ML19209C371
| ML19209C371 | |
| Person / Time | |
|---|---|
| Site: | 07100231 |
| Issue date: | 09/06/1979 |
| From: | CHEM-NUCLEAR SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML19209C369 | List: |
| References | |
| NUDOCS 7910150178 | |
| Download: ML19209C371 (55) | |
Text
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QUALITY ASSURAllCE PROGRAi1 L
CHEM-NUCLEAR 5-YSTEMS, INC.
11'.6 152 y 91015 0 \\73
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"The Leader in Nuclear Waste Management and Support Services"
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SYSTEMS INC.
NUCLEAR AND INDUSTRIAL WASTE SERVICES Project management, system operation, cask and transportation systems and compliance assurance services.
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, ~ _u WASTE SOLIDIFICATION AND/OR REMOVAL PROJECTS, complete project management, necessary component design and equipment selection including total operating, health physic: shielding and trans-portation support.
MOBILE PROCESSING AND SOLIDIFICATION of waste sturry is available from Chem-Nuclear Systems.This service is fiexible and readily adapted to customer r equirements.
MOBILE DEMINERALIZATION AND ION EXCHANGE for emergency service, as well as fixed in-plant systems.
CASK, CONTAINER AND TRANSPORTATION VEHICLE design and fabrication is supplied by Chem-Nuclear Systems. Experience with steel fabrication and lead application is integrated with Chem-Nuclear's de-sign, cperating and handling capabilities with casks, containers, shio-ping vehicles and disposal operations.
COMPLIANCE ASSURANCE through programmatic review and audits.
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CNS1 provides licensing assistance, health physics, emeroency plan-ning, e 1vironmental and third party quality assurance services.
11'6 153
CHEM-NUCLEAR SYSTEMS INC.
'C; P.O. Box 1866
- Bellevue, Washicgton 98009 e (206) 827-0711 QUALITY ASSURANCE PROGRAM t\\
Prepared by:
Man er, Quality Assurance Approved b
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Eirsctor of Re.guh tory Affairs f
Approved by: -
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Pr'esidentfC;NS Assigned to:
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PAGE REVISION STATUS Page Rev.
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DOCUMENT REV.
SHCET QA-AD-001 A
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CNSC 10018-78
3 r-REVISIONS
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Description of Revision Rev. A Revised per Change Request QA-AD-001-01 (Approved by CNSI Safety Review Board 8/30/79)
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Date 6
-6 156 Approved by'
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J CNSC 1002;8 78
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3 TABLE OF CONTENTS Page TITLE PAGE PAGE REVISION STATUS I
REVISIONS II TABLE OF CONTEMTS III FOREWORD VII 1.0 ORGANIZATION 1-1 2.0 QUALITY ASSURANCE PROGRAM 2-1 2.1 Management 2-1 2.2 Personnel Qualifications 2-1 9
2.3 Quality Assurance Policies, Goals and Objectives 2-2 2.4 Quality Assurance Manual Distribution 2-2
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2.5 CNSI Procedure List 2-2 3.0 DESIGN CONTROL 3-1 4.0 PROCUREMENT DOCUMENT CONTROL 4-1 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 5-1 6.0 DOCUMENT CONTROL 6-1 6.1 Document Types Controlled 6-1 6.2 Document Review 6-1 6.3 Document Control 6-1 6.4 Document Change Control (Excluding Drawings) 6-2 6.5 Drawing Control 6-3 6.6 Document Control for Suppliers t
6-3 6.7 Document Availability 6-4 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT.CD SERVICES 7-1 7.1 Supplier Evaluation 7-1 oOCUMENT R E V-SHEET QA-AD-001 A
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CNSQ 100L 8-78
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,3 TABLE OF CONTENTS, cont.
(j Page 7.2 Procurement Requirements 7-1 7.3 Supplier Surveillance 7-2 7.4 Receiving Inspection 7-3 7.5 Supplier Audit 7-3 8.0 IDENTIFICATION AND CONTROL OF CCMPONENTS AND MATERIALS 8-1 8.1 Ccmponents and Materials 8-1 8.2 Bulk Raw Material 8-1 9.0 CONTROL OF SPECIAL PROCESSES 9-1 9.1 Personnel Certification 9-1 9.2 Subcontractor Control 9-1 9.3 Procedures 9-2 10.0 INS?ECTION 10-1
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10.1 Inspection Procedures 10-1 10.2 Supplier Inspection 10-2 10.3 Indirect Control 10-2 11.0 TEST CONTROL 11-1 12.1 Test Procedures 11-1 11.4 Test Records 11-1 11.3 Test Control for Procured Items 11-2 11.4 Modifications, Repairs and Replacements 11-2 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12-1 12.1 CNSI's Equipment Calibration and Control 12-1 12.2 Measuring and Test Equipment at Subcontractors 12-1 12.3 Inspection Validity 12-2 11'6 158 DOCUM ENT REV.
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TABLE OF CONTENTS, cont.
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Page 13.0 HANDLING, STORAGE AND SHIPPING 13-1 13.1 Procured Items 13-1 13.2 Transport Casks 13-1 14.0 INSPECTION, TEST AND OPERATING STATUS 14-1 14.1 Equipment Status 14-1 14.2 Establishment of Examinations and Tests 14-1 14.3 Hold Points 14-1 14.4 Check Lists of Examinations, Tests and Inspections 14-2 14.5 Examination or Process Status 14-2 14.6 Inspection Status 14-2 14.7 Control of Inspection Stamps 14-2 15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS 15-1
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15.1 Internal Nonconformances 15-1 j
15.2 Subcontractor Control 15-1 15.3 Verification of Rework or Repair Acceptability 15-2 15.4 Nonconformance Disposition 15-2 15.5 Assessment of Nonconformances 15-2 l
16.0 CCRRECTIVE ACTION 16-1 17.0 QUALITY ASSURANCE RECORDS 17-1 17.1 Maintenanca and Access to Records 17-1 17.2 Contents of Record Files 17-1 17.3 Permanent Records 17-2 17.4 Non-Pe rmanent Records 17-2 17.5 Record Storage Facilities 17-2 11'6 159 DOCUMENT REV.
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TABLE OF CONTENTS, cont.
Page 18.0 AUDITS 18-1 18.1 Audit Schedule 18-1 18.2 Audit Personnel 18-1 18.3 Audit Reports 18-1 18.4 Audit Follow-Up 18-2 O
11'6 160 DOCUMENT REV-SHEET QA-AD-001 A
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CNSC 1002/9 78
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FOREWORD This program defines and describes the basic policies and procedures used by Chem-Suclear Systems, Inc. (CNSI) to establish quality assurance re-quirements for all activities af fecting safety-related functions of systems and components, including transport casks, of CNSI. The activities include designing, purchasing, fabricating, handling, shipping, storing, inspecting, testing, operating and using, maintaining, repairing and modifying.
Chem-Nuclear Systems, Inc. top management has approved and fully supports ad-herence to the policies and procedures contained in this program.
