ML19332C334

QA Program for Packaging of Radioactive Matl for Transport & Transportation of Radioactive Matl Under Certain Conditions (10CFR71)

ML19332C334
Person / Time
Site:	07100245
Issue date:	10/16/1989
From:	NAVY, DEPT. OF, NAVAL SEA SYSTEMS COMMAND
To:
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ML19332C328	List: ML19332C327 ML19332C334
References
NUDOCS 8911270174
Download: ML19332C334 (20)

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L. Y. SPEARIts? 5100.18 16 00T 1989 i

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i QUALITY ASSURA?CE PRCGRAM l

KR THE PACKAGI!G OF RADIOACTIVE MATERIAL KR TRANSNRT APO 'IRAPEPORTATION OF RADIQhCTIVE MATIRIAL UtOIR CERTAIN CDOITIONS (10CIP71) i I

1 NAW RADIOACTIVE MATERIALS PIRMIT l

tb. 59-05851-AINP KR GAM RADIOGRAPHY A!O No. 59-05851-ClNP KR RADIAC CALIBRATION 1

l PIRMIT IOLDER:

l DEPARDENT OF EE NAW l

USS L.Y. SPEAR (AS-36)

FPO NEW YCRK 09547-2600 t

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L. Y. SPTARI!ET 5100.18 16 OCT 1989 l

TABLE OP 00NIDfrS i

TABLE OF CONTN TS i

i RB00RD OF M 11 DEFINITIWS 111 SBCTION ONE 1-1 APPDOIX A - SDCIION ONE 1-A-1 APPDOIX B - SECTION ONE l-B-1 SDCTION M 2-1 i

APPDOIX A - SBCTION 'IWO 2-A-1 SBCTION 'IHREE 3-1 I

SECTION FOUR 4-1 SBCTION FIVE 5-1 n

SECTION SIX 6-1 APPDOIX A - SBCTION SIX 6-A-1

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L. Y. SPEARINST 5100.18 16 0CT 1559 i

DEFINITIONS

'Ibe folicwing terms are defined as they are intended to be used in this Instruction.

C m - Code of Federal Regulations.

Licensee - Department of the Navy, Chief of Naval Operations.

Licensed Materials

'Ihose materials for which the Department of the hhvy holds an }MC a@ roved license and USS L.Y. SPFAR holds an approved Permit.

1RC - U.S. Nuclear Regulatory Ccmmission.

NDP Laboratory - lbn-destructive Test Laboratory.

Package - A shipping container for licensed radioactive materials.

Permit - Navy Radioactive Materials Permit Issued by the Licensee.

Permit Holder - USS L.Y. SPFAR (AS-36)

RASO - Radiological Affairs Suwort Office, Yorktcun RCP - Radiac Cal.ibration Facility.

RCO - Radiological Controls Officer.

RMPQA Officer - Quality Assurance Officer for the Quality Assurance Program for the Packaging of Radioactive Material for Transport and Transportation of Radioactive Material Under Certain Conditions (10Cm71).

RSO - Radiation Safety Officer.

111

c-4 L. Y. SPPARINST 5100.18 16 00T 1983 SICTION ONE CRGANIZATION 1.1 Purpose, mis section sets forth the organizational responsibilities in the Radioactive Material Packaging Quality Assurance (RMRA) Program.

1.2 Description. The RMMM Program is ccurposed of four levels of responsibility:

I a.

Ocnmanding Officer - By definition, the senior official of the licensed activity, who is responsible for the establishment, execution of and authorizing revisions to the RMRA Program, me Ccamanding Officer assigns and certifies the qualificatien of the RMKA Officer.

b.

Repair Officer - In his role as Department Head which actually uses licensed materials, the Repair Officer has a vested interest in the RMK A Program. Berefore, he is responsible for ensuring that the RMKA Officer has sufficient organizational freedom to fulfill his function and for ensuring that corrective action (s) is/are accanplished in an effective, timely manner and is/are not being delayed by production schedules or other conflicts.

Radiological Controls Officer (ROO) - Responsible for the safe receipt, c.

handling, operation and shipment of licensed materials in/by the Radiac Calibration Pacility (RCP), the RCO is responsible for the following attributes of the RMRA Program:

(1) Ensuring that shipment of licensed materials'used by the RCP are conducted in accordance with references (b), (c) and (d).

