ML20204H630
| ML20204H630 | |
| Person / Time | |
|---|---|
| Site: | Perry |
| Issue date: | 05/03/1974 |
| From: | Campbell M, Rabin R GILBERT/COMMONWEALTH, INC. (FORMERLY GILBERT ASSOCIAT |
| To: | |
| Shared Package | |
| ML20204H531 | List:
|
| References | |
| SP-706-4549, SP-706-4549-00, NUDOCS 8411120339 | |
| Download: ML20204H630 (28) | |
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' ATIACHMENT SPECIFICATION.
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SP-706-4549-00 5-3-74 CONTENTS
-Item _
Title Page 1:01 Purpose 1
1:02 Scope 1
^
1:03 Definitions 1
1:04 Quality Assurance Program Administrative Requirements 3
s 1:05-General Quality Assurance Requirements 7
1:06 Quality Assurance Program Requirements 10 INFORMATION ONLY ATTAC10iENTS (Typical)
A
_ QA Release For Fabrication (Page 1 of 1)
.B
. Corrective Action Request (Page 1 and 2)
C Certificate of Inspection (Page 1 of 1) v r
SP-706-4549-00 5-3-74 1
'1:01 Purpose 1:01.li This Specification establishes QUALITY ASSURANCE and QUALITY CONTROL program requirements for procurement of ITEMS and manufacturing-services defined by IEEE No. 279 and of IE systems as defined by IEEE 308 for the Perry Nuclear Power Plant, Units 1 and 2.
1:01.2 A Quality Program as outlined herein shall be developed by the VENDOR and shall be reviewed and resolved to the satisfaction of the OWNER. The requirements shall include written procedures, processes and any other documents used to describe the VENDOR'S Quality Program.
1:01.3 The VENDOR'S Quality Program shall meet the requirements specified by this Document.. In the event the VENDOR'S procedures or methods do not accomplish their objectives, they shall be corrected and resolved to the satisfaction of the OWNER'S Quality Assurance Element or the QA AGENT.
INFORMATION ONLY 1:02 S~e 1:02.1-This Specification establishes the OWNER'S QUALITY ASSURANCE and QUALITY CONTROL program requirements imposed on the VENDOR as part of the OWNER'S QUALITY ASSURANCE program for procurement of ITEMS and manufacturing services' for the Perry Nuclear Power Plant, Units 1 and 2.
1:02.2 The requirements of this Specification are mandatory and shall be imposed by the VENDOR on all SUBVENDORS furnishing safety related ITDiS or services.
1:02.3 The requirements set forth shall be applied to all safety related activity during design, purchasing, fabricating, handling, shipping, storing, cleaning, installing, inspecting, modifying, and repairing.
1:03 Definitions In addition to the definitions set forth in the Parent Specification, to which this Specification is attached, the following terms shall have the meanings set forth:
1.
QUALITY ASSURANCE shall mean all those planned and I
systematic actions necessary to provide adequate confidence that components, structures and systems will perform satisfactorily in service.
l 3
~
SP-706-4549-00 5-3-74 2
2.
QUALITY CONTROL shall mean those actions (related' to the physical characteristics of materials, components, struc-tures and systems) which provide a means to control the quality of materials, components, structures and systems to predetermined requirements.
3.
0WNER'S QA ELEMENT - The OWNER'S organizational group j
responsible for QUALITY ASSURANCE.
4..
QUALITY CONTROL MANAGE shall mean the QUALITY CONT 20L Administration Manager at the construction site.
5.
-ITEMS shall mean services, materials, equipment (parts,
sub-assembi.es, assemblies, components, systems), or INFORMATION ONLY 6.
Tha QA AGENT is the authorized representative of the OWNER
.for assigned QUALITY ASSURANCE Functions.
7.
NONCONF0rJfANCE - A deficiency in characteristic, documentation or procedure which renders the quality of an ITEM unacceptable or indeterminate. Examples of NONCONFORMANCES include: physical defects, test failures, incorrect or inadequate documentation or deviation from prescribed processing, inspection or test procedures.-
8.
REWORK - The process by which a NONCONFORMING ITM is made to conform to a prior specified requirement by completion, remachining, reassembling or other means.
9.
REPAIR - The process of restoring a NONCONFORMING characteristic to a condition such that the capability of an ITEM to function reliably and safely is not impaired, even though that ITM still may not conform to the original requirement.
l..
10.
SCRAP - A disposition which is imposed for NONCONFORMANCE when it -is established that the discrepancy renders the ITEM unfit for its intended use and it is either uneconomical (or impossible) to effect corrections such as REPAIR or REWORK.
~
11.
USE-AS-IS - A disposition which may be imposed for a NONCONFORMANCE when it can be established that,the discrepancy will result in no adverse conditions and that the ITEM under consideration j
.will continue to meet all engineering functional requirements L
including performance, maintainability and fit.
m.
A
SP-706-4549-00 5-3-74 3
12.
SALVAGE - Parts, components, or assemblies which are contained in material designated as unfit for intended use or not economically repairable may be reclaimed through disasse=bly procedures and used only if such action is approved by OWNER'S Agent.
13.
SUEVENDOR - any organization under contract for supplying items or services to the VENDOR.
1:04 Quality Assurance Program Administrative Requirements 1:04.1 This section establishes the VENDOR'S interfaces with the OWNER'S activities, which provide the control and data to fulfill the responsibility of the OWNER to maintain a complete QUALITY ASSURANCE Program.
INFORMAT10H ONLY 1:04.2.
