ML19267A257

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Forwards Protested QA Procedure.Submits Reasons for Protest
ML19267A257
Person / Time
Site: 07100210
Issue date: 12/15/1978
From: Peeples W
CHEVRON U.S.A., INC. (FORMERLY GULF OIL CORP.)
To: Mcdonald C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
References
NUDOCS 7901020519
Download: ML19267A257 (20)
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.,a e s EXHIBIT A i u N U C1.E A R R E G U l. A T O R Y C O M M I S S I O N M'- '.<. 17 k M, c o - 10 7 5 I:* r IN THE M ATTER OF: ~ ,y MEETING on DESIGN OF RADICGRAPHIC EXPOSURE DEVICES _ (' 1

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'f ' i-Place. Bethesda, Maryland Octe - Tuesday, 18 April 1978 Pes es 1-123 ? $I I \\ Teie:rece: ("C'", ~47 37CC i, F t ACE. FED E?J.L R.E?ORTERS. DiC. Of.da.l 3epor:er: .LLt Ner n C:::irci St eer Weshingt n, O.C. 2GC01 NATICNWiOE COVERAGE OAILY -sq G

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l l 1 UNITED STATES OF AMERICA .3 l-l 2 NUCLEAR REGULATORY CO'd_".ISSION ') 4 MEETING 5 on l 6! l DESIGN OF RADIOGRAPHIC EXPOSURE DEVICES 7l 1 8 9 ~ Rocm 118 10, 7920 Nor'olk Avenue i Bethesda, Maryland Tuesday, 13 April 1973 1 12 1 l The meeting was convened, purs2 ant to nutice, at 9:30 a.m., 13 i' Rc' cert Sernero, chairman, presidint/. j i 14 i PRESENT: 15 i I ROBERT SERNERO, Chairman 7 2 16 l EDGAR ASiiLEY gg ) Lug. l l EDGAR D. BAILEY M* 4 17 ' ROBERT F. 3ARKER NATHAN BASSIN 18 ROSS 3ROWN STEPHEN SOYKO 19 M. R. 3EEEE I F. N. CASE 20 FRANCIS COSTELLO N. H. CUTSHALJ. i 21 SOB DODA LOUIS F. G.GCIA 22 'l TIM GAINES GEORGE JACK 23 li JAMES A. JONES i i ANTHONY 73GSTRA 24 ! RCD MASON -:s sa:mi amor m. inc. f W. O. MILLER 25 ! JOHN J. MUNRO f _m W

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.. - - ~ ~ - 1 JOHN 3. McCOR".ACK k.t 1-I STEVE McGUIRE 2 WALTER P. PEEPLES, JR. ROBERT PREST 3 . PETER ROSAUER HARRY D. RICHARDSON 4 GARY RUSINOVICH MICHAEL SANTORO 5 DONOVAN SMITH ALLAN C. TAPERT 6 l JOHN C. TASCENER RICHARD ODEGAARDEN. 7 8 9 10 11 12 13 14 15 16 I 17 i i 18 i 19 l l 20 1 4 21 i 22 ~ 23 9 i Aa Federal Recor-ers, Inc. 25 l i i l fr==,n.p.5 . 2==... g n.-.

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?.7064 1 MR. CDEGAARDEN: On July 1st of this year, shcr:ly f ^7.AN K ':1414-1'

