IR 05000313/1974005
| ML19320A142 | |
| Person / Time | |
|---|---|
| Site: | Arkansas Nuclear  |
| Issue date: | 04/02/1974 |
| From: | Kidd M, Robert Lewis, Murphy C NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML19320A139 | List: |
| References | |
| 50-313-74-05, 50-313-74-5, NUDOCS 8004140738 | |
| Download: ML19320A142 (24) | |
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RO Inapection Report No. 50-313/74-5 Licensee: Arkansas Power and Light Company Sixth and Pine Streets Pine Bluff, Arkansas 71601 Facility Name: Arkansas Nuclear One, Unit 1 Docket No.:
50-313 License No.:
CPPR-57 Category:
B1 Location:
Russellville, Arkansas Type of License: B&W, PWR, 2568 Mwt Type of Inpsection: Routine, Announced Dates of Inspection: March 4-8, 1974 Dates of Previous Inspection: February 26, 1974 to March 1, 1974, and March 6.., 1974 Principal Inspector:
M. S. Kidd, Reactor Int; actor Facilities Test and Startup Branch Accompanying Inspectors:
C. E. Murphy, Chief Facilities Test and Startup Branch t
R. C. Parker, Ruactor Inspect >r Facilities Test and Startup Branch K. W. Whitt, Reac, or Inspector Facilities Test and Startup Branch Other Accompanying Personnel:
No".e Principal Inspector:
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'7 -b M. S. Kidd, Reacter Inspector Date Facilities Test and Startup 13 ranch
.i Reviewed By:
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R. C. Lewis, Acting Branch Chief
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Facilities Test and Startup Branch es norr s m 10: FDR (
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RO Rpt. No. 50-313/74-5-2-
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SCCIARY OF FINDIUC3 I.
Enforcement Action None II.
Licensee Action on Previously Ide !tf fied Enforcement Matters Not inspected. This was not within the scope of this inspection.
III. New Unresolved Ite g Deficiencies and weaknesses identified in the i=plementation of the ANO-1 operational QA program described in the FSAR are grouped
as unresolved items relating to the criteria i Appendix B to 10 CFR 50 to facilitate resolution and closecut.
74-5/1 Organization (Datails, paragraph 4.a)
74-5/2 Quality Assurance Program (Details, paragraph 4.b)
74-5/3 Design Control (Details, paragraph 4.c)
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74-5/4~ Procurement Document Control (Details, prmagraph 4.d)
74-5/5 Instructions, Procedures, and Drawings (Details, paragraph 4.e)
74-5/6 Document Control (Details, paragraph 4.f)
74-5/7 Centrol of Purchased Material, Equipment, and Services (Details, paragraph 4.g)
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74-5/8 Id..nification and Control of Materials, Parts, and Components (Details, paragraph 4.h)
74-5/9 Control of Special Processes.(Details, paragraph 4.1)
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74-5/10' Inspection (Details, paragraph 4.j)
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74-5/11 Test Control (Details, paragraph 4.k)
74-5/12 Control of Measuring and Test Eauipment (Details, paragraph 4.1)
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R0 Rpt. No. 50-313/74-5.
-3-74-5/13 Handling, Storage and Shipping (D< tails, paragraph 4.m)
74-5/14 Inspection, Test, and Operating Status (Details, paragraph 4.n)
74-5/15 Nonconforming Materials, Parts, or Compc;nents (Details, paragraph 4.o)
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74-5/16 Corrective Action (Details, paragraph 4.p)
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74-5/17 Quality Assurance Records (Details, paragraph 4.r,)
74-5/18 Audits (Details, paragraph 4.r)
IV.
Status of Previotmiv Reported Unrevolved Items
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Not inspected. This was not within the scope of this inspection.
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V.
Unusual Occurrences
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None
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VI.
01her Simificant Findings None VII. Manacement Interview On March 4, 1974 the inspectic team met. with Messrs. Anderson, Moore, and Orlic; to discuss th purpose and scope of the quality assurance -inspection that was to be performed.
(Details, paragraph 2)
On March 6 and 7, 1974, the inspection team met with Messrs. Anderson, Moore, and Orlicek to discuss specific deficiencies that had been identified and their implications with regard to the adeqi.acy of impicmentation of ANO-l's operational QA program.
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On Mare!
8, 1974,' a closcout management interview was conducted to diset.ss the inspection findings. The following licencce representatives attended:
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R0 Ppt. No. 50-313/74-5-4-
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Arkansna Power and Light Conp.nnv (AP&L)
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J. W. Anderson - Plant stiperintendent
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N. A. Moore - Manager of Quality Assurance W. Cavanaugh, III - Production Project Manager B. A. Teruilliger - Operations Supervisor M. H. Shanbhag - Procedure Administrator J. L. Orlicek - Quality Control Engineer Specific deficiencies and weaknesses discucsed during the March 6, 7 and 8, 1974, meet.ings are identifed and discussed in the report
details.
(Details, paragraph 4)
The ins,7ectors summarized the inspection findings as follous:
A.
Significant deficiencies and weaknesses in the implementation of the ANO-1 QA program for operations had been detected in areas related to all eighteen criteria of Appendix B to 10 CFR 50.
i B.
Prior to licensing AP&L will be required to satisfactorily implement their operational QA progran.
Regulatory Guides
__N and national standards that provide guidance with regard
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to acceptable methods for impler.entation of an operationni s_,
QA program were identified to AP&L.
i C.