Documentation to be Submitted with Proposals:
With the Proposal submittal the Bidder shall supply two copies of his WE program which will be utilized to implement the requirements of this Specification. This submittal will be in the form of a QUALITY ASSURANCE or QUALITY CONTROL Manual or equivalent. This document will be reviewed by the OWNER I
or the QA AGENT and will be evaluated for adequacy of the QA/QC Progra= and will be considered in the selection of the successful bidder.
1:04.3 Documentation to be Submitted after Award of Contract:
1.
Within g calendar days af ter award of Contract, the VENDOR shall submit for review and acceptance his detailed QA/QC Plan r.nd the related procedures. The QA/0C Plan shall indicate implementation of the QA Program referenced in it.em 1:04.2. The Plan shall identify all ITEMS to be furnished for the Contract and by whom they are provided, i.e., VENDOR, SUEVENDOR etc.
It shall contain a manufacturing, inspection and test flow chart as well as a listing of the detailed procedures, specifications, instructions and other documentation, by title and revision number, to which these steps are performed (inspection points and other hold points shall be suggested by the VENDOR). All of the aforementioned documents shall be identified and listed by title and control number and shall be provided by the VENDOR as a separate entity. This listing shall indic, ate those documents that shall be submitted to the OWNER and which shall be retained by the VENDOR until delivery of the ITEM. The QA AGENTS review of the QA/QC plan may suggest additional and/or alternate hold or witness points which are considered significant to the OWNDI or QA AGENT.
~
SP-706-4549-00 5-3-74 4
2.
Subsequent changes of the above QA/QC Plan or any related documents shall be reviewed and accepted by the OWNER or QA AGENT prior to implementation of these. changes. TORK performed prior to this approval will be subject to rejection.
3.
As a guide in the preparation of the QA/QC Plan, the following typical
. points shall be addressed:
- a.
The inspection and tests to be.performe.
!~l.
b.
When, during the activity, the inspection and tests will be performed.
[
c.
A list of written instructions, including revision numbers, which will be utilized by persons performing the inspections and tests to verify the ITDiS l-acceptability.
d.
The titles of personnel authorized to perform the inspections and tests, their qualifications and to whom they report.
i I
e.
The types of reports that will be prepared to indicate i
that inspection and test results are acceptable.
./:
f.
The tests which will be conducted under special environmental conditions, and under what conditions l
these will be conducted.
r g.
Outdoor or long term preservation, packaging, and shipping procedures.
h.-
Complex / critical ITEMS purchased from SUBVEND"25 y
may require that a QC Plan be submitted and accepted by the OWNER and QA AGENT.
1:04.4'
. Documentation to be Submitted Prior to Manufacturing:
At least 60 calendar days prior to the start of fabrication the VENDOR shall furnish, as a minimum, the following listed procedures, instructions, data and other documentation, as applicable, to both the OWNER and the QA L
AGENT. This documentation shall be reviewed and evaluated, and upon
. acceptance, a subsequent "QA Release for Fabrication" (Attachment A) must be cbtained by the VENDOR prior to the start of manufacturer.
Manufacturing shall not commence until approval is received from both ENGINEERING and QUALITY ASSURANCE Divisions. The documentation shall include the following types of documents:
1.
Procedures:
s E
('
4..
Welding and Weld repair Procedures.
i b.
Welding Procedure Qualifications and Operator Qualifications.
I
SP-706-4349-00 5-3-74 5
c.
Nondestructive Examinacion (NDE) Procedures, d.
SDE Operacor Qualifications.
e.
Cleaning Procedures.
f.
Heat Treatiag Procedures.
g.
Hot / cold forming Procedures.
h.
Packaging, Shipping, Painting, and Storage Procedures.
i.
Performance Test Procedures.
j.
Hydrostatic and Leak Test Procedures.
k.
Electrical Test Procedures (when applicable).
1.
SUBVENDOR Quality evaluation and Monitoring Procedures.
Procedures for methods to be used to verify design (when m.
applicable).
n.
Procedure for verifying wall thickness of pressure
/_
boundaries of castings and forgings for valve bodies, pump casings, pipe and pipe fittings, etc.
o.
Inspection and Test Procedures, including process monitoring at specific points (when applicable).
.p.
Sampling plan details, if applicable, q.
'Special inspection, tooling, test equipment and instrumentation details.
r.
. Marking and identification procedures.
s.
The sources for purchased material and or subcontracted work and the Purchase Orders (unpriced).
~
t.
SUBVENDOR procedures for control of quality, when required by the OWNER.
NOTE: These procedures must demonstrate how the applicable requirements will be met.
2.
Manufacturing Sequence Sheets.
3.
Manufacturing Schedule.
4.
A sample documentation package.
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o SP-706-4549-00 5-3-74 6
liO4.5 Notification of Inspection Hold Points, Audits, and Shop Tests:
1.
Based on manufacturing sequence and schedule data provided, the OWNER or the QA AGENT may establish hold or witness points at which inspections or the witnessing of special processes are required. The VENDOR shall provide at least seven calendar days advance notice to the OWNER and QA AGENT of the readiness for accomplishing these required inspection or witnessing points or processes. Audits of the VENDOR'S quality program =ay be performed by the OWNER or QA AGENT in conjunction with any of the above.
2.
Manufacturing shall not proceed beyond these hold points without inspection by the OWNER or QA AGENT or waiver of the subject hold point.
1:04.6 Documentation to be Submitted at completion of Manufacturing:
1.
A complete documentation package shall be prepared by the VENDOR and will be made available to the OWNER or the QA AGENT during final inspection and prior to shipment of the ITEM. The documentation package shall donsist of such items as the following, plus other documents as listed in the Parent Specification and other CONTRACT DOCUMENTS:
INFORMATION ONLY a.
NDE Reports.
.b.