It is intended that policies and procedures described in this program meet or exceed the appropriate requirements of ASME Boiler and Pressure Vessel Code Section VIII, ANSI N45.2-1977, 10CFR50 Appendix B, 10CFR71 Appendix E and MIL-Q-9858A.
This program, in full or in part, is subject to review and comment by customer representatives.
Revisions or additions to the prcgram will be made as necessary to con-form to the current needs of the company. All revisions will be dated and referenced on the revision page in front of the program.
Copies of the Quality Assurance Program will be issued to the customer and government representatives, as required. Assigned copies of this oro-gram will be serialized and a record maintained showing the transmittal of each revision.
Information copies of the program may be distributed without serialization and they will not be updated with revisions.
This program is reviewed in total by CNSI's management at least once a year to assure conformance to current practices and requirements.
The Quality Assurance (QA) Program for CNSI was established and imple-mented by the President of CNSI.
The Q.A. Program has the full support of CNSI's management and all CNSI's employees shall adhere to its provisions.
11'6 161 DOCUMENT REV.
SHEET QA-AD-001 VII j
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r-3 1.0 ORGANIZATION
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The Quality Assurance organization within Chem-Nuclear Systems. Inc., con-sists of a Quality Assurance Manager with the overall responsibility for pro-viding quality assurance of design, fabrication and operation.
He has a staff of quality assurance personnel reporting to him, who are assigned to the following areas:
A.
Vendor inspection B.
Engineering / Fabrication C'.
Field Operations D.
Barnwell operations The individual assigned to vendor inspection is responsible for quality assurance activities to assure CNSI that all vendor and/or subcontractor activities are conducted in accordance with a written program that addresses the applicable criteria of CNSI's Quality Assurance Program.
Quality assurance for engineering / fabrication is responsible for
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verifying that all equipment has been designed, fabricated and tested in accordance with established CNSI procedures.
Quality assurance for field operations has the responsibility for audit performance of all CNSI field operations. Audits include verification of field unit operation in accordance with prescribed procedures and instructions.
The individual assigned to the Barnwell site is responsible for monitoring all quality-related activities. Special emphasis is placed on assuring that the operation (use), maintenance and performance of applicable quality control checks oa casks licensed per 10CFR71 are conducted in accordance with written procedures.
He also has the responsibility for monitoring the rolling stock maintenance and health physics activities performed at Barnwell.
All quality assurance personnel report directly to the Quality Assurance Manager.
The Quality Assurance >bnager reports to the Director of Regulatory Affairs of Chem-Nuclear Systems, Inc. (see Figure 1-1).
DOCUMENT R EV-SHEET QA-AD-001 A
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This reporting rouce has been selected specifically to allow the Quality Assurance Manager sufficient authority and autonomy to implement and
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direct CNSl's Quality Assurance program, to assure conformance to quality requirements, and to function independent of undue influences and responsibilities for schedules and costs (see Figure 1-2).
Quality Assurance personnel shall have the responsibility and authority, specified in written procedures, to perform the following functions effectively and without hindrance or reservation:
a.
Identify quality problems, stop unsatisfactory work, and control further processing, delivery or installation of nonconforming material; b.
Recommend and/or approve solutions through proper channels; c.
Verify implementation of solutions.
Position descriptions of the Quality Assurance Manager and all Quality Assurance personnel shall include prerequisite experience and/or required training, which assures that they are competent to perform the assigned duties. Qualifications for the position of Quality Assurance Manager are as follow:
a.
A bachelor's degree in a technical field; b.
At least ten years of experience in engineering or manufacturing; c.
A working knowledge of applicable quality-related codes, standards, regulatory and statutory requirements; d.
The ability to prescribe, apply and assess compliance with applicable requirements.
While other organizations may be delegated the tasks of establishment and execution of a quality assurance program, it must be recognized that tha responsibility for equipment owned and operated by CNSI is retained by CNSI.
The Quality Assurance Manager, upon notification of need for further direction or resolution of Q. A. problems, has the authority to communicate or direct coamunications with any contractor doing business with CNSI.
Ordinarily, such communications will be through the branch of CNSI having responsibility for the function provided by the contractor involved.
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3 2.0 QUALITY ASSURANCE PROGRAM The Quality Assurance Program is comprised of those planned and systematic actions necessary to assure adequate confidence that all Chem-Nuclear activi-ties will be conducted in a satisfactory manner and that all equipment and material will perform satisfactorily in service.
It is the intent of this program to insure that all activities are conducted in a manner that has the degree of reliabill:7 on which safety and perfor=ance of these activities were evaluated. The CNSI Quality Assurance Program applies to the design, manuf acture and operation of casks, liners, mobile solidification units, demineralization units and decontamination units and the operation of trans-portation trailers.
2,1 Management In order to assuce effective implementation, assess the scope and status, and determine the effectiveness of the Q. A. Program, the President of Chem-Nuclear has appointed a member of Senior Management, with broad authority, to execute these functions. Programmntically, these functions are executed through the use of internal audits, field investigations, customer / user service reports and internal reporting procedure.
2.2 Personnel Qualifications The personnel assigned to perform quality assurance functions are trained and qualified to perform those functions in accordance with ANSI N45.2.6, JRC Regulatory Guide 1.58, ANSI N45.2.12 and other applicable documents.
Further, an indoctrination and training pro-gram is established such that:
a.
Personnel responsible for performing quality-related activities are instructed as to the purpose, scope and implementation of qut411ty-related manuals, instructions and procedures; b.
Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed;
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The scope, objective and the method of implementing the indoc-c.
trination and training program are documented; d.
Proficiency of personnel performing quality-affecting activities is maintained by retraining, re-examining and/or recertifying.
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2-1 QA-AD-001 CNbQ 10018 78
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2.3 Quality Assurance Policies, Goals and Obj ectives It is the policy of Chem-Nuclear that all activities which are governed
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by the Code of Federal Regulation, license, Certification of Compliance, Letter of Approval or other regulatory requirements, be conducted in accordance with written, approved procedures which incorporate the regulatory requirements in a manner which is easily understood by the user / operator. Quality-related activities shall be performed with specified equipment and under suitable environmental conditions, and prerequisites shall be satisfied prior to inspection and test.
Adherence to the procedure requirements is mandatory for all Chem-Nuclear employees. All procedures which are required to assure health and safety are required to be submitted to the Safety Review Board for approval prior to implementation.
It is the stat 2d goal and objective of the Chem-Nuclear Q,uality Assurance Program to provide those nechanisms and environments necessary to achieve a reliable Quality Assurance Program for all activities which affect health and safety or are specified by a regulatory re-
- Q quirement. This goal and objective is promulgated throughout the company through the use of written procedures, management memoranda and management / staff meetings.
Differences of opinion between QA personnel and other CNSI depart-ments shall be resolved in a meeting of the Safety Review Board.
2.4 Quality Assurance Manual Distribution Measures to control the distribution of the Quality Assurance Manual and revisions thereto are described in Section 6 of this document.
2.5 piSI Procedure List Sble 2-1 provides a su= mary listing of written CNSI procedures cross-referenced to tne 18 criteria of 10CFR 71, Appendix E and 10CFR50, Appendix 3.
