ML20034E767

Rev 3 to Wp 13-4, Waste Isolation Div QA Plan for Procurement,Use,Maint & Repair of TRUPACT-II

ML20034E767
Person / Time
Site:	07100760
Issue date:	08/31/1991
From:	Coplinga W ENERGY, DEPT. OF
To:
Shared Package
ML20034E766	List: ML20034E765 ML20034E767
References
WP-13-4, NUDOCS 9303010335
Download: ML20034E767 (35)

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WP 13-4 i

Revision 3 1

j Waste Isolation Division Quality Assurance Plan for the Procurement, Use, Maintenance, and Repair of TRUPACT-II k.

l August 1991 l

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i Cognizant Department:

QUALrrY ASSURANCE i

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j Approved By:

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BS iBSSR E715kgo CONTROLLED EbEv"

's Narch 1991 i

QUALITY ASSURANCE PLAN FOR THE PROCUREMENT, i

USE, MAINTENANCE, AND REPAIR OF TRUPACT-II

,WP 13-4, R.ev. 3 t

Table of Contents Section Title Pace

1.0 INTRODUCTION

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2.0 SCOPE OF WORK 2-1 i

i 3.0 QA PROGRAM DESCRIPTION..................

3-1 3.1 Organization....................

3-1 3.2 QA Program.....................

3-5 3.3 Package Design Control...............

3-6 3.4 Procurement Document Control............

3-8 3.5 Instructions, Procedures, S i

Drawings.......-.. pecifications and 3-8 3.6 Document Control..................

3-9 3.7 Control of Purchased Items and Services 3-10 3.5 Identification and Control of Items' 3-10 3.9 Control of Processes................

3-10 3.10 Internal Inspection 3-11 3.11 Test Control..................

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3.12 Control of Measuring and Test Equipment 3-12 3.13 Handling, Storage, and Shipping 3-12 3.14 Inspection, Test, and Operating Status.......

3-12 3.15 Control of Nonconforming Items...........

3-13 3.16 Corrective Action 3-13 3.17 QA' Records.....................

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3.18 Internal and Supplier Audits............

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2 March 1991 QUALITY ASSURANCE PLAN FOR THE PROCUREMENT, USE, MAINTENANCE, AND REPAIR OF TRUPACT-II WP 13-4, Rev. 3 i

i Table of Contents (Continued) list of Ficures Fiaure Title Pace I

WID Organization Chart.

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4 March 1991 QUALITY ASSURANCE PLAN FOR THE PROCUREMENT, USE, MAINTENANCE, AND REPAIR OF TRUPACT-II-I i

WP 13-4, Rev. 3 I

i Table of Contents I

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(Continued)

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List of Attachments i

Attachment Title i

1 Implementing Procedure Matrix r

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QUALITY ASSURANCE PLAN FOR. THE PROCUREMENT, l

USE, MAINTENANCE, AND REPAIR OF TRUPACT-II WP 13-4, Rev. 3 Chanoe History t

Revision 3 is updated to include TRUPACT-II fleet management as a M0C responsibility, and to present the QA plan as an activity-specific document for WACCC review and approval. Since Revision 3 is a major rewrite, sidebar indicators of changes are not used. Attachment 1, pages I through 7 -

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t QUALITY ASSURANCE PLAN FOR THE PROCUREMENT, USE, MAINTENANCE, AND REPAIR OF TRUPACT-II WP 13-4, Rev. 3 List of Acronyms AGM - Assistant. General Manager AL - Albuquerque Operatians Office (DOE)

C of C - Certificate of Compliance CFR - Code of Federal Regulations DGM - Deputy General Manager t

DOE - Department of Energy GM - General Manager HLD - Helium Leak Test MOC - Management and Operating Contractor (WID)

MRC - Master Records Center MT - Magnetic Particle Testing NDE - Nondestructive Examination (or testing)

NRC - Nuclear Regulatory Commission 0&M - Operations and Maintenance PM&RA - Project Management and Regulatory Assurance PT Liquid Penetrant Testing QA - Quality Assurance QC - Quality Control QI - Quality Inspector RT - Radiographic Testing SARP - Safety Analysis Report for Packaging SMIs - Standard Measuring Instruments TRU - Transuranic TRUCON - TRUPACT Content Code TRUPACT-II - Transuranic Package Transporter WACCC - Waste Acceptance Criteria Certification Committee i

WID - Westinghouse Electric Corporation, Waste Isolation Division WIPP - Waste Isolation Pilot Plant WP0 - WIPP Project Office (DOE) t i

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00ALITY ASSURANCE PLAN INTRODUCTION

1.0 INTRODUCTION

i' 1.1 The DOE is the owner of the WIPP, and holds overall responsibility for the successful implementation of the WIPP Project.

The DOE is supported by Westinghouse Electric Corporation, WID, the WIPP MOC.

In its role as the MOC, Westinghouse has the authority and responsibility to implement a program, delegated by DOE, to procure, maintain, inspect, repair, and if necessary modify Type B packaging, hereafter called TRUPACT-II, and to manage the TRUPACT-II fleet for all users; however, overall responsibility for TRUPACT-II remains that of the D0E.

The purpose of this QA Plan is to identify the applicable QA requirements, and state how those QA requirements as assigned to the M0C in DOE /WIPP 89-012, Quality Assurance (QA) Plan for the Transportation and Receipt of Transuranic.(TRU) Waste, will be implemented, j

t 1.2 In addition to fleet management, the MOC is considered a user of TRUPACT-II.

1.3 This WID QA plan for procurement, use, maintenance, and repair of TRUPACT-II complies with QA requirements imposed by Title 10 CFR 71, Subpart H and DOE /WIPP 89-012.

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j Scope requirements for this QA plan include DOE Orders 1540.2 and 5480.3;

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Title 10 CFR 71, Title 40 CFR 262, Title 49 CFR 100-199; DOE /WIPP 88-026, and the TRUPACT-II C of C/SARP.

