REPORTING OF DEFECTS AND NONCOMPLIANCE

Current Congressional approved version dated December 1, 2009; 74 FR 62680.

What is it? – The regulations in this part establish procedures and requirements for implementation of section 206 of the Energy Reorganization Act of 1974. Obtain information reasonably indicating: (a) That the facility, activity[Service] or basic component supplied to such facility or activity fails to comply with the Atomic Energy Act of 1954 relating to substantial safety hazards or (b) that the facility, activity, or basic component supplied to such facility or activity contains defects, which could create a substantial safety hazard.

What it applies? All goods and services that have been provided as “Safety Related”. (3) Definitions of application in the Regulation.

21.1 Purpose. 21.2 Scope. 21.3 Definitions. 21.4 Interpretations. 21.5 Communications. 21.6 Posting requirements. 21.7 Exemptions.

21.8 Information collection requirements: OMB approval.

21.21 Notification of failure to

comply or existence of a defect and its evaluation.

21.31 Procurement documents. 21.41 Inspections. 21.51 Maintenance and inspection

of records. 21.61 Failure to notify. 21.62 Criminal penalties.

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Discovery

Evaluation

Notification

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Discovery –

◦ The initial step that establishes the timeline for reportabilty

◦ Starts the process to determine if the entity has the

data and capability to perform the evaluation

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Evaluation –

◦ Determine, within 60 days of discovery, if deviation could create a substantial safety hazard

◦ Issue an interim report when the evaluation can not be

completed within 60 days of discovery ◦ If the supplier does not have the capability to perform

the evaluation, notify all affected purchasers within 5 days of discovery [10 CFR 21.21(b)]

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Notification – [10 CFR 21.21(d)]

◦ Inform a director or responsible officer, as soon as practicable and, in all cases, within 5 working days after completion of the evaluation

◦ Notification to Commission Initial notification by facsimile within 2 days of informing

the responsible officer Written notification within 30 days of informing the

responsible officer

◦ Written notification has mandatory content

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Disc

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Evalu

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60 days

Inter

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5 days

Infor

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Offic

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2 day

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30 days

Writt

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For suppliers: 5 days to notify customer if not capable to perform evaluation

Definitions [10 CFR 21.3] ◦ Basic Component Item with a safety function that assures: The integrity of the reactor coolant pressure boundary, The capability to shutdown the reactor and maintain a safe

shutdown condition, or The capability to mitigate accidents that could result in offsite

exposure comparable to those referenced in 10 CFR 50.34, 50.67 or 100.11, and

Item designed and manufactured under 10 CFR 50 Appendix B, or

Commercial grade item successfully dedicated.

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Definitions (cont.)

◦ Deviation A departure from the technical requirements included

in a procurement document.

◦ Discovery Completion of the documentation first identifying a

deviation.

◦ Evaluation Documented process of determining that a deviation

could create a substantial safety hazard, or violate a license technical specification safety limit.

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Definitions (cont.) ◦ Defects Deviation in a delivered basic component that on a

basis of an evaluation could create a substantial safety hazard, or violate license technical specifications safety limits.

◦ Substantial Safety Hazard Loss of safety function to the extent that creates a

major reduction in the degree of protection provided to the public health and safety.

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Posting Requirements [10 CFR 21.6]

◦ Post documents [10 CFR 21.6(a)]

Most recent 10 CFR Part 21 Regulation,

Section 206 of the Energy Reorganization Act of 1974, and

Your procedures developed pursuant to Part 21.

◦ If impractical – Post Section 206, and a notice describing the regulations / procedures, the name of the individual to whom reports are made, and where they can be examined.

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Notification Requirements ◦ Notification to the Commission of a defect must be

performed by a director or responsible officer. [10 CFR 21.21(d)(1)] ◦ Defect notification time period to Commission [10

CFR 21.21(d)(3)] Initial Notification – within 2 days of notifying director

or responsible officer. Written Notification – within 30 days of notifying

director or responsible officer. Advice given to purchasers (licensees) related to the

defect.

Maintenance of records [10 CFR 21.51]

◦ Entities subject to this regulation must prepare and retain records for a minimum period:

Evaluations of deviations – 5 years Notifications sent to purchasers – 5 years Record of purchasers of basic components

(procurement documents) – 10 years

Example: Supplier notified of material specification deviation by their authorized nuclear inspector ◦ Material supplied by ASME certificate holder did not

conform to ASME material specification requirements. ◦ Supplier handled issue under corrective action

program. ◦ Root cause identified that subcontractor did not

understand material specification requirements. ◦ Material was supplied to multiple utility purchasers. ◦ Supplier notified their customers of material

specification deviation.

◦ Does the example meet requirements of Part 21 for reportability?

Knowledgeable in the Law and its application

Documented Training

Satisfactory Evaluation Records ◦ Linkage with NCR & CAR processes

Developed and implemented Procedure that addresses the elements of Part 21

Proper Posting

Evaluations are retained for 5 years, use sound engineering judgment, and adequate documentation supporting conclusions

Timelines are maintained and entities requiring notification have been executed in a timely manner.

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