DOE-HDBK-1148-2002, Work Smart Standards (WSS) Users Handbook

TS NOT MEASUREMENT SENSITIVE DOE-HDBK-1148-2002 February 2002 DOE HANDBOOK WORK SMART STANDARDS (WSS) USERS HANDBOOK U.S. Department of Energy AREA MGMT Washington, D.C. 20585 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. This document has been reproduced from the best available copy. Available to DOE and DOE contractors from ES&H Technical Information Services, U.S. Department of Energy, (800) 473-4375, fax: (301) 903-9823. Available to the public from the U.S. Department of Commerce, Technology Administration, National Technical Information Service, Springfield, VA 22161; (703) 605-6000. DOE-HDBK-1148-2002 iii TABLE OF CONTENTS Paragraph Page FOREWORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi 1.0 Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1.1 Organization of the Work Smart Standards User’s Handbook . . . . . . . . . . . . . . 1 2.0 Scope of the Handbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Figure 2. Integrated Safety Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3.0 Applicable Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4.0 Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 5.0 Understanding the Necessary and Sufficient (N&S) Closure Process . . . . . . . . . . . . . 13 5.1 Incorporation of the Process within the Integrated Safety Management System (ISMS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 5.2 Cooperative Engagement, Communications, and Flexibility . . . . . . . . . . . . . . . 15 6.0 N&S Process Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 6.1 Overview of Key Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Table I. Key Participants in the N&S Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Table II. Examples of Participants in Typical Contract-Level N&S Applications . . . . . 19 6.2 Involvement of Senior DOE and Contractor Managers . . . . . . . . . . . . . . . . . . . 21 6.3 Role of Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 7.0 Initiating the Necessary and Sufficient Closure Process . . . . . . . . . . . . . . . . . . . . . . . 25 7.1 Initiating the Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 7.2 Role of the Agreement Parties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 7.3 Role of the Convened Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 7.4 Role of the Process Leader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

8.0 Defining the Work and Associated Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 8.1 Defining the Work and Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 8.2 Role of the Process Leader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 8.3 Role of the Convened Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 8.4 Stakeholder and Interested Parties Involvement . . . . . . . . . . . . . . . . . . . . . . . 39 9.0 Creating Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 9.1 Creating Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 9.2 Roles of the Convened Group and Process Leader . . . . . . . . . . . . . . . . . . . . . 41 9.3 Criteria for the Identification Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 9.4 Criteria for the Confirmation Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 9.5 Selecting the Identification and Confirmation Teams . . . . . . . . . . . . . . . . . . . . 44 DOE-HDBK-1148-2002 iv 10.0 Defining and Agreeing to Protocols and Documentation Requirements . . . . . . . . . . . . 46 10.1 Protocols and Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 10.2 Role of the Convened Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 10.3 Role of the Process Leader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 10.4 Audiences for Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 11.0 Identifying the Set of Work Smart Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 11.1 Identifying the Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 11.2 Standards Reference Base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 11.3 Role of the Process Leader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 11.4 Role of the Identification Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 11.5 Role of Technical and Operational Experts . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 11.6 Process Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 12.0 Confirming the Set of Work Smart Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 12.1 Confirming the Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 12.2 Readiness for Confirmation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 12.3 Role of the Identification Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 12.4 Role of the Process Leader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 12.5 Role of the Confirmation Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

13.0 Approving the Set of Work Smart Standards and Authorizing Work to the Set . . . . . . 71 13.1 Approving the Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 13.2 Role of the Process Leader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 13.3 Role of the Approval Authorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 13.4 Criteria for Sufficiency of the Process Elements . . . . . . . . . . . . . . . . . . . . . . . . 74 14.0 Implementing the Set of Work Smart Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 15.0 Maintaining the Set of Work Smart Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 16.0 Providing Feedback and Lessons Learned . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 APPENDICES Appendix A - The Necessary and Sufficient Closure Process frequently asked questions. Appendix B - Actions and assigned responsibilities for Stakeholder involvement in the N&S Process at the Savannah River Site. Appendix C - A protocol defining the qualification requirements for Identification Team Members who participated in the N&S Process Pilot at the Los Alamos National Laboratory. Appendix D - N&S Process organizational structure at the Fermi Laboratory. DOE-HDBK-1148-2002 v Appendix E - The charter and confirmation protocols used during the N&S Process conducted at the Fermi Laboratory. Appendix F - The Los Alamos National Laboratory matrix, “Orders and Rules of Interest to the DNFSB and Appendix G of the LANL Contract,” developed for the Work Smart Standards set at Los Alamos National Laboratory. Appendix G - Criteria for Evaluating the Performance of the N&S Process and Confirmation of Readiness. Appendix H - Request for approval of the WSS set and the final approval document used during the N&S Process conducted at the Fermi Laboratory. Appendix I - The procedure for managing change control of laboratory operating standards and requirements (including the WSS set) at the Los Alamos National Laboratory. DOE-HDBK-1148-2002 vi PAGE INTENTIONALLY LEFT BLANK DOE-HDBK-1148-2002 1In this Handbook, consistent with Department practice, "The Integrated Safety Management System" or "Integrated Safety Management" is spelled out or designated as either ISMS or ISM. "The Necessary and Sufficient Closure Process" is referred to as the N&S process or simply the process. vii FOREWORD A set of Work Smart Standards (WSS) is the product of the Necessary and Sufficient Closure Process. This Handbook provides amplification, practical examples, and cross references to assist users in the application of the Necessary and Sufficient (N&S) Closure Process within the context of the Integrated Safety Management System (ISMS)1. This Handbook is based on practical experience and lessons learned in applying the Process across the DOE complex over the course of four years. It reflects not only the collective principles of the ISMS and the N&S Process, but the applied knowledge of many people who have successfully used the Process in a variety of applications. The N&S Process is based on the same safety philosophy as prescribed for DOE’s Integrated Safety Management System which begins with a thorough understanding of the work and associated hazards. Within the contractual framework of ISMS, DEAR 970.5204-78, Laws,

Regulations, and DOE Directives, requires contractors to use a DOE approved process to identify environment, safety and health (ES&H) requirements appropriate for work and the associated hazards. The N&S Process provides a DOE approved means of identifying sets of standards that, when properly implemented, will provide reasonable assurance of adequate protection of workers, the public, and the environment. The N&S Closure Process can be used for the identification of standards in situations where there exists significant uncertainty: about the definition of the work; the nature of the hazards associated with a piece of specific work definition; or in regard to what work plan(s) can provide the assurance of adequate protection from those hazards. Significant uncertainty may exist simultaneously in all these aspects of standards identification and approval. Accordingly, the N&S Closure Process incorporates features that are intended to systematically build confidence in the resulting WSS set. Confidence is created during the course of recognizing, eliminating or mitigating the potential effects of the various uncertainties that arise from the need to do the specific work. DOE-HDBK-1148-2002 viii The N&S Process depends on the cooperative agreement and engagement of all affected parties. The commitment of senior managers, participation by workers, and input from Stakeholders and Interested Parties are all essential elements in successful N&S Process applications. The means of successfully achieving these goals and the techniques used in doing so will vary substantially among different applications. DOE P 450.3, Authorizing Use of the Necessary and Sufficient Process for Standards-Based Environment, Safety, and Health Management, permits flexibility in developing and implementing standards. DOE M 450.3-1, The Department of Energy Closure Process for Necessary and Sufficient Sets of Standards (the N&S Manual), states basic requirements for the Process and is the primary source document. The contents of this Handbook are not additional requirements. This Handbook is not written to stand alone, but relies on its users to be knowledgeable of the N&S Manual and committed to its requirements. Both the N&S Manual and this Handbook are components of the overall knowledge base concerning the N&S Process. Authoritative information about the N&S Process is available on the Work Smart Standards web site located at: http://tis.eh.doe.gov/dsc/index.html This Handbook identifies and discusses a selection of significant information on this web site and identifies where to locate specific items of interest. Users about to assume responsibilities in the N&S Process, or contemplate using the Process, are encouraged to carefully review the web site in its entirety. Process participants should confer with appropriate line management for any additional assistance. Further support to line management is available from the collective experience of the DSC. The initiation and implementation of the N&S Process has occurred widely across the complex since its inception in 1995. Through early pilots and follow on N&S Process applications, a considerable number of lessons were learned. A discussion of these lessons learned can be found on the Work Smart Standards home page (http://tis.eh.doe.gov/dsc/index.html). General information about Integrated Safety Management implementation is available at the ISM home

page. In addition, the Department’s Lesson Learned home page (http://tis- DOE-HDBK-1148-2002 ix hq.eh.doe.gov:80/LL/) has specific information useful to managers and participants who intend to use the N&S Process in the future. This is Revision 0 of this Handbook. This Department of Energy Handbook is approved for use by all DOE components and their contractors. Beneficial comments (recommendations, additions, deletions) and any pertinent data that may improve this document should be sent to: Executive Secretary, Department Standards Committee, U. S. Department of Energy, 1000 Independence Avenue, SW, Washington, DC 20585 by letter or by using the Document Improvement Proposal (DOE F 1300.3) appearing at the end of this document. DOE-HDBK-1148-2002 x PAGE INTENTIONALLY LEFT BLANK DOE-HDBK-1148-2002 1 1.0 Purpose The purpose of this Handbook is to provide users of the N&S Process with amplification, practical examples, and references to available resource material to assist in developing, implementing, and maintaining the WSS set as a vital component of Integrated Safety Management (see Section 3.0, Applicable Documents.) This Handbook is intended to improve the understanding of the application of the N&S Process so that substantial benefit can be realized in terms of worker and public safety, environmental protection, mission accomplishment, and cost. The information in this Handbook is based on lessons learned from applications of the Necessary and Sufficient Closure Process for Work Smart Standards and was prepared by an experienced team of DOE and contractor practioners of the N&S process and the ISMS. 1.1 Organization of the Work Smart Standards User’s Handbook This Handbook provides amplifying explanations on the methods and processes that should be considered by users in conducting a formal process to develop, implement, and maintain the WSS set. The Handbook discusses topics based on the N&S Process actions. Figure 1 is a graphic illustration of the actions as listed in the N&S Manual. T h e N ecessa ry an d S u ffic ien t C lo su re P ro cess D efin e W o rk & A n a ly ze H aza rd s C rea te T eam s Id en tify N ece ssa ry & S u ffic ie n t S e t o f S tan d a rd s C o n firm S e t A p p ro v e S e t In co rp o ra te S e t w ith in In teg ra te d S a fe ty M an ag em en t S y stemW ork F ee d b a ck & Im p ro v e m en t D efin e p ro to c o ls & d o cu m e n ta tio n S ta r t Figure 1. Necessary and Sufficient Closure Process DOE-HDBK-1148-2002 2 Scope: Section 2.0 discusses the relationship of this Handbook to Department policy and guidance as established in the Necessary and Sufficient Closure Process, the Integrated Safety Management System (ISMS) Policy, and the Department of Energy Acquisition Regulations (DEAR). Applicable Documents: Section 3.0 lists references directly applicable to the methods and processes described in the Handbook. Glossary: Section 4.0 reiterates the definitions listed in the N&S Manual and introduces a new term “Interested Parties.” Understanding the Necessary and Sufficient (N&S) Closure Process: Section 5.0 describes the interface between the Process and ISMS, emphasizes the need for cooperation among parties, the importance of establishing good communications, and the need to provide for flexibility. N&S Process Participants: Section 6.0 provides an overview of the roles and responsibilities

of key participants in the Process, describes the need for involvement of senior DOE and contractor managers and discusses the value of workers in the Process. Conduct of the Process: Sections 7.0 through 13.0 describe the actions and techniques found useful in successfully conducting the Process. These topics amplify requirements found in the N&S Manual, M 450.3-1, The Department of Energy Closure Process for Necessary and Sufficient Sets of Standards, and provide practical examples and lessons learned from experience in the field. Each section is introduced with a chart that depicts the key features of the N&S Process element as described in that section. References to other applicable materials and web sites are provided. Implementation: Section 14.0 describes field experience in successful implementation of the standards sets developed by the N&S Process. DOE-HDBK-1148-2002 3 Maintaining the Set of Standards: Section 15.0 discusses establishing effective change control mechanisms from experience and practical application. Providing Feedback and Lessons Learned: Section 16.0 discusses the use of feedback and lessons learned. Appendices: The appendices contain detailed information and example documentation useful to those responsible for implementing an application of the N&S Process and maintaining the resulting set of Work Smart Standards. These appendices are provided as examples of methods, processes and work products which have been found to be successful in field applications. They make up only a small part of the available information included in the authoritative data base which is available on the Work Smart Standards web site at – http://tis.eh.doe.gov/dsc/index.html. C Appendix A contains frequently asked questions with corresponding answers concerning the N&S Process. C Appendix B contains a sample outline of actions and assigned responsibilities pertinent to Stakeholder involvement in the N&S Process at the Savannah River Site. C Appendix C contains a sample of a protocol defining the qualification requirements used for Identification Team Members who participated in the N&S Process at the Los Alamos National Laboratory (LANL). C Appendix D contains examples of N&S Process organizational structures used at Fermi Laboratory. C Appendix E contains a charter and confirmation protocols used during the N&S Process conducted at the Fermi Laboratory. DOE-HDBK-1148-2002 4 C Appendix F contains a crosswalk “Orders and Rules of interest to the DNFSB and Appendix G of the LANL Contract” developed for the Work Smart Standards Set at Los Alamos National Laboratory. C Appendix G contains "Criteria for Evaluating the Performance of the N&S Process and Confirmation of Readiness." C Appendix H contains a request for approval of a WSS set and the final approval document used during the N&S Process conducted at the Fermi Laboratory. C Appendix I contains a procedure for managing change control of laboratory operating standards (including the WSS set) at LANL. DOE-HDBK-1148-2002 5 Define Institutional Scope of Work Analyze Hazards for Institution Identify Institutional Standards & Requirements Ensure Performance for Institution Ensure Performance for Facility Ensure Performance for Activity Perform Work Identify & Implement Controls for Activities Define Facility Scope of Work Define Activity Scope of Work Analyze Hazards for Facility Identify Facility Standards & Requirements