11'6 167 oOCUMENT REV.
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TABLE 2-1
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CNSI PROCEDURES CROSS-REFERENCED TO THE 18 CRITERIA 0F 10CFR 71, APPENDIX E
& 10CFR 50, APPENDIX B Key:
I.
0 aani:stion II.
Quality Assurance Program III. Design Control IV.
Procurement Document Control V.
Instructions, Procedures and Drawings VI.
Document Control VII. Control of Purchased Material, Equipment, and Services VIII.
Identificction and Control of Materials IX.
Control of Special Processes X.
Inspection
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Test Control XII. Control of Measuring and Test Equipment XIII. Handling, Storage and Shipping XIV.
Inspection, Test, and Operating Status g'
XV.
Nonconforming Materials, Parts, or Components XVI.
Corrective Action XVII. Quality Assurance Records XVIII. Audits CNSI Procedure Title Criteria Number Addressed CN-AD-001 Safety Review Board II CN-AD-002 Document Storage and Control VI, XVII CN-AD-003 Procedure for Document Preparation IV CN-AD-004 Defect Reporting Procedure XV CN-AD-005 Incident Reporting Procedure XV, XVI CN-AD-006 Radioactive.'uterial License State of South n.a.
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Carolina CN-AD-007 Purchasing Procedures and Cuidelines VII, IV CN-AD-008 Quality Assurance Records XVII CN-AD-009 Packaging, Shipping, Receiving, Storage XIII and Handling Procedure oOCUMENT REV.
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y TABLE 2-1 (CONT'D)
T CNSI Criteria Procedure Title Number Addressed CN-AD-010 Control of Special Processes IX CN-AD-Oll Control of Measuring and Test Equipment XII CN-AD-012 Training and Indoctrination Program II CN-AD-013 Test Control XI CN-AD-014 Internal Audit Procedure XVIII, I CN-AD-015 Procedure for Control of Nonconforming Items XV CN-AD-016 Corrective Action Procedure XVI CN-AD-017 Approved Vendor List IV, VII CN-AD-018 Inspection Program X
CN-EM-001 Emergency Notification Procedure n.a.
CN-Qi Oui Instructions for Nonconfor=ance Report XV, XVI CN-QI-t02 Instructions for Inspection / Rejection Report VII, XV, XVI DC-OP-001 Operating Procedure Electro-Con Decontamination V,
Systems
~N EN-AD-001 Drawing Control Procedure III, VI EN-AD-002 Design Control Program
- III, EN-AD-003 Engineering Drafting Standards III, V EN-0P-001 Crimp-A-Cap Lid Crimper Installation V
Operation, and Maintenance Manual 3C-MF-001 Glass Inspection Procedure V
HC-MF-002 Grounding Procedure V
HC-MF-003 Glass Hand Polishing Procedure V
HC-MF-004 Band Frame Disassembly Procedure V
HC-MF-006 Handling, Rigging, Packing and Shipping XIII Procedure HC-MF-00 7 Radioactive Contamination Control Procedure V
QA-AD-001 Quality Assurance Program I -- XVIII QA-AD-002 Field Audit Procedure XVIII I
QA-AD 003 Procurement Docume.
- RevV7g 6y Quality IV Assurance QA-AD-004 Supplier Surveill,->s VII QA-AD-005 Supplier Survey
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VII QA-AD-006 Supplier Furnishes Records VII, VI, IX, XII QA-AD-007 Supplier Audit Procedure VII, XVIII
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3 TA ELE 2-1 (CONT'D)
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- P-31 Procedure Title Number Addressed RP-AD-001 Radiation Exposure Reco.-ds and Procedures XVII SD-AD-001 Topical Report CNSI Radwaste Solidification V
System SD-0P-001 Operating Procedure for CNSI Solidification V
System Units 7 through 13 TR-EM-001 Transportation Emergency Plan XIII TR-OP-001 Handling Procedure for CNSI Transport Cask XIII Number 6-101 TR-0P-002 Handling Procedure for CNSI Transpot. Cask XIII Number 4-45 TR-OP-003 Handling' Procedure for CNSI Transport Cask XIII Number 8-120 (LL-50-100)
TR-OP-004 Handling Procedure for CNSI Transport Cask XIII Number 4-85 (6244)
TR-0P-005 Handling Procedure for CNSI Transport Cask XIII Number 7-100 TR-OP-006 Handling Procedure for CNSI Transport Cask XIII Number 14-190 (BC 48-220)
TR-0P-007 Handling Procedure for CNSI Transport Cask XIII Number 6-75 (AL-33-90)
TR-OP-008 Handling Procedure for CNSI Transport Cask XIII Number 14-195H TR-OP-009 Handling Procedure for CNSI Transport Cask XIII Number 15-160B (6144)
TR-OP-010 Handling Procedure for CNSI Transport Cask XIII Number 6-80-2 TR-OP-011 Handling Procedure for CNSI Transport Cask XIII Number 21-300 TR-OP-012 Handling Procedure for CNSI Transport Cask XIII Number 1-13C TR-0P-013 Handling Procedure for CNSI Transport Cask XIII Number 1-13G TR-0P-014 Cask / Trailer / Tractor Inspection Procedure XIII TR-OP-015 Interline Trailer Inspection XIII 11'6 170-oOCUMENT REV.
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3.0 DESIGN CONTROL x
The Design Control Program at CNSI ensures that design characteristics, es-pecially those related to safety, are controlled, inspected, and tested; that designs developed by the CNSI Engineering Department meet all applicable regulatory requirements; and that design activities are carried out in a planned, controlled, and orderly manner.
A comprehensive system of established procedures and policies is used for developing and implementing design projects, as well as controlling design documents (drawings) and design document distribution.
Variousf individuals in the CNSI Engineering Department bear responsibility for the selection and control of design parameters and for the development of design documenta. Their responsibilities are summarized below:
a.
The Project Engineer is responsible for the initial interpretation of design requirements and for confirming that applicable regulatory re-quirements are correctly translated into specifications, drawings, procedures, and instructions. Design requirements are also reviewed by
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Quality Assurance to ensure that suitable design controls are applied to such activities as seismic, stress, ther=al, hydraulic, radiation, and accident analyses; compatibility of materials; and accessibility for inservice inspection, maintenance, and repair, b.
The Design Lead coordinates with the Project Engineer and serves as a liaison between the Drafting Department, the Project Engineer, and Quality Assurance. The Design Lead also supervises the Draf ting Department, confirms that design specifications are properly referenced on drawings and other design documents, and controls access to the drawing vault.
c.
The Design Draftsperson produces accurate and precise drawings that con-form to the design specifications and that properly list or reference those specifications.
d.
The Design Checker reviews the drawings for technical accuracy and checks the design to ensure that the equipment can and will perform the functions for which it was designed.
e.
A representative from the Quality Assurance Department also reviews the design to confirm that all quality assurance requirements have been pro-DOCUMENT REV.
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y perly identified and that the requirements have been met in the finished s
design.
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The Engineering Manager reviews the derign and confirms that the total design package meets all regulatory requirements and is ready for release and fabrication.