(2) Ensuring that required inspection and testing incidental to shipnent of licensed materials used by the RCP are properly conducted and documented.

l (3) Canpleting records of shipnents to/by the RCP prior to releasing l

them to the appropriate record keeping officer.

(4) Ensuring that corrective action, when required, is accanplished by the RCP in an effective, timely manner.

l (5) Ensuring that personnel under his cognizance assigned to use licensed material are trained in the requirements of this instruction and references (b), (c) and (d).

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L. Y. SPFARINST 5100.18 L

16 0CT 1999 d.

Radiation Safety Officer (R90) - Either the Quality Assurance Officer or the Ibn-Destructive hst (ter) Laboratory Supervisor is normally assigned as the R90. In addition to his/her responsibilities for ensuring the safe receipt, handling, operation and shipment of licensed materials used in radiography, is responsible for:

(1) Ensuring that shiptents of licensed materials used by the IUP laboratory are conducted in accordance with references (a), (c) and (d).

(2) Ensuring that required inspection and testing incidental to shiptent of licensed materials used by the IUT laboratory are properly conducted and documented.

(3) Maintaining records of shipnents as required in later sections of this instruction.

(4) Ensuring that corrective action, when required, is acccmplished in an effective, timely manner by the IUT Laboratory.

(5) Ensuring that personnel under his cognizance, who are assigned to process licensed materials are trained in the requirements of this instruction and references (a), (c) and (d).

e.

RMP(A Officer. 'Ihe RMP(A Officer shall be certified as to his qualification and appointed by the Ccmmanding Officer. His/Her primary function in the RMP(A Program is the verification of the credibility of the program in this regard he/she is responsible fort (1) Development of an audit schedule for approval by the Ccomanding Officer.

(2) Conducting or directly supervising the conduct of all audits of the RMP(R Program.

(3) Conducting or directly supervising the conduct of unannounced spot checks of the RMP(A Program.

(4) Reporting his findings directly to the Ccr.nunding Officer with copies to the Pepair Officer, Radiological Controls Officer and Radiation Safety Officer.

(5) Conducting follow-up audits to ensure corrective action is acccuplished.

f.

Amendices. Appendices (A) and (B) to this section contain an organizational chart and matrix which graphically displays the division of responsibility of the above functions into five levels of responsibility.

1-2

Fi, L. Y. SPPARINST 5100. 's 1 6 0CT 1969 SD3'ICH ONE APPDOIX "A" ORGAN 1ZATI0taL O RRT i

i CD9WOI!G OFFICER s

RDW R OPF1CER RMEA

- RADIOLOGICAL RAD:ATICN OFFICER CDimOLS SAFcry OFFICIR OFFICER.

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9 L. Y. SPEARINST 5100.18 16 00T 1939 SIIT. ION OE APPDOIX "B" RESPONSIBILITY MATRIX RADIOILGICAL RADIATION CONANDDC.

REPAIR ColfIROLS SAFLTY g

IUCTION OFFICER OFFICER OFFICER OITICD1 OFFICER P50 GRAM A

E E

E E

TRAINDO A

C D,E D,E CERTIFICATIO4 B

E E

TESTDC B

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DOCI.NENT CHAICES A

C D

D SHIPPDG A

C E

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AUDITS B

E AUDIT SCHEDULE A

C D

rJr:no A - Approve B - Accept C - Concur D - Initiate E - Perform f

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4 L. Y. SPCARINST S100.18 16 0CT tm SDCI'ICH 'IHO QUALITY ASSURANCE PROGRAM 2.1 Purpose. ' Ibis section specifies the necessary action which must be undertaken to successfully establish and execute a viable quality assurance program for packaging licensed materials.

2.2 Discussion. USS L.Y. SPEAR holds a permit to use certain radioactive materials as specified in reference (a) and (b). As an end user, USS L.Y. SPEAR receives these materials frca NRC licensed suppliers in IRC approved containers. 'Iherefore, the thrust of the @ Program aboard USS L.Y. SPEAR shall be directed toward establishing proof of and maintaining the quality of provided containers. Manufacture or repair of shipping containers for licensed materials shall not be conducted aboard USS L.Y. SPEAR without prior a groval by the PRC.

2.3 Procedure a.

The prcmulgation and enforcement of this instruction by the appropriate level of the chain of camnand establishes and inplements the RMPCA Program.

b.

Training and experience for all RMPCA Program functions shall be in accordance with established procedures.

