ML20151A007
| ML20151A007 | |
| Person / Time | |
|---|---|
| Site: | 07109218 |
| Issue date: | 01/31/1983 |
| From: | WESTINGHOUSE ELECTRIC COMPANY, DIV OF CBS CORP. |
| To: | |
| References | |
| WIPP-DOE-120, WIPP-DOE-120-R01, WIPP-DOE-120-R1, NUDOCS 8804060187 | |
| Download: ML20151A007 (16) | |
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QUALITY ASSURANCE REQUIREMENTS FOR CERTIFICATION OF TRU WASTE FOR SHIPMENT TO THE WIPP JANUARY 1983
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DISCLAIMER This report was prepared as an account of work sponsored by an agency of the United States Government. Neither the United States Government nor any agency thereof, nor any of their employees, makes any warranty, express or implied, or assumes any legal liability or respon-sibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed, or represents that its use would not infringe privately owned rights. Reference herein to any specific commercial product, process, or service by trade name, trademark.
manufacturer, or otherwise, does not necessarily constitute or imply its endorsement, recom-mendation, or favoring by the United States Government or any agency thereof. The views and opinions of authors expressed herein do not necessarily state or reflect those of the United States Government or any agency thereof.
Pnnted in the Unded States of Amer Ca Ava:labte from National Technical Information ServlCe U S. Department of Commerce 6285 Port Royal Road Springfield. VA 22161 NTIS pnce oces Pnnted copy: A03 MicrofeChe CoDy A01 TECHNICAL SUPPORT CONTRACT OE AC04 78ALD5346 WESTINGHOUSE ELECTRIC CORP.
D'APPOLONIA CONSULTING ENGRS.
ORAVO MINING GIBBS & HILL INC.
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l WIPP-00E-120 Rev. 1 UC-70 QUALITY ASSURAt4CE REQUIREMEf4TS FOR CERTIFICATI0!i OF TRU WASTE FOR SHIP!1EtiT TO THE WIPP i
JANUARY, 1983 WESTINGHOUSE ELECTRIC CORPORATI0ft WIPP TECHNICAL SUPPPORT C0fiTRACTOR
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QUALITY ASSURANCE REQUIREMENTS FOR CERTIFICATION OF TRU WASTE FOR SHIPMENT TO WIPP I.-
INTRODUCTION This document presents the basic Quality Assurance (QA) requireraents which shall be included in the Quality Assurance Program established by sites planning to certify Transuranic (TRU) Waste to Waste Isolation Pilot Plant (WIPP) Waste Acceptance Criteria.
These QA requirements were modeled after ANSI /ASME SQA-1-1979 (Reference 1).
This document should be useo in conjunction with Reference 2, 3, 4, 5, and 8, and other available guidance documents, to develop the overall TRU Waste Certification Programs.
The application of quality assurance to Waste Certification Programs is required by WIPP-00E-069 (Reference 2) and DOE Order 5700.6A (Reference S), as implemented by DOE Order AL 5700.6A (reference 8).
This document also furnishes guidance for definition of all those planned and systematic activities that provide adequate confidence that each site's TRU Waste Certification Program will perform satisfactorily.
The definition of those activities is considered to be part of the site's QA plan.
The waste is not the product, and QA/QC is not applied to the waste as a product, but to the certification activities for shipment of waste to WIPP, Plans and actions to assure quality activities shall be established, icplenented, and maintained with pricary emphasis on achieving a high degree of operational success and with due consideration to health, safety, and I
environmental protection.
The extent of quality program requirements and the level of associated QA activity vill be commensurate with the scope and i
importance to the certification program.
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REFERENC E_S_
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ANSI /ASitE NQA-1-1979, Quality Assurance Program Requirements for Nuclear Power Plants.
2.
WIPP-DOE-069 Rev.1, TRU Waste Acceptance Criteria for the Waste Isolation Pilot Plant, September 1981, i
3.
WIPP-DOE-ll4, TRU Waste Certification Compliance Requirements for Newly Generated, Contact-Handled Wastes for Shipment to the WIPP, October 1981.
i 4.
WIPP-DOE-137 TRU Waste Certification Compliance Requirements for Contact-Handled llastes Retrieved from Storage for Shipment to the WIPP, September 1982.
I 5.
00E Order 5700.6A, Quality Assurance, August 13, 1981.
6.
"Guidelines for Developing Certification Programs for Newly j
Generated TRU Waste."
To be issued.
I 7.