The Design Control Program also provides for design reviews at regular intervals to assure that design characteristics can be controlled, inspected, and tested, and that inspection and test criteria are identified.
Formal design reviews take place at 25%, 50%, and 100% completion and include the Project Engineer, the Design Lead, and any other individuals or groups involved in the develop-ment oh the design. The Engineering Manager participates in the 50% and 100%
completion reviews. Design reviews may also be called at any time a problem is identified. Records are kept of these design reviews, and measures are taken to ensure that design errors are corrected and not repeated. Design controls also extend to other individuals or groups in interfacing design organizations.
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Materials, parts, equipment, and processes are controlled according to procure-ment procedures outlined in Section 7.0 of this document. The procurement documents specify all design base requirements including the applicable regula-tory requirements, material and component requirements, drawings specifications, codes and industrial standards, test and inspection criteria, and special process instructions. No equipment is released to the requisitioning party until it meets the requirements specified in the purchase order. All materials, parts, and equipment are reviewed for suitability prior to selection.
Drawing changes are made in accordance with procedures outlined in Section 6.5 of this document. Engineering Change Orders (ECO's) and/or design docu-ments (drawings) must be approved by the Project Engineer, Quality Assurance, and the Engineering Manager before a revised drawing can be released and the design fabricated.. Drawing revisions are subject to the same reviews and approvals as the original drawing.
CNSI drawing control procedures ensure that obsolete drawings are destroyed at the time a revised drawing is released.
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4.0 PROCUREMENT DOCU>ENT CONTROL The procurement of materials, components, services at, or services affecting
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assemblies, for use of utility customer sites or other licensed activities is accomplished with a written Purchase Order. Purchasc Order forms are controlled, and in the possession of a limited number of individuals. Only these individuals are authorized to release Purchase Orders, and are re-sponsible for conforming with established procurement and record keeping procedures. The sequence of events leading to Purchase Order issuance, and the associated record keeping activities, is in compliance with procedures published in ANSI N45.2.13.
It is CNSI's policy that procurement documents, except for administrative i
supplies, are reviewed by the cognizant department / site manager. Where the department / site manager or his designee determines that the procurement action is governed by an applicable standard, specification, code, regulation, license or Certificate of Compliance, the procurement document is submitted to Quality Assurance for review and approval.
The Quality Assurance reviewer examines the procurement document to assure
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that complete information is provided to identify:
a.
The applicable 10CFR Part 50, Appendix B and 10CFR71, Appendix E re-quirements which must be addressed; b.
The design basis technical requirements including the applicable regula-tory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, tests and in-spection requirements, and special process instructions; c.
The documentation to be prepared, maintained, and submitted to the purchaser for review and approval; d.
The records to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use or installation of the materials or components; e.
The procuring agency's right of access to supplier's facilities and records for source inspection and audit; f.
Quality requirements, which must be correctly stated, inspectable and controllable with adequate acceptance and rejection criteria.
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The individual authorized to control and release Purchase Orders prepares T
the Purchase Order, incorporating all applicable information referenced in the preceding paragraph. One copy of all Purchase Orders is maintained in a control file.
Procurement documents for spare or replacement parts shall be subject to the same controls that are applied to the original equipment. Changes and revisions to procurement documents are subject to the same review process as original documents.
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 pro-cedures in ef f ect at time of preparation.
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5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS
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Activities affecting product quality in design, manufacturing, operation, s-and maintenance are prescribed by documented instructions, procedures or drawings of a type appropriate to the circumstances. They include quantitative and/or qualitative acceptance criteria for determination that the prescribed activities have been satisfactorily performed. The activities are accomplished in accordance with the instructions, procedures or drawings.
The purpose of the instructions, procedures and drawings as described here-in is to provide and communicate standards for the quality determination within the company, to the vendors and to the customers and are directed at maintenance of an overall quality program. These instructions are avail-able for review ty customer representatives.
Procedures and instructions are prepared by the cognizant department. All instructions and procedures are maintained current with a documented method of revision. Instructions, procedures and drawings are readily available to personnel at locations requiring their use.
The drawings, instructions and procedures detail, where applicable, any equipment, environmental conditions and the exact method to be used to determine the condition of the item under examination. Prerequisite calibration of all special test equipment is clearly stated in detail. All acceptance criteria are clearly defined.
If visual aids or standards are available and applicable, they are referenced in drawings, instructions and procedures.
The CNSI's Quality Assurance organization reviews and concurs with in-spection plans; test, calibration and special process procedures; drawings and specifications and their changes; and verifies that methods for 'com-plying with regulations, such as Code of Federal Regulations (10CFR50, 10CFR71) are specified in instructions, procedures and drawings requiring such verifications.
11'6 175 DOCUMENT REV.
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CNSI's Q. A. organization shall review instructions, procedures and drawings to ensure that adequate quantitative and qualitative acceptance criteria are
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present.
The CISI procedure for document preparation shall be followed exactly in the course of preparation, review, approval and control of instructions and procedures. Drawings shall be prepared, reviewed, approved and controlled in accordance with engineering departrent procedures.
sU 11'6 176 COCUMENT REV.
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6.0 DOCUMENT CONTROL
(}
Written CNSI procedures control drawings, specifications, procedures, in-structions and their respective changes to assure adequacy.
6.1 Document Types Controlled The control includes all documents and their changes affecting the quality program. These decu=ents include, but are not limited to, design drawings and specifications, manufacturing drawings, procure-ment documents, quality assurance manuals, manufacturing, inspection, operating and testing instructions, test procedures and design change requests. 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 documentation from defined docu-ment control centers.
6.2 Document Review All design drawings, design procedures and specifications are issued by Engineering. They are reviewed and approved by Quality Assurance
-for adequacy and compliance with applicable quality standards and/or
(}
contractual requirements. The review assures the availability of all information required to produce an article in complete conformity with design requirements. The review process is the same for document changes.
All procedures and instructions are reviewed by CNSl's Quality Assurance. Documents which are not safety-r-lated are approved by the cognizant department or site manager.
AAA
.m sty-related documents are reviewed and approved by CNSI's Safety Review Board.
6.3 Document Control Execution of an effective document control system requires the following:
a.
Each document shall have an identifying number and a complete
. descriptive title.
b.
Each document shall have means for identifying the revision status and the effective date of each revision.
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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 immediately when such material is made obsolete by a new or revised document.
Obsolete documents are destroyed except for a hictory copy maintained in the document file.
Procedures and their changes are distributed on a formal basis and are of standard format. In cases of emergeacy, however, approved handwritten procedures or marked-up changes can be considered satis-factory as long as they are converted to the standard form and be-come official within 30 days.
Drawings and/or documents sent to a custumer or subcontractor are accompanied by a document transmittal letter showing the drawing and/or document number, revision and date of transmittal.
A copy of the transmittal letter is kept in the project file.
Ci Purchase orders used on manufacturing type projects are changed to indicate the effect of engineering changes. On completed projects, as-built drawings and documents are maintained in the project control file to reference the documents to which the item was built.
