ML19209C470
| ML19209C470 | |
| Person / Time | |
|---|---|
| Site: | 07100248 |
| Issue date: | 08/31/1979 |
| From: | MONSANTO RESEARCH CORP. |
| To: | |
| Shared Package | |
| ML19209C469 | List: |
| References | |
| NPD-STD-001, NPD-STD-1, NUDOCS 7910150618 | |
| Download: ML19209C470 (74) | |
Text
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COPY #4 NPD-STD-001 QUALITY ASSURANCE PROGRAM MANUAL 1134 177 6
7910150 (/8
PREFACE POLICY STATEMENT Monsanto Engineered Products has long maintained a reputation for the manuf acture of nuclear equipment of the highest c.uality and dependability.
Inspection and Quality Assurance is an integral part of our normal manufacturing process to insure a high degree of confidence in the deliverable product.
It is the established policy of the Monsanto Research Corporation that all goods delivered shall fully conform to the contract description and requirements; that all services shall be performed with honesty and integrity; and that all business dealings shall be pursued in a direct, forthright and businesslike manner.
This Manual outlines the Quality Assurance procedures and practices to be followed in the manufacture of equipment that must comply with the requirements contained in 10CFR50 and 10CFR71.
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Robert L. Schimmel Manager i134 178 6
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l NPD-STD-001, Rev. 3 Page 1 of 33 TABLE OF CONTENTS SECTION TITLE PAGE 1.0 ORGANIZATION 1.1 ENGINEERED PRODUCTS DEPARTMENT 5
1.2 QA/QC FUNCTIONS OF EPD 5
1.3 EPD FUNCTIONAL ORGANIZATION 5
1.4 DUTIES OF RESPONSIBLE QA/QC INDIVIDUAL 7
1.5 QUALIFICATIONS OF RESPONStBLE QA/QC INDIVIDUAL 8
1.6 AUTHORITY TO STOP UNSATISFACTORY WORK 8
2.0 QUALITY ASSURANCE PROGRAM 2.1 PURPOSE 11
'2 QUALITY ASSURANCE MANUAL 11 2.3 QUALITY AS5URANCE APPLICABILITY 11 2.4 ITEMS CONTROLLED BY QA PROGRAM 11 2.5 RESOLUTION OF QUALITY DISPUTES 12 2.6 INDOCTRINATION AND TRAINING PROGRAMS 12 2.7 QUALITY-RELATED ACTIVITIES 12 3.0 DESIGN CONTROL 3.1 DESIGN CONTROL MEASURES 14 3.2 DESIGN DOCUMENTS 14 3.3 QUALITY STANDARDS 14 3.4 DESIGN REVIEWS 14 3.5 DESIGN VERIFICATION 14 3.6 DESIGN REVIEW INDIVIDUALS 15 3.7 CHANGES TO DESIGNS AND SPECIFICATIONS 15 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 PROCEDURES FOR PROCUREMENT DOCUMENTS 1134 i80 16 4.2 PROCUREMENT DOCUMENT DESCRIri10NS 16 I7 4.3 CHANGES TO PROCUREMENT DOCUMENTS
NPD-STD-001 Rev. 3 Page 2 of 33 SECTION TITLE PAGE 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 51 QUALITY ACTIVITIES 18 5.2 SPECIFIC PROCEDURES 18 5.3 QUALITY ASSURANCE CONCURRENCE 18 6.0 DOCUMENT CONTROL 6.1 SPECIFIC PROCEDURES 19 6.2 CHANGES TO DOCUMENTS 19 6.3 AVAILABILITY OF DOCUMENTS 19 6.4 DOCUMENT LIST 19 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7.1 EVALUATION OF SUPPLIERS 20 7.2 METHODS OF EVALUATION 20 7.3 VENDOR SURVEILLANCE 20 7.4 VENDOR-SUPPLIED RECORDS 20 7.5 RECEIVING INSPECTION - PURCHASED ITEMS 21 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMP 0NENTS 8.1 CONTROL OF MATERIALS, PARTS AND COMPONENTS PROCEDURE 22 8.2 ITEM IDENTIFICATION 22 8.3 IDENTIFICATION OF SAFETY RELATED ITEMS 22 8.4 RELEASE OF CONTROLLED ITEMS 22 9.0 CONTROL OF SPECIAL PROCESSES 9.1 SPECIAL PROCESS CONTROL 23 9.2 SPECIAL PROCESS QUALIFICATIONS 23 9.3 RECORDS 23