Analyze Hazards for Activity Work Output 2.0 Scope of the Handbook Figure 2. Integrated Safety Management System 2.1 Scope The DOE Guiding Principles of Integrated Safety Management permit different approaches to tailoring a set of implementing mechanisms. Figure 2 portrays the ISMS concept. The objective of ISMS is to perform work safely. As the figure illustrates, ISMS is a comprehensive management system approach that integrates safety into all levels of DOE work: sitewide, facility and activity. The DOE mission comprises exceptional diversity in its scope and complexity. In some cases, the uncertainties associated with the characterization of the work, the work environment, and the hazards require tailored management approaches. DEAR 970.5204-78. Laws, Regulations, and DOE Directives, states in paragraph (c): DOE-HDBK-1148-2002 6 “Environmental, safety, and health (ES&H) requirements appropriate for work may be determined by a DOE approved process to evaluate the work and the associated hazards and identify an appropriately tailored set of standards, practices, and controls, such as a tailoring process included in a DOE approved Safety Management System implemented under 48 CFR (DEAR) 970.5204-2. When such a process is used, the set of tailored ES&H requirements, as approved by DOE pursuant to the process, shall be incorporated into List B as contract requirements with full force and effect.” DOE P 450.3, Authorizing Use of the Necessary and Sufficient Process for Standards-Based Environment, Safety, and Health Management, establishes the N&S Process as a means of addressing work, hazards, and related controls. For many routine activities, experience has been codified in formally promulgated standards and procedures. For other non-routine activities, guidance documents identify best practices that, while not prescriptive requirements, communicate what is known at the edge of formalized consensus standards. The result of the N&S Process is a set of tailored environment, safety and health (ES&H) standards. This set is termed the Work Smart Standards set to emphasize the importance that the actual work definition plays in resolving safety uncertainty. This policy further states that carrying out this Process with fidelity and implementing the results will provide reasonable assurance of adequate protection of the workers, the public and the environment and will increase Stakeholder trust and confidence. When the N&S Process is selected as the means to arrive at a tailored set of standards, then compliance with the N&S Manual is mandatory as stated in the Policy. The Manual provides the framework for conducting the N&S Process. Manual requirements and the individual steps of the Process are designed to ensure that the Work Smart Standards set can result in reasonable assurance of adequate protection, is feasible for implementation where intended, and can be applied with confidence. Lack of fidelity to the requirements of the Manual may void the results of the Process application. Since 1995, as the Process has been applied, the Manual has been validated. This Handbook is intended to be used in conjunction with the Manual to provide users of the N&S Process with useful guidance based on lessons learned. DOE-HDBK-1148-2002 7 3.0 Applicable Documents a. 48 CFR (DEAR) 970.5204-2, Integration of Environment, Safety, and Health into Work Planning and Execution

b. 48 CFR (DEAR) 970.5204-78, Laws, Regulations, and DOE Directives c. DOE Policy 450.3, Authorizing Use of the Necessary and Sufficient Process for Standards-based Environment, Safety, and Health Management d. DOE Policy 450.4, Safety Management Policy e. DOE Policy 450.5, Line Management, Safety, and Health Oversight f. DOE Policy 450.6, Secretarial Policy Statement, Environment, Safety, and Health g. DOE Policy 1210.1, Public Participation h. DOE Manual 450.3-1, the Department of Energy Closure Process for Necessary and Sufficient Sets of Standards I. DOE Guide 450.3-1, Documentation for Work Smart Standards Applications: Characteristics and Considerations j. DOE Guide, 450.3-2, Attributes of Effective Implementation k. DOE Guide, 450.3-3, Tailoring for Integrated Safety Management Applications l. DOE Guide 450.4-1, Integrated Safety Management System Guide m. DOE-STD-1083-95, Requesting and Granting Exemption to Nuclear Safety Rules n. Criteria for the Department Standards Program (DOE/EH/-0416) DOE-HDBK-1148-2002 8 4.0 Glossary This section reiterates and supplements the definitions as listed in the N&S Manual for the purpose of standardizing terms used in this Handbook and introduces the term "Interested Parties." Agreement Party: Any party, including at a minimum the Responsible Organization and the Customer Organization, that must agree to the necessary and sufficient set of standards for the work (e.g., parties to a contract) as in the case of DOE and an M&O/M&I contractor. Approval Authority: One or more Department and contractor employees designated by the Convened Group to determine the adequacy of the Work Smart set of standards and to approve or disapprove a set of standards. Confirmation Team: A group of individuals who meet the membership criteria and qualifications defined by the Convened Group with responsibility for confirming the adequacy and feasibility of the necessary and sufficient set of standards based on documentation provided by the Identification Team. Convened Group: A steering committee for the conduct of the Process, which represents the Agreement Parties, the Resource Authority, and other appropriate Federal organizations. The Convened Group establishes the criteria for approval of the set of standards identified by the Identification Team and must, therefore, consist of organizational representatives empowered to make the necessary commitments. Customer Organization: The organization with direct responsibility, accountability, and authority for having the work performed subject to the agreed-upon set of standards. Identification Team: A group of individuals who meet the membership criteria and qualifications defined by the Convened Group and are responsible for identifying and justifying the necessary and sufficient set of standards based on the work, the performance expectations, and the associated hazards and uncertainties defined in Process Element 1. DOE-HDBK-1148-2002 9 Interested Party: DOE contractors or subcontractors, Federal organizations or State organizations not directly participating in the Process but having significant interest or responsibility in the outcome. An example is the Defense Nuclear Facilities Safety Board (DNFSB) which has statutory responsibilities relating to defense nuclear facility standards. Operational Experts: Individuals with knowledge and expertise relevant to the work and

the site, facility, and activities addressed by the necessary and sufficient set of standards. Resource Authorities: Organizations or individuals with control over and authority to commit the equipment, facilities, personnel, and budget necessary to accomplish the work. For example, line managers are typical resource authorities in classical organizations. Program and project managers are also line managers who are typical resource authorities in matrix organizations. Some organizations may have resource managers who are independent of programs and projects. Responsible Organization: The organization with direct responsibility, accountability, and authority for performing the work subject to the agreed-upon set of standards. Stakeholder: Any party other than Federal employees or DOE contractor or subcontractor employees that will be materially affected by, or can materially affect, the outcome of the work, either favorably or unfavorably (for example, representatives of state and local governments, labor unions, and citizens' groups). Technical Experts: Individuals with knowledge and expertise relevant to the work or to one of the environment, safety and health disciplines (for example, industrial hygiene, criticality control, or industrial safety). DOE-HDBK-1148-2002 10 5.0 Understanding the Necessary and Sufficient (N&S) Closure Process The authority for Process use is established in the contracting mechanisms specified in the Department of Energy Acquisition Regulation (DEAR). When adopted, it is envisioned that the Process will form a key tailoring mechanism for the standards set established within a formally structured Integrated Safety Management System (ISMS). The Process always builds on the cooperative engagement of the parties involved and will not function properly if this precept is not fully understood and honored. The Process promotes good communication among all participants and a recognition that the application of the Process is tailored based on the work, hazards and work place. Poor communication and preemptive rigidity in Process implementation are signs that an “agreement to agree,” that is the basis for cooperative engagement, is lacking. Frequently asked questions with corresponding answers concerning the N&S Process are provided in Appendix A. 5.1 Incorporation of the Process within the Integrated Safety Management System (ISMS) DOE P 450.4, Safety Management Policy, commits the Department to conducting work efficiently and in a way that provides reasonable assurance of adequate protection of workers, the public and the environment. Demonstrating ISMS effectiveness is more than just an internal affair between the Department and its contractors. While protecting the environment and the safety and health of the public and workers, DOE is also committed to demonstrating good stewardship of resources, and to building public trust and confidence in its programs and plans. The Department has deliberately adopted a standards-based approach to safety management that is intended to allow for good judgment in work design and resource allocation. This approach creates consistency and stability of expectations and accountability, permits judgment to be exercised at the level appropriate to effective management, and helps people do their jobs through teamwork. These features are the outward sign of an effective ISMS at work. Central

to understanding ISM are the five core functions and seven guiding principles that undergird the contract requirements that mandate an ISMS. Key references for the establishment of ISMS include DOE P 450.4, Safety Management Policy; DOE G 450.4-1, Integrated Safety Management System Guide; DEAR 970.5204-2, Integration of Environment, Safety, and Health into Work Planning and Execution; and DEAR 970.5204-78; Laws, Regulations, and DOE DOE-HDBK-1148-2002 11 Directives. DEAR 970.5204-78(a) requires that the contractor assist DOE to comply with any applicable federal, state, and local laws (List A), and conform to the agreed upon requirements of those Department of Energy directives, or parts thereof, identified in the List of Applicable Directives (List B). As noted in the ISMS Guide, ES&H requirements appropriate for work conducted by a contractor may be determined using a DOE-approved process to: C evaluate the work and the associated hazards, and C identify an appropriately tailored set of standards, practices, and controls. The resulting approved set shall be incorporated into the contract as required by DEAR 970.5204-78. Approved processes for establishing ES&H requirements include the following: C incorporation of a Standards/Requirements Identification Document (S/RID) into the contract, C use of the Necessary and Sufficient Closure Process, and C compliance with the DOE directives and other applicable laws and regulations. Within the overall context of ISM, the Process can be used to demonstrate that an agreed upon, tailored, and standards-based definition of work, hazards, and expected controls exists. The relationship between the specific ISMS and the WSS set is inseparable when the Process is used. This is not to say that an ISMS cannot be established with a previously established S/RID or order compliance base first, but the subsequent initiation of the Process may necessitate conducting a follow on verification of the ISMS after the WSS set has been selected and implemented. Process leadership and the Convened Group are charged with ensuring that implementation of the WSS set is feasible and that the basis for this assurance is examined as part of confirmation. DOE-HDBK-1148-2002 12 5.2 Cooperative Engagement, Communications, and Flexibility The N&S Process is based upon the principle of cooperative engagement, which involves two elements: C The right parties are involved in the Process. As stated in the N&S Manual: “To establish a basis for agreement, all parties who must agree on the set of standards shall participate in the Process planning.” Additional Stakeholders and Interested Parties are always invited to contribute to the Process. C The identified Agreement Parties “agree to agree” at the outset. They recognize that they are engaged in a common task and focus their efforts on finding ways to reach agreement. Cooperative engagement is sustained through a sense of partnership among those involved and affected by the work to be performed. The relationship requires communication and a shared vision of the work outcome that includes commitment to reasonable assurance of adequate protection of the workers, the public, and the environment. Process effectiveness improves in direct measure to the degree of communication and shared vision among the participants. Cooperative engagement by senior management, designated representatives on

the Convened Group, and the various team members is the backbone of successful application of the Process. The N&S Process is not intended to be a task or “project” that DOE assigns to a contractor and reviews after completion. The N&S Process is intended to engage DOE, its contractors, Stakeholders, and Interested Parties (as determined by the likely effects of the actual work and hazards) in a cooperative and constructive dialogue that leads to greater mutual trust in the pursuit of a common goal. There is no single recipe or step-by-step procedure for application of this principle. The N&S Process is designed to be rigorous yet flexible and to require thoughtful application. The N&S Process is also designed to achieve final agreement through iteration. Results from one process element may indicate a need to revise or expand information from a previous DOE-HDBK-1148-2002 13 element. This is true of the earlier process elements, where identification of the work and hazards, creation of the teams, and establishment of protocols are closely related and interdependent. Hence in Figure 1, these elements are shown as being accomplished together rather than in a stepwise linear fashion. Similarly, in later stages of the N&S Process (for example, standards identification or confirmation), a number of factors such as the need for different/additional team members, or the need to better define the work and hazards may arise that will require revisiting one or more of the earlier process elements. In addition, considerations of feasibility can lead to iteration. Such iterations should be expected as part of a robust, properly operating N&S Process application. DOE-HDBK-1148-2002 14 6.0 N&S Process Participants An essential element for success in performing the N&S Process is assigning clear roles and responsibilities to persons in key positions for administering the Process and in assigning to these positions knowledgeable and competent individuals. Management support is demonstrated most critically in selection of key Process leadership and Convened Group personnel. 6.1 Overview of Key Participants A principle of the N&S Closure Process is that teams must be comprised of the people with requisite knowledge and expertise; people who have direct experience with the work, hazards and specific work place. The concept of “workers” as used in WSS is intentionally broad. It is intended to include people experienced in the large number of skill and knowledge categories required to perform the work of DOE. Scientists, engineers, mechanics, electricians, financial specialists, contracts specialists and many others all bring important knowledge to the identification and approval of a set of standards. Within the context of the Closure Process application, the term “workers” is particularly intended to underscore the need to involve those who perform the physical work such as operating equipment, conducting experiments, construction, testing and other similar activities. They are the individuals most directly exposed to hazards and most directly knowledgeable of work conditions and practices. The N&S Manual uses a number of unique terms to describe roles and responsibilities in conducting the N&S Process. Since N&S Process roles and responsibilities are not defined in terms of specific contractor or DOE organizational levels, flexibility is afforded for each Process

application to determine the appropriate parties for participation. Tables I and II describe the N&S roles and give examples of the organizational levels at which they were performed for representative applications. These examples and illustrations are intended only to aid in understanding some of the most common Process applications, and do not limit the ability of the N&S Process to be applied at other levels. DOE-HDBK-1148-2002 15 Table I. Key Participants in the N&S Process Group or Person Who They Are (typical contract-level application) What They Do Agreement Party DOE and Contractor organizations Designate members of Convened Group and Process Leader. Identify Resource Authorities, Stakeholders, and Interested Parties. Customer Organization DOE One of the Agreement Parties Responsible Organization Contractor One of the Agreement Parties. Convened Group Personnel from DOE and Contractor organizations Oversees the Process and provides direction to Process Leader. Designates the Approval Authorities. Process Leader From Contractor organization Leads the N&S Process. Works with Convened Group to assemble Identification and Confirmation Teams. Resource Authorities DOE and Contractor officials who control funding, resources, equipment, and personnel Identify available resources and resource constraints. Stakeholders Representatives of organizations outside of DOE and Contractor and other Federal agencies As desired, provide input via channels established by the Convened Group. Interested Parties Representatives of DOE contractors, subcontractors, or federal organizations who are not directly participating in the Process but have a significant interest in the outcome. As desired, provide input via channels established by the Convened Group. Technical Experts Operational Experts Subject matter experts from DOE, Contractor, and outside organizations Assist the Convened Group, Process Leader, and Identification and Confirmation Teams as requested. Identification Team Usually DOE and Contractor personnel Identify N&S set. Confirmation Team Usually DOE and Contractor personnel Confirm adequacy of the N&S set. Approval Authorities DOE and/or Contractor senior managers, (usually from same organizations as Agreement Parties), including the Contracting Officer Approves the Work Smart Standards set. DOE-HDBK-1148-2002 16 Table II. Examples of Participants in Typical Contract-Level N&S Applications1 Group or Person Examples Fermi LBNL LANL Agreement Parties C DOE-BAO C Universities Research Association (URA) C Office of Science-DOE HQ C DOE C University of California C LBNL C DOE C University of California Customer Organization DOE-BAO C DOE C University of California DOE Responsible Organization URA LBNL University of California Convened Group 5 individuals from: C Fermi C DOE-BAO C SC (HQ) C DOE-CH The Extended Convened Group included the above plus support of 4 other senior managers from: C Fermi (Deputy Dir.) C DOE-CH (Manager) C SC (HQ) (Assoc. Div. Dir.) C URA (Vice President) 11 individuals from: C LBNL C Univ. of California C DOE-OAK C DOE-BSO C Fermi C LLNL C SC (HQ) 8 individuals from: C DOE-AL C DOE-LAAO C Univ. of California C LANL C DP (HQ) C EH (HQ) Process Leader Line manager at Fermi Line manager at LBNL Senior Technical Manager at LANL Resource Authorities Director, SC HQ High Energy Physics Division Line management from LBNL, Univ. of California, DOE, and other organizations supporting research at LBNL.