6.4 Document Change Control (Excluding Drawings)
Proposed changes to existing documents shall be recorded on CNSI Change Request Forms. These forms are also used to subrit proposed changes to customers when their approval is required prior to change incorporation.
All proposed changes are reviewed by Quality Assuranc' prior to their approval to determine the effect of the change on the quality of the article and the resultant changes in inspection, procedures or operations.
Quality Assurance shall approve changes only after receipt of a completed Change Request with authorized approval signatures. Leiartments approving the change (s) shall be the same as indicated on the approval page of the document to be changed.
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Approved change documents are attached to the original document and g-are incorporated in the document. The changed document will be distri-buted by Quality Assurance to the individuals indicated in the document distribution log.
6.5 Drawing Control Drawing changes are made using the Engineering Change Order (ECO) form. The forn is a one-part reproducible form used to specifically delineate a proposed change. The form is also used to submit proposed changes to customers when their approval is required prior to change incorporation. Minor design cnanges may be recorded directly on design drawings in the revision block. When this procedure is 'ollowed, an ECO is not required.
All proposed changes are reviewed by Engineering and Quality Assurance prior to their approval to determine the effect of the change on the quality of the article and the resultant changes in inspection, procedures or operations. Revisions, changes and modifications of affected systems are made only after approval of the ECO. Approved
^'
changes are maintained in an ECO file by Engineering. When changes are extensive, the ECO form may be attached directly to the drawing (s) re-issued.
0.6 Document Control for Suppliers Subcontractors and vendors are required to maintain an effective drawing change control system ahen these drawings are p avided as part of the contractual requirements.
Procurement of articles to CNSI's design requires a document control system that includes assurance of notification of changes to the subcontractor or vendor, verification of change incorporation and appropriate in atification of those items on which the change is incorporated.
Procurement of articles of subcontractor's design requires a docu-ment control system that ascures notification of CNSI by the sub-ooCUMENT REV.
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contractor of the proposed change, approval of the change by CNSI and appropriate identification of the items on which the change is incorporated.
6.7 Document Availability Documents will be available, prior to commencement of work, at the locations where activities involving them are to be performed.
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11'6 180 v
cocuMENT REV.
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7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES p
The procurement control methods CNSI use.s establish measures to assure that procured items and/or services are clearly and adequately specified in pro-curement documents and are supplied by vendors and subcor*ractors who are capable of producing items and furnishing services which conform to pro-curement document requirements. These procurement control methods, which consist of procedures or instructions, include provisions for vendor evalua-tion, review of procurement requirements and surveillance of vendor's facility.
7.1 Supplier Evaluation CNSI Engineering, Procurement,and Quality Assurance personnel parti-cipate 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 capabilities and facilities for technical, manufacturing and y.lity performance, and
. include any or all of the following as appropriate:
Historical performance data, particularly in product quality a.
and delivery; b.
Review and comment on supplier's quality assurance program; Source audits to verify supplier's implementation of his quality c.
assurance program, as required; d.
Scurce qualification programs.
The evaluation considerations include the elements of the NRC's Qurlity Assurance Criteria to the extent these criteria are applicable to the equipment being procured. Actions to correct deficiencies in the supplier's organization or quality program are resolved with the supplier's management prior to fabrication of ordered items.
7.2 Procurement Requirements Requirements to be met by the supplier are detailed in the procurement documents which may include procurement specifications. This document details the aspects of supplier quality assurance, for example, inspection reports, provisions for inspection, equipmm.6 calibration prior to use, and provisions for inspection after oOCUMENT REV.
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component repair. The procurement specification may also require the successful bidder to submit the following for CNSI's review:
,s k.
Special process procedures for performing welding, heat treat-a.
ment, nondestructive examination; b.
Recommended inspection point program; c.
Appropriate documentation as required by applicable codes, standards and procurement documents; d.
Notices of nonconformances and deviations; Test procedures in accordance with applicable codes and standards.
e.
7.3 Sunolier Surveillance CNSI Quality Assurance is responsible for conducting and documenting supplier surveillance. Surveillance activities typically include:
a.
Witnessing test inspections and nondestructive examinations and various special process operations; b.
Monitoring heat treatment, welding, cleaning, preserving, packing and packaging activities; c.
Verifying supplier conformance with established procedures, such as:
(-
1.
use of CNSI accepted drawings and procedures 2.
use of accepted product and process quality planning 3.
document change control 4.
material identification and tracaibility control 5.
control and calibration of measuring equipment 6.
control of major repair welding d.
Reviewing completed product quality documentation and/or checklists prior to release of equipment for shipment.
Documentation of nonconformances shall be provided by suppliers as prescribed in Section 15 of this program.
CNSI's quality assurance personnel perform a review to assure the validity of supplier documentation during in-process, testing and final inspection stages.
The entire documentation package is reviewed prior to shipment of manufactured items.
This documentation includes material test reports, inspection and test reports, NDE reports and applicable code data reports.
11'6 182 DOCUMENT REV.
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The frequency and extent of the surveillance are consistent with the importance to safety, complexity, and quantity of the item or (5
~
service being furnished.
The measures to evaluate the effectiveness of the control of vendor quality are described above.
7.4 Receiving Inspection Receipt inspections shall be performed on purchased items (including spare or replacement parts) to assure that:
a.
Material, components or equipment are properly identified and corresponds to the receiving documentation; b.
Material, components, equipment and acceptance records are inspected and judged acceptable in accordance with specified requirements prior to installation and use; c.
Inspection records or certificates of conformance attesting to the acceptance of material, components and equipment are available and are filed in the project file prior to use; d.
Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or
-)
releasing them for installation or further work.
7.5 Supplier Audit Measures for auditing suppliers are described in Section 18 of this document.
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8.0 IDENTIFICATION AND CONTROL OF COMPONENTS AND MATERIALS
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The identification and control as described herein shall apply to ecmponents, production materials, bulk raw materials, parts and assemblies at all stager of fabrication and installation from rereipt of components and material to completian of the system or component suaplied.
These requirements shall be imposed on CNSI's subcontractors and suppliers.
8.1 Components and Materials The inspection status of all components and material shall be evident at all times. This shall be accomplished by marking, tagging or stamping components or material and the stamping of work orders or material requests accompanying them at the appropriate stages of fabrication or installation.
Identification of components and material with an identification number shall be accomplished with a method that will provide legible identification as permanent as the normal life expectancy of the item
' marked, without adverse effect on its Jife and utility.
O Components or material not suitable for individusi marking, shall be individually tagged or shall be placed on an identified container.
The storage area shall contain only components or material which have l
been inspected and accepted. Surveillance shall be maintained over the storage areas to assure that materials subject to matching material certification control or age limit requirements are properly segregated, dated and controlled. This surveillance shall also include checking for conformance to proper standards of packaging and storage of all components, material, parts and assemblies.
I 8.2 Bulk Raw Material Following the acceptance of bulk raw =aterials, a tag showing the purchase order, the material identification, mill heat number or heat code and the date of receipt shall be factened to the material.
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r-3 If during fabrication all identification has been removed from the g3 part of the material being used, the remnant shall be marked before being returned to stock.
