 Corrective. Action

-0 10/17/90

- 8.0 Quality Assurance Records 0

10/17/90' 9.0 Audits and Surve111ances 0

10/17/90.

')

m I

t l

L Revision 0, 10/17/90

pS' 43 j

L 1..

g v,

g

INTRODUCTION-The Division's Quality Assurance (QA) Program is based upon the program defined in NUREG-1293,. " Quality Assurance Guidance for Low-Level Radioactive Waste Dis-posal-Facility," and in Appendix B of 10 CFR Part-50.

The criteria. addressed in this document are determined:to cover the work activities performed by division personnel in the conduct of prelicensing, licensing and regulation activities associated with the management, treatment, and commercial disposal of low-level nuclearwaste(LLW),uraniumrecoveryactivitiesincludingmilltailings management, and related decomissioning activities.

This document-provides assurance that work is completed by qualitied employees and for formal planning of work to be performed to meet the Agency's philosophy y

on regulations and strategic goals outlined in the current issue of the J

Comission Policy Planning Guidance document, NUREG-0885, Issue 6, and in the Agency's Five Year Plan.

Routine' programmatic work will be conducted according to approved procedures, and the work will be retained and documented to provide objective evidence of completion.

Consistent and high-quality licensing and decomissioning decisions will result l

from the disciplined use of the QA policy and requirements described in this q

plan andlthe implementing procedures found in the Division's QA Manual.

It is the responsibility of the Division's statt.to ensure proper implementation of the QA program.

The QA program provides the staff a mecaanism that ensures that the work is accomplished and meets the highest standards of quality, a

1 ORGANIZATION l

1.1 -Objective l

The Division has structured its organization to provide for assurance of quality of its products and services, which consist of prelicensing, i

licensing, regulation development, and enforcement associated with the inanagement, treatment, and commercial disposal of Low-Level Waste, uranium recovery activities including mill tailing management, and decomissioning

-activities. Management systems have been designed to result in projects and tasks being staffed with highly qualified team members, often under the-direction ot an assigned project leader.

This section describes the Division's organizational units and their responsibilities and authority to ensure the achievement and assurance of quality. consistent with the high quality of standards-of the NRC.

1.2 Division Organization l

L The Division is organized into three branches, which provide the necessary 1:

support for the Division to achieve its designated Agency goals. The Divi-sion's organization and responsibilities, as well as the responsibilities of each branch, are identified on page 6.

Revision 0, 10/17/90 V

_ _. _l'iff j

yv

_y -

g.

1 IThe Deputy Director is assigned.the responsibility but may delegate the '

function of conducting periodic scheduled verification activities such as g

L, audits, to measure the effectiveness 1of the implementation of the QA Plan..

The purpose of;the verification activities is to. provide the Division i

Director timely status information, to permit the identification and i

correction of: potential problem areas, and to ensure the quality of end J

products and/or services.

Project managers, as necessary, are assigned by the Branch Chiefs or Section

-Leaders having program responsibility within the Division. The designated-1

, individual is delegated the-authority to carry out the assignment, and resources are established and assigned by Section Leaders and Branch Chiefs 3

to support this effort.

+

i 4

=

.)

Revision 0, 10/17/90 r

c

<. n 8

-i gIl j,,hI'l!

tiliulilI! i I

3 gh pp

!*!di!!;Q'Ijdjk11n;0 L

i I 1111 11 htil u j[!!1

[i l!ji p]H i

11l4![

l i

J I,1: jgli ' !

iPliil!!

i,lililIlh!,

i s+

Revision 0, 10/17/90 g

w

'e* ;

• .j.

2 QUALITY ASSURANCE PROGRAM 2.1 Objective

-The Division has established a QA program to assign the responsibility of'

'l H

quality to all LLWH employees, to assure the high quality of LLWM work, to assure work assigned to qualified employees, to provide the necessary management controls to ensure careful planning to meet-agency goals,

-effective and efficient implementation of plans,-and retention of records to provide objective evidence of performance. The program provides for accomplishing planned activities in accordance with written procedures or instructions. The Division's QA Program requires that individuals performing prelicensing activities, licensing reviews and regulations-activities will be trained and qualified to perform designated assignments',

and that their proficiency is maintained. Each individual in the Division nas the responsibility to implement and comply with the policies and J

procedures of the QA program and to ensure that he/she accomplishes his/her work in a manner meeting the highest standards of quality.

]

2.2 Division QA Program The Division Director recognizes the need to develop, implement, and main-tain a comprehensive and effective QA program. The policies established by this QA Manual are mandatory and shall be addressed in plans and procedures and implemented by all personnel.

