ML19310A583
| ML19310A583 | |
| Person / Time | |
|---|---|
| Site: | 07100173 |
| Issue date: | 05/16/1980 |
| From: | Battelle Memorial Institute, PACIFIC NORTHWEST NATION |
| To: | |
| Shared Package | |
| ML19310A582 | List: |
| References | |
| 16464, NUDOCS 8006200292 | |
| Download: ML19310A583 (15) | |
Text
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05/07/80 PNL-MA-593
~ 71-0173)
(NRC Docket No.
i QUALITY ASSURANCE PROGRAM DESCRIPTION FOR SHIPPING PACKAGES OF RADI0 ACTIVE MATERIALS i
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I Prepared for the U.S. Nuclear Regulatory Comission a
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Battelle, Pacific Northwest Laboratories
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Richland, Washington 99352 134C4
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80062 0 0M N
I PNL-MA-593 i
RECORD OF REVISIONS
$ hf80 Director, Laboratory Support Date Manual Purpose For Date Revision No.
Revision Released 0
Initial issue 06/28/78 1
To revise the scope and to reflect 12/22/78 the requirements of the BNW QA Manual (PNL-MA-65), December 1978 revision.
l 2
To include comments from NRC 05/16/80 i
and changes required by the BNW QA Manual (PNL-MA-65),
March 1980 revision.
Manual number changed from PNL-2628 to i
PNL-MA-593.
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SUMMARY
This document describes the Battelle, Pa.cific Northwest Laboratories (BNW) quality assurance program for shipping packages of radioactive material.
This document describes how 6
will comply with.the applicable criteria of the Code of Federal Regulations, Title 10, Part 71, Appendix E.
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PNL-MA-593 TABLE OF CONTENTS
' Item Pace No.
Cover Page i
Record of Tevisions ii Summary iii Table of Contents iv Introduction 1
I Organization 2
II Quality Assurance Program 4
III Procurement Control 4
IV Instructions, Procedures and Drawings 5
V Document Control 6
VI Inspection and Test 6
VII Control of Measuring and Test Equipment 7
VIII Handling, Storage and Shipping 7
IX Nonconformance and Corrective Action 8
X Quality Assurance Records 8
l XI Audits 8
Attachment A 1A Attachment B 1B iv t
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QUALITY ASSURANCE PROGRAM DESCRIPTION FOR SHIPPING PACKAGES OF RADIOACTIVE MATERIAL INTRODUCTION Battelle, Pacific Northwest Laboratories (Battelle, BNW), is operated by Battelle Memorial Institute. Battelle will make radioactive material shipments in compliance with the Code of Federal Regulations, Title 10 (10CFR), Part 71.
The quality assurance program summarized in the following sections is provided by the Director, Laboratory Support.
This QA program covers the shipment of radioactive materials initiated by BNW with the exception that these shipments will not include high-level waste, irradiated fuel, or plutonium in excess of amounts listed in 10 CFR 71, Paragraph 71.42.
Battelle will not design or fabricate shipping containers for packaging radioactive materials.
9 PNL-MA-593 1 of 8
I ORGANIZATION Battelle has a Quality Assurance Office (QAO) that is responsible for developing quality assurance programs for BNW. The QA0 interfaces with Radiological Safety and Engineering to assure that the necessary QA activities are applied to the shipment of radioactive materials. An organization cnart (Figure 1) shows the relationship of the QA0 with other BNW components that have radioactive material shipment responsibilities. The QA responsibilities of the organizational elements (shown in Figure 1) that have assigned QA responsibilities are outlined in Attachment A.
The qualification requirements for the Manager, QA0 are provided in Attachment B.
The Director, Laboratory Support with input from the Manager, QA0 is responsible for establishirg BNW's QA policies, goals and objectives. The Laboratory Director has the ultimate responsibility for the effectiveness of the BNW QA Program.
Verification of conformance to established quality assurance requirements will be accomplished by individuals or groups who do not have direct responsibility for performing the work that is to be verified.