Deficiencies identified during this inspection should not be
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considered to represent t il the deficiencie' in the QA program implementation. The inst : tion effort did not constitute a 100 percent review of the implemsntation of the'ANO-1 operational QA program. AP&L should rnview and upgrade the implementation of their entire operational QA program.
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AP&L stated that they would satisfactorily implement their operational QA program to conform to AEC requirements. Per a telephone cons rsation between Messrs. Murphy and Cavanaugh on March 13, 1974, AP&L stated their schedule for upgrading the implementation of their operational QA program is as follows:
l A.
April 1, 1974 - Most of the upgraded QA program implemerting
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procedures will be ready for Region II review.
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P4 Rpt. !o. 50-313/74-5-5-
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April 15, 1974 - APEL'c operational QA program will be l
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satisf ac'.orily implemented.
In addition, AP&L stated that some organization changes would be made to assure independence of onsite QC and QA activities.
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R0 Rpt. No. 50-313/74-5-l-
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Prepared Byr, f. ' /1."- ;, /
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DETAILS
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C~. E. Murphy, Bras. ChIci
'Date Facilities Ciastruction Branch
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R.,C. Parker Reactor Inspcetor Date Facilities Test and Startup Branch
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K. W. Whitt, Reactor Ir pactor Date Facilities Test and Startup Branch Dates of Inspection: March 4-8, 1974 Reviewed By: f.T. [..~,,,m).,
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R. C. Ledis', Acting Branch Chief
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Date Facilities Test and Startup Branch 1.
Individuals Contacted
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Arkansas Power and Light Comoany (AP&L)
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J. W. Anderson - Plant Superintendent s
G. H. Miller - Assistant Plant Superintendent B. A. Terwilliger - Operations Supervisor T. M. Martin - Maintenance Supervisor D. R. Sikes - Reruits Engineer J. A. Or11ceh - Quality rentrol Engineer R. ". Culp - Test Admini;:trator N. A. Moo'a - Manager of Quality Assu*ance T. Gre an - Operations Training Coordinator
H. Hollis - Administrative Assistant 2.
Diccussion The purpose.of this inspection was to verify hnplementation of the operational quality assuranee (QA) program as described in the ANO-1 Final Safety Analysis Report (FSAR). Regulatory guides, and appropriate national standards were used as guidance for the evaluation of the QA program impicmenting instructions.
3.
Licensee Documents Reviened By Inspectors During the Ir pec. ton Listed below are the licensee doct unts reviewed during the inspection along with a brief summary of the purpose or scope of each as stated.
in the individuo1' documents.
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ANO-1 Quality Assurance !!anual - To insure that the nuclear perer plant is designed,. constructed, and operated without undue risk to the health and safety of the public.
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Quality Control Procedure (QCP) 1004.01, " Design Control" - Provides dirce. 'on for control of design moosures for the modification of those plant systems and to plant equipment identified on the plant Q-List.
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QCP 1004.02, "QC Audits" - To provide a plan for audits to verify c.
confa;mance to 10 CFR 50, Appendix B, FSAR commitments, and license application comnitments, d.
QCP 1004.04, " Turnover of QA Documents from Construction to AP&L" -
To effect the turnover of quality assurance documentation to AP&L in a manner uhich uill ansure its safekeeping and availability to all parties concerned.
QCP 1004.05, "Q-List Spare Parts Quality Control" - To define the e.
practices and procedures euployed in the procurement, receiving, storage and use of sparc parts far Q-List items and to define the areas of responsibility for the individualn or plant section,
-s concerned with the control and utilization of these parts.
f.
QCP 1004.06, " Control of Purchased Material and Services" - To provide direction toward assuring that purcuaced material, equip-ment, nnd services affecting those items identified as Q-List items, whether purcheced directly or through contractors and subcontractors conform to the procurement documents.
g. - QCP 1005.07, " Control of Special Processes" - To insure that speci.8 processes, including welding, heat treating and nou-
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destructive testing are centrolled and accomplished by qualified perronnel using approved procedures in accordance with applicable codes, standards, specificationa, criteria and other special requirements for those plant items and systems 11.ted on tLa plant Q-List.
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QCP 1004.08, "QC Inspections" - To pro.ide direction for inspecting equipe nt and activities to verify conformance with the applicable approved procedi res, instructions, and drawings.
- L. - QCP 1004.10, "ANO-1 Test Equipment Calibration" - To outline a program.
for calibration of test instruments, tools, and equipment used by-plant personnel to inspect, test, and assemble Q-List components
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and to id: ntify those individuals responsible for the implementation of this program.
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'R0 Rpt. 'Nci. 50-313/74-5-3-
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- j. QCP 1004.11, ' " Hand ling, S torage, and Shipping of Q-List !!aterials" -
To pre.lde direction-for the control of handling, storage, and shipping of Q-List material, parts, components, ans'
sscublics.
k.- QCP 2004.12. " Operational Test Control" - Establishes a test control program which assures that all testing required to demonstrata that structures, systems, and com; onents, which prevent or mitigate the consequences of postulated accidents that could cauce undue risk to the health and safety of the public, are identified ar,d performed in accordance with uritten
procedures.
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QCP 1004.13, "donconforning Metorial, Parts, or Compouants" -
To provide direction for the c ontrol cf mat rial, parts or components whici do not conform to operating requirements and to. insure that the repair of these itens is appropriately reviewed and documented.
QCP 1004.15. "ANO-1 Quality Control Pr gram" - Intended to satisfy m.
the quality accurance criteria for operating nuclear p ner plants as set forth in 10 CFR 50, Appendix B.