The_QA-Program is described in this QA Plan and in the implementing procedures. : Division-implementing procedures are consistent with the QA Plan and delineate the measures, systems, or methods necessary to address and/or implement: specific activities. These procedures are contained in a procedures manual,1are issued and controlled by a system of Low-Level Waste procedures and apply to all licensing and regulation activities.

Preparation of program specific procedures are assigned to the branch with lead responsibility for the activity or area. Division-wide procedure development responsibility is assigned to the Director and Deputy Director of Low-Level Waste. Review and concurrence requires that each affected branch assure that appropriate requirements and interfaces are defined.. Both general and specific procedures are approved by the Director before release and use, a

3 PROCUREMENT DOCUMENT CONTROL 3.1 Objective The Division provides for the establishment of controls to ensure that agency procurement procedures are properly implemented. Procurement documents

. include quality requirements as well as technical requirements. Requirements such as appropriate codes, supplier quality assurance programs, purchaser-access authority, and necessary documentation are included.

The technical and quality specifications included in the procurement documents are reviewed by the assigned contract mau;an and concurring / approving supervisors to Revision 0, 10/17/90

7 w

y

=

8 c

D t

h ensure that QA provisions are included.

Changes or revisions to quality-

-related procurement documents are reviewed and approved by the same groups that reviewed the original-document. Activities affecting quality of L

products and services are hereafter referred to as quality-related.

+

3.2 Division Procurement Document Control The assigned-contract manager for a Division procurement conducts reviews to ensure that documents and changes thereto, for the procurement of services, whether purchased by the Division or contractors, include or reference the following, as necessary to achieve the required quality:

1.

QA Program requirements 2.

Requirements for the documents (e.g., instructions, procedures, drawings, specifications, and records be prepared and submitted or made available for Division review or approval.

3.

Requirements for retention, control, and maintenance of. supplier QA records 4.

Provisions for purchaser's right of access (Division) to contractor's facility and work documents, for inspection and audits /surveillances 5.

Provision for contractor to report items that do not meet procurement requirements 6.

Contractor individuals are indoctrinated, trained, and qualified to perform designated assignments.

4. INSTRUCTIONS AND PROCEDURES i

4.1 Objective

-Quality-related activities are prescribed by instructions and procedures and are accomplished in accordance with these documents. These documents 1

are developed, as appropriate, for quality-related activities included in J

the ' scope or work of projects or tasks preformed under work plans for the -

Division. These documents require approval of appropriate personnel, before work is initiated on quality-related activities.

4.2 Division Instructions and Procedures The Director is responsible for ensuring that quality-related activities are prescribed in appropriate. documents and that the work is accomplished in.accordance with these documents and procedures. Project-level implementing procedures delineate the project-specific documents to be used, and the responsibility for preparation, review, approval, and control of these quality activity plans.

Revision 0, 10/17/90

1

g.

V d

...('

]

7 1

2

,g 5' DOCUMENT CONTROL 5.1. Objective The Director is responsible for establishing and maintaining a document control system.that provides for control of_ documents that specify quality requirements.or prescribe quality-related activities, to ensure that correct documents are.being used.

These. controls include identification-of persons who review for adequacy and approve documents for release, provisions for distribution and control, and provisions for change control.

5;2 Division Document Control' l

4 Documents are controlled in accordance with this manual. The Branch Chief ensures that needed-documents are available and in use at the location where prescribed activities are performed, and that work is accomplished

.in accordance with the latest revision of issue.

Documents developed by the Division or its-contractors must be controlled in their approval, issuance, and distribution. The Division identifies the types of document to be developed and the group responsible for the review.

5.3 Document Change Control a

Special procedures will be developed and included in the implementing procedures to control changes in documents.

This includes document devel-opment to ensure that the original intent is not changed as the document progresses through review.

It'is also necessary that change control proce-dures be included for computer codes during review and development, as well as during application.

All documents:

1.

Must be reviewed for adequacy (i.e., information is clearly and accurately stated) and signed off by appropriate technical and i

managerial levels.

lt 2.

Must. include such means as a master list or table of contents, etc.,

i, showing revision number and the date of revision, to ensure that l

obsolete or superseded sections are replaced in a timely manner.

L 3.

Changes must be reviewed and approved by the section leader / branch

~~

L chief responsible for the original review and approval, unless l

responsibility is delegated in writing.

l-l 4.

Prelicensing guidance must have an independent technical review, to l-the extent necessary, to ensure that content is consistent with Nuclear Regulatory Commission (NRC) requirements, and must have concurrence by the responsible Section Leader and Branch Chief.