Material Test Reports (shall be available for review prior to Fabrication).
c.
Final Inspection Reports / Certificates.
~-
d.
Performance Test Reports.
e.
~ Code Data Inspection Reports.
f.
Hydrostatic and Leak Test Reports.
i g.
Electrical test. reports (when applicable).
h.
As-built Drawings.
1.
Design changes / specification deviations (Requests).
- j.
Radiographs.
h.
Weld maps and joint history records.
1.
Verifiention of wall thicknesses.
Radiographs shall be available for review by the OWNER'S or QA AGENTS inspector during manufacturing, and subsequent to shipment-to the QUALITY CONTROL MANAGER.
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SP-706-4549-00 5-3-74 7
-x 2.
The documentation package shall be sent by. the VENDOR to the QUALITY CONTROL MANAGER at the construction site via certified U.S. mail or other pre-approved conveyance prior to each shipment
.from the VENDOR'S shipping point.
1:04.7 Certificate of Inspection:
1.
Unless specifically waived by the OWNER or QA AGENT no I.
. shipment shall be made to the. construction site until a '"QA Certificate of Inspection" (attachment C) is
[-
issued. The "QA Certificate of Inspection" will be issued af ter review and acceptance of the documentation.
(Final acceptance of the ITEM is made only af ter inspection at the construction site.)
2.
The OWNER reserves the right to reject and retura all ITEMS received at the construction site which do not have a "QA Certificate of Inspection" included with the shipment.
3.
The documentation package shall be complete and include all items required by item 1:04.6 and the "QA Certificate of Inspection". This documentation must be received at the construction site prior to final acceptance of the ITEM (S).
1:04.8 Submittals:
The VENDOR shall supply copies of all data, documents, transmittals, and. notifications required by this Quality Level Attachment Specification in addition to the distribution required by the Parent Specification, unless otherwise specified herein:
a.
Two copies to:
The Cleveland Electric Illuminating Cmpany l
'P. O. Box 5000 Cleveland, Ohio 44101 Attention: Mr. John G. Marjenin Senior Engineer in charge of Quality Assurance
- b.
Two copies to:
Gilbert Associates, Inc.
P. 0.. Box 1498 Reading, Pa..19603 Attention: QA Program Manager (PNPP) 1:05 General Quality Assurance Requirements For inspection, witnessing of tests, and audit purposes the OWNER 1:05.1 or.QA AGENT shall have free access to the VENDORS and SUBVENDOR'S WORK and documentation.
Inspectors from the AEC Directorate g
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SP-706-4549-00 5-3-74 3
of Regulatory Operations shall be permitted to accompany the CWER or QA AGENT during these visits.
Inspection by the
' 0WNER or QA AGENT is not a waiver of any warranty or other rights of the OWNER.
1:05.2-Access to Quality Assurance Information:
Access to data or information which affects QUALITY ASSURANCE will be insisted on by the OWNER or its' Agents. Failure to comply with this requirement shall be sufficient reason for cancellation of Contract.
Written agreements not to divulge proprietary information will be entered into if necessary to obtain access to such quality information.
1:05.3 Significant Deficiencias:
1.-
In the went that significant deficiencies are discovered in the VENDOR'S QUALITY ASSURANCE Program the OWNER or QA AGENT shall order the VENDOR to "stop all affected contract WORK" until such deficiencies are resolved to the satisfaction of the OWNER.
(See USAEC 10 CFR 50 paragraph INFORMATION ONLY
' "*)
2.
If the OWNER warrants it necessary, a " resident" inspector will be placed in the VENDOR'S facilities until the resolution of such defic.iencies is satisfactory to the OWNER.
I 1:05.4' Release for. Fabrication:
i The VENDOR shall not begin manufacture of the ITEM (S) until a i-QUALITY ASSURANCE " Release For Fabrication" (Attachment A) has been issued.
(This release is in addition to the Engineering approvals required prior to fabrication.) This i
release indicates that QUALITY CONTROL and testing procedures have been accepted.
1:05.5 Material Furnished by Owner:
y When material is furnished by the OWNER or any of its Agents, the
' VENDOR'S procedures shall include as a minimum, provisions L
for the following:
1.
Examination upon receipt:
a.
To detect shipping damage.
b.-
For completeness and proper type.
L c.
For conformance to Specification and contract requirements.
d.
For verification of quantity and quality with notification in writing to the OWNER within twenty days of receipt or before VENDOR use, whichever is earlier.
l
SP-706-4549-00 5-3-14 9
2.
Periodic inspection and precautions to assure adequate storage and to guard against loss, damage from handling or deterioration during storage.
3.
Functional testing, either prior to or after installation, or both. -as required by the parent Specification to determine satisfactory operation.
4 4.
Identification and protection from 1:nproper use or disposition.
-5.
At the time of installation or shipment of the respective unit or assembly, the VENDOR shall provide the OWNER with a written certification that the material used in the respective unit or assembly is in fact that which was furnished by the OWNER or its agents.
6.
h VENDOR shall report in writing, to the OWNER, any OWNER-furnished material found damaged, malfunctioning, or other-wise unsuitable for use, at receipt, during, or af ter installation. h VENDOR shall determine and report probable cause and necessity for withholding materia.1 from use. Such material shall not be used without written authority from the OWNER.
1:05.6 Delay of Shipments:
lh The OWNER or QA AGENT shall have the right to delay the sh M ent of ITEMS from the VENDOR'S or SUBVENDOR'S shop or to delay final acceptance pending corrections of errors or omissions in
-manufacture, test, drawings, shipping preparations or documentation.