The functions performed by the QA0 are described in the BNW QA Manual (PNL-MA-65). Normally, inspection activities are performed by department personnel. The training of shipping representatives and final authorization of radioactive material shipments are delegated to the Hazardous Material Transportation Officer (HMTO).
The HMT0 is assigned to the Radiological Safety and Engineering Section, and is responsible for training, document control, inspection, and auditing activities associated with shipments of radioactive material.
Authority has been delegated to the HMT0 by the Manager, Occupational and Environmental Protection Department (0&EP) to stop shipments that are not in compliance with regulations.
This action is upheld by the Director, Laboratory Support and the BNW Director. After a shipment has been detained for noncompliance, approval to proceed with the shipment must be obtained from
'the HMT0 and the Manager, 0&EP. The HMT0 works with the QA0 to purchase specification containers, and to compile inspection and test results.
Personnel from Radiological Safety and Engineering who are independent of the shipping activities will perform periodic internal audits to determine if the shipping program is administered according to BNW manual and procedural requirements.
The QA0 Manager has the responsibility and authority to stop work that does not comply with QA Program requirements.
PNL-MA-593 2 of 8
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II OUALITY ASSURANCE PROGRAM The quality assurance program for shipment of radioactive materials is documented in Battelle management guides and manuals.
These guides and manuals provide the procedures by which training, inspections, tests, recuirements, surveillance and audits are to be ac'complished, and provide for controlling the package characteristics that are critical to safety.
1 BNW uses a centralized manual control system to control the distribution of specific manuals and Management Guides and their revisions.
Quality-related disputes that arise between QA0 personnel and other BNW (engineering, research, procurement, crafts, etc.) personnel are resolved by involving whatever level of line management is necessary to obtain agreement. The Laboratory Director has the ultimate responsibility for quality-related activities at BNW.
The indoctrination and training (including periodic retraining) program for Shipping and Radiation Monitoring personnel will be performed and documented in accordance with writtan procedures, and will include:
a.
The applicable portions of the BNW QA Program as described in the QA Manual (PNL-MA-65), the Quality Assurance Program Description for Shipping Packages of Radioactive Material (PNL-MA-593), Radioactive Materials Shipping Manual (PNL-MA-81) and associated instructions and procedures.
b.
The principles and techniques used to document and prepare containers for shipment.
The HMT0 assures that all radioactive material shipping packages designed or fabricated after December 31, 1978 are designed and manufactured under a quality assurance program that is consistent with the above guides and i
manuals and approved by the Nuclear Regulatory Commission (NRC).
This requirement may be satisfied by receiving a certification to this effect from the manufacturer.
The Director, Laboratory Support, regularly assesses the scope, status, implementation and effectiveness of the BNW QA Program.
This assessment will include an evaluation of the adequacy of BNW compliance with 10CFR, Part 71, Appendix E criteria.
III PROCUREMENT CONTROL Pracurement activities will be planned, documented and performed in accordance with the BNW Procurement, Quality Assurance and Radioactive Materials Shipping Manuals.
PNL-MA-593 4 of 8
4 The review and concurrence for the adequacy of quality requiremnts stated in procuremen't documents will be performed by qualified personnel.
All Purchase Requisitions are reviewed by a QA0 Representative who is responsible for obtaining additional reviews from personnel qualified in the discipline involved (e.g., HMTO).
The purpose of this review is to determine if the quality requirements are correctly stated, inspectable and controllable; that adequate acceptance and rejection criteria exist; and that t".e procurement document has been prepared, reviewed and approved in accordance with QA Program requirements.
The review and approval of procurement documents will be documented prior to award and available for verification.
Procurement documents for Type B shipping containers will identify 10CFR71, Appendix E, requirements applicable to the supplier. A BNW QA0 representative will verify that the supplier is qualified to comply with these requirements prior to award of the procurement.
Procurement documents will contain or reference sufficient design basis technical requirements to assure that the Type B shipping container being procured meets the applicable regulatory requirements, codes and industrial standards.
The procurement documents will identify the documentation (e.g.,
certificates of compliance) to be prepared and certif_ied by the supplier and submitted to BNW when delivery of the shipping container is completed. The supplier will be required to maintain sufficient records to verify that the Type B shipping container was fabricated in accordance with the applicable QA requirements and to support the documentation provided to BNW.