(1) 'Ihe Ccmmanding Officer, Repair Officer and Radiological Controls Officer are specifically assigned by the Bureau of Naval Personnel in accordance with established directives.

(2),'Ibe Radiation Safety Officer shall be assigned and certified by the Camanding Officer in accordance with reference (a).

(3) 'Ihe RMPQA Officer shall be assigned and certified by the Ccmanding Officer following ccmpletion of Appendix "A" to this section.

(4) Radiographers shall be qualified in accordance with reference (a).

(5) RCP Technicians shall be qualified in accordance with reference (b).

j c.

Revisions to the @ program may be made only by a formal change to this instruction signed by the Ccananding Officer. Revisions which would significantly alter the program nust be approved by the RASO. Each revision shall be entered in the manner directed by the revision and documented on the i

Record of Revisions page.

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L.,Y. SPEARINST 5100.18 16' OCT MB9 d.

Prior to use, all defined quality control procedures, engineering procedures and specific provisions of the package design approval shall be satisfied for any shipping package used in conjunction with licensed materials.

(1) Ebcumentation of this shall be maintained on board USS L.Y. SPTAR for any contractor supplied shipping containers for use with licensed materials.

(2) Specific approval by the RASO shall be obtained, documenting the above attributes prior to locally fabricating, repairing or altering a shipping container for use with licensed materials, While in the custody of USS L.Y. SPEAR, shipping containers for use' e.

with licensed materials shall be controlled in such a manner that those characteristics of the package which are critical to safety are maintained.

(1) Damage to shippire containers shall be reported innediately to competent authority.

(2) Shipping containers for use with licensed radiographic sources shall be maintained and used in accordance with reference (a). 'Ihey shall be stored in the Radiation Vault when not in use.

(3) Snipping containers for licensed radiac calibration sources shall be maintained and used in accordance with reference (b). 'Ihey shall be stored in the locked section of the RCP when not in use.

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f-t L. Y. SPEARINST 5100.18 16 0CT 1999 SDCTICN N APPDOIX "A" Front (RMKA Officer Designato)

'Ib Camanding Officer, USS L.Y. SPEAR (AS-36)

Subj Training and Experience as RMWA Officer 1.

I have reviewed and am familiar with the nest recent revisions to the following instructions and regulations:

Title 10, Code of Federal Regulations, Part 71.

USS L.Y. SPEARINST 5100.18, RMPQA Program.

t USS L.Y. SPEAR RMKA Records and Audits.

USS L.Y. SPEAR Navy Radioactive Materials Permit No. 59-05851-A1NP for Ganna Radiography.

USS L.Y. SPEAR Navy Radioactive Materials Permit No. 59-05S51-ClNP for Radiac Calibration.

2.

I am prepared to assume the responsibilities of the USS L.Y. SPEAR RMKA Officer.-

Signature t

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Approved:

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Camanding Officer / Date 2-A-1

L. Y. SPEAR W 5100..S t

16 OCT 1989 l

SDCTION THREC IWOLIN3, SKRAGE AND SHIPPIN3

.3.1 Purpose. 'Ihis section describes those aspects of handling, storage and shipping of packages which are inportant to safety and includes assignnents of responsibilities for the critical aspects of handling, storage and shipping.

3.2 Discussion Established safety restrictions concerning the handling, storage and a.

shipping of packages for special form radioactive material will be followed.

Shipments will not be made unless all tests, certifications, acceptances and final inspections have been empleted. Work instructions have been provided for handling, storage and shipping operations for those shipping containers in Work instruction will be provided for handling, storage and shipping use.

operations for those shipping containers contsplated for future use.

b.

'Ibe responsibilities of certain personnel involved in the RMIG Program are described in section one. 'Ihis section provides anplification of those responsibilities by specifying requirements for the aspects of handling, storage and shipnent N. packages which are considered critical.

3.3 Procedure a, 'Ihe Radiological Controls Officer is responsible for the critical handling, storage and shipping operations for each shipment of licensed materials by the RCP. He/She shall ensure, for each shipping container, that:

. (1) Established safety restrictions cancerning the handling, storage and shipping of packages for certain special form radioactive material are being followed.

(2) Shipnents are not made unless all test, certification, acceptances and final inspections have been empleted.

(3) Wark instructions have been provided for handling, storage and shipping operations.

b. 'Ihe Radiation Safety Officer is responsible for the critical handling, storage and shipping operations for each shipnent of licensed material by the NETP Laboratory. He/She shall ensure, for each shipping container, that:

(1) Established safety restrictions concerning the handling, storage and shipping of packages for certain special form radioactive material are being followed.