1:05.7 Corrective' Action Requests:
The VENDOR shall correct NONCONFORMANCES to the Contract, as noted and reported on " Corrective Action Request" (Attachment B) issued by.the QA AGENT. h action taken to correct the NONCONFORMANCE shall be entered on the Corrective Action Request form and returned to the QA AGENT for acceptance of the action taken.
1:05.8 Records:
ch VENDOR shall maintain all records and documentation pertaining to the ITEM. W records shall be provided with security and pro-tection against destruction and deterioration during the manufacturing period until submitted in accordance with item 1:04.6.
. 1:05.9
- Nonconforming items:
VENDOR NONCONFORMING material dispositions requiring action by the OWNER are those dispositioned REPAIR, USE-AS-IS, or SCRAP (if the material is furnished by the OWNER).
Such dispositions shall require approval through submission of a request for deviation from Contract requirements to the OWNER and the ENGINEER for processing and final approval.
Items shall not be submitted for final inspection until approvals of waiver requests are received by the VENDOR.
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SP-706-4549-00 5-3-74 10 1:05.10 Conflicts:
In the event of discrepancies between the Parent Specification and this Specification, with regard to QA requirements, this Specification shall prevail, except where the Parent Specificacion lists additional requirements. Discrepancies shall be brought to the attention of the OWNER.
1:06 Quality Assurance Program Requirements INF0 NATION ONLY 1:06.1 Program:
1.
The VENDOR'S QUALITY ASSURANCE Program shall meet the l
requirements as specified herein. These requirements i
are consistent with the quality requirements of l
governing codes, such as ASME BAPV Code Section III, l
10CFR50, Appendix B, " Quality Assurance Criteria for l
Nuclear Power Plants", and 6.
2.
The QUALITY ASSURANCE Program shall be described with j
written policies, procedures, and instructions. The l-program shall provide for indoctrination and training of personnel performing activities affecting quality l
to assure that suitable proficiency is achieved and maintained. The program shall provide for regular review l
by the VENDOR'S management to verify the status, effectiveness and adequacy cf the program. The program shall include monitoring of SUBVENDORS to assure compliance to quality l
requiremects.
3.
The program shall recognize the OWNER'S and QA AGENT'S l-right to audit the VENDOR'S QUALITY ASSURANCE Program l
as necessary to comply with the OWNER'S obligation under the applicable codes, standards and regulations. The program shall provide that the necessary documentation l
and records, referenced in iteme 1:04.2, 1:04.3, 1:04.4, 1:04.5 and 1:04.6, be furnished to the OWNER on a timely basis.
4.
If the VENDOR'S QUALITY ASSURANCE Program is not in effect, no work shall be done on ITEMS covered by the Contract until the VENDOR'S QUALITY ASSURANCE Program as set forth in the VENDOR'S Proposal has been established, audited, and accepted by the OWNER or QA AGENT. Changes to the VENDOR'S Quality Assurance Program af ter work constences shall be submitted by the VENDOR to the OWNER or QA AGENT for review and acceptance.
i t
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SP-706-4549-00 3-3-74 11 1:06.2-Organization and Planning:
1.
The VENDOR shall _ have a' QUALITY ASSURANCE organization in which persons performing quality functions have well defined responsibility, authority and freedom from production pressures to effectively identify, pursue, and resolve
~
quality related problems, and to assure that the VENDOR'S Quality Program is established, planned, and implemented 4
in accordance with the requirements established in this Specification. The lines of authority, organizational structure and functional responsibilities shall be clearly established and delineated in writing. The organizational description shall include statements of functions and responsibilities down to the first level of supervision within the Division or Plant where WORK is to be performed.
It. is rece gnized that QUALITY ASSURANCE is an inter-disciplinary function involving many organizational groups
' and not necessarily limited to a single -QUALITY ASSURANCE group. However, the organization shall be arranged so that the individual or group assigned the responsibility for
. checking, reviewing, inspecting, auditing, or otherwise verifying that an activity has been correctly performed is independent of the individual or group directly responsible for performing the specific activity.
-2.
The VENDOR'S Quality Organization shall define in writing all responsibilities and duties of personnel involved in the Quality Program. These personnel shall be fully qualified and properly trained and shall have adequate knowledge of the specific function which they are responsible to perform.
3.
The VFNDOR, immediately after award of Contract, shall perform a complete review of the Contract and take timely action to ensure that the necessary procedures and provisions are established in accordance with the Parent Specification.
Purchase Order, applicable codes and standards, or other-CONTRACT DOCUMENTS. Where there are unique requirements which require special equipment, especially trained personnel, procedures for process control, process or personnel l
qualifications, or other actions to control quality, they shell-be specified and documented as necessary on travelers, process sheets, work instructions and inspection plans.
1:06.3 Design Control:
i 1.
' The VENDOR, when responsible for design activity or for conformance to specified design criteria, shall provide measures to assure that specified design requirements such as design bases, regulatory requirements, codes and e
r; H
SF-706-4549-00 5-3-74 12 1
standards are correctly translated into specifications, drawings, procedures,' and instructions. Design control measures shall provide for, but not necessarily be limited to, design analysis such as stress analysis, thermal analysis, hydraulic analysis, seismic analysis, and accident analysis; compatibility of materials; accessibility for in-service inspection, maintenance and repair; and delineation of acceptance criteria for inspection and tests. Maans shall also be established for the selection and review for suitability of application of materials, part, equipment and processes that are essential to the funct fta
~
structure, system,.or components.
2.