.The AP&L Company es policy statement on quality control for ANO-1 which is included (s _<)- '
as a part.of the progran states, in part, that the plant superintendent is the final management authority responsible s
for assuring that the policy statement and the quality control progra::n is implemented.
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Administrative Procedure (AP) 1005.01, " Administrative Controls
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Manual" - Delineates the written rules, orders, instructions, policies, practices, and designation of authorities and respon-sibi.icies by the AP&L managenent to obtain assurance of safety and' reliability of operations, and effective maintenance of the
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ANO-1 station, AP 1005.02, " Handling ~of Procedure " - Defines a standard. method o.
for developing, reviewing, filing, using, and revising ANO-1 operating procedures.
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AP 10;-3.03, "D.,cument Control" - Provides direction for. control and dism;'.butien of docue'nts such as procedures ano technical
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. specifications, including changes thereto, which prescribe activities affecting quality.
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AP 1005.04, '" Control and Use of Bypasses and Jumpera" - To delineate a means for controlling and docunenting the installation and removal of electrical bypasses and juapers.
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AP 1005.03, "Draning Control" - To establich rcrpensibility of the-1 staff and method by which engineering dravings are controlled including receipt, filing,. indexing, distribution, retention, and dispositi i of sup2rsede< drauings.
_AP11005.09, " Plant Records Management" - To establish the adminis-s.
trative controls and responsibilities for management of plant
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records by the ANO-1 staff.
4.
Findi n.u_s.
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Deficiencies and weshnesses identified in the implementation of the ANO-1 operational QA program were as outlined below. The identified deficien'cies and~veaknesses ucre categorized, separated, J classified as unresolved items ac;crding to the eighteen criteria of Appendi:: B to 10 CFR 50. Deficiencies and ueaknesses identified in this section are provided as exampics only, and should not be interpreted as being all inclusive. AP&L should assure that implem -tation of the ANO-1 operation:? program described in' the FSAR is equivalent to or better
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than guiduace provided in regulatory guides and appropriate national l'
-standarda.
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a.-~Crfterion'I, "Ornanization" The ANO-1 on-site Quality Control Engineer (QCE) is assigned
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responsibility for on-sime QA in Paragraph 3.0 of ANO-1 Procedure 1004.02, "QC Audits," which states, in part:
'"The QCE, and/or his representative (s), shall conduct
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periodic c.udits to verify implementation and adherence to
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the Op:. rational QC Program...."
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The AN'-l on-site QCE is also assigned direct responsibility for certain ca-site QC activities. Examples of specific QC
.re.jonsibilities delegated to the QCE are as follows:
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(1) ANO-1 Procedure 1004.05, Paragraph 2.1.3, states:
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" Requisitions and specifications for Q-List sparcs will be reviewed by the QCE and will incorporate all applicable codes r
and standards."
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(2) ANO-1 Procedure 1004.06, Paragraph 4.2, states, in part:
"...The-QCE or his representative shall visually insptet the
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. items. received and determine if the documentation requested
'by the procurement documents is availabic...."
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-(3) AUD-1 Proedur 10)4.07, Paragre:ph 3.4, states, in part:
"The QGE shn11 monitor the work as required by the anproved procedure specification or required code ch.:h--off forms, such
. as Fo ra L'A-1.... "
(4) A50-1 Procedure 1004.J ', Paragraph 2.2, states:
"The QCE is responsible for ensuring that Q-List equipment or material received at the plant is handled, chipped, and precorved in accordance uith the requirements listed in the manufacturer's technical manual or if such requirements
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do not exist in the manufacturer's technical manual, in accordance with the guidelines outlined belou."
In effee, the QCE is charged with the responsibility to audit himself in areas uhere he has direct responsibility ior QC-activities. Dc:Eciencies in the performance of these QC related activities are not likely to be identified by self-audit.
It appears that a major portion of the QCE's avaliable time will be required to perfor. the QC activities for uhich he has direct s s responsibility. It is doubtful that the QCE uould have adequate time to plan and conduct a meaningful periodic audit program to verify implementation and adherence to the overall operational QA program.
b.
Criterion II, " Program" Impler 'atation of the AU0-1 employee training program does not conform to ANSI N18.1 in that:
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(_1) For emp'oyees other than operators and maintenance personnel a general employee training program for all persons regularly employed in ti nuclear pcuer plant hac not been implemented that includes training in the following areas:
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(a) Appropriate plan ~s and p.ocedures
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(b) Radiological he:'lth and safety
_(c). Industrial safety
--(d) Plant controlled access. areas and security procedures
(e) Use of protective clothing and equipment L
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,RO Rpt. No. 50-313/74-5-6-
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4, An' informal document, the subject of which
.is " Training Programs
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for Nei-Operationc Personnel" did specify en "Orier.tation Program for Administrative Personnel." Neither the source, date, e ithor, or approve 1 of this document uas recorded. This Orientation Program for Adninistrative Personnel had not beca
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implemente nor was it sche uled to be implemented.
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(2)' Individual records of qualifications, experience, training, and retraining of. plant personnel other than licensed operators are not maintained.
(3)'The plart training program is informal and lacks control. Th'e
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only forr. ally documented. responsibilities for plant training are in AKO-1 procedure 1005.01, which basically states that i
cach supervicor is responsible for the training of his subordinate
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personne5. Plant supervicors had not docunented qualification or training requirecents foc personnel not requirin,; AEC licenses.