2. thereafter, with or without that recuirement of making it into 1

3 regulations, all of these cameras in one sense or another, are 4 going to meet the 18 criteria of Appendix E to Part 71, because 5 any camera that doesn't meet Appendix E to Part 71 will not*be t l 6 I shipped. Period. 7 And the design and construction of the cameras that i t S have been built to date are sort of grandfathered. In other l I 1 9 words, you won't have to go back and redo the Q.A., but any 10 cameras that are built effectively after, designed, built or i 11 i any ecmbination after July 1st of this year, will have to meet i 12 the 18 criteria to Part 71. 13 So there will be a transportation r quirement en 14 Q.A., where it wasn't really designed from the standpoint that i 15 this regulation was written. Effectively, it will do the same 16 job. The cnly job it may not ecver will be reliability. If 17 ! that is the intent here, to get into reliability rather than 1 13 ! Q.A., then it probably should be spelled cut a little bit dif-i 19 - ferently. I, 20 But after July 1st, there will have to be O. A. on 21' all of these cameras that are introduced. 22 MR. BAILEY: Is this a DOT requirement? I 23 MR. ODEGAARDEN: NRC requirement. 24 MR. 3AILEY: Ecw does that affect agreenent states a'30 E4DQr*ers. IflC. 25, which are in the majority? I ... s r..:-- = ~. - .~ ~- --~=>c ;y..v 4 . ;.&Sj l t '.'.. ~ ' '.. A,._*g' V ; _ * - o' .*e

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1] MR. ODEGAARDEN : Ncw, it is sort of a gray area, but fel-2 o 2 l' it may not affect the agreanen: states unless the licensee re-I 3 ceives the package. 4 MR. BAILEY: Clarify it. I heard the words, but -- Sj MR. ODEGAARDEN: All right. An agreement state i 6 licensee is not explicitly ccvered by Part 71. He is indirect .~ I 7 ly involved because of DOT requiring package identification 0 3i n"" er from NRC. I i t 96 So there is a gray area involved there which hasn't 10 been quite, I don't think, fully been resolved. But any NRC 11 licensee uno uses one of those cameras is going to have to have 12 ; a Q.A. program that meets A,cpendix E, Part 71. Otherwise, he i 13 is going to receive the camera and wi,ll never be able to return 14 it to anybcdy. I i 15 j MR. SASSIN: Correct me if I am wrong, Dick. If I u 16 ;linterpret what you are saying correctly, although we, NRC, will i 17l not have any direct regulatcry control over a manufacturer in i 18 l an agres=ent state, iny licensee in a nonagreement state which I 19 ! uses that device would be subject to Part 71 requirenents, so I l 20, perhaps indirectly there would be a need for persons who manu-i 21 facture devices in agreement states to conform to the require-22 ments in Part 71 because of the involvement with customers in l 23 i nonagreement states. I 24 ( MR. ODEGAARDEN: That is correct. - = nwu wooners anc., 25 va. LA MAS 7RA: Is that applicable only to type 5 i I I

3 j quantities or Type A quantities? A 2 MR. ODEGAARDEN: It doesn't apply to Type /r. 3 MR. LA MASTRA: So if it is under 20 curies, it 4' wouldn't have to meet it. ~ j 5 MR. CDECAARDEN: That is correct. Only in excess of 6 Type requirements, but it is also to DOT specification l 7 requirements as pertains to licensees. 8 MR. EAILEY: Could I ask for'more clarification? l 9 Are you essentially saying that the manufacturers l 10 that are located in agreement states will have to come to NRC l II to have that camera reevaluated? Is that what you are saying? i I2 MR. ODEGAARDEN: No. Right now, the manufac urers I3 are coming to NRC anyway because they need a package identifi-t Id cation number in order to be able to introduce it in interstate ' 15, ccmmerce. l 16 In other words, this is required by DOT regulations. 37 So, in essence, we won't approve the package unless they meet la ! all of our requirements, so indirectly we get back to the I9 ; =anufacturers, because he can't ship a Type 3 quantity, or 1 20 greater, without coming to NRC for this identification n=nber. 21 The cnly my that NRC will issce an identification number is if it 22 meets our regulations. If it doesn't meet it, we won't issue 23,' l the n=nber. 24 l Therefore, by COT regu'lations, you can't ship it,

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I 20 l because DOT doesn't issue any special permits anymore, or they i i We m.3 ~... ....., - + ~. -

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1 legally could, but they den't as a ra:ter of practice, so in that sense,

2) we can see that the ranufacturers felicw a Q. A. program.