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00ALITY ASSURANCE PLAN

' SCOPE OF WORK,*

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2.0 SCOPE OF WORK

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2.1 This plan has been prepared to provide an outline of the specific QA requirements that are required of the MOC:

l when using TRUPACT-II and when performing receipt, maintenance, and i

repair activities associated with TRUPACT-IIs, as a TRUPACT-II user;

and,

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when acfing as TRUPACT-Il fleet manager for all TRUPACT-II users i

Each section of this plan is supported by procedures which provide details of each operation and function. See Implementing Procedure Matrix, (Attachment 1).

2.2 The M0C fleet management scope of work shall include, but not be limited to:

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Management of the TRUPACT-II fleet for all users, with fleet management responsibilities comprising the following task areas; TRUPACT-II quality assurance program TRUPACT-II inspection, maintenance, repair, and modification program TRUPACT-II records management program l

TRUPACT-II occurrence reporting program TRUPACT-II control and dispatching National TRU Program Integration for TRUPACT-II Use and Readiness Configuration control for the TRUPACT-II C of C, including renewal Document control of C of C documents Procuring and providing items (spares) and services to ' support TRUPACT-Ils as directed by program requirements Procuring the services-for the design and fabrication of a fleet of Type B packages. (TRUPACT-II) certified by the NRC, ensuring that the certification (s) are maintained as specified by the NRC C of C and the SARP i

Ensuring that approved designs and changes thereto and TRUPACT-II i

fabrication are in compliance with the C of C and the SARP 2.3 The MOC scope of work, as a user of TRUPACT-II shall include, but not be limited to:

Receiving TRUPACT-II from the carrier Handling TRUPACT-II i

Loading and unloading TRUPACT-II 2-1

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QUALITY ASSURANCE PLAN SCOPE OF WORK 4

Delivering TRUPACT-II to the carrier 2.4 This QA plan is not applicable to operation and maintenance of the trailer i

used for the transport of TRUPACT-II. Such activities shall be covered by other i'

j activity-specific QA plans, or WP 13-1, as appropriate.

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OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION 3.0 QA PROGRAM DESCRIPTION l

The programmatic QA requirements imposed on the MOC for the aforementioned scope of work satisfies the "QA Plan for the Transportation and Receipt of TRU Waste,"

i DOE /WIPP 89-012 and the MOC QA Program. How those programmatic QA requirements i

are implemented by the MOC, is presented in this document as a 18 criteria for-mat similar to DOE /WIPP 89-012. The procedures that are used to implement the programmatic QA requirements are listed in Attachment 1.

3.1 Orcanization 3.1.1 This section presents a summary of the Westinghouse WID organizational structure, functional responsibility, levels of authority, interfaces, and lines of communication for activities affecting quality and the safety-related function of structures, systems, and components.

3.1.2 Organization Structure The WID organization is structured so that quality is achieved, acknowledged, and maintained by those organizational components performing work; independent ver-ification of quality achievement is done by the QA department, which is not directly responsible for performance of the work. An organization chart for WID senior management components is shown in Figure 1.

Effective implementation of the QA program involves every WID department.

Additionally, effective implementation of the QA program extends to all levels of the organization, from the GM and DGM, through senior management, to line management and supervisors, and to personnel performing quality-related work activities. The QA department is responsible for describing, integrating, and assuring effective implementation of QA activities among the various disciplines.

3.1.3 Lines of Communication and Interfaces GM and DGM Lines of Communication and Interfaces The WID GM reports to the General Manager, Westinghouse Government Operations Business Unit External WID GM interfaces include the DOE-WP0 Project Manager, the Scientific Advisor, and federal and state regulatory agencies The WID DGM reports to the GM, acts on behalf of the GM, and directs WID technical and administrative activities Senior Manaaement The WID senior management comprises the following departments:

Project Management and Regulatory Assurance Operations

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• Controller Environment, Safety, and Health 3-1 CONTROLLED COPY

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-c OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION r

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PROJECT OPERATIONS MANAGEMENT CONTROLLER AND REGULATORY ASSURANCE Quality Assurance 1

ENVIRONMENT, EXTERNAL AND' HUMAN SAFETY GOVERNMENTAL ENGINEERING RES W RCES AND HEALTH AFFAIRS seis a u i

Figure 1 Westinghouse Electric Corporation Waste Isolation Division Organization Chart j

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t OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION Engineering Human Resources

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l Total Quality and Communications Senior Manacement Lines of Communication and Interfaces

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The WID senior management reports to the DGM. Interfaces include WID department managers, corresponding 00E-WP0 staff counterparts, TRUPACT-II users (WID fleet management), and the Scientific Advisor.

l 3.1.4 Responsibility and Authority General Manaaer Responsibility and Authority The GM has overall responsibility for the WID QA program.

As such, the GM is authorized to establish an appropriate organizational structure for developing, implementing, and monitoring the program.

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Overall responsibility for effective implementation of the WID QA program belongs to the GM, although execution of the QA function is delegated to the WID QA manager.

The GM is responsible to ensure that authorities and duties of persons and organizations performing activities affecting the safety-related functions of structures, systems, and components are clearly established and delineated in writing, e.g. consolidated management plans or charters.

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i Assistant General Manaaer. Proiect Manacement and Reculatory Assurance The AGM, PM&RA reports to the DGM, and is responsible for approval of the QA i

program and policies.

Ouality Assurance Department Manaaer f

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The QA manager reports to the AGM, PM&RA, and is authorized, through written l

endorsement by the GM, to assure effective implementation of the QA program.

l WID management policy grants the QA department sufficient authority, access to work areas, and organizational freedom to:

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identify quality problems; initiate, recommend, or provide solutions to quality problems through e

appropriate channels-verify implementation of solutions; and i

assure that further processing or use of nonconformances, deficiencies, or unsatisfactory conditions is controlled until proper disposition is determined The WID QA department has direct access to line and senior management where l

action can be effected, as appropriate, to ensure compliance to QA procedures and safety.

The WID GM has delegated the QA department sufficient authority, l

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OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION organizational freedom, and independence from cost and schedule considerations to issue stop work orders for unsatisfactory work and/or dilivery or installation of nonconforming material.

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WID management shall assess the effectiveness o.

i.hc control of quality by j

subcontractors at intervals consistent with the importance, complexity, and quantity of the product and services.