(4) Training has r. t been provided concerring the QA progran at
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the site.
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Criterion ITI, "Desien C^ntrol"
The deficiencies listed belou are examples of inadcquacias which indicate th:t implementation of the ANO-1 program for design
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control does not conform to the provisions of ANSI U45.2.11.
(1) QCP 1004.01 only describes a mechanism for initiating a desig.:
change reiuest. The mecharism for performing design changes has not been identified, i
(2) QCP 1004.01 does not identif3 the organizations..:d responsi-bilities of cach organitation par 'cipating in the design control. function.
(3) There does net appear to be any requiremont-for the following types of information:
(a) Design input requirements
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'(b) The design process
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(c) Interface control
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(c) Docaaent Control (f) Correctis e Actions (g) Records Requirements (h) Auditing (4) QCP 1004.01 assigns to the plant superintendent the responsi-bility for arranging for design changes uithout providing guidance or imposing limitations as to the required organi-zational responsibilities or for imposing other design control.
measures for actively cil : ting the design changes. The FSAR, Amendment 2.1, houever, assigns the responsibility for the QA program, including design review, to the vice president and chief engineer.
(5) Th2 APLL QA manu 1 assigns the responsibility fo,
'esign QC to the. architect engineer and the NSSS engincec, but it doce not addre a the plant c: rating phase. The manual should i updated and expanded to cover the operating phase.
f'^;)
(6) QCP 1004.15 states in Section 1.4.1.1, in part, that the plant (
superintendent has the authority to make design chace,es and
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modificatione to those itema which are not Q-List items. The authority to make Q-List item design changes has not been specifically defined, d.
Critorion IV, ' Procurer at Document Con rol" The implem: dating procedures for procurement docunent cc:-trol at ANO-1 do not adequately co form to the provisions of AEC extracts from ANSI N45.2.13 and A". i N45.2 as illustrated by the following deficiencies:
(1) The procurement do. ument control section of QCP 1004.15
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requires revier and approval of the procurement documents by the cognizant supervrsor, plant QCE and by either the plant superintendent or assistant superintende.
but it does not
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define the required documents nor the acceptance criteria necessary to determine document acceptability.
(2) Section 4.4 of QCP 1004.15 requires that specifications for Q-List replacenent parts shall be at least equivalent to the specification under which the equipnent was original.'
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furnished. This section does not consider the cases where (
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the part is being replaced because it was inadequate for the se rv ic or becauce the operational requirements have been a dified.
(2) Sec*. ion 4.4.2 of QCP 1004.15 requires, in part, that Q-List specifications be revicued by someone other than the originator to as..u. a that applicable codes, standards and other design bases are included or ref erenced and that appropriatc and sufficient requirements for QA docuc.cntation are incorporated ther:in. This section appears to be deficient as follows:
(a) It does not specify the qualifications of the persons performing the revie. and the originctor is not required to have specific qualifications.
(b) The method of deterrining what constitutes " applicable" codes, standards, and design bases is net included nor is the criteria provided for dets anin.*,g appropriate and sufficient requirements for quality assurance docunentation.
(4) Section 4.5.2 of QCP 1004.15 specifies that purchase orders
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will requi~o vendors and their subvendors to have a QA s
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program wh.1 applicable and will include provisions for source
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surveillance and inspection. This section is def'tient in that it does not define or reference documents that dt
".ne whc constitutas a QA prograc, nor does it define source surve;11ance and inspection requir.
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(5) Sectin 4 of the ANO-1 QA ennual does not app.tr to adequately adC.ress the provisions of ANSI N45.2.
(6) The procurement document control program a: implenented does not 1-rovide for the follouing activities which are necessary for a viable program:
(a) Planning activities establishing a sequence of actions to be accomplished in the preparation of procurerient documents and ident*fying interfacing organ:zations have not been delineated in writing.
(b) A process has not been developed for verifying ecmpliance to procure,ent procedures and evalenting the effectiveness of the proce:.s.
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C (c) Meexures to deternine the status of decu.tatc. Including chang.ts, ha.
not been cutabilshed.
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. (4) Measures to nastre that specific QA requirements are inunk d directly into the procurement document have not been establiched.
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(c) The pe :edures do not consider multiple procurement and sub-ticr procurement.
e.
C_r1te 'lon V. " Instructions', Proceduren, and Dracinuc" The deficienci a listed beJon are examples of in.alequacios uhich
- indicata that the ANO-1 program for assuring that activities affecting quality are prescribed by and poiformed in accordatce with appropr8 ate instructions, procedurec, or drawings has not been implemented
.0 onform to the provisions of AMS1 N45.2 and ANSI'N18.7.
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(1) AI 1005.02 provides a format for preparing, procedures. This format does rot appear to adequ.ctoly provid for the preparation
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of all the various procedures ueeded for plant operation such s
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as operating procedurcs, surveillanca procedures, maintenance
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. procedures, and others. Further, a distinction.batveen ac
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different types of procedures has not been made in the discu.riion
of procednre handling. AP 1005.02 should be expanded to address each type;of procedure, or a new procedure to cover th..i aspect of procedure development should be peopared.
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(2) Section 6.1.3 of AP 1005.01 provides a list of operator
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requirements. TL2 following items are not included and should be added to this list:
'i (a) Responsibility to determine the circumstances, analyze
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the cause, and determine that operaticn can proceed saroly before the reactor is returned to power after an unscheduled or unexplained power reduction.
