ML20035A215

Rev 2 to QA Program for Diamond H Testing Co

ML20035A215
Person / Time
Site:	07100764
Issue date:	03/01/1993
From:	DIAMOND H. TESTING CO.
To:
Shared Package
ML20035A213	List: ML20035A212 ML20035A215 ML20035A216
References
NUDOCS 9303240297
Download: ML20035A215 (13)

Text

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QUALITY A99URANCE PROGRAM FOR J

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United Ct.atec Nucioar Regulatory (brntniccion Ruinc and Regulatioric Title 10. Civpter t. Code of Federal Rogo!alionc Part 71 (April 30.1992) i 9303240297 930313 peo Anncu 071**e**

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. D!AMOND H TEST!tJG CO.

-S.O.P. 1030 REV 2 i

OUAUTY ASSURANCE MANUA1.

DATE: '3/1/93

~ SUEUECT: NRC QUAUTY ASSURANCE PROGRAM PAGE-2 OF 13 l

t TABLE OF CONTENTS 7

A.

Quahty Assurance Requirements 3

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-Quality Assurance Organization 3

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5 C.

Quality Assurance Peogram 3

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D.

Package Design Control 3

E.

Procurement Document control 3

F.

Instructions. Procedures and Drawings 4

G.

Document Control 4

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H.

Control of Purchased Material. Equipment and Services 4

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Identification and Control of Materials Parts and Componenets 4

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Control of Special Processes 4

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K; internal inspection

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Test Contrni 5

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Control of Measuring and Test Equipment 5

N.

Handling Storage and Shipping Control 5

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O.

Insnactinn Tact anri nnaratinn Sta'"c 5

P.

Nonconforming Materials, Parts or Components 5

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O.

Corrective Action G

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Quality Assurance Records 6

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Audits G

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Organizational Chart 7

FORMS / REPORTS:

1 Shipments of incoming / Outgoing Source inspection Form 8

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2. Shipments of incoming / Outgoing inspection Repor1 9

3. Certificates of Comptiance Log 10

4. Quality Assurance Audit form' 11

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5. Diamond H Testing Operating & Emergency Procedures, Attachment D 12 l

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DIAMOND H TESTING CO.

S O P.

1030 REV 2'

OUALITY ASSURANCE MANUAL DATE: 3/1 FJ3

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SUBJECT:

NRC OUALITY ASSURANCE PROGRAM PAGE 3 OF 13 i

A. QU ALITY ASSURANCE REQUIREMENTS 1.

This revision of Diamond H Testing Co., Quahty Assurance Program is in response to new requirements f

appearing in 10 CFR Chapter 1, Part 71, Subpart H - Ouality Assurance from United States Nuclear l

Regulatory Commission. Rules and Regulations" April 30,1992.

2.

This Program delineates the satisfying of any specific provisions of applicable criteria of 44 71.101 through l

71.137 in a graded approach, i.e. to the extent that it is consistent with its importance to safety.

I B. QUALITY ASSURANCE ORGANIZATION l

1 1.

The responsibility for the establishment and execution of the Ouality Assurance (OA) Program rests with s

Diamond H Testing Co.

2.

IIsu CudIily Abdurorwe iurwiivird oru.

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a.

Assuring that an appropriate Quality Assurance Program is established and effectively executed.

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Verifying, by procedures such as checking, auditing and inspection, that activities affecting the safety-

~i related functions have been correctly performed.

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3.

This OA Program is implemented using the Organization Chart attached.

C. QUALITY ASSURANCE PROGRAM 1.

Design and f abrication of packaging shall not be conducted by Diamond H Testing Co. and so specific l

provisions for design and iabrication are not applicable criteria covered under this OA Program.

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The Radiation Safety Officer is responsible for overall administration of the Program.

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3. The Radiographers are responsible for handling, storing, shipping, inspection, operating status and

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nuumng wm ue tne redpundiuuny on the nuui: 6eam J

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D. PACKAGE DESIGN CONTROL 1.

