Information Notice 1997-89, Distribution of Sources & Devices Without Authorization

Distribution of Sources & Devices Without Authorization

ML031050015
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	12/29/1997
From:	Cool D NRC/NMSS/IMNS
To:
References
IN-97-089, NUDOCS 9712220015
Download: ML031050015 (6)

. I

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 December 29, 1997 NRC INFORMATION NOTICE 97-89: DISTRIBUTION OF SOURCES AND DEVICES

WITHOUT AUTHORIZATION

Addressees

All sealed source and device manufacturers and distributors.

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to alert

addressees to the situation of unauthorized sources and devices being distributed to specific

and general licensees, and the breakdown of the vendor's regulatory program that allowed such

distribution. This notice provides information that vendors of sources and devices may consider

to avoid distribution of products that have not been authorized. It is expected that recipients will

review the information for applicability to their licensed activities and consider actions, as

appropriate, to avoid similar problems. However, suggestions contained in this information

notice are not NRC requirements; therefore, no specific action nor written response is required.

Description of Circumstances

A routine inspection of a vendor authorized to distribute products to specific and general

licensees revealed that the vendor distributed products that had not been distributed in

accordance with its license or certain commitments made in support of its application for safety

evaluation and registration of the products. After the inspection, a Confirmatory Action Letter

was issued, to the vendor, indicating the vendor's commitment to review all past distributions of

sources and devices to determine if the products were in accordance with its license and the

registration certificate, and to verify whether commitments made in support of its application for

safety evaluation and registration had been met. The vendor's investigation identified that:

(a) there were several hundred instances where products were distributed contrary to the

conditions in the registration certificate; and (b) certain of the vendor's commitments had not

been met. The deviations from the registration certificate identified by the licensee varied from

minor modifications to essentially complete redesigns. In addition, a number of the deviations

indicated potential health and safety concerns that required further review.

Several factors contributed to the improper distributions and commitments not being met.

These included: (a) the vendor's not having and maintaining a program sufficient to identify and

prevent distribution of products containing deviations from the registration certificate;

INOl5 T*1

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JT'qj 8

- 97-89 December 29, 1997 (b) uncertainty as to interpretations of information contained in the registration certificate and

the information submitted in support of the safety evaluation and registration of the product; and

(c) a lack of oversight and communication between the vendor and the manufacturer of the

products. The root cause of these factors seems to be not implementing an effective quality

assurance and quality control (QANQC) program.

The vendor's QA/QC program failed to ensure that products were distributed in accordance with

the approved designs, for several reasons. These included: (1) the vendor failed to verify the

validity of design information, submitted by former distributors, vis a vis the current design of

the products; (2) the vendor's audits of the manufacturer were not sufficiently In-depth to

identify changes in product design; and (3) the vendor relied on the manufacturer to compare

the actual design of the product being distributed with the design contained in the registration

certificate. As a result, the vendor committed to designs that, in some cases, did not accurately

reflect the current designs of the products. In addition, the manufacturer based its reviews on

the current designs of the products and not on the designs contained in the registration

certificates, and was unclear about the types of changes that should be identified to the

licensee. Therefore, the manufacturer did not identify differences between the previous designs

and the current designs and did not notify the vendor of all design changes that should have

been identified.

Subsequent to the inspection of the vendor, that identified the improper distributions, several

similar inspections of other vendors were performed. These inspections concentrated on the

QAJQC programs of the vendors and whether the vendors had distributed products that were

not authorized. Several of these inspections identified similar problems where a lack of an

effective QA/QC program or not following the QA/QC program led to a vendor distributing

products not in accordance with its license and/or the registration certificate for the product.