"TRU Waste Certification Compliance Requirements for Remote Handled Wastes for WIPP." To be issued.
8.
DOE Order AL 5700.6A, Quality Assurance,llay 10, 1982.
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DEFINITIONS
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1.
SITE QUALITY ASSURANCE PROGRAF t.A system of activities defined by documents which implement the site's total Quality Assurance Program.
The QA Program should define in written form quality assurance policy, requirements, authority and responsibility, organization, method of implementation, and activities required to l
establish and maintain Quality Assurance.
The QA Program should 1
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activities subject to control (e.g., design, processes, tests, procura73nt); non-conformance identification; corrective action requ records functions (identification, control, l
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j preservation 9tc.1; the QA documentation scheme; methods of 3
independent verification (inspection, surveillance, and QA audit);
procedures for imple.nenting all aspects of the QA Program; and a method for assessirig the QA Program's effectiveness.
2.
JRU WASTE QUALITY ASSURANCE PLAN. A decription of the qu?1ity-related requirements, responsibilitier,, activities, procedures, and methods of implementation which are applicable to the specific task of TRU Waste Certification and a description of l
how organization level quality assurance programs, manuals, and procedures are effectively translated for use on that task.
The QA Plan may invoke existing manuals and procedures (or parts thereof),
or it nay be a full / se1 %,,tained document.
The QA Plan may be included in the site TRU Waste Certification Plan or it may be a separate cocument.
In either event, the two must be completely integrated.
3.
QUALITY-RELATED.
Of or pertaining to quality or the process that assures quality, or having a cause-and-effect influence on quality or on a quality assurance function.
TRU Waste Certification quality-related activities are those important to public health and safety, environuental protection, and process equipment performance and reliability, with primary emphasis on achieving a high degree of operational success in those activities.
These include activities considered part of the process for valid data acquisition, facility and equipment design, testing, peer group review, project monitoring, records management, planning, purchasing, fabricating, handling, shipping, storing, cleaning, assembling, installing, inspecting, auditing, surveillance, measuring, documenting, analyzing, maintaining, repairing, and modifying.
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_QUAllTY ASSURANCE PROGRAft ELEMENTS i
1.0 ORGANIZATION l
The organizational structure, functional revonsibilities, levels of authority, and ifnes of communication for those individuals and groups performing the TRU waste processing, handling, verification and other certification activities shall be identified in the site's waste certification QA Program Plan.
Persons or organizations responsible for assuring that an appropriate waste certification QA Program is established and verifying that activities affecting certification have been correctly performed shall have sufficient authority, access to work areas and organizational freedom to:
identify certificetion t
problems; initiate, recommend or provide solutions to certification problems through designated channels; verify effective implementation of solutions; and assure that further processing or
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shipment to the WIPP site is controlled until proper disposition of any nonconformance, deficiencies or other unsatisfactory conditions has occurred.
Such person or organizations shall report to a management level i
such that required authority and organizational freedom necessary l
to comply with the requirements of the plan are provided, including sufficient independence from cost or schedule considerations.
2.0 QUALITY ASSURANCE PROGRAM PLAN Each generator or storage site shall prepare, maintain, and 1
implement a documented TRU Waste Certification Quality Assurance Plan (or Program Plan) which is appropriate for the types of waste generation, waste processing, and waste certification activities being performed at the site.
In preparing the Plan the site shall 4
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address the eighteen (18) QA Program eleuents presented in this document and determine which are applicable to the certification program.
The Plan shall describe methods of coupifance with the applicable elements, including justification for exclusions of those elements considered not to apply to the site's specific activity.
A review of critical program aspects shall also be included to assure that certification quality requirements are adequately and correctly stated.
The Plan shall apply to all activities affecting the certification of TRV waste.
Each QA Program Plan and subsequent revisions shall be submitted to the WIPP Project Office for review and approval prior to implementation.
3.0 DESIGN CONTROL Design activities associated with waste certification shall be performed in accordance with documented procedures which include the following control features as a mininum:
1)
Provisions for applicable design inputs and interfaces to be identified, documented and approved as part of the design verification process.
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Provisions for verifying the adequacy and correctness of designs by the performance of design reviews, alternate calculations, or qualification testing.
The extent of design verification required is a function of the importance of the item being designed to the certification process, the complexity of the design, and the degree of similarity with previously proven designs, i
3)
Provisions for changes to final designr including shop or field changes, to be documented and <
...ed by qualified I
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design.