Senior line and program management at LANL and DOE Stakeholders C Union representatives C General public C Research user community C Neighbors C General public C State, county, city, and tribal government representatives C Labor unions C Citizen’s groups Interested Parties2 C Employees C State and local regulators C Site subcontractors C Regulatory agencies DOE-HDBK-1148-2002 Group or Person Examples Fermi LBNL LANL 17 Identification Team 15 individuals from: C ANL C BNL C Cornell Univ. C LLNL C TJNAF C SLAC and the Extended Convened Group 40 individuals from: C LBNL C LLNL C DOE-OAK C DOE-BSO approx 200 individuals from C LANL C DOE-AL C DOE-LAAO C LANL subcontractors Confirmation Team 6 individuals from: C ANL C BNL C Cornell Univ. C LBNL C TJNAF C SLAC Extended Convened Group 17 individuals from: C BNL C Carroll Ramsey Assoc. C Bechtel International C Fermi C LLNL C LANL C Univ. of California C DOE-OAK C Lichtenstein Assoc. C SC (HQ) C E.I. DuPont de Nemours 13 individuals from: C LBNL C DOE-NV C LANL C DOE-AL C Nat’l.Safety Council C indep. consultants C LANL subcontractors Approval Authorities C URA President C SC HQ Div. Director C DOE-BAO Manager (Contracting Officer) C LBNL Director C DOE-OAK Manager (Contracting Officer) C LANL Director C LAAO Manager C DOE-AL Manager (Contracting Officer) 1Conventions for defining Process roles and participants have varied, particularly among some of the early Process applications. For a complete understanding of Process participants and their roles in the above examples or other applications, the complete report of the individual Process application should be consulted. These records are available from the organization which performed the Process application. Reference information is available through the DSC Home Page. 2The DNFSB did act as an Interested Party for LANL. However, at the time of the LANL N&S Process application, the term "Interested Parties" had not been established to denote a particular category of participants. DOE-HDBK-1148-2002 18 6.2 Involvement of Senior DOE and Contractor Managers As specified in the Criteria for the Department’s Standards Program (DOE/EH/-0416), DOE line management and contractor management are to implement necessary and sufficient sets of standards to provide protection during the accomplishment of work, including all requirements imposed by law. Central to management involvement in the N&S Process is the awareness and acceptance by managers of the fundamental role of the proper standards on the managers' success in meeting the ISMS objective: Doing Work Safely. Senior managers are expected to demonstrate their safety ownership by: C being knowledgeable and involved in their commitment to the safety culture; C aligning resources (fiscal, personnel, and time) to meet agreed-upon standards; C assigning recognized leaders of the organization to safety culture strengthening activities; C ensuring the presence or assistance of experts and knowledgeable participants; C interacting personally with Stakeholders and Interested Parties; and C insisting on accountability for improved safety performance. Experience has shown that proper discharge of the management responsibility and accountability for this Process may necessitate significant organizational and work practice restructuring to clearly identify the ownership of safety by line management and to make explicit

where accountability resides. For this reason, Process leadership and the Convened Group are expected to attend, throughout the Process application, to actions needed to make implementation of the WSS set feasible. Where necessary, managers should take the initiative and direct these reorganizations. Reorganization can be essential in clarifying roles, responsibility, and accountability among the organization components. Such clarification is essential for an organization to conduct work safely. DOE-HDBK-1148-2002 19 The emphasis of DOE on standards-based work represents a change in DOE culture. DOE relies on senior management to confront and resolve the disharmony inherent in achieving this significant cultural change. DOE’s ISMS clearly establishes line managers as responsible for safe mission performance. To achieve this, the line manager is expected to rely on staff functional expertise for department policy, guidance, and support. In the context of the N&S Process, senior management commitment and involvement are crucial. For a Process application to be successful, DOE and contractor management must provide the necessary resources (people, time, and funding). Since the N&S Process is often resource-intensive, providing the right people may require reassignment or deferral of other high-priority activities. This cannot be done without the strong and continued commitment of senior management. Furthermore, the members of the Agreement Parties and the Convened Group must be empowered to make decisions and commitments for their respective organizations. Senior management participation with these groups is therefore essential. Finally, a successful N&S Process application may need to draw on resources and expertise throughout the DOE and contractor organizations, as well as possibly from outside organizations. For example, Fermi Lab engaged the DOE and academic accelerator community. (Reference Appendix D) Such cross-organizational participation is not readily obtained without strong support from senior management. 6.3 Role of Workers Effective use of the N&S Process depends upon the demonstrated skills, knowledge, and abilities of the DOE work force. Those resources are derived from many collective years of experience with the types of hazards that characterize the Department’s diverse missions. For many routine activities this experience has been codified in formally promulgated standards and procedures. For other non-routine activities, guidance documents identify best practices that while not prescriptive requirements communicate what is known at the edge of formalized consensus standards. When the N&S Process is applied, the contemporary knowledge present in the work force is integrated with historical knowledge found in recognized standards. For those engaged in exploratory work design, the N&S Process encourages the integration of both practical knowledge and all forms of received wisdom. In the standards-based approach to DOE-HDBK-1148-2002 20 ISMS, the expectations for involving workers are addressed with standards identification processes that are tailored to the specific characteristics of the work. In the N&S Process, workers can provide invaluable contributions either as members of the Identification or Confirmation Teams, or as Operational Experts who assist these teams with their “knowledge and expertise relevant to the work and the site, facility, and activities.” The

definition of who is a “worker” will of course depend on the nature of the work. For purposes of the N&S Process, “workers” may include crafts personnel, engineers, designers, researchers, ES&H professionals, and others. Workers can be particularly valuable in the N&S Process by: C Identifying the work, associated hazards and standards. Those who regularly perform the work in question will have detailed knowledge of how that work is done, and may often be able to identify specific hazards, standards utilized or inefficiencies associated with the work that would not be apparent to an outside analyst. C Evaluating the feasibility of the WSS set for implementation. Because workers are the ones who directly implement the standards, they can provide insight into whether those standards are reasonable and practical in the context of the actual work environment. Unions representing workers are Stakeholders in any N&S Process application and should be informed about the N&S Process and its expected effects on the workplace. Both the communication of information about the N&S Process and the involvement of union workers as Operational Experts should be coordinated through appropriate channels such as union representatives. DOE-HDBK-1148-2002 21 Process Leader (Section 7.4) Convened Group (Section 7.3) Approval AuthoritiesAgreement Parties (Section 7.2 & subsections) Determine that one or more initiation criteria is met: • Set of standards does not exist (e.g., new activity, OR • Existing standards set no longer appropriate, OR • Contract requires use of N&S process, OR • Stakeholder demonstrates that existing standards set is not necessary or not sufficient Designate a Process Leader Designate members of Convened Group Identify Resource Authorities Identify Stakeholders and Interested Parties Prepare N&S Process training for members of Convened Group Assemble and train the Convened Group Establish Convened Group protocols and documentation requirements Identify Approval Authorities Agree to function as Approval Authorities Become knowledgeable about the N&S Process Evaluate need for mentor to assist Convened Group Provide guidance on initial work definition and performance expectations Establish strategy to demonstrate Process fidelity and WSS set feasibility Consult with DNFSB as appropriate 7.0 Initiating the Necessary and Sufficient Closure Process 7.1 Initiating the Process There must first be appropriate conditions for initiating the N&S Process. As stated in the N&S Manual, one of the following criteria must be met: C A set of standards does not exist, as in the case of a new activity. This may include a newly constructed facility, or new activities at an existing facility. DOE-HDBK-1148-2002 22 C An existing set of standards (for example, the current set of all applicable Department directives) is no longer appropriate due to changes in mission, regulatory environment, degree of hazards, performance expectation, or knowledge. For example, facilities that are undergoing transitions from operations to decommissioning and deactivation will require a transition to a different set of standards. C The applicable contract requires that the Process be used. The N&S Process may be specifically called out in a new or modified contract. C A Stakeholder (or Interested Party) demonstrates to the satisfaction of the Agreement Parties that the existing set of standards is either not necessary or not sufficient to

provide reasonable assurance of adequate protection. Evidence provided should be based on the set of standards, not on the way the standards are implemented. To meet this criteria, two conditions are necessary: (1) input from a Stakeholder (or Interested Party), and (2) Agreement Parties agree that the Stakeholder (or Interested Party) has a valid concern. A Stakeholder complaint, regardless of validity, does not in itself satisfy this condition to initiate the Process. However, all input from Stakeholders and Interested Parties should be carefully evaluated to determine if the adequacy of current standards is at issue. DOE-HDBK-1148-2002 23 7.2 Role of the Agreement Parties The Agreement Parties must be fully supportive of and interactive within the Process and be capable of reaching full agreement in the outcome. They should fully understand and agree on the form of the contract or contract modification as specified in the DEAR which will result from implementing the Process. Agreement Parties provide the initial description of the scope of the work and hazards to the Convened Group and provide related performance expectations. Throughout the Process, they should maintain close communication with the Convened Group as the work and hazards identifications are refined and a set of standards is identified within the context of the specified expectations. They must be able to agree on the defined scope of work. Any boundaries for the Process must be established and agreed to at the outset. Early identification of all the Agreement Parties is essential to ensure that the N&S Process can proceed to closure. The Agreement Parties, having concluded that at least one of the criteria for initiating the N&S Process has been met, must: C jointly designate a Process Leader; C designate individuals from their respective organizations to serve as members of the Convened Group, and identify members needed from other organizations; C identify the Resource Authorities and include them as members of the Convened Group; and C identify Stakeholders and Interested Parties. The Agreement Parties should also consider and provide guidance in the form of their performance expectations for the Process application. Key performance expectations may include: C the schedule and cost for conducting the Process, DOE-HDBK-1148-2002 24 C cost savings to be achieved by the new set of standards, C degree of continuous improvement to be called for in the standards set developed, C the extent of institutional change the new standards set may bring about when implemented, and C feasibility of the standards set including considerations of the implementation of the set within the ISM system, changes that may be required to existing equipment, infrastructure or work processes and cost. 7.2.1 Assigning the Process Leader When the Agreement Parties have reached a decision that it is appropriate to initiate the Process, they should jointly designate, preferably from within the Responsible Organization, a Process Leader who will be responsible for conducting the Process and will represent the interests of all the Agreement Parties. They should select a Process Leader who has their confidence and will be able to effectively interface with all levels of appropriate management, the Convened Group, the Identification and Confirmation Teams, and Stakeholders and Interested Parties. The Process Leader should serve as a trusted agent for the communication

of issues among these groups and should be the conduit for formal liaison. In this role, the Process Leader will be expected to bring important issues for resolution to the attention of the appropriate people. A technical background in the standards to be considered, a proven record of organizing and coordinating diverse groups of technical personnel, and knowledge of the work should be considered as prerequisites for assignment as Process Leader. The designation as Process Leader is a significant assignment. As this individual will be required to dedicate extensive amounts of time to ensuring the success of the Process, this assignment should be a principal duty. Other assignments made to this individual during the time of conducting the Process should be made only on a collateral basis. The Process Leader must provide leadership and guidance to the Identification and Confirmation Teams and is responsible for supervising the preparation of reports which will serve as the basis for approving the agreed-upon standards DOE-HDBK-1148-2002 25 set. The Responsible Organization should make available to the Process Leader the necessary resources to ensure the success of the effort. A successful N&S Process application requires commitment and a large amount of effort by well qualified and motivated people. Before standards identification begins, the Process Leader should fully understand the Process. This understanding can be obtained by previous experience in the Process or can be gained by a review of information found on the Work Smart Standards home page (http://tis.eh.doe.gov/dsc/index.html). Involvement of mentors and personnel experienced in the Process can be invaluable. Effective training and coaching/mentoring programs have been proven to be valuable in successful applications of the N&S Process. The existence of an effective training program is important to reinforce the understanding of the Process, explain roles and responsibilities, and help establish expectations for the outcomes. Training should be customized for the groups receiving the training. This customization should focus on the roles and responsibilities of management in initiating the Process, roles and responsibilities of management representatives on the Convened Group in setting the course of the application and steering its progress, roles and responsibilities of the Identification and Confirmation Team members, and the involvement of Stakeholders and Interested Parties in the Process. This training should be provided as early as practical in the Process. As with ISM, faithful application of the N&S Process depends more on a conceptual understanding of the principles involved rather than a rote following of procedural steps. Training for both ISM and the N&S Process should emphasize understanding of key concepts and principles. Teams should be fully trained prior to conducting N&S Process responsibilities. Plans for training should take into account that new members may need to be added as the Process develops. These personnel may need to be trained before participating. A complete discussion of available training materials is included on the Department Standards Committee home page (http://tis.eh.doe.gov/dsc/) under the report of Standards Process Action Teams (SPAT) 8, Training for the Necessary and Sufficient Process. DOE-HDBK-1148-2002 26 7.2.2 Assigning the Convened Group