Revision 0, 10/17/90

.1

+

{:

y s

10 6 CONTROL OF PURCHASED SERVICES 6.1.0bjective 4

The Division provides for control of purchased services. Contro1' methods established include procurement planning, source evaluation and selection,

{.

monitoring the activities of the contractor, and confirmation'that deliver-ables conform to procurement documents. When necessary, documentary evidence of conformance of. items will be made available at the designated location, before use. Control and monitoring of contractor activities is

.t accomplished through one or more of the following:

review and/or approval of suppliers' QA plans and procedures; source inspection; audit; and exami-

[

nation of deliverables upon completion.

6.2 Division Services The contract manager ensures that purchased services are controlled. The control of purchased services is commensurate with the-scope of work assigned.and the relative importance of the work to be performed. The contract manager is directly responsible for monitoring the activities of suppliers, including review and/or approval of supplier QA programs and procedures,' source inspection, audit, and/or surveillance.

7 CORRECTIVE ACTION

]

7.1 Objective l

The Division provides for the identification and timely correction of conditions adverse to quality. Quality deficiencies 'are identified on audit reports and surveillance reports. Additionally, identified deficiencies are evaluated to determine if a condition adverse to quality

~

exists. Conditions adverse to quality are documented and reported to the Division Director through line supervision by any Low-Level Waste

- Management employee identifying such condition. Deficiencies require that the responsible Section Leader or Branch Chief determine the underlying (root) cause of the deficiency, so that appropriate actions can be taken to preclude recurrence of the deficiency.

Followup review by-the responsible l

Branch is taken to verify that the action taken to preclude recurrence of the deficiency has been accomplished and is effective.

l-I 7.2 Division Corrective Action The designated Section Leader or Branch Chief responsible for the task L

ensures that reported deficiencies are corrected in a timely manner and that all deficiency reports are evaluated to determine if a condition l

adverse to quality has been identified.

For conditions adverse to quality,

.the Section Leader or Branch Chief ensures that:

l l

L Revision 0, 10/17/90 l:

o

. ~ ~.

g t

x -

• 11 T

a.

Conditions are documented and distributed to' Division management,

~

-responsible project management,land the contractor.

b.

The identified deficiency is corrected in a timely manner.

c.

The root cause of.the deficiency is determined.

d.

' Actions are taken to preclude recurrence of the def.iciency.

3 R

1 e.

Followup action is taken to verify that the action taken to preclude -

recurrence of the deficiency has been accomplished and is effective.

)

ihe responsible Branch Chief verifies the determination of a plausible root

-cause and identifies appropriate corrective. action to preclude recurrence.

through the review-and concurrence of the completed corrective action.

j

8. QUALITY ASSURANCE RECORDS 8.1 Objective i

L The Division, as an element of its QA program, will retain records.- The Division also.provides for the identification,-protection, and storage of records. The Division provides for safe retention, indexing, retrieval, and storage, using procedures established by the agency-for identification,-

storage, etc.

8.2 Division QA Records Procedures document those QA records that are to be retained. The responsible. Branch Chief reviews the task or contract work activities before start of work, and a listing is made of all QA records to be identified, j

protected,~and retained.

Identified QA records are required for clarity and completeness and are protected and stored upon their completion, in accordance with stated task or contract requirements.

9. AUDITS AND SURVEILLANCES 9.1 Objective

' The Division' plans and conducts audits and surveillances to verify.the adequacy of. the effectiveness of the QA ~ program in assuring quality. A key objective of the audits and.surveillances is to determine compliance.

with specified requirements, and identify potential,nroblem areas such that corrective measures can be taken before a problem occurs. The Division uses these reviews to assure effective and efficient implementation of planned management controls. The Division Director is apprised of the status of the; implementation of the QA Program through audit and surveillance reports, providing the Director with the opportunity to make timely changes in L

management controls.

Revision 0, 10/17/90

l' '

., =

al c-9.2: Audits. Surveillances Planning and executing'QA audits and surveillances will be addressed in

~

QA implementing procedures.

All Low-Level Waste Management staff:are expected to support the audit /<

surveillance )rogram by recommending areas to be audited as-well as assigning tec1nical personnel, as needed, to be team members.of audits-and surveillances.

The results of audits and surveillances are formally reported to the responsible' staff, line supervisor, and the Division Director.-

The audits /surveillances will:

1.

Be conducted on a regular basis at. least once a year.

2.

Document results.

3.

Schedule follow-up audits /surveillances, when necessary.

1 j

Revision 0, 10/17/90 1

. -