4)
Provisions for drawing reviews, spec'ification reviews, and audits of design activities.
j 4.0 PROCUREHENT DOCUMENT CONTROL Procurement documents associated with the site's waste j.
certification program shall be prepared, reviewed, approved, issued and contrulled in accordance with documented procedures.
Procurement documents shall contain administrative, technical and quality requirements, as appropriate, to assure conformance with applicable design requirements, waste acceptance and certification criteria, and other applicable codes and standards.
Procurement documents snall be reviewed to assure that quality requirements are adequate and correctly stated.
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5.0 INSTRUCTIONS, PROCEDURES AND ORAWINGS.
Waste certif ication activities such as waste treatment, inspection, testing, packaging, labelling and other certification activities shall be appropriately prescribed by written instructions, work plans, task descriptions, drawings or other procedures.
4 Documents which involve inspection, testing or other type of verification activities shall include or reference appropriate qualitative and nuantitative acceptance criteria, thereby establishing a mechanism for determining the acceptability of the a
activity.
In those cases where verification steps are specified in work documents and/or procedures, the independent organizational unit responsible for performing the verification shall be clearly specified, 1 j 1
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One example inay be procedures controlling the segregation of waste r
streams to prevent the mixing of incompatible waste categories i
requiring different certification procedures.
i 6.0 00CUMENT CONTROL 1
The genera tion, review, approval, distribution, and revision of documents related to waste certification shall be controlled 1
l through written document control procedures.
These procedures shall ensure that the certification documents are valid, correct, l
and up to date.
Documents shall be reviewed for adequacy and approved for release by independent qualified personnel.
i The document control procedures shall also include the methods used to change documents.
These methods shall assure that changes in documents are reviewed and approved by organizations responsible I
1 for the original review and other appropriate individuals, and that tne changes are included in the documents prior to the implementation of the change in the activity.
k 7.0 _ CONTROL OF PURCHASED ITEMS AND SERVICES 4
The procurement of items or services associated with waste certification shall be controlled, to the extent necessary, to i
i assure conformance with specifications.
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i Such control of procured items and services shall provide for the following, as necessary:
source evaluation and selection, bid evaluation of objective evidence of quality furnished by the supplier, source inspection, control of nonconformances, audit and examination of items or services upon delivery or completion.
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4 8.0 IDENTIFIC/ TION AND CONTROL OF ITEMS Identification requirements shall be established for waste, packages, containers and other items associated with waste certification where loss of identification could invalidate certification efforts.
The method and location of the identification marking shall be unambiguous, indelible, and shall be directly maintained on the item or on records traceable to the item or process.
The correct identification of items involved in certification shall be verified and documented prior to the release of that item or i
process for testing, packaging, packing or shipment.
l 9.0 CONTROL OF PROCESSES Certification Processes shall be performed under controlled conditions in accordance with documented instructions, procedures, drawings, checklists, travelers, or other appropriate means.
Processes which are mainly dependent upon the expertise or skill of the personnel conducting the activity, such as remote welding or real time radiographic inspection, shall be considered special j
processes, and shall be identified in the site's QA Plan, together with methods for qualification of personnel performing those activities and control over the work performed.
Records shall be maintained for qualification of procedures equipment, and personnel performing operations associated with special processes.
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10.0 INSPECTION Inspections shall be plannad and performed at appropriate points in the certification process to assure conformance to applicable waste acceptance and certification criteria.
Inspections shall be performed by qualified personnel, and the results of the inspections shall be documented. Procedures for inspection activities, including the responsible organizational unit and standards for acceptance / rejection, shall also be included.
Independent inspections, which are used to verify conformance to certification requirements shall be performed by personnel other than those who performed or directly supervised the work being inspected.
Inspection records shall be prepared for all specified inspections and be maintained in accordance with the site's record retention program.
11.0 TEST CONTROL Tests performed to provide verification data or acceptance for waste certification shall be planned, documented, and controlled, including test description, objectives, proposed frequencies, and
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rejecion criteria.
These tests shall be performed by qualified personnel and the results documented.
Test records shall be prepared for all specified tests and be maintained in accordance with the site's record retention program.
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT Measuring and test equipment used for activities involving certification shall be controlled and calibrated at specified i
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1 intervals in accordance with written procedures to maintain accuracy within acceptable limits.
Calibration and standarization shall be addressed in the QA plan.
These may consist of standards traceable to NBS, recognized industrial standards, or standards specifically developed for TRU waste certification.