WID Senior Manacers l

WID senior managers are authorized to establish and implement policies and procedures which control work quality in accordance with the QA program.

I Senior management responsible for quality-related activities shall:

Write and maintain plans, policies, or procedures that implement the QA i

program, Manage the TRUPACT-II fleet for all users, Ensure that computer programs that affect quality are documented, validated, and controlled, Ensure QA department participation or concurrence in quality-related decisions or commitments, i

Ensure ' adequate training is provided for personnel whose work affects

quality, Support WACCC activities in accordance with DE management plans and i

management directives, Ensure compliance with all applicable Federal Regulations, DOE Orders, the Prime Contract, and WIPP requirement documents, Perform internal self assessments to determine effectiveness of

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departmental activities and the QA program,

• Provide documented notification to the QA department when nonconformances are identified, f

Enforce established policies and procedures for generation, iden-tification, maintenance, storage, handling, and disposition of QA

records, Stop work and initiate corrective action whenever continuation could result in personnel injury, damage to essential items, or violation of i

I approved work requirements.

Ensure performance of peer reviews when technical reviews on state-of-l the-art items or activities are not feasible.

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OUALITY ASSURANCE PLAN OA PLAN DESCRYPTf6R WID Department and Line Manacement Implementation of the QA program and achievement of quality is the responsibility of every WID department.

Each WID department manager involved with activitie affecting quality shall periodically assess the effectiveness of QA program implementation.

Each WID department is responsible for maintaining and conducting a periodic internal self a!Fsessment of activities within the cognizance of the department.

The internal self assessment may be perfcrm % conjunction with the management assessment of the QA program.

WID management shall assess the effectiveness of the control of quality by subcontractors at intervals consistent with the importance, complexity, and quantity of the product and services.

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3.2 OA Procram 3.2.1 QA Requirements The established MOC QA program is documented as WP 13-1, the WIPP WID CA i'rogram.

The QA program complies with DOE Order 5700.68 and AL Order 5700.68, and is approved by DOE-WPO. Implementation of the QA program shall be effected through approved written procedures, and shall be carried out in accordance with those procedures throughout the period during which packaging is used.

Those pro-cedures listed in Attachment 1, Implementing Procedure Matrix, are applicable to the scope of this QA plan.

In addition to requirements of the QA program, this WID QA plan for procurement, use, maintenance, and repair of TRUPACT-II complies with QA requirements imposed by Title 10 CFR 71, Subpart H and 00c/WIPP 89-012.

Scope requirements for this QA plan include DOE Orders 1540.2 and 5480.3; Title 10 CFR 71, Title 40 CFR 262, Title 49 CFR 100-100; DOE /WIPP 88-026, and the TRUPACT-II C of C/SARP.

This QA plan is approved by DOE-WPO and the WIPP WACCC.

Specific materials and components to be covered by this plan include the TRUPACT-11 package, spares, and equipment to ensure payload compliance or compliance to the C of C.

3.2.2 The Graded Approach A graded approach is used to provide control over items and activities affecting the quality of the identified materials and components to an extent consistent with their importance to safety, and as necessary to ensure conformance to the approved design of each 1.1dividual package used for the shipment of radioactive material.

The graded approach applicable to TRUPACT-II is based on the follo' wing guidance, unless otherwise specified:

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, 9 OUALITY ASSURANCE PLAN DA PLAN DESCRIPTION Quality Category A - Structures, components, systems, or activities whose 1

failure could result directly in a condition adversely affecting public health and safety.

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Quality Category B - Structures, components, systems, or activities whose failure could result directly in a condition adversely affecting public health and safety. An unsafe condition could result only if the primary event occurs in conjunction with a secondary event or other failure.

Cuality Category C - Items having a minor impact on safety. Failure would not significantly reduce the effectiveness of the product.

Quality Category A structures, systems, or componerits are scrutinized through audits, surveillances or inspections by QA to. ensure those QA requirements are applied. On the other hand, items or activities assigned Quality Category C only require that good commercial or engineering practices be applied. The extent of QA department involvement in areas that relate solely to Quality Category C items or activities routinely includes only procurement document review, except when requested by other departments, or when performing a random surveillance or random audit.

Therefore, the responsibility-for ensuring the quality of a Quality Category C item or activity rests with the cognizant individual, e.g.,

cognizant engineer.

3.2.3 Indoctrination and Training WID personnel assigned to quality-related activities within the scope of this QA plan shall be qualified and trained to perform the specific tasks required, in j'

accordance with approved procedures.

The requirements for. training are as follows:

Personnel are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures; personnel verifying activities that affect quality are trained in the principles, techniques, and requirements of the activity being performed; proficiency of personnel performing and verifying activities affecting e

quality is maintained and documented by annual refresher training, re-examining, and/or recertifying as determined by management or program commitment.

3.3 Packace Desian Control Engineering has. the responsibility for design control and the care and maintenance of the C of C.

3.3.1 TRUPACT-II Design The design of TRUPACT-II is approved by the NRC and is documented in the C of C.

Changes to the approved design that impact the C of C conditions shall be per-formed under a QA program approved by the NRC, in accordance 'with Title 10 CFR 71.107.

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t OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION 3.3.2 General Design Requirements Procedures for the control of design activities shall ensure the following requirements as applicable:

Measures to ensure the correct translation of DOE requirements and design basis into drawings, specifications, procedures, instructions, and that design documents are prepared in a controlled manner; definition of organizational responsibilities for the preparation, review, approval, and the verification of design documents such as design input, design analysis, design verification, design drawings, specifications, and computer program validation; controls to ensure that quality standards are specified in design documents and that deviations from such standards are controlled; methods to ensure that adequate reviews for application suitability are conducted for materials, parts, equipment, and processes; provisions for ensuring that standard commercial (off-the-shelf) items receive adequate reviews for suitability of use; measures for applying design control practices to various analyses, such as material stress behavior and accident analysis, material compat-ibility studies, and accessibility studies for in-service inspection, maintenance, and repair; management review of the status and adequacy of the design control program; controls for internal and external design interfaces which shall include the review, approval, release distribution, and revision of documents involving design interfaces among participating design organizations, suppliers and contractors; I

methods for the verification or checking of design adequacy by inde-pendent design review, peer review by a multi-organization review or single person review, by alternate calculations, or by a qualification test program; provisions to ensure that design changes, including field or supplier changes, are subject to the same review and requirements as the original design; provisions for design process and verification procedure review and modification as necessary; controls to ensure that design verification actions are accomplished by e

groups or individuals other than the original designer or immediate supervisor; provisions to ensure that design verification, if other than by a

qualification testing of a prototype or lead production unit, is completed prior to release for procurement or other uses; 3-7 CONTROLLED COPY