l NPD-STD-001 Rev. 3 Page 3 of 33 SECTION TITLE PAGE 10.0 INSPECTION 10.1 INSPECTION PROCEDURES 24 10.2 INSPECTION PERSONNEL 24 10.3 INSPECTOR QUALIFICATIONS 24 10.4 INSPECTION OF MODIFICATIONS AND REPAIRS 24 10.5 INSPECTION HOLD POINTS 24 11.0 TEST CONTROL 11.1 TEST PROGRAMS 25 11.2 MODIFICATIONS, REPAIRS AND REPLACEMENTS 25 11.3 TEST RESULTS 25 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12.1 CALIBRATION OF INSTRUMENTS 26 12.2 EQUIPMENT IDENTIFICATION 26 12.3 OUT-OF-CALIBRATION CONDITIONS 26 12.4 CALIBRATION TO STANDARDS 26 13.0 HANDLING, STORAGE AND SHIPMENT 13.1 HANDLING, STORAGE AND SHIPMENT 27 13.2 REGULATORY REQUIREMENTS 27 13.3 TRANSPORTATION MONITORING 27 1l34 i82 M
l NPD-STD-001 Rev. 3 Page 4 of 33 SECTION TITLE PAGE 14.0 INSPECTION, TEST AND OPERATING STATUS 28 14.1 COMMUNICATION OF STATUS 28 14.2 STATUS INDICATORS 28 14.3 BY-PASSING INSPECTIONS 28 14.4 NON-CONFORMING ITEMS 15.0 NON-CONFORMING MATERIAL, PARTS OR COMP 0NENTS 29 15.1 NOTIFICATION OF NON-CONFORMING ITEMS 29 15.2 DOCUMENTATION 29 15.3 IDENTIFICATION 15.4 REINSPECTION OF REPAIRED / REPLACED ITEMS 29 16.0 CORRECTIVE ACTION 30 16.1 SPECIFIC PROCEDURES 30 16.2 ACTION TO PRECLUDE RECURRENCE 30 16.3 CORRECTIVE ACTION FOLLOW-UP 17.0 QUALITY ASSURANCE RECORDS 31 17.1 QUALITY ASSURANCE RECORDS 31 17.2 RETENTION OF Q.A. RECORDS 31 17.3 TYPES OF QUALITY ASSURANCE / QUALITY CONTROL RECORDS 17.4 INSPECTION AND TEST RECORDS 18.0 AUDITS 18.1 AUDIT PROCEDURES 33 18.2 AUDIT RESULTS 33 18.3 DEFICIENT AREAS AND REAUDITS 4
l03 33 18.4 AUDIT PERIOD
l NPD-STD-001 Rev. 3 Page 5 of 33 1.0 ORGANIZATION l.1 ENGINEERED PRODUCTS DEPARTE NT The Engineered Products Department is an organization within the Dayton Laboratory of Monsanto Research Corporation. Within the Engineered Products Department are the Marketing, the Engineering Design and Development and the Operations groups, all of which report to the Department Manager. See Organization Chart in Figure 1.
Responsibility for the overall Quality Assurance Program for products and shipping containers is retained and exercised by the Engineered Products Department of Monsanto Research Corporation, Dayton Laboratory.
1.2 QA/QC FUNCTIONS OF EPD The Engineered Products Departme t QA/QC personnel shall carry out or delegate to other qualified organizations the following QA Program functions to assure appropriate elements of regulatory criteria will be implemcnted-(1) Assure that an appropriate QA program is established and effectively executed via controls, procedures, processes, etc; (2) Verify by means such as checking, auditing and inspecting that activities affecting safety related functions have been correctly performed.