The Agreement Parties will establish the Convened Group to provide leadership and to serve as the focal point for decision making authority for the Process. To properly support the Process Leader, the Convened Group members should be knowledgeable and effective personnel who can provide advice and guidance on a timely basis. The Convened Group is fully responsible and accountable for the entire Process and the resulting set of WSS, and its members should understand and accept this role. In general, members of the Convened Group should be selected from the managers responsible for allocating resources and managing the affected work. The personnel selected must be capable and designated to make commitments on behalf of the management of their parent organizations. Members to be assigned to the Convened Group should be individuals who fully support and will become fully engaged in the N&S Process. Should it be necessary to provide an alternate for these personnel during the Process, this substitution should only be considered if the replacement is adequately trained, experienced, and empowered. All Convened Group members should have sufficient knowledge and the appropriate authority if they are to make a significant contribution. Typical members of the Convened Group include representatives from the Agreement Parties, Resource Authorities, and other appropriate Federal organizations. In support of the requirement that the proposed WSS set be feasible, a range of key function managers in the affected contractor organizations should be included in the Convened Group. The Convened Group may be chaired by the Process Leader who is the catalyst for ensuring that the Process is formally developed and approved. 7.2.3 Identifying the Resource Authorities Resource Authorities are organizations or individuals who control the equipment, facilities, personnel, and budget necessary to accomplish work. Line managers, including program and project managers, are typical Resource Authorities. Some organizations may have multiple resource managers and some of these may be independent of programs and projects. Without the proper recognition and active participation of the Resource Authorities, the Process will fail. This does not mean, however, that each Resource Authority must be a member of the Convened Group. DOE-HDBK-1148-2002 27 7.2.4 Informing and Involving Stakeholders and Other Interested Parties Key Stakeholders and Interested Parties should be informed early of the intent to conduct the Process and be invited to contribute. Experience has proven the value of inviting these parties’ participation, even when it merely provides them with an opportunity to decline. Informing and inviting Interested Parties’ participation and input is particularly crucial since these organizations often play important decision making roles (outside of the N&S Process) regarding the acceptability of the WSS set in relation to the work being performed. A Process application can fail if it is not well understood and supported by the relevant Interested Parties. The Defense Nuclear Facilities Safety Board (DNFSB) should be considered as an Interested Party in all N&S Process activities associated with defense nuclear facilities since the DNFSB has statutory responsibilities regarding standards for such facilities. Once a decision has been made to undertake the Process, Agreement Parties should consult with the DNFSB on the

nature and opportunities of DNFSB involvement in a Process application. Including representation from the applicable DOE Headquarters staff organization as an Interested Party has been useful to ensure that issues and lessons learned from other DOE N&S Process activities can be quickly identified and assimilated. Considering key citizens groups as Stakeholders is particularly important. State and federal regulators should be considered as Interested Parties because they often define the scope and requirements of activities. Examples of these organizations include the Environmental Protection Agency (EPA) and State Departments of Health. To properly include the public in these matters requires good judgment and often dictates that public relations experts be involved. Scheduling of public meetings may be needed to ensure that the public is apprised of the key aspects of the Process application. News releases, newspaper advertisements, and announcement to employees in electronic and printed forms have been useful. The involvement of local unions and members of professional societies should be considered. DOE Policy P 1210.1, Public Participation, provides a framework for the operation of public participation programs at all DOE sites. Stakeholder involvement in N&S Closure Process applications should be conducted though those existing programs and specialists in those programs should be involved early in the initiation of the Process. A sample DOE-HDBK-1148-2002 28 discussion pertinent to Stakeholder involvement in a Process application at the Savannah River Site is included as Appendix B. 7.3 Role of the Convened Group A fully engaged Convened Group will significantly reduce the time needed to define the work and identify the hazards. Throughout the Process the Convened Group acts in a leadership role and closely interacts with assigned task teams to: C Define the work; C Identify the hazards; C Identify performance objectives and expectations to be satisfied by the WSS set; C Identify resource constraints; and C Ensure that the implementation of the resulting WSS set is feasible. Should the Convened Group fail to come to a consensus on any one of these tasks or fails to communicate its consensus clearly, the Process will not proceed efficiently and there will be a continuous need to provide revised guidance. When the Convened Group “begins with an end in mind,” one that is focused first on the work performance objectives, the Convened Group helps the Identification and Confirmation Teams to converge on a tailored set of standards. A tailored WSS set contributes directly to accomplishment of doing work safely. To provide a framework for the formal structure to the Process, the Convened Group will establish protocols and documentation requirements. These are developed and presented for approval by the Process Leader. While the Convened Group is responsible for deciding on subjects to be addressed by protocols (based on complexity and uncertainty), the following is a typical list of items for which a protocol should be developed or a specific decision should be reserved to the Convened Group: C identification of the Approval Authorities, DOE-HDBK-1148-2002 29 C identification of the process to be followed to gain approval (schedules, time limitations, and approval defaults), C identification of methods for identifying significant issues and for resolving differing opinions,

C identification of qualification requirements for team members, and C identification of the basis for the establishment of a necessary and sufficient set of standards While the primary documentation for adequacy of the Process product will be developed by the teams, the Convened Group should develop a formal method to document their decisions as the Process develops. Many of the attributes that support a feasibility determination for the proposed WSS set will be captured in this record. It will be necessary to describe in detail some of the key steps and responses to the uncertainties which are inevitable. Experience has shown that it is far better to document these events when they occur, rather than attempting to build the record later. Effective Convened Groups obtain Stakeholders and Interested Parties’ views often as input to the decision making process and provide clear, consistent information to the Process Leader concerning performance expectations and objectives that must ultimately be satisfied by the implemented WSS set. 7.4 Role of the Process Leader The Process Leader should be proactive in identifying appropriate individuals to serve on the Convened Group. Typical candidates are representatives from the Agreement Parties and the Resource Authorities. The Process Leader convenes the first meetings of the Convened Group. There are two items of business which should be addressed during the early meetings. First, the Process Leader DOE-HDBK-1148-2002 30 should conduct an appropriate level of training and indoctrination for members of the Convened Group. This training can be tailored based on the experience and background of the Convened Group. Second, the Process Leader should present to the Convened Group a recommended approach for the development of Convened Group protocols and documentation requirements. These are the top level or initiating decision making processes, which are discussed as Convened Group responsibilities in Section 7.3 above. The objective of these tasks is to establish a credible structure that will provide assurance that the final set of standards will be adequate and meet the Process work requirements of the Approval Authorities. The efforts of and documentation created by the Process Leader typically provide the foremost evidence of fidelity to the Process Manual requirements. DOE-HDBK-1148-2002 31 8.0 Defining the Work and Associated Hazards Process Leader (Section 8.2) Convened Group (Section 8.3) Tech. & Op. Experts (Section 8.3) Resource Authorities (Section 8.2) Stakeholders & Interested Parties (Section 8.4) Request info on work to be performed and resources Assist in providing info on work to be performed Provide info on resource availability and constraints Provide info on work & resources Coordinate Acquire and organize info on work to be performed and resources Establish channels of communication, provide info about the process, and obtain input Provide feedback & input Provide feedback on Stakeholders’ & Interested Parties’ concerns Review & endorse initial definition of work, hazards, and expectations Compile definition of work, hazards, and performance expectations Revise definition of work, hazards, and expectations as necessary Feedback from other process elements Agreement Parties (Section 8.1) Provide further information on work to be performed and performance expectations DOE-HDBK-1148-2002 32 8.1 Defining the Work and Hazards

The identification of work and associated hazards is one of the most critical elements in the N&S Process. Proper identification requires application of the collective knowledge of DOE and contractor personnel who have direct experience with the work, the hazards and the workplace. Without a clear definition of the work and its associated hazards and uncertainties, a set of standards may be insufficient to provide the desired level of protection or may contain inappropriate standards that will waste resources. For established and on going activities, this may only require assembling existing documentation. For new activities, this effort may involve the development of a rigorous hazards identification process conducted in conjunction with the formal engineering design process. The identification of the work and the hazards actually begins with the determination that the N&S Closure Process should be applied. DOE and contractor management identify the scope(s) of work for Process application. As work progresses from Agreement Parties to Convened Group to Identification Team, the definition of the work and hazards becomes progressively more refined. The N&S Closure Process is by intent iterative in nature and this iteration among the teams has been most evident in reaching agreement on clear definition of the work and hazards. Teams have gone though many cycles of work design, hazards elimination and hazards control in order to first eliminate hazards from the work place and then agree on the residual hazards which must be controlled. Good communication among teams is essential and the Agreement Parties must be well engaged to assure themselves that factors of engineered design, process design, work design and other hazard controls are addressed. 8.2 Role of the Process Leader Ensuring the accurate identification of the standards set for the scope of work and associated hazards is one of the most important duties performed by the Process Leader. After conducting any research and study of the subject, the Process Leader should schedule a session with the members of the Convened Group to ensure that a good understanding of the scope of work and the definition of the hazards has been established. The Process Leader should have resolved any questions on this subject with key personnel such as line managers, the contracting officer, DOE-HDBK-1148-2002 33 and the Resource Authorities, and should be prepared to present the findings to the Convened Group. Accurate definition of the work and hazards is the heart of the N&S Process, and reaching closure on this definition is an iterative process that will require the Process Leader, with assistance from the Convened Group, to acquire and organize information from other sources such as Agreement Parties, Technical and Operational Experts, and Resource Authorities. The end result should be a clear definition of the work, hazards, and performance expectations that is agreed upon by both the Process Leader and the Convened Group. Typical questions and concerns that the Process Leader should discuss and resolve with the Convened Group include: C What are the goals for safety, quality, and performance expectations for the work? C What is the scope of the work and what are the associated hazards? C What are the physical conditions within which the work is performed? C What materials and conditions could cause adverse consequences?

C What are the areas of uncertainty associated with the work? C What are the resource availabilities and constraints? C What are the organization and management relationships that must be considered? C Who are the Stakeholders and Interested Parties? C What is the previous extent of Stakeholders’ and Interested Parties’ involvement? C What are Stakeholders’ and Interested Parties’ concerns and channels of communication? DOE-HDBK-1148-2002 34 C Are there unions involved who need to be contacted? C Will the work to be done have an impact on the public as well as workers? C Are there citizen’s groups that need to be notified? C How will Stakeholders and Interested Parties be notified? 8.3 Role of the Convened Group As discussed above, the Convened Group should provide any necessary direction to the Process Leader to ensure that the scope of work and the identification of hazards are well understood. This scope may be broader than originally conceived. Just as ISM encompasses all aspects of safety management, the N&S Process should include all ES&H aspects of the performance and management of work. The Convened Group should carefully review any data and information assembled by the Process Leader to ensure that it is complete. To do a credible job may require additional Technical Experts to assist the Convened Group. This review also provides an opportunity for the Convened Group to determine if any of the identified hazards can be reduced or eliminated by the use of alternative material or methods. At the end of this assignment, the Convened Group should be able to endorse the initial definition of the work, hazards, and performance expectations as compiled by the Process Leader. The Convened Group must decide what interfaces will be established with Stakeholders and Interested Parties. After establishing the need for the interface, there will be a need to establish how the information can best be provided to them. The goal of this step should be to achieve Stakeholders’ and Interested Parties’ support for the Process and to solicit their input. Input received should be provided to the Process Leader for consideration in developing the definition of work, hazards, and performance expectations. 8.4 Stakeholder and Interested Parties Involvement Stakeholders and Interested Parties who have indicated that they want to participate should be provided ample opportunity to do so. The effective involvement of Stakeholders and Interested DOE-HDBK-1148-2002 35 Parties will help to ensure that the resulting tailored set of standards will be received with support and understanding. The procedures for involving the Stakeholders and Interested Parties should follow the normal site practices or site plan for conducting these interactions. DOE-HDBK-1148-2002 36 Process Leader (Section 9.2) Convened Group (Section 9.2) Identification & Confirmation Team Members (Section 9.5) Coordinate and assist in developing specifications for team qualifications and composition Provide information concerning nature of the work, its complexities, hazards, and uncertainties Determine specifications for the Identification and Confirmation Team(s): •Team functions, relationships, and composition •Team member qualifications Consider inviting consultations from experts from other organizations inside or outside of DOE Arrange for individuals to be assigned to the team(s) Participate in team meetings and decision- making

Ensure documentation of actual team member credentials 9.0 Creating Teams 9.1 Creating Teams Teams are formed to identify the Work Smart Standards set and to confirm that the set is adequate for protection and feasible for implementation. These teams are: the Identification Team, the Confirmation Team, and additional teams, as required (for example, Work/Hazard Identification Team). It is important that the criteria for selecting all team members reflect the full breadth of issues to be addressed, and that well qualified personnel are made available for these critical assignments. DOE-HDBK-1148-2002 37 9.2 Roles of the Convened Group and Process Leader The Process Leader and the Convened Group should carefully deliberate and agree on the composition and prerequisite qualifications and experience required for membership in the Identification Team(s) and the Confirmation Team. The breadth and specialties of technical and management systems should be specifically identified. Typical candidates to be considered include personnel who are knowledgeable of the work design and performance as well as experts in occupational safety and health, radiation safety, waste management, environmental protection, and quality assurance. Each application of the N&S Process will be unique, so the selection of technical expertise should be appropriate for the work; including personnel with operational expertise and practical work experience is essential. Typical candidates include representatives from facility management and operations. Consideration should also be given to inviting participation by experts from other organizations, either inside or outside the DOE complex. Such broadened participation will enhance the Process and the resulting set of Work Smart Standards. The Convened Group, in coordination with the Process Leader, should establish the specific criteria for assignment to membership on the Identification and Confirmation teams. These requirements may include a prerequisite number of years experience in a technical field, educational degrees, and specified operational expertise. It may be appropriate to require demonstrated performance in fields requiring knowledge of both commercial standards, DOE Orders and standards applicable to the discipline. Establishing the correct prerequisites for assignment to the Identification Team is an essential first step to ensure that qualified personnel are assembled to develop a comprehensive set of standards. Appendix C provides an example of such qualification requirements. 9.3 Criteria for the Identification Team The identification of a Work Smart Standards Set for a defined scope of work relies on the collective judgment of a team of people who are knowledgeable of the work. The team must establish that implementation of the set is feasible and that the set provides a basis for reasonable assurance of adequate protection. The nature of the work, its complexity, hazards, and uncertainties will determine the breadth of knowledge needed within the Identification DOE-HDBK-1148-2002 38 Team. Stakeholder input should be managed by the Convened Group since the Federal Advisory Committee Act (FACA) precludes direct involvement by Stakeholders. The Identification Team collective qualifications should include: C relevant knowledge, experience, and competence in the work to be performed under the WSS set; C relevant knowledge, experience, and competence in identifying and evaluating the

hazards associated with the work; C relevant knowledge and competence in the broad array of existing requirements, standards, and proven techniques for control of hazards (for example, DOE Directives, industry codes and standards, applicable laws and regulations); and C the contribution of subject matter experts, as needed, when qualifications and skills are required. A sample of a protocol defining the qualification requirements for membership in an Identification Team is included in Appendix C. 9.4 Criteria for the Confirmation Team There is considerable latitude available in selecting the Confirmation Team. The Confirmation Team should be separate from the Identification Team but need not be completely independent, for example, the same organization may provide individuals to serve on both teams. The level of formality and degree of independence should be determined by the Convened Group based on individual circumstances of the particular Process application. For complex or controversial issues, Confirmation is expected to involve rigorous methods including, as appropriate, fully independent review teams. The decision of the Convened Group on the Confirmation approach should be based on an evaluation of the complexity, risk, and significance of the work. Past Confirmation Teams have consisted of a separate peer review group within the Identification Team in lower hazard applications; Confirmation Teams in applications dealing with nuclear DOE-HDBK-1148-2002 39 category II hazards have included an independent group of technical experts, many from external organizations. Including technical experts from outside the DOE complex can provide useful perspectives to the Confirmation Team. The requirements of the Federal Advisory Committee Act may apply to Confirmation Team activities. Appropriate legal counsel should be consulted if it is desired to include personnel other than DOE and other Federal employees, and DOE contractor and subcontractor personnel. The collective qualifications of the Confirmation Team should be sufficient to demonstrate and justify the team’s conclusion that the proposed WSS set can provide reasonable assurance of adequate protection and is feasible for implementation. The collective skill inventory of the Confirmation Team should be sufficient to examine the application of skills by the Identification Team. The collective skills inventory of the Confirmation Team should overlay the collective skill inventory of the Identification Team; however, it is not expected to be identical. The Confirmation Team should have maturity of view, broadness of perspective and application of skills. The Confirmation Team collective qualifications should include: C relevant knowledge, experience, and competence in the work to be performed under the WSS set; C relevant knowledge, experience, and competence in identifying and evaluating the hazards associated with the work; C relevant knowledge and competence concerning existing requirements, standards and proven techniques (both technical and management) for controlling hazards; and C “intellectual expertise” as would be required in the application to hazards control of scientific, engineering, analytical, and legal matters and “experience expertise” as would be required to conduct skilled hands-on work, applied engineering, work planning and procedure development, and management/supervision. DOE-HDBK-1148-2002 40