9 OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION provisions for the appropriate review, approvals, and maintenance of design documents and design records; methods for documenting and correcting errors and deficiencies in the a

design activities, including design methods, and for ensuring that corrective action is taken to preclude recurrence; control of design documents to prevent the inadvertent use of superseded design information; measures to ensure that design documentation and QA records provide e

evidence that the design development and review process was performed in accordance with applicable procedural requirements;

• measures to ensure that design activities, including experimental activities, are carried out in a planned, controlled, and orderly

manner, measures to ensure that design activities performed by subcontractors e

on behalf of the WID are adequately described and controlled;

• measures for describing the design classification system and establishing the basis for classifying items, structures, systems, components and software; and for defining the corresponding QA requirements; and, measures to ensure changes to design documents are controlled.

3.4 Procurement Document Control Procurement of items or services that are associated with the TRUPACT-Il shall be based on the requirements identified in the NRC-approved design drawings tnat comply with the TRUPACT-Il C of C.

Quality Category A items and services shall be procured from qualified suppliers that appear on the approved WID Qualified Suppliers List.

Quality Category B items and services are not required to be procured from qualified suppliers that appear on the approved WID Qualified Suppliers List, unless specified in the procurement document.

Repairs which involve welding, radiography, penetrate testing, and foam pouring shall involve the requirements of the original design / manufacturing specification.

Procurement of items or services pertaining to maintenance, inspection, repair, and parts for the TRUPACT-Il trailers shall be the responsibility of the carrier; WID has no responsibility in this regard.

The procurement of maintenance, spare parts, and repairs shall be implemented through approved procedures that ensure conformance to specified requirements.

3.5 Instructions. Procedures. Specifications. and Drawines 3.5.1 Documentation Requirements for TRUPACT-II Activities Documentation affecting quality, including work performed on the TRUPACT-II and the verification of that work, shall be prescribed and documented in instruc-tions, procedures, specifications, or drawings.

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QUALITY ASSURANCE PLAN OA PLAN DESCRIPTION or reference, appropriate quality acceptance recuirements, when applicable, for the quality related activity.

The actual implementing procedures that will control the quality-related activities (e.g. procurement,. maintenance, in-spection, repair, modification, etc.) are provided in a matrix on Attachment 1.

3.5.2 Maintenance Procedures and Documentation Requirements TRUPACT-II maintenance, repair, and periodic inspection shall be programmed and controlled, and shall be performed using approved procedures.

The procedures-shall provide -the details for the maintenance, inspection, repair, and/or replacement of components, and shall specify the required documentation.

3.6 Document Control 3.6.1 General WID QA Requirements Document Control procedures shall specify the requirements that are considered necessary to ensure that documents such as procedures, specifications, instruc-tions, records, and drawings (including changes thereto) are properly reviewed, approved, and controlled and that the latest revisions are made available at the locations where used by those responsible for their implementation.

Revisions shall be reviewed by the same organizations that approved the originals.

3.6.2 TRUPACT-II Fleet Manager Document Control As the TRUPACT-II fleet manager, WID shall be responsible for TRUPACT-II document control.

Applicable documents shall be distributed for u-9 at the locations where TRUPACT-II is to be used; that is, at all user sites.

WID Operations is responsible for document control.

Documents required to be controlled include, but are not limited to the following:

QA/QC manuals, associated plans, and procedures Operating procedures

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Maintenance procedures Inspection and test procedures Loading and unloading procedures Repair procedures Packaging for transport. procedures Procurement documentation SARP and C of C O W. manuals Configuration Drawings NRC correspondence and documents, and supporting documentation 3-9 CONTROLLED COPY

e OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION TRUPACT-II content codes (TRULON) 3.7 Control of Purchased Items and Service's Measures shall be established to assure that purchased material, equipment, and services, whether purchased directly or through subcontractors, conform to the procurement documents. These provisions must include provisions, as appropriate, for source inspection, evaluation, and selection, objective evidence of quality furnished by the subcontractor, and receipt inspection of products upon delivery.

Documentary evidence that material and equipment conform to the procurement specifications prior to installation /use shall be available, and shall be retained for the life of the package to which it applies.

The effectiveness of quality control by subcontractors shall be assessed at intervals consistent with the importance, complexity, and quantity of the materials and services.

Management of subcontractors participating in the quality assurance program for i

WIPP transport packaging shall regularly review the status and adequacy of that part of the QA program which they are executing.

3.8 Identification and Control of Items The required physical identification markings of the TRUPACT-IIs and associated items and the maintenance of these markings shall be documented in procedures, drawings, or instructions.

Material traceability to original heat numbers and/or lot numbers on TRUPACT-IIs 1

shall be maintained for items, welding materials, and replacement parts.

1 Procedures shall be established to ensure that items used for repair or rework for maintenance purposes are adequately identified to preclude use of incorrect or defective items. Also, where replacement of limited-life items is specified, measures shall be established to preclude use of items whose shelf life or operation times have expired.

Identification and records shall be such that all parts of, and operations per-formed on each TRUPACT-Il shall be traceable to that particular TRUPACT-II serial number.

3.9 Control of Processes l

Processes associated with TRUPACT-IIs, such as preparation for transportation, waste handling (loading, unloading), maintenance, and cleaning shall be controlled by approved procedures.

Special processes associated. with TRUPACT-Ils that control or verify quality, such as tnose used in NDE, welding and heat treating shall be performed using qualified personnel, procedures, and equipment.

The NDE (PT, MT, RT, HLD)

I shall be performed by personnel certified in accordance with the. guidelines of SNT-TC-IA using qualified procedures and approved by an NDE Level III individual.