(b) Responsibility for the senior reactor operator to provide
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direction for returning the reactor to pouer follouing an
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unscheduled or unexplained power reduction.
(3) The licensee documents reviewed did not appear to contain a requirement for detailed instructions, procedures, or drar'ng to include appropriate quantitative or qualitative accepta
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criteric.
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Cr : te rion VI. " Doc"nont Control" As tripic..ented ;he AS0-1 QA progre.m for operat tono does no t require that documents required for perforr ace of an.ictivity be distrH uted to and used at the location where the activity is being performed.
g.
Cri terion VII, " Centro 1 'f Purchased ?!aterial. reuineent. and Ser~ ices" Implementation of the A: C.-l program for control e f purcha.':ed material, parts, and compontata does not appear to confc m to the p; avisions of the A"C c:: tracts f eca Au3I H45.2.13 based on t' a follouing examples of deficiencies:
(1) Section 3.1 of QCP 100'4.06 specifics, in part, that nar vendors m:: be aC led t o t te approved vendors lict af ter approval of their qualification by the QCE. This section is deficiont in that it d: 2 not defina or reference the standards to which the vender must qualify.
(2) Section 3.2 of QCP 10.'4.06 specifies that the chief CA coorJ nator (CQAC) periodical:y be furnished a list of all
!
outstanding Q-List purchase orders for his use in plar.ning QA
'
aud ' t c.. This section is deficient in that it does not require that tra Cyt.C be furnished information on all Q-List purchase orders.
(3) Section 3.3 of QCP 1004.06 requires that the QC inspect the mann acturer at each inspection holdpoint. This section is deficient in that it does not identify or reference the requirements for inspection holdpoints c.I standards for inspection.
'
(4) Section 4.2 of QCP 1004.06 pcovides instructions for the roccipt of material. Thi" section is deficient in that it decs not specify, the actions to be completed for handling nonconforning mater tals or materirls that have not received source inspection.
There is no provision for the identification of the required documentation.
No basis has been gir a, nor criteelen referenced for making the deterr.ination to accept or reject discrepant materia).
(5) Sect ',n 5.3 of QCP 1004.06 discusses ideatification of stored material.
It does not identify actions to be taken if the identification tag becomes detached or is lost.
/
.
RO Ipt. '< o. 50-313/7' 3-11-(6) Section 5.0 of QCp 1004.06 discusseq atorage cequirc its.
!!cithr thin ;
,cah. :e nor the procedurn for handl in;; and stor.t:a of Q-Lit.: materials cpecify that nonconfo. :in;;
materials are to be segregai J.
(7) Sectfon 6.0 of QCP 1004.06 specifica the steps to be taken to relea 5 material for installation. This section does not define nor reference the need to adcquately identify the location and usa of the matn-ial, i.e.,
system and service identification necessary for tracca' 111ty.
(8) S : tion 7.0 of QCT 1004.06 discussca the control of perchased'
se rvic es. This section does not adequately define the require-ment for th vendors Ql. program. This section references section 3.0 for audit requirements. S.ation 3.0 does not discuss the auditing of services.
Section 7.2 does not define the level of approval for vendor procedures nor the need for t'a licensee to have an input to the procedures. The conduct of Q.i aud!ts chould not be armissive.
Specific requirements should be defined or refert..ced.
- -,
(9) " action 7.2 of QCP 100.15 specifies that centractors chall
)
be selected on the basis of demont. rated capability uithout
-
'
defining the acceptance criterion or referencing the source s_,
of the criturion against which the capability fu dctermined.
(10) S.cticn 7.3 of QCP 1004.15 speci'ics that the QCE sha'
inspect at t. 2 supplier facilit'as, but does not spec '._y the inspection requ!rexents or acceptance criterion or refer cce the source of this inforr tion.
(11) Section 7.4 of ( P 1004.15 specif'es that the QCE review the
vender docum"ntation withou-pro..-ing guidance as to what is to be reviewed or hou the review is to be performed or the acceptance criteria to be used.
(12) Section 7.4.3 of QCP 1004.15 specifics that telephnne confirr tion of the exist, ice of vendor documentacien is acce p table. This 1
- t sufficient. Aa a minimen, a written certifica:Lon provided by the vendor is required at the plant prior to installation.
(13) Section 7.3.2 of QCP 1004.15 is not acceptable uith the qu.,11fying; stat.-- at uhich is included. Q-List material must be cegreg _ed from non Q-List materia'.
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.h'.:CriterionNTII."TJenti~ica'
.n and Cont. col of ~".te tabr. Facts.
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Impic :en' atw of t!i X'0-1 progesa for the ide ;1ff atton and control of.naterials, parta and conconents does not appear to
- .
- conform to the provinii s of /SSI M45.2 b.me o.the folic"Ln;
! ~
examplen of deficiencit :
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(1) Section 8.2.1 of QCP 1004'15 states.that the supplic s are
.
resycnsible for, marking materials, parts, and ccmpenents.
-Purchase order docunent:c avaf.lable to the inspector did not
impose this ro tuitement on t: a vendors. There is no
provision in QCP 1004.15 for the identif tention of natorial,
'
[
such as piping, that t.ould be subdivided'at the plant site.
1:
,
t-(2) Sec. tion 8.2.2 of QC' 1004.15~ scates, in essence, that
. marking requirenants chall assure that idertifice. tion
!
,
shall be positive and s. hall-allor traceabi
- ty, but the :sthod of fulfilling this requirement L a not been defined.