Procurement documents or attachments will contain a statement that provides BNW with the right of access to the supplier's facilities and records for source inspection and audit.
j Changes and revisions to procurement documents will be reviewed and approved by those individuals or their representative that approved the original document and that are affected by the change or revision.
IV
_ INSTRUCTIONS, PROCEDURES AND DRAWINGS Activities aifecting quality will be prescribed and accomplished in accordance with written instructions, procedures or drawings.
Examples are as follows:
training of personnel packaging radioactive material inspecting radioactive material packaging maintaining containers PNL-MA-593 5 of 8
purchasing specification containers contracting manufacturers (other than BNW) to fabricate containers.
The QA Manual outlines the sequence of actions to be accomplished in the preparation, review, approval and control of instructions, procedures and drawings.
The QA0 representative will review and concur with instructions, procedures, drawings and inspection and test instructions as required by the QA Manual and the Radioactive Materials Shipping Manual.
V DOCUMENT CONTROL The HMT0 will ensure that controlled documents are prepared, reviewed and approved for use. The HMT0 will also ensure that the documents are distributed and used by personnel where packaging and shipping activity is performed.
Changes in released documents will be included in other appropriate instructions, procedures, drawings and other documents prior to implementation of the changes.
A master list will be maintained to identify the current revision number of instructions, procedures, specifications and drawings.
The HMT0 will maintain the list and will ensure that all radioactive material shipments are conducted in accordance with the latest changes. The same organizations that performed the original review and approval will reviaw and approve all changes.
VI INSPECTION AND TEST The inspections and tests performed by BNW include inspection of procured containers upon receipt (or before packing) and pre-shipment inspection after the containers have been packed and loaded. These
- inspections and tests will be performed and documented in accordance with written and controlled procedures and instructions. Receiving inspection may be performed by an agent selected and. approved by the QA0, and pre-shipment inspection will be performed by Shipping and Radiation Monitoring personnel and the HMT0.
The HMT0 and other BNW personnel (or their agents) performing the inspections and tests will be independent from the individuals performing the activity under inspection.
Inspection, testing and operating status of empty and packaged containers will be indicated and controlled by written procedures which include the use of tags and labels.
PNL-MA-593 6 of 8
Controls to prevent bypassing of required inspections, tests and other critical op'erations are provided by the Radioactive Materials Shipping hanual. The HMT0 has cuntrol of this process by use of the "Offsite Radioactive Shipment Record", which includes documentation of the inspe.tions and tests appropriate to a shipment.
The QA0 m'aintairs awareness of L process by periodic audits of the HMT0.
VII CONTROL OF MEASURING AND TEST EOUIPMENT Measuring and test equipment used to inspect new packages on receipt and before shipment will be controlled in accordance with the BNW QA Manual and will include:
a.
Measuring and test equipment identification, and traceability to calibration records.
b.
Calibration of measuring and test equipment at specified intervals based on the purpose, degree of use, required accuracy, stability characteristics and other conditions affecting the measurement and test.
c.
Inspection evaluation to determine validity of inspections when the as-found condition of measuring and test equipment is determined to be cutside allowable tolerances.
d.
Use of standards traceable to nationally recognized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
An agent selected to perform inspections for BNW will be required to have a system of controlling measuring and test equipment equivalent to the BNW system.
VIII HANDLING, STORAGE AND SHIPPING Written procedures for handling, storing and shipping radioactive materials will be foll' awed. Shipments will not be made unti it has been determined that the container:
- 1) has a current cert'Fkate of compliance; 2) has been inspected and released; 3) has been packaged accoro Sg to written procedures, if appropriate; and 4) has packaging records comp.eted for future f~iling.
The Radioactive Material Shipping Representative from each department will perform the handling, storing and shipping operations.
Before the shipment is released, the HMT0 will make final inspection of the packaging.
The HMT0 will sign a certification indicating that to the best of his/her knowledge the shipment meets all applicable regulations.