l 3' The other thing is, de ranufacturers that make careras, 4 he cculdn't sell then to a licensee because the lice.see, ence he receives 5' the carera muld never be able to de anything with it unless he kept it en 6 his prcperty, f 7 So, in essence, the cr. era ranufacturers will have a Q. A. i a preg a 1 under Part 71. In sea cases, you can't trace it back, raybe that t 9 they have to, which is just a ratter of practical ccurse. They ken't be i 10 able to introduce the Type 3 quantity interstate c:xcerce wit' rut cm.ing I1 i to N?C. l 12 i MR. BAIL:.Y: Sat I think en a lot of these careras, ccrrect 1 13

  • ra if I am wrcng, the source is reucinely replaced to ra'<a separate 14 cenwir.ers, as I understard it, wil' nct have to reet all the tests, so ence,

15 i I had a camera, I could receive sources frc= now en frca that i I 16 manufacturer, even though that camera was nc: nanufactured under 17 lthese regulations. 1 18 j MR. ODEGAARDEN: That is pcssibly because cur r.egu-1 19 ' lations only apply to the camera -- I mean if the camera was 20 shipped without a source, then the camera would not be covered. 21 ' .vR. BASSIN: You might be referring to the scurce 22 { changef which in itself wculd still be a shipping container. 23 As I look at it, whether the camera or the source 24 changer, it becomes a package used for shi. cent. So the source www aeoemn. inc. I f 25 changer would then be subj ect to those requirements. i 6 4 6

fel-5 I MR. ODEGAARDEN: That is true. 2 MR. BASSIN: So either way, there is no cuick and ~ l 3 dirty.way to say, Hey, I will use the source changer instead of 4 a device, because from the transportation standpoint, I don't 5 think it really makes any difference what ydu call the thing. It. i 6 is still a package. I 7 MR. SANTORO: Don't you feel most of the manufac-i i 8i turers presently have or have had over the past 20 years Q. A. i 9' programe set up? Jugt .I 10 MR. ODEGAARDEN: I have no knowledge. We den :- 11 approve designs. We don't go in and inspect. You will have to 12 ; talk to I&E. 13 MR. SANTORO: Or how sophisticated is the Q. A. pro-14 l gram -- are the requirements of the 0. A program? 15 What I am saying is, we have a shipping container we l 16 j have used hundreds of times, and before we ship it, we survey it, I to make sure it 17 and we monitor and record the level of radiationj 18 closes, and the locking mechanism, and so forth. This is all by l 19 ' visual observation. How detailed de we have to go into a Q.A. 20 j program to ship a container, that we haven't had problems with, I 21! say in 10 years? I 22 MR. ODEGAARDEN: That is not true. The biggest, one 23 1 of the biggest problems we have had is the fact that people have I t 24 lmade shipments where they haven't put the source in the prcper -,. -w e a,:wr m,ix., 25 ' position bef ore they made a shipment and, in face, we have o b.

u.-. ftl-6 1 licensees, or agreement sta,a licensees in more trouble than anything else. All it takes is just -- to use the term "a few- ? 3; bad a,pples" and it spoils the whole thing, but in a few cases, 4 that happens. 5 Scmetimes it is inadvertent. In other words, some l 6! things will happen no matter what you have.done. But people I i 7' have not, in what we consider a good Q.A. program, have not had ' 8 a good program,and it has gotten a dirty eye for the industry, 9 and it doesn't take very many people to do that. f 10 There is a rec srd of people not using gcod Q. A. and 11 Q.C., but it hasn't been so much the camera manufacturers as I-Tf14 12 the users. I 13 ~ 14 15 16 17 I i 18 19, 20 21 l 22 23 24 .e.... a.:mners. m. : 25 il t il