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~(3) Section'
.2.4 of CCP=1004.15 permits narklag bundles c~
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~ material witho t icp(sing the rcquirenent that identi:1-
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cation be transfer;ed uhen aa item is used.
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(4) Section '.3 of QCP 1004.15 relatec to tt ;ging and secrage.
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This e ution should be referenced to QCP 1004.06.
'l f-(5) 'Sec.icn' 8.5 should properly be ircluded in a procedure for
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'nonronforming natcrial.
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1. _Criterie-IX,~"Special Procasces" l
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-Implementation of the ANO-1 progran for centrol of specici processes
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.
-does notff) pear to be in conformance with the provisions of Al?SI
-
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N45.2 ba:dd on the folicwing examples of deficiencies.
I
2(1)1QCP=1004.07 discusses only-those iters specifically included (
in tec_ title, and only in gcedral--terns. Responsibilities are assigned only for maintenance and quality control..The L'
- procedure does not reference all applice'le codes.
~
_
(2), 0 thc : special proce ces such as chemicci analyses, e
a radiological an;1yses, cont.alnatloa control and
,
docunentation, maint: unca activities, e.g.,
stean
genurator; tuba plug
- c.g, and special operatic:
processes, i
e.g'.
- defeeling, are not addrer, sed by QCr 100$,07.
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- no.Rpt.)No. 50-313/74-5
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(3) QCp 1004.07 should addecan requirements for procedura
.
d evelopnt,.t n7d.' qualification of personnel in each area.
Codes, ' stand. ils, rc:plations, and sin 11ar items aunt-he included. Tr.: lain.;, qualification, anJ deternination of
- proficiency cust be included. This does not cean that all
,
procedures that may be required -in.he frtura mus'.:bc developed now, but the controls for developing thesc~ pro-m
,
.
.
cedures mast be addressed at thic time..
,
j. Criterfon~X, "Indnection"-
.
. Implement tion lof the tu!0-1 program fcr increction of activities '
l n focting' quality 'does not appear to be in conf
.ance with the
~
provisions of 133I N45.2 based on the following c::c=ples of deficicacies:
.
.(1) S;ction 2.2 of C/P 1004.08 states that the QCE, or his repre-
.senta:ive, shall perform cil required inspecciens, perforced within the plant and at vendor's sheps. Section 4.1 states
,
that vendor inspections shall be performed by plant personnel or production department peraonnel, or other qualified personnel
+
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as' required to pr7 vide asturance that iters supplied c-t the quality requiremen':s'. These two statocer a appear to canflict with each other.
,
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.(2)~0CP 1004.08 was the only document.available to the inr,acter that. described.the ins tetion progrca.- If the entire program-consists only of thor,e aspects dcccribed in this decurtat, it app 2ars that the ICE i:t responsible for all inspections
-
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of activities.affecting quslity. The responsibilities for the inspection progrca should be clearly defined.
'
.
~(3) Written instructions have rat been provided to require that inspections cast be performed by personnel other than those
~
who perform the activity being inspected.
- (4) The. documents made available to the inrpector do not indicate tlist an ins'ervice 15spect;.on program h. s be a conpletely
- developed.and approved.
,
.(5) Requirc: ntn for: inspection of specific proc"acia such~as
c welding and ~ heat treating have not been discussed in. urit ten
_procedur i
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(6) 16quiret.vnts ' Cor.cther inwpcer.ionn noch as Innpeat ionc of F
major npdIficat' ss t.o ' tlw atien.md sinniii.ccer changes in h
operating'prc.cdurca: major repnic or repincenent of equipment;
..raceipt of Q-1,ist naterials, par'.s, or cc:ponents; and operatit,n
- .
- of safety related nyctens have not been discussed in t ritten
i proceduren.
.
,
'(7) The requirement for special eculpcent and. tools needed for the
_
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inspection to be identified hes not beca defined.
i (8) The requirement for uritten procedures or chechlists to be
used for inspections has not ' acn-defined.
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(9)' The requirc. ment for 11 spection holdpoints to be identified
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in proced:.res coverin; the activity has not been d dined.
.
- (10) Rules and methods for indirect.-ontrols such ac moni orir ;
and campling have not been discus.ed in uritten instructions or procedures.
(11)' /Jfrequency and trend analysis of. vital negative factors such
!-
as equipment failure and malfunctions, uncchedul rl systems
- .
' outages for repairn, no conforming materia!. un! cordit!an-
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-reporta,;and st=ilar items has not been discussed in uritten procedures.
t (12) Th ae-iries subf ect to ins; action and th inspec 'on
.frequ have not been identified.
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Crite ion XI, " Test' Control"
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- t coitrol prorram inplementf * procclurc QCP 100s.12,.is
undergoing c..jor revision and tl crt.ru has ncc H en. approved.
This procedure. trill identify r.sponsibilities and general pro-cedures fo. ~ implementing the ::urveillance tect prc:;rt.m described
.
.in the plant toGnical specifica: ions.
1 planned pro;; ram for-cDmputerized scheb ling and control of-j.
. surveillance testing :has not been documc.ced, r
,
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'l.. Criterton XII, " Control of Meacurins and Tcat EauD tent"
-Implenentation of the X 0-l' program for control of meas; ring and -
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- test equipa.
doce'not conform to !"uI N45.2 in that it does not:
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.inctn :enta, cod other taspser: ion, r.murin;, and testing
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- cqu iptunt un?..dir i.cc3 3cd in activitia:2 affecting quality
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arc of: Llic ' prop::c rent,u, tyba, and occuracy to vecify con-l
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foraance toitbe catcaliched requirc:ents,
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(2) Est B.ish tha criteria or assign.ti responsibility for.