With respect to feasibility of the proposed WSS set, the Confirmation Team is expected to assess the credibility of the Convened Group’s demonstration on this point. The Confirmation Team is not expected to develop a completely independent verification of feasibility. Subject matter experts should be provided to the Confirmation Team to augment the team with detailed knowledge if required. The individuals selected for membership on the Confirmation Team should be capable of rationally developing and articulating their judgments and should have the ability to judge the feasibility of the WSS set. 9.5 Selecting the Identification and Confirmation Teams Once the criteria for team selection have been established, the process of selecting and notifying the team members should proceed. Members selected should be able to dedicate themselves for the period of time allotted to develop/confirm the comprehensive list of standards. For this process to work effectively, managers should support the assignment of qualified individuals to these teams. The Process Leader may consider the assignment of personnel within subteams to efficiently address selection of standards within specific disciplines. Selection of effective subteam leaders is an important step to ensuring that the identification efforts are closely coordinated, well managed, and that good communications among the subteams and the Process Leader are established. Examples of organizational structures established to conduct the N&S Process are included in Appendix D. DOE-HDBK-1148-2002 41 Process Leader (Section 10.3) Convened Group (Section 10.2 & subsections) Identification & Confirmation Team Members (Sections 10.2.2 & 10.3) Communicate process and team protocols and documentation requirements Establish team protocols and documentation requirements regarding: • team member roles and responsibilities; • training team members on the N&S Process; • developing plans, procedures, schedules, and cost estimates; • resolving team comments; • interacting with non- members; and • additional team-level documentation requirements Establish protocols and agreements regarding: • schedules; • resolution of differing opinions; • Convened Group/Team interactions; and • Convened Group/Stakeholder interactions Establish requirements for documenting: • definition of the work, hazards, and performance expectations; • the set of Work Smart Standards; • justification for the set’s adequacy; • implementation assumptions and interfaces; and • justifications for exemptions Conduct process in accordance with protocols and documentation requirements Provide information concerning qualifications and experience Participate in establishing team protocols and documentation requirements Communicate process protocols and documentation requirements 10.0 Defining and Agreeing to Protocols and Documentation Requirements 10.1 Protocols and Documentation Effective protocols and documentation requirements provide an important foundation for smooth functioning of the Process and understanding of its results by others who were not directly involved. As discussed in Section 7.3, the Convened Group, with the support of the Process Leader, should identify and develop protocols and documentation requirements beginning DOE-HDBK-1148-2002 42 shortly after the Convened Group is assembled. This is particularly important so that necessary records can be constructed early in the application. Then records can continue to be

maintained as the Process proceeds, rather than having to reconstruct the history of decisions later. Before beginning the work of identifying, confirming, and approving the set of WSS, all participants must understand and agree to the “ground rules” governing how the various groups and teams will interact with each other and with outside parties. Clear and concise protocols will aid in efficient team functioning, while overly prescriptive protocols that are not thoroughly thought out can cause confusion and lead to inadequate results. It is equally important to define documentation requirements. Careful documentation of the N&S Process will aid in communication between the Identification and Confirmation Teams and assist others in understanding the standards set developed. Records of Process decisions help to demonstrate both the feasibility and fidelity of the Process results. The relationship between protocols and documentation requirements is an important one. A protocol should address each item of documentation (expected output) from the Process. 10.2 Role of the Convened Group The Convened Group establishes the framework for how their particular application of the N&S Process will be conducted. Decisions are needed in two areas: (1) protocols and agreements for interactions among the various groups and teams involved in the N&S Process, and (2) documentation requirements for the Process and its results. These decisions should be made in close coordination with the Process Leader, and should be documented in a record of decisions. Doing so will establish a common basis for implementing the Process, aid in orienting new team members, and provide a record that will be helpful in demonstrating Process fidelity. DOE-HDBK-1148-2002 43 10.2.1 Establishing Protocols and Agreements The Convened Group establishes protocols and agreements concerning the following: C Schedules and time limitations. The schedule for completing the N&S Process may need to be linked to internal or external commitments, or to schedules for related activities such as ISMS implementation or contract renegotiation. C Resolution of differing opinions within the Convened Group and the team(s). Careful and thoughtful application of the N&S Process will often result in differing opinions among team members. Since this is an expected part of the N&S Process dynamic, this protocol should provide a means for reaching closure on important issues while ensuring due consideration (and, if necessary, documentation) of differing opinions. Existing site practices or protocols for conflict resolution or differing professional opinions may prove helpful. Such a protocol should also address how collective differences of opinion among various groups (for example, Identification and Confirmation Teams) would be resolved. C Interactions between the Convened Group and the team(s). These protocols should address the formality and frequency of interactions between the Convened Group and the Identification and Confirmation Teams, including how the Convened Group will provide direction to and address questions from the team(s). In many cases it has been found helpful to conduct all communications between the Convened Group and the team(s) via the Process Leader. Consideration should be given to the size of the team(s) and whether all members are at the same geographic location. C Interactions among the Convened Group and the Stakeholders and Interested Parties.

Appropriate interaction with Stakeholders and Interested Parties is critical to the success of the Process. The Convened Group provides the primary point of contact for Stakeholders and Interested Parties relative to the N&S Process. The value of a carefully thought-out approach for communicating with Stakeholders and Interested Parties about the Process has been proven even when interactions with these groups DOE-HDBK-1148-2002 44 are expected to be relatively minor. Existing mechanisms for Stakeholder and Interested Party involvement and input should be used where feasible. The above areas represent the minimum protocols established by the N&S Manual that must be considered by the Convened Group. The Convened Group may well discover other areas for which protocols and agreements should be established. Protocols and agreements should be clearly communicated to all other Process participants. A sample of a charter which includes a protocol developed during a N&S Process application is included in Appendix E. 10.2.2 Establishing Documentation Requirements The Convened Group establishes requirements for which items need to be documented during the Process and the level of detail for each. For some items, determination of an appropriate format and level of detail may need to be accomplished iteratively as the Identification Team develops the set of standards and provides recommendations concerning its documentation. The N&S Manual specifies five areas for which the Convened Group must establish documentation requirements. These and additional areas that may need to be documented to ensure an adequate record of how the N&S Process is to be implemented are discussed below. C Definition of the work, hazards, and performance expectations and objectives. Existing safety documentation concerning work and hazards may be useful, but should be evaluated to ensure that all hazards are addressed. Definition of performance expectations and objectives may include schedules for completion of the WSS set, determination of costs, or establishment of performance measures. Documentation for this area should be planned to: C identify the linkage between the work and associated hazards; C match the level of detail to the specific application; C support documentation of the safety program; C establish buy-in for performance metrics; and DOE-HDBK-1148-2002 45 C establish the basis for composition of the teams. C Documenting the Set of Work Smart Standards. This documentation compiles the set of standards appropriate for safe conduct of work, including all applicable laws and regulations. There are a number of considerations for deciding how to document a WSS set: C How standards are to be expressed in the WSS set: Successful N&S Process applications have used a variety of means to document the set of standards selected including citing the overall regulation or standard, the specific applicable subsection of a regulation or standard, and even the text of the requirement. A high degree of specificity may facilitate development of local procedures from the standards. However, attempting to precisely identify specific sub-sections may risk excluding some applicable portions of a regulation or standard. Listing the full text of all standards may make the set unwieldy, but may be useful when internal standards are used or when only minor portions of a source document are relevant.

C How the WSS set is to be organized: Documentation of the WSS set should be planned to provide ease of use for all potential users. Computerized databases offer enhanced ability to sort and search the standards list. C Tools to be used for documenting the set: The expected size of the WSS set and how it will be used should be considered. Word processing and spreadsheet programs have limited searching and sorting capabilities as compared to data base systems. C Justification for the WSS set’s adequacy. Documentation should clearly show that the N&S Process has been faithfully followed by qualified people. Documentation should clearly establish the linkage between the work, the hazards/safety issues, and the WSS set. Key factors to document are : (1) a qualified group of individuals considered the work and hazards, logically selected an appropriate set of standards, justified the DOE-HDBK-1148-2002 46 selections, and resolved any differences of opinion; and (2) a second group of qualified individuals confirmed the chosen set as adequate and feasible. Documentation of these activities, to whatever level of detail the Convened Group deems appropriate, should include the following components: C team member names, responsibilities, and qualifications; C results of the confirmation process; C discussion of differing opinions and their resolution; and C documentation of linkage between the WSS set, the work, and the hazards. C Implementation assumptions and interfaces. Assumptions are statements that provide additional information helpful to understanding and implementing the WSS set. They may provide limits on applicability, interpretation of scope, clarifications, feasibility, or acceptable degrees of implementation. Interfaces clarify where information is located, the boundaries of the work scope, and how the WSS set relates to other sitewide safety standards. The level of detail is an important consideration in planning how to document interfaces and assumptions. Guidance on where to document the information (for example, in connection with a particular standard in the WSS set, or in the Process description documentation) should be carefully considered to support later demonstrations of feasibility. C Justifications to support exemptions from legal requirements. Exemption requests should be considered for regulatory requirements that are deemed unnecessary for adequate protection. Documentation to support requests for regulatory exemptions will need to be rigorous and meet any requirements established in applicable regulations. Exemption requests will normally need to be supported by additional documentation beyond that which satisfies the requirements of the N&S Process. C Involvement of Stakeholders and Interested Parties. Documentation of Stakeholders’ involvement in the Process provides a vehicle for meaningful input while recognizing that DOE-HDBK-1148-2002 47 Stakeholders are not decision makers in the N&S Process. Documentation may include a summary of organizations or individuals contacted, public or other meetings held, feedback from those meetings, desire for further participation by attendees, and disposition of comments received. Stakeholders may provide opinions and comments but the scope of their involvement must adhere to the requirements of the FACA. Stakeholders do not participate directly in the deliberative process. Documentation

should demonstrate that Stakeholders have been appropriately involved consistent with protocols and FACA constraints. Interested Parties may participate more directly in the Process, and the Process documentation similarly should make clear what Interested Parties were invited to participate, the extent of their involvement, and the disposition of their input. In establishing requirements for each area of documentation, the Convened Group should consider both the appropriate level of detail of documentation and the target audience. Specific considerations concerning the target audience are discussed in Section 10.4. A discussion of documentation characteristics and considerations can be found in DOE Guide 450.3-1, Documentation for Work Smart Standards Applications. 10.3 Role of the Process Leader The Process Leader works closely with team members to establish protocols for the internal operation of the Identification and Confirmation Teams. These protocols should mesh with the overall Process protocols developed by the Convened Group, and include the following: C Establishing team members’ roles and responsibilities. The Process Leader and team members should agree on the responsibilities and time commitments expected of team members. C Orienting team members. Initially, most team members may not be familiar with the N&S Process, so some amount of training and orientation will be necessary. The means and schedule for accomplishing this should be planned early on in the Process so that team members can be prepared to assume their duties. DOE-HDBK-1148-2002 48 C Developing plans and procedures, including schedules and cost estimates. These should be consistent with the overall Process schedule developed by the Convened Group, though they will necessarily reflect a greater degree of detail. C Resolving team comments within the team. Before beginning their deliberations, the teams should have a common understanding of how they will work to reach consensus on important issues while ensuring that differing opinions are fairly considered. In the event that a team cannot reach consensus on an issue, then the “differing opinions” protocol developed by the Convened Group should be applied. C Interacting with non-members. The teams should be expected to consult Operational and Technical Experts or other parties to clarify information included in the definition of work and hazards. Plans for these exchanges, including assignment of responsibilities and points of contact within the teams, should be made before the teams begin their work. Interactions with Stakeholders and Interested Parties will generally be conducted via the Convened Group and according to protocols they have established. The Process Leader may be tasked to interact on behalf of the Convened Group with these various parties. As with the Process protocols developed by the Convened Group, the team protocols should be documented. The Process Leader and team members should also establish any additional requirements for documentation of team activities that they deem appropriate and that are not included in the Convened Group’s documentation requirements. 10.4 Audiences for Documentation Documentation requirements should be planned with an awareness of the target audience and their concerns. Primary audiences for N&S Process documentation are: C workers and staff (such as ES&H and technical staff) associated with the safe

performance of the work for which the N&S Process was performed; DOE-HDBK-1148-2002 49 C management, contracting, and legal personnel (both DOE and contractor) who may need to establish and monitor compliance with contract requirements; C individuals performing the N&S Process, particularly the Convened Group; C inspection, enforcement, and legal personnel from the site, the cognizant DOE Operations Office, or DOE Headquarters who may need to review compliance with the WSS set and adherence to the Process; C Stakeholders and Interested Parties, including federal, state and local regulatory authorities with legally assigned interests in the work for which the N&S Process was performed; and C Confirmation Team members and Approval Authorities who will judge the adequacy and feasibility of the WSS set. It is intended that the performance of the N&S Process will be progressively documented as it is performed and that a report will be developed that documents the basis for the identification of the work, the identification of the hazards, and the development of the selected set of standards. The final report should be made available to the public. The report may need to be reviewed for security and business proprietary concerns before being released. Process documentation should be prepared to be understood by objective and reasonably informed individuals knowledgeable of technical and management safety practices. The substance of Process documentation is to establish that the N&S Process has been applied with fidelity to produce an appropriate WSS set that is feasible to implement. Most items of documentation will need to serve multiple audiences, perhaps with markedly different interests and backgrounds. Some may desire information in greater detail. Detailed backup information progressively maintained as the N&S Process is performed can be used to augment the report for audiences who need additional detail. Process documentation justifies the sufficiency of the outputs in a positive sense, by demonstrating that the Process was applied with fidelity. No rationale or justification is needed DOE-HDBK-1148-2002 50 for standards that are not selected as part of the WSS set. Examples of N&S Process documentation can be found on the WSS home page (http:tis.eh.doe.gov/dsc/worksmart.html). DOE-HDBK-1148-2002 51 Process Leader (Section 11.3) Identification Team (Section 11.4) Technical & Operational Experts (Section 11.5) Provide additional information needed to define the work Provide input and assistance as requested Document: • the WSS set; • justification for the set’s adequacy; • implementation assumptions and interfaces; & • justifications for exemptions from legal requirements, if applicable Identify add’l info needed to define the work Evaluate relevant sources of existing standards Identify set of WSS including those legally required and others necessary for adequate protection. Ensure set is feasible to implement. Request additional input/assistance if needed Identify implementation assumptions/interfaces Identify laws/regulations not necessary for adequate protection, as candidates for possible exemption requests Reach consensus on and justify the WSS set Maintain process documentation If unable to identify a necessary & sufficient set, recommend revisions to work definition and/or development of new standards Review & consult with Convened Group Ensure Process protocols are followed; assist in coordination.