The VENDOR, when responsible for design activity, shall provide measures approved by the ENGINEER or OWNER to verify the adequacy of the design, by design reviews, calculation verification or performance testing. The verification of design adequacy shall be performed by individuals or groups who are independent of the original design effort, (but need not be from a different organization). The depth of review performed may vary depending upon the importance and complexity of the design, state-of-the art, and previously proven designs. The scope of design verification can range -from a formalized multi-organization review to an informal, single-person review. As a minimum, the verification shall consist of reviewing the design, checking calculations or analyses, and evaluating the results against the original
. bases and functional requirements.
In particular, the VENDOR shall perform design verifications on ITDiS as set forth in the Parent Specification, and then verify by proper documenta-tion that actual conditions meet the specified values. If
- performani.e testing is used as a design verification, tests i
shall be performed under the most adverse design criteria.
The VENDOR, when responsible for design activity, shall submit a certification to the ENGINEER that his design has been verified in accordance with these requirements. Documented evidence of the design verification shall be made available on request.
's j
- 3. -
The VENDOR shall establish, when che design responsibility required L
by the Contract of which this Specification is a part is shared, interface control measures which control and coordinate the activity.
l These measures shall include procedures governing the review, approval, release, distribution and revision of documents involving l
- design interface information. Similarly, any design changes shall
, be by a means of design change control which obtains the necessary notification, review, approval and distribution to the responsible interfacing individuals, groups or organizations.
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SP-706-4549-00 5-3-74 13 1:06.4 Procurem-ment Control:
e 1.
The VENDOR is responsible for assuring that all VENDOR procurement documents contain or reference all applicable requirements of this Specification, material specifications, tests, inspections, and other necessary quality requirements.
2.
Changes -in procurement documents shall be subj ect to che same
- controls as the original document.
-3.
Procurement Documents shall require suppliers to provide, as necessary, a QA program consistent with this Specification.
.[
4.
Procurement Documents shall include provision for the following as applicable:
a.
Define the level of QA program development required for the SUBVENDORS.
~
INFORMAT10N ONLY b.
Specify technical requirements:
Drawings, specifications, inspection requirements, standards, special instructions and requirements for designing, fabricating, cleaning, erecting, packaging, handling, shipping, extended field storage, and for test equipment.
j c.
' Source Inspection and Audit:
Provision for access to plant facilities and records for source inspection and audit shall include the VENDOR, OWNER and/or the OWNER'S Agent. Provision shall also be made for imposing mandatory hold points on the SUBVENDOR as required by OWNER or QA AGENT.
d.
Documentation:
Provision shall be made for record preparation, retention, and disposition. Records shall include drawings,
- specifications, inspections, and test results as a minimum.
c.
SUBVENDOR Procurement:
- Provision shall be made for extending applicable
- requirements to SU5 VENDOR'S including the OWNER'S right of access to facilities and records.
1:06.5 Procedures, Instructions, and Drawings:
All activities performed by the VENDOR or SUBVENDOR which affect the quality of ITEMS shall be prescribed by and performed to clear and j<
complete documented instructions, procedures or drawings. These documents
~
shall adequately describe the necessary actions and acce.ptance criteria to affect. control of quality. These activities may be described in operating or procedura manuals, test procedures, job
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SP-706-4549-00 5-3-74 14 specifications, planning sheets, shop or construction drawings, or any other type of written form, provided the description will fulfill the contractural requirements. Proc edur es, -
instructions, and drawings shall include acceptance criteria such as dimensions, tolerances, and comparisor of voricnanship samples. The applicable forms, inspection sheets, reports, or documents that will be used to verify work performance and qualify compliance shall also be included.
1:06.6 Document Control:
1.
This element requires the establishment of measures that will assure control of the issuance, revision and distribution of documents including changes thereto affecting quality. These documents which include drawings, instructions, procedures, 4
etc. require review for adequate coverage to control quality and shall be approved for release by VENDOR authorized personnel.
Disttibution of these documents shall be to the locations or d
persons using the ' documents to perform the prescribed activity.
' Changes to documents shall be reviewed.and approved by the same organizations that performed the original review and approval, unless another responsible organization is designated.
2.
Listed below are the areas that will be documented for this element of the quality program:
a..
- Identificatf.on of those individuals or organization authorized to approve the issuance and revision of documents.
b.
The system that will effect proper distribution of documents and the control of obsolete ones.
c.
Identification of the proper documents to be used in performing the activity.
d.
The measures that will be exercised to assure that the -
r latest approved documents are being used to perform the activity.
e.
Measures to coordinate and control interface documents.
1:06.7L
- Control'of Purchased Materials, Equipment, and Services:
1.
The VENDOR shall assure that all ITDfS and services conform to Contract requirements. The selection of SUBVENDORS and the degree.of control to be exercised by the VENDOR is dependent upon the type of ITDf, how well the SUBVENDOR has demonstrated his capability to perform, and the quality evidence made available. The VENDOR shall review and assess all SUBVENDORS I
as frequently as deemed necessary to assure that the established controls for quality are effective and that the-l.
l integrity of the procured ITDtS is maintained.
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SP-706-4549-00 5-3-74
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15
.2.
The procedure for control of this e describe how the following vill be accompt sne.
Selection of'SUBVENDORS, including the criteria used to a.
determine that they are qualified.
The forwarding of design, quality requirements and other
- b..
data pertinent to the procured ITDi to the SUBVENDOR.
Evaluation of the procured ITEM for conformance to Contact
- c.. requirements, obtainable through the VENDOR'S inspection or surveillance of procured ITEMS, and/or review of the SUBVENDOR'S documents related to quality, i.e., test reports, certificates, and inspection reports.
d.
Early detection, feedback of information and correction of nonconforming conditions.
Provisions to up-date Purchase Order requirements to a.
comply with latest revisions to applicable specifications, drawings and codes..
l':06.8 Identification and Control of Materials, Parts, and Caponents:
-1.
