ML20153H346

10CFR71 QA Program for Industrial Radiography

ML20153H346
Person / Time
Site:	07100569
Issue date:	01/07/1986
From:	AMERICAN TESTING & INSPECTION
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ML20153H343	List: ML20153H341 ML20153H346 ML20153H354
References
NUDOCS 8602280772
Download: ML20153H346 (20)

Text

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American Testing and Inspection, Inc.

P.O. Box 878 Mokena, Illinois 60448 January 7, 1986 10 CFR PART 71 QA PROGRAM FOR INDUSTRIAL RADIOGRAPHY - NRC License No. 12-21101-01 1.

Organization The final responsibility for the Quality Assurance (QA) Program for Part 71 Requirements rests with American Testing and Inspection, Inc. Design and Fabrication shall not be conducted under this QA Program. The QA Program is implemented using the organization as described on " Exhibit A" Organizational Chart as appended to this QA Program description.

The Radiation Safety Officer is responsible for overall administration of the QA program, training and certification, document control, and auditing.

The Radiographers are responsible for handling, storing, shipping, inspection, test and operating status, and recordkeeping 2.

Quality Assurance Program The management of American Testing and Inspection, Inc. establishes and implements this QA Program. Training, prior to engagement, for all QA functions is required according to written procedures. QA Program revisions will be made according to written procedures with management approval. The QA Program will ensure that all defined QC procedures, engineering procedures, and specific provisions of the package design approval are satisfied. The QA program will emphasize control of the characteristics of the package which are critical to safety.

The Radiation Safety Officer sha.ll 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 af ter January 1,1979. This requirement will be satisfied by receiving a certification to this effect from the manufacturer.

NOTE:

Ron Preston obtains these certificates fran the manufacturer. To simplify this task, only Tech-Ops, Inc. Iridium-192 industrial radiography units of the same type are being used.

If another individual manufacturers radiography system would be acquired, individual certification would also be obtained.

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 approved by management.

8602280772 860107 PDR ADOCK 07100569 C

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The Radiation Safety Officer shall insure that all QA functions are conducted in accordance with the latest applicable changes to these documents.

NOTE: The Nuclear Consultants assist in auditing these documents periodically, and at least once a year.

4.

Handling, Storage, and Shipping Written safety procedures concerning the handling, storage, and shipping of packages for certain special form 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.

Radiography personnel shall perform the critical handling, storage, and shipping operations.

NOTE: These procedures are detailed in American Testing and Inspection, Inc. NRC license No 12-F1101-01 and license applications which are a part of the initial and annua' radiation safety training review for all ATI radiographers.

i 5.

Inspection, Test, and Operating Status Inspection, test, and operating status of packages for certain special form radioactive material will be indicated by tag, label, marking, or log entry. Status of non-conforming parts or packages will be positively maintained by written procedures.

Radiography personnel shall perform the regulatory required inspections and tests in accordance with written procedure. The Radiation Safety Officer snall ensure that these functions are performed.

NOTE:

This is accomplished by the R.S.0. personal inspections of packages and supervision of tests, operating status, and records.

6.

Quality Assurance Records Records of package approvals (including references and drawings) procurement, inspections, tests, operating logs, audit 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 identified and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.

NOTE: The QA records are specified in ATI's NRC license; 10 CFR Part 34, and 10 CFR Part 71 Subpart H.

These records are maintained in the

" Inspections" file cabinet in the ATI business office.

l 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 dependent on the safety significance of the activity

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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.

l i

Members of the audit team shall have no responsibility in the activity being audited.

NOTE: The typical written check list used by ATI in its annual audits is titled " Radiography Inspection Report", of which a sample is attached.

These audits are conducted by the R.S.0. and the nuclear consultants, with

. interviews of the ATI radiographers and office personnel, to assure an objective audit of overall activities including compliance with QA Program, license conditions, and regulations.

A s

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Exhibit A American Testing and Inspection, Inc.-(ATI)

Organizational Chart for-10 CFR Part 71 Q.A. Program President Nuclear

/.

l Consultant N

R.S.0.

i I

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.I Radiographer Radiographer Radiographer Radiographer l etc.

Assistant Radiographer Notes:

1.

The President and Radiation Safety Officer (R.S.0.) is Ron Preston, who is the responsible individual for Part 71 Q.A.

requirements.

2.