11.0 Identifying the Set of Work Smart Standards 11.1 Identifying the Set A Work Smart set of standards is the principal product of a successful N&S Process application. A WSS set includes all applicable federal, state, and local laws and regulations as well as other standards that are necessary and sufficient to provide adequate protection for workers, the public, and the environment. The set must also be feasible for implementation, meaning that it DOE-HDBK-1148-2002 52 can be implemented within expected resource and time constraints. The work of identifying standards is carried out by the Identification Team, operating within the protocols and documentation requirements previously established. Experience has shown that properly performing the identification process will often require more time than initially expected. Identification Team discovery time can be reduced if participants are provided adequate training, a well thought out charter or statement of work from the Convened Group, and strong liaison between the Team and the Convened Group (via the Process Leader). 11.2 Standards Reference Base The term "standards" is intended to have broad meaning. Standards are the expressed expectations for performance of work. Standards may be reference points against which to measure excellence or may become enforceable requirements (either under law or under Department contract.) Standards includes: Federal, state, and local laws and regulations; Department Orders; nationally and internationally recognized standards; and other documents (such as industrial standards) that protect the environment and the safety and health of our workers and the public. Standards are an accepted way of communicating to our workers and the public the performance we expect in our daily operations. They are supportive of work, not barriers or extra burdens. The “starting point” for determination of which standards will be considered during application of the N&S Process is a thorough understanding of the work and its associated hazards. The WSS set is expected to include standards that, when properly implemented, will provide reasonable assurance of adequate protection for workers, the public, and the environment. The WSS set is expected to include all applicable requirements in federal, state, and local laws and regulations, as well as other standards identified through the N&S Process which are necessary and sufficient to provide adequate protection to workers, the public, and the environment. Potential sources of such other standards include, but are not limited to, DOE directives, DOE Technical Standards, and nationally and internationally recognized commercial consensus standards. DOE-HDBK-1148-2002 53 Some safety control topics that are of particular or unique interest to DOE are typically identified for standards definition only in DOE directives. These directives represent a broad-based collective knowledge developed over a wide expanse of often unique hazards and should be considered for applicability to the particular work and hazards under consideration by the WSS set. Safety control topics that are uniquely addressed and invoked by DOE Orders must be addressed in the WSS set if they are relevant to the work and the hazards. Direct incorporation of DOE Orders into the WSS set is one, but not the only, means of addressing these topics. Considerations for the Identification Team in identifying a standard for inclusion in the WSS set

from among competing standards reference bases include: C the expectations of the Convened Group, C acceptability of the identified standard to the collective judgment of the Identification Team, C confidence in the identified standard by the audiences for Process documentation, C feasibility of implementing the identified standard in the context of the work and hazards, C experience in practices for implementing the identified standard, C specificity with which the identified standard addresses the work and the hazards, C familiarity of the work force with implementation of the identified standard, and C the synergistic effect of implementing the identified standard to control more than a single hazard. In some cases, it has proven valuable when documenting the adequacy of the WSS set to include a mapping matrix which illustrates where the topical area of a DOE directive is linked to the same topical area in the identified standards. Such mapping is not mandatory but will facilitate familiarization with the WSS set by other parties. A sample of a mapping matrix which was developed during a N&S Process is provided as Appendix F. DOE-HDBK-1148-2002 54 11.3 Role of the Process Leader The Process Leader plays a vital role in the performance of the Identification Team. The Process Leader facilitates and coordinates the activities of the Identification Team, providing the team with direction and focus that are consistent with direction from the Convened Group. Acting as the formal liaison between the Identification Team and the Convened Group, the Process Leader will need to ensure frequent communication and feedback between the two groups, in accordance with the protocols established previously. In particular, the Process Leader must ensure that the definition of the work and hazards being used by the Identification Team becomes clear and complete. The Process Leader should be alert for the need to seek clarification on this or other issues from the Convened Group, and ensure that the Convened Group stays actively engaged in the Identification Team’s activities. Finally, the Process Leader should guide the Identification Team in documenting their work so that the documentation requirements are met. 11.4 Role of the Identification Team The work of the Identification Team depends on a good definition of the defined work and hazards, and proceeds according to the pre-established protocols under the guidance of the Process Leader. While the team is provided with the definition of the work and the hazards, they should know the work sufficiently to verify that the input they are provided is correct and complete. Because the definition of the work and hazards is intimately related to the process of identifying a set of standards, further refinement of these definitions is an appropriate function for the Identification Team. Throughout their work, they should continue to validate this and challenge the adequacy of the work and hazards definitions. This philosophy should be part of the training for the team. The feasibility of the WSS set depends upon the standards implementors’ recognition of the work as defined. In the event that a significant re-organization of a current work scope is being implemented (for example, with the transition from a Management and Operating to Integrating type contract), this often leads to alternative mechanisms for work planning, increased

interfacing among groups and thus different roles and responsibilities. The Identification Team DOE-HDBK-1148-2002 55 must thoroughly examine the context in which the work will be performed and include standards that address these features. ISM Plans often reflect such standards. Identification Team members should work together to satisfy objectives and expectations established by the Convened Group as a whole, and not to represent individual or organizational agendas. Even with the proper mix of committed, knowledgeable personnel, some time will be needed for the group to “jell” as a team, and to begin working productively under a common set of expectations. The Process Leader’s earlier work with team members in developing protocols and documentation requirements will provide an important foundation for developing a common team approach. Central to this team approach is the need for all team members to be fully qualified, empowered to make decisions, and dedicated to participate. The N&S Process is designed to be carried out by a team, not by an active few reporting back to a larger group of individuals who are only marginally or sporadically involved. Reliance on “alternate” Team members, while permitted, will often impede the timely and effective resolution of issues. The N&S Process is designed to be iterative. As work proceeds in one process element, information from a previous element may need to be revised or expanded. During identification a number of factors (such as the need for different/additional team members, or the need to better define the work and hazards) may arise that require revisiting one or more of the earlier process elements. In addition to identifying other information or expertise needed, the Identification Team performs the following: C Evaluate relevant sources of standards. Drawing on their expertise, the Identification Team evaluates relevant existing standards that address the identified hazards as discussed in Section 11.2, Standards Reference Base. Though it may be tempting at this point to “cut and paste” from the standards set used by another (perhaps similar) DOE site, experience has proven the value of conducting a zero-based analysis to focus on the specific work, hazards and work environment. Such local tailoring ensures that potential feasibility issues are fleshed out and addressed, if necessary, by the Convened Group. DOE-HDBK-1148-2002 56 C Identify the standards that constitute a necessary and sufficient set and are feasible to implement. The WSS set must include all applicable federal, state, and local laws and regulations plus any other standards that are judged necessary to provide adequate protection for workers, the public, and the environment. The determinations of adequacy and feasibility are based on team members’ judgment and experience, buttressed by team interaction and discussion, and the involvement of additional experts if needed. Feasibility relates to the local context and the Responsible Organization’s readiness to implement the WSS set. Contentious issues of feasibility should be referred to the Convened Group as they are responsible for line management buy-in with the WSS set. C Reach consensus on and justify the WSS set. It is essential that team members begin by “agreeing to agree” and engage in constructive dialogue to reach consensus.

Protocols for group decision-making and consensus should be applied. Since experience has shown the value of synergistic interactions among team members with different technical backgrounds, most of the team’s work should be conducted in face-to- face meetings. Justification means that a rationale is developed for the adequacy and feasibility of the standards proposed for inclusion in the WSS set. Consideration of feasibility should be in consonance with the conclusion that the standards set provides reasonable assurance of adequate protection. Feasibility focus is not on the ability of the standards to guide performance (i.e. "adequacy"), but rather on a potential future failure to achieve standards-based and safe work. Such failures could occur if management systems and processes are not capable of delivering work based on the WSS set or if resources are not sufficient to design and perform the work consistent with the WSS set. The N&S Closure Process requires the Identification and Confirmation Teams to assess both the adequacy and feasibility of the standards set. The agreed upon definition of the work and the institutional implementing assumptions about how that work will be carried out are first developed as a description of initial conditions by the Convened Group during Process Element 1: Defining the Work and Hazards. The requirements for describing both work objectives and a relationship for those work objectives to some organized system for the delivery of that work are equally important to the ultimate utility of the WSS set. By starting with the Convened Group’s core of guidance, the identification team is reasonably expected to further refine the definition of DOE-HDBK-1148-2002 57 work, hazards and controls in a way that integrates implementability and technical sufficiency to provide for adequate protection. Explaining the disposition of standards which were not selected is neither required nor desired. It is often helpful to provide a mapping matrix which illustrates how the topical area of identified standards link to the same topical area of DOE directives. Although not required, such cross-referencing will facilitate later review of the WSS set. Mapping the proposed WSS set back to the identified work and hazards has proven to be an effective way to evaluate the comprehensiveness of a proposed WSS set. Also, experience has shown that a WSS set derived from the work and hazards may result in a need to modify existing management systems. Mapping is an extremely valuable tool to aid in transitioning from the as-is management systems to revised management systems that can effectively deliver the WSS set. C Identify any implementation assumptions and interfaces. Implementation assumptions include any unique resource requirements or time constraints for the use of certain selected standards. Interfaces relate to the relationship between the requirements associated with the work to be performed and others beyond the scope of that work. These requirements may be organizational, physical, or programmatic. Clear identification of any implementation assumptions and interfaces is critical to prevent the WSS set from being applied counter to the Identification Team’s intentions. These factors should be addressed in detail to support the Confirmation Team’s review for the feasibility of the set. C Identify legal requirements that may be candidates for exemption requests. The

Identification Team may judge the value of applicable regulatory requirements included in the WSS set. Exemption requests may be appropriate for regulatory requirements that are deemed unnecessary for adequate protection. If such requirements are found, the Identification Team should provide a thorough justification to support an exemption request from the appropriate regulatory body. Actual preparation and follow up of any exemption requests will be performed separately from the N&S Process itself, but will rely heavily on the work of the Identification Team. Each applicable legally binding requirement is mandatory and continues in force until and unless the mandating authority provides an exemption to the requirement. DOE-HDBK-1148-2002 58 C Document results. Documentation should be prepared according to the Process and team protocols discussed earlier. The importance of careful and thorough documentation cannot be overemphasized. Documentation prepared by the Identification Team will form the basis for demonstrating fidelity to the N&S Process, for understanding the WSS set, and for communicating Process results to the Confirmation Team, the Approval Authorities, and to Stakeholders and other Interested Parties. 11.5 Role of Technical and Operational Experts Assistance from Technical Experts or Operational Experts may be requested when the Identification Team requires additional expertise in a specific area. Technical and Operational Experts are not necessarily members of the Identification Team, but are requested as required to provide input and assistance for a specifically defined area. The use of such contributing experts will be dictated by the complexity of the Process application and the composition of the Identification Team. The Identification Team is solely responsible for its work product; use of subject matter experts is not a compensatory measure for inadequate range of knowledge and experience on the Identification Team. The Team should recommend its membership be expanded if it becomes dissatisfied with its collective knowledge and experience. 11.6 Process Documentation General considerations for developing N&S Process documentation have been discussed earlier in Section 10.2.2. Documentation from the Identification process will be needed to support confirmation, approval and maintenance of the WSS set. The bases documentation should be sufficient to clearly identify the bases for the WSS set. This is of significant importance for maintaining the standards set. Specifically, documentation from the identification process should demonstrate the following: C Identification Team members are adequately qualified, both collectively and individually, in relation to the work and hazards addressed by the WSS set. Since the qualification of team members is crucial, documentation should relate the team’s qualifications to the DOE-HDBK-1148-2002 59 standards set. An adequately formed Identification Team must demonstrate that it is more than the sum of narrow discipline expertise. C The N&S Process was implemented with fidelity to the requirements of the N&S Manual. This may include documentation describing the initiation of the Process, assignment of responsibilities within the Identification Team, meeting notes, results of deliberations, plans, schedules, training records, issue identification and resolution, and others. In

addition, documenting input from contributing experts, resolution of differing opinions, and development of consensus among the Identification Team will provide valuable insights for confirmation. C The proposed set of WSS addresses all hazards related to the work and, when properly implemented, will provide adequate protection from those hazards for workers, the public, and the environment. When the use of locally developed standards is judged necessary, the documentation for these standards needs particular care. Documentation of feedback from Identification Team members and contributing experts is important. C The proposed set of WSS is feasible to implement within the context of the work to be accomplished and known resource constraints. The Identification Team’s consideration and determination of feasibility should be clearly documented to facilitate review by the Confirmation Team and the Approval Authorities. The quantity and detail of documentation should support and not overwhelm subsequent reviewers or the eventual users. Simply “documenting everything” will not necessarily ensure that the needs of all (or even most) users will be met. Documentation that reflects some synthesis or summary is generally more useful than a mass of raw data (for example, a summary of issues raised by the team and their resolution versus detailed minutes of every meeting and phone conversation). However, documentation and retention of certain items of “raw data” obtained during the Process may be important to preserve corporate memory of the Process and to corroborate summary reports. A discussion of documentation characteristics and considerations can be found in DOE Guide 450.3-1, Documentation for Work Smart Standards Applications. DOE-HDBK-1148-2002 60 Process Leader (Section 12.4) Identification Team (Section 12.3) Confirmation Team (Section 12.5) Provide appropriate process documentation Review documentation Provide documentation of Identification Team’s work and results Determine if the proposed set of standards is adequate and feasible Document confirmation activities and results Assist Confirmation Team in understanding the Process, following protocols, and meeting documentation requirements 12.0 Confirming the Set of Work Smart Standards 12.1 Confirming the Set Confirmation occurs after satisfactory completion of the identification process, when the Identification Team’s results are turned over by the Convened Group to the Confirmation Team. The confirmation process is akin to peer review of a scientific paper or research results. It may identify serious flaws or minor adjustments needed in the WSS set, or may completely confirm the Identification Team’s selections with no changes. In each case, confirmation strengthens the N&S Process by providing assurance that conclusions reached by the Identification Team were sound. The results of confirmation allow the Approval Authorities and other parties -- particularly those external to the Process application -- to have greater confidence in the adequacy and feasibility of the WSS set. DOE-HDBK-1148-2002 61 12.2 Readiness for Confirmation The WSS set is ready for confirmation when the Process participants (including the Process Leader, the Identification Team, and the Convened Group) are satisfied that they can demonstrate fidelity to the Process; can justify that the WSS set will afford reasonable

