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UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555

December 29, 1997

**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; (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 (QA/QC) 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 QA/QC 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QA/QC 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 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 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 QA/QC 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.

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