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L. Y. SPEARINST 5100.18 18 OCT 1963 (2) Shipments are not nade unless all tests, certifications, acceptances and final inspections have been empleted.

(3) Work instructions have been provided for handling, storage and shipping operations.

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.i L. Y. SPETRINST S100,18 16 0CT F SECTION FOUR INSPDCTION, TESI AND OPERATION STA'IUS

?.1 Purpose. his section describes those aspects of inspection, test and.

operation status of packages which are important to safety and includes assignment of responsibilities for the critical aspects of inspection, test and operating activities.

4.2 Discussion

-a. Inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by established procedures. The status will be indicated by the tag, label, marking or log-entry. We' status of nonconforming parts or packages will be positively maintained by established procedures.

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b. S e responsibilities of certain personnel involved in the RMPQA Program are described in section one. 21s section provides amplification of those responsibilities by specifying requirements for the aspects of inspection, test and operating status which are considered critical.

4.3 Procedure

a. We Radiolcgical Controls Officer is responsible for the critical inspection, test and operating activities associated with each shipping

-container which may be used for shipment of licensed materials by the RCF.

He/She shall ensure, for each shipping container, that:

(1) Inspection, test and operating status of packages for certain l

special form radioactive material is indicated and controlled by established procedure.

(2) Status is indicated by tag, label, marking or log entry.

l (3) Status of nonconforming parts or packages are positively maintained by established procedures.

b. Se Radiation Safety Officer is responsible for the critical inspectjon, l

test and operating activities associated with each shipping container which may be used for shipnent of licensed materials by the NUT laboratory. He/She shall i

L ensure, for'each shipping container, that:

l (1) Inspection, test and operating status of packages for certain L

special form radioactive material is indicated and controlled by established procedures.

(2) Status is indicated by tag, label, marking or log entry.

(3) Status of nonconforming parts or packages are positively maintained by established procedures.

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L. Y. SPEARItBT 5100.18 i

16 0CT 1989 SDCTION FIVE QUALITY ASSURANCE RD00RDS 5.1 Purpose. 21s section provides the necessary requirements and guidance for satisfactorily documenting the operation of the RMPOA Program aboard USS L.Y. SPEAR.

5.2 Discussion. Adequate documentation will be maintained to denonstrate to interested parties that USS L.Y. SPEAR possesses an effective functional RMPQA Program. 'Ib this end the following actions shall be taken:

a. Records will be maintained and include operating logs, inspection, tests and audit results.

b. Other records to be maintained will include qualification of personnel and descriptions of procedures and equipment.

c. Records will be maintained ac: cording to established procedures.

d. Records will be identifiable and retrievable.

e. A list of the required records and their storage location will be maintained.

5.3-Procedure:

a. W e RMPOA Officer shall maintain the original audit reports for all audits and shall maintain a master listing (index) of all required records which shows their location.

b. W e Radiation Safety Officer'shall maintain all other records. He/She shall maintain them in an auditable fashion, i.e., they shall be identifiable and retrievable. Rese shall include, but not limited to:

(1) Operating logs, inspections and tests.

(2) Qualification of personnel.

(3) Descriptions of procedures and equipment.

(4) Records of shipnents.

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.L. Y. SPEARINST S100.18 16 0CT ism SDCTION SIX AUDITS-6.1 Purpose. This section specifies the requirements which must be met to establish an effective audit program.

6.2 Discussion Appendix (A) to this section contains the audit plan for use in audits a.

of the RMPCA Program. 'Ihis format specifies the minimum requirements of each audit. 'Ihe auditor should audit to the intent rather then the letter of the audit plan. 'Ihat is to say-each area described in the audit plan should reveal several questions which nust be answered to satisfactorily cmplete the audit.

b. Established schedules of audits of the RMK A Program will be performed.

Results of all audits.'ill be reported to tne Ccmnanding Officer, with copies to the Repair Officer, Madiological Controls Officer and Radiation Safety Officer. Audit reports will be evaluated and deficient areas corrected. The audits being performed will be dependent of the safety significance of the activity being audited. Audit reports will be maintained as part of the quality control records.

6.3 Procedure

a. Audits shall be conducted by or under the direct supervision of the RMEA Officer.

b. An audit.of each receipt or shipnent, shall be conducted within two weeks following that receipt or shipnent.

c. Seni-annually, a cmplete audit of the RMMA Program will be conducted.

