ML19350C300
| ML19350C300 | |
| Person / Time | |
|---|---|
| Site: | Wood River Junction |
| Issue date: | 12/12/1980 |
| From: | UNC RECOVERY SYSTEMS, UNITED NUCLEAR CORP. (SUBS. OF UNC, INC.) |
| To: | |
| Shared Package | |
| ML19350C297 | List: |
| References | |
| QAP-004, QAP-4, NUDOCS 8103310886 | |
| Download: ML19350C300 (13) | |
Text
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GUALITY ASSURANCE PROGRAM
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UNITED NUCLEAR CORPORATION UNO RECOVERY SYSTEMS QUALITY ASSURANCE PROGRAM FOR PREPAPATION AND SHIPPING OF LSA RADIOACTIVE MATERIALS l
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ISA MOICimVE FlCOUAIS O AP. 004 f,, f g TABLE OF CONTENTS 1.0 Purpose 2.0 Scope 3.0 Organization 4.0 Quality Assurance Program 5.0 Design Control 6.0 Procurement Control 7.0 Instructions, Procedures, and Drawings 8.0 Document Control 9.0 Control of Purchased LSA Shipping Containers 10.0 Identification and Control of LSA Shipping Containers 11.0 Control of Packaging and Shipr.ent Processes 12.0 Inspection 13.0 Test Control 14.0 Control of Measuring and Test Equipment i
15.0 Handling, Storage and Shipping 16.0 Inspection, Test and Operating Status 17.0 Nonconforming Items 18.0 Corrective Action 19.0 Quality Assurance Records 20.0 Audits 87
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1.0 Purpose This document describes the quality assurance program of UNC Recovery Systems (UNC-RS) for the preparation and shipping of Low specific activity (LSA) radioactive materials.
This program has the objective of assuring that the packaging and shipment of materials are performed in a manner that complies with all applicable regulations and assures that they arrive at their destinction in an acceptable form.
2._0 Scope The application of this program is limited to LSA radioactive materials, and has been prepared using Appendix E to 10 CFR 71 as a guide.
Shipping of.other radioactivo materials is governed by QAP-001 which was approved by the NaC as required by 10 CPR 71.5'l.
3.0 Organization 3.1 Corporate organization UNC's management structure for shipment of radioactive material begins at the division level, and, therefore, no corporate organization is presented.
The General Manager is responsible for all activities at UNC-RS.
3.2 Site Organization The General Manager.for UNC-RS is responsible for the overall management of the plant.
The Plant Manager reports directly to the General Manager and is responsible for the day to day operation of the plant.
The Manager, Quality Assurance (QA) reports directly to the Plant Manager and is responsible for the planning, administration, and con-trol of quality assurance programs for UNC-RS.
He has the responsibility and authority, delineated in writing, to stop work in any aspect of the operation which is not in compliance with the Quality Assurance Program.
A chart depicting the organization structure for UNC-RS, designed specifically to identify the units which have responsibilities associated with this quality assurance program, is shown in Figure 1.1.
This organization structure provides the separation of functions and inde-pendence of actions necessary for proper quality assurance.
Fion e 1.2 describes the functions normally performed by each operational unit, r31ative to this QA Program.
Although aspects of this program may be delegated to other organizations or individuals, UNC-RS retains and exerciscs overall responsibility.
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4.0 Quality Assurance Program Quality Assurance comprises all necessary actions to provide adequate confidence that preparation and shipment of LSA materials meets all applicable regulatory requiiements.
h 4.1 OA Manual Control Any QA manuals prepared in support of this QA Program will have controlled distribution.
Revirions thereto will similarly be controlled.
4.2 OA Program Implementation Provisions are established for communicating to all responsible organizations and individuals that quality policies, CA manuals, and procedures are mandatory requirements which must be implemented and enforced.
4.3 QA Program Applicability This program is applicable to all LSA radioactive material shipments.
4.4 Resolution of Disputes Disputes involving quality, arising from a difference of opinion between QA personnel and other departments shall be resolved in su'ch a manner as to assure compliance with safety and regulatory requirements.
4.5 Indoctrination and Training Personnel performing quality-related activities are g
provided with indoctrination and training'to the degree l
necessary to assure an adequate level of knowledge and l
proficiency.
When deemed necessary, such personnel are l
. retrained in those activities wherein weakness.has been,
detected.
i 5.0 Design' Control
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Regulations require that LSA materials be shipped in strong, tight packages.
UNC-RS utilizes DOT 17H containers (55 gallon drums), which do not involve any design activities.
In addition, i
UNC, utilizes boxes / crates which are designed and fabricated to maintain their integrity.throughout the shipping process.