Repairs which involve welding, radiography, penetrate testing and foam pouring shall involve the requirements of the original design / manufacturing specification.

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OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION 3.10 Internal Insoection 3.10.1 Independent Inspection A program for inspection of activities affecting quality by or for the orga-nization performing the activity to verify conformance with the documented instruction, procedures, specification, and drawings for accomplishiry the activity shall be established and executed. Inspections for acceptance of items, services, and activities at WIPP shall be perforned by qualified personnel independent from those performing the activity being inspected.

3.10.2 Inspection Plans Inspection plans, as appropriate, shall be prepared and followed, and shall specify the following:

characteristics to be inspected organization authorized to perform inspections inspection sequence, if applicable inspection methods to be employed e

acceptance criteria required documentation of inspection results 3.10.3 Qualification of Inspection Personnel QI personnel shall perform or verify all acceptance inspections and tests, utilizing personnel who are qualified and certified in accordance with the applicable QA procedures to meet codes, standards, or other technical re-quirements.

Inspection for enroute damage may be performed by any qualified person, not necessarily QI.

Information or self-check type inspections may be performed by any organizational component or person.

3.10.4 Inspection Records Inspection records and activities shall comply with approved management policy in accordance with the QA program.

3.10.5 Inf.pection Requirements In conjunction with QA departmental personnel, qualified Operations personnel are responsible for ensuring that activities involving receipt, maintenance, and handling of waste packaging meet the packaging requirements prior to being returned or delivered to the transport carrier.

3.11 Test Control Tests that are required shall be in accordance with approved procedures that require results to be documented, evaluated, and dispositioned.

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OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION The procedures shall ensure the following, as a minimum:

characteristics to be tested e

test methods i

acceptance / rejection criteria provisions for assuring that all prerequisites are met, that adequate e

test iItstrumentation is available and used, and that the test is i

performed under suitable environmental conditions Personnel performing these activities shall be qualified and/or certified in accordance with written procedures or instructions.

l 3.12 Control of Measurino and Test Eauipment All SMIs and test equipment requiring calibration for the procurement, operation, maintenance, inspection, or repair of TRUPACT-IIs shall be _ controlled, cal-ibrated, properly adjusted, and recalibrated at specified intervals to maintain accuracy within predetermined limits. The calibration shall be against certified i

equipment having known valid relationships to nationally-recognized standards.

If no national standard exists, the basis for calibration shall be documented.

1 Records of the use of SMIs shall be such that whenever SMIs or test equipment are found to be out of calibration during or after use, all items inspected, or tests performed during that period with the suspect equipment, shall be controlled pending review action for possible reinspection, retest, or. other appropriate corrective action.

These reviews shall be performed in accordance with Sec-tion 3.15, Control of Nonconforming Items, and/or Section 3.16, Corrective Action of this QA Plan. Calibrated SMIs or test equipment will be identified and trace-able to applicable calibration test data and have an indication of calibration status.

3.13 Handlina. Storace, and Shippino Handling, storage, and shipping of TRUPMT-IIs performed by the MOC shall be defined in written procedures. The procedues shall require documented verifi-cation by qualified personnel that those activities meet specified requirements.

3.13.1 Cleaning Requirements Necessary cleaning requirements for TRUPACT-II components and spares shall be defined in operating procedures. Cleaning requirements shall address cleaning and preservation of materials and equipment to be used in packaging to prevent damage or deterioration.

3.14 InsDection. Test. and Ooeratina Status The identification of inspection and test activities, and the operating status of TRUPACT-IIs shall be defined in implementing. procedures including record requirements.

The operating ' status shall be controlled throughout receiving, testing, inspecting, maintenance, and shipping.

3-12 CONTROLLED COPY

.~

00ALITY ASSURANCE PLAN OA PLAN DESCRIPTION 3.15 Control of Nonconformino Items TRUPACT-IIs which are not in compliance with~ the C of C, design drawings, and/or SARP, shall be identified, segregated, and controlled until the condition has been resolved.

Nonconforming conditions on items associated with TRUPACT-Ils shall be documented on a Nonconformance Report. NCR dispositions require M0C ap-proval prior to implementation. QA shall verify acceptability of the disposition action by inspection or retesting to original acceptance criteria.

The MOC has the Tesponsibility to analyze all NCRs pertaining to packaging and transportation equipment for adverse quality trends. The MOC also has the re-sponsibility for reporting the following to the DOE, who will in turn report to the Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, within 30 days:

Any instance in which there is significant reduction in the effective-ness of any authorized packaging during use Details of any defects with safety significance in the packaging after first use, with the means employed to repair the defects and prevent their recurrence Copies of Nonconformance Reports initiated by the MOC, pertaining to packaging and transportation equipment, will be submitted to the WIPP MRC.

3.16 Corrective Action Hardware or process control-related significant conditions adverse to quality or safety that require corrective action to prevent recurrence shall be processed in accordance with procedures that require data compilation, review, evaluation, and record retention.

The procedures shall also require that the condition, cause, and corrective action taken to prevent recurrence, be documented and reported to the cognizant manager.

3.16.1 Documentation of Conditions Requiring Corrective Action Conditions adverse to quality detected by personnel during the performance of assigned duties shall be identified, documented, and corrected in accordance with the provisions of applicable project QA procedures. Examples of conditions adverse to quality include, but are not limited to:

deficiencies, deviations, defective material and equipment, and nonconformances.

3.16.2 Significant and Non-Significant Conditions All documentation of conditions requiring corrective action shall be reviewed to determine whether the conditions are to be considered "significant conditions adverse to quality".

For WIPP transport packaging, a. "significant condition" is a failure of mal-function of.a safety-related component, either Quality Category A or B, which could reduce the ' effectiveness of WIPP transport packaging during use.

A non-significant condition is defined as a situation or equipment failure which is not likely to reduce the effectiveness of WIPP transport packaging.

Malfunction or failure of a Quality Category C component would be considered a non-significant condition.

3-13 CONTROLLED COPY.

00ALITY ASSURANCE PLAN OA PLAN DESCRIPTION Significant conditions adverse to quality shall be reported to DOE in accordance with approved WID Occurrence Reporting policy.

