ML19309G836
| ML19309G836 | |
| Person / Time | |
|---|---|
| Site: | 07100384 |
| Issue date: | 04/15/1980 |
| From: | Demaria E, Killian C NORTHEAST NUCLEAR ENERGY CO. |
| To: | |
| References | |
| 16056, TSC-1, NUDOCS 8005070639 | |
| Download: ML19309G836 (21) | |
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Page of New England Nuclear Corporation 601 Treble Cove Road.
North Billerica, Massachusetts 01862 Telephone:
(617)667-9531 Quality Assurance Program In accord with 10 CFR Part 71 Appendix E i
Document Number TSC - 1 Prepared by h
C Ermes DeMaria Manager DOT Compliance Office Approved by C&
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Charles Killian Director of Environmental Control Department Copy No.
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Table of Contents Section Subject Page Title Page 1
Record of Revisions 2
Table of Contents 3
1 Introduction and Scope 4
2 Organization and Responsibility 5
3 Quality Assuance Program 8
4 Procurement Document Control 10 5
Instruction, Procedures and Drawings 11 6
Document Centrol 12 7
Control of Purchased Material 14 8
Identification and Control of Purchased 15 Containers 9
Inspection 16
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10 Handling, Storage and Shipping 17 11 Nonconforming Materials 18 12 Corrective Action 19 13 Quality Assurance Records 20 13 Audits 21
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- 1. 0 Introduction and Scope 1.1 New England Nuclear Corporation (NEN) is a manufacturer and distributor of radiochemicals, radiopharmaceuticals and radioactive sources for a broad spectrum of user applica don.
These radioactive materials are predominately shipped in small quantities as Type A packages.
On occasion a Type B quantity is shipped.
- 1. 2 It is the policy of New Eagland Nuclear Corporation that all activities which are governed by the Code of Federal Regulation, license, certification of compliance, letter of approval or other regulatory requirements, be con-ducted in accordance with written, approved procedures which incorporate the regulatory requirements in a manner which is easily understood by the user.
Quality related activities shall be performed with specified equipment and under suitable environmental conditions.
Adherence to the procedure requirements is mandatory for all New England Nuclear Corporation employees.
All procedures which are required to assure health and safety are required to be submitted to the Transporation Safety Committee for approval prior to implementation.
- 1. 3 The Quality Assurance Program describes the prima'ry policies and procedures used by New England Nuclear Corporation to control safety-related functions involved in the purchasing, handling, shipping, storing and inspection of Type B packagings for radioactive material.
All Type B containers are purchased or rented from a manufactuer or supplier of Type B containers.
New England Nuclear Corporation does not design, fabricate or modify Type B container.
The Quality Assurance criteria for these functions are delegated to the container manufacturer.
- 1. 4 The management of New England Nuclear Corporation has approved and requires adherence to the policies, procedures and objectives of this program.
- 1. 5 Revisions or additions to this program will be made as necessary to conform to current requirements.
Such revisions will be incorporated and cited on the revision page in front of the program.
Copies of this Quality Assurance Program are available to regulatory agencies, as required, and issued to each operative unit identified in the program.
Assigned copi~es of this program will have controlled distribution and documented revision.
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Orrsanization and Responsibility Document Number TSC-1 O
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- 2. 0 Organization and Responsibility 2.1 The administration of this Quality Assurance organization within New England Nuclear Corporation is vested in the Transportation Safety Committee (TSC), the members of which represent the controlling levels of mangement for each of the operative program areas.
Transporation Safety Committee members manage the following functions affected by this program.
A.
Compliance with the Department of Transporation hazardous materials regulations; B.
radiation protection; C.
quality control, Nuclides and Sources Division; D.
distribution and transportation.
Within the scope of this program, the functions of the TSC shall be directed by the Quality Assurance Program Manager.
The Quality Assurance Program Manager shall be directed by the Director of Environmental Control.