assurance of adequate protection for workers, the public, and the environment; and that the WSS set is feasible for implementation. This means that confirmation may begin when, in their view, the Process participants have completed, documented, and are prepared to report the results of their use of the N&S Process. Confirmation itself is neither a self-assessment nor a forum for adjudicating issues unresolved by the Identification Team. Self-assessments of the Process and its results can be of great value and should be conducted prior to confirmation. Such self-assessments (sometimes referred to as “murder boards”) should be rigorous to ensure the WSS set and Process documentation are ready to withstand scrutiny by the Confirmation Team. Issues or questions raised during confirmation should be resolved between the Confirmation and Identification Teams, or if necessary, with the Convened Group. Confirmation itself should not be undertaken until all participants, including the Convened Group, are satisfied that all previous process elements have been fully completed and appropriately documented. A sample of evaluation criteria to be used in the development of self-assessment programs for evaluating the performance of the N&S Process and confirming readiness is provided in Appendix G. Experience with the Process has demonstrated that on occasion readiness for confirmation is judged primarily against the adequacy of the WSS set and at the expense of demonstration that implementation of the set will be feasible. The Confirmation Team may lack the Identification Team’s familiarity with local infrastructures for planning and doing work. Confirmers may benefit from briefings or documentation regarding the “as is” condition that is the foundation upon which the new WSS set will be laid. 12.3 Role of the Identification Team The work of the Identification Team, including their documentation, provides the starting point for confirmation as well as approval of the WSS set. It is essential for the Identification Team to DOE-HDBK-1148-2002 62 understand the confirmation and approval processes and to prepare documentation that will clearly demonstrate, under rigorous review, fidelity to the N&S Process and the adequacy and implementability of the WSS set. Complete documentation justifying the adequacy of the proposed WSS set should be prepared for transmittal to the Confirmation Team, along with a list of the complete set of proposed standards linked to the work and hazards. 12.4 Role of the Process Leader The Process Leader plays a key role in confirming the WSS set. The Process Leader facilitates and coordinates the activities of the Confirmation Team and provides the team with direction and focus that are consistent with direction from the Convened Group. Although the Confirmation Team is expected to operate more independently than the Identification Team, the Process Leader should be sufficiently involved in the confirmation process to ensure that a proper understanding of the N&S Process application and the protocols established by the Convened Group are followed. Any significant issues raised by the Confirmation Team should be brought to the attention of the Convened Group as they are raised, in the event that the Convened Group may need to act on issues raised by the Confirmation Team. Since the Confirmation Team will likely involve individuals who are new to the N&S Process, the Process

Leader should orient the team members to the goals, objectives, and methods of the N&S Process in general as well as to the particulars of the individual Process application. Finally, the Process Leader should guide the Confirmation Team in documenting their work to meet the previously established documentation requirements. 12.5 Role of the Confirmation Team The role of the Confirmation Team is to independently assess whether the proposed WSS set developed by the Identification Team is adequate and feasible. Membership qualifications, criteria, and assignments are developed by the Convened Group earlier in the Process. Typically membership of the Confirmation Team is independent from the Identification Team. Should members of the Identification Team be included in the Confirmation Team, those members should not review their own work. Once constituted, the Confirmation Team performs the following tasks: DOE-HDBK-1148-2002 63 C Review the material provided by the Identification Team and any other documentation required for confirmation. Documentation and presentations provided by the Identification Team should facilitate an understanding of the work and the set of standards selected and the rationale for a judgment of adequacy. The Confirmation Team should be free to draw upon whatever additional resources they feel are necessary to arrive at an independent conclusion. If additional documentation from the identification process is needed, this should be requested through the Process Leader. The Confirmation Team’s principal focus is to assess the adequacy and feasibility of the proposed WSS set, not to repair shortcomings identified or to lobby for alternative standards. C Determine whether the proposed set of standards is adequate and feasible. These conclusions should represent independent judgments by the Confirmation Team, based on their collective knowledge and experience. Confirmation does not seek to reproduce the WSS set from scratch, nor is it a “rubber stamp” for judgments made by the Identification Team. Rather, the Confirmation Team provides an independent assessment of the adequacy and feasibility of the proposed WSS set. The confirmation process is guided by the expectations defined by the Convened Group and draws upon the results and documentation from the identification process. C Document the confirmation activities and their results. As in the identification process, documentation from the confirmation process should be prepared according to the Process and team protocols developed earlier. This documentation together with that prepared by the Identification Team will form the basis for a decision by the Approval Authorities. It will also be a key tool for communicating the Process and its results to Stakeholders and other Interested Parties, and should be prepared accordingly. If the Confirmation Team judges the proposed WSS set to be inadequate or infeasible, the Convened Group should be informed and the Confirmation Team’s findings should be referred back to be addressed by either the original or a new Identification Team. The Confirmation Team should provide a thorough explanation and rationale for their decision, so that problematic areas can be appropriately addressed. Even if the proposed WSS set is judged to be adequate or feasible, information from confirmation may suggest the need for rework or improvement in DOE-HDBK-1148-2002 64

some areas. Such actions should be dispositioned and followed up by the Process Leader according to the previously established Process protocols. DOE-HDBK-1148-2002 65 Process Leader (Section 13.2) Convened Group (Section 13.3) Approval Authorities (Section 13.3) Provide appropriate process documentation Establish adequacy of the WSS set: • Process correctly implemented? • Protocols followed? • Identification Team endorsed and justified set as necessary and sufficient for adequate protection? •Confirmation Team agreed that set is adequate and feasible? Determine schedule for approval decision Approve or disapprove set of standards within the scheduled time Inform of approval or disapproval Celebrate or start over 13.0 Approving the Set of Work Smart Standards and Authorizing Work to the Set 13.1 Approving the Set Approval of the WSS set is based on the results of the identification and confirmation processes, and requires continuous engagement by the Approval Authorities from the beginning of the N&S Process. Approval of a WSS set means that the management of the involved organizations (generally DOE and a contractor) formally agree to the following: C that proper implementation of the proposed WSS set will provide reasonable assurance of adequate protection, and that any residual risks are acceptable; C that Resource Authorities will provide, or seek through the normal budget process, the resources necessary to implement the WSS set; and DOE-HDBK-1148-2002 66 C that the WSS set is authorized and accepted for use for the defined scope of work, subject to any implementation assumptions. In many cases, the agreed-upon WSS set resulting from an N&S Process application will need to be incorporated into a contract in order to become effective and binding upon the contractor. Approval itself does not incorporate the WSS set into a contract. However, approval of a WSS set represents a significant agreement between DOE and a contractor and should be planned so that it facilitates contractual modifications. In previous N&S Closure applications, the appropriate DOE Contracting Officer has served as the WSS DOE Approval Authority. The Contracting Officer was involved as an Approval Authority at the beginning of the N&S Closure Process application and was engaged throughout the Process. Contractual negotiations for changes to the contract followed directly from approval of the WSS set. As stated in DEAR 970.5204-78. Laws, Regulations and DOE Directives, paragraph (C): "Environmental, safety, and health (ES&H) requirements appropriate for work may be determined by a DOE approved process to evaluate the work and the associated hazards and identify an appropriately tailored sets of standards, practices, and controls, such as a tailoring process included in a DOE approved Safety Management System implemented under 48 CFR (DEAR)970.5204-2. When such a process is used, the set of tailored ES&H requirements, as approved by DOE pursuant to the process, shall be incorporated into List B as contract requirements with full force and effect." Should the scope of work be revised in such a manner that the work or hazards bases are significantly altered, a reinitiation of the N&S Closure Process may be appropriate. If the standards set is used to identify contractual requirements, a revision to the WSS set will typically be incorporated into List B as a revision to the contract. DOE-HDBK-1148-2002 67

13.2 Role of the Process Leader The Process Leader ensures that all appropriate documentation is made available to the Approval Authorities. The documentation should be sufficiently clear and concise to stand alone and to facilitate decision making by the Approval Authorities. 13.3 Role of the Approval Authorities Following confirmation, the WSS set is presented to the Approval Authorities who have been previously designated by the Convened Group. Approval of the WSS set should be at the level of management where allocation of resources and direction of work clearly reside. It is at this level that the authority to approve will be matched with the responsibility to carry out the work safely. The role of the Approval Authorities is not to “second-guess” the set of standards selected by the Identification and Confirmation Teams, nor to single-handedly replicate the identification and confirmation processes. Rather, the Approval Authorities are tasked to evaluate three specific areas: 1) Whether the Process has been implemented with fidelity, including the provision of proper documentation as defined by the Convened Group. 2) Whether the Identification Team has endorsed and justified the WSS set as providing reasonable assurance of adequate protection when properly implemented. 3) Whether the Confirmation Team has confirmed the adequacy and feasibility of the WSS set. In other words, the Approval Authorities should evaluate whether the N&S Process has been followed with fidelity. The Approval Authorities should not insert changes; however, they may question the results as appropriate. Each step in the N&S Process is designed to build confidence that the WSS set, when properly implemented, will provide reasonable assurance of adequate protection for workers, the public and the environment. Early and continuous close DOE-HDBK-1148-2002 68 involvement by those who will ultimately approve the set ensures a smooth approval process. Examples of Approval Authorities for some successful applications are presented in Tables 1 and 2. Examples of a request for approval of the WSS set and the final approval document are included in Appendix H. The approval of the WSS set should be the final step by the Approval Authorities to assure themselves that the Process has been conducted with fidelity and that all parties involved in developing the set have confidence in the product of the Process. 13.4 Criteria for Sufficiency of the Process Elements Among other things, the Approval Authorities are required to determine whether the N&S Process has been implemented in accordance with the requirements of the N&S Manual. The process elements defined in the Manual are written in performance-based terms, and do not form a prescriptive or generally applicable checklist for determining Process sufficiency. The Convened Group, in implementing the N&S Manual, sets performance expectations and objectives for each step of the N&S Process. If these expectations and objectives have been effectively established, full performance to those expectations and objectives should demonstrate that the Process is sufficient. Appendix G provides a comprehensive assessment tool that can be used to obtain insight about the extent of Process fidelity demonstrated during the application. DOE-HDBK-1148-2002 69 14.0 Implementing the Set of Work Smart Standards For any particular scope of defined work, an approved Work Smart Standards set forms an

essential component of the basis for the related DOE-approved Safety Management System. The WSS set can be viewed as the specifications to the integrated implementing mechanisms, (i.e. procedures and manuals of practice) for the delivery of standards based work. Application of these specifications provides confidence work will be done safely. Throughout the Identification, Confirmation and Approval steps, participants should consider the feasibility of implementing the WSS set through the ISM system. They should identify and document changes that may be required to existing equipment, infrastructure or work processes and cost. The existing procedures and practices may enable implementation of the WSS set or it may be necessary to develop new administrative controls. Where discrepancies are identified with existing implementing mechanisms, these discrepancies are targeted for corrective action and should be tracked to closure. In the case of a new organization that is initiating activities not previously authorized, the implementation of operational readiness review provisions in the WSS set may dictate that a significant level of activity and structure be applied to the conduct of implementation. Criteria for implementation accrue during the Process. As the work of the Process progresses, effective implementation must be an ongoing concern of the Approval Parties, Process Leader, the Convened Group, the Identification Teams and the Confirmation Team. Line management and staff are responsible for implementing the set. The N&S Process participants are responsible for the implementability of the set. The Necessary and Sufficient Closure Process Manual requires that a WSS set be both adequate and feasible. To have a set accepted as feasible it must be implementable. (See also Appendix A, Q&A 20 on Feasibility.) Under the guidance of the Convened Group the Process participants complete responsibilities that will provide most of the criteria for adequate implementation. The following serve to guide managers in the Responsible Organization. In Process Element 1: Defining the Work and Hazards, the requirements for describing both work objectives and a relationship of the work objectives to some organized system for the delivery of that work are equally important to the ultimate utility of the WSS set. By starting with the Convened Group’s core of guidance, the Identification Team refines the definition of work, DOE-HDBK-1148-2002 70 hazards, and control infrastructure in a way that integrates implementability and technical sufficiency to provide for adequate protection. Records of these considerations are made to aid those charged with implementation. In Process Element 4: Identifying the Necessary and Sufficient Set of Standards, relevant knowledge of the work and the available mechanisms of performance are brought to bear to achieve an adequate and feasible WSS set. The requirement that the Identification Team confirm and document implementing assumptions serves to address issues of feasibility in going from the pre-WSS situation of the organization to a post-Process state of WSS conformance. Properly developed WSS sets will document assumptions about the specific “system for managing the work” into which the care and implementation of the new standards set will be entrusted. During Process Element 5: Confirming the Necessary and Sufficient Set of Standards, the

