Supply Chain Quality Assurance –Procurement of Hazmat Packaging Response to a Paradigm Change Mark D. Bowers Senior Operations Specialist – Packaging Acquisition & Use Lead Contractors Transportation Management Association Conference and Workshop, Point Clear AL July 6-9, 2015

Presentation Overview Events of 2011/2012 effecting the supply of hazmat packaging Commercial Grade Packaging Dedication - 7A Type A Drums Tailoring NQA-1 Requirements for DOT Packaging – presented by Mark Hawk

Importance of Supply Chain for Hazmat Packaging & Event of 2011/2012 Supply chain is the life blood of a Site’s operations Holds true for Hazmat Packaging; interruptions on a timely supply can negatively effect: Facility operations Safety & ALARA in relation to the timely packaging, removal and disposition of hazardous materials Shipping schedules Contractor milestones (including milestone incentives!) Surveys have shown that most DOE contractors use NQA-1 as their Quality Assurance (QA) program basis and for the flow-down of requirements to suppliers 2011-2012 DOE contractors experienced a significant impact on the ability to readily procure and supply some packaging types due to a paradigm change in the flow-down of ASME NQA-1 based, quality assurance requirements for implementation by suppliers

Source Documents - Flow-down of Packaging Quality Assurance Requirements Invoking a Quality Assurance Program for Packaging and Transportation (P&T) Activities is a requirement of applicable DOE Orders DOE O 460.1C, DOE O 461.1B, and DOE O 461.2 require DOE contractors to have an approved QA program compliant with 10CFR71 Subpart H for Type B/AF packaging and with DOE O 414.1D for remaining rad/nonrad packaging Each of the P&T Orders discuss QA program implementation for packaging activity; in addition, 460.1C clearly states it includes procurement activities DOE O 414.1D provides for the use of numerous Quality Assurance Standards, including two versions of ASME NQA-1 DOE O 414.1D clearly states that contractors are required to flow-down applicable QA requirements from the order to subcontractors (includes suppliers) at any tier DOE O 460.1c, Packaging and Transportation Safety DOE O 461.1B, Packaging and Transportation For Offsite Shipment of Materials of National Security Interest DOE O 461.2, Onsite Packaging and Transfer of Materials of National Security Interest DOE O 414.1D, Quality Assurance

ASME NQA-1 (2008 w/2009 Addenda) Structure, Use & Supplier Flow-Down Title: Quality Assurance Requirements for Nuclear Facility Applications Multiple Parts Part I, contains primary requirements for Quality Assurance (QA) programs Part II, contains supplemental requirements to Part I Parts III and IV, contains nonmandatory guidance to Parts I & II Used as quality assurance standard for operations by many DOE contractors Applicable requirements often invoked on supplier’s by contract (i.e., flow-down) for controls over manufacturing activities – Primarily from Part I Part I consists of: Introduction (Including guidance on applicability for use of NQA-1) 18 separate Requirements (i.e., Parts/Chapters) with a combined total of 183 individually numbered sections/paragraphs distributed throughout the Requirements Each Requirement has a section 100 that is titled “Basic”; provides a general summary that is expanded on in all following sections/paragraphs within the Requirement (except that Requirements 5, 14 and 16 have only section 100, Basic)

Flow-down of Section 100 Basic & ASME NQA-1 Committee Interpretation Pre 2011/2012, for many DOE contractors a typical supplier flow-down of NQA-1 Requirements was primarily from section 100, Basic only Use of other sections/paragraphs within any of the 18 Requirements was mostly voluntary (although often recommended) A Defense Nuclear Facilities Safety Board (DNFSB) memorandum dated May 5, 2010 documented a concern over the practice of invoking only section 100 on suppliers and made reference to corresponding discussions with the ASME Committee on Nuclear Quality Assurance In March of 2012, the ASME NQA Committee issued Technical Interpretation Record #10-1365 to the DNFSB on the practice of applying only Section 100 as a QA program basis In summary, the committee stated the practice was insufficient as a basis to claim credit for implementing Part I (or Part II) of an NQA-1 based program –and- insufficient for invoking on suppliers and expecting results equivalent to specifying all of Parts I or II (application was to versions 2000 through 1b-2011)

Response to ASME Committee Technical Interpretation – A Change in Paradigm Response in action to the interpretation varied among DOE Contractors Many began the transition from invoking only Section 100 to full NQA-1, Part I** Transition included some temporary grandfathering of suppliers and issuing of questionnaires/surveys to determine the [full Part I**] compliance status of QA programs Initially, few suppliers could demonstrate full compliance. Additionally, some expressed no interest in modifying their programs or stated it would result in a significant increase in pass down costs for the purchase of their products At this time, a number of suppliers were temporarily or permanently removed from DOE Contractor’s lists of NQA-1 qualified suppliers As a result, procuring entities were required to find alternate methods for assuring the quality of purchased items (i.e., increased use of source verification, commercial grade dedication, etc.) ** Defining Full Part I varies depending on the nature of the commodity and on how the NQA-1 guidance on applicability is interpreted

