ML20058H678

Responds to 931130 Telephone Inquiry W/T Matula Re Procedure for Reinstatement of QAP Approval for Radioactive Matl Package 0682.Also,forwards 910822 QA Termination Ltr,Qa Program & Sample QAP for Radiography & Sealed Sources

ML20058H678
Person / Time
Site:	07100682
Issue date:	12/08/1993
From:	Janovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Nalley D PACIFIC TECHNICAL INDUSTRIES, INC.
References
NUDOCS 9312130180
Download: ML20058H678 (1)

Text

.

December 8, 1993 SCDB: TOM 071006B2 Pacific Technical Industries, Inc.

ATTN: Mr. Douglas L. Nalley, President 1414127th Place, NE, No.107 Bellevue, WA 98005

Dear Mr. Nalley:

This is in response to your telephone inquiry of Novembtr 30, 1993, to Mr. T. Matula of my staff, as to the procedure for reinstatement of your Quality Assurance (QA) Program Approval for Radioactive Material Packages No. 0682.

Enclosed is a copy of the QA Program termination notification letter dated August 22, 1991, your original QA Program dated May 1992, and a copy of a sample QA Program for Radiography and Scaled Sources acceptable to the Commission for meeting the applicable quality requirements of Subpart H of 10 CFR Part 71.

If you wish to have your QA Program reinstated, please send a letter requesting us to take this action.

If you wish to use the May 1992 QA Program, please state so. Otherwise, enclose your updated QA Program with your re:;uest for reinstatement. A reinstatement _ fee of $370.00 is also required.

Sincerely,

%1Slgned by John P. Jankovich, Section Leader Quality Assurance Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NMSS

Enclosure:

As stated DISTRIBUTION:

NRC_F/C PDR RGN V MMessier NMSS/SCDB EZiegler 50'Connor RBaer WBrach b

n#CDB b

0FC SCDB 6

_,STSB NAME aMa/ tom kBennington hJbankovich DATE

!? /7 /93

/.3/ r)/93 1 "/7/93 C = COVER E = COVER & ENCLOSURE N = NO COPY r

000 Cir't

$$ #200!k S!$0!s2 ids $ $ E b[idibb N Y O'

Oh s,

C PDR

i

.l P

O'_

j AUG 2 2199; SGTB:GMB 71-0682 71-9007 Pacific Technical Industries, Inc.

ATTN:

Douglas L. Nalley, President 1414 127th Place, NE Bellevue, WA 98008

Dear Mr. Nalley:

As requested on your letter dated July 23, 1991, Quality Assurance Program Approval No. 0682 has been terminated.

Your authority to use Certificate of Compliance No. 9007 under the general license provisions of 10 CFR 71.12 is also terminated.

Please note that records required by 10 CFR Part 71.91 are to be retained for a period of three years.

Also note that under the reciprocity provisions of 10 CFR 150.20, an Agreement St%t-licensee is subject to the requirements of 10 CFR Part 71.

This would include having a Quality Assurance Program approved by the Commission as satisfying the provisions of Subpart H of 10 CFR Part 71.

Sincerely, N 0dak f. hgA Charles E. MacDonald, Chief Transportation Branch Division of Safeguards and Transportation, NMSS DISTRIBUTION:

NRC File Center PDR TMatula GMBennington EZiegler JJankovich

! MSS R/F SGTB R/F Region V MMessier OFC:

SGT

SGT

SGTB f

SGTBh%

l

\\

l NAME:

Bennington :TMat a

JJa.ovich :CEM Donald DATE: 08/2//91

08/,2//91 :08/12f91

08/ f t/d31 l

(T N. ~_,

3 g

\\ l D / Y () l

~

~

4

, s.

• 'f U.

S.

NUCLEAR REGULATORY COMMISSION j/

FY 91 Annual Materials Fee Invoice 10 CFR 171.16 7/ - 6 6 9 3 ~

?

Invoice Date Invoice Number 08/09/1991

==

AM08559-91 PACIFIC TECHNICAL INDUSTRIES, INC.

ATTENTION:

RADIATION SAFETY OFFICER 1414 127TN Pl. ACE, NE BELLEVUE WA 98008

~3 Mark THIS COPY with any billing address changes Code Annual Fee License Number AA905 Category (s)

Fee' Amount Amount Surcharge

=

===

0682 ANN 10B(2) 1,700.00 s

100.00

==

TOTAL:

1,700.00 4

100.00 TOTAL INVOICE:

1,800.00 Moko Checks Payable To:

===========

U.S. Nuclear Regulatory Commission

<=== This PO Box address is License Fee & Debt Collection Branch

<=== for receipt of payments PO Box 954514

<=== only.

St. Louis, MD 63195-4514 i

Torms and conditions are attached.

Hunpayment of your annual fee any result in the revocation of your license (s) in accordance with tho onforcement provizions of 10CFR171.23 of the Commission's rogulations.

PA YMEN T C0P Y I

i

• • • • • • • • • • • • • • • • • v**************

> To ensure accurtte credit, return this copy of the <

===> invoice with your payment.

Processing may be

<===

===> delayed if the invoice is not included.

<===

&')f/?(4&

lI had W!

ws:nwya.wrmpmx muu.w.mmencmn,asna;a,swezwquepq;,cg&g., _,. n.g...

w

, - - -~

a a.. ax:1wu;;gggy gg ggy s;,,.

c

~

n c

--, r JQ:

Q

+

w.

,pg 9

g

~. y.

~

i

}

)

. c.

July 281989 -

l

.a j

P ACr AC TECHNIC At IND J5,T RJ fgl[,C,.

sen pom nr.e wcv wwc. wA 95022 (2X M s?2 H

' ore 72919

()2ality Assurance Progrma ' for j

hXTR Part 71 Ret [uituirrits,

1. g pnization i

9, h final rnstrxnibility for the Quality 1:n:urance(OA) Program for Part 71 RyJIInacats rest with Pa.cific Technica) Irrlectrics,Ir:c. Design and Fabrication shall not be condacto3 trider this OA Progrenn.

f

'Ibe QA Progr.n is inpler nted usirig the cryarization prtsental in 7ppendix A forrting e

put of this QA program.

h Radiation Safety Of ficcr is rmponsible f or omrall administration of the progrcr,, training mal certif icat5:m,dra::,r.n ontrol and auditing.

'1hn Radiograrbcu: cre ar:' n'sp:na ible for 5.s:dling, storing,nhippirr3, inspection,tet and operatiirq strtus. an: n tn r.S:cging, f

2, Quality 7csortnen Pr E l

4, 7H;J i e,7n: CA Prograa establir.bes and h mr.aprnt of P.4e: "

ca i

Inplanunts this p* !, -

i c,pg=mnt,fcr all QA functionc in.

.u M,1m.7@tinistrative Prooteures

]

rajoimi an cet1 % - i.

• -"c

.1 & file with the Statn 5

Nnra) and the Cp -

1

l d DV OffiCO.

'~~

(

Cf htShingtN IL hl I

QA Prograt rev i.s -

' :r_._ t b -': proved by the ascerent s

4 l

terc.re it:pirrymtat i' 7 hv Maren Mmual subnittel

'Ibe Certif icate io 4

to us frun the 1y4 cc rtifimtr of Crnpliance for d

3 t

Itadinetiw' !btc-i w i -

qora!c.1 into car (v, 'prt/frem anr3 farther "t 't 'n,7Prani.>us f tsterials Ecgulation -

has b oa rry ir.tx.: '

m

} x..rc& na c-V-

? ~: T c.C.

3. l.o. a.._: L..

( < >..r. -

All cocwents rel a'.c.' -

, p dage vill ba controlled through the i 13 : 'vanf.ir "i ' itnd "C" and "D" fcrming rt. ' of the writ * 'i <

c-p-

o! this OA Pror-m n

i0 e d.vingw vi13 b? impicnented as required.

I h 0809D 99072g

~~

j l _PDR,ADOC On seses,4 l ~ ' '~

,.C PDR E*d

_ h,m ra n h

.._._...._~;_.-.-

. = -

_~.

t y

s p

.s'g-v

~

i, s %w, -

- 4.y

~,.

s e

n 1mr v }p a.

.[

e 4w.

.Q -Q y._ ~f. } !

! ::4.

--- _,,7 9, ;

i i

~

.-4. Hsndling, Storage 4md Sh pp ngj i

.mu,

. x..

'Jhe written proacdures prcccntsd in Pacific 'JE:hnical(IndustricsjInc.'s Op2rerating, and Fccrgc cy PrtceJures frenual, p3ragraph bl' Udough 824 Cdidincc the noccessary rt<pirements for rooting,]atcling and grcu2:1 transportation of-Radioactive Msterials i

in Pacifie ' Technical Indastrica,Inc. pyr.sesitin. Identifiedds : Appendix 1"D" of this Oh_Pr6 ram.

3 Appendix "B" "C" ard *D* identifies all cther m;uiremnts for handling, storage and r, hipping.

When shipping. by C.sruo o11v Aircrc.ft an aimill as exhibited under 7qpendix "E" of 1

must le empleted Lefore presentirg tn carrier.

i d

i Radiography retconnoi nh111 re:f om the cJ Hical handling, storage and-shippir.9

)

operat. ions.

.1

5. Inspratico, Test and Gaerating r.tatua 1.

Insprtion, test and cperating Ut;st.us o? pint gEs for certain syscial form rad.ioactive rmtcrial wi]I le cantrofic-1 as o:llined in Reilic 'lbchnical Indtutrics,1nc.

Orerating and Therger.cy iS c< dor r K u";n] rr Apend ixm "B", "C",TD" aM "D".

1 timtunf orming luckeyc tml if ::.tc Prlin :icri errnicion tejar$ }9stissible limits 1

will be considerc0 on F.1' 3.v.

LL pig: Will be isolatal until the lccal f

Ra liaticn Pr'et i:

F

'wf nul the err 1 carrier have-1 con

]

notified and a pl.m o

i

'] r * + th r'eficieny of tbn package

]

tc, an acceptahl.-

4 /

Rn-ligghy Pers': ~

- ' iw:ps ionn and tests in

~

i accoolance to t].

(c

" T: > <r.

'n o radiation Safety l

Offimr shall en.m

-n d.

i

6. Chul ity la, uran.vq i -

j j

Record; of Fu:'a@

a.

r.r. ' Tcutngs) pr txcunamt,inc;pect. ions, 1

trGts,cseraLing 1:2,, s,

,N' c q -. ! yMli!irat_irrs and records f

of shirrnnts vil]

r. ' i v -.p, m.

1

,:2: e i) ~ b

> ; p ri(h car +, r itM1 procodum%'Ihe records

.u e deat. i f.iW c o.

,t

' vi 11 their ntnrage locations,will

[

lx rm intainnl by the R - E c O')

..u 1

q _.

s i

1

'. ' d i:C: MF ";NI 9t;IJJJIbid 10Gd 'EE:20 68,.lE.Tif.

o-

.. xa. wn ess -

Lw 7.

y girgyuyf p:ll3 y;y;gg;y.fp.: 9y ;.;4y.y

,3. ;;;. -

l f

-n Q.Wi.?67.lp".' ]- h.;[.,*cu.3g;;f:

.~.w-.

. a,,=p

-

?.1,

,uo..a

.., :, a.a.

r.

7

-w.

a-

.C

. %.. w f

. un.

+

4 r

y.

~

-7.

A__uditn 4

- ~

t.s.~

Established ucht-Jules of audits of the'@ Pasir.itn will In padfoinn1Itii;2ng a written -

check list.Appndix "G" b: ring. rhrt of-thic QT Progrnm cx2tlines die'fomat tri(xl in

t.,

crJr a'.vlits.

q, Recults of the audit will b? nuint/ Lined and nprted tn nanag: rent. Audit reports will l

in ev.altated and deficient arns eme.sl a:y1 ailitjanal training prtnrided"if nrrrossag, j

h audita will N dcTeul snt on tre safety sicini f icanm of the activity tcing audited, int e)cli activity will b: audited at Ioint once txtr year. Audit reprts will be nointainn3 as part of the genlity assur.inm ac")rds.Madcrc of the audit tmm shall ha.e no reciercibility in ttua a:tivity atr3itecl.

i i

i 1

1 h

r 3

I p

p.

r t

r v

-3~

!'b

" Y15 * ))

E ) l{ }{p -

}

{e g

-,z 9.

-. =+:

w--x:-a

+. :..

. Q-

- ; ~

e i

I APPEllDIX "A" i

i l

ADMINISTRATIVEORGANIZATION. CHART FOR RADIATION SAFETY PROGRAM i

1 1

l l

l

~

TRE51 DENT

• I Soren F. Johanson I

1 I

i j

i

.u _.

i l

RADIATJOt SAFETY OFJJCER*

.' o h a n :, o n

..--- -_' : o r e n R.

_J

't 6

d

{

s

. _.~.-........ - - _

4.

("

s-

{ f i l, }3 q

g ** 1 4 g *

/.".'

8 J w t.

e.

e q

O' 4 h! l Ibd i

i I

} tT l

Ie >

3 l

i r

b

}

i a

l

't i

l 3

In th' p r t r--

r>, '

Oi i; 1

, rat:,

the Prt;sident and the j

I Is ': 5 G T'

[

R;1d55tiCli '

4 i

l l

Tv' TO']i M.h'a; i ns i s ;41, ' 1 07-tjn part 71 g,A, j

i 1". JU k.1 1 Vii' '

'~n 4

3 l

4 4

i s#

b

_.1 i

I"d i F C.S.

E:5PC'- ','e11 DiJ11f JIdd ;Cr3 r 3 ; : gg' C>? < l E Td l

..,.s-,

...u. -

t90R 188 902.[,

" ' ~ ~

i May, 1992 i

10 CFR PART 71 OA PROGRAM FOR INDUSTRIAL RADIOGRAPHY LICENSEES 1.

Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with (Company Name). Design and fabrication shall not be conducted ur. der this QA Program. The QA Program is implemented using the following organization.

Note:

The Organizational Chart as used in the license application should be presented for organizational elements (e.g. procurement, quality assurance, radiation safety) functioning under the QA program.

Principal contractors should be identified.

The (

) is responsible for overall administration of the program, training and certification, document control, and auditing.

The (

) are responsible for handling, storing, shipping, inspection, test and operating status, and recordkeeping.

2.

Quality Assurance Program The management of (Company Name) establishes and implements this QA Program. Training, p.rior to engagement, for all QA functions is required according to written procedures. QA Program revisions will be made i

according to written procedures and with management approval. The QA Program will ensure that all defined QA procedures, engineering procedures, and specific provisions of the packaging design approval are satisfied. The QA program will emphasize control r,f the characteristics of the package which are critical to safety.

1 The (

) shall assure that all radioactive material shipping packages are designed and manufactured under a QA Program approved by the Nuclear Regulatory Commission for all packages designed or fabricated after January 1,1979. This requirement will be satisfied by receiving a certification to this effect from the manufacturer or supplier of the package.

3.

Document Control All documents related to a specific shipping package will be controlled through the use of written procedures. All document changes will be performed according to written procedures and approved by management.

The (

) shall assure that all QA functions are conducted in accordance with the latest applicable changes to these documents.

Typically this responsibility is vested in the radiation safety officer (RS0).

Typically this is the responsibility of the radiographers or the RSO assistant.

4. ' Handling, Storage, and Shipping Written safety procedures concerning the handling, storage, and shipping of packages for radioactive material will be followed.

Shipments will not be made unless all tests, certifications, acceptances, and final inspections 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 radioactive material will be indicated and controlled by written procedures. Status will be indicated by tag, label, marking, or-log entry.

Status of nonconforming parts or packages will be positively maintained by written procedures.

Note:

10 CFR Part 34 identifies specific inspections and tests to be conducted during use and maintenance.

6.

Quality Assurance Records Records of package approvals (including references and drawings),

procurement, inspections, tests, operating logs, audit results, and records of shipments will be maintained. Descriptions of equipment, written procedures, and records of personnel training and qualifications will be retained for three years beyond the date activity, for which this QA Program was developed, ends.

These records, will be maintained in accordance with written procedures.

The records will be identified and retrievable. A list of these records, with their storage locations, will be maintained by (

).

7.

Audits Established schedules of audits of the QA program will be performed using written check lists. Results of audits will be maintained and reported to management. Audit reports will be evaluated and deficient areas corrected. The audits will be d? pendent 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.

i a