The measures established for identification and control of materials, parts and ccaponencs, including partially fabricated subassemblies, shall be documented and provide a means for assuring that only correct and acceptable ITDiS are used in the fabrication, assembly, processing, installation and repair. These measures chall at all times be capable of relating the ITDi to any stage _ of production activity to the applicable specifications, drawings or other documents, from initial receipt of materials through final acceptance upon
- completion and/or installation. When required by Contract, traceability of the ITEMS shall be maintained and documented. The traceability method shall be such that the ITEM and any parts thereof are identifiable to all associated records such as material test reports, quality records, certifications, drawings or other pertinent documents.
2.
Contained within the procedure for this quality program element shall be a description of the following:
a.
. Identification methods:
Permanent low stress dir, stemps, vibro etching, stenciling, paint, tags, etc.
b.
Those ttages or points at which verification of identification is performed by VENDOR QUALITY CONTROL personnel.
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SP-706-4549-00 5-3-74 16 f-c.
Unique numbering' systems when used (coded letters or numbers in lieu of actual part or component numeers).
d.
Method for determining the fabrication, installation, or inspection' status at all stages such as special tags, travelers, process sheets, etc.
Traceability methods (when required), i.e., numbering a.
system and cross referencing to inspection, test and associated quality documents.
' 1: 06'. 9 Control of Special Processes:
The manufacture of cerr.ain ITEM 5%7gpate the ne nse 1.
special processes such as velding, nondestructive examination, heat treating and cleaning. These special processes are of complex and specialized nature and require more precise detailing than ordinary work instructions, as well ae i.
qualifications of the personnel, procedures, and equipment.
Written instructions for these processes will be necessary and require the ENGINEER, the OWNER or the QA AGENT'S review and acceptance. The procedures for the control
. of this quality program element shall describe how the following will be accomplished:
a.
Identify methods for controlling manufacturing, construction and special processes.
r b.
Describe special processes, procedures and-personnel qualifications which will be used.
2.
When welding is used during fabrication, or for major repair, g~.
the VENDOR will prepare a weld map identifying each veld by number. A composite list will amplify this map and will include, but not necessarily be limited to, the following for each weld: The identifying number of the approved weld
[
procedure; cleaning and heat treatments, if required; E
methods and-frequency of the non-destructive tests:
[
- identifying number of the pertinent NDT procedures including radiographic outline and shooting sketches, and the NDT y.
acceptance standard. These-documents vill be kept current and a copy of each will be forwarded to the QA AGENT for information.
'1:06.10 Control of. Inspections and Tests:
1.
A complete and current program of inspections and tests shall be prepared for all activities affecting quality, and
.snall identify those inspection and test points to be L
verified for conformance to documents auch as instructions,
[ ~
procedures, drawings, specifications, etc., that are used to perform the activity. The inspection and tests shall be
(
performed by individuals other than those who performed the I
t
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SP-706-4549-00 5-3-74 17 activity being inspected or tested and who do not report to the supervisor who directed the original work. There shall be an. adequate number of inspections and tests performed to assure that all operations of the activity fulfill the pre-determined quality requirements. Mandatory inspection hold or witness points requiring the witnessing or inspection of a specific activity by the OWNER and/or QA AGENT shall be indicated in appropriate documents. The VENDOR shall submit a recommended list of inspection hold points to the OWNER and QA AGENT for approval prior to the start of fabrication. The VENDOR, for ITEMS fabricated in his shop, shall notify the QA AGENT in writing at least I week in advance of readiness for inspection at a hold point. WORK
- shall not proceed beyond the approved inspection hold point
-until the WORK has been inspected and accepted or the inspection is waived in writing.
2.
N procedure for control of inspection and tests shall as a minimum describe the following:
Inspections and tests which will be performed.
a.
b.
When, during the activity, inspections and tests will be performed.
/
What written instruction the person performing the c.
inspections and tests will be working to, including the specific acceptance criteria, tolerances, etc.,
which must be verified.-
d.
The personnel who are qualified to perform the inspections and tests, to vbom they report.
I~
The type of reports that will be. prepared to indicate e.
that inspection and test results are a-ceptable, f.
When inspection of processed material or products is impossible or disadvantageous, what indirect controls.
is l
by monitoring processing methods, equipment and personnel shall be provided. Both inspection and l,(
process monitoring shall be provided when control is L
inadequate without both.
What tests will be conducted under special environmental i
g.-
conditions, and under what conditions these will be conducted.
i l
5-3-74 18
- g 1
- 06.11' Control'of Measurements, Inspection and Test Equipmant:
1.
Me.asures shall be established by the VD' DOR to assure that tools, gauges, instruments and other measuring and testing p
devices affecting quality are controlled. To assure accuracy these devices shall-be calibrated and adjusted at a VENDOR specified frequency, or prict to use. The measuring devices shall be the proper type, range, and accuracy for the application to verify conformance to established requirements. Calibration of measuring Uvices shall be to equipment that is CERTIFIED to standards recognized by the National Bureau of Standards.
If the device cannot be calibrated to a national standard, the calibration method shall.be documented to provide justification for the use of the measuring devic 2.
If production devices such as jigs, fixtures, templates, and patterns are used as media for inspection, such devices shall also be checked and proved accurate at periodic intervals.
Records of such actions shall be maintained for verification.
3.
Listed below are the areas to be defined for this element of the quality program:
a.
A listing of all measuring and test devices affecting quality that require calibration.
(Measuring equipment such as steel rules, levels and similar equipment will not require calibration when their usage does not require a precise degree of accuracj.)
b.
The method of calibration for each ITEM in the listing specified in subitam a. above, including recognized
..E standard use, for certification of calibrating egoipment.
c.