.15.1 106 .;s h I. MR. LA MASTRA: I have a difficult time 2 understanding how, because users have failed to follow 3 regulations and procedures, why that requires the manufacturer ~ to go and make something different that is not going to 4 5 guarantee again that the user is going to follow procedures. 6 I don't understand the logic in what you were 7 Just saying. 8 MR.* ODEGAARDEN: It was dacided sometime ago all 9 transportation would be covered by a QN program. I think it 10 was first proposed in 1974 It has been based on the 11 record that not only for radiographer devices, but for any 12 other type of shipment, that mistakes have been made. 13 At that time, the Commission felt, and other 14 people in the government felt, that a good QA program was 15 r< quired. 16 So they went out for public comment in 1974 17 The original ones were in 1973. Then there was. time for la pu bli~c co mme nt, essentially public comment. While it 19 c.dn't come out and jump for joy, certainly had no 2C negative aspec:sl 21 Since that time, Part 71 has incorporated Appendix 22 E, made effective in October of '77, and ful.1 implementation 23 will occur July 1st of this year. 24 We are planning in the next couple of weeks, I 25 hope, we are going to get some draf t information out to all

4.15.2' 107 gsh* I our registered users Es to what might be required of 2 Appendix E, especially f*'a the user's standpoint and the 3 QA program takes a graded approach and this information, 4 some of it is going to be -- in draft form -- will be 5 released so users will have some. knowledge of it. 6 MR. BAILEY: This whole thing of transportation, 7 I admit I'm sort of fuzzy on it. It started out for DOT 8 taking all the responsibility. Then it came back where NRC 9 was going to do it and at that time, the agreement states 10 were more or less led to believe you will provide it. .Il So when the stuff for Part 71 cam ( out, it 12 really wasn't clear what was going on. 13 I.think maybe not only the licensees but 14 agreements states were led down the primrose path. 15 It's a confusing situation. No one really sort 16 of explained what is going on in transportation. 17 CHAIRMAN SERNERO: We.11,' Ed, you know, this la whole area,' I think we are ge tting f arther and f arther 19 away from the scope of the meeting here. Ib's something that 20 I'm not trying to set aside as a trivial issue at all. 21 It's certainly'a big question. 22 But I would like to bring us back to the 23 design requLrements and ask you to defer that dialogue and 24 discussion. to separate treatment, if you would. 25 If you could take that up with Dick odegaarden

T' e j . a; EXIIIBIT B QUALITT ASS 1 TRANCE RK OIRrdINTS TC1 PACKAGING AND TRANSPCRTA!!CN CF RADICACTI7E MATIRI.M.S R. F. Barkar C. E. MacDonald, a_d R. J. Doda U.S. Nuclear Regulatory C:::.ission ashington, D.C. 10355 A3STRACT This paper discusses the new qualiry assuran:e regulatiess of the Nuclear ,tegulatory Coc=ission (NRC) for packaging and transportation of radioactive ats-rials. ~hese regulations became eff ective on Cet:bar 15, 1977. 3ackgrou=d infat- =.acion ecccersing these regulations and packaging and tra:sportation history is included. The quality assurance progra.s is described with indications of how it is e== posed of geceral (ad=iniserstive) provisiens vnich ust cast the 13 quslicy assurat:e criteria and be approved by the E C; specific provisions which appear in DCT and RC regulatio:s and in the i=dividual package design approval; and other specific procedures which are not required by regulations but which are necessary for the proper control of quality. The quality assurance pregram is to be developed using a graded approach for the application of parti:est criteria and cpti=izisg the required degree of safety and centrol efforts involved is achieving this level of The 1 m reae-user is responsible for all ;hases of quality assurance for safety. packaging activities 1-clud12g: design, ca=ufacture, test, use, :.ainte:ance and repair. The package design ;hase is ccusidered to be particularly imper:aut in producisg adequate safety is operational activities cc cersi:g pack 251:g and :: ass-portation of radioactive aterials. DEyINITIONS Ouality assurance ce= prises all those placned a_d syste=atic actiocs necessary to provide adequate ccnfidence that a systes or c::po:ent sill ;trfors satisfacterily 2a service. Quality assurance includes eumlity c:: trol, which ce:prisas those quality assurance actions related to centrol of the ;hysical characteristics and quality of the =aterial or ec=po:ent to predeternized require:e es. INTICDUCTICN The purpose of this paper is to provide a sy:opsas of the currert qualiry assurance regulations for packagisg and :: anspor:atien cf radioactive.rtarials. The NRC's regulations concer:1:g quality assura:ce require =ects for packagsg and transpor ation are cos.cained is 10 Cy17 art 71.