Appropriate corrective action shall be identified, documented, and completed for each reported condition adverse to quality.

The term " corrective action" (as used in this section) refers to a documented commitment to accomplish a specific -

action plan to resolve an identified condition adverse to quality. Corrective actions shall address the following points, as appropriate:

Determination of the root cause of the problem; action to resolve the initial problem; action to preclude recurrence of the problem; assessment of impact of the problem on related items or activities; forecast completion dates for the required actions, and individuals responsible for follow-up.

3.16.4 Corrective Action Follow-Up System A follow-up system shall be established to verify proper implementation of scheduled corrective action in a timely manner.

3.17 Ouality Assurance Records Procurement records shall be retained in order to maintain TRUPACT-IIs C of C and QA data related to M0C providing TRUPACT-IIs.

Records of M0C activities and functions associated with the MOC use of these items shall also be retained. The records shall be stored to minimize the risk from damage or destruction.

The details ror the specific control's that are' applied to implement QA records requinments are defined in implementation policies and procedures.

The QA records that are to be retained include, but are'not limited to the following:

Appropriate design and production-related records that are programmed by the procurement and are generated throughout manufacturing and furnished with TRUPACT-IIs Records demonstrating evidence of operational capability Records verifying repair, rework, replacement, and maintenance

• Audit plans, audit reports, corrective actions, source inspection records TRUPACT-II shipping papers (records)

Personnel, procedures, and equipment qualifications Instructions, procedures, specifications, and drawings required by section 3.5 of this QA plan, that address work performed on the TRUPACT-II or the verification of that work, and that include or reference prescribed QA requirements.

3-14 CONTROLLED COPY j

OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION i

Records of each shipment shall be maintained for a period of five years after t

shipment. The records shall include the following:

Identification of the packaging by identification number Verificat' ion that there are no significant defects in the packaging, as shipped Type and quantity of certified material-in each package, and the total quantity of each shipment

]

I Date of the shipment i

Name and address of the transferee i

i

. Address to which the shipment was made'

~

Results of the special processes required by Paragraph 3.9 i

Personnel, procedures, and equipment qualifications Records of activities required by procedures to ensure that the rout'ine I

required determinations are performed prior. to releasing a certified J

waste shipment to a carrier 1

Records are valid only of stamped, initialed, or signed and dated by authorized j

personnel,.or ctherwise authenticated.

~

Records such as letters, drawings, and specifications must include all pertinent i ~

information such as stamps, initial s, and signatures.

The records must be 7

legible throughout the required retention pe.riod, i

l Inspection, test, and audit records must identify the inspector or data recorder.

The type of observation, the results, acceptability, and action taken in connection with any' deficiencies noted.

I for each activity identified in this section requiring record retention, the s

' following complete QA records shall also be retained at the WIPP MRC:

The procedures that support the record retention program that has been established by the DOE, with special requirements established by the NRC Packaging records shall be' retained for a minimum of five years beyond the date when TRUPACT-IIs are nol longer controlled under the WIPP QA Program Plan

• Records of ~ certified waste shipments will be retained for a minimum of five years after each shipment

. If any portion of the written procedures or instructions are superseded, i

the superseded material will be-maintained as a part of the.QA record

-for a minimum of.five years after itcwas superseded For each' cognizant organizational component, a WID. Records l'nventory' and Dis-

~

position. Schedule shall define. record retention requirements and the schedule for._

transmitting completed QA records to the WIPP MRC.

i 15-H CONTROLLED COPY

OUALITY ASSURANCE PLAN OA PLAN DESCRIPTION 3.18 Internal and Supplier Audits A listing of the WID and WID supplier activitias to be audited and the frequency at which each activity is to tse audited shall be established and maintained to reflect current status. The fraquency of audits shall be based on the importance of the activity to safety; however, each activity should be audited at least once a year. Audits are performed in accordance with approved procedures by qualified personnel not having direct responsibility in the areas being audited.

Measures shall te established to ensure that audits are performed on the manu-facturers of TRUPACT-II, to determine the extent of compliance with the purchase order and to verify that the work is being controlled by their QA program that is approved by NRC.

l l

Measures shall be established to ensure that audits are performed on the manu-facturers of TRUPACT-II, to determine the extent of compliance with the purchase order and to verify that the work is being controlled by their QA program that is approved by NRC.

Performance of audits on other TRUPACT-II users is outside the scope of this QA pl an.

User quality audits relating to TRUPACT-II will be included with TRU cer*.ification audits performed by the WACCC.

3.18.1 General Requirements for WID Audits WID internal audits shall be conducted in accordance with approved procedures.

The major characteristics of the internal audit program are outlined below.

The QA manager shall assure that audits are scheduled to provide coverage and coordination with ongoing QA program activities.

Audits shall be scheduled at a frequency commensurate with the importance of the activity being considered for audit An audit plan shall be documented for each audit to identify the specific audit scope, requirements, audit personnel, activities to be audited, organizations to be notified, applicable documents, and schedule Auditors shall have sufficient authority and organizational freedom to make the audit process meaningful and effective. An audit team leader shall be assigned to each audit to organize and direct the audit, coor-dinate the preparation and issuance of the audit report, and evaluate responses Adequate notification shall be given to the responsible management of the work activity to be audited.

Responsible management shall be ad-vised of the audit scope, the audit team members, and the audit dates Audit checklists or procedures, either unique to the audit or generic, shall be used for itemizing areas to be audited and recording resulting observations Preparation of audit checklists and the orientation of team members shall be the responsibility of the lead auditor 3-16 CONTROLLED COPY

00ALITY ASSURANCE PLAN OA PLAN DESCRIPTION' l

A pre-audit meeting shall be scheduled with the management personnel

~

responsible for the audited activities Conditions requiring prompt corrective action shall be reported immediately to management of the audited organization A post-audit meeting to discuss audit findings shall be scheduled with the management personnel responsible for the audited activities The audit report shall be signed and issued to responsible management by the lead auditor and shall. include a description of the audit scope, identification of the auditors, identification of. persons contacted during audit activities, summary of audit results, including a statement on the effectiveness of the QA program elements which were audited, and a description of each reported audit nonconformance and observation in sufficient detail to enable corrective action to be initiated by the audited organization Audit. responses shall include, as applicable, root cause - of non-conforming condition, actions' planned to correct specific conditions noted, evaluation for related conditions, interim corrective actions, actions to prevent recurrence, and a schedule for.. implementation of proposed corrective actions The adequacy of audit responses shall be evaluated by the lead auditor Follow-up action shall be taken to verify that corrective actions are accomplished as scheduled Audits shall be closed out when all findings are resolved and follow-up actions are completed Audit records shall be retained, including audit plans, audit reports, and completed Audit Nonconformance Reports.

