Supply Chain Quality Assurance –Procurement of Hazmat PackagingResponse to a Paradigm Change

Mark D. BowersSenior 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

2

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

3

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

4

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)

5

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)

6

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

7

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

8

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

9

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)

10

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

11

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

12

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

13