Effects on Procurement of Hazmat Packaging by Type Type B, Type AF and [Nonrad] Spec Packaging Minimal to no effect - various reasons (e.g., QA Program standards other than NQA-1 invoked or purchased at lower quality levels where no QA Program standards invoked) 7A Type A, Industrial, and Excepted Custom or Engineered Packaging Moderate effect on supply; examples are metal boxes and ISO Freight Containers Temporary removal from qualified supplier list with temporary compensatory actions imposed to maintain supply of items Most suppliers enhanced QA Programs in a timely manner to meet specified NQA-1 Part I requirements and compensatory actions were removed 7A Type A, Industrial, and Excepted Commercially Available Packaging Significant effect on supply; examples are drums and sample carrying cases Suppliers unwilling or unable to enhance QA Programs or would significantly increase per unit cost of product to cover upgrade and maintenance expenses Long term compensatory actions and alternative methods of ensuring item quality required implementation to maintain supply of items Out of all packaging types, greatest impact was on the supply of 7A Type A drums

Meeting the Challenge – EFCOG/PMC Working Group In 2012, EFCOG Supply Chain Quality and the PMC joined forces and formed the UN Performance and 7A Type A Packaging Working Group Vince Grosso, Chair Ronald B. Natali, Co-Chair for the Tailoring NQA-1 Requirements for DOT Packaging Subgroup Mark D. Bowers, Co-Chair for the Procurement & Dedication of Commercial Grade Packaging Subgroup Since initiation, the Working Group’s has strived to: Evaluate the impact of the NQA-1 requirements transition (i.e., Basic to Full Part I) on suppliers and supply of packaging Formulate solutions within the framework of maintaining the assurance of quality for procured packaging in concert with mitigating the overburden of controls on suppliers and the corresponding costs of packaging supply Each subgroup is purposed with development of concepts and documented guidance for review/acceptance by the Working Group at large

Commercial Grade Packaging Dedication - 7A Type A Drums Initial efforts of the Commercial Grade Packaging Dedication (CGPD)Subgroup is focused on the commonly used 7A Type A Drum and development of guidance documents for use with the PMC standardized UN/Type A 55-gallon drum specification The primary basis for the development of CGPD guidance documents is ASME NQA-1 Part II, Subpart 2.14, Quality Assurance Requirements for Commercial Grade Items and Services Section 100 General states [use of] Subpart 2.14 is to provide reasonable assurance that an item or service will perform its intended safety function Safety function determined as containment of [radioactive] Hazmat for 7A Type A commercially available drums; includes use of drums within nuclear facilities, inter-facility transfers within site boundaries, and DOT in-commerce shipments In addition, Subpart 2.14 states that an acceptance process using an NQA-1 dedication is deemed equivalent to an item designed and manufactured/provided under the requirements of NQA-1 (i.e., by a full Part I supplier)

Subgroup Deliverables Technical Evaluation Report (TER Scope is for commercially available 7A Type A drums with standardized features and options; provides a narrative on drum supply, use, reasons for dedication and prerequisites prior to initiating a procurement Lists & analyzes applicable regulatory design, construction and performance requirements as well as manufacturing requirements Establishes critical characteristic, acceptance criteria and methods of acceptance CGPD Planning and Instruction Procedure Establishes the process for initiating a CGPD Includes a planning template and instructions for the procurement, dedication and acceptance of drum lots Commercial Grade Survey (CGS), Source Verification (SV) and Receipt Inspection (RI) Plans and Checklists Each Utilizes criteria established in the TER Methods of Acceptance from Subpart 2.14; RI is always used and then combined with either CGS or SV

Document Development and Distribution TER and CGPD Planning and Instruction Procedure are with Subgroup for review Templates for CGS, SV and RI plans and checklists have been developed and require finalization** Goal is for all documents to with the Subgroup by August, 2015 and to the Workgroup at large by September, 2015

Why Use the Dedication Approach for Procuring Select Types of Packaging? Useful tool but not applicable to all packaging types For P&T activities, DOE Orders require QA processes & controls be evaluated for applicability Contracts with DOE and/or QA Management Plans may require the use of NQA-1 for other than just nuclear facility activities and items Some packaging types are credited in a nuclear facility safety basis, receive functional classification when used within the facility, and require application of corresponding QA processes and controls 49 CFR 173.474 and 173.475 assign shipper responsibilities for assuring the quality of packaging Many suppliers of commercial grade packaging can not be qualified as full NQA-1 Part I suppliers so when appropriate for the packaging type, alternative approaches of assuring quality must be used