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der" c.!ning tim naihed and interval of cal fbrat ton for me~.ris.g cnd test equip =ent, or
.;
-(3) Lquivc th t when inspection, t ca.eurtag, and test equirment F
are=fennd La be cut of.calibcation, an evalr; tion should l
be cada and documen'ced of the validity of p. avious inmection I
or-taut:recults 'a t of
.ae acceptability of itens previously l
inspected.or tested.
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Critecien Pf *, "Handi tr,. S tora e.
nnd Shln13" (
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Impiccer :iLica of the N:0-1 pr ran to control the ha:Mling, storcge,
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L a..d.sh!, jing of natorial and c;ulpcent docs net appt ar - to be in
'l con for=anc.: with the provisions of /diSI 1:45.2.2 bas I on the l
- following exceples :of deficiencloc:
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(1) QC 1004.13 doc: not contain a discussion of tb ontheds used for 'det.erminin; specific 'stcrcge requirenents tc.at would
-
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F (2) Other deficient areas of QC' 1004.13 are as follou :
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F (a) The-asponsibit '.ty for establi:,,hing the level of protection'
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'has not been i a t i ' l..l.
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-(* ) Packaging' design and methods hnve not been discust cd.
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(c) Shipping requirement: and methods hata not been establiched.
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. (d) Qile'several handlic.g precautions have been licted, the
meth..d:for detol-Lning specific stcrage requirements has-not been addrosadd.
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.(e) Re' corda receirements are refere md to QCP 1004.04,1,t
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-this We' ant does not prov-:de for proper accottplishr.ent p
of: handling,. storage;or sh pping.
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30 'I'1/74-5-16-
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(f) '.:ve ra l ru u d.: cf r <s..rva.Inr have besi decr.
J, Lu the rvL'%I of dctor11:*a3 n:'ee:fic rega re.wn"s n, ac t r
been idustliIc].
,
(t;) Sp. c'f ic ah T ir;' requiremeurs br"e not N "1
- 1ven.
Sor:e f
cou;ib2 cr. i e.: 1, c.3., rad ioa ' t ive n:.
- t a..;.
(h) The requirenento f or "pocific record::, st ch p rocedares,
'
rcports, parsor: el qunlificatloc.3, an-: inspc<.;ica cnd ex.mination rece:Ja are either not included o inndequata.
n.
Critorion "JV. "I:'apoc r 'on. Te an:1 0 ;ya t in - S r.' cun"
/d:0-1 QCP 1005.0' does not crufer:t to id:3I :;1S.7 in that:
(1) For 1 c t.
~ ol o f J t::Prc, byp:'330s, c d lif ted 1 n'c is not
.
regi red t a ucrk la
.rfor ed on s"stens or corg.cnunts whten are "liold Carded,"
(2) Jumpc-n and 1.ypausca requ' r:2 during trouble shoo.ng h! :h will l resto.ed prior to 1 caving the jo! are not contrelied, and (3) The.re in no retuirt 2n f a.- incpecti n or veri..ication of j umpars, bype es, anl lif ted leada unic': are iictalled on or re::.ov d f r.
cafety related equipment or m 2: s.
N: 1 Office Pro :t. dure '!c.11. "Use of !!ald Cards:, do 's r t confo r:.1 to id!SI NIG.7 in that:
It d~ts t rer t re incpection o v 1rifir.ti i c.f l',ld c:.rd ins:
lations or ecravals on safuty related equi,
..c or
',
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..:3.
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Criterinn "tf
" Men ton F ning '!cteriale
,artn, o r c;)nn e:g,p.,4 n Imple';cntation of the A:?0-1 program for contral of noncc,nfor :!.ng
'
traterials, parts, and cc,pon~ es does not a, ear to confor2 to the provisicas of /J:SI. '45.2 based on the fo1L.. ing c::anples of
'
deficiencies:
(1) The acc;e of QCP 1004.13 is too restric tive.
Conf.r o.c '
to all rcquirencnts, not just operating recuir; mat. nu ;t be cddressed. I oc only ec alt, but also additiorel alternativca (accepta.'e as is, rej ect, and ruar ) :m it l
be considerad.
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(3) Scetion 3. t of OcP 100'.13 deem not couire :ut the c.c:at:a;
pcopie be noti f i ed c.:an nonoper.: tin:; ; noni;l f ind n :-
c onf. :.
o i t e:u. The operatia ; cupaccisc r s:.euld be notified it.ac<lbu;ely er.my nenconf ormance in order tl.t a det Tinatica of caf:':-f significance might be
.;c.
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(4) Section 3.0 of rCP 100'.
1.') should be ren i to establish a level of urgeac:e for noti: ' e s t le r.s, tor;. ' r wi'.h a ti 2 frn..e for r.edificatien. The caph.:ci in this c.:ctien as improperly placed on ;;enerating ec.pabil:ty; It nust be on
safety. Safety rela: d fe.,tures could i empl: tely ciuc:In
.
i e.:., all ECC3 cy.uters could be cut c? scrv.,ce uithout dir2ctly af f actinr Su Ter. Ling ca;..sility.
!
".rj::c c h 3. 7. and t h.
sur :'rting ficu chart simuld be acaificd to reflect the ir.
ta: n: of safaty. Tue flou ch r t sh ld als, be c;dified to aao: sh ' f t cui..rsiisor r. ricrir., 1.it ! I notificatic i of all
.
nonconf aces ir the cpart. ting pl: It.