Design and fabrication of packaging shall not be conducted by Diamond H Testing Co. and so specific

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3 provisions for package design control are not applicable criteria covered under this OA Program.

2.

Radiahon Safety Officer shall ascertain that regulatory requirements for the package design used by the f

manuf acturer of the Shipping Containers shall conform as provided in Part 71.

E. PROCUREMENT DOCUMENT CONTROL i

i 1.

Design and f abrication of packaging shall not be conducted by Diamond H Testing Co.

l 2.

The Radiation Safety Officer is responsible for procurement of equipment used in shipping of radioactive j

j materials. The Shipping Containers shall be obtained from companies possessing the required " NRC l

Ccrtificate of Compliance" authorizing such activitics. A copy of the Certificate (s) of Compliance along with l

the related drawings and other documents referenced in the approval shall be kept in the OA Program file.

F. INSTRUCTIONS, PROCEDURES AND DRAWINGS l

1.

Design and f abrication of packaging shall not be conducted by Diamond H Testing Co. and so specific pro-l visions contained in this paragraph conceming instructions, procedures and drawings are not applicable criteria covered under this OA Program.

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f D!AtAOND H T ESTING CO.

SOP 1030 REV 2 OUAlti Y ASSURANCE MANUAL DATE 3/1/93-SUEUECT NRC OUALITY ASSURANCE PRCGRAM PAGE 4 OF 13 2.

The Radiation Safety Officer is responsible for procurement of equipment used in shipping of radioactive materials. The Shipping Containers shall be obtained from companies possessing the required

• NRC i

Certificate of Comphance" authorizing such activities. A copy of the Certsficate(s) of Compliance along with j

l the related drawings and other documents referenced in the approval shall be kept in the OA Program file.

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G. DOCUFAENT CONTROL 1.

ine Haciation Safety Otticer is responsDie for procurement of equipment used in shipping of radioactive materials. The Shipping Containers shat! be obtained from companies possessing the required " NRC Certificate of Compliance" authorizing such activities. A copy of the Certificate (s) of Compliance along with j

the related drawings and other documents referenced in the approval shall be kept in the OA Program file.

1 H. CONTROL OF PURCHASED FAATERIAL, EQUIPIAENT AND SERVICES

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The nad;at;or,06futy C;;cs. 5l.el wuly 1;iat paaag.ng conforms to the procurement documents through

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the "Certihcato of Comphance" a!ong with the related drawings and other documents referenced in the

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approval s.

2.

Objective evidencn of the quality of the containers shall be accomplished by inspection of the container 2

upon delivery. This will be noted by completing the cnteria listed on the " Shipments of incoming / Outgoing i

Sourco inspection Form" included in " Diamond H Testing Operating and Emergency Proceduros".

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3 3.

The documentary evidence that the containers conform to the specifications are verified in a.

the " Certificate of Compliance" from the Shipping Container Manufacturer along with the related draw-ings and other documents referenced in the approvals and 4

b.

'he completion of the " Shipments of incoming / Outgoing Source inspection Form".

I 4.

The audit team will assess the effectiveness of the control of the Container quakty during its routine au-l dits. The audits will be carried out using the "Quahty Assurance Audit Report" Form submitted with this 1

document and retained as a part of the OA Records.

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IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS i

t Ces;9n and lab&,auvo vi paday;ng diiaii nui be wnducted by Diamond H Testing Co. and so specific pro-

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visions in this paragraph conceming control of materials. parts and components are not applicable cnteria i

covered under this OA Program.

1 J. CONTROL OF SPECIAL PROCESSES 2

1.

Design and f abrication of packaging shall not be conducted by Diamond H Testing Co. and so specific pro-I q

visions in this paragraph concerning welding, heat treating and nondestructive testing are not applicab'e entena covered under this OA Program.

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K. INTERNAL INSPECTION

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1.

Objective evidence of the quality of the containers shall be accomplished by inspection of the container upon delivery, This will be noted by completing the enteria listed on the " Shipments of Incoming / Outgoing Source inspection Form".

2.