This reporting route has been selected specifically to allow the Quality Assurance P.'ogram Manager sufficient authority to implbment and direct New England Nuclear Corporation's Quality Assurance Program, to assure conformance to quality requirements and to function independent of undue influence and re-sponsibilities for schedules and cost's.
(see Figure 1-1) 2.2.1 In order to assure effective implementation, assess the scope and status and determine the effectiveness of the Quality Assurance Program, the Environmental Control Director, a member of Senior Management, has been granted broad authority to execute these functions.
These functions are executed through the use of internal audits, site investigations, customer / user service reports and internal reporting procedure.
2.2.2 The Manager of Corporate D.0.T. Compliance is responsible for corporate compliance with the Department of Transporation hazardous materials regulations is chairman of the Transportation Safety Committee and is designated as the Quality Assurance Program Manager.
2.2.3 The Director of Corporate Radiation Protection or his delegate (s) is responsible for implementing all program elements relating to purchase or rented Type B containers utilized in low level waste shipments.
2.2.4 The Product Quality Assurance Manager or his delegate (s) of the Nuclides and Sources Division is responsible for implementing all program elements relating to purchase or rented Type B containers utilized for product shipments.
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2.2.5 The Operation Manager, Corporate Distribution or his delegate (s) is responsible for compliance with the U.S. Department of Transporation hazardous material safety regulations and for assuring that all Quality Assurance controls have been performed prior to shipping and/or transporting a Type B container.
2.3 The TSC shall have the authority, specified in written procedures, to per-form the following functions effectively.
A.
identify quality problems, specify corrective action and control the disposition of nonconforming material; B.
recommend and/or approve solutions through proper channels; C.
verify implementation of corrective actions.
Differences of opinion between the TSC and other N N England Nuclear Corpora-tion departments shall be resolved by the Director of Environmental Control.
2.4 Positions descriptions of the Quality Assurance Manager and all Quality
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Assurance personnel shall include prerequisite experience and/or required training, which assures that they are competent to perform the assigned duties.
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organization and Responsibility
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Figure 1-1 President V.P. Administration Environment Control Director TRANSPORATION SAFETY COMMITTEE CORPORATE 00T COMPLIANCE MANAGER
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(Quality Assurance Program Manager)
CORPORATE QUALITY' CONTROL DEPARTMENT DISTRIBUTION AND RADIATION PROTECTION NUCLIDES & SOURCES DIVISION TRANSPORTATION OFFICE DEPARTMENT
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3.0 Quality Assurance Program The Quality Assurance Program is comprised of those planned and systematic actions necessary to assure adequate confidence that all New England Nuclear Corporation activities will be conducted in a satisfactory manner and that all equipment and material will perform satisfactorily in service.
It is the in-tent of this program to insure that all activities are conducted in a manner that has the degree of reliability on which safety and performance of these activities were evaluated.
The New England Nuclear Corporation Quality Assurance Program applies to the purchase, use, handling, storage and shpping of Type B containers.
3.1 Procedures Cross-referenced to the 18 Criteria of 10 CFR 71, Appendix E Key:
I.
Organization II.
Quality Assurance l
III.
Design Control IV.
Procurement Document Control V.
Instructions, Procedures and Drawi'ngs VI.
Document Control VII.
Control of Purchased Material, Equipment and Services VIII.
Identification and Control of Materials IX.
Control of Special Processes X.
Inspection XI.
Test Control XII.
Control of Measuring and Test Equipment XIII.
Handling, Storage and Shipping XIV.
Inspection, Test and Operating Status XV.
Nonconforming Materials, Parts or Components XVI.
Corrective Action XVII.
Quality Assurance Records XVIII.
Audits n.