1.3 EPD FUNCTIONAL ORGANIZATION 1.3.1 Manager of Engineered Products Department Reports directly to the Director of the Dayton Laboratory of Monsanto Research Corporation and is responsible for all functions 1134 184 M
NPD-STD-001 Rev. 3 Page 6 of 33 1.3.1 Manager of Engineered Products Department (Cont'd) of the Engineered Products Department.
1.3.2 Marketing Group Under the supervision of the Marketing Manager who reports to the Manager of Engineered Products. Marketing solicits business and receives and/or initiates all contractual documents relative to customer work being performed by EPD, including QA requirements 1.3.3 Design Engineering Group Designs and performs analyses under the cognizance and supervision of the Manager, Engineering Design and Development; reviews technical requirements of customer contracts; and approves and generates detailed manufacturing requirements for items subject to NPD-STD-001, sere appropriate.
1.3.4 Opg ations Group Reports to the Manager of Engineered Products Department and is responsible for Nuclear Manufacturing, Nuclear Quality Control, Health Physics, Nuclear Shipping / Receiving and Manufacturing Engineering.
1.3.5 Nuclear Manufacturing Reports to the Manager of Operations and is responsible for all nuclear manufacturing and production activities.
l.3.6 Nuclear Quality Control Reports to the Manager of Operations and is responsible for Quality 1134 18$
M
NPD-STD-001 Rev. 3 Page 7 of 33 1.3.6 Nuclear Quality Control (Cont'd)
Assurance and Quality Control of materials, parts and components.
Nuclear Quality Control may also be referred to as QA/QC.
1.3.7 Manufacturing Engineerina Reports to the Manager of Operations and is responsible for fabrication and maintenance of shipping containers; designs, performs analyses and generates detailed manufacturing requirements for items subject to NPD-STD-001 where appropriate. Manufacturing Engineering is responsible for departmental shop activities.
1.3.8 Nuclear Shipping / Receiving Reports to the Manager of Operations and is responsible for activities relating to inspection, preparation and packaging outgoing shipments 71d inspection and check-in of applicable incoming shipments, and is responsible for assuring that items to be shipped and those received meet applicable EPD and regulatory requirements.
1.3.9 Health Physics Reports to the Manager of Operations and is reeponsible for the implementation of the health physics program such that EPD meets appli;able regulations and the NRC Operating License.
1.4 DUTIES OF RESPONSIBLE QA/QC INDIVIDUAL The person designated by EPD as having overall QA/QC functional task authority and responsibility shall have the responsibility and authority delineated in job descriptions on file at EPD.
In exercising the authority the QA/QC individual shall:
(1) Conduct periodic audits of all aspects of design, manufacturing, 1134 186 m
NPD-STD-001 Rev. 3 Page 8 of 33 1.4 DUTIES OF RESPONSIBLE QA/QC INDIVIDUAL (Cont'd) inspection, testing, and documentation pertinent to the completed product to verify adherence to procedures.
(2) Monitor work on items covered by this NPD-STD-001 and have the authority to stop unsatisfactory wo.-k and control further processing, delivery, or installation of non-conforming material.
(3)
Identify quality problems and recommend and provide solutions for these problems.
(4) Apprise management of the status of the Quality Assurance Program by means of memorandum reports.
(5) Prepare, interpret, revise and administer the QA Program and the associated policies and procedures.
1.5 QUALIFICATIONSOFRESPONSIBLE0A/QCINDIVIDUA The individual designated by EPD as being responsible for the QA/QC program shall be the QA/QC Specialist. This person shall have had at least 2 years experience in QA/QC-related work and applicable experience in the nuclear or similar high-technology field. Other detailed qualifications are on file at EPD.
1.6 AUTHORITY TO STOP UNSATISFACTORY WORK The EPD-designated QA/QC individuals have the responsibility and authority to stop unsatisfactory work and control further processing, delivery or installation of nonconforming material.
Continuation of the rejected work or use of rejected parts must 1134 187 M
NPD-STD-001 Rev. 3 Page 9 of 33 1.6 AUTHORITY TO STOP UNSATISFACTORY WORK (Cont'd) be proceeded by an appropriate signed waiver or written QA/QC authorization.