The documentary evidence that the containers conform to the specifications are verified in j

a the "Cortificate of Ccmpliance" from the Shipping Container Manuf acturer along with the related draw-ings and other documents referenced in the approvals and b.

the completion of the " Shipments of Incoming / Outgoing Source inspection Form".

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DIAMOND H TESTING CO S.O.P, 1030 REV 2 OUALITY ASSURANCE MANUAL DATE. 3/1/93 SUBJECT NRC QUALITY ASSURANCE PROGRAM PAGE 5 OF 13 i

I L. TEST CONTROL 1.

Design and f abrication of packaging shall not be conducted by Diamond H Testing Co. and so specific pro-visions in this paragraph concoming a test program to demonstrate that the packaging components will j

perform in accordance with written test procedures are not applicable criteria covered under this OA Program.

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M. CONTROL OF MEASURING AND TEST EQUIPMENT 1.

Design and f abrication of packaging shall not be conducted by Diamond H Testing Co. and so specific pro-3 visions in this paragraph concoming measures to assure that tools, gages, instruments and other' j

measuring and testing devices are controlled are not applicable criteria covered under this OA Program.

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l N. HANDLING, STORAGE AND SHIPPING CONTROL l

1 The P.adiographcr; ;h :: bc rc;peno!bic to 0;;ure that the handling, storage and shipping of the shipping containerc shall be carried out according to operations outlined in the Diamond H Testing Operating i

j and Emergency Procedures. A copy of the relevant Procedure " Attachment D Leak Tests &

j Source Changes"is attached to thic OA Program. The references specifically denoting compliance with this paragraph are highlighted:

l 4.1 P!aco sourco camera or changor in shipping drum.

4.2 Put decay curve inside drum along with source changer tube and then seallid on drum with wire seat.

4.3 Survey shipping container at surface and at three feet. Record this reading on the " Shipments of in-

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coming / Outgoing Source Inspection Form".

4.4 Make out two appropriate radioactive labels. Record the pertinent information on these two labels and '

l paste them on either side of the shipping container.

l 43 Paste th6 address 6d labulio the IOp of the sidpp;ng container.

3 4.6 Have a carrier's Bill of Lading made out and call the carrier for pick up or deliver the source shipping l

j container to carrier.

4.7 Make out three copies of the " Shipper's Certshcation for Radioactive Materials" Two are attached to carrier's Bill of Lading and one is attached to a copy of the Bill of Lading and the ' Shipments of incom-4 ing/ Outgoing Source inspection Form".

4.0 I;; e cop, u: the "OMg. 6n 3 c: :nec,v,;c.g.'Ou;90;ag Source inspection Form", " Shippers Certification for Radioactive Malerials" and the " Bill of Lading"in the Source Shipping Fife.

a O. INSPECTION, TEST AND OPERATING STATUS 1.

The Radiographers shall be responsible to assure that the inspection and operating status of the shipping i

4 containers shall be carned out accordrng to operations outlined in the Diamond H Testing Operating and Emergency Procedures A copy of the relevant Procedure

• Attachment D, Leak Tests &

j Source Changes"is attached to this CA Program. The references specifically denoting compliance with i

this paragraph are highlighted-i i

i 1.4 All source changing equipment shall be inspected for damage before a source change is made.

Visual damage or suspected damage will be reported to the RSO. No source change will be made until a

the RSO has inspected the damage and authorized the source change."

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Routine determination of the efficacy of the Shipping Container shall be performcd according to the criteria listed on the " Shipments of incoming / Outgoing Source inspection Form".

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P. NONCONFORMING MATERIALS, PARTS OR COMPONENTS I

1.

Design and f abrication of packaging shall net be conducted by Diamond H Testing Co. and so specific pro-visions in this paragraph concoming measures to controt materials, parts or components which do not con-form are not applicable enteria covered under this OA Program.

i DIAMOND H T:

CO.

S O.P.

1030 REV 2 l

OUAUTY ASSL i MANUAL DATE: 3/1/93 SUBJECT. NRC CUALITY ASSURANCE PROGRAM PAGE 6 OF 13 i

i O. CORRECTIVE ACTION I

j 1.