'Ihe specific dates shall be approved by the Ccmnanding Officer.

d. 'Ihe signed audit report shall be forwarded to the Ccananding Officer on the empletion of'each audit. Copies will be provided to the Repair Officer, Radiological Controls Officer and Radiation Safety Officer.

e. '1he Repair Officer will review proposed corrective actions and assign cm pletion dates.

f. 'Ihe original audit re;nrts and original records of corrective action l.

shall be maintained in an auditable fashion by the RMEA Officer.

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h L. Y. SPEARINST 5100.18 I6 0CT 099 USS L.Y. SPEAR SIMIAINIAL ALDIT OITELISP KR

'IBE GALITY ASERRAICE 190 GRAM KR 'IHE PACEAGDC CF RADIQhCTIVE MA 1 RIALS Y

N N/0 N/A A. RMPQA RECORDS

1. Has the current RMK)A Officer ccmpleted I

Enclosure (1), Section two, Appendix A, of L.Y. INST 5100.18 (series) and has been approved by the Cannarding Officer?

Ref: USS L.Y. SPEARINST 5100.18

2. Have all RMPQA revisions been approved by the Ccumanding officer and each revision entered in the record of revisions page?

Ref: USS 1,.Y. SPEARINST 5100.18

3. Are there records of conpleted audits for the Receipt and transfer of each source?

Reft USS L.Y. SPEARINST 5100.18

4. Are there records of ocmpleted Semiannual audits?

Ref: USS L.Y. SPEARINST 5100.18

5. Are there records on file of the manufacturers NRC approval for each Package?

Ref: USS L.Y. SPEARINST 5100.18

6. Are there records on file of semiannual inventory of sources?

Ref: USS L.Y. SPEARINST 5100.2 l

7. Are there records of radiac instrument calibration for each instrument?

l' Ref: USS L.Y. SPEARINST 5100.2 6-A-1 L

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B. SOURCE REOmDS 1.~ Do copleted records for each radiographic

- source contain as a minirun the following:

Source receipt form.

Source leak test form.

Custody accountability form fr m supplier.

Decay chart fr m manufacturer.

Supplier shipping invoice.

Utilization logs.

Transport requests.

Daily prior to use inspections.

Field surveys.

Source transfer form.

Shipping document 1149.

Acknowledgement of receipt of shipped sources

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by supplier.

Ref: USS L.Y. SPEARINST 5100.2

2. Do c.wyleted records for each calibration source contain as a mininum the following:

Source receipt form.

Source leak test form.

Decay chart frm manufacturer.

Supplier shipping invoice.

Utilization logs.

Radiation survey records.

Ref: USS L.Y. SPEARINST 5100.2 l

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N N/O N/A 3.

Ref:

C. QUALIFICATION REDORDS i

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1. Have all radiographers empleted qualification by:

Cm pleting course A-701-0033.

Medically qualified radiation worker.

Cmpleted on board qual check sheet.

Assigned in writing by RSO.

Ref: USS L.Y. SPEARINST 5100.2

2. Have all RCP personnel cmpleted qualification by:

Cm pleting course A-670-0020 Radiac instrument maintenance.

Medically qualified radiation worker.

Cm pleted on board qualification.

Assigned in writing by RCO.

Ref: USS L.Y. SPEARINST 5100.1

3. Has the Radiation Safety Officer cmpleted course S-4J-0016 and S-4J-0020 and been appointed in writing by the Cmmanding Officer..

Ref: USS L.Y. SPEARINST 5100.2

4. IIas the Senior Radiographer cmpleted course

-S-4J-0016 and S-4J-0020 ard been appointed in writing by the Cmmanding Officer.

Ref: L.Y. SPEARIET 5100.2 l

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. A-Is Y. SPEARINST 5100.18 t

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D. TRAINIlG RDOORDS

1. Are there records for training on the following topics:

L.Y. SPEARINST 5100.18 OA Program.

L.Y. SPEARINST 5100.2 GNNA RADIOGRAPHY L.Y. SPEARINST 5100.16 CALIBRATION Title 10, CER, Part 19 Title 10, CER, Part 20 Title 10, CFR, Part 21 Title 10, CFR, Part 30 Title 10, CFR, Part 34 Title 10, CFR, Part 71 Title 49, CFR

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Ref: USS L.Y. SPEARINST 5100.18 2.

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