External (supplier) audits shall, in general, include the-same characteristics as indicated above.

00401 3 CONTROLLED COPY' t

ATTACMMENT I WP 13-4, Rev. 2 Page 1 of 7 IMPLEMEllTING PROCE6URE MATRIX

/

The following matrix, based on NCA-1, also satisfies the eighteen criteria of 10 $/

CFR 71.

CRITERIA IMPLEMENTING PROCEDURE

~

1.

Organization Organizational structures are provided in WP 13-1.

2.

QA Program MOC QA Program WP 13-1 approved by the DOE-WPO.

3.

Design Control WP 09-024, Configuration Control Board /

Engineering Change Proposal WP 09-029, Cognizant Engineer Responsibilities WP 15-10, Transport Packaging Fleet Management WP 09-09, Confiauration Manaaement Plan WP 09-007, Engineering and Design Document Preparation W?09-018, Design Verification W?09-025, Engineering Data Transmittal / Design Input 4.

Procurement Document WP 15-041, Approval / Variation Request Control Preparation WP 15-030, Records Management WP 15-009, Preparation and Review of Purchase Requisitions WP 13-009, Procurement Control Procedure kP 15-6, Purchasina Policies and Procedures Fanual CONTROLLED COPY

=

e ATTACHMENT 1 WP 13"4, Rev. 2 IMPLEMENTINGPROCEbuREMATRIX

/

f/

CRITERIA IMPLEMENTING PROCEDURE 5.

Iastructions, WP 06-102, Shipment of Radioactive Materials Procedures, Specifications, and WP 06-104, Empty TRUPACT-II Shipment Drawings WP 09-8, WIPP Specification Preparation Style Guide WP 04-902, TRUPACT II Work Control DOE-WIPP 88-026, TRUPACT II Maintenance Program WP 15-041, Approval / Variation Request Preparation WP 15-009, Preparation and Review of Purchasei Requisitions i

WP 13-009, Procurement Control Procedure WP 15-7, Operations Procedures Writers' Guide WP 15-701, Review and Approval of WID Operations Procedures WP 15-702, Operations Procedures Safety Review Committee WP 15-101, Preparing, Revising, Reviewing Procedures WP 05-WH 1001, TRUPACT-II Loading WH 1005 Loading TRUPACT-II Trailer WH 1010, TRUPACT-II Receipt WH 1011, TRUPACT-II Unloading WH 1015, Preparation of an Empty TRUPACT-II For Shipment 4

WH 1032, Payload Transportation Certification WH 1033, TRUPACT-Il Payload Assembly I

WH 1051, Varian Porta-Test Leak Detector WH 1080, TRUPACT-II Verification Leak Checks k

CONTROLLED COPY

+

ATTACHMENT 1 WP 13-4, Rev. 2 Page 3 of 7 IMPLEMENTING PROCEDURE MATRIX N

CRITERIA IMPLEMENTING PROCEDURE WH 1101, Surface CH TRU Waste Handling Area Inspections 6.

Document Control WP 15-103, Document Control WP 13-604, WIPP Transport Packaging Records Management WP 09-006, Engineering Document Distribution WP 09-007, Engineering and Design Document Preparation and Change Control WP 15-1, WIPP Documentation Plan 7.

Control of Purchased WP 04-901, TRUPACT II Material Control Items-and Services WP 15-041, Approval / Variation Request Processing WP 15-009, Preparation and Review of Purchase Requisitions WP 13-009, Procurement Control Procedure j

QAI 7-2, Quality Assurance Source Inspection WP 13-012, Supplier Evaluation / Qualification WP 15-518, Receipt of Materials and Services WP 15-517. Spare Parts Inventory Control 8.

Identification and WP 04-910, TRUPACT II Material Control Control of Items WP 15-517, Spare Parts Inventory Control

}

(control of limited life items) 9.

Control of Processes WP 05-WH 1080, TRUPACT-II Verification Leak Check QAI 9-1, Training, Qualification, and Certification of Personnel in Nondestructive Examination WP 13 014, TRUPACT II Leak Check QAI 9-5, Liquid Penetrant Examination CONTROLLED COPY

=.'

ATTACHMENT 1 WP 13 '4, Rev. 2 Page 4 of 7 IMPLEMENTINGPROCEbuREMATRIX j

i IMPLEMENTING PROCEDURE CRITERIA 10.

Inspection WP 04-901, TRUPACT II. Material Control WP 04-902, TRUPACT.II Work Control WP 06-104, Empty TRUPACT Shipment i

Material

[

DOE-WIPP 88-026, TRUPACT II Maintenance Program QAI 7-1, Quality Assurance Inspection and Test Planning QAI 7-2,-Quality Assurance Source Inspection l

QAI 7-4, Quality Assurance Inspection WP 13-011, Quality Assurance Surveillance QAI 10-1, Qualification and Certification of t

Inspection Personnel

[

QP 15-518, Receipt and Inspection of Materials l

and Services

[

11. Test Control WP 13-014, TRUPACT-II Leak Check WP 04-902, TRUPACT II Work Control t

DOE-WIPP 88-026, TRUPACT 11 Maintenance I

Program WP_05-WH 1080 TRUPACT II Verification Leak-Check l

WP 10-007, Control, Use, and Testing of i

Rigging Components-

12. -Control of Measuring WP 10-003, Instrumentation, Control, and and Test Equipment Calibration j

