3. Reviewing and Approving Contractor's Unreviewed Safety Question (USQ) Process and Processing Potential Inadequacies of the Document Safety Analysis (PISA)

Management System: Environment, Safety, and Health

Subject Area: Facility Safety Authorization

Procedure 3. Reviewing and Approving Contractor's Unreviewed Safety Question (USQ) Process and Processing Potential Inadequacies of the Document Safety Analysis (PISA)

Subject Matter Expert: ROGER CASTEEL
Management System Owner: LARRY KELLY
Secondary Management System Owner: JUSTIN ZAMIROWSKI

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Issue Date:  06/21/2011
SCMS Revision:  3.0

1.0  Applicability

This procedure is to provide the Office of Science (SC) a consistent method for reviewing and approving contractor’s new or revised procedure for its Unreviewed Safety Question (USQ) process and evaluating the contractor’s annual submittal of USQ Determination summaries.

This procedure also provides a consistent method for processing the notifications of Potential Inadequacies of the Documented Safety Analysis (PISAs) and the associated evaluations of the safety of the situations (ESSs) and approving actions by the contractor to remove any operational restrictions initiated upon the discoveries of PISAs.

2.0 Required Procedure

Section 830.203 requires a contractor responsible for a Hazard Category 1, 2, or 3 nuclear facility to submit its procedure to the U.S. Department of Energy (DOE) for approval. Section 830.203 further requires documentation of DOE’s approval in a Safety Evaluation Report (SER). The SER will be used to document DOE’s review and provide the basis for approval of the contractor’s procedure for its USQ process.

For PISAs that are determined to involve USQs, the review and approval of safety basis documents intended to address these PISAs, such as Justifications for Continued Operation (JCOs), USQ Change Packages, etc., are addressed by Procedure 1, Reviewing and Approving of Nuclear Facility Safety Basis Documentation, in this subject area.


For reviewing and approving of contractor’s procedure for its USQ process, go to Step 1.

For evaluating of the contractor’s annual submittal of USQ Determination summaries, go to Step 10.

For processing of notifications of PISAs, evaluating ESSs, and approving actions by the contractor to remove any operational restrictions initiated upon discoveries of PISAs, go to Step 12.

This procedure correlates with Title 10 Code of Federal Regulations (CFR) Part 830, Subpart B, Section 830.203, Unreviewed Safety Question Process (Nuclear Safety Management), latest version.

Reviewing and Approving of Contractor’s Procedure for its USQ Process
Step 1 The SC Site Office Manager, if applicable, designates a responsible individual to lead the review of contractor's new or revised procedure for its USQ process.

NOTE: SC Site Office procedures, written agreements, or correspondence may designate the Review Team Leader (with Approval Authority agreement). This approved designation eliminates the need for Steps 2 and 3.

Step 2
  1. If an individual at Headquarters (HQ) is the Approval Authority, the SC Site Office Manager or designee prepares a memorandum recommending the appointment of the Review Team Leader and submits it to the SC Deputy Director for Field Operations (SC‑3) for signature.

  2. When approval authority has been delegated to an individual in the SC Site Office, the SC Site Office Approval Authority signs the memorandum designating the appointment of the Review Team Leader.

NOTE: The memorandum is normally prepared in advance of the contractor’s procedure being submitted for approval.

Step 3

The Approval Authority formally approves the Review Team Leader appointment and provides that information to the SC Site Office Manager (if an individual at HQ is the Approval Authority) or Review Team Leader (if an individual in the SC Site Office is the Approval Authority).

NOTE: The contractor’s new or revised procedure for its USQ process submitted for DOE approval must be formally transmitted from the contractor to the responsible SC Site Office.

Step 4 The Review Team Leader performs the following:
  • Evaluates the scope of the review effort to determine if additional resources are required and if a review plan is warranted.

  • Requests support as needed from SC Site Office, SC Integrated Support Center (SC-ISC) in conjunction with SC Site Office, and HQ.

  • As appropriate (graded approach), prepares a review plan and submits the review plan to the Approval Authority for approval. The review plan can be approved by the SC Site Office Manager if qualified Senior Technical Safety Managers exist at the SC Site Office and review the plan.