Discussion

Persons who distribute products that have been issued registration certificates must ensure that

distributed products are in accordance with the statements and representations contained in

their applications, as well as the provisions of the registration certificates for the products. This

requirement is codified in 10 CFR 32.210. Specifically, 10 CFR 32.210 requires, in part, that

applicants submit information concerning their quality control programs to the regulatory

authorities for review. This information must provide reasonable assurance to the reviewer that

the quality control programs are sufficient to ensure that distributed products are in accordance

with the approved designs. To this extent, a vendor's QANQC program should ensure that all

changes to the product are reviewed for safety implications, before implementing the change;

that changes which require amendment to the registration certificate are submitted .to the

regulatory authority for review; and that the changes submitted to the regulatory authority are

approved and included in the registration certificate before distribution of products that include

the change. Deviations from the approved design and processes may cause the product to be

unable to survive its intended conditions of use or may cause the radiation safety features of

the product to be ineffective.

When establishing QA/QC programs, manufacturers and distributors should be certain that they

contain the essential elements needed to ensure that products are distributed in accordance

K- 9789 December 29, 1997 with the approved designs. In addition, QANQC programs should periodically be reviewed, to

determine their effectiveness and to identify needed modifications or updates to reflect changes

such as new technology, manufacturing processes, and corporate reorganizations. Examples

of elements that are considered critical to an adequate QA/QC program include: design control;

a process to identify and address deviations; inspection and testing programs (performed on a

continuous or periodic basis); and periodic audits of the QA/QC program and the programs and

processes of suppliers, to ensure they remain effective. Additional guidance on what are

considered essential elements necessary for the establishment of an adequate QA/QC program

is contained in Regulatory Guide 6.9, "Establishing Quality Assurance Programs for the

Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material.

It should be noted that vendors who do not have QA/QC programs that are adequate to ensure

that products are manufactured and distributed in accordance with the design and processes

approved by the regulatory authority, or that fail to follow their approved QAIQC programs, may

be subject to enforcement actions, including revocation of the approvals contained in their

registration certificates.

This information notice requires no specific action or written response. If you have any

questions about the information in this notice, please contact the technical contact listed below

or the appropriate regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Douglas Broaddus, NMSS

301-415-5847 E-mail: dab@nrc.gov

Attachments: # A1 § 44

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

DOCUMENT NAME: 97-89.IN

attachmenVendosure 'E -Copy with atachnent/enclosure

To receive a copy of this document, Indicate In the box: "CTa Copy wthWou vW No copy

OFFICE IMAB E IMAB C Tech Editor N IMOB E IMe

NAME DBroaddus ILCamper EKraus via FAX JPiccone Dot6--

DATE 12/10/97 12/ /97 12/10197 12/14/97 ILIWZ97 OFFICIAL RECORD COPY

1-~

IN 97-XX

December XX, 1997 When establishing QAIQC programs, manufacturers and distributors should be certain that

they contain the essential elements needed to ensure that products are distributed in

accordance with the approved designs. In addition, QA/QC programs should periodically be

reviewed, to determine their effectiveness and to identify needed modifications or updates to

reflect changes such as new technology, manufacturing processes, and corporate

reorganizations. Examples of elements that are considered critical to an adequate QA/QC

program include: design control; a process to identify and address deviations; inspection and

testing programs (performed on a continuous or periodic basis); and periodic audits of the

QA/QC program and the programs and processes of suppliers, to ensure they remain

effective. Additional guidance on what are considered essential elements necessary for the

establishment of an adequate QAIQC program is contained in Regulatory Guide 6.9, uEstablishing Quality Assurance Programs for the Manufacture and Distribution of Sealed

Sources and Devices Containing Byproduct Material."

It should be noted that vendors who do not have QAIQC programs that are adequate to

ensure that products are manufactured and distributed in accordance with the design and

processes approved by the regulatory authority, or that failpo follow their approved QA/QC

programs, may be subject to enforcement actions, includirfg revocation of the approvals

contained in their registration certificates.