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FIGURE 1 I
ENGINEERED PRODUCTS DEPARTMENT FUNCTIONAL ORGANIZATION CHART Dayton Laboratory I
i Engineered Products 1
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NPD-STD-001 Rev. 3 Page 11 of 33 2.0 QUALITY ASSURANCE PROGRAM 2.1 PURPOSE The purpose of this section is to outline the quality assurance program used by the Engineered Products Department in order to fulfill require-ments of 10 CFR Part 71, Appendix E,10 CFR 50, Appendix B or other Quality Assurance Programs. Management of r > (outside the specific QA section) shall regularly assess the scope, status, implementation and ef fectiveness of the quality assurance (also known as QA/QC) program to assure that the program is adequate and complies with 10 CFR Part 71, Appendix E,10 CFR 50, Appendix B and/or other applicable criteria (See Section 18.0 Audits).
2.2 QUALITY ASSURANCE MANUAL The quality assurance program established by the Engineered Products Department shall be described in NPD-STD-001 Quality Assurance Procram Manual. Provisions shall be established to control the distribution of the QA Manuals and the revisions thereto.
2.3 OUALITY ASSURANCE APPLICABILITY Provisions shall be established for communicating to responsible organization and individuals that quality policies, QA Manuals and QA procedures are mandatory requirements which must be implemented and enforced.
2.4 ITEMS CONTROLLED BY QA PROGRAM The quality program controlled by NPD-STD-001 shall apply to all safety related systems, structures and components relating t? power reactor components, type B shipping packages and/or other items sJ designated 1134 190 M
NPD-STD-001 Rev. 3 Page 12 of 33 2.4 ITEMS CONTROLLED BY QA PROGRAM (Cont'd) by the Engineered Products Department. A cross reference between NPD-STD-001 and 10 CFR 50, Appendix B and 10 CFR 71, Appendix E is shown in Figure 2.
2.5 RESOLUTION OF QUALITY DISPUTES Procedures shall be established and followed in resolving disputes involving quality arising from differences of opinion between QA/QC personnel and other department personnel.
2.6 INDOCTRINATION AND TRAINING PROGRAMS Indoctrination and training programs shall be established such that:
(1) Personnel responsible for performing quality-related activities are instructed as to the purpose, scope, and implementation of the QA manuals, instructions, and procedures.
(2) Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
(3) The scose, the ob,iactive, and the method of implementing the indoctrination and training program are documented.
(4) Proficiency of personnel performing quality-affecting activities is maintained by retraining, reexamining, and/or recert*fying.
2.7 OUALITY-RELATED ACTIVITIES All quality related activities shall be perfomed with equipment appropriate to the task required, under suitable environmental condit ons i
and following the satisfaction of required test and inspection pre-requisities.
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NPD-STD-001 Rev. 3 Page 13 of 33 Figure 2 iis mai ECMGE wC5sm~em=wyH8 10CFR50 APPENDIX B AND
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b b b b b o b'o b b b o o o 'o b'o o 10CFR71 APPENDIX E CRITERIA X
(1) Organization X
(2)
Q.A. Program X
(3) Design Control X
(4) Procurement Document Control (5)
Instructions, Procedures and X
Drawings X
(6) Document Control (7) Control of Purchased Materials, X
Parts and Components (8)
Identification and Control of X
Materials, Parts and Components X
(9) Control of Special Processes X
(10)
Inspection X
(11) Test Control (12) Control of Measuring and Test X
Equipment (13) Handling, Storage and Shipping X
(14)
Inspection, Test and Operating Status X
(15) Non-Conforming Material, Parts or Components X
(16) Corrective Action X
l(17) Quality Assurance Records X
(18) Audits Cross Reference Between Criteria of 10CFR50, Appendix B and 10CFR71, Appendix E and NPD-STD-001.
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NPD-STD-001 Rev. 3 Page 14 of 33 3.0 DESIGN CONTROL 3.1 DESIGN CONTROL MEASURES Procedures shall be established by the Engineered Products Department ir.
order to assure that design activities are carried out in a planned, controlled and orderly manner.
3.2 DESIGN DOCUMENTS The design control procedures shall establish measures to correctly translate applicable regulatory requirements and design bases into specifications, drawings, written procedures,- instructions and/or any other documents that may be established or required by EPD or EPD customers.