The Radiographers shall be rer90nsible to assure that the inspection and operating status of the Ship-ping Containers shall be carried out according to operations outlined in the Diamond H Testing Oper-l ating and Emergency Procedures. A copy of the relevant Procedure

• Attachment D. Leak Tests &

l Source Changes"is attached to this OA Program. The references specifically denoting compliance with i

this paragraph are high!ighted:

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1.4 All source changing equipment shall be inspected for damage before a source change is made.

Visual damage or suspected damage wi.'l be reported to the RSO. No source change will be made unti!

l the RSO has inspected the damago and authorized the sourco change "

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Should the Radiographer, as he is fulfilling thc inspection requirements listed on the " Shipments of in-coming /Uulgoing Source Inspection Form", discover significant conditions adverso to the integrity of the j

shipping container and not be able to answer items 5. 6 or 8 "Yes", he shall contact the RSO.

I 3.

In any instance where the RSO determines that there is significant reduction in the effectiveness of any authorized packaging during use, he shall report same to the Director. Office of Nuclear Material Safety and Safeguards. U.S. Nuclear Regulatory Commission Washmton, DC 20555. within 30 days.

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He shall also send a notice to the manufacturer of the Shipptr9 untainer giving details of the alleged do-4 focts. Ho chail tag the damaged container in such a f ashion that it will not inadvertently be used until it is i

retumed to the manufacturer for repair.

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R. QUALITY ASSURANCE RLCORDS 1.

The Radiation Safety Officer shall verify that the following records will be maintained on file with the OA Program.

a.

" Quality Assurance Audit Reports" b.

" Certificate (s) of Compliance" from the Shipping Containor Manuf acturer along with the related draw-ings and other documents referenced.

c.

" Certificate (s) of Compliance Loa" i

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" Shipments of incoming / Outgoing Source Inspection Form" j

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" Shipments of Source inspection Report"

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The Quality Assurance Records cha!! be retained by Diamond H Testing Co. for three years beyond the date when the activities covered in the records were portormed.

S. AUDITS 4

1.

The Aud:t Team shall audit the records listed in Section R at least annually, or when there is reason to behovo an audit is warranted.

2.

Should a deficiency be found, correctivo action will be taken with the responsibio party or parties and l

an audit will be performed again within throc months to assure that compliance is achievod.

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4 DIAtAOND H TESTING CO.

S.O.P.

1030 REV 2 QUALITY ASSURANCE fAANUAL

~ DATE: ' 3/1/93 SuttECT: NRC OUALITY ASSURANCE PROGRAM PAGE 7 OF 13 l

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DIAMOND H TESTING CO. ORGANIZATIONAL CHART i

PRESIDENT AUDIT TEAM -

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VlUb l'HbblubN I R ADIAT.ON SAFETY OFFICER

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i NDT LEVEL lli RAD OGRAPHER l

EXAMINER i

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ASSISTANT PERSONNEL RADIOGRAPHER i

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Note: 11 is tho intent of the Organizational Chari to identily the positions w!!hin the organization associated with various levels of authority and responsibility. One person may occupy more than one position dependent upon the individual's qualification.

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ATTACHMENT D Ndbb b

bh ca 4929 Yellowctone Ave.. Chubbock. Idalso 832O2 i

(208) 237-194 O SHIPMENTS OF INCOMING / OUTGOING SOURCE INSPECTION FORM Prior to carb shipment of licensed material, the RadioDrapher shall ensure that the package with its contents satisfies the following inspection requirements (10 CFR Part 71):

YES NO

1. The Shipping Container used is authorized by Diamond H Testing Co. license.

2. The step-by-step instructions for loading and closure issued by the manufacturer l

of the Container were fonowed in detail and in the sequence presented.

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3. The Source is securely locked in the fully shielded position as confirmed by care-fully performed and recorded radiation surveys.

4. The package labeling and accompanying Shipping Papers have been properly com-g[

pleted?

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5. A thorough inspection of the Shipping Container reveals no cracks, pinho!c-s, uncon-O iruiied vuid>, or other irnpairment of its physical condition except for superficial defects such as marks or dents.