Procedure Criteria Number Title Addressed TSC-1 Quality Assurance Program I - XVIII TSC-1/QA-4 Procurement Document Control IV TSC-1/QA-5 Instructions, Procedures and Drawings V
TSC-1/QA-6 Document Control VI TSC-1/QA-7 Control of Purchased Material VII
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Page of Procedure Criteria Number Title Addressed TSC-1/QA-8 Identification and Control of Materials VIII TSC-1/QA-9 Inspections X
TSC-1/QA-10 Handling, Storage and Shipping XIII TSC-1/QA-11 Nonconforming Materials XV TSC-1/QA-12 Corrective Action XVI TSC-1/QA-13 Quality Assurance Records XVII TSC-1/QA-14 Audits XVIII
Procurement Document Control
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Page of 4.0 Procurement Document Control The procurement of Type B containers is accomplished with a written Pur-chase Order.
Purchase Order forms are controlled and in the possession of a limited number of individuals.
Only these individuals are authorized to re-lease Purchase Orders, and are responsible for conforming with established pro-curement and record keeping procedures.
It is New England Nuclear Corporation's policy that procurement documents are reviewed by the cognizant department / site managers.
Where the department /
site manager or his designee determines that the procurement action is governed by on applicable standard, specification, code, regulation license or Certifi-cate of Compliance, the procurement document is submitted to Quality Assurance for review and approval.
The Quality Assurance reviewer examines the procurement document to ensure that complete information is provided to identify:
A.
the applicalbe 10 CFR Part 50, Appendix B and 10 CFR 71, Appendix E requirements which must be addressed; B.
the technical requirements including the applicable regulatory re-quirements, identification requirements, specifications, codes, and industrial standards; C.
the documentation to be prepared, maintained, and submitted to the purchaser for review and approval; D.
the procuring agency's right of access to supplier's recores for in-spection and audit; E.
quality requirements, which must be correctly stated, inspectable and controllable with adequate acceptance and rejection criteria.
The individual authorized to control and release Purchase Orders prepares the Purchase Orders, incorporating all applicable information referenced in the preceding paragraph.
One copy of all Purchase Orders is maintained in a control file.
Original and revised procurement documents shall be clearly annotated to indicate the completion of the aforementioned review and approval sequence.
Record copies shall be maintained in accordance with document control procedures in effect at time of preparation.
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Inseruction, Procedures and Drawings l
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Page of 5.0 Instructions, Procedures and Drawings Activities affecting quality are prescribed by documented instructions, procedures or drawings of a type appropriate to the circumstances.
The purpose of the instructions, procedures or drawings is to provide and communicate standards for the quality determination within New England Nuclear Corporation and are directed at maintenance of an overall quality program.
Procedures and instructions are prepared by the cognizant department.
All instructions and procedures are maintained current with a documented method of revision.
Instructions, procedures or drawings are readily available to per-sonnel at locations requiring their use.
New England Nuclear Corporation's Quality Assurance organization shail review instructions, procedures or drawings to insure that adequate quantitative and qualitative acceptance criteria are present.
Subject:
Document Control Document Number TSC-1/QA-6
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Page of 6.0 Document Control Written New England Nuclear Corporation's procedures control specifications, procedures, instruction and their respective changes to insure adequacy.
6.1 Document Types Control The control includes all documents and their changes affecting the quality program.
These documents include, but are not limited to, specifications, pro-curement documents, Quality Assurance manuals and inspections.
The control system provides adequate and timely distribution of all documents to recipients listed on a document distribution list and prompt removal of all obsolete docu-mentation from defined document control centers.
6.2 Document Review All safety related documents are reviewed and approved by New England Nuclear Corporation's Quality Assurance organization.
6.3 Document Control Execution of an effective control system requires the following:
A.
each document shall have an identifying number and a complete des-criptive title; B.
each document shall have a means for identifying the revision status and effective date of each revision; The number of copies made and issued of a document is controlled by a document distribution list maintained in the document file.
The removal of obsolete documents, procedures, details, forms etc. is accomplished immeidately when such material is made obsolete by new or revised documents.
Obsolete documents are destroyed except for a history copy maintained in the document file.