Quality Assurance reviews-the box / crate designs to assure that I
they provide assurance that the regulatory shipping requirements will be met.
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y 6.0 Procurecent Control UNC-RS utilizes procedures which assure that shipping ~ containers are not procured without Quality Assurance review and input of quality requirements.
Quality Assurance inputs, as a minimum, the information necessary to assure that applicable regulatory requirements are imposed upon the supplier.
Changes and revisions to procure =ent documents are subject to at least the sa:e review and approval as the original document.
7.0 ' Instructions, Procedures, and Drawings UNC-RS utilizes formal systems of operating procedures and quality procedures to assure that packaging and shipping of LSA caterials are performed and inspected in co=pliance with regulatory require-ments.
These procedures are prepared, reviewed, and controlled by clearly defir.ed action sequences.
Quality Assurance reviews and approves all such procedures.
8.0 Document Control UNC-RS controls documents in the following manner:
8.1 Document Adecuacy The review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
8.2 Change Review and Implementation Changes to' documents are reviewed and approved by the same organizations that performed the original review and approval or by other qualified responsible organizations delegated by UNC-RS.
Approved changes are issued prior to implementation of the change.
S.3 ' Document Availability Documents are available in the area where the activity will be_ performed prior to commencing the work.
8.4 Document Master Lists A master list, or equivalent, is established to identify the current revision nurbar of documents.
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This system provides for inspection of incoming containers for compliance with purchase order requirements, and for identification, segregation, and Quality Assurance disposition of rejected items.
Provision is also made in written procedures for evaluation and auditing of shipping container suppliers.
10.0 Identification and Control of LSA Shipping Containers Procedures are utilized to uniquely identify each loaded LSA shipping container in a manner such that the container and its contents are traceable to the container preparation, inspection, and shipping records.
11.0 Control of Packaging and Shipment Processes The processes utilized for packaging and shipment of LSA materials are procedurally controlled.
Personnel performing those activities are trained in the utilization of the processes.
12.0 Inspection UNC-RS utilizes the following inspection controls for the packaging and shipment of LSA materials:
12.1 Inspection Procedures An inspection program which verifies conformance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written and controlled procedures.
These procedures provide for in-process verification of acceptability to Quality Assurance designated attributes, with sample over-inspection by Quality Assurance personnel.
As a minimum, procedures provide for inspection of shipping containers, materials being shipped, completed containers, and shipping vehicles.
Complete Quality Assurance inspection is required for key attributes /activitie's as defined'by Quality Assurance.
12.2 Inspection Personnel Quality Assurance inspection personnel are independent from the individuals performing the activity being inspected.
12.3 Inspection of Modifications, Repai ry, and Replacements Modifications, repairs, and replacements are inspected in accordance with the original design and inspection require-
~ments or acceptable alternatives.
12.4 Inspection Hold Points Provisions are established that identify mandatory inspection hold points for witness by an inspector.
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13.0 Test Control When testing is utilized to verify packaging and shipment acceptability, UNC-RS provides the following test controls:
13.1 Test _ Procedures Testing is performed in accordance with written, controlled procedures.
13.2 Testing of Modifications, Repairs, and Replacements Modifications, repairs, and replacements are tested in accordance with the original design and testing require-ments or acceptable alternatives.
13.3 Tes't Results Test results are documented, evaluated, and their acceptability determined by a trained, responsible individual or group.
14.0 Control of Measuring and Test Equipment When measurement and testing of shipping packages by UNC-RS is performed, the following controls are utilized:
14.1 Calibration Measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the mdasurement.
14.2 Identification and Traceability Measuring and test equipment is identified and traceable to the calibration test data.
14.3 Validity of Previous Inspections Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
Where possible, those items will be held until they are demonstrated to be acceptable.
14.4 Standards Reference and transfer standards are traceable to nationally recognized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
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15.0 Handling, Storage, and Shipping UNC-RS provides the following controls to the degree determined to be necessary and applicable.
15.1 Work and Inspection Instructions Special handling, preservation, storage, cleaning, packaging, and shipping requirements are established and accomplished by trained individuals in accordance
.with predetermined work and inspection instructions.
15.2 Regulatory Conditions All regulatory requirements (state, NRC, DOT, burial site) are satisfied prior to shipment.
Internal controls placed on the preparation and packaging of materials for shipment are designed to ensure maintained compliance during transport through receipt of the shipment at its final destination.
15.3 Shipping Papers All necessary shipping papers are prepared.
16.0 Inspection, Test, and Operating Status When applicable, UNC-RS. implements the following controls:
16.1 Identification of Status The inspection,. test, and operating status of packages and shipments can be readily ascertained by affected organizations.