6. Each closure device of the packaging, includina say require gasket, is properly O

installed and secured and free of defects.

7. There is an "NRC Certificate of Compliance" on record along with the drawings C

and other documents referenced in the approval relating to the use of the Shipping Container.

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8. Any structural part of the package which could be used to lift the package during tianspon is rendered inoperable for that purpose.

9.

External radiation level at surface of Container mr.

(Shall not exceed 200 mr/hr)

10. External radiation level at 3 feet from Contarner mr.

CAMERA SOURCE i

S/N S/N DATE PERFORMED BY SIGNATURE - RADIOGRAPHER l

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i Diamond H Testing Co.

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*'*3 Quality Assurance Program i

Shipments of incoming / Outgoing inspection Log Shipment incoming /

Incpection Cnteria OK?

Location Source S/N Technician dato Outgoing 1 l2l3l4l5l6l7 l 8 l 9 l 10 i

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Diamond H Tecting Co.

j Quality Assurance Program Date 3/12/93 Certificates of Compliance Log t

Rev Certificate Cortir. ato Cortificato No.

Package Mentification Drawings 0-Dato Exp Date h

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Quality Assurance Program Audit Report l

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Date of Report Audit by

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Report for period i

1. The following " Certificates of Compliance" were found to be in order and current.

Revision Certificate Certificate Certificate No.

No.

Date Expiration Date 1

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L Deficiencias:

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2. The " Shipments of incoming / Outgoing Source Inspectior. Forms" were found to be in order and cunent i

except as noted under deficiencies. The " Shipments of incoming / Outgoing Source inspection Report" t

is attached to this document.

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3. Other relevant findings noted during the aud.!-

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Auditor Signature RSO Signature f

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OPERATING & EMERGENCY PROCEDURES-l ATTACHMENT D Leak Tests & Source Changes

1. Leak Test and Source Changes:

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1.1 Scaled sources that are kept six months or longer will be wipe tested by the RSO or a radiographer. The l

wipo test will bo made using a !cak test kit or a cotton swab with a decantaminating solution. The leak test

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will be shipped to one of the companies listed in 5.8 of this section.

l 1.2 Only RSO or radiograph 3rs shall perform leak tests and source changes. This will bo done in accordance f

with Section 5. Assistant radiographers will assist with the operation only.

1.3 A survey of the shipping container when it is received from the source shipper, will be made at the froight pick up ooCK. Inis Coulo De at Air Pre?gnt or t ruck Lines. The survey willinclude the entire circumference of the container. A reading will be taken at three feet from any exterior surface and at the surface of the chipping container. These readings will be recorded on the form Shipments of Incoming / Outgoing l

Sourco Inspection. If you obtain a reading over 200 mr at the surfaco or 10mr/hr at three feet, notify the RSO.

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1.4 All source changing equipment shall be inspected for damage before a source change is made. Visual i

damage or suspected damage will be reported to the RSO. No source change will be made until the RSO has inspected the damage and authorized the source change.

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Detailed instruction for Making Source Changes:

2.1 Always have proporly operating survey meter at hand when changing sources.

2.2 Survey entiro circumference of the container with meter. Surface reading should not exceed 200 mr/hr.

2.3 Unlock locking device on empty side of source changer and remove plug.

l 2.4 Connect the short exposure tube provided to the empty sourco hole with the other end attached to l

your camera.

t 2.5 Crank source from your camera into shipping container.

2.6 Survey entire circumference.

l 2.7 Disconnect source tubo from shipping container.

2.6 Disconnect pigtail from the control cable.

2.9 Replace plug and lock.

2.10 Unlock new source sido.

2.11 Connect controf cable to pigtail.

2.12 Screw source tube into coupling of container.

2.13 Standing as far away from the source as possible, retract the control cable which will pull source out of shipping container and into camera 2.14 Survey entiro circumference.

2.15 Disconnect control cable from pigtail.

2.16 Unscrew sourco tubo from camera and from the shipping coniainer.

2.17 Survey entire circumference shipping container. Notify the RSO if radiation levels exceed 200 mr/hr at suriace or 50 mr/hr at 6".