The established frequency of calibration.
d.
The method of identification for each ITEM under
. calibration control.
y a.
The method for determining the calibration status of each ITEM, such as the attachment of a sticker showing the last calibration date, date when due for recalibration and the person's stamp or signature who performed the last calibration.
f.
The type of records that will be maintained.
g.
The method for determining and recalling equipment when calibration is due.
h.
The measures to be exercised when equipment that is out
'of calibration hac been found to have been used to accept ITEMS.
=: -..
SP-706-4549-00 5-3-74 19 1:06.12 Handling, Storage and Shipping:
1.
Handling, storage, and ' shipping including cleaning, packaging, and preservation of ITEfS shall be controlled by the VENDOR through documented measures to protect the ITEM from damage, deterioration, or loss or substitution of parts. When the nature of the ITDi dictates the need for special environmental control or special handling equipment, they shall be specified by the VENDOR and their use verified.
Special handling equipment shall be programmed for periodic inspection and testing as necessary to ensure that they are adequately maintained. The identification, marking and labeling of ITEMS shall be in a manner that will assure no loss of identity and permit permanent and easy recognition of special handling and storage requirements.
2.
The areas to be described for this activity are:
a.
The measures that will be utilized to protect ITSiS, f_
requiring special handling packing, cleaning, f
preservation, storage and shipping techniques.
b.
Measures that will be used to protect identification, marking and labeling from deterioration and loss of recognition when the method is not a permanent type.
1:06.13-Inspection, Test and Operating Status:
The VIMDOR shall maintain a system for identifying the inspection and test status of products. This may be accomplished by marking, tagging travelers, inspection records, etc., of the 'ITDiS.
Where the identification is removed as a result of the process, the material / component shall be re-identified as soon as the in-process step (such as machining) has been complaced. During
//
storage, the material shall be identified to the Contract or Purchase Order; a permanent metind shall be used when practical.
If marking methods other than cho w permitted or specified by applicable codes or specifications are to be used, the method of marking and its location shall be approved by the OWNER or QA AGENT prior to use.
'1:06.14 control of Nonconforming Materials, Parts or Components:
1.
Measures shall be established and documented by the VENDOR to control ITEMS when there is evidence of nonconforming conditions to established requirements. These measures shall provide a means of identifying, documenting, segregating, dispositioning and notifying all concerned parties of nonconforming conditions.
The noncor 'rming ITEM shall be reviewed by the VENDOR to determine I
appropriate disposition. The dispositioning of nonconforming
~
ITDiS shall be by persons so authorized by the VENDOR.
Nonconforming ITEMS may be resolved by acceptance "As Is", REPAIR, REWORK or SCRAP. ITDiS considered acceptable "As Is", repaired, or reworked l
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SP-7CS-4549-00 5-3-74
~
20 require documentation that will verify their acceptability and provide a permanent record of the ITa5 "as bui' t".
Appropriate controls and measures shall be established and maintained for the nonconforming ITES to prevent any further processing until the disposition of the nonconforming condition has been approved.
2.
When material is first found to depart from requirements, it shall be identified and withheld from normal production channels.
- A means for recording each action shall be provided and :naintained by the VENDOR reflecting the condition of material and action (s) taken to correct the condition. Provision will also be made for recording the disposition action taken, i.e., USE-AS-IS, REWORK, REPAIR (See item 1:05.9).
3.
A description of the following shall be included in the Quality Program:
JFPannringMATION ONLY a.
Method for identifying, reporting pr nonconforming ITES.
7 b
b.-
Individuals or organizations responsible for the actions specified in subites a. above.
Individuals or organizations authorized to prepara and c.
approve the dispositioning of nonconforming ITEMS.
d.
The type of form (include sample) to be used for 3-reporting and dispositioning nonconforming ITES.
a.
The distribution of.the initial report, disposition and verification'of acceptability for the nonconforming
' ITEMS.
i f.
The measures for control of the ITEMS to prevent further
- processing'of the ITEM until disposition has been approved; 1.e.
' segregation, tagging, marking or other positive means.
g.
The measures-for control of the documentation that verifies and supports all actions relative to the nonconforming ITE.
l':06.15 Corrective Action:
1.
Measures shall be established by the VENDOR to assure that conditions adverse to quality are identified and corrected. Nonconforming conditions, deviations, deficiencies and def ective material and equipment are considered adverse'to quality, and upon detection shall be documented and appropriate action taken to correct the condition. When the condition is significant and dictates the
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SP-706-4549-00 5-3-74 21 f
'need for corrective action to preclude repetition, these actions shall be documented, initiated and monitored to assure
- 7...
that the corrections are adequate and eff ective. The prescribed corrective action may involve SU3 VENDORS, and should this
'be the case the VENDOR'S quality program shall provide the necessary measures to assure control of quality. Records of corrective action shall be available for review by the OWNER or QA AGENT.
4 2.
The. procedure shall adequately describe the following:
The list of individuals or organizations responsible for a.
identifying those conditions requiring corrective action.
fb.
The list of individuals or organizations responsible for preparing and approving the corrective action measures.
1 Guidelines for.. determining the need for corractive IqQor documentingRM
.c.
d.
Type of form (include sample) to be use this activity.
Distribution list including the appropriate levels of e.
management..
f.
. Measures that will assure the prescribed corrective actions, including those that extend to the performance of subcontractors and suppliers, are properly initiated, adequate and e.ffective.
1:06.16 Documentation and Records:
1.