Material marking shall be such that it shall not be affected by con-tact incident to normal handling, exposure to the elements, shipment or storage. All markings shall offer ready readability and prompt idencification of the material. Physical marking of material shall be accomplished in a manner which will not adversely af fect the machining, forming or febrication of the material.
l Identification requirements shall be determined during generatica of specifications and design drawings.
Identification of materials and parts for safety-related systems or components shall be traceable to the appropriate documentation, such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports and physical and chemical mill test reports.
Prior to release for fabrication, assembling, shipping and installa-tion the correct identification of icterial, parte and components must be verified and documented.
1146 185 oocuMENT REV.
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3 9.0 CONTROL OF SPECIAL PROCESSES f-All special fabrication, installation and inspection processes which could
^'
have an effect upon the quality of the component, system se fabrication operation shall be controlled by process procedures.
9.1 Personnel Certification Personnel responsible for performance, inspection and control of special processes and operctions which require special skills and coula have an effect upon quality shall be certified. Certification of personnel for these processes or operations (such as welding, heat treating and nondestructive testing) may include a formal training program followed by mandatory testing to assure proficiency of each individual. Personnel certification requirements shall conform to the applicable codes and standards, such as ASME Section IX for welding and heat treating and SNT-TC-1A for nondestructive testing.
The period of effectivity for all certifications shall be specified and each individual shall be re-certified at the end of such period through re-testing. Persons failing the re-test shall be removed from operations and shall be provided with additional training as required for re-certification. Inspection results and quality audits shall be used as indicators of the need for additional training and re-certification of fabrication, installation and inspection personnel withou: regard for established re-certification periods. Personnel shall ilse be re-certified in accordance with the applicable standard.
A record of the names of certified personnel, their skills and certification periods shall be maintained in quality assurance record files.
9.2 Subcontractor Control Special processes performed by CNSI's subcontractors and suppliers I
shall be specified in procurement documents and shall be monitored by Quality Assurance for conformance to CNSI requirements. A certi-ficate of compliance shall be required from all subcontractors and suppliers performing special processes.
E 1146 186 oOCUMENT REV.
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9.3 Procedures Special process procedures shall be reviewed and approved by Quality Assurance which conducts a surveillance to assure that the approved procedures are adequately followed. Process procedures shall include the method required for periodic verification of adequacy of the pro-cessing materials, solutions, equipment and their associated control parameters and the recording of the inspection results and process verifications performed.
4 1146 187 REV.
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10.0 INSPECTION
~N The established inspection program at CNSI verifies the conformance of quality t-related activities with the applicable requirements. The verification is performed in accordance with written inspection procedures, instructions or drawings. Personnel performing the inspection are independent from the individuals performing the activity being inspected. The inspectors are qualified in accordance with applicable codes and standards and their qualifications and certifications are kept current.
Equipment modifications, repairs and replacements are inspected in accordance with the original design and inspection requirements unless an approved alternative exists. Provisions for mandatory inspection hold point identifi-cation requiring witnessing by an inspector are incorporated in the appropri-ate documents, such as procurement specifications, test procedures, etc.
The inspection program also provides for identification and documentation of deficiencies discovered during inspection and ?he required corrective action.
10.1 Inspection Procedures Insper. tion procedures and instructions are written documents which provide the following information:
A.
Identification of characteristics and/or activities to be inspected; B.
Identification of the individual or group responsible for per-forming the inspection; C.
Acceptance and rejection criteria; D.
A description of the inspection method; E.
Recording evidence of completing and verifying a manufacturing, inspection, or test operation; F.
Recording inspector or data recorder and the results of the inspection operation.
Inspection procedures and/or instructions are used in conjunction with the specified specifications or drawings when inspection operations are performed. Inspection procedures are maintained _ current by established
}]4h
)hh document control measures.
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10.2 Supplier Inspection
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CNSI identifies instaction requirements in procurement documents issued to subcontractors and suppliers. The subcontractors and suppliers are responsible for inspection of their products, and CNSI Quality Assurance verifies their controls to assure adequacy of inspection. Supplier's inspection plans are required to recognize those CNSI notification or hold points epacified by procurement documents.
10.3 Indirect Control In the event that direct inspection is not possible, indirect control of the inspection process shall be provided through monitoring pro-cessing methods, equipment and personnel where applicable.
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11.0 TEST CONTROL A test control progrca established at CNSI assures that all required testing
~^
s is identified and performed in accordance with written test procedures, which incorporate the requirements and acceptance limits specified by the applicable design documents.
11.1 Test Procedures Test procedures prepared by the responsible CNSI department are re-viewed by Quality Assurance in accordance with st-Jards, procedures or instructions that require inclusion of the fou swing quality assurance requirements, as applicable:
A.
Requirements and acceptance limits as contained in the applicable design documents; B.
Detailed instructions for performing the test; C.
Test prerequisites, including, but not limited to the following:
a.
calibrated instrumentation b.
adequate and appropriate equipment trained, qualified, and as appropriate, licensed and/or c.
(~
certified personnel d.
preparation, condition and completeness of the item to be tested suitable and, if required. controlled environmental conditions e.
D.
Mandatory inspection hold points for witness by responsible in-dividual; E.
Acceptance and rejection criteria; F.
Method for docuaenting or recordir.g test data and results; G.
Designation of the individual (s) or group (s) respensible for evaluating and making decisions based on test results.
Test procedores shall be subject to document control as outlined in Section 6 of this program. They shall be maintained current by revisions issued upon changes in specifications, documentation, drawings or contracts.
11.2 Test Records Records of tests performed shall be prepared, shcwing the applicable drawing or procedure revision, identification of test performed, DOCUMENT REV.
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date, test data and other essential test information.
~(1 The test record shall be signed by the individual performing the test and any test witnesses, if so required. Test records shall be maintained in quality assurance record files.
f 11.3 Test Control for Procured Items Test control requirements are imposed on suppliers by procurement documents. They identify the tests to be performed and stipulate l
l
' hat suppliers' test procedures be submitted for approval. Tests are conducted by groups within the supplier organization considered acceptable during supplier seJection, and test control systems are monitored during Quality Assurance surveillance.
Also, records of tests are reviewed for acceptability during surveillance, and this review includes consideration of the qualifications of the supplier group making acceptance disposition of test results.
11.4 Modifications, Repairs and Replacements
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Modifications, repairs and replacements shall be tested in accordance with the original design and test requirements or acceptable alter-natives approved in the same manner as the original.
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12.0 CONTROL OF MEASURING AND TEST EQUIPMENT Measuring and test equipment with the necessary range and accuracy shall be provided to qualified personnel for the inspection, test and acceptance of material, parts, components and systems. Equipment accuracy shall be assured by calibration traceable to national standards or a documented alternative basis for calibration.
12.1 CNSI's Equiement Calibration and Control All inspection and test equipment shall be subjected to maintenance and calibration at periodic intervals by qualified personnel or sub-contractors. Frequency of calibration shall be based on the equipment type, historical experience and operational requirements. Calibrating standards have an uncertainty (error) requirement of no more than 1/4th of the tolerance of the equipment being calibrated.