+

1 L

L CONTROLLED COPY

ATTACHMENT 1 WP 13-4, Rev. 2 Page 5 of 7 IMPLEMENTINGPROCEbUREMATRIX g,l P

CRITERIA IMPLEMENTING PROCEDURE

13. Handling, Storage, WP 04-902, TRUPACT II Work Control and Shipp_ing WP 05-017, Canister Overpacking WP 05-1, Waste Handlino Operations Manual WH_1010, TRUPACT-II Receipt WH 1011, TRUPACT-II Unloading WP 06-1, WID Transoortation Plan WP 06-2, Waste Transoortation Manual WP 06-3, Transcom Tracking System /CMR Operator Guidelines WP 06-4, Defense ' Transuranic Waste Procram Transportation Manacement and Operation Plan WP 06-102, Shipment of Radioactive Materials WP 06-104, Empty TRUPACT-II Shipment WP 12-4, WIPP Hoistino and Ricaina Manual WP 05-WH 1001, TRUPACT-II Loading WH 1005, Loading TRUPACT-II Trailer WH 1010, TRUPACT-II Receipt WH 1011, TRUPACT-II Unloading WH 1015, Preparation of an Empty TRUPACT-II For Shipment WH 1032, Payload Transportation Certification WH 1033, TRUPACT-II Payload Assembly i

i WH 1051 Varian Porta-Test Leak Detector WH 1080, TRUPACT-II Verification Leak Checks i

WH 1101, Surface CH TRU Waste Handling Area l

Inspections j

WP 14-1, WIPP Trainino Procram Manual B

CONTROLLED COPY

ATTACHMENT 1 WP 13-4, Rev'. 2 Page 6 of 7 IMPLEMENTINGPROCEbUREMATRIX

/

CRITERIA IMPLEMENTING PROCEDURE 14.

Inspection, Test, and WP 13-008, Stop Work Operating Status WP 04-902, TRUPACT II Work Control WP 04-901, TRUPACT II Material Control WP 13-007, Hold Tag Issuance WP 06-1, WID Transoortation plan WH 1010, TRUPACT-II Receipt WH 1001. TRUPACT-II Loading l

15. Control of Noncon-QAI 15-1, Trend Analysis forming Items WP 04-901, TRUPACT II Material Control WP 13-003, Nonconformance Item Control WP 13-007, Hold Tag Issuance WP 13-008, Stop Work WP 15-041, Approval / Variation Request Processing

16. Corrective Action WP 02-506, Environmental Incident Reporting j

QAI 15-1, Trend Analysis WP 13-003, Nonconformance Item Control I

WP 13-002, Corrective Action WP 13-008. Stop Work

17. QA Records WP 15-030, Records Management DOE-WIPP 88-026, TRUPACT II Maintenance Program WP 15-604, WIPP Transport Packaging Records Management WP 13-6, OA Records Manacement Policy WP 15-i, WIPP Documentation Plan WP 06-105, Transportation Operations Record Keeping CONTROLLED COPY

~

ATTACHMENT 1 l

WP 13-4, Rev. 2 Page 7 of 7 IMPLEMENTINGPROCE5UREMATRIX CRITERIA IMPLEMENTING PROCEDURE l

18. Audits _

WP 13-004, Auditor Training and Qualification l

WP 13-005, Quality Assurance Internal and l

External Audits i

I o

1 I

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9 f

I i

l i

CONTROLLED COPY

OFFICE OF THE GENERAL MANAGER i

I E E'8 21 N3 Eiys g io a

9. o a5 8*

PROJECT OPERATIONS MANAGEMEN CONTROLLER 5: [-

ASSURANCE 9a o Oo ouelity Assurance 6m W R a m W e.

8.

O ENVIRONMENT, EXTERNAL AND HUMAN SAFETY GOVERNMENTAL 3

RESOURCES IN ERING AND HEALTH AFFAIRS O

sc 6919 0484 U

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Waste Isolation Pilot Plant rubric iteiotiona/

Proiect Integration Office

"'$*,'* n"[$"o' gf"l=""e"tal Denuty Director

, Manager - T. Loughead M.L. Matthews

. Institutional Program Manager Secretarv

- L. Tilton Waste Isolation Pilot J. Iliggins, Temp.

Plant Project Site Office

• Site Manager - A. Ilunt

• Deputy Site Manager -

V. Daub (Acting)

WPIO Plannina &

Exocrimental Programa &

Quality Assurance &

Adminiatration Branch Waste Interration Branch Comnliance Branch

• Branch Chief-D. Olona (Acting Albuquerque Office Branch Chief-L. Gage

• Secretary - Y. Valenzuela

• Branch Chief-P. Iliggins

• Secretary - vacant

• Secretary - vacant

• Quality Assurance Manager-WIPP Plannic? Groun IWPG)

• Repository Compliance Program vacant Manager - vacant

• Environmental Compliance

• Prograrn Integration Analyst -

• Waste Criteria &

Manager - D. Mercer J. Norte Characterization Program

• Environmental Specialist-

• Project Control Manager -

Manager-P. Dickman vacant D. Lineback

• Waste Systems Integration

• Safety Engineer. vacant Financial Ollicer - vacant Manager -J. Coffey

• Technical Writer D. Lindsay

• TRU Waste Experiments R&D Engineer-D. Ilouck

• Disposal Room Systems R&D Project Manager - vacant Gaarlsbad Office

• Repository Systems R&D Project Manager - J. Lippis

• Repository Isolation System Engineer - R. Batra a Fluid Flow & Transport Engineek

- R. Becker

• Institutional Program Manager-L. Tilton a Transportation & Packaging ManaCor - R. Spooner September I,1992

r.

WIPP ORGANIZA' N STRUCTURE Assistant Secretary for Environmental Restoration and Waste Management EM-1 Albuquerque Field Office l

l

Manager, Director, Office of Deputy Assistant Secretary for Waste Management l

Waste Management Projects EM-30 EM-34 Assistant Manager, En:rgy and Special Programs, l

Albuquerque Field Office

Director, I

Director WIPP Pr c Division WIPP Pro ct integration

-=========i I

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Manager, Site Manager, Quality Assurance Project Director Staff WIPP Project Site Office i

L i

1 1

General Manager, Department Manager, WIPP Project Westinghouse Sandia National Laboratory Site Office Staff Waste isolation Division DIRECTION / REPORTING 4/15/97

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