Documentation and records shall be prepared concurrent with the activities they describe and maintained at the VENDOR'S shop. The documentation and records shall furnish evidence that the activities affecting quality have been performed, monitored, inspected, tested, audited, analyzed (materials), etc.,
as prescribed... Inspection and test records shall be dated and as a minimum, include the results and acceptability, the nature and type of acceptances and deficiencies found, the nonconformances approved and rejected, identify the inspector
.or data recorder, the type of observation performed, and the action'taken to resolve nonconforming conditions. Data related to the qualification of personnel, procedures and equipment used to perform nondestructive examin.stion, welding or other special processes shall be a part of the records. Records and requirements concerning transmittal, retention and storage shall be consistent with the codes, standards, and other requirements of these specifica'tions and procurement documents. All documents shall bear the name of the OWNER, the OWNER'S Purchase Order Number,
~
and the name,' Perry Nuclear Power Plant - Unit 1 or 2, for ready identification by the OWNER and the QA AGENT.
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SP-706-4549-00 5-3-74 22 2.
The VENDOR shall have written procedures covering the preparation, control, storage, and disposition of all records.
These proc _edures shall describe what steps he will take to ensure that# the records he retains will be identifiable, retrievable, and adequately stored to preclude loss or deterioration of records. - The VENDOR shall also provide the following in his Proposal:
- Listing of all' documents and records affecting quality a.
that are to be.a part of the record system. This list shall include and identify records which will be
[-
submitted to the OWNER and those which will be retained.
b.
Identification of the applicable forms that will be used to record the quality data obtained for each activity.
h, 1 o' 17
^=41=='
INFORMATION ONLY
~
1.
VENDOR Quality-Programs require planned and systematic audits by the VENDOR in order to determine their effectiveness.
Auditing shall be performed in accordance with procedures and i
check lists that will enable auditors to verify all aspects of the quality program. - Auditors shall be trained personnel and have no direct responsibility for that area or activity
_ being audited. - The results of the audit shall be docu-N mented and reviewed by management having responsibility for the area or activity audited. Appropriate actions shall be taken to correct deficient areas or activities, with
- followup action to ensure that the deficiency has been satisfactorily corrected.
2.
_ A description of the following items shall be required:
L The criteria for determining when and at what frequency p
a.
(periodic, random. etc.) audits shall be performed, i.e.:
(1) When extensive changes are made to the Quality
(
Program (procedures, methods, organization).
l (2) When the ITEM becomes suspect of its quality being jeopardized due to numerous deficiencies
[
or nonconforming conditions.
f' 4
.(3) When an assessment is deemed necessary to evaluate the offectiveness of the Quality Program.
l-b..
The system that will be used to. perform the audits.
c.
.How the audit findings, corrective actions and results
[
will be documented and to whom they will be distributed.
l d.
The titles'and duties of persons having responsibility l
for the audit.
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4 ATTACHMENT A Page 1 of 1 7
GILBERT ASSOCIATES, INC.
, QUALITY ASSURANCE DIVISION RELEASE FOR FABRICATION 4
DATE:
VENDOR.NAME ADDRESS:
. ATTENTION INFORIRATION ONLY c.ntlemen:
Documents necessary to satisty QUALITY ASSURANCE requirements have been reviewed and found acceptable. Authorization is hereby given to utilize the documented procedures for fabrication of the ITEN(S) listed below. This release shall not relieve the contractor of his responsibility for conforming to all applicable requirements and shall not be considered a waiver of l
warranty or other rights. Fabrication shall not proceed until engineering approvals have been received.
ITEN(S) DESCRIPTION PURCHASE ORDER l
[
CLIENT,
UNIT By l
PROGRAM MANAGER QUALITY ASSURANCE j
l-cc: As req'd. by project l-l l
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4 Attachment B
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Page 1 of 2 i
INFORMAT,IArLDHLY
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CORRECTIVE ACTION REQUEST GILBERT ASSCClATES INC.
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- 4. SPECIF-C A f rom 4.C0081
- 2. QUALITY COut BOL 7eOCt0uSE S. PURCMait 0#0E 4 T.
- 3. ENC:me t eenc sta.-aec et00 etastmf No.
CCAAECTivt ACTION AtQut1TRO TO Rtlo'.vt TME CDwelTION$ NOTt0 AELOW
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'at1PCaest TO REQUEST. (C*4RICTIVE ACTION wE ASURE15NALL BE su1TAINING AND PROv10E NON 4ECURAENCE OF THE CON.
DITION p.OTED I i
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Attachment C Page 1 of 1 GILSERT ASSOCI ATES. INC.
QU ALITY A55URANCE DEP ARTMENT CERTIFICATE OF INSPECTION CLIENT UNIT
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ORDER NO.
.lDENTIFICATION NO.
VENDOR APPLICA8LE DRAWING NO.' AND REVISON h
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~ (ENGINEERING, VENDOR, ETC.)
APPLICABLE DOCUMENT NO. AND REVISON (REQUIREMENT OUTLINE, SPECIFICATION) i CERTIFICATION 15 MERESV GIVEN THAT THE ITEM (5) LISTED ASOVE NAVE SEEN
.-INSPECTED AND FOUND TO MEET THE APPLICA8LE REQUIREMENTS EXCEPT A5 j-NOTED BELOW..THl5 CERTIFICATION SH ALL NOT RELIEVE THE CONTRACTOR f
OF MIS RESPONSIBILITY FOR CONFORMING TO APPLICABLE REQUIREMENTS AND SH ALL NOT BE CONSIDERED A WAIVER OF WARRANTY OR OTHER RIGHTS.
INF0llMATION ONLY
- EXCEPTIONS:
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. REMARKS:
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l 8Yr VENDOR INSPECTOR QUALITY ASSURANCE DATE:
l G,u/0A (F) 11.33 II.1249 l
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