'
(5).iP 1005.01 uhich Ic r canced by QC2 100'. 13 requir2; printen
p oc. educes fcr Q-List
- . :t s:3 ar nr lear safetf safct.:.s:
at j
nur laar saf ety systena have '. it been defined. G:? 10.d.13
n.
's to be revised t, reficct the safe.cy r-J.ed acpect cf j
ne accafo rmanc ac.
i, (6) Section 3,0 o. 1004.13 does not roo: re that-equip.ent design
!
be 2 ciwed an*:
t'
.t repe ir or rerurk '
at spli;ued so as to restore the e.,uipe n.
to the originc.1 de:. gn re..,
, cements.
t (7) The dtsposition of nonconforming material that is remored f rc=
service is n st described in QCP 1004.13.
(8 S2crion 3.3 of QCP ?O4.13 does no'; clearly c:
Ify that
-
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siptent whic' is returned to serv *.ce mot bu iced if.
is safety relaa d. - Such tests are tandatory.
p.
Criterion DI, "i rrecti'te Ic
- n" o
QC' 1004.13, whit
"as the only or racional QA prcgram impicnentin; precednt nade av:;;able t-t he Inspector that c vered i ny : spect of ccer :tize cetion, uns.
-iewed.
Th:c pr,etare discuset
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In,1 -~:nte r ion of the 10:0-1 pregen for the en112ct_cn, rterage, c a m..:urer ce of cuclity nazurance recort's does n. ap rar to i
be in (ence :n.:c ri th the provision of 1."I ':'.5. 2.9 '..ced on the c:::r.p1's cf deficier.: 2c listel telmt:
/2 10.5. ) v.c rev;eued cnd fo..: to b2 d.fi icnt in tha fell i n..
.
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(1) "Lif, s.e" and "nonperna
- " records unca ne': defined.
i ( ~ ) T.. :.uthed of han '.lin ; c, mlity records S t are t 3 be retair.ad for a r. riod of time lose then ec venre
.- net
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.
d r.;;ut rad.
(3) 'fc; :ararj < tcr
.
of recor3c was n >t discussed.
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(4) A pr?-c-tr' lished rec. -ds ch: h11st vau nyt described c
.
.
ret..ran ac.
(5) Tha mathed N r,
ifyin~
iat the reen -ds rece: cd arr. in agret.nen with t..
mranualct.1 dect at uad that the records ar in good conditions t as not diccussed.
(6) Rules gover....ng access to and control of files ve.s not described.
(7) Th2 nethed for main cining control of accountabilit/ for
!
records renovt frc= the storage fccillt'f ras n _ discu.:cc?.
,
(3) Tr: nathed for fil'n: su;pl ental infor;atien and d'.c,oct.1~,
.
of cuper.:c.ed reco;ds ca. not de:.ribed.
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,
0) The 'c uircn n: ce sapac.:. curre.1t record.2 fr 1 historical i
rece;de m: nc" d ef in.:d.
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?(10) Th: r 21.'.Jd sf prot.:et tor. of recor *
in;:t condev. Ion f
t v. ns. ' d es':rilsd.
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'(ll)lThe nethed-of'storlag loon dccume ts uns not dc
..lhed.
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.'(12)'The rey ' r J.r.att ~ to store cpucial ~ pre. med records in
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accurJ n.en utth - the recordo r:ateri.1 manufacturer's
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recour dation uns "at defined'.
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(13): i denc sption of' the per.utcat and torporary secrc;
'
arecc
= t;as provided.
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.
t~(14) The rcquireent fac recuric to be vuthe cicat d and dated by I
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authort: A..ctsonnel was net d.cfl...d.
.
l-(15) Ti i dos" e"l co -truction raquf cer:ents for the perrracoi
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I storage f..cility te.nre not defined.
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_C.. t te in ::VTT_I, ' " Audits"
'
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_ - - - -
41cm.:ntin; procedarun fc the A50-1 s: sten of plann. d and periodic codics docc not a mear to.confera conpletely to che prow sions of
NJSI U13.7 an3 SCSI 1:'.3.2.12 based on the follouba e::a:.,.lcs of I
I def".clencica:
I (1) The re uirerent fo: all saf y relat:' activieles to ~ bc l
.:;dited each ye : has ~ not baan deF*rd in the docur.unta -that j
t;are : ace' '.. ail :21e to " the inder..rs.
'
(2) A' macter plan outlining the nudit frequcacy of each activity tre that-all =activitics are a lited annually <~ es not to ac to have !:en developed.
appe ~
(3) The-requir eent for'an audit to escu a that the QA rcccrds stor. ;e facJ lty is'ia good cr.iitica cud t!v the t apwature
.
'and htmidit cont;.ols and prei.ect *, e devices ::e functionic,3
. pro.:rly chcal :.a addql 'to check 1.st AKO-14.7 of QA procedure A"0- 14i "Operati. g Plmt General Audit." -
.
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,
(4).-and uclection and orientuden of personnel hco not been a require ent.. c a t ri #en nicn to identify the cudit icopa (
!.
identified.
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.(5) The discuss ton' of. the acItt-tec: 1ebder recpo.: sib tlities
-
presented AUJ-14lsh.,uld he e::panded to inelude su_h thiap
- as ' coordination.of. audit; preco:s, coord :aah ica f
,
i cor: Lunic0 t ons,. id. cstablir!' :nt of the p:ce Of the audit.
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