Quality Assurance Approval Program
Frequently Asked Questions

  1. What documents should you submit to the DOE Headquarters Certifying Official?
  2. Submit your QAAP Compliance Matrix, QA Program Description (QAPD), and implementing documents to the DOE Packaging QA Lead if you participate in the design, fabrication, procurement, use, or maintenance of Type B or fissile radioactive material packagings certified by DOE, or if you're a DOE/DOE Contractor and ship packages certified by NRC.  Your QA Program must satisfy the requirements of 10 CFR 71  Subpart H and be approved and auditied by the DOE Headquarters Certifiying Official as required by DOE Order 460.1D.  However, if your QA Program has been approved by NRC, DOE will accept NRC Form 311 and the approval letter from NRC as evidence of compliance with the the Order in lieu of the matrix and implementing documents referenced in the matrix.  If your QA Program has been approved by the NNSA Certifying Official for Subpart H, DOE will accept the NNSA Certifying Official's approval documentation as evidence of compliance with the Order in lieu of the matrix and implementing documents referenced in the matrix.

  3. Where do you send these documents?
  4. Mail your compliance documentation (1 paper copy and 1 CD/DVD or flash drive in pdf) to the address listed below:

    Dr. James Shuler
    U.S. Department of Energy, EM-4.24
    c/o L.F. Gelder
    Savannah River Research Campus
    227 Gateway Drive, Rm 310
    Aiken, SC 29803

  5. Can DOE/DOE Contractors ship Type B or fissile material in DOE or NRC certified packages, or participate in the design, fabrication, procurement, use, or maintenance of DOE certified packagings if their QAPD has not been conditionally approved or fully approved by the DOE-HCO?
  6. No, you are not in-compliance with DOE 460.1D.  Contact Dr. Shuler to discuss your particular situation.

  7. While my QA Program description (QAPD) is under review by the DOE Packaging Certification QA Review Team, what is the status of my "Conditional Approval."?
  8. Your QAPD "Conditional Approval" status remains in effect until your QAPD is approved by the DOE-HCO, or is revoked by memorandum/letter issued from the DOE-PCP QA Lead or DOE-HCO.   The status of QAPDs are posted on RAMPAC at QA Docket Status

  9. Question from DOE/NNSA Contractor - DOE Order O 460.1C is not clear as to who should approve my 10 CFR 71 Subpart H Quality Assurance Program (QAP) for Type B or fissile radioactive material packages?
  10. If you participate in the "design, fabrication, procurement, use, or maintenance..." of a Type B or fissile RAM package certified by DOE, DOT, or NRC then you must have a QAP approved by the DOE Headquarters Certifying Official (HCO).  For weapons packages, the National Nuclear Security Administration would approve your QAP.

    Note - The changes in DOE Order 460.1D should have clarified this question.       

    The HCO issues Quality Assurance Program Approvals based on a.) An audit performed by staff or b.) endorsement of a QAP approved by NNSA or NRC.  This arrangement (endorsement) recognizes the roles of the various federal organizations and the associated sensitivities, that is, under normal circumstances, NRC doesn't perform Subpart H audits of DOE, DOE doesn't audit NNSA, and NNSA doesn't audit DOE.

    The bottom line is that if a DOE/NNSA Contractor wants to use (or continue to use) a Type B or fissile package certified by DOE, DOT, or NRC, then you need to request HCO approval or renewal of your QAP, and then, after the QAP Approval is issued, you would register with the DOE to become a user of the DOE, DOT, or NRC package of interest.  Click here for registration information.

  11. Question from DOE/SC - Can my contractor make "non-intent" (i.e.,administrative) changes to supplement a QAP approved by HCO, in lieu of a QAP revision and document submittal?
  12. No.  The term "non-intent" or "administrative"  changes can be interpreted quite differently from one organization to the next. Although NRC allows such changes per §71.106(b), DOE has experienced many contractors with an acceptable Quality Assurance Program (QAP)  at the time their QAP was approved, only to witness a severe decline in compliance within a few years later; therefore, DOE entities/contractors must continue to notify the DOE PCP of any changes to the QAP, prior to implementing the proposed changes, and submit the changes for HCO approval.  DOE PCP will also continue its practice of issuing QAP approvals for 5-years, despite the change (see Final Rule FR Vol 80, No. 113/Friday June 12, 2015)  to NRC's practice to issue their Form 311 without an expiration date.

  13. Question from Packaging Management Council -Requirements (for DOE elements or persons under contract to DOE elements) to ship under 10 CFR 71.22 – Does a shipper have to have a Subpart H QAP in place or not?
  14. Yes, §71.22(b) requires a Subpart H QAP.

  15. Question from Packaging Management Council -Requirements (for DOE elements or persons under contract to DOE elements) Is a Use/User registration required for shipping empty certified Type AF or B containers?
  16. Yes.  DOE Order (O) 460.1D, Section 4.a.(2), Requirements for Radioactive Material Packagings, Use of Type B or fissile Materials Certified Packagings, requires Departmental elements when using a Type B or fissile material packaging with contents authorized by a CoC to comply with the conditions of the CoC and register in writing prior to first use.  Once a packaging is placed in service, that is, used to ship radioactive contents, it is no longer non-radioactive and always assumed to contain radioactive contents (albeit residual contents when empty).  In addition, Chapter 7 of a SAR/SARP includes a Section, Preparation of Empty Package for Transport, with specific procedures for preparing the package for shipment in accordance with 49 CFR 173.428, Empty Class 7 (Radioactive) Materials Packaging.  Furthermore, the definition of Use/User in O 460.1D means “The use of certified Type B or fissile material package and packaging includes all package operations, acceptance testing, and maintenance in accordance with the requirements in Chapters 7 and 8 of the SARP and the CoC.” 

  17. When a DOE/NNSA Operations, Site, or Field Office changes Management and Operating (M&O) Contractors, the new M&O Contractor typically adopts the previous contractor's programs, procedures, and policies during the transition period to ensure continuity of operations.  This process/procedure is sometimes referred to as "blue-sheet" provisioning.  Question - can the new M&O Contractor adopt and work under the previous contractor's 10 CFR 71 Subpart H compliant quality assurance program (QAP) that was approved by the HCO? 
  18. Yes.  The DOE HCO may approve the new M&O Contractor to work under the previous contractor's QAP subject to the following conditions: The applicable DOE Head of Operation Offices or Field Office/Site Office Manager must review and process the request from the contractor and submit it to the HCO for approval [Ref DOE Order 460.1D, Section 5.c.(8)] and the contractor must provide documented evidence to the HCO that they adopted the previous contractor's QAP (e.g., copy of the approved "blue sheet" form as an attachment to the request to the HCO).

    When these conditions are satisfied the HCO may issue a Quality Assurance Program Approval form to the Operation, Site, or Field Office Manager for the new M&O Contractor. 

    Additional Questions? Contact Dr. Shuler, (301) 903-5513, james.shuler@em.doe.gov

Updated ​​December 1, 2017

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