  • as: Aug40, the Cc==ission pub-lished general requirements for quality assuracce pregrams for persons who are 1

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Y /* . + ne underlying reason for these programs, of cou:se, is to provide assurance that the packagias performa in service as designed and intended. Tests or evaluatione for ec.tinued effectiveness should be made in use to provide feedback information for cbsnge or nodification of any provisions of the QA prog:aa, if necessary. FACIAG DG A C TRANSPCRT.ATICN EISTORY ne packaging and transportation history of co==arcial radioactive =ateriale is exe=pla_ry,, compared to other hazardous materials. C:17 a few known cases of radiation uposurer have occurred during the many years of tra:sportation activities 1:volvi=g radioactive sacer141s and none of those 1svolved the larger or = ore complex type of packages. With the large nu=bers of packages of radioactive aterial being hacdled, there vill concisue to be some at:cidents and, possibly, s::e ui:or radiation exposures. We have shown is WRIC-0170, "71 sal Esviron= ental Statemest on the Transportation of Radioactive Katarial by Air and other Modes," [3],

t. hat the risk in transportation of radioactive material is very s=all. Also, we are co==itted to sini=1 zing exposures of transportation workers and the public to values as icv as reasonably achievable. No reasonable a=ount of regulatory effort, however, can e sure absolute saf ety; and no reasonable a:must of enforcement effort, can ensure total co=pliance. ne nuclear industry bears ths primary responsibility for assur1=g safety and full co=pliance with the regulations. It is our opinion that the industry has acted res sensibly, carefully and effectively is providing adequate safety and can taka =uch credit for the good record that has been established.

There have been two well-publicized air tra: spor: iscidents isvolving radiological exposures which may point out areas of possible safe:7 benefits that could be derived from an effective QA program. Neither case 1svolved as accident or as abnormal transport condition, but both incidents caused so=a==:ecessary and a few cases of excessive radiation exposures to transport workr and se=bers of the general public. In the first iscident which occurred on New Year's Day, 1972, an esti=ated 10-15% of a ship =ent of a gha solution leaked out of the inner contaiser while it was bei=g transported in the cargo compart=ent of a passe:ger aircraft. The cap on the i==ar polyethylene bottle was not " seated" properly, and a portir2 of the gasket on the outer container was missing. Further, because the u scainer was heavy and taller than most luggage, it was loaded is the baggage c:=part=ent on its side, although clearly marked to be shipped upright. As a result, contasination of the cargo ec=part=ent and ciamy pieces of luggage occurred duri=g the next few days before the leak vas discovered. Had QA procedures for checking the bottle cap and the gasket been applied prior to releasing the ship =ent, or even if the package had been carried upright, the leakage could have been prevented. A second incident occurred is April 1974 A sealed source of W Ir, Icaded is a " source changer" so that it was only partially shielded, vas shipped by passenger aircraft. Is this case, the cpecies is the shieldi=g of the package has as 5-shape design for ease of in:ertics of two sources vich " pigtails." Freper shieldicg de; ended on the perses leading the sources insert 1=g each source.i.h the " pigtail" e:d out. I.- A case, one source was shipped with the " pigtail" and in, probably as a resulc of i=serting a second source in behind a source already is place, pushi=g the first source on through the 5-shaped tube is the shield a:d e.7. osi:g the source instead of the pigtail. Adequate application of QA during the desig: phase could have identified the possibility 7f such a loadi:g error as a weakness is the design of the ;ackage, and the desigs could have been modified accordi= gly. Also, a co=plete sut-rey of the package before of fering it for trar. sport, as required by regulaticus, vould have pre-vented such a packste from being of fered for tra=spc::. 5 s e

~ - w.. -::::.u ~ ?'~~~i, e - ;;%, ~ W / V_ n,_ .f W~~~L.'*3*$ =. 25750 EXHIBIT C The petitioners make the following statements in suppor*. of thier pet!- t!on:

1. Only two of the seven camera manufacturing firms are located in the jurisdiction of the U.S. Nuclear Regu-latory Commiss!on even though the Department of Transportation re-quired the NRC to evaluate Its type.B requests covering all manufacturers unless the manufacturer uses a DOT-specification container.