The Nuclear Consultants are Stan A. Huber Consultants, Inc. - New Lenox, Illinois. They assist the R.S.0. with periodic compliance and Q.A. audits and in conducting formal training.

3.

The Radiographers names are listed on ATI's NRC License #12-21101-01 and may change from time to time.

4 Assistant Radiographers are generally upgraded to Radiographers after they have successfully completed on-the-job and formal training requirements as specified in ATI's NRC license and 10 CFR Part 34, Appendix A.

i

s.

Modula No. 75710B RADIOGRAPHY INSPECTION REPORT Inspection Report No.

Licensee.(Name and address)

Licensee

Contact:

. Telephone No.

License No.

Docket No.

Last Amendment No.'

Date of Amendment:

' Category: C Priority:

II Date of Inspection:

Type of Inspection:

( ) Announced

( ) Initial

( ) Unannounced

( ) Special

( ) Reinspection i

E xc=ary of Tindings and Action:

( ) No Noncompliance, Clear 591 issued

( ) Action on Previous N/C

( ) Nonco=pliance, 591 issued

( ) Regional Action

( ) Noncompliance, Appendix A

( ) Hg-Acition t

Inspector:

(Signature)

(Date Signed)

I Approved:

(Signature)

(Date Signed) 2/81

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2 1.

INSPECTION HISTORY a.

Item (s) of noncompliance or deviations no'ted during last inspection conducted on:

~( ) Yes

( ) No b.

Requirement Severity Corrected Status If any item (s) of noncompliance or deviations noted during last j

c.

inspection were not corrceted, explain:

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2.

ORGANIZATION 3

.a.

F2nagement Structure 5

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.i l-j b.

Persennel Interviewed I

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• Attende'd Management close-out meeting l

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c.

Administrative structure meets licence requirements: ( ) Yes

.( ) No,. *

(L/C - MPA) d.

Radiography Personnel Radiographers Radiographer's Assistants

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3.

TRAINING,RETNININGANDSUPERVISIONOFRADIOGRAPHYPERSO.NEL V

a.

Radiographers and ssistants named in license:

( ) Yes

( ) No b.

Radiographer's Assistant under direct supervision of a Radiographer:

( ) Yes

( ) No (34.44 - BPY) c.

Approved training program:

( ) Yes

( ) No d.

Deficiencies noted:

( ) Yes

( ) No

' (L/C - MPA) e.

Training provided by:

f.

Written tests:

(') Yes

( ) No g.

Oral tests:

( ) Yes

( ) No l,

h.

Record of test r'etults:

( ) Yes

( ) No (34.31(c) - EPY)

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Test results reviewed by NRC inspector:

( ) Yes

( ) No

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Retraining program required by License Condition:

( ) Yes

( ) No' l

k.

Retra'ining program implemented:

( ) Yes.

( ) No (L/C - MPA) l i

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Records of retraining reviewed:

( ) Yes

( ) No

(

m.

Instruction to workers in accordance with 19.12:

l'1 Yes

(') No (19.12 - HAI) or '

4 INTERNAL AUDITS AND INSPECTIONS a.

Required by License Condition:

( ) Ye s

( ) No b.

Audits or inspections conducted:

( ) Yes

( ) No (L/C - MPA) c.

Records maintained:

( ) Yes

( ) No (L/C - IIPA) 5.

INSPECTION & MAINTENANCE OF DEVICES, CONTAINERS, AhT) CHANGERS a.

Included in Operating and Emergency Procedures

( ) Yes

( ) No (34.32(j) - BSC) s.

b.

Equipment check prior to use each day:

( ) Yes

( ) No '

(34.28(a) - BEM) l.

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c.

Record of results maintained:

( ) Yes

( ) No l

(34.28(b) - BEM) f d.

Equipoent check at 3 month intervals:

( l Yes

( ) No l

(34.28(b) - BEM) i e.

Record of results maintained:

( 1 Yes

( ) No (34.28(b) - BEM) r 6.

NRC RECULAYIONS, LICENSE AND OPERATING & DfERGENCY PROCEDURES Parts 19, 20 and 34; the license; and Operating and Emergency a.

Procedures furnished to all radiographers and radiographer's I

assistants:

( ) Yes

( ) No (34.31(a)(2) - BSA) l l

l l

b.

Operating and Emergency Procedures approved by NRC:

( ) Yes

( ) No i

7.

UTILI2ATION LOG l

a.

