Information Notice 1997-89, Distribution of Sources & Devices Without Authorization
. 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;
.Gl
INOl5 T*1 JT'qj
8
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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
To receive a copy of this document, Indicate In the box: "CT a Copy wthWou
attachmenVendosure 'E -Copy with atachnent/enclosure
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 ILI WZ97
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- REC ORD 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
97-86
97-75
97-72
97-65
97-64
97-61
97-58
Second Retrofit to Industrial
Nuclear Company IR100
Radiography Camera, to
Correct Inconsistency in
10 CFR Part 34 Compatibility
Additional Controls for Transport
of the Amersham Model No. 660
Series Radiographic Exposure
Devices
Enforcement Sanctions Issued
as a Result of Deliberate
Violations of NRC Requirements
Potential for Failure
of the Omega Series
Sprinkler Heads
Failures of High-Dose-
Rate Remote Afterloading
Device Source Guide Tubes,
Catheters, and Applicators
Potential Problems
Associated with Loss
of Electrical Power
in Certain Teletherapy
Units
U.S. Department of
Health and Human
Services Letter, to
Medical Device Manu- facturers, on the
Year 2000 Problem
Mechanical Integrity of
In-Situ Leach Injection
Wells and Piping
12/12/97
12/12/97
09/24/97
09/22/97
08/15/97
08/13/97
08/06/97
07/31/97
All industrial radiography
licensees
Registered users of the Model
No. 660 series packages, and
Nuclear Regulatory Commission
industrial radiography licensees
All U.S. Nuclear Regulatory
Commission licensees
All holders of OLs or CPs
for nuclear power reactors
and fuel cycle facilities
All high-dose-rate remote
afterloader licensees
All U.S. Nuclear Regulatory
Commission medical tele- therapy licensees
All U.S. Nuclear Regulatory
Commission medical
licensees, veterinarians, and manufacturers/distri- butors of medical devices
Holders of and Applicants
for Licenses for In-Situ
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
97-87
97-86
Experiences During Recent
Steam Generator Inspections
Second Retrofit to
Industrial Nuclear Company
IR 100 Radiography Camera, to Correct Inconsistency in
10 CFR Part 34 Compatibility
Additional Controls for
Transport of the Amersham
Model No. 660 Series
Radiographic Exposure Devices
Effects of Crud Buildup
and Boron Deposition on
Power Distribution and
Rupture in Extraction
Steam Piping as a
Result of Flow-Accelerated
Corrosion
Seismic Adequacy of
Thermo-Lag Panels
12/16/97
12/12/97
12/12/97
12/11/97
12/11/97
12/10/97 All holders of OLs for pressurized- water reactors except those who
have permanently ceased
operations and have certified that
fuel has been permanently
removed from the reactor
All industrial radiography
licensees
Registered users of the Model
No. 660 series packages, and
Nuclear Regulatory Commission
industrial radiography licensees
All holders of OLs for pressurized- water reactors, except those
licensees who have permanently
ceased operations and have
certified that the fuel has been
permanently removed from the
reactor vessel
All holders of OLs for nuclear
power reactors except those
who have permanently ceased
operations and have certified
that fuel has been permanently
removed from the reactor vessel
All holders of OLs for nuclear
power reactors
97-85
97-84
95-49, Sup. 1 OL = Operating License
CP = Construction Permit