Pro-cedures and their changes are distributed on a formal basis and are of standard format.
In case of enhrgency, however, approved handwritten procedures or marked-up changes can be considered satisfactory as long as they are converted to the standard form and become official within 30 days.
6.4 Document Change Control All proposed changes are reviewed by Quality Assurance prior to approval to determine the effect of the change and the resultant changes.
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th*M Document Number TSC-1/QA-6
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Page of 6.5 Document Availability Documents will be available, prior to commencement of work, at the loca-tions where activities involving them are to be performed.
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control of Purchased Material
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7.0 Control of Purchased Material The procurement control methods tiew England tiuclear Corporation uses establishes measures to assure that procured items are clearly and adequately specified in procurement documents and supplied by vendors who are capable of producing items which consist of procedures or instructions, include provisions for vendor evaluation and review of procurement requirements.
7.1 Supplier Evaluation New England Nuclear Corporation Quality Assurance personnel participate in evaluation of procurement sources.
Recommendation of procurement sources is based on these evaluations.
Results of supplier evaluations performed prior to contract award are documented and filed.
The evaluations cover review of cap-abilities and include the following:
A.
historical performance data, particularly in product quality and delivery; B.
review and comment on supplier's Quality Assurance program.
The evaluation considerations include the, elements of the NRC Quality Assurance Criteria delegated to the supplier to the extent these criteria are applicable to the container being purchased or' rented.
- 7. 2 Receiving Inspection Receipt inspections shall be performed on rented or purchases items to assure that:
A.
material is properly identified and corresponds to the receiving documentation; B.
material is inspected and judged acceptable in accordance with speci-fied requirements prior to use; C.
inspection records attesting to the acceptance of material are avail-able and are filed in the Compliance Office; D.
items accepted and released are identified as to their inspection status prior to forwarding them to controlled storage areas or releasing them for use.
7.3 Supplier Audit Measures used for auditing suppliers are described in the Audit section of this document.
Identification and Control of Purchased
Subject:
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Page of 8.0 Identification and Control of Purchased Containers The identification and control described herein shall agply to all purchased Tvpe B containers from receipt of the container.
The inspection status of all containers shall be evident at all times.
This shall be accomplished by marking, tagging or stamping.
Identification of containers with an identifying number shall be accom-plished with a method that will provide legible identification as permanent as the normal life expectancy of the item marked, without adverse effect on its life and utility.
Containers not suitable for individual marking shall be individually tagged.
The storage area shall contain only containers which have been inspected and accepted.
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Page of 9.0 Inspection The established inspection program and New England Nuclear Corporation verifies the performance of quality related activities with the applicable requirements.
The verification is performed in accordance with writtin in-spection procedures.
The inspection program also provides for identification and documentation of deficiencies discovered during inspection and the required corrective action.
9.1 Inspection Procedures Inspectiori procedures and instructions are written documents which provide the following information:
A.
identification of activities to be inspected; B.
identification of the individual responsible for performing the in-spection; C.
acceptance and rejection criteria; D.
a description of the inspection method; E.
recording evidence of completing and verifying an operation; F.
recording inspector or data recorder and the results of the in-spection operation.
Inspection procedures and/or inttructions are maintained current by established document control measures.
Subject:
Handlinz.storace and shippinz S" "t Document Number TSC-1/QA-10 1,, "M i 9
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10.0 Handling, Storage and Shipping Quo'ity Assurance requirements for the packaging, handling, storage and shipping shall be documented.
Prior to the shipment and/or transporation of a container, all conditions of the Quality Assurance Program shall be satisfied, and the shipment is pro-perly described and the container properly marked and labeled according to the applicable regulations of the Department of Transportation.
SubisctNonconfornina Materials II'r)<C.)3 r
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Page of 11.0 Nonconforming Materials Procedures for control of nonccaforming materials assure that such mat-erials are adequately identified and segregated from acceptable materials to preclude their inadvertent use.