    NOTE: It is recommended that most reviews of the contractor’s new or revised procedure for its USQ process have at least one qualified Nuclear Safety Specialist reviewer under DOE‑STD‑1183‑2007, Nuclear Safety Specialist Functional Area Qualification Standard. Review Team Membership should include program representation and other disciplines consistent with the degree of changes in the contractor’s procedure. In some cases, the review may be able to be conducted by one individual.

  • Promptly communicates comments/issues generated during the review to the contractor through formal communications from the SC Site Office Manager or designee. Elevates areas where agreement cannot be reached through the chain of command for resolution.

  • If DOE is unable to approve the submitted document without substantial clarification and or numerous conditions for approval, notifies the appropriate Site Office individual with programmatic responsibility for the facility of the required action and formally transmits the document back to the contractor, with the basis for DOE’s disapproval clearly documented.

  • If the contractor’s procedure can be approved, prepares an SER (or coordinates the Review Team’s input on the SER) to document the review and basis for approval of contractor’s procedure in accordance with DOE‑STD‑1104‑2009, Review and Approval of Nuclear Facility Safety Basis and Safety Design Basis Documents.

    NOTE: Although DOE‑STD‑1104‑2009 provides the SER format and content requirements for the review and approval of Documented Safety Analyses and Technical Safety Requirements, it can be conceptually utilized for documenting the review and basis for approval of the contractor’s procedure for its USQ process.

Step 5 The Review Team Members perform the following:
  • Document any comments/issues identified.

    NOTE: Use Documenting the Unreviewed Safety Question (USQ) Process and the USQ Procedure Requirements Checklist to perform and document the review.  For contractors utilizing the Expert USQ Process, verify the USQ procedure appropriately incorporates provisions and restrictions on the use of the Expert USQ Process.

  • NOTE: Contractors that choose to implement the Expert USQ Process and have an approved procedure are expected to enhance their oversight of the Expert USQ Process for the first 1-2 years of implementation. Similarly, Site Offices should increase their oversight of the contractor’s Expert USQ Process for the same time period until proven reliable.

  • If the contractor’s new or revised procedure for its USQ process can be approved, contribute to the preparation of the SER (as directed by the Review Team Leader) to document the review and basis for approval of the contractor’s USQ procedure in accordance with DOE‑STD‑1104‑2009.

  • Ensure the DOE’s conditions for approval in the SER constitute an appropriate and minimal essential set of conditions that is clearly stated to facilitate their implementation and closure.

NOTE: The Expert USQ Process utilizes expertise of contractor safety analysts who are familiar with the facility and its safety basis for mature, compliant Hazard Category 1, 2 and 3 nuclear facilities. Expert preparers may perform screenings or determinations for simple changes. The Expert USQ Process was adopted from Y-12 National Security Complex based upon the low risk of incorrect decision (determination of approval level) during the pilot project and focusing the USQ process on its primary purpose. Additional information regarding the Expert USQ Process is available from the SC‑3 Senior Nuclear Safety Advisor.

Step 6 The SC Site Office Manager or designee submits the SER and the contractor’s new or revised procedure for written approval from the Approval Authority.
  • If the Approval Authority is an individual in the SC Site Office, the Review Team Leader or Line Manager submits the SER.

  • If the Approval Authority is an individual at SC HQ, the SC Site Office Manager or designee prepares a memorandum recommending approval of the contractor’s USQ procedure with a provision on the memorandum for the Approval Authority to mark as either Approved or Disapproved. The approval recommendation memorandum, SER, and contractor’s USQ procedure are submitted to SC‑3.

NOTE: Approval of this procedure by SC-1 with concurrence for S-4 was completed since the Expert USQ Process is considered an alternative method for that specified in DOE G 424.1-1B, Implementation Guide for Use in Addressing Unreviewed Safety Question Requirements.

Step 7 The Approval Authority reviews the SER and formally approves or disapproves the document. The Approval Authority provides a copy of the approval or disapproval to the SC Site Office Manager (if an individual at HQ is the Approval Authority) or the Review Team Leader/Line Manager (if an individual in the SC Site Office is the Approval Authority).
Step 8 After the contractor’s new or revised procedure for its USQ process is approved, the SC Site Office Manager or designee prepares and formally transmits to the contractor the approval letter with a copy of the SER.