16.2 Control of Status Indicators The application and removal of inspection and status indicators such as tags, markings, labels, and stamps are procedurally controlled.
16.3 Control of Operational Bypasses Bypassing of required inspections, tests, and other critical operations is procedurally controlled.
16.4 Status of Unacceptable Packages The status of nonconforming packages is identified to prevent inadvertent use.
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l 1"7. 0 ' Nonconforming Items UNC-RS controls nonconforming items by techniqu_; suitable for assuring that they are not utilized until their acceptability is established and documented.
Where applicable, such techniques will include the following elements.-
17.1 Procedural Controls The identification, documentation, segregation, review disposition, and notification to affected organizations of nonconforming items are procedurally controlled.
17.2 Documentation Documentation identifies the. nonconforming item; describes the nonconformance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.
17.3 Identification Nonconforming items are clearly identified as discrepant until properly dispositioned.
17.4 Acceptance of Rework and Repair Acceptability of rework or repair of nonconforming items is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and testing method.
18.0 Corrective Action When appropriate to the circumstances, UNC-RS* takes the following steps relative to corrective action:
18.1 Corrective Action Evaluation Evaluation of conditions adverse to quality (such as
,nonconformances, failures, malfunctions, deficiencies, deviations, and defective material and equipment) is conducted to determine the need for corrective action.
18.2 Initiation of Corrective Action-Corrective action to protect 'against~ recurrence is initiated following the determination of'a condition adverse to quality and the need for'such action.
18.3 Follow-up Reviews Follow-up reviews are conducted to verify proper imple-mentation of corrective ~ actions and to closeout the corrective action documentation.
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. OT3C v/,,4 19.0 Quality Assurance Records Appropriate records are kept by UNC-RS, as required elsewhere by this program and by regulations, and maintained in a manner consistent with applicable regulatory requirements.
Sufficient records are maintained to provide documentary evidence of the quality and safety of items and the activities affecting quality and safety.
When applicable, the following records and controls will be utilized.
19.1 Types of Records QA records include operating checklists; results of reviews, inspections, tests, audits, and material analyses; qualification of personnel, procedures, and equipment; and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and corrective action reports.
19.2 Records Control and Retention A list of the required records and their storage locations is maintained.
The records will be identifiable and retrievable.
All records are maintained for a minimum of two years, unless otherwise provided for in the regulations.
19.3 Contents of Inspection and Test Records Inspection and test records contain the following where applicable:
a (1)
A description of the type of observation.
(2)
Evidence of completing and verifying a manufacturing, inspection, or test operation.
(3)
The date and results of the inspection or-test.
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Information related to conditions adverse to quality.
(S)
Inspector or data recorder identification.
(6) -Evidence as to the acceptability of the results.
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20.0 Audits Audits will be carried out by UNC-RS to verify compliance with all aspects of this Quality Assuranc6 Program and to determine the effectiveness of the program.
Elements of these audits include the following:
20.1 Audit Performance
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Audits are performed in accordance with pre-established written procedures or checklists and conducted by personnel not having direct responsibilities in the areas being audited.
20.2 Documentation, Review, and Corrective Action Audit results are occumented and then reviewed with management having responsibility in the area audited.
Responsible management then takes the necessary action to correct the deficiencies revealed by the audit.
20.3 Reauditing_
Deficient areas are reaudited on a timely basis to verify implementation of corrective actions which minimize recurrence of-deficiencies.
20.4 Audit Frequency Audits of the QA program are performed at least annually based on the safety significance of the activity being audited.-
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General Manager Plant Manager I
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- Manager, Manager,
- Manager, Nuclear Finance &
Quality Operations and Adminis-Assurance Industrial tration Safety Purchasing
_ Quality Control Nuclear Material Control m
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1.
General Manager Responsible for -overall managenept of UNC-RS.
2.
Plant Manager Responsible for the day to day operation of the plant.
4 3.
Finance and Administration Responsible for purchasing and procurement of shipping containers and shipping services.
4.
Manager, Quality Assurance Responsible for overall planning, administration, and control of the Shipping Quality Assurance Program.
5.
Quality Control i
Responsible, when applicable, for training, documentation and document control, control of purchased materials, parts and components, identification, control of special processes, inspection, test control, measuring and test equipment control, status control, control of non-conforming items, corrective action programs, quality assurance records, and audits.
6.
Nuclear Material Control Responsible for shipping document preparation and control.
7.
Nuclear and Industrial-Safety Responsible for safety analyses and inspection and preparation for shipment.
8.
Operations Responsible for handling and storage of shipping containers and components, repair and rework of shipping containers, in-process quality verification, and preparation for shipment.
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