A greater uncertainty may be acceptable when limited by the " state-of-the-art".
Each item of measuring and test equipment shall be serialized for record and identification purposes. A sticker shall be attached to the equipment to indicate date of ealibration, due date of next calibration and the stamp or signature of the person conducting the calibration. A status file shall be maintained for all calibratable equipment.
Measuring and test equipment shall be issued to and retained between calibrations by those requiring its use.
Each user has the responsi-bility to ascertain, prior to use, that the measuring and test equipment calibration date has not expired and that damage or rework has not taken place since the last calibration. Compliance with the above requirements is monitored by Quality Assurance.
12.2 Measuring and Test Ecuipment at Subcontractors Measuring and test equipment used by subcontractors, vendors and sup-pliers engaged in fabricating and furnishing materials, parts and components to CNSI shall be under the surveillance of CNSI's Quality Assurance. The surveillance shall cover production tooling, j igs, fixtures and other fabrication equipment which controls dimensions, contours, etc., and which is used for acceptance. Surveillance DOCUMENT REV.
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activities include checks to assure that inspection operations are or have been performed with appropriate measuring and test equipment, currently adjusted with calibration traceable to national standards.
Where no national standards for equipment calibration exist, the documentation for the basis of calibration is audited.
12.3 Inspection Validity When measuring and test equipment is found to be cut of calibration, measures shall be taken to ensure the validity of previous measure-ments and tests conducted during the period when the equipment is likely to have been operating in such a condition.
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1146 193 cOCUMENT REV.
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13.0
- 'DLIMG, STOPAGE AND SHIPPING 13.1 Procured Items Measures used to control packaging, shipping, storage and handling of components and material ta prevent damage or deterioration shall be documented to reflect contractual or C:iSI specified requirements.
Ptocurement documents shall identify the required control measures to suppliers.
The supplier must have adequate wtitten work and inspection in-structions for storage, preservation and packaging of shinment to protect the products from damage, loss, deterioration or substitution.
As required by the equipment specification and/or,rrocurement docu-ments, these procedures may be subject to approval by CNSI.
13.2 Transport Casks Transport cask handling and operation shall conform to the written handling and operation procedure for each licensed cask.
Prior to the shipment of a transport cask all conditions of the MP.C's Certificate of Compliance (specifications, tests, inspections) shall be satisfied. All required shipping papers shall be prepared and shall accompany the shipment.
Quality Assurance through the Q. A. personnel located at Barnwell, S.C.,
is resoonsible for auditing all critical cask handling, storage and shipping operations conducted by Barnwell Site Operatie's personnel.
Established safety restrictions concerning handling, storage and shipning shall be included in the handling and operating procedures for transport casks.
i146 I94 t
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h 14.0 INSPECTION, TEST AND OPERATING STATUS
/m 14.1 Equipment Status The inspection, test and operating status of systems and components used for processing or transportation of radioactive matcrials shall be known at all times during manufacturing and use.
Transportation and operating,3rocedures shall include reporting re-quirements which establish the equipment status at key events (after unloading, prior to shipment, etc.).
Equipment status will be maintained by operating personnel who are responsible for critical inspection, test and operating activities.
Quality Assurance personnel shall verify equipment status and compliance with procedures. Bypassing of required tests or other critical operations shall be procedurally controlled under the cognizance of Quality Assurance personnel with the concurrence of
.the Q. A. Manager.
14.2 Establishment of Examinations and Tests In-process and final examinations and tests shall be established to assure conformance with documented instructions, procedures, drawings, rules and regulations.
- 14. 3 Hold Points The procurement documents, drawings, quality plans, transportation and operating procedures shall establish any required mandatory hold points which shall be reflected in fabrication or operational schedule.
Hold points shall be designated points in the fabrication or operation schedule beyond which the operations shall not proceed without consent of quality assurance because of witnessing, examination or testing requirements.
1i46 195 DOCUMENT REV.
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3 14.4 Check Lists of Examinations, Tests and Inspections Prepared check lists shall include the document number and revision s
to which the examination, inspection or test shall be performed.
The check 'ist shall have space provided for recording results of examination, test or inspection and for uitness signatures, initials or stamp and date for activities witnesses.
14,5 Eximination or Process Status Measures shall be established to indicate during receiving, fabri-cation and equipment operation the status of examinations and test performed upon items, systems and components by use of markings that are attached to, remain with, or are traceable to the material, item, systems and components such as stamps, tags, labels, routing cards or other suitable means. These measures shall provide identification of those items which conform to examination and test requirements and those that do not conf'orm.
14.6 Inspection Status CNSI inspection stamps or authorized Quality Assurance signature shall be applied to materials, items, systems, components or t.he controlling documentation to indicate the inspection status and to provide traceability to the individual performing the inspection.
The inspection stamp shall normally be applied directly to the item which has been accepted by inspection, material which has been accepted for limited use, and to material which has been rejected and dispositioned as scrap. When size, material or finish, etc.,
preclude stamping the material, a tag shall be attached to the item appropriately stamped to indicate the status.
14.7 Control of Inspection Stamos Inspection stamps shall be serialized for traceability to the in-dividual inspector. Quality Assurance shall control and issue in-spection stamps, as required, to authorized personnel.
Records of individual issue shall be maintained and audits shall be periodically 1146 196 DOCUMENT REV.
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Stamps removed from service because of loss, employee termination, etc., shall be retired for a minimum of three months.
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15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS Procedures for control of nonconforming materials, parts or components assure that such materials are adequately identified and segregated from acceptable materials, if feasible, to preclude their inadvertent use.
15.1 Internal Nonconformances CNSI system materials, parts and components which are determined to be discrepant shall be identified with a tag and a numbered Nonconformance Report and, when feasible, physically separated from acceptable items.
The method of identification shall clearly describe the nature of the defect. The Nonconformance Report shall be forwarded to the designated department (s) for disposition. A holding area with controlled access shall be provided when necessary for material and/or component segre-gation. The Nonconformance Report shall indicate the nature and extent of the discrepancy and the disposition. Minor discrepancies that can be reworked shall be identified by an Inspection Tag until rework has been satisfactorily accomplished.
15.2 Subcontractor Control Subcontractors shall promptly notify CNSI of all deviations from the procurement requirements, such as deviations from the required codes or approved drawings. A nonconformance notice chall be initiated by the subcontractor in accordance with the subcontractor's quality assurance manual. After detection of the deviation, further fabrication operations on the material or component shall not be performed until the nonconformance has been resolved by the subcontractor and CNSI. The subcontractor shall supply records of nonconformance reports dis-positioned " accept as is" or " repair".
These reports shall be made part of the inspection records and forwarded with the hardware to Chem-Nuclear for review and assessment.
15.3 Verification of Rework or Repair Acceptability Acceptability of rework or repair of materials, parts, components, systems and structures shall be verified by reinspecting and retesting the item as originally inspected, or by a method which is at least equal to the original inspection and testing method.
Inspection, 1146 198 coCUMENT REV.