Measurement and test equipment control procedures shall provide for identification of equipment and calibration status, inclucing methods to ensure that test equipment is properly calibrated when used.
Calibration records shall be prepared and maintained for measuring and test equipment and associated standards important to certification.
These records shall be maintained in accordance with the site's record retention program.
13.0 HANDLING, STORAGE AND SHIPPING Procedures or instructions shall be written and implemented to provide control of handling, storage, labeling and preparation for shipping of waste packages, containers, packaging materials, and associated equipment significant to certification.
The documents shall assure proper handling, storage, labeling, and preparations for shipping of TRU waste.
14.0 INSPECTION, TEST AND CPERATING STATUS The status of certification activities shall be identified either on the items (e.g., waste forms, waste packages, etc.) or in 5
documents traceable to the items.
It is necessary to assure that required inspections and/or tests are performed and to assure that items which have not passed the required inspections and/or tests are not later marked Certified and shipped. Certification status
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shall be maintained through indicators, such as being placed in a specified location and tagged, markings, shop travelers, stamps, l
inspection records, or other suitable means.
The authority for application and removal of tags, markings, labels, and stamps shall be specified.
15.0 CONTROL OF NONCONFORMING ITEMS t
4 Procedures shall be iuplemented for prompt detection, documenting, j
and dispositioning of waste, waste containers, waste packages, processes, etc., important to certification, which do not conforu to specifications.
The procedur s shall assure that i
nonconformances are positively identified and that notification of their existence and proposea disposition are sent to all affected organizations.
Nonconforming itens shall be either tagged or segregated to prevent inadvertent certification.
Nonconformances that result in waste which does not meet WIPP waste acceptance and certification requirements shall render the waste not certifiable.
A request for approval, which shall include
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definition of the cause, proposed corrective action and rationale for acceptance by WIPP, shall be submitted to the WIPP Project l
Office.
Nonconformance shall be docuuented and copies of all nonconformance reports shall be maintained in accordance with the site's record retention program.
16.0 CORRECTIVE ACTION Procedures shall be implemented to ensure conditions adverse to certification are promptly identified and corrected as soon as i
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In the case of a significant condition adverse to i
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certification, the cause of the condition shall be determined and appropriate corrective action taken to preclude recurrence of the condition.
The identification, cause, and corrective action for significant conditions adverse to certification shall be documented and reported to appropriate levels of management.
Follow-up action saail ee aken to verify implementation of corrective action.
Certification activit ies related to the nonconfernances shall not rasur:e..ct i! writ ten >pproval frca the or i.'iPP Project Office is
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, iia :! oc i ntified, readily retrievable, and o
re.a i..e j v.d pro tec ted aga tut dar' age, ioss and deteriora tion a s pre.7 iU :, by lecu:Je"te 1 ptacedurea.
The responsibilities and recu ir en:nt. tur reccrd preparation, review, transmittal, uaintenance, anu retention shall be speci'ied.
The organization ana :'.dividuals re:ponsible for the collection, review, storage and dispo;iticn of certification records, and the designation of the types of reccrds to be maintained shall be specified.
Cert'fication records may include, but are not limited to:
inspection, test, nont;onformance and audit reports; results of routine assays of waste; operating logs; calibration records; equienent certifications; personnel qualification records; and otner records which provide technical support for the validity of the certification.
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- it :c atico eccrd. >nalf se reviewed by the designated r
' e r t i r c n'S Gtficili at the waste generating site.
This individual r:
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have been followed and that the waste packages meet all WIPP J
criteria and requirements.
18.0 AUDITS Planned and scheduled audits shall be conducted by appropriate site personnel to verify compliance with all aspects of waste certification. Audit responsibility and minimum frequency shall be defined in site Quality Assurance Plans. Audit activities shall include: planning and performance of audits; evaluation of certification procedures and activities, with emphasis on implementation of controls; reporting of audit results to responsible management; assigning responsibility of correcting deficiencies, and follow up to assure that appropriate corrective action has been taken.
The site quality assurance audit procedures shall specify how audits are planned, documented, implemented and closed out.
All audits shall be performed in accordance with written procedures or checklists by personnel who do not have direct responsibility in the areas being audited. Audit results shall be documented, and reported to and reviewed by responsible management. An appropriate I
level of management shall be responsible for assuring that l
1 necessary actions are taken to correct deficiencies.
Copies of all completed audit reports and associated responses shall be maintained in accordance with the site's record retention pro gram.
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