11.1 Nonconformance Disposition The Quality Assurance personnel shall have the responsibility and authority for the disposition of nonconforming item.
11.2 Assessment of Nonconformance Nonconformance instances shall be analyzed periodically to show quality trends of a manufacturer or supplier.
Instances of nonconformance shall be documented and retained in the procurement documents.
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l 12.0 Corrective Action flew England tiuclear Corporation Quality Assurance personnel shall evaluate conditions adverse to quality standards to determine thc need for corrective action.
Corrective action shall be promptly initiated when it is determined l
that the condition is due to an assignable cause and is repetitive in nature.
The corrective action procedure is divided into five basic steps:
)
A.
invastigate the condition; B.
determine the cause; C.
define the corrective action;-
D.
implement corrective action; E.
evaluate the corrective action.
Specific individuals from appropriate departments shall be assigned the rasponsi-bility of accomplishing each of the phases.
The results of each phase shall be documented and become part of the corrective action.
Quality Assurance shall review records to verify proper implementation of corrective action.
The cor-rective action documentation shall not be closed out until results of the cor-rective action have been evaluated and approved by Quality Assurance.
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Page of 13.0 Quality Assurance Records 13.1 Maintenance and Access to Records The records system maintained by New England Nuclear Corporation includes the reten' ion of those procurement, inspection and nonconformance records essen-tial to demonstrate container quality.
All records are maintained according to established procedure and will be identifiable and retrievable.
13.2 Contents of Record Files It is the policy of the Quality Assurance organization that adequate records be maintained of all procurement, nonconformance and inspection.
Inspection shall contain the following when applicable:
A.
a description of the type of observation; B.
evidence of completing and verifying the inspection operation;
(
C.
the date and results of the inspection; D.
information related to conditions adverse to, quality; E.
inspector or data recorder identification; F.
evidence as to the acceptability of the results; G.
identification of the procedure (s) used.
Records shall also be maintained of suppliers Quality Assurance programs and documents pertaining to New England Nuclear Corporation's internal Quality j
Assurance audits.
File of personnel qualifications and training shall also be maintained.
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14.0 Audits Planned audits shall be performed to provide comprehensive, independent verfication and evaluation of the New England Nuclear Corporation Quality Assurance Program and that the supplier has an NRC approved Quality Assurance Program.
The audit scope shall encompass evaluatic of quality system prac-tices and/or procedures and the effectiveness of their implementation, monitor-ing of operations and activities and a review of pertinent documents and their control and maintenance.
Audit checklists shall be established prior to con-ducting an audit.
14.1 Audit Schedule Internal audits shall normally be conducted once every twelve months.
How-ever, unscheduled audits may be performed more frequently in specific areas, when the need is indicated by the existence of chronic problems.
All audits shall be performed on a random unannounced basis to assure optimum effectiveness and I
a prompt disclosure of deficiencies.
14.2 Audit Personnel Audits shall be performed by the Director for Environmental Contrl and an outside consultant with no direct lin'e responsibility for the function audited.
The outside consultant shall have the required level of technical capability to accomplish the audit functions satisfactorily and to conform to the requirements.
14.3 Audit Reports A verbal presentation of the findings and conclusions of the audit is made to the Transportation Safety Committee.
Recommendations for quality related improvement are presented as well.
A writeen report containing the findings and recommendations reviewed in the verbal report is prepared and distributed to the responsible management personnel affected by the audic findings.
Audits shall include an assessment as to how well the Quality Assurance Program meets regulatory or other requirements.
14.4 Audit Follow-up The originator of'an audit report or a designated alternate is required to follow an open item until action is taken to satisfy an audit action item.
Records of actions taken to achieve resolution are maintained.
Follow-up actions are taken to verify corrective action is effective.
Responsible Quality Assur-ance personnel shall evaluate each audit report item and corrective deficiencies as promptly as possible after they are revealed.
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