NOTE: The transmittal letter establishes DOE’s expectations regarding any implementation issues.

Step 9

The SC Site Office Manager or designee ensures the contractor has properly implemented its USQ procedure.

NOTE: This portion of the procedure is concluded; for Record Retention, go to Step 15

Evaluating of the Contractor’s Annual Submittal of USQ Determination Summaries
Step 10 The SC Site Office Manager or designee ensures the contractor annually submits a summary of USQ Determinations performed since the prior submission to DOE.
Step 11

The SC Site Office Manager or designee evaluates the adequacy of the summary of USQ Determinations and requests additional information from the contractor as warranted.

The SC Site Office Manager or designee should document the results of their review.

NOTE: This portion of the procedure is concluded; for Record Retention, go to Step 15.
Processing of Notifications of PISAs, Evaluating ESSs, and Approving Actions by the Contractor to Remove Any Operational Restrictions Initiated Upon Discoveries of PISAs
Step 12 After the SC Site Office is notified of a PISA, the SC Site Office Manager or designee monitors the contractor’s actions to ensure the requirements of 10 CFR 830.203 are implemented in an appropriate and timely manner.

The SC Site Office Manager or designee ensures the contractor:

  • Takes appropriate actions to place or maintain the facility in a safe condition,

  • Expeditiously notifies DOE upon discovery of the information,

  • Performs USQ Determination and notifies DOE promptly of the results, and

  • Completes an evaluation of the safety of the situation and submits it to DOE prior to removing any operational restrictions.

Step 13

The SC Site Office Manager or designee evaluates the contractor’s actions to place or maintain the facility in a safe condition for appropriateness and directs the contractor to take additional actions if necessary.

NOTE: Justifications for Continued Operation (JCOs) offer an alternative to ceasing operations when a condition arises that would otherwise require shutting down the facility. JCOs should be used only as a short‑term, temporary measure until a permanent change to the safety basis document can be developed, approved, and implemented. DOE’s review and approval of JCOs are addressed by Procedure 1, Reviewing and Approving Nuclear Facility Safety Basis Documentation. Recommended format and contents of a JCO are addressed in DOE G 424.1-1B.

Step 14

The SC Site Office Manager or designee reviews the ESS provided by the contractor.

  • If the USQ Determination associated with the PISA is negative, the SC Site Office Manager's approval of the contractor’s actions to remove operational restrictions is not necessary; however, the SC Site Office Manager needs to agree with the conclusion of the associated ESS.

  • If the USQ Determination associated with the PISA is positive, DOE’s review and approval are required for any proposed resolution. DOE’s review and approval of a proposed resolution are addressed by Procedure 1, Reviewing and Approving Nuclear Facility Safety Basis Documentation.

This portion of the procedure is concluded; for Record Retention, go to Step 15.

NOTE: The ESS is an assessment of the safety of the situation. For a negative USQD, the ESS provides evidence that the immediate controls placed on the facility or activity to ensure a safe condition are not required and can be removed. For a positive USQD, the ESS provides the basis for how the actions taken (including the implementation of operational restrictions) and/or planned actions, ensure safety. Please reference DOE G 424.1-1B for recommended content of an ESS.

Step 15 The responsible SC Site Office organization must control and maintain the following documents as quality assurance records which include:
  • Submitted contractor’s new or revised procedure for its USQ process, SERs and supporting documentation associated with DOE’s review and approval (e.g., review plan, review comments, resolution matrices, completed USQ Procedure Requirements Checklist, transmittal correspondence between the contractor and DOE and between the Approval Authority and the SC Site Office),

  • Annual summaries of the contractor’s USQ Determinations,

  • Submitted ESSs and documentation associated with DOE’s review and approval of actions to remove any operational restrictions initiated upon discoveries of PISAs.

3.0  References


This is the online OFFICIAL SCMS COPY of this file. Before using a printed copy, verify that it is the most current version by checking the Last Major Revision and Last Minor Revision dates (at the bottom of each document) on the SCMS Web site.


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