The supervisor of the Receiving, Shipping, Traffic and Excess Section will determine the mode, routing and estimated time of arrival (ETA) and will prepare the shipping papers for delivery to the carrier.
He/She will follow PNL-MA-593 7 of 8
the progress of the shipments, expedite delaying facters, and verify that the shipments have bee: delivered to the consignee.
The HMT0 will notify the consignee by teletype.that the package has been shipped and provide an estimated time of arrival, and will request the consignee to inform BNW when a shipment is not.r ceived on the day estimated for arrival.
IX NONCONF0RMANCE AND CORRECTIVE ACTION The handling and status indication of nonconforming parts or packages and the need for corrective action will be controlled in accordance with the BNW QA Manual.
These controls will include the identification, documentation, segregation, review, disposition and notification to affected organizations of nonconforming materials, parts, components or services.
X OUALITY ASSURANCE RECORDS Records of package approval, procurement, inspections, tests, audit results, personnel training and qualifications and shipments will be ma i n::ai.aed.
These records will be identifiable and retrievable. An index of the seco.ds including storage location will be maintained by the HMT0.
XI AUDITS Periodic and scheduled audits will be performed to verify the program's effectiveness. The audits will be performed by the QA0 and other organizations that have no responsibility for the activity being audited.
The audits'will be performed using written checklists, and the findings and appropriate corrective action w.ll be documented.
Copies of the audit report will be provided to the responsible managers. Audit personnel will perform follow-up action to assure that designated corrective action has been adequately performed.
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ATTACHMENT A OUALITY ASSURANCE RESPONSIBILITIES 1.
Quality Assurance Office Issue the QA Manual (PNL-MA-65) with the approval of the Director, Laboratory Support.
Interpret QA Program intent and determine appropriate application.
Review and/or approve documents where application of QA Progrgm requirements would be appropriate.
Request and obtain access to all facilities, activities aid documentation necessary to determine compliance to the QA Program by BNW and outside organizations (including Hanford Contractors and others providing materials, items or services) or to investigate problems that may involve lack of adequate QA controls.
Request and obtain correctivelaction or stop activities not in compliance with Quality Assurance Program requirements.
Inform the Laboratory Director of quality-related problems and obtain resolution when required.
' Audit the HMT0 and other BNW organizations for compliance to the BNW QA Program (including PNL-MA-81 and PNL-MA-593).
2.
Radiological Safety and Engine'ering Section Issue and maintain Radioactive Materials Shipping Mttual (PNL-MA-81).
Assign a HMT0 with the authority to implement PNL-MA-81 and the Quality Assurance Program Description for Shipping Packages of Radioactive Material (PNL-MA-593).
Delegate to the HMT0 the authority to stop any shipment of hazardous material that does not comply with established requirements.
Audit other BNW organizations for compliance with PNL-MA-81 and PNL-MA-593.
3.
Radiation Monitoring Section Perform radiation inspections (surveys) on packed containers in accordance with the requirements of'PNL-MA-81 a:d internal procedures.
4.
Department Radiation Material Shippina Representatives Prepare radioactive material shipments in accordance with the requirements of PNL-MA-81.
PNL-FA-593 1 A of 2A
Provide training, if appropriate, of department personnel involved in radioactive material shipments.
, 5.
-Procurement Department Hold procurement requisitions until reviewed (and signed) by a QA0 representative and.the HMT0.
Obtain approval from the QA0 and the HMT0 for all changes made to procurement documents that are related to the procurement of shipping containers.
Close out procurement action only after all QA requirements have been satisfactorily accomplished.
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k ATTACHMENT 8 OVALIFICATION REQUIREMENTS FOR MANAGER, 0A0 Listed below are the minimum qualification requirements for the Manager, Quality Assurance Office.
Education BS or equivalent in science or engineering.
College or other courses in quality assurance including auditing, or certification by examination as an ASQC Certified Quality Engineer or Professional Engineer (Quality).
r Experience Five years of experience in quality assurance in a high technology industry including two years in.a management position.
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Two years of experience in a research or development position or in quality assurance for research or development projects.
One year of experience in a nuclear industry assignment that included radiation protection'and criticality considerations, or courses in nuclear engineering.
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