This information notice requires no specific actionr nor written response. If you have any

questions about the information in this notice,,Rplease contact the technical contact listed

below or the appropriate regional office. /

Donald A. Cool, Director

Division of Industrial and

/ Medical Nuclear Safety

a* Office of Nuclear Material Safety

//' and Safeguards

Technical contact: pXglas Broaddus, NMSS

(301) 415-5847 E-mail: dabenrc.gov

Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

DOCUMENT NAME.  :\WPDOCS\GENERIC.COM\97-XX.lN

To receive a copy of this document, Indlcate In the box: Tc" a Copy without ttachmnendcosure "E Copy with attach sncbure " = No copy

OFFICE IMAe E TIMAB 1 Tech Editor N EIMNS

NAME DBrEgtdus I-CamptEirEKraus via FAX t e DCool

DATE 12/10/97 12/ q /97 12/10/97 12/)497 / /97 O-RECORD COPY

- A,

kCoKment 1 IN 97-89 December 29, 1997 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

97-87 Second Retrofit to Industrial 12/12/97 All industrial radiography

Nuclear Company IR100 licensees

Radiography Camera, to

Correct Inconsistency in

10 CFR Part 34 Compatibility

97-86 Additional Controls for Transport 12/12/97 Registered users of the Model

of the Amersham Model No. 660 No. 660 series packages, and

Series Radiographic Exposure Nuclear Regulatory Commission

Devices industrial radiography licensees

97-75 Enforcement Sanctions Issued 09/24/97 All U.S. Nuclear Regulatory

as a Result of Deliberate Commission licensees

Violations of NRC Requirements

97-72 Potential for Failure 09/22/97 All holders of OLs or CPs

of the Omega Series for nuclear power reactors

Sprinkler Heads and fuel cycle facilities

97-65 Failures of High-Dose- 08/15/97 All high-dose-rate remote

Rate Remote Afterloading afterloader licensees

Device Source Guide Tubes, Catheters, and Applicators

97-64 Potential Problems 08/13/97 All U.S. Nuclear Regulatory

Associated with Loss Commission medical tele- of Electrical Power therapy licensees

in Certain Teletherapy

Units

97-61 U.S. Department of 08/06/97 All U.S. Nuclear Regulatory

Health and Human Commission medical

Services Letter, to licensees, veterinarians, Medical Device Manu- and manufacturers/distri- facturers, on the butors of medical devices

Year 2000 Problem

97-58 Mechanical Integrity of 07/31/97 Holders of and Applicants

In-Situ Leach Injection for Licenses for In-Situ

Wells and Piping Leach Facilities

V..-dthment 2 IN 97-89

. - December 29, 1997 Page 1 of I

LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject - Issuance Issued to

97-88 Experiences During Recent 12/16/97 All holders of OLs for pressurized- Steam Generator Inspections water reactors except those who

have permanently ceased

operations and have certified that

fuel has been permanently

removed from the reactor

97-87 Second Retrofit to 12/12/97 All industrial radiography

Industrial Nuclear Company licensees

IR 100 Radiography Camera, to Correct Inconsistency in

10 CFR Part 34 Compatibility

97-86 Additional Controls for 12/12/97 Registered users of the Model

Transport of the Amersham No. 660 series packages, and

Model No. 660 Series Nuclear Regulatory Commission

Radiographic Exposure Devices industrial radiography licensees

97-85 Effects of Crud Buildup 12/11/97 All holders of OLs for pressurized- and Boron Deposition on water reactors, except those

Power Distribution and licensees who have permanently

Shutdown Margin ceased operations and have

certified that the fuel has been

permanently removed from the

reactor vessel

97-84 Rupture in Extraction 12/11/97 All holders of OLs for nuclear

Steam Piping as a power reactors except those

Result of Flow-Accelerated who have permanently ceased

Corrosion operations and have certified

that fuel has been permanently

removed from the reactor vessel

95-49, Seismic Adequacy of 12/10/97 All holders of OLs for nuclear

Sup. 1 Thermo-Lag Panels power reactors

OL = Operating License

CP = Construction Permit