3.

Instructions for Installing New Source in Radiographic Cameras 3.1 Unscrow cap over port with new sourco. Check end of connector. It should protrude about 1/8" beyond l

port.

t 3.2 Position camera with drive cable protruding about 41/2" beyond end of changer tube. Avoid kinks. Tube should be laid out as straight as possible, install adapter on end of sourco tube.

3.3 Connect now source cable to drive cable. Be careful not to pull now source further than 1" out of source changer.

3.4 Screw coupling at end of changor tubo tightly into source changer.

DIAMOND H TESTING CO.: ATTACHf4ENT D 3.5 Standing as far away as possible from the camera and source changer, pick up ree! and crank source l

quickly into camera After transfer the operator should immediately survey camera, change tube and source changer 5 double check that the operations have been completed safely.

3.6 After surveying the entire circumference of the camera has demonstrated that everything is in order, the changer tube should be unscrewed from source changer and camera.

3.7 Replace changer tube in changer under lid. Replace cap on empty port in source changer.

3.8 Remove metal source identification plate from source changer and fasten to camera.

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3.9 Survey shipping container. Notify RSO if radiation level exceeds.200 mr/hr at the surf ace or 10 mr/hr at 3-feet.

4.

Detailed Instructions for Shipping Old Sources back to Suppiler in their Source Changer:

4.1 Place source camera or changer in shipping drum.

4.2 Put decay curve inside drum along with source changer tube and then seal tid on drum with wire seal.

4.3 Survey shipping container at surf ace and at three feet Record this reading on the Shipmonts of incoming / Outgoing Source Inspection Form.

4 4 Makn not twn annrnnriato radinactiva labolc Anmrd the pertinent information on these two labels and l

paste them on either side of the shipping container.

4.5 Paste the addressed label to the top of the shipping container.

4.6 Have a carrier's Bill of Lading made out and call the carrier for pick up or deliver the source shipping con-l tainer to carrier.

4.7 Make out three copies of the Shipper's Certification for Radioactive Materials. Two are attached to carrier's Bill of L ading and one is attached to a copy of the Bill of Lading and the Shipments of incomng / Outgoing Source inspection Form.

4.8 File a copy of the Shipments of Incoming / Outgoing Source inspection Form, Shippers Certification for ~

l Radioactive Materials and the Bill of Lading in the Source Shipping File.

l 5.

Detailed Instruction for Making a Leak Test using a Leak Test kit or a Cotton Swab with Decentam!nant:

5.1 Leak tests shall be performed by RSO or radiographer according to the following instructions:

5.2 With the capsule in the safe position in camera, remove safety plug and cable from exit tube.

5.3 Dissolve detergent in packet in small amount of water.

7 5.4 Remove swab from plastic container on left and dip it into water solution and proceed to wipe source l

container inside S tube exit port. Replace swab in plastic containor from which it was removed.

s ; nnmnva dry cwas frnm nines;r mnen;nor nn riahi and repeat wipe process. PO NOT dio this swab :n l

detercent. Rep! ace thic cwab in p!actic container from which it was removed.

5.6 Af ter wiping tube, replace safety plug and cable in camera. Survey swab just used. If there is any indication I

of possible source leakage, secure the exposure device in the storage area, tag it noting that it should not i

be used for radiographic operations, and notify RSO (if performed by radiographer).

5.6 Fill out source serial number and camera serial number on leak test packet cover and give to RSO.

5.7 RSO will mail the leak test swabs kit to the appropriate laboratory for testing.

i 5.7.1 The returned leak test results will be filed in the Source Leak Test file and kept for a period i

of three years.

4 5.8 Companies used for Leak Test reporting are:

5.8.1 Amersham Corporation,40 North Avenue, Burlington, Mass. 01803 Lic. No.

5.8.2 Gamma Corporation,410 Ki!ani Ave., Suite 202, Wahiawa, HI 96786 NRC Uc. No. 53-23207-01 4

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