3.3 OUALITY STANDARDS Procedures shall be established to assure that quality standards are specified in design documents and to assure that deviations and changes from these quality standards are controlled.
3.4 DESIGN REVIEWS Provisions for design reviews shall be established to assure that:
(1) design characteristics can be controlled, inspected and tested, and (2) inspection and test criteria are identified.
3.5 DESIGN VERIFICATION Measures shall be established to provide that proper selection and accomplishment of design verification or checking processes such as 1134 193 m
NPD-STD-001 Rev. 3 Page 15 of 33 3.5 DESIGN VERIFICATION (Cont'd) design reviews, alternate calculations or qualification testing are performed. Test or qualification programs, if used, should be carried out under design conditions or design-equivalent conditions were applicable.
3.6 DESIGN REVIEW INDIVIDUALS
/
The individuals responsible 'or design verification shall be other than the original designer. Written procedures snall identify the positions or groups responsible for design reviews and other design verification activities and their authority and responsibility.
3.7 CHANGES TO DESIGNS AND SPECIFICATIONS Changes to design and specifications shal! be subject to the same controls and approvals that are applicable to the original design unless EPD
. designates another qualified organization for control : nd approvals, l134 194 M
a NPD-STD-001 Rev. 3 Page 16 of 33 4.0 PROCUREMENT DOCUMENT CONTROL 4.1 PROCEDURES FOR PROCUREMENT DOCUMENTS Specific EPD procedures shall be established that clearly deline.
the sequence 3f actions required in the preparation, review, approval and control of procurement documents.
4.2 PROCUREMENT DOCUMENT DESCRIPTIONS Procurement documents for materials, equipment or services shall have provisions which include the following items as applicable to the contracts with the vendors:
(1)
Identification of the applicable regulatory and/or EPD regt 'ements which must be complied with and described in the vendors quality program.
(2) A reference to the design basis technical requirements including to the extent required applicable regulatory require-ments, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
(3)
Identification of the documentation to be prepared, maintained and submitted to EPD for review and approval.
(4)
Identification of records which are to be retained, controlled and maintained by the vendor, and of those records to be delivered to EPD prior to use or installation of the items procured.
(5) Inclusion of EPD's right to have access to the vendors' facilities and records for source inspection and audit.
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NPD-STD-001 Rev. 3 Page 17 of 33 4.3 CHANGES TO PROCUREMENT DOCUMENTS Changes and revisions to procurement documents shall be subject to at least the same review and approvals as the original document.
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NPD-STU-001 Rev. 3 Page 18 cf 33
- 5. 0 INSTRUCTIONS, PROCEDURES AND ORAWINGS 5.1 QUALTIY ACTIVITIES Activities affecting quality shall be prescribed and accomplist.ed in accordance with documented instructions, procedures, drawings cr other applicable docueents.
5.2 SPEC 3FIC PROCEDURES Procedures shall be estrMished which clearly delineate the seqJence of actions to be acccep?ishLd in the preparation, review, approval and control of instructions, procedures and drawings.
5.3 QUALITY ASSURANCE CONCURRENCE The QA organization shall review and concur with:
(1) inspection placs, (2) test, calibratic and special process procedures; (3) drawings and tpecifications.
Changes or acceptable alternatives to any of the above must be reviewed and accepted by the QA organization.
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NPD-STD-001 Rev 3 Page 19 of 33 6.0 DOCUMENT CONTROL 6.1 SPECIFIC PROCEDURES Specific procedures shall be established to control, review, approve, issue and revise documents prior to their release to assure that they are adequate and that the quality requirements are stated to the extent required by EPD.
6.2 CHANGES TO DOCUMENTS Documents shall be reviewed and approved by same organizations that performed the original review and approval or by other qualified responsible organizations delegated by applicable EPD personnel.
Approved changes shall be included in instructions, procedures, drawings and other documents prior to implementation of the changes.
6.3 AVAILABILITY OF DOCUMENTS Documents shall be avilable at the location where the activity will be perfomed prior to the connencing of the work.
6.4 DOCUMENT LIST A master list or equivalent shall be established to identify the correct revision number of instructions, procedures, specifications, drawings and procurement documents.
I134 198 M
NPD-STD-001 Rev. 3 Page 20 of 33 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7.1 EVALUATION OF SUPPLIERS Qualified personnel shall evaluate a supplier's capability to provide acceptable quality services and products. Results of the supplier's evaluation shall be documented and filed.
7.2 METHODS OF EVALUATION Evaluation of suppliers shall be based on but not limitec to one or more of the following.
(1) The suppliers capability to comply with those elements of Appendix B of 10CFR50, Appendix E of 10CFR71 or any other appropriate criteria applicable to the type of material, equipment or services being procured.
(2) A review of previous records and perfomances of suppliers who have provided similar articles of the type being procured.
(3) A survey of the supplier's facilities and QA programs to determine his capability to supply a product which meets the design, manufactur-ing and gality requirements.
7.3 VENDOR SURVEILLANCE If vendor surveillance is required during vendor fabrication, inspection, testing and shipment of materials, equipment and components, the surveillance shall be planned and performed in accordance with written procedures to assure conformance to the purchase contract requirements.
7.4 VENDOR-SUPPLIED RECORDS A vendor shall supply to the extent required by EPD at least the following records:
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NPD-STD-001 Rev. 3 Page 21 of 33 s
7.4 VENDOR-SUPPLIED RECORDS (Cont'd)
(1) Documentation that identifies the purchased material or equipment and the specific procurement requir2ments met by the items.
(2) Documentation that identifies any orocurement requirements which have not been met together witn a description of those nonconformances dispositioned " accept as is" or " repair" or equivtlent terminology.
7.5 RECEIVING INSPECTION - PURCHASED ITEMS Purchased materials or equipment when received at the Dayton Laboratory shall undergo receiving inspection by QC personnel for conformance to procurement documents, prior to release for use in order to assure the following:
(1) The item received is properly identified anc corresponds with the identification on receiving documentation.
(2) Received items and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions, prior to installation or ute.
(3)
Inspection records or certificates of conformance attesting to the acceptance of material and components are available prior to installation or use.
(4)
Items accepted and released are identified as to their inspectior status prior to forwarding them to a controlled storage area or releasing them for further work.
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NPD-STD-001 Rev. 3 Page 22 of 33 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS 8.1 CONTROL OF MATERIALS, PARTS AND COMPONENTS PROCEDURE Identification and control of materials, parts and components, including partially fabricated subassemblies, shall be in accordance with specific EPD procedures.
8.2 ITEM IDENTIFICATION The specific EPD procedures for control of materials, parts and components shall assure that identification is maintained either on the item or on records traceable to the item to preclude use of incorrect or defective items. The location and the method of identification shall not affect the fit, function or quality of the item being identified.
8.3 IDENTIFICATION OF SAF'.Y RELATED ITEMS Identification of items important to the function of safety-related systems and componenets shall be traceable to the appropriate documentation such as drawings, specifications, purchase orders (contracts), manufactur-ing and inspection documents, deviation reports and physical and chemical mill test reports.
8.4 RELEASE OF CONTROLLED ITEMS Correct identiffcation of items shall be verified and documented prior to release for fabrication, assembling and installation.
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NPD-STD-001 Rev. 3 Page 23 of 33 9.0 CONTROL OF SPECIAL PROCESSES 9.1 SPECIAL PROCESS CONTROL Special processes such as welding, heat treating, non-destructive testing and cleaning shall be procedurally controlled.
9.2 SPECIAL PROCESS QUALIFICATIONS Procedures, equipment and personnel connected with special processes shall be qualified in accordance with applicable codes, standards and specifications.
9.3 RECORDS Records of the qualification of procedures, equipment and personnel associated with special processes shall be established, filed and kept current.
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NPD-STD-001 Rev 3 Page 24 of 33 10.0 INSPECTION 10.1 INSPECTION PROCEDURES An inspection program shall be established, documented and accomplished in accordance with written and controlled pt,.2dures. The program shall verify conformance of quality affecting activities with the quality affecting requirements.
10.2 INSPECTION PERSONNEL Inspection shall be done by personnel independent from the individuals perfonning the activity being inspected.
10.3 INSPECTOR QUALIFICATIONS Inspection personnel shall be qualified in accordance with applicable codes, standards and EPD training programs to the extent required by EPD. Personnel qualifications and certifications shall be kept current.
10.4 INSPECTION OF MODIF: CATIONS AND REPAIRS Modifications, repairs, etc. shall be inspected in accordance with the original design and inspection requirements or acceptable alternatives as approved by appropriate design and QA/QC personnel.
10.5 INSPECTION HOLD POINTS Where mandatory hold points, witness points or inspection points exist such points shall be indicated in the above documents and work shall not proceed beyond these points without QA/QC release.
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NPD-STD-001 Rev. 3 Page 25 of 33 11.0 TEST CONTROL 11.1 TEST PROGRAMS Test programs when used to demonstrate that an item or component will perform satisfactorily in service shall be established, documented and accomplished with written, controlled procedures.
11.2 MODIFICATIONS, REPAIRS AND REPLACEMENTS Modifications, repairs and replacements to items and components shall be tested in accordance with the original design and testing requirements.
Alternative requirements may be used if deemed acceptable by appropriate personnel, 11.3 TEST RESULTS Test results shall be documented, evaluated and acceptability determined by qualified responsible personnel as defined by EPD.
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NPD-STD-001 Rev. 3 Page 26 of 33 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 12.1 CALIBRATION OF INSTRUMENTS Each unit of measuring equipment shall be routinely calibrated against an appropriate master or standard. Calibration of measuring equipment and instrumentation shall occur at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics and other conditions affecting the measurement.
12.2 E0VIPMENT IDENTIFICATION Each unit of measuring and test equipment shall be pennanently identified where applicable with a gage number and/or code number. An alternate method of control, dependent upon the physical configuration of the unit, will be used when a unit cannot be permanently identified.
The identification shall be traceable to calibration test data for each specific piece of equipment.
12.3 OUT-0F-CALIBRATION CONDITIONS Any unit of measuring equipment found to be out of calibration shall be appropriately marked and immediately segregated for repair or re-placement and shall not be used again until it has been recalibrated to the required standards of accuracy. Appropriate measures shall be taken and documented to determine the validity of previous inspections perfonned when measuring and test equipment is found to be out-of-calibration.
12.4 CALIBRATION TO STANDARDS All devices shall be calibrated against certified standards which have shown valid relationships to the nationally recognized or other estab-lished reference standards, in accordance with manufacturer's specifica-tions for a measuring device.
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NPD-STD-001 Rev. 3 Page 27 of 33 13.0 HANDLING, STORAGE AND SHIPMENT 13.1 HANDLING, STORAGE AND SHIPMENT Special handling, preservation, storage, cleaning, packaging and shipping requirements shall be established and accomplished by qualified individuals in accordance with predetemined work and inspection instructions.
13.2 REGULATORY REQUIREMENTS All regulatory requirements shall be met prior to shipment of items subject to NPD-STD-001 including checks for critical safety character-istics and general condition and integrity, and a final inspection for radiological control and compliance to U.S. Department of Transportation and, if applicable, International Atomic Energy Agency or other regulations for packaging, marking, labeling, etc. All necessary shipping papers shall be prepared.
13.3 TRANSPORTATION MONITORING Departure, arrival time and destination of items shipped shall be established and monitored to a degree consistent with safe trans-portation of the package.
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NPD-STD-001 Rev 3 Page 28 of 33 14.0 INSPECTION, TEST AND OPERATING STATUS 14.1 COMMUNICATION OF STATUS Procedures shall be established to assure that identification of inspection, test and operating s.atus of items subject to NPD-STD-001 shall be known by affected organizations.
14.2 STATUS INDICATORS Application and removal of all status indicators shall be procedurally controlled. Typical status indicators are inspection stamps, welding stamps (if used), tags, markings, etc. as appropriate to the item subject to NPD-STD-001.
14.3 BY-PASSING INSPECTIONS Any by-passing of required inspections, tests and other critical operations shall be controlled by applicable procedures.
14.4 NON-CONFORMING ITEMS Procedures shall be established to assure that the status of non-conforming, inoperative or malfunctioning packages or components shall be identified to prevent inadvertent use.
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NPD-STD-001 Rev. 3 Page 29 of 33 15.0 NON-CONFORMING MATERIAL, PARTS OR COMPONENTS 15.1 NOTIFICATION OF NON-CONFGRMING ITEMS Identification, documentation, segregation, review disposition and notification to affected organizations of non-conforming materials, parts and components shall be procedurally controlled.
15.2 DOCUMENTATION Documentation regarding non-conforming items shall identify the non-conforming item, describe why the item is in non-conformance, describe the disposition of the non-conformance, describe the inspection requirements of the item, and include proper signature approvals of the disposition of the non-conforming item.
15.3 IDENTIFICATION Non-conforming items shall be segregated from acceptable items and identified as discrepant until dispositioned.
15.4 REINSPECTION OF REPAIRED / REPLACED ITEMS Acceptability of rework or repair of materials, parts, components and :;ystems shall be verified by proper reinspection and retesting the item as originally inspected and tested or by a method which is at least equal to the original inspection and test method.
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NPD-STD-001 Rev. 3 Page 30 of 33 16.0 CORRECTIVE ACTION 16.1 SPECIFIC PROCEDURES Specific procedures shall be established by the Engineered Products Department controlling the evaluation of conditions adverse to quality and the detennination of the need for corrective action.
16.2 ACTION TO PRECLUDE RECURRENCE When it is determined that a condition adverse to quality exists, a corrective action shall be initiated to preclude recurrence.
16.3 CORRECTIVE ACTION FOLLOW-UP When corrective action is taken, follow-up reviews shall be
- enducted to verify the proper implementation of the corrective actions and th:t documentation was properly closed out.
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,em NPD-STD-001 Rev. 3 Page 31 of 33 17.0 QUALITY ASSURANCE RECORDS 17.1 QUALITY ASSURANCE RECORDS The Engineered Products Department shall maintain sufficient records in order to provide documentary evidence of the quality and safety of items and the activities affecting quality and safety. These records shall be identifiable and retrievable, and a list of the records and the storage locations of the records shall be maintained.
17.2 RETENTION OF 0.A. RECORDS Design-related records shall be maintained for a length of time appropriate to usage life of the item subject to NPD-STD-001; all other records shall be maintained for at least two years.
17.3 TYPES OF QUALITY ASSURANCE / QUALITY CONTROL RECORDS The QA/QC records that EPD shall retain may include, but are not limited to, the following items:
(1) operating logs; (2) results of reviews, inspections, tests, audits and material analyses; (3) personnel, procedure and equipment qualification; (4) drawings, specifications, procurement documents, calibration procedures and reports; (5) nonconformance and corrective action reports.
17.4 INSPECTION AND TEST RECORDS To the extent applicable, inspection and test documents shall include, but not be limited to, the following items:
(1) descriptions of the types of observations; I134 210
NPD-STD-001 Rev. 3 Page 32 of 33 17.4 INSPECTION AND TEST RECORDS (Cont'd)
(2) evidence of the completion and verification of a manufacturing, inspection or test operation; (3) date and results of the inspection or test; (4) any information relating to conditions adverse to quality; (5) identification of the inspector or the data recorder; (6) the evidence relating to the acceptability of the results.
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NPD-STD-001 Rev. 3 Page 33 of 33 18.0 AUDITS 18.1 AUDIT PROCEDURES The Engineered Products Department shall establish a specific audit procedure which deliniates the steps to be taken to carry out an audit of the QA/QC program. These audits shall be carried out by personnel not having direct responsibilities in the areas being audited.
18.2 AUDIT RESULTS Audit results shall be documented and then reviewed with the management having direct responsibility in the area audited.
18.3 DEFICIENT AREAS AND REAUDITS If the audit reveals deficiencies, the person responsible in the deficient area shall take action to correct the deficiencies.
The deficient areas shall be reaudited on a timely basis to verify that the corrective action which minimize recurrence of the deficiencies have been implemented.
18.4 AUDIT PERIOD Audits of the QA/QC Program of EPD shall be performed periodically in accordance with EPD Audit Procedures and based on safety significance of the activity being audited, but no less often than every 18 months.
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