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testing, rework and repair records shall be documented and filed in CNSI quality' records files.
s 15.4 Nonconformance Disposition The individuals or groups identified on nonconformance forms shall have the responsibility and authority for disposition of nonconforming items.
CNSI Quality Assurance is responsible for reviewing, approving and verifying the disposition of nonconformances.
15.5 Assessment of Nonconformances Nonconformance reports shall be analyzed periodically to show quality trends, and the results reported to CNSI management for review and
[
assessment.
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3 16.0 CORRECTIVE ACTION CNSI shall evaluate conditions adverse to quality (e.g., nonconformances,
(
i failures, malfunctions, deficiencies, deviations, defective material, etc.)
to determine the need for corrective action in accordance with established procedures.
Corrective action shall be promptly initiated when it is determined that an existing nonconformity in a material, a process or a product is due to an assignable cause and. is repetitive in nature.
The corre tive action procedure is divided into five basic steps:
(a)
Investigate discrepancy (b) Determine cause (c) Define corrective action (d)
Implement corrective action (e) Evaluate corrective action Specific individuals from appropriate departments shall be assigned the responsibility of accomplishing each of the phases. Corrective action includes, but is not limited to, procurement or manufacturing operations, design, l
construction and operation. The results of each phase shall be documented and become part of corrective action records. Quality Assurance shall review records to verify proper implementation of corrective action as soon as l
ef fectiveness can be measured. Effectiveness shall be continuously monitored as a function of quality surveillance. The corrective action documentation l
shall not be closed out until results of the corrective action have been evaluated and approved by Quality Assurance.
Significant conditions adverse l
co quality, the cause of such conditions, and the carrective action taken i
shall be reported to cognizant levels of CNSI management for review and assessment.
When corrective action requests are addressed to a CNSI supplier, the supplier shall be required to provide the following information:
(a) A description of all factors contributing to the deficiency (b) A description of corrective actions taken to prevent recurrence of the discrepancy in future production (c) The identification of effectivity point in production.
oocuMENT AEV.
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CNSQ 1CO2. 8-78 1146 200
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3 17.0 QUA*ITY ASSURANCE RECORDS 17.1 Maintenance and Access to Records
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The records system maintained by Chem-Nuclear Systems, Inc. includes the retention of those design, fabrication, inspection and surve111cnce records essential to de=onstrate product quality.
It provides for the identification of materials and their corresponding manufacturing, f
installation, test and inspection records and certificates. Operating records maintained will include inspection, test and audit results.
All records pertaining to a specific project shall be available for review by the appropriate inspection agencies, the customer and/or his representative. All records maintained according to established procedures will be identifiable and retrievable.
17.2 Contents of Record Files It is the policy of Quality Assurance that adequate records be maintained i
of all component and material inspections and tests.
Inspection and test records shall contain the following, when applicable:
a.
A description of the type of observation; b.
Evidence of completing and ver'ifying a manufacturing, inspection
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or test operation; c.
The date and results of the inspection or test; 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) and revision (s) used.
Records shall also be maintained of supplier and subcontractor quality assurance reviews, surveillances and audits, and documents pertaining to CNSI internal quality assurance audits.
Records shall be kept for control and as evidence of inspections, tests, audits, monitoring of work performance, material analysis and certifications, i.e.,
record files shall contain all documents pertaining to product quality assurance functions. The files shall also contain procedures and specifications written for a specific p ro'j ect.
Files of personnel qualifications and training shall also be maintained.
1146 201 oOCUMENT REV.
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2 CNSo :C42.8 *8
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m 17.3 Permanent Records Permanent records in the record file shall contain: design specifica-(
tions, stress reports or stress calculations, "as built" and inter-face control drawings, copies of all certified material test reports, tabulation of materials for "as built" configuration, nondestructive examination reports, including examination results, and disposition reports.
17.4 h -oermanent Records All non-permanent records required to verify compliance with the applicable codes and the supplier's or subcontractor's Quality Assurance Program shall be maintained until project completion, unless otherwise atipulated.
17.5 Record Storage Facilities Reco-d storage facilities shall be constructed, located and/or secured to prevent destruction of records by fire, flood, theft, and deterior-ation due to environmental conditicas such as temperature or humidity.
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41146 202 oOCUMENT REV.
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CNSO 1002 8-78
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18.0 AUDITS Planned audits shall be performed to provide comprehensive, independent
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verification and evaluaticn of the CNSI or supplier activity being audited.
The audit scope shall encompass evaluation of quality system practices and/or procedures and the ef fectiveness of their implementation, monitoring of I
operations and activities, and a review of pertinent documents and their l
control and maintenance. Audit checklists shall be established prior to conducting an audit.
18.1 Audit Schedule Internal audits shall normally be conducted once every 12 months.
However, unscheduled audits may be performed more frequently in specific areas, if deemed necessary by Quality Assurance and/or 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 a prompt disclosure of deficiencies.
Supplier audits shall be conducted at least once every 36 coaths.
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18.2 Audit Personnel ik)
Audits shall be performed by CNSI personnel with no direct line responsibility for the function audited. The audit personnel shall have the required level of technical capability to accomplish the audit functions satisfactorily and to conform to the requirements of ANSI N45.2.23.
When required, representatives from various CNSI departments may be called upon for technical advice or assistance.
18.3 Audit Reports A verbal presentation of the findings and conclusions of the audit is made to management personnel affected by the audit findings.
Recommend-ations for quality-related improvement are presented as well.
A written report containing the findings and recommendations reviewed in the verbal report is prepared and distributed to the responsible divisien and appropriate Headquarters management.
Audits shall include an assessment as to how well the Quality Assurance Program meets regulatory or other requirements.
DoCUMEN T RE" SHEET QA-AD-001 A
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J CNSO 1002.8-78
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18.4 Audit Follow-Up
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The originator of an audit report or a designated alternate is re-
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quired 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 management personnel shall evaluate each audit report item and correct deficiencies as promptly as possible after they are revealed.
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DOcuYENT REV.
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CNSQ 10o2;S-78
WASTE PROBLEM SOLVING CENTER Compliance assuranceincluding licensing assistance, health physics, emergencyplanning, environmental and third party quality assurance services.
Waste systems engineering and consulting services.
Waste solidification and/or removal g
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project scheduling and management.
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Mobile solidification services and customer's in-plant system operation.
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Mobile demineralization and ion exchange services.
Mobile electropolishing/
decontamination services.
Manufacturing associations for Engineering consulting relationships for fabrication of casks, disposable waste analytical design capability, including containers and piping sub-systems.
structural, seismic, shielding, hydraulic, piping and electricaldesign.
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I CHEM-NUCLEAR SYS O CORPORATE OFFICE
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HEADQUARTERS AND OPERATIONS CORPORATE HEADQUARTERS (206) 827-0711 SOUTHEAST /SO.UTHWEST OPERATIONS (803)259-3588 li4b 2 Db HORTHEAST/MIDWE'sT OPERATIONS (716)662-2562 COMPLIANCE ASSISTANCE / TECHNICAL SERVICES lgg n CHEn4 i
(404)993-3150 HAZARDOUS CHEMICAL DIVISION l
d (503) 223-1912 l
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