Confirmation Team examines how well the Convened Group and the Identification Team in working to closure on the proposed WSS set have anticipated and addressed the conditions in the implementing organization. This is done to provide the Approval Parties assurance that the existing “system for managing the work” can “get there” (to WSS conformance) “from here” (the prevailing condition of the organization). The Process Leader, in presenting the documentation of the WSS set to the Approval Parties, should indicate what prior steps have been taken toward adequate implementation. Additional implementability actions recommended in the Process documentation should be brought to the attention of the Approval Parties. While the bulk of any needed actions will normally fall to the Responsible Organization, in many situations some supporting actions may be necessary by the other Agreement Parties. These actions should be coordinated by means of the normal processes for contract change control at the level of ISMS approval for the defined scope of work (e.g. DOE to prime contractor, or prime contractor to major subcontractor). In addition to the verification that the WSS set has been faithfully applied in the sense of a specification, there is often a cultural component involved with implementation. The successful application of the Process as a decision-making discipline has often worked a notable transformation of attitudes between the Responsible Organization participants and their DOE DOE-HDBK-1148-2002 71 counterparts. This product of the Process may stand in considerable contrast to expectations of cooperative engagement that exist elsewhere in the organizations. In such instances, the Convened Group is expected to have considered the necessity of widespread cultural adjustment as a factor in WSS set implementation. As with any significant safety initiative, senior management has the authority to employ many proven techniques to facilitate organizational acceptance of the transition to a more standards-based and work-centered approach to the conduct of work. DOE Guide 450.3-2, Attributes of Effective Implementation, provides a description of outcome criteria for evaluation of WSS set implementation effectiveness. This Guide identifies 21 measurable attributes which have been correlated with effective standards implementation. DOE-HDBK-1148-2002 72 15.0 Maintaining the Set of Work Smart Standards Work and its hazards are dynamic. Static sets of requirements – even when carefully developed and fully complied with – cannot be relied upon indefinitely to provide assurance of safety. A number of conditions may indicate a need to revise the WSS set or some portion thereof. Such conditions could include: C changes in mission and work, or work conditions, resulting in a different set of hazards; C discovery of new hazards or better understanding of existing hazards; C input from Stakeholders, Interested Parties, or Departmental lessons learned that suggests the existing standards set may not be necessary and sufficient to adequately address all hazards; C changes to laws, regulations, standards, or DOE directives that are included in the WSS set; or C changes in contract or contractor. Effective maintenance of the WSS set requires continuing vigilance for change. Changes to mission, equipment, facilities, processes, materials, etc. may introduce new hazards. Changes

to procedures, personnel or budgets may likewise introduce new circumstances that should be evaluated. New regulations, revision of standards or DOE directives are also sources of changes that must be evaluated. Robust change control mechanisms are a requirement of Integrated Safety Management and WSS sets should be controlled through these mechanisms. When changes are noted that may raise safety concerns, the WSS standards basis should be evaluated to determine if the WSS set should be revised. In practice it is considered advisable that the WSS set contain a standard for controlling the set. The guiding principle should be that a single standards change control mechanism for controlling all standards, including the WSS set, should be established as part of the ISMS. DOE-HDBK-1148-2002 73 Many of the above noted potential change conditions mirror the N&S Process initiation criteria that are stated in the N&S Manual and discussed in Section 7.1 of this Handbook. These criteria apply not only to an initial application of the N&S Process, but also to subsequent conditions under which the N&S Process may be reinitiated. Change control, therefore, may often amount to reinitiating the N&S Process, although typically on a more limited scale. Change control for a set of WSS should preserve or renew the integrity of the original N&S Process determination of adequacy and feasibility. By design, the N&S Process uses the collective expertise of carefully selected teams to reach a thorough understanding of the work and its associated hazards and to identify and confirm a set of standards that can be implemented to provide reasonable assurance of adequate protection from those hazards. If changes to the resulting WSS set are not made with fidelity to the N&S Process, then the integrity of the entire standards set, and the assurance of protection that it represents, may be compromised. “Replacement parts” for the WSS set must be identified and considered with the same rigor that went into the original set. Documentation for the approved WSS set should be sufficient to clearly identify the standards bases. When changes to the WSS set are made, the WSS documentation should be revised to reflect the changes and the bases for those changes. This is of significant importance for maintaining the WSS set. At the same time, a WSS change control process should be simple enough to be readily usable within the existing organizational structure. An overly complex process or one which takes great effort to initiate will only invite disuse, with correspondingly negative impacts to the integrity of the WSS set. While the change control process should include the basic elements of the N&S Process, it need not (and in most cases, should not) duplicate the scale and scope of the original N&S Process effort. Change control amounts to a focused application of the N&S Process, appropriate to the scope of the proposed change. Change control for the WSS set is an integral part of the ISMS. Establishment of an ISMS will include a hierarchy of documents to flow down contractual requirements for the work. A change control process is an expected component of such a document system. Since the same document hierarchy will also contain the WSS set and lower-level requirements flowing from it, the change control process established as part of the ISMS should be designed to handle DOE-HDBK-1148-2002 74

changes to the WSS set as well as other site documents. Change control for the WSS set is therefore not divorced from other site processes, but rather is an integral part of the ISMS. Establishing fixed organizational responsibilities for change control allows change control to be accomplished in a routine manner while preserving fidelity to the N&S Process. And finally, the change control process should screen proposed changes on the basis of their safety significance, so that the system does not become clogged with items of low importance. It may be helpful to collect “minor” changes for periodic (for example, quarterly, semiannual) review by the appropriate team(s) rather than reviewing them individually, or to provide for streamlined processing of certain types of changes. In summary, an effective change control process should be characterized by the following: C The change control process should be a part of the organization’s Integrated Safety Management System, as is the N&S Process. C The change control process should be implemented at an appropriate point in the N&S Process, typically after approval of the initial WSS set. C The change control process should provide for screening of new inputs (for example, information about new work or changed hazards) to determine the need and appropriate mechanism for further action. Not all changes will require the same degree of attention. Minor administrative changes to existing standards could be issued with little review, while information about a new hazard may require more extensive review to identify appropriate standards. C The standards bases described in the documentation of the approved WSS set should be used as the principal configuration control reference. C When changes to the WSS set are made, the WSS documentation should be revised to reflect the changes and the bases for those changes. DOE-HDBK-1148-2002 75 C The change control process should replicate the N&S Process, with roles and responsibilities that correlate to those in the N&S Process, to ensure that changes to the WSS set are made deliberately and are adequately justified. C The change control process should be well-defined, so that potential changes can be handled “routinely,” within a framework of defined tasks and responsibilities. C The change control process should be managed by a single organization to ensure consistency and comprehensiveness in addressing potential changes. C The change control process should be integrated with existing site mechanisms for documenting and promulgating standards so that changes can be communicated to those who use the standards in a timely fashion. C The change control process should be integrated with existing processes and personnel responsibilities for contract modification, since some changes to the WSS set may be required. An example of a change control process used at the Los Alamos National Laboratory that exhibits these characteristics is presented in Appendix I. DOE-HDBK-1148-2002 76 16.0 Providing Feedback and Lessons Learned Providing feedback and continuous improvement is the fifth core function of ISM. This function, however, is more than simply a single step in a five-step process. Continuous evaluation and improvement should characterize all the functions and activities of an effective ISMS. The development and application of lessons learned is an effective means of doing this. Since the

N&S Process provides one means for carrying out some of the ISM core functions (definition of work scope, analysis of hazards, and development of hazards controls), the N&S Process should similarly involve a deliberate and purposeful search for and application of lessons learned. Because the N&S Process and ISM are consonant and share a common conceptual foundation, lessons learned during an N&S Process application can be particularly valuable in implementing ISM. A consistent focus on the work; the development of tailored sets of standards to perform work and control hazards; and, the involvement of Stakeholders, Interested Parties, and workers are central tenets of both ISM and the N&S Process. An application of the N&S Process will provide a wealth of practical insight into these and other principles and their application in the context of a specific site, facility, or project. In order to effectively translate and utilize these insights in establishing an ISMS, individuals experienced in the N&S Process should be selected to help spearhead ISM implementation. Similarly, application of the N&S Process should be undertaken as part of an overall ISMS rather than as a separate activity. This Handbook is a compilation of lessons learned from N&S Process applications and pilots. The initiation and implementation of the N&S Process has occurred widely across the complex since 1995. Through early pilots and follow on N&S Process applications, a considerable number of lessons were learned. The N&S Process is most effective when the lessons learned in developing, implementing, and maintaining the set of standards are shared. Sharing lessons learned in the N&S Process is an effective means to ensure that the lessons learned in one application will be effectively communicated. A discussion of these lessons learned can be found on the Work Smart Standards home page (http://tis.eh.doe.gov/dsc/index.html). General information about Integrated Safety Management implementation is available at the ISM home page (http://tis-nt.eh.doe.gov/ism/). In addition, the Department’s Lesson Learned home page DOE-HDBK-1148-2002 77 (http://tis-eh.doe.gov/dsc/ll/ll.html) has specific information useful to managers and participants who intend to use the N&S Process in the future. DOE-HDBK-1148-2002 78 INTENTIONALLY BLANK DOE-HDBK-1148-2002 A-1 APPENDIX A THE NECESSARY AND SUFFICIENT CLOSURE PROCESS FREQUENTLY ASKED QUESTIONS DOE-HDBK-1148-2002 A-2 THE NECESSARY AND SUFFICIENT CLOSURE PROCESS Frequently Asked Questions The following questions have been raised during training sessions and applications of the “Closure Process for Necessary and Sufficient Sets of Standards.” They address issues about the functioning of the Process and about the product of the Process, the Work Smart Standards set. The answers are based on the experience of Process practitioners as collected by the Department Standards Committee. Q1 Does the N&S Closure Process put aside Department responsibilities for safety standards to the contractor? A1 No, the N&S Closure Process does not put aside the Department’s responsibilities for safety standards. Rather, it emphasizes thorough understanding of the work and the hazards as conditions for identifying and approving the controlling safety standards. The N&S Process requires that both DOE and the contractors be fully engaged at the management, worker and technical levels throughout the Process. Both DOE and the

contractors must approve the set of standards and agree that the set when properly implemented will provide reasonable assurance of protection to the public, the workers and the environment. DOE and contractor personnel who have successfully completed the N&S Process report that they have gained an improved shared understanding of the work, the hazards and why the standards selected are appropriate to provide adequate safety. Several sites have expanded their standards base as a result of the N&S Process. Sites now “own” the WSS set, whereas before sites often viewed standards as forced upon them by DOE. The N&S Closure Process supports the implementation of Department of Energy Acquisition Regulation (DEAR) clause concerning integration of environment, safety, and health into work planning and execution (48 CFR 970.5204-78), and is a Department- approved tailoring process for inclusion in the DEAR-required contractor Safety Management System. The Department’s N&S Closure Process is described with requirements for its application in DOE M 450.3-1. The N&S Closure Process relies on DOE-HDBK-1148-2002 A-3 a thorough understanding of the work to be performed and of the hazards associated with that work and on knowledge of appropriate controls to identify a set of standards (The Work Smart Standards set) that when implemented will provide reasonable assurance of adequate protection of the workers, public and environment. The requirements and process for approval of the Work Smart Standards set are within DOE M 450.3.1. Q2 How do we know that the Work Smart Standards set will provide adequate protection? A2 Each element of the N&S Closure Process is designed to establish confidence in the governing set of standards resulting from proper Process application. Key features of the Process are teams of knowledgeable people well grounded in the work and hazards, technical justification, peer review and stakeholder involvement. All of these are hallmarks of successful standards and regulatory processes. The N&S Closure Process emphasizes: • Team-enhanced collective competence, knowledge, and experience of qualified practitioners • Thorough understanding of the work and associated hazards and of experience- supported controls for those hazards. • A documented justification, available for review of the correctness of the WSS set for the work and the hazards. • The identification, review, and approval practices of the N&S Closure Process. These key features of the Process, joint DOE and Contractor approval of the standards set, continuing feedback and improvement with rigorous change control provide confidence in the protection provided by a properly implemented standards set. DOE-HDBK-1148-2002 A-4 Q3 How can we be assured of adequate safety if some alternative standards to the DOE ES&H Orders are identified for the WSS set? A3 Proper application of the N&S Closure Process establishes a WSS set that provides reasonable assurance of adequate protection whether or not particular standards, including DOE Orders, are identified within the WSS set. It is the collective control of the WSS set, developed according to the N&S Closure Process, that provides adequate protection when appropriately implemented through Integrated Safety Management. The DOE ES&H Orders represent an effective way of achieving safety for certain work done by the Department, particularly for work which is essentially unique to the

Department. The DOE Order system has provided a consistent approach across the Department for control of the hazards considered in the Order development. The Orders are by necessity somewhat broad in scope. The focus of the N&S Closure Process is on understanding the particular work to be performed, hazards associated with that work and identification of a proper experienced-based set of standards for control of those hazards. Fidelity to the N&S Closure Process leads to identification of the proper WSS set. The Process does not specify sources of standards. The principal issue is adequate protection not the source(s) of the standards selected. Consideration of the DOE Orders developed for particular hazards within the scope of a specific N&S Closure Process application is appropriate where selection of a particular DOE Order may be advantageous because of: • Familiarity and experience of the work force with the DOE Orders • Existing implementation processes for the Orders • Ease of explaining to DOE and order-experienced personnel the coverage of the WSS set DOE-HDBK-1148-2002 A-5 • Linking controls of the WSS set to the controls exercised through the Orders. In some cases, DOE Orders may not be appropriate for specific work and hazards; or, other standards, such as commercial standards, may more closely correspond to the work and hazards environment. Similarly, the work force may be more familiar with working to consensus standards. In ensuring that the appropriate safety topics are addressed in a WSS set, it may be beneficial to provide a mapping of the coverage of the safety topics by a WSS set and by the DOE Safety Orders. Q4 Are there any ES&H Orders that must be included in the WSS set identified by the Closure Process? A4 As the responsible federal agency, the Department of Energy has the authority, unless prohibited by law, to require of its contractors the inclusion of specific conditions (requirements) within DOE contracts. In accordance with normal contracting practices, such inclusion is subject to negotiation between the DOE and the contractor. The contents of the set are governed by the actual work and hazards in the contract statement of work and the hazards associated with that actual work. The elements of a WSS set are mandatory if: • They include applicable Federal, state, and local laws and regulations, or • The WSS set, or portions of it, become contract requirements by inclusion within a DOE contract. By agreeing to the application of the N&S Closure Process, the DOE has strongly indicated that it intends to accept the WSS set resulting from the faithful application of the N&S Closure Process. Q5 Is the N&S approach the same as the “graded approach?” DOE-HDBK-1148-2002 A-6 A5 The “tailored approach” of the N&S Closure Process is not the same as the “graded approach” even though the two approaches may arrive at a similar objective of applying requirements in a manner that recognizes the significance of the hazard being controlled. Tailoring is work and hazards based; grading is primarily requirements based. The Tailored Approach is based on an understanding of the specific work, the work environment, and the hazards associated with the specific work and on knowledge of experience-supported standards that control the specific hazards. The N&S Closure Process identifies a tailored set of standards from applicable standards sources. When

implemented, the standards provide for those hazards reasonable assurance of adequate protection of workers, the public and the environment. The N&S Closure Process “tailoring” is fundamentally work and hazards based. The “graded approach” means grading selection of standards or grading application of standards. In the graded approach the standards are DOE Orders or specific requirements within DOE Orders. The application of “grading” varies the degree, intensity or rigor of application of the standards across a range of defined work depending on the relative significance of work hazards to be controlled. “Grading” is fundamentally requirements based. A definition appears in the SAR Order (DOE O 5480.23.) Q6 What happens if oversight personnel do not agree that the set provides adequate protection or was developed without the required fidelity to Process requirements? A6 If oversight personnel challenge the adequacy of the WSS set or challenge the bases for its approval, the challenge must be resolved. Resolution is provided by: • Under Chapter 1 of the N&S Closure Process any challenge to the WSS set is to be submitted to the Agreement Parties where the challenge is decided on its merits. DOE-HDBK-1148-2002 A-7 • If the Agreement Parties decide the challenge has merit, action will be taken to correct the deficiency. This may include re-performing the N&S Process for the area(s) of concern. • If the Agreement Parties decide the challenge does not have merit, the basis for this decision is provided to the challenging party. If the challenging party does not agree with the basis for the decision, as necessary, the challenge is argued before the appropriate level of line management. Once a standards set has been established and implemented any challenges to the adequacy of the set are typically addressed through change control mechanisms. Q7 Does agreement on the set of standards require a change of the contract? A7 Whether the standards set is included and specified as contract requirