ML20207N660
| ML20207N660 | |
| Person / Time | |
|---|---|
| Site: | 07100619 |
| Issue date: | 11/21/1986 |
| From: | Crawford H, Eggers P EGGERS, RIDIHALGH PARTNERS, INC. |
| To: | |
| Shared Package | |
| ML20207N650 | List: |
| References | |
| QAM-001, QAM-1, NUDOCS 8701140340 | |
| Download: ML20207N660 (91) | |
Text
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EGGERS RIDIHALGH PARTNERS, INC.
1445 Sumit Street Columbus, Ohio 43201
., 4 QUALITY ASSURANCE PROGRAF 1 Prepared by:
Herman L. Crawford V
f0$hfffj}{f,,
D Approved by:
Philip E. Eggers
// /
President, Eggers Ridfhalgh Partners Copy No.
Assigned to:
l PAGE REVISION STATUS Page Rev.
Page Rev.
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Eggers Ridihalgh Partners, Inc.
1445 Summit Street REVISIONS
' Columbus, Ohio 43201 Description of Revision f-Revised by:
Date:
Approved by:
Date:
Document Rev.
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TABLE OF CONTENTS Page TITLE PAGE I
PAGE REVISION STATUS II REVISIONS III TABLE OF CONTENTS IV FORWARD VII 1.0 ORGANIZATION 1-1 2.0 QUALITY ASSURANCE PR03R/M 2-1 2.1 Management 2-1
- 2. 7.
Personnel Qualifications 2-1 2.3 Quality Assurance Policies, Goals and Objectives 2-2 2.4 Quality Assurance Manual Distribution 2-2 2.5 ERP Procedure List 2-5 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 DocumentChangeControl(ExcludingDrawings) 6-2 6.5 Drawing Control 6-3 6.6 Document Control for Suppliers 6-3 6.7 Document Availability 6-4 7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT AND SERVICES 7-1 7.1 Supplier Evaluation 7-1 7.2 Procurement Requirements 7-1 7.3 Suppiter Surveillance 7-2 Document
-0M Rev. O IV
TABLE OF CONTENTS (CONTINUED)
Page
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7.4 Receiving Inspection 7-3 7.5 Supplier Audit.
7-3 8.0 IDENTIFICATION AND CONTROL OF COMPONENTS AND MATERIALS 8-1 8.1 Components 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 INSPECTION 10-1 10.1 Inspection Procedures 10-1 10.2 Supplier Inspection 10-2 10.3 Indirect Control 10-2 11.0 TEST CONTROL 11-1 11.1 Test Procedures 11-1 11.2 Test Records 11-2 11.3 Test Control for Procured Items 11-3 11.4 Modifications, Repairs and Replacements 11-3 12.0 CONTROL OF MEASURING Af!D TEST EQUIPMENT 12-1 12.1 ERP's Equipment Calibration and Control 12-1 12.2 Measuring and Test Equipment at Subcontractors 12-1 12.3 Inspection Validity 12-2 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 Document Rev.
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TABLE OF CONTENTS (CONTINUED)
Page 14.2 Establishment of Examinations and Tests 14-1 14.3 Hold Points 14-1 14.4 Checklists of Examinations, Tests and Inspections 14-2 14.5 Examination of 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 15.1 Internal Nonconformances 15-1 15.2 Subcontractor Control 15-1 15.3 Verification of Rework or Repair Acceptability 15-1 15.4 Nonconformance Disposition 15-2 15.5 Assessment of Nonconformances 15-2 16.0 CORRECTIVE ACTION 16-1 17.0 QUALITY ASSURANCE RECORDS 17-1 17.1 Maintenance and Access to Records 17-1 17.2 Contents of Record Files 17-1 17.3 Permanent Records 17-2 17.4 Non-Permanent Records 17-2 17.5 Record Storage Facilities 17-2 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 Document heet QAM-001
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FOREWORD This program defines and describes the basic policies and procedures used by Eggers Ridihalgh Partners, Inc. (ERP) to establish quality assurance require-ments for all activities affecting safety-related functions of systems and components, including transport casks, under ERP control. The activities in-clude designing, purchasing, fabricating, handling, shipping, storing, inspect-4 ing, testing, operating and using, maintaining, repairing and modifying.
ERP's top management has approved and fully supports adherence 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, 10CFR50 Appendix B and 10CFR71, Subpart H (latest edition of these documents). This program, in full or in part, is subject to review and comment by customer representatives.
Revisions or additions to the program will be made as necessary to conform to i
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 program 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 ERP's management at least once a year to assure conformance to current practices and requirements.
The Quality Assur1nce (QA) Program for ERP was established and implemented by the President of ERP.
The QA Program has the full support of ERP's management and all ERP's employees and consultants shall adhere to its pro-visions.
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1.0 ORGANIZATION The Quality Assurance organization within Eggers Ridihalgh Partners, Inc.,
(ERP), consists of a Quality Assurance Manager with the overall responsi-bility for providing quality assurance of design, fabrication and operation.
This person has a staff of quality assurance personnel, as required, report-ing to the QA Manager, and they are assigned by the QA Manager to perform QA functions.
All quality assurance personnel report directly to the Quality Assurance Manager. The Quality Assurance Manager reports to the President of Eggers Ridihalgh Partners, Inc.
This reporting system has been selected specifically to permit the Quality Assurance Manager sufficient authority and autonomy to implement and direct ERP's Quality Assurance program, to assure conformance to quality require-ments, and to function independently of undue influences and responsibilities for schedules and costs (See Figure 1-1).
Quality Assurance personnel shall have the responsibility and authority 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 implenentation 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 follows:
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PRESIDENT EGGERS RIDIHALGH PARTNERS QUALITY ASSURANCE MANAGER OF ENGINEERING MANAGER PROJECT ENGINEER I
DESIGNATED QA PERSONNEL SUBCONTRACTORS FIGURE l-1.
EGGERS RIDIHALGH PARTNERS ORGANIZATION Document Rev.
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a.
A bachelor's degree in a technical field;
- b.
At.least two years of experience in engineering and/or manufacturing; c.
A working knowledge of applicable quality-related codes, standards, regulatory and statutory requirements; d.
The abiliti 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 the responsibility for equipment owned and operated by ERP is retained by ERP.
The Quality Assurance Manager, upon notification of need for further direction or resolution of QA problems, has the authority to communicate or direct communications with any contractor doing business with ERP.
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2.0 QUALITY ASSURANCE PROGRAM The Quality Assurance Program is comprised of those planned and systematic actions necessary to assure adequate confidence that all Eggers Ridihalgh Partners (ERP) activities 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 reliability on which safety and performance of these activities were evaluated.
The ERP Quality Assurance Program applies to the design, manufacture and operation of casks, liners, mobile solidification units, demineralization units and decontamination units and the operation of transportation trailers.
2.1 Manaaement In order to assure effective implementation, assess the scope and status, and determine the effectiveness of the QA Program, the President of ERP has appointed a member of Senior Management, with broad authority, to execute these functions.
Programmatically, 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, NRC Regulatory Guide 1.58, ANSI N45.2.12 and other applicable documents.
Further, an indoctrination and training I
program is established such that:
a.
Personnel responsible for performing quality-related activities l
are instructed as to the purpose, scope, and implementation of quality-related manuals, instruction, and procedures; l
b.
Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being perforned; i
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c.
Tha scope, objective, and the method of implementing the indoc-trination and training program are documented; d.
Proficiency of personnel performing quality-affecting activities is maintained by retraining, re-examining and/or recertifying.
2.3 Quality Assurance Policies, Goals and Objectives It is the policy of ERP that all activities which are governed by the Code of Federal Regulation, license, Certification of Compliance, Letter of Approval, or other regulatory requirements, be conducted according to 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 ERP's employees and consultants. All procedures which are required to assure health and safety are required to be submitted to the QA Review Board for approval prior to implementation.
It is the stated goal and objective of the ERP Quality Assurance Pro-gram to provide those mechanisms and environments necessary to achieve a reliable Quality Assurance Program for all activities which affect health and safety, or are specified by a regulatory requirement. This gcal 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 ERP personnel shall be resolved by the President of Eggers Ridihalgh Partners.
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.
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2.5 ERP Procedurn List Table 2-1 provides a sumary listing of written ERP procedures cross-referenced to the 18 criteria of 10CFR71, Subpart H, and 10CFR50, Appendix B.
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TABLE 2-1.
ERP PROCEDURES CROSS-REFERENCED TO THE 18 CR1TERIA 0F 10CFR71, SUBPART H & 10CFR50, APPENDIX B Key to Regulatory Regulatory Criteria Title Criteria I.
Organization II.
Quality Assurance Program III.
Design Cont'rol IV.
Procurement Document Control V.
Instructions, Procedures and Drawings VI.
Document Control VII.
Control of Purchased Material, Equipment, and Services VIII.
Identification and Control of Materials IX.
Control of Special Processes Inspection X.
XI.
Test Control XII.
Control of Measuring and Test Equipment XIII.
Handling, Storage and Shipping XIV.
Inspection, Test, and Operating Status XV.
Nonconforming Materials, Parts, or Components XVI.
Corrective Action XVII.
Quality Assurance Records XVIII.
Audits ERP Key to Regulatory Procedure ERP Procedure Title Criteria Addressed Number QAP 01.1 QA Program Control I, VI, XVIII QAP 02.1 QA Indoctrination and Training II, III, VI, XVII, XVIII QAP 03.1 Design Control III QAP 04.1 Control of Purchased Material, Equip-IV, VII ment, and Services Document QAM-001 0
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i TABLE 2-1.
ERP PROCEDURES CROSS-REFERENCED TO THE 18 CRITERIA 0F 10CFR71, SUBPART H & 10CFR50, APPENDIX B (CONTINUED)
ERP Key to Regulatory Procedure ERP Procedure Title Criteria Addressed Number QAP 16.1 Deviation Report and Corrective Action XVI QAP 18.1 ERP QA Self-Audit Checklist XVIII Document QAM-001 0
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3.0 DESIGN CONTROL The Design Control Program at ERP ensures that design characteristics, especially those related to safety, are controlled, inspected, and tested; that designs developed by ERP 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.
Various individuals at ERP, including consultants, bear responsibility for
- the selection and control of design parameters a.nd for the development of design documents. 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 Quality Assurance to ensure that suitable design controls are applied to such activities as seismic, stress, thermal, hydraulic, radiation, and accident analyses; compatibility of materials; and accessibility for inservice inspection, maintenance, and repair.
The Project Engineer also serves as a liaison between the Drafting Department and Quality Assurance. The Project Engineer supervises the Design Draftsperson and confirms that design specifications are properly referenced on drawings and other design documen'ts.
b.
The Design Draftsperson produces accurate and precise drawings that conform to the design specifications and that properly list or reference those specifications.
c.
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 is was designed.
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d.
The Quality Assurance Manager, or a designated QA representative, also reviews the design to confirm that all quality assurance requirements have been properly identified and that the requirements have been met in the finished design.
f.
The Engineering Manager reviews the design and confirms that the total design package. meets all regulatory requirements and is ready for re-lease and fabrication.
The Design Control Program also provides for design reviews at regular intervals to assure that design characteristics can be controlled, inspected, and testied, and that inspection and test criteria are identified.
Formal design reviews take place at least once during the project, and include the Engineering Manager and Project Engineer, and Design Checker, and any other individuals or groups involved in the development of the design. 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.
Materials, parts, equipment, and processes are controlled according to pro-curement procedures outlined in Section 7.0 of this document. The procure-ment documents specify all design base requirements including the applicable regulatory 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 requisit-ioning 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.
Design changes and/or design documents (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.
ERP drawing control procedures ensure that obsolete draw-Document QAM-001 0
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I ings are removed from files to preclude their use at the time a revised drawing is released.
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4.0 PROCUREMENT DOCUMENT CONTROL The procurement of materials, components, services at, or services affect-ing assemblies, for use of customer sites or other licensed activities is accomplished with a written Purchase Order.
Purchase Order forms are con-trolled, 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 pro-cedures published in ANSI N45.2.13.
It is ERP's policy that procurement documents, except for administrative supplies, are reviewed by the cognizant manager. Where the 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 that complete information is provided to identify:
a.
The applicable 10CFR Part 50, Appendix B and 10CFR71, Subpart H require-ments 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 inspection requirements, and special process instructions; c.
The documentation to be prepared, maintained, and submitted to the l
purchaser for review and approval; l
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; i
f.
Quality requirements, which must be correctly stated, inspectable and j
controllable with adequate acceptance and rejection criteria.
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The individual authorized to control and release Purchase Orders prepares 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 ccpies shall be maintained in accordance with document control procedures in effect at time of preparation.
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5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS Activities affecting product quality in design, manufacturing,. operation, 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 herein 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 available for review by customer representatives.
Procedures and instructions are prepared by cognizant personnel. All instructions and procedures are maintained current with a documented method of revision.
Instructions, proceoures 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.
l ERP's Quality Assurance organization reviews and concurs with inspection plans; test, calibration and special process procedures; drawings and specifications and their changes; and verifies that methods for complying with regulations, such as Code of Federal Regulations (10CFR50, 10CFR71) are specified in instructions, procedures and drawings requiring such verifications.
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ERP's QA organization shall review instructions, procedures and drawings to ensure that adequate quantitative and qualitative acceptance criteria are described.
The ERP procedure for document preparation shall be f' llowed exactly in o
the course of preparation, review, approval, and control of' instructions and procedures. Drawings shall be prepared, reviewed, approved, and controlled in accordance with engineering department procedures.
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6.0.
DOCUMENT CONTROL Written ERP proced'ures 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 documents 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 the Engineering Manager. 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 con-formity with design requirements. The review process is the same for document changes.
All procedures and instructions are reviewed by ERP's Quality Assurance.
Documents which are not safety-related are approved by the cognizant manager. All safety-related documents are reviewed and approved by ERP's QA Review Board.
6.3 Document Control Execution of an effective document control system requires the following:
Each document shall have an identifying number and a complete a.
descriptive title.
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b.
Each document shall have means for identifying the revision status and the effective date of each revision.
The number of copies made and issued by 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 history copy maintained in the document file.
Procedures and their changes are distributed on a formal basis and are a standard format.
In cases of emergency, 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 customer or subcontractor are accompanied by a document transmittal letter showing the drawin~g and/or document number, revision, and date of transmittal. A copy
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of the transmittal letter 1: kept in the project file.
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 ERP Change Request Forms. These forms are also used to submit proposed changes to customers when their approval is required prior to change incorporation.
All proposed changes are reviewed by 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 Document Rev.
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operations. Quality Assurance shall approve changes only after receipt of a completed Change Request with authorized approval signatures.
Approved change documents are attached to the original document and are incorporated in the document.. The cnanged document will be distributed by Quality Assurance to the individuals indicated in the document distribution log.
6.5 Drawing Control Drawing changes are made using the Design Change form.
The form is a one-part reproducible form used to specifically delineate a pro-posed change. The form is also used to submit proposed changes to customers when their approval is required prior to change incorporation.
Minor design changes may be recorded directly on design drawings in the revision block. When this procedure is followed, the Design Change. form is not required.
All proposed changes are reviewed by.the Engineering Manager 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 Design Change. Approved changes are maintained in a Design Change file.
When changes are extensive, the Design Change form may be attached directly to the drawing (s) re-issued.
6.6 Document Control for Suppliers Subcontractors and vendors are required to maintain an effective drawing change control system when these drawings are provided as part of the contractual requirements.
Procurement of articles to ERP's design specifications requires a document control system that ir.cludes assurance of notification of changes to the subcontractor or vendor, verification of change incorporation and appropriate identification of those items on which Document QAM-001 0
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the change is incorporated.
Procurement of articles to subcontractor's design specifications re-quires a document control system that assures notification of ERP by the subcontractor of the proposed change, approval of the change by ERP 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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l 7.0 CONTROL OF PURCHASED MATERIALS, EQUIPMENT AND SERVICES The procurement control methods ERP uses 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 subcontractors 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 provisi.ons for. vendor evalua-tion, review of procurement requirements and surveillance of vendor's' facility.
7.1 Supplier Evaluation ERP Engineering, Procurement, and Quality Assurance personnel parti-cipate in evaluation of procurement sources.
Recommendation of procurement sources is based on these evaluations.
Results of
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supplier evaluations performed prior to contract award are documented and filed. The evaluations cover review of capabilities and facilities for technical, manufacturing and quality performance, and include any or all of the following 'as appropriate:
a.
Historical performance data, particularly in product quality and delivery; b.
Review and comment on supplier's quality assurance program; c.
Source audits to verify supplier's implementation of his quality assurance program, as required; d.
Source qualification programs.
The evaluation considerations include the elements of the NRC's Quality 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 document (Purchase Order) which may include procurement specifications.
This document details the aspects of supplier quality assurance, for Document Rev.
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example, inspec. tion ~ reports, provisions for inspection, equipment calibratiori prior to use, and prbvisions for inspection after com-ponent repair.
The procurement specification may also require the successful bidder to submit the following for ERP's review:
a.
Special process procedures for performing welding, heat treat-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; e.
Te.st procedures in accordance with applicable codes and standards.
7.3 Supplier Surveillance ERP 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; i
b.
Monitoring heat treatment, welding, cleaning, preserving, packing and packaging activities; c.
Verifying supplier conformance with established procedures, such as:
1.
use of ERP accepted drawings and procedures 2.
use of accepted product and process quality planning 3.
document change control 4.
material identification and traceability control 5.
control and calibration of measuring equipment 6.
control of major repair welding d.
Reviewing completed product quality documentation and/or check-lists prior to release of equipment for shipment.
Documentation of nonconformances shall be provided by suppliers as prescribed in Section 15 of this program.
ERP's quality assurance personnel perform a review to assure the validity of supplier documentation during in-process, testing and Document QAM-001 0
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final inspection stages. The entire documentation package is re-viewed' prior to shipment of manufactured items. This documentation includes material test reports, inspection and test reports, NDE reports and applicable code data reports.
The, frequency and extent of the surveillance are consistent with the importance to safety, complexity, and quantity of the item or 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 part's) 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.
Inspection status of items accepted and released are identified prior to forwarding the items 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 The identification and control as described herein shall apply to components, production materials, bulk raw materials, parts, and assemblies at all stages of fabricatiori and installation from receipt of components and material to completion of the system or component supplied.
These requirements shall be imposed on ERP'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.
Indentation stamping of parts shall not be used for marking, unless specified in writing by ERP.
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 life and utility.
Components or materi'al not suitable for individual marking, shall be individually tagged or shall be placed on an identified container.
The storage area shall contain only components and material which have 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 in-clude checking for conformance to proper standards of packaging and storage of all components, material, parts and assemblies.
8.2 Bulk Raw Material Following the acceptance of bulk raw materials, a tag showing the purchase order, the material identification, mill heat number or heat code and the date of receiit shall be fastened to the material, l
or marked on the raw material with a suitable crayon or other marker, Document QAM-001 0
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unless this information is already stamped on the material from the supplier.
If during fabrication all identification has been removed from the 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 contact incident to normal handling, exposure.to the elsments, ship-ment or storage. All markings shall offer reading readability and prompt identification of the material.
Physical marking of material shall be accomplished in a manner which will not adversely affect the machining, forming, or fabrication of the material.
Identification requirements shall be determined during generation of specifica'tions and design drawings.
Identification of materials and parts for safety-related systems or components shall be trace-able 'to the appropriate documentation, such as drawings, specifica-tions, purchase orders, manufacturing and inspection documents, deviatior, reports, and physical and chemical mill test reports.
Prior to release for fabrication, assembling, shipping, and installa-tion the correct identification of material, parts and components must be verified and documented.
8.3 Marking Material Marking material shall not contain substances known to be detrimental to the material being marked.
8.3.1 Stainless Steel. Titanium, and Nickel-Base Alloys Marking material containing graphite shall not be used on the materials in Paragraph 8.3.1.
The chloride and sulfide content of marking material shall each be less than 100 ppm (0.01 per-cent by weight), when used on Paragraph 8.3.1 materials.
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9.0 CONTROL OF SPECIAL PROCESSES All special fabrication, installation, and inspection processes which could have an effect upon the quality of the component, system, or fab-rication operation shall be controlled by process procedures.
9.1 Personnel Certification Personnel responsible for performance, inspection, and control of special processes and operations which require specia'l skills and could have an effect upon quality shall be certified.
Certification o.f personnel for these processes or operations (such'as welding, heat treating and nondestructive testing) may include a formal train-ing 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 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 and re-certification of fabrication, installation and inspection personnel without regard for established re-certification periods. Personnel shall also 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 foes.
9.2 Subcontractor Control Special processes performed by ERP's subcontractors and suppliers shall be specified in procurement documents and shall be monitored by Quality Assurance for conformance to ERP requirements. A certi-ficate of compliance shall be required from all subcontractors and suppliers performing special processes.
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9.3 Procedures Special process procedures shall be reviewed an'd approved by Quality Assurance which conducts a surveillance to assure that the approved procedures are adequately followed.
Process procedures shal'1. in-clude the method required for periodic verification of adequacy of the processing materials, solutions, equipment and their associated control parameters, and the recording of the inspection results and process verifications performed.
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10.0 INSPECTION The established inspection programat ERP verifies the conformance of quality related activities with the applicable requirenents. The verif1-cation is performed in accordance with written inspection procedures, instructions, or 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 witness point and man-datory inspection hold point identification with optional or required witnessing by an inspector are incorporated in,the appropriate documents, such as procurement specifications, test procedures, etc.
The inspection program also provides for identification and documentation of deficiencies discovered during inspection and the required corrective action.
10.1 Inspection Procedures Inspection procedures and instructions are written documents which provide '.he following information:
a.
Identification of characteristics and/or activities to be inspected; b.
Identification of the individual or group qualified for performing the inspection; c.
Acceptance and rejection criteria; d.
A description of the inspection method; e.
Recording evidence of completing and verifying a man-ufacturing, inspection, or test operation; f.
Recording inspector or data recorder and the results of the inspection operation; g.
Date and signature of inspector or qualified person..
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9 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 document control measures.
10.2 Supplier Inspection ERP identifies inspection requirements in procurement documents issued to subcontactors and suppliers.
The subcontractors and suppliers are responsible for inspection of their products, and ERP Quality Assurance verifies their controls to assure adequacy of inspection. Supplier's inspection plans are required to recog-nize those ERP witness or hold points specified by procurement documents.
.10.3 Indirect Control In the event that direct inspection is not possible, indirect con-trol of the inspection process shall be provided through monitoring processing methods, equipment, and personnel, where applicable.
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11.0 TEST CONTROL A test control program established at ERP assures that all required testing 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 ERP person are reviewed by Quality Assurance in accordance with standards, procedures, or instructions that require inclusion of the following quality assur-ance requirements, as applicable:
a.
Requirements and acceptance limits as contained in the applic-able design documents; b.
Detailed instructions for performing the test; c.
Test prerequisites, including, but not limited to the following:
.1.
calibrated instrumentation 2.
adequate and appropriate equipment 3.
trained, qualified, and as appropriate, licensed and/or certified personnel 4.
preparation, condition, and completeness of the item to be tested 5.
suitable and, if required, controlled environmental condi-tions d.
tiandatory inspection hold points for witness by qualified ~
individual; e.
Acceptance and rejection criteria; f.
Method for documenting or recording test data and results; g.
Designation of the individual (s) or group (s) qualified for evaluating and making decisions based on test results.
Test procedures 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.
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11.2 Test Records Records of tests performed shall be prepared, showing the applicable drawing or procedure revision, identification of test performed, date, test date, and other essential test information.
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.
11.3 Test Control for Procured Items Test control requirements are imposed on suppliers by procurement documents.
They identify the tests to be perfarned and stipulate that suppliers' test procedures be submitted for approval. Tests are conducted by group's within the supplier organization considered acceptable during supplier selection, 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 quali~fications of the supplier group making acceptance disposition of test results.
11.4 Mcdifications, Repairs and Replacements 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 CONTRCL 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 ERP's Equipment Calibration and Control All controlled inspection and test equipment shall be subjected to maintenance and calibration at periodic intervals by qualified personnel or subcontractors.
Frequency of calibration shall be based on the equipment type, historical experience and operational require-ments.
Calibrating standards have an uncertainty (error) requirement of no more than 1/4th of the tolerance of the equipment being cali-brated.
A greater uncertainty may be acceptable when limited by the
" s ta te-of-the-a rt".
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 calibration, due date of next calibration, and the stamp or signature of the person conducting the calibration. A status file shall be maintained for all con-trolled 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 equip-ment 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 Measurina and Test Equipment at Subcontractors Controlled measuring and test equipment used by subcontractors, ven-dors and suppliers engaged in fabricating and furnishing materials, parts and components to ERP shall be under the surveillance of ERP's Document Rev.
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Quality Assurance.
The surveillance shall cover production tooling, jigs, fixtures, and other fabrication' equipment which controls dimensions, contours, etc., and which is used for acceptance.
Sur-ve'illance activities include checks to assure that inspection opera-tions 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 out 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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r 13.0 HANDLING, STORAGE AND SHIPPING 13.1 Procured Items Measures used to control packaging, shipping, storage, and handling of components and material to prevent damage or deterioration shall be documented to reflect contractual or ERP-specified requirements.
Procurement documents shall identify the required control measures to suppliers.
The supplier must have adequate wiitten work and inspection in-structions for storage, preservation, and packaging of shipment to protect the products from damage, loss, deterioration, or sub-stitution. As required by the equipment specification and/or procure-ment documents, these procedures may be subject to approval by ERP.
13.2 Transport Casks Transport cask handling and operation shall conform to the written handling and operation procedure for each cask.
Prior to the shipment of a transport cask containing radioactive material, all conditions of applicable regulations, e.g., NRC's Certificate of Compliance (specifications, tests, inspections) shall be satisfied.
All required shipping papers shall be prepared and shall accompany the shipment.
The shipment of radioactive empty casks (casks that have been used to ship radioactive material) also shall conform to applicable regulations.
However, new casks that have not been in contact with radioactive material may be shipped as general cargo under applicable regulations.
Established safety restrictions concerning handling, storage, and shipping shall be included in the handling and operating procedures for transport casks.
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14.0 INSPECTION, TEST AND OPERATING STATUS 14.1 Equipment Status The inspection, testing, and operating status of systems and components used for processing or transportation of radioactive materials shall be known at all times during manufacturing and use.
Transportation and operating procedures 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, testing, and operating activities.
Quality Assurance personnel shall verify equipment status and com-pliance with proc dures. Bypassing of required tests or other critical operations shall be procedurally controlled under the cog-nizance of Quality Assurance personnel with the concurrence of the QA 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, and transportation and operating procedures shall establish any witness points or're-quired mandatory hold points which shall be reflected in the fabri-cation or operational schedule. Witness points are observation points which may be waived by ERP Engineering or QA Manager, or their desig-nated representatives. 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 witness-ing, examination, or testing requirements.
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14,4 Ch3cklists of Examinations, Tasts, and Insp:ctions Prepared checklists shall include the document number and revision to which the examination, inspection, or test shall be performed.
The checklist shall have space provided for recording results of examination, test, or inspection and for witness signatures, initials or stamp, and date for activities witnesses.
14.5 Examination 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 meausres shall provide identification of those items which conform to examination and test requirements and those that do ndt conform.
14.6 Inspection Status ERP inspection stamps or authorized Quality Assurance signature shall be applied to materials, items, systems, components, or the 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 accept-ed for limited use, and to material which has been rejected and dis-positioned as scrap.
When size, material or finish, etc., preclude stamping the material, a tag shall be attached to the item appropriate-ly stamped to indicate the status.
14.7 Control of Inspection Stamps Inspection stamps shall be serialized for traceability to the individual inspector. Quality Assurance shall control and issue inspection stamps, as required, to authorized personnel.
Records of individual issue shall be maintained and audits shall be periodically performed to assure legibility and proper ownership.
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becausa of less, employen 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 ERP system materials, parts, and components which are determined to be discrepant shall be identified with a tag and a numbered Noncon-formance Report and, when feasible, physically separated from accept-able 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 segregation.
The Nonconformance Report shall in-dicate 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 ERP of all deviations from the procurement requirements, such as deviations from the required codes or approved drawings. A nonconformance notice shall be initiated by the subcontractor in accordance with the subcontractor's quality assurance manual. After detection of the deviation, further fab-rication operations on the material or component shall not be per-formed until the nonconformance has been resolved by the subcontractor and ERP.
The subcontractor shall supply records of noncoriformance reports dispositioned " accept as is" or " repair". These reports shall be made part of the inspection records and forwarded with the hardware to ERP for review and assessment.
15.3 Verification of Rework or Repair Acceptability i
Acceptability of rework or repair of materials, parts, components, systems, and structures shall be verified by reinspecting and re-testing the item as originally inspected, or by a method which is at least equal to the original inspection and testing method.
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testing,.rewsrk, and repair records shall be documented and filcd in ERP quality records files.
15.4 Nonconformance Disposition The individuals or groups identified on nonconformance forms shall have the responsibility and authority for disposition of nonconforming 1.tems.
ERP 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 ERP management for review and assessment.
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i 16.0 CORRECTIVE ACTION ERP shall evaluate conditions adverse to quality (e.g., nonconformances, 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.
The corrective action procedure is divided into five phases:
(a)
Investigate discrepancy (b)
Determine cause (c)
Define corrective action' (d)
Implement corrective action (e)
Evaluate corrective action Specific individuals shal-1 be assigned the responsibi.lity of accomplishing each of these phases.
Corrective action includes, but is not limited to, procurement or manufacturing operations, desigri, 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 effectiveness can be measured.
Effectiveness shall be periodically monitored as a function of quality surveillance.
The corrective action documentation shall not be closed out until results of the corrective action have been evaluated and approved by Quality Assurance.
Significant conditions adverse to quality, the cause of such conditions, and the corrective action taken shall be reported to cognizant levels of ERP management for review and assessment.
When corrective action requests are addressed to an ERP supplier, the suppli-er shall be required to provide the following information:
(a) A description of all factors contributing to the deficiency (b)
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9 of the discrepancy in future production (c) The identification of effectivity point in production.
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17.0 QUALITY ASSURANCE RECORDS'
~17.1 Maintenance and Access to Records The mcords. system maintained by ERP includes the retention of those design, fabrication, inspection, afid surveillance records essential to demonstrate product gi" ity.
It provides for the identification of materials and their corresponding manufacturing, installation, test and inspection records, and certificates.
Operating records maintained will include inspection, test, and audit results. All records per-taining to a specific project shall be available for review by ' he t
appropriate inspection agencies, the customer, and/or their repre-sentatives. All records maintained according to established pr'o-cedures will be identifiable and retrievable.
17.2 Contents of Record Files It is the policy of Quali,ty Assurance that adequate records be main-tained 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 verifying a manufacturing, inspection, or test operation; c.
The date and results of the inspection or test; d.
Information related to conditions adverse to quality; e.
Data recorder identification, if applicable; f.
Inspector or responsible person name and signature; g.
Evidence as to the acceptability of the results; h.
Identification of tk procedure (s) and revision (s) used.
Records shall also be maintained of supplier and subcontractor quality assu'rance reviews, surveillances and audits, and documents pertaining to ERP internal quality assurance audits.
Records shall be kept for control and as evidence of inspections, tests, audits, monitoring of work performance, and material analysis and certifications, i.e., record files shall contain all documents pertaining to product quality assurance functions. The files shall Document heet QAM-001
- 0 17-1
.also contain procedures and specifications written for a specific project.
Files of personnel qualifications and training shall also be maintained in the ERP QA file.
17.3 Permanent Records Permanent records in the record file shall contain:
design specifica-tions, stress reports or stress calculations, "as buidt" and interface 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 Non-permanent 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, un-less otherwise stipulated.
17.5 Record Storage Facilities Record storage facilities shall be constructed, located, and/or secured to prevent destruction of records by fire, flood, theft, and deterioration due to environmental conditions s'uch'as temperature or humidi ty.
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-18.0 AUDITS Planned audits shall be performed to provide comprehensive, independent verification and evaluation of the ERP.or supplier activity being audited.
The audit scope shall encompass evaluation of quality system practices and/or procedures and the effectiveness of their implementation, monitoring of operations and activities, and a review of pertinent documents and their 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.
N Supplier audits shall be conducted at least once every-36-month _s 18.2 Audit Personnel Audits shall be performed by ERP personnel with do direct line re-sponsibility 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 for ERP 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.
Recommendations 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 division and appropriate Headquarters management.
Audits shall include an assessment as to how well the Quality Assur-ance Proaram meets reculatory or other reouirements.
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t 18.4 Audit Follow-up The originator of an audit report or a designated alternate is re-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 managemen't personnel shall evaluate each audit report item and correct deficiencies as promptly as possible after they are revealed.
Document Rev. O Sheet 18-2 QAM-001
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 01.1 Columbus, Ohio 43201 Rev. 0 (614)299-2318 Page 1 of 3 Date:
2/7/86 QA PROGRAM CONTROL 1.0
Reference:
ERP QA Program, QAM-001, Forward, and Paragraphs 2.3, 6.2, 15.0, 16.0, and 18.0.
2.0 Scope
To provide control of ERP QA Program.
3.0 Objective
To establish a QA Review Board and procedures for implementing QA program control.
4.0 QA Review Board:
4.1 The ERP QA Review Board shall be established consisting of the following personnel:
ERP President, ERP QA Manager, and other persons designated by either the ERP President or the ERP QA Manager.
4.2 Personnel will be appointed to the QA Review Board as the need arises.
This system of appointment provides maximum flexibility and permits expert advice for each situation.
Formal notice of appointment to the QA Review Board is not required.
Confirmation of appointment will be recorded as a result of QA Review Board meeting summaries.
4.3 Duties of the QA Review Board shall include but not be limited to the following:
a.
Approve revisions to the QA Program, Document QAM-001.
b.
Review project procedures and instructions related to safety.
c.
Review deviation reports and initiate corrective actions, d.
Conduct annual ERP internal audit.
5.0 Document QAM-001 Control Procedures:
5.1 The latest revision of each page of the ERP QA Program Document QAM-001, and a brief description of each revision shall be shown on forms at the front of every controlled document.
5.2 A distribution log (Page 3) shall be maintained in the Corporate QA files for controlling the distribution of the QA Program, Document QAM-001.
Uncontrolled copies of this document, for example, review copies requested by prospective customers, may be distributed without logging.
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 01.1 Columbus, Ohio 43201 Rev. 0 (614)299-2318 Page 2 of 3 Date: 2/7/86 QA PROGRAN CONTROL (CONTINUED) 5.3 All revisions to the QA Program, Document QAM-001 shall be sent to each owner of controlled document.
However, there is no obligation to pro-vide revisions to uncontrolled documents.
6.0 QA Review Board Procedures:
6.1 A majority vote is required for decisions of the board. Therefore, an odd number of members is advisable, but not required.
6.2 Corrective actions shall be performed according to procedures in the QA Program, Document QAM-001, Paragraph 16.0, When corrective action is initiated by the QA Review Board, the deviation report and procedures in QAP 16.1 shall be followed.
6.3 The ERP internal audit shall be performed according to procedures in the QA Program, Document QAM-001, Paragraph 18.0 and QAP 18.1 procedures.
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Date:
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Eggers Ridihalgh Partners, Inc.
o 1445 Summit Street QAP 01.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 3 of 3 Date:
2/7/86 ERP QA MANUAL DISTRIBUTION LOG Preceding Entry Manual Page Version Date Number Numbers Revision Supersedes Withdrawn Distribution l
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Eggers Ridihalgh Partners, Inc.
1445 Summit Street -
QAP 02.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 1 of 3 Date: 2/7/86 QA IND0CTRINATION AND TRAINING 1.0
Reference:
ERP QA Program, QAM-001, Paragraph 2.2
2.0 Scope
To provide QA Indoctrination and Trainiv to ERP personnel and consultants working on safety-related projects.
3.0 Objective
To ensure that all personnel performing work under a contract requiring a QA program are informed of their duties regarding QA.
4'. 0 Procedure:
4.1 The-REA QA Manager shall instruct REA Designers, Draftsmen, any other personnel preparing or checking drawings in the procedures of ERP QAM-001, Paragraphs 3.0 and 6.0, which discusses design and design document control.
4.2 The ERP QA Manager shall instruct all engineers and analysts performing calculations and analyses that (a) Hand calculations shall be identifi-able and retrievable, (b) Computer input and output data shall be re-trievable in hard copy, magnetic tape, or microfilm (the preferred method depends on the situation, length of output, etc.), (c) All analyses shall be stored for a designated period of time as specified by the proj-ect engineer, project contract, etc., (d) All analyses must be checked (audited) at least once during the life of a project, and (e) Each analyst shall be instructed in the procedures of ERP QAM-001, Paragraph 17.0, which discusses maintenance and contents of record files.
4.3 The ERP QA Manaaer or Project QA Manager shall audit drawing tracings and analyses ac>.. ding to ERP QAM-001, Paragraph 18.0.
4.4 The ERP President will designate lead auditors. A lead auditor will in-struct other Project QA personnel in procedures, codes, etc. Tne ERP QA Manager shall maintain a Training Record (Page 3) for each Project QA Person.
s Eggers-Ridihalgh Partners, Inc.
-1445 Summit Street QAP 02.1 Columbus, Ohio 43201 Rev. 0 (614)-299-2318 Page 2 of 3 Date: 2/7/86 QA INDOCTRINATION AND TRAINING (CONTINUED) 5.0 Qualifications of ERP QA Personnel:
The minimum qualifications of all QA Personnel (lead auditor, auditor, REA QA Manager, Project QA Manager) are the same, but. project specific require-ments will be considered.in selecting personnel.
5.1 Education
One bachelor's degree in a technical field from an accredited institution
5.2 Experience
2 years experience in engineering and/or manufacturing.
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Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 02.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 3 of 3 Date: 2/7/86
-QA TRAINING RECORD FOR
. Previous Qualifications:
Given Date QA Type of Training By Completed Approved i
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Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 03.1 Columbus, Ohio 43201 Rev. 0 (614).299-2318 Page -1 of 13 Date: 2/7/86 DESIGN CONTROL 1.0
Reference:
ERP QA Program, Paragraph 3.0
2.0 Scope
To control the design of ERP's safety-related products.
3.0 Objective
To ensure that design characteristics-related to safety are controlled.
4.0 Procedure
To ensure that these designs meet all applicable regulations, and that design activities are performed in a planned, controlled, and orderly manner.
l 4.1 The Design Control Checklist (Page 3 through 6) will be-utilized in reviewing the adequacy of controlled designs and each reviewer shall have the qualifications and experience of an auditor (QAP 02.1) and not directly associated with those aspects of the project being reviewed.
4.2 Each engineer shall maintain a file of their computer and manual calculations, notes, telephone calls, etc.
Data not in their files shall be maintained in a central project file.
4.3 The ERP Project Engineer shall maintain a Computer Printout Log (Page 7) for locating trade-off study and final computer inpute and output hard copy, magnetic tape of project data and computer pro-grams, and microfilm of project computer data or algorithms.
4.4 A qualified engineer (s) not directly responsible for the original analysis shall review all final analysis (notebooks, data sheets, final computer input and output, etc.) and indicate review by sign-ing and dating the documents reviewed.
For example, if five pages pertain to a calculation of one subject, only one page of the five need to be signed, but if calculations of separate subjects are on each page, all pages must be signed.
4.5 The design reviewer or reviewers will also sign drawings in the title block under design approval.
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 03.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 2 of 13 Date: 2/7/86 DESIGN CONTROL (CONTINUED) 4.6 The ERP QA Manager shall review the calculations for compliance of ERP QA procedures (reviews accomplished, signatures shown, etc.). The QA Manager shall also give signed approval to all drawings and drawing revisions. Major drawing revisions must be preceded by an approved Design Change (form on Page 8).
4.7 A Tracing Log (Page 9) shall be used to control and show the latest revision of each tracing. A Print Distribution Log (Page 10) shall be used to control the distribution of drawing prints. The QA person or the Design Manager shall complete the " Print Distribution Log".
For ERP internal distribution of drawings, the receiving person should sign or initial in the " Signed Distribution" block.
For external distribution of prints, the person that prints are being sent will appear in the
" Signed Distribution" block.
If prints are being sent to a client for review, a letter from an ERP QA person shall accompany the prints re-questing the client stamp the prints as being reviewed, approved, etc.
A sufficient number of prints will be sent to assure ERP, subcontractors, and anyone else needing the prints that each has his required number of client-stamped prints for his use.
If prints are sent to a nonapprov-ing agency, such as a subcontractor, the QA Document Control Sheet (Page 11) shall be sent with the prints, be completed by the print re-ceiver, and returned to an ERP QA person acknowledging receipt of the prints.
4.8 Before prints are sent to a subcontractor for fabrication of parts, ERP Engineering and QA Departments will release the drawings by completing the " Drawing Release Approval" form (Page 12).
Approved by:
+
Date:
I pm
P 03.1 February 7,1986 Design Review Report y,
Page 3 of 13 Date: 2/7/86
. Verification of Adequacy of Design Adequacy of design for the has been verified by conducting a formal design review.
The checklist used in this design ^evi_ew is attached. A complete response to each question on the enecklist is included.
Design adequacy has been veri-fied by the:following persons and is attested to by their signatures:
Design Review written by:
Date:
Signature Title
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 03.1 Columbus, Ohio 43201 Rev 0 (614)299-2318 Page 4 of 13 1
Date: 2/7/86 l
DESIGN CONTROL CHECKLIST FOR PROJECT i
Component Name Drawing Numbers i
l Requirements and Specifications 1.
Have component design requirements been written?
Yes Location No Explain 2.
Have the following preliminary analyses been completed, verified or reviewed (See Laboratory and Computer Printout Logs)?
Structural Yes No Thennal Yes No i
Criticality Yes No j
Shielding Yes No If no, explain:
i 3.
Have component design bases, trade-off studies and material selection been reviewed and justified?
Documentation
Title:
By:
I Location:
i Date:
i Documentation
Title:
By:
j Location:
Date:
If no, explain:
QAP 03.1 Rev. 0 Page 5 of 13 4.
Have code-specified safety factors been used in the analyses of Date: 2/7/86 safety-related components?
Yes No Explain 5.
Are required special process procedures (e.g., welding, NDE, gamma scan, etc.) called out in notes in drawings?
Yes No Explain:
6.
Are special process procedures written or referenced?
4 7.
If special process procedures are referenced, have the procedures been written and made available to each of the following locations?
Fabrication Quality Assurance Manager Supplier Quality Control Mananger Qualified personnel to carry out the special process procedures If no, describe corrective action to be taken:
l 8.
Have inspection acceptance criteria been specified?
Yes No Explain 9.
Do tolerances exist, compatible with good engineering and economics, and consistent between mating components?
Yes No Explain Manufacturing Issues
- 10. Are welds full penetration?
l Yes No Explain i
- 11. Are threads of mating components the same size and type?
Yes No Explain l
12.
At dissimilar material joins, are the materials galvanically compatible?
Yes No Explain
QAP 03.1 Rev. 0 Page 6 of 13
- 13. Are test coupons needed?
Date:
2/7/86 Yes Explain 14.
If testing is required, have test conditions and specif1 cations been written?
Yes By:
Date:
Location:
Document
Title:
Yes By:
Date:
Location:
Document
Title:
No Explain
- 15. Are component dimensions and spectrications on drawings in compliance with written design requirements?
Yes No Explain
- 16. Are assembly specifications on drawings in compliance with design requirements?
Yes No Explain Drawings
- 17. Have testing check points been identifled on drawings?
Yes No Expain
- 18. Are mandatory hold points indicated on drawing?
Yes No Explain 19.
Is title block completed with required sign-off approvals?
Yes No Explain
- 20. Are sufficient views shown to describe the shape of parts and assemblies?
Yes No Explain
- 21. Are proper scales indicated?
Yes No Explain
- 22. Have all materials been specified?
Yes No Explain 23.
Is material list shown on drawing, if required?
Yes No Explain
- 24. Has the Project Tracing Log been completed?
Yes No Explain
QAP 03.1 Rev. 0 Page 7 of 13 Date:
2/7/86 Drawing Revisions 25.
Does a completed Design Change Form exist as authority to make each drawing revision?
Yes No Explain
- 26. Are zone area, revision letter, revision description and date shown?
Yes No
- 27. Has title block revision letter been updated?
Yes No
- 28. Has the latest revision been entered on Project Tracing Log?
Yes No
- 29. Does the revision agree with the description on the Design Change Form?
Yes No
.__-_.____,--,r,,-,
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 03.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 8 of 13 Date: 2/7/86 TRADE-0FF STUDY AND FINAL COMPUTER PRINT 0UT LOG FOR PROJECT Project No.
Page:
Entry Identification Date Location Repository Brief Number Symbol Logged Back-up Calculations, location Description if any
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 03.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 9 of 13 Date: 2/7/86 DESIGN CHANGE FOR PROJECT Design Item Design Change No.
Drawing Numbers Revision No.
Requested By Drawing Date Company
}
Summary Description of Change:
[
(
Reason for Change:
Effect on Schedule and Cost:
Procurement Items and Responsibility by Disposition of Stock on Hand, On Order Detailed Description of Change Attached Instructions for Perfonning and Testing the change Attached Approved By Co.
Date Approved By Co.
Date Approved By Co.
Date Approved By Co.
Date
QAP 03.1 Eggers Ridihalgh Partners, Inc.
Rev. O 1445 Summit Street Page 10 of 13 l
~
Columbus, Ohio 43201 Date:
2/7/86 (614) 299-2318 TRACING LOG FOR DRAWING NO.
TITLE LOCATION PROJECT PROJECT NO.
PAGE OF i
DRAWING ENTRY LATEST REVISION DATE DATE REVISION DATE 1
.... - - -. = - -
Eggers Ridihalgh Partners, Inc.
QAP 03.1 1445 Summit Street Rev. O Columbus, Ohio 43201 Page 11 of 13 (614) 299-2318 Date:
2/7/86 PRINT DISTRIBUTION LOG FOR PROJECT Project No.
Page of Preceding Entry Drawing Revision Signed Date Number Revision Supersedes Withdrawn Distribution
Eggers Ridihalgh Partners, Inc.
QAP 03.1 1445 Summit Street Rev. O Columbus, Ohio 43201 Page 12 of 13 (614) 299-2318 Date:
2/7/86 QA DOCUMENT CONTROL SHEET FOR PROJECT Project No.
Page of No. of Document Type Copies or Drawing No.
Revision Document Received Received Number Date Title or Description P-i l
Date Sent By ERP Date Document (s) Received I
Document Received by Title Company Name Company Address Return a copy of this signed Document Control Sheet to ERP QA Depart.
ERP Cask.QA Person Date Document Returnea
Eggers. Ridihalgh Partners, Inc.
QAP 03.1 1445JSummit Street Rev. O Columbus, Ohio 43201 Page 13 of 13 (614) 299-2318 Date:
2/7/86 ERP DRAWING RELEASE APPROYAL FOR PROJECT Client Drawing Number Date Revision No.
Date Title Dwg. Release Prepared by Date Drawing Prepared by Date Drawing Checked by Date Drawing QA Review by Date Disposition / Action on:
Work in Process Completed Parts including delivered and/or spares If this is a reviard part, is it equal and interchangeable with the previous part
- Yes, No, N/A Is serial number required on part Yes, _____No Is 10CFR21 applicable on procurement
- Yes, No Have client approval & stamped prints been secured
- Yes, No l
copy of drawing to for transmittal to Co. Name Address with a purchase order / contract change specifications, instructions and/or procedures on work in process and finished parts.
i Approved for Release by Date l
Program Office ERP Engineering Department p
ERP QA Approval
-Date i
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 04.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 1 of 12 Date: 2/7/86 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 1.0 '
Reference:
ERP Quality Assurance Program, Document QAM-001, Paragraphs 4.0 and 7.0.
2.0 Scope
This Quality Assurance Procedure (QAP) applies to the purchase of material, equipment, and services related to safety.
3.0 Objective
To control the selection of suppliers and me quality of purchased material, equipment, and services related to safety.
4.0 Procedure
4.1 Suppliers of products fabricated to ERP specifications shall be surveyed at least once every 36 months, using the prepared Fabrication Supplier Survey Checklist on Pages 3 through 6.
Vendors of standard items pur-chased through catalogs are not required to be surveyed or audited, unless quality problems arise.
4.2 The Supplier History, Page 7, shall be maintained by the ERP QA Manager for all suppliers of purchased materials, equipment, and services related to safety, according to the procedures in ERP QA Program, Document QAM-001, Paragraph 7.1.
4.3 Purchased naterials, equipment, and services related to safety shall be ordered, using the Purchase Order, Pages 8, 9, and 10, and the procedures in t3P QA Program, Document QAM-001, Paragraph 7.2.
Issue of the purchase order forms" s'nall be cuntrolled by the ERP President, and he shall sign the completed Purchase Order. The ERP QA Manager, or his designate, shall approve the Purchase Order, after reviewing it for the requirements in ERP'QA Penram, Document QAM-001, Paragraph 4.0.
4,4 The quality of fabricated products and special processes shall be certified, as required in ERP QA Program, Document QAM-001, Paragraphs 7.2 and 7.3.
For suppliers of standard catalog products, the packing slip or a copy of the purchase order shall be signed and dated by the supplier, which certi-fies conformance to published product data and to specifications in the purchase order. Where appropriate, supplemental data, test data, etc.
shall be sought to confirm or amplify adherence to performance specifica-tions.
a Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 04.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 2 of 12 Date: 2/7/86 CONTROL 0F PURCHASED MATERIAL, EQUIPMENT, AND SERVICES (CONTINUED) 4.5 Inspection of materials ordered directly by ERP on its Purchase Order shall be inspected using procedures in ERP QA Program, Document QAM-001, Paragraphs 10.1 and 14.0, and the Material Inspection Report on Page 7.
If additional space or more appropriate headings are required, supple-mental sheets shall be attached to the Material Inspection Report form and becone a part of the report.
If defects are found, these shall be reported on the Deviation Report, Page 8.
Corrective action shall be initiated within a reasonable tine, and the deviation shall be cleared by at least two qualified persons, one from ERP Engineering and the other from ERP QA. Defective material shall be segregated as provided in ERP QA Program, Document QAM-001, Paragraph 14.6.
l I
L t
Egg:rs Ridihalgh Partners, Inc.
1445 Summit Street QAP 04.1 Columbus, Ohio 43201 Rev. 0 (614)299-2318 Page 3 of 12 Date:
2/7/86 FABRICATION SUPPLIER SURVEY CHECKLIST Evaluation Criteria Evaluation Sat.
Unsat.
Written QA Program Loc.*
Com.**
QA organization existing Loc.
Com.
Is QA organization autonomous, function independently of undue influences and responsibilities of schedules and cost, suffi-cient authority?
Loc.
Com.
Are personnel training and proficiency required in various job descriptions (QA, shop) according to codes and standards (ASME IX,SNT-TC-lA,etc.)?
Loc.
Com.
Is 10CFR21 notice posted?
Loc.
Com.
Documented program to assure purchased materials and services conform to procurement documents.
Loc.
Com.
Assess supplier's control of quality, conformance to specifi-cations.
Loc.
Com.
Loc. - Location, name, document number, revision number, and/or date, as applicable.
- Com. - Comments or additional information.
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 04.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 4 of 12 Date:
2/7/86 FABRICATION SUPPLIER SURVEY CHECKLIST (CONTINUED)
Evaluation Evaluation Criteria Sat.
Unsat.
Special process instructions and procedures written (welding, penetrant inspection, magnetic particle inspection, X-ray, etc.)
Loc.
Com.
Are special process procedures approved by customer prior to use?
Loc.
Com.
Documents for coordinating shop work (route and operations sheets).
Loc.
Com.
Method of controlling latest drawing revision.
Loc.
Com.
Materia,1 inspected against procurement specifications at deli ve ry.
Loc.
Com.
On bulk raw material, is material tagged or identified by purchase order, material type, mill heat number, and date of receipt of material?
Loc.
Com.
Is material identifiable during processing?
Loc.
Com.
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 04.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 5 of 12 Date:
2/7/86_
I FABRICATION SUPPLIER SURVEY CHECKLIST (CONTINUED)
Evaluation Evaluation Criteria Sat.
Unsat.
Does inspection procedures identify characteristics to be in-spected and acceptance / rejection criteria?
Loc.
Com.
Does inspection procedures require date and signature of inspector?
Loc.
Com.
Is material protected against contamination (chlorides, graph-ite not in contact with stainless steel, wire brushes and grinding wheels used on carbon steel not used on stainless steel)?
Loc.
Com.
Shop areas lighted, clean, equipped consistent with fabrication requirements.
Loc.
Com.
Is measuring equipment tagged showing date of calibration, date due for next calibration, and the stamp or signature of person conducting calibration?
Loc.
Com.
Is measuring equipment serialized for identification and record keeping?
Loc.
Com.
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 04.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 6 of 12 Date:
2/7/86 FABRICATION SUPPLIER SURVEY CHECKLIST Evaluation Evaluation Criteria Sat.
Unsat.
Are witness and hold points indicated on docuaents (drawings, schedule sheet)?
Loc.
Com.
Procedures for controlling norconforming material (deviations).
Loc.
Com.
Is corrective action initiated promptly when a deviation is detected?
Loc.
Com.
Are records kept for insertion into a project document package, as specified in purchase order?
Loc.
Com.
Is a self-audit and supplier audit system in place?
Loc.
Com.
6 28 1/ 7 1
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PURCHASE ORDER PURCHASE ORDER NO.
QAP 04.1 ACCOUNT NO.
Rev. O Page 8 of 12 Date:
2/7/86 i
To:
Amendent No.
First Delivery Date:
Final Delivery Date:
F.0.B.
Delivery Unit Quantity Description Date Price TOTAL PRICE:
Eggers Ridihalgh Partners, Inc.
1445 Summit Street Columbus, Ohio 43201 (614) 299-2318
PURCHASE ORDER NO.
.QAP 04.1 Rev. 0 ACCOUNT NO.
Page 9 of 12 Date: 2/7/86
-Drawings
. Work performed under this purchase order must be according to the following drawings, and subsequent revisions thereto:
Shipping and Packaging Instructions Eggers Ridihalgh Partners, Inc.
1445 Summit Street Columbus, Ohio 43201 (614) 299-2318
TERMS AND CONDITIONS QAP 04.1 Rev.'0 PURCHASE ORDER N0.
Page 10 of 12 Date:
2/7/86 ACCOUNT N0.
Contract Requirements Compliance with the Federal Code of Regulations Work performed and services rendered under the terms of this purchase order must comply with the requirements of Title 10 of the Code of Federal Regulations (10 CFR) checked below:
Part 50, Appendix B
_ Part 71, Subpart H In particular, it is required that, upcn ERP request, you agree to open your shops and records to Quality Assurance inspection and audits, in order that 4
the ERP QA Manager (or designee) can ascertain that the purchase of material,
. the manufacture of goods and the performance of services comply with the specifications in this purchase order.
In addition, work performed under this purchase order is subject to the authority of 10 CFR Part 21.
In the event that you, or one of your suppliers, identify a deviation (i.e., a departure from the technical requirements included in this purchase order or other ERP procurement documents), the ERP QA Manager is to be immediately contacted by telephone. The ERP QA Manager may provide assistance to evaluate the safety significance of the deviation or other condition.
A written report describing the deviation shall be prepared, and separate copies mailed to the ERP President and the ERP Quality Assurance Manager immediately after notification is made.
Signed:
Approved:
Name Name Title Title Date Date Eggers Ridihalgh Partners, Inc.
1445 Summit Street Columbus, Ohio 43201 4
(614)299-2318
Eggers Ridihalgh Partners, Inc.
1445 Summit. Street QAP 04.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 11 of 12 Date: 2/7/86 MATERIAL INSPECTION REPORT FOR PROJECT QA Review No.
Date Part Narae No.
TYPE REPORT:
Cask Buyer Receiving Final Drawing No.
Rev:
Date In-Process Contract No.
Date External Total No. of Parts Mfg. Lot Size QC Sample Size Character-Drawing Actual istic Dimension, Dimension, Occurrence Number inche; inches of defect Comments t
i i
Nonconformance:
l Corrective action:
1 Accept Reject Inspector
~
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 04~1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 12 of 12 Date: 2/7/86 DEVIATION REPORT FOR PROJECT:
Item: Name Drawing No.
Part No.
Page of DEVIATION:
Reported By:
Date:
CORRECTIVE ACTION:
By:
Date :
COMMENTS:
Deviation Cleared By:
Approved By:
Date:
Date:
- Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 15.1 Columbus, Ohio 43201 Rev. O
~(614) 299-2318 Page 1 of 2 Date:
5/1/86 l
REPORTING 0F DEFECTS AND NONCONFORMANCE 1.0
Reference:
1.1 ERP QA Program, QAM-001, Paragraph 15.0 1.2 10CFR21 (January 1,'1985), " Reporting of Defects and Noncompliance",
Code of Federal Regulations, Title 10, Part 21.
2.0 Scope
Encompasses all safety-related functions of all safety-related ERP projects and pertains to all ERP employees, consultants, and subcontractors.
3.0 Objective
To establish a procedure for reporting substantial safety hazards and non-compliance with 10CFR21.
4.0, Procedure:
'4.1 The procurement documents for safety-related components shall specify that 10CFR21 applies.
4.2 When an employee suspects a substantial defect, the employee shall verbally inform their immediate supervisor, or acting supervisor, and complete a deviation report.
At ERP, deviation reports can be obtained from the President or QA Manager.
4.3 The President and/or QA Manager shall evaluate the deviation within 2 days of its being reported and decide disposition, which includes, but not limited to, the following:
a.
Report has no basis, document reason b.
Initiate corrective action and document action c.
Refer deviation to QA Review Board for expert consultation d.
Deviation is a substantial safety hazard.
Three copies of a report shall be sent to the Director, Office of In-spection and Enforcement, NRC; one copy t'o the Administrator of a Regional Office, NRC; one copy to ERP President; and one copy to the ERP QA Manager, within 5 days after the deviation was known.
l 4.4 Deviation reports to NRC shall contain as a minimum, the following:
l a.
Naae and address of individual informing NRC 1
o
v Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 15.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 2 of 2 Date: 5/1/86 REPORTING OF DEFECTS AND NONCONFORf1ANCE (CONTINUED) b.
Identify facility, activity, or component which fails to comply.
with safety c.
Identify the component supplier d.
Describe the defect and the safety hazard created or which could be created e.
Date of defect detection f.
Number.and locations of all components containing the defect g.
Describe corrective action taken or will be taken, name of individual and organization taking corrective action, and length of time estimated for completing the corrective action h.
Advice of defect fomarded or will be supplied to purchasers or licensees.
4.5' ERP and its subcontractors must submit to inspection of its premises, records, and activities by NRC representatives.
5.0 Report Retention:
5.1 Before ERP destroys copies of reports to NRC, they shall be offered to the component purchaser, unless a copy has already been sent to the purchaser.
6.0 Document Posting:
6.1 The following documents shall be posted for employee review by ERP and its subcontractors:
a.
10CFR21 b.
Section 206 of Energy Reorganization Act of 1974 c.
QAP 15.1 Procedures Employees shall be aware that, if defects have not been properly and adequately corrected, they may communicate directly with NRC via the telephone numbers listed in 10CFR21, Paragraph 21.2, Footnote 1.
Approved by:
Date: I
.k i
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 18.1 Columbus, Ohio 43201 Rev. 0 (614)299-2318 Page 1 of 7 Date:
2/7/86 ERP QA SELF-AUDIT CHECKLIST 1.0
Reference:
ERP Quality Assurance Program, Document QAM-001, Paragraph 18.0.
2.0 Scope
Annual self-audit of ERP QA Program and intermediate audits, if quality problems are indicated of any ERP functions related to safety.
3.0 Objective
To maintain the high quality of the ERP QA Program and to provide a forum for updating the program to meet current and future needs.
4.0 P rocedure:
The procedures in ERP QA Program, Document QAM-001, Paragraph 18.0 shall be followed, using the self-audit checklist on subsequent pages of this QA procedure.
it 1
i 1
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 18.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 2 of 7 Date: 2/7/86 ERP QA SELF-AUDIT CHECKLIST Date:
REA QUALITY ASSURANCE ANNUAL REVIEW e Pre-audit Conference and Orientation of Audit Team o Self-audit Implementation e Post-audit Conference REA Technical Unit Being Audited:
List of Participants - Name, Title, Audit Function:
Evaluation ERP QA SELF-AUDIT CHECKLIST Sat.
Unsat.
1.
Organization The ERP QA Manager must be identified, be independent of pro-duction, have direct access to appropriate management, and retain responsibility for QA Program when work is delegated to other organizations.
Loc.*
Com.*'
Loc. - Location, name, document number, revision number, and/or date as applicable.
- Com. - Comments or additional information
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 18.1 Columbus, Ohio 43201 Rev. O i
(614) 299-2318 Page 3 of 7 Date:
2/7/86 ERP QA SELF-AUDIT CHECKLIST (CONTINUED)
St U
t.
2.
Quality Assurance Program,
A QA program must be established that complies with 10CFR50, Appendix B and 10CFR71, Subpart H with written and approved policies and procedures that are used and under-stood by qualified personnel.
Loc.
Com.
3.
Design Control Measures must be established to ensure that:
(1) design requirements are correctly translated into specifications, drawings, procedures, and instructions, (b) changes of de-sign requirements or quality standards are identified, documented and controlled, (c) design adequacy is checked or verified by individuals other than those who performed the original design including but not limited to such items as reactor physics analysis, and stress, thermal, hydraulic, and accident analysis, and (d) prior to drawing release, a QA and engineering review is documented to ensure that supplementary information is recorded for procurement ac-tions and inspection acceptance criteria.
Loc.
Com.
t 4.
Procure-nt Document Control i
ERP engineering and QA must review procurement documents assure that:
(a) applicable regulatory requirements and design basis which are necessary to assure adequate quality are suitably referenced, (b) procurement request forms are reviewed by QA and are subject to document control, (c) draw ings, specifications, inspection requirements, and special instructions are included as applicable, and (d) provision l-for access to facilities and records are included and app-licable procurement document requirements are extended to subcontractors and suppliers.
Loc.
l l
Com.
l L
E Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 18.1 Columbus, Ohio 43201 Rev. 0 (614)299-2318 Page 4 of 7 Date: 2/7/86 E
ERP QA SELF-AUDIT CHECKLIST (CONTINUED) 3at n
t.
5.
Instructions, Procedures, and Drawings Activities affecting quality must be prescribed and accomp-lished with docurmnt instructions, procedures, or drawings, including appropriate acceptance criteria and these documents must be reviewed by QA.
Loc.
Com.
6.
Document Control All documents prescribing activities affecting quality must be controlled such that they are reviewed for adequacy and approved for release by the QA Manager. Such controlled documents include purchase specifications, drawings, test and inspection plans, and procurement documents and each copy must be controlled, as shown on a document control sheet.
Loc.
Com.
7.
Control of Purchased Material, Equipment, and Services Purchased material, equipment, and services must conform to procurement documents whether purchased directly or through subcontractors. A Supplier Directory shall be maintained listing products available and their approval status.
Im-plementation and control of quality by suppliers of products fabricated to ERP specifications must be audited at least once every 36 months.
Loc.
Com.
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 18.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 5 of 7 Date:
2/7/86 ERP QA SELF-AUDIT CHECKLIST (CONTINUED)
[at ns t.
8.
Identification and Control of Material, Parts, and Components Measures must be established for the identification and con-trol of materials, parts, and components including partially fabricated assemblies. Procurement documents, material test reports, and inspections shall be correlated to provide ma-terial traceability.
Loc.
Com.
9.
Control of Special Processes Special processes must be controlled by written procedures that are approved for use by ERP QA and are accomplished by qualified personnel using qualified procedures.
Loc.
Com.
10.
Inspection Quality inspection plans must document and verify examination at hold and witness points that are specified in appropriate documents.
ERP Engineering shall provide acceptance criteria for determining the acceptability of materials, parts, com-ponents, and assemblies including final acceptance criteria.
Loc.
Com.
- 11. Test Control All tests must be accomplished in accordance with written test procedures which incorporate the requirements and acceptance limits contained in applicable design documents.
Test resul ts shall be documented and evaluated to assure that test require-ments have been satisfied.
Loc.
Com.
r-Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 18.1 Columbus, Ohio 43201 Rev. 0 (614)299-2318 Page 6 of 7 Date: 2/7/86 ERP QA SELF-AUDIT CHECKLIST (CONTINUED)
S[t Uns t.
12.
Control of Measuring and Test Equipment Measuring and test equipment must be calibrated with regular verifications conducted to assure accuracy.
Loc.
Com.
13.
Handling, Storage, and Shipping Handling, storage, and shipping of materials and equipment must be controlled to prevent damage or deterioration.
Loc.
Com.
14.
Inspection, Test, and Operating Status Markings must be used to indicate the status of inspection, test, or operating status of individual items during manu-facturing.
Loc.
Com.
15.
Nonconforming Materials, Parts, or Components Measures must be established to control materials, parts, or components (services or activities) which do not conform to requirements in order to prevent their inadvertent use or installation. ERP QA shall also verify through audits, surveys, or source inspections that suppliers, fabricating products to ERP specifications, identify and segregate non-conforming, defective, or rejected material, parts or com-ponen'ts.
Loc.
Com.
Eggers Ridihalgh Partners, Inc.
1445 Summit Street QAP 18.1 Columbus, Ohio 43201 Rev. 0 (614) 299-2318 Page 7 of 7 Date:
2/7/86 V
ERP QA SELF-AUDIT CHECKLIST (. CONTINUED) 3t Unsat.
- 16. Corrective Action Conditions adverse to quality such as defective materials and nonconformances must be promptly identified and corrected.
The cause of such conditions shall be determined and approved corrective action taken to preclude repetition.
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- 17. Quality Assurance Records QA records must be identifiable and retrievable for articles and materials throughout fabrication, processing, procure-ment, inspection, test and operations.
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- 18. Audits A comprehensive system of planned and periodic audits must be carried out to verify compliance with all aspects of the ERP QA Program and to determine its effectiveness.
Audits shall be performed in accordance with written procedures or checklist by appropriately trained personnel not having direct responsibilities in the areas being audited. Audit results will be documented and submitted to the ERP President by the ERP QA Manager or a designee.
The appropriate QA porson or a designee will verify that follow-up corrective action has been performed, when a corrective action has been deemed necessary.
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