2. The U.S. Nuclear Regulatory ~ Commission did not notify those man-ufacturers in agreement States of the pending part 71, appendix E. changes. ,r /

3. There is a distinct discrepancy concerning the NRC position and the Informatfort passed to agreement States concerning the understanding of the material contained in appendix E, part 71. (Reference meeting on Design of Radiographic Exposure De<

vices, Bethesda, hid.. Tuesday. April [75?0-01} 18,1978, page 100 of the transcript.) IDocket No. PRM 'll-71

4. There is a lack of distinction con-NON DEsicUC*lVE TEST:NG MANAGEMENT s!!c materials and type B quantitles of m socjAnoN, Et At.

specific Isotopes. In the field of Indus ' FNag of Petiflon for Rufemoking trial radiography we are concerned l with only a fcw byproduct materials. Notice is hereby given.that hfr.

5. The program cited in part 71, ap.

Walter P. Peeples. Jr., President, Non pendix E, is not national in scope since Destructive Testing hianagement As-th U.S. NRC services less than one. sociation. by letter dated hfay 10,1978 half of the Industry and cannot truly on behalf of Non Destructive Testing express that It represents a majority. hinnagement Association, seven unde, Th!s is pointed out by the fact that - signated radiography camera manu. the U.S. NRC splits with agreement facturers, and six undesignated source States and that.in the case of Industri-manufacturers, has filed with the Nu. clear Regulatory Commission a peti. al radiography it represents only one-tion for rulemaking to amend the third of those manufacturing and Commission's ' regulation, " Packaging, shipping type B quantities, of Radioactive hiaterial for Transport

6. The further lack of proper consid.

and Transportation of Radioactive cration. price to adopting the' part 71, Afaterial Under Ccrtain Conditions." i appendix E, qua!ity assura'nce, pro-gram is indicatcd in the fact that a 10 CFR Part 71.- ! Tat the great deal of the purpose is lost to ex. The, petit!oners request Commission revoke Appendfx E-isting exemptions atid the fact 'that Quality Assurance Criteria for Ship-those using DOT-spacifNa tion con-ping Packages for Radioactive hiateri i talners do not fall under the program.. als--of 10 CFR Part 71. TIfe petition-] ' A copy of the petit!cn for ruicinak ', crs afsa request a delay in the effective i ing is available for public inspection in ! date of Irnr!ementation of appendix E l the Commission's Public Document' until a her. ring can be conducted. The, Room.1717 H Street NW., Washing-petitioners.stste that the basis for ton, D.C. A copy of the petition may their petit!on is "* *

  • the rule was bc obta!ned by writing to the Rules foicol on the industry and nut dis 4 and Procedures Branch, Division of cu:2cd nor did the ComnusMon at i Ru!es and Records, Office of Adminis-tempt to notify two-thirds of the runn ;

tration. U.S. Nuc! car Reguistory Com-uff.cturcrs in this speciGc area of its ' minicn, WashingNo D C. 20555.- e tt. tu pt to rrcate an ahnast insur-All perscas who da!re to subruit incent: b!e.md e pens!ve pwtrwork vait*M commenta or sug 'c ;ijons con-N " * " *_ cernir.1 the p *ti!!cn for tu!cmr. king ~ shcuht re:.il thc!r c mmcats to the Secretary of the Commbsion, U.S. Nu-clear 17ccu! story Ccnr nicsion, Wash-hicton, D.C. 705M, Attent!c:n Docket-f.M and Wrvice Uranch, by August t4, 1978. DMed rt Wuhindon. D C., this Orh .%y of J.::'c W R. For the Nuc! car Regulatory Com-minio n. b m t. J. Cu tLK. 5 crch:r; cine CanLdost.

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' '.:IC'c C'. ;72R BLVL . 23 37 7 ' '7.... d 77593 1 i December 7, 1978 United States Nuclear Regulatory Corraission Transportation Branch Washington, D.C. 20555

Dear Str:

Attached is a copy of the requirement for a Quality Assurance Program to comply with Appendix E of Part 71. This program will be active at all Gulf Nuclear, Incorporated facilities. Very truly yours, Frank A. Malek, Jr. Radiation Safety Officer FAM/dfc Enclosure cc: Texas State Department of Eealth Radiation Section

A QUALITY ASSURANCE PROGRAM FOR APPENDIX 3 TO PART 71 GULF NUCLEAR, INC. December 7, 1978 1. Organization: ~ The final responsibility for the quality assurance pro-gram for Appendix E to Part 71 rests solely with Gulf Nuclear, Inc. and its management. Design and fabrica-tion shall not be conducted under this quality assurance This program is implemented using the following program. organization chart. PRESIDENT RADIATION PROTECTION OFFICER WALTER P. PEEPLES, JR. VICE PRESIDENT VICE PRESIDENT RADIATION SAFETY OFFICER ELICK H. ACREE SUNYA L. FITZ FRANK A. MALEK, JR. The Radiation Safety Officer, Frank A. Malek, Jr. is res-ponsible for overall administration of the program, train-ing and certification, document control and auditing. Packers and shippers are responsible for handling, storing, shipping, inspection, test and operating status and record keeping. This area is generally manned by professionals (that is degrees), technicians and assistants. 2. Quality Assurance Program: The management of the Gulf Nuclear, Inc. program establishes and implements this quality assurance program. Thaining prior to engagement, for all quality assurance fune.tions, is required according to procedures. Quality assurance program revisions will be made according to written pro-cedures, engineering procedures and specific revisions of the package design approval are satisfied. i

Quality Assurance Program December 7, 1979 Page 2 This quality assurance program will emphasize control of the characteristics of the package which are critical to sayety. 3. Document Control: All documents related to a specific shipping package will be controlled through the use of written procedures. All documentschanges will be performed according to written procedures approved by management. The Radiation Safety Officer shall ensure that all quality assurance functions are conducted in accordance with the latest applicable changes to these documents. 4. Handling, Storage and Shipping: Written safety procedures concerning the handling, storage and shipping of packages 6or certain special form radioactive materials will be followed. Shipments will not be made un-less all tests, certifications, acceptances and final in-spections have been completed. Work instructions will be provided for handling, storage and shipping operations. 5. Inspection, Test and Operating Status: Inspection, test and operating status of packages for certain special form radioactive materials will be indicated and controlled by written procedures. Status will be indicated by tag, label, marking or log entry. Status of nonconforming parts of packages will be positively maintained by written procedures. Shipping personnel shall perform the regulatory required inspections and tests in accordance with written procedures. The Radiation Safety officer shall ensure that these functions are performed. 6. Quality Assurance Records: ' / Records of pac.kage approvals liceluding references and draw-ings), procurement, inspection, tests, operating logs, audit

' e Quality Assurance Program December 7, 1978 Page 3 results, personnel training and qualifications and records of shipments will be maintained. Descriptions of equipment and written procedures will also be maintained. These records will be maintained in accordance with written procedures. The records will be identifiable and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer. 7. Audits: Established schedules of audits of the Quality Assurance Program will be performed using wiitten check lists. Results of addits will be maintained and reported to management. Audit reports will be evaluated and deficient areas corrected. The audits will be dependent on the safety significance of the activity being audited, but each activity will be audited at least once per year. Audit reports will be maintained as part of the quality assurance records. Members of the audit team shall have no responsibility in the activity being audited. .}}

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