Utilization log maintained:

(') Yes

( ) No j

l (34.27 - BEL) b.

Utilization log contains all required information:

( ) Yes

( ) No (34.27(a), (b), (c) - BEL) 2 l

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E.

QUARTERLY INVENTORIES Quarterly physical inventories conductedi

( ) Yes

( ) No a.

(34.26 - BEK) b.

Quarterly inventories cor.tain all infor=ation:

( ) yes

( ) No (34.26 - BEX) l l

c.

Byproduct Material inventory un:

f s

Quantity Isotope Source S/N Carcra Model S/N I

l d.

Procureuent and use of byproduct caterial in accordance with license requirer:ents:

( ) Yes

( ) No (L/C - MAT) l i

e.

Scope of Progra=:

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9.

MATERIALS, FACII.1 TIES AND EOUIPF.EE

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Fi,;xed Facility:

1)

As described in application dated

. Report dated

' Or a

2) b, trance c.ontrolled in secordance with 20.203(c)(2):

'l i Ye s

( ) No (20.203(c)(2) - ALC) 3)

Exit. in accordance vigh 20.203(c)(3):

-( ) Yes

( )~No

~

(20.203(c)(3) - ALD) 4)

Surveillance to prevent unauthorized entry:

( ) Yes

( ) No (20.203(c)(4) - ARY) 5)

Visible and audible signals to worn of the presence of radiation:

( ) Yes

( ) Wo (34.29/h) - RPY) 6)

Alara system tested at 3 month intervals:

( ) Yes

( ) No (34.29(c) - B7Y) h 7)

Record of 41arn system test:

( ) Yes'

()No (34,29(c) - 37Y) s O

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8)

Radiographic exposure devices and storage containers meet radiation level limits of 34.21:

( ) Yes

( ) No (34.21 - LEA)

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b.

Storage Area:

1)

Sources locked in device:

( ) Yes

( ) No, (34.22(a) - BEB) 2)

Devicis secured to prevent unauthorized removal from an unrestricted area:

( ).Yes

( ) No (20.207 - ACA) l c.

Field Location 1)

Field work authorized:

( ) Yes

( ) No (L/C - PJL1) 2)

Field inspection conducted:

( ) Yes

( ) No NOTE:

If yes, complete inspection report for Module No. 75720B d.

Survey Meters i

i 1)

Calibrated and operable meters available and used:

( ) Yes

( ) No (34.43(a) - EPC) 2)

Type and nu=ber available:

O

3) 2 mR/hr through 1 R/hr can be measured:

( ) Yes

( ) No (34.24 - BED) 4)

Calibrated by:

5)

Calibration method authorized:

( ) Yes

( ) No (L/C - MPA) 6)

Calibrated at 3 month intervals:

( ) Yes

( ) No (34.24 - EED)

.e e.

Special Equipment (shields, collimators, etc.)

10.

PERSONNEL MONITORING a.

Tile or TLD badge supplier:

Frequency:

b.

Reports reviewed by:

Frequency:

NRC inspector reviewed personnel monitoring records for c.

period

~

to d.

1.icensee exposure limit:

1.25 R/ Quarter 3 R/ Quarter e.

NRC forms or equivalent:

1)

NRC-4:

( )'Tes

(-) No complete:

( ) Yes

(*) No 2)

NRC-5

(.) Yes

( ) No Complete:

( ) Yes

( ) No

.(20.401(a) - AEA) i f.

. Maximum quarterly exposure:

A erage:

t 4' e.

e

^

]o.

l Each individual assigned film bad e and dosimeter: (') Yes

( ) No E

g.

(34.33(a) - BSD) h.

Dosimeter type:

_ Range:

1.

Annual check of dosimeter for correct response: ( ) Yes

( ) No (34.33(c) - BPY) j.

Dosimete/r recharged at start of each shift: ( ) Yes

( ) No (34.33(a) - BSD)

.1 1

k.

Dosimeter dose recorded daily:

( *) Ye s

()No i

(34.33(b) - BSE) 1.

Dosimeter readings co= parable to film badge readings:

( ) yes

( ) No If No, explain:

II. LEAK TESTS leak test method approved:

( ") Yes

( ) No a.

(34.25(c)- BEG) s b.

Model of leak test kit:

Test at 6 month intervals:

( ') Yes

( ) No c.

(34.25 (b)- BEF) 1

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'( ) Yes

( ) No d.

Record of leak test results maintained:

(34.25(c) - BEC) e.

Records reviewed by NRC inspector for period to 12.

SURVEYS Area or facility survey conducted to show ce=pliance with a.

20.105:

[)Yes

( ) No (20.201(b) - ASD) 3 b.

Area or facility survey recorded:

( ) Yes

( ) No (20.401(b) - AEB)

NRC inspector reviewed records for period to c.

d.

Maximu= radiation levels in unrestricted areas:

e.

Survey after each exposure:

( ) Yes

( ) No (34.43(b) - EPD) f.

Survey includes guide tube:

( ) Yes

( ) No (34.43(b) - BPD) g.

Record of final survey before securing device:

(-) Yes

( ) No (34.43(d) - BPF)

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e 13.

POSTING AND LABELING Hi h Radiation Area posted as required:

( ) Yes

( ) No F

a.

(20.203(c)(1) - ALB) b.

Radiation Area posted as required:

( ) Yes

( ) No,

(20.203(b) - ALA) c.

Use or storage area posted " Caution - Radioactive Material:

( ) Yes

( ) No (20.203(e)(1) - ALT) d.

Containers or devices properly labeled:

( ) Yes

( ) No (20.203(f) - ALG) 9 Posting of " Notice to Workers:"

{ } Yes

( ) No e.

(19.11(a) or (b) - HAE) f.

P9 sting of " Notice to Employees:"

( ) Yes

( ) No (19.11(c) - HAF) 14.

CONTIRMATORY MEASURD!D?TS a.

Independent measurements made by inspector:

( ) Yes..

( ) No b.

Survey Instrument:

NRC Serial No.

Last date of calibration:

g a

_13-c, Describe type and results of measurements and co= pare these with licensee's measurements:

15.

RECEIVING AND SHIPPING OT RADIDACTIVE MATERI ALS Procedures for picking up, receiving, and opening of packages:

a.

( ) Yes

( ) No (20.205 - APA) b.

k'ritten proceduresi

( ) Yes

( ) No c.

Shipping incidents since last inspection:

( ) Yes

( ) No d.

Survey of packages when received:

( ) Yes

( ) No (20.205(c)(1) - APA) l e.

Escord of survey of packages:

( ) Yes

( ) No,

(20.401(b) - AEB) f.

Shipment 'of sources since last inspection:

( ) Yes

.(.) No 1)

Only container authorized by license has been used:

( ) Yes

( ) No 2)

Shipping papers and package labeling properly completed:

( I Yes

(,) No (71.5 - LAB) 3)

Licensed caterial transferred in accordance with (30.41):

l ) Yes

( ) No (30.41 - BAY)

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Record of receipt and transfer:

( ) Yes

( ) No (30.51 - BAC) 16.

NOTITICATIONS AND REPORTS a.

Licensee in co=pliance with 19.13 (Reports to individuals):

( ) Yes

( ) No (19.13 - HAK) b.

Licensee in ce=pliance with 20.405 (over exposures):

( ) Yes

( ) No (20.405(a) - ARM) c.

Licensee in co=pliance with 20.403 (Incidents):

( ) Yes

( ) No (20.403 - AR? or AR?)

d.

Licensee in co=pliance with 20.402 (Theft or loss):

( ) Yes

( ) No (20.402(a) - ARA) or (20.402(b) - ARE)

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e.

Annual report to Co==ission:

( ) Yes

( ) No (20.407 - ARR).,

s. '

f.

Termination report to Com=ission:

( ) Yes

( ) No 4

(20.408 - ART)

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a

17. ' LICENSE CONDITIONS

( ) Yes. ( ) No All License Conditions reviewed during inspection:

a.

Activities were conducted in accordance with License Conditions b.

( ) Yes

( ) No except as noted elsewhere in this report:

IB.

BULLETINS AND CIRCULARS

( ) Yes

( ) No Bulletins and Circulars issueL4uring c6r'reiit ye'ar:

s.

4M Ar,!l'n '(-) Yes

( ) No Bulletins and Circulars-receiver by 12censee:.N u %)iir a b.

Licensee took appropriate action in res, pop'se.to. Bulletins and c.

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Circulars:

( ) Ye s _ _ _( )

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19.

ITEMS OF NONCOMPLIANCE

..M' See Appendix A CONTINUATION OF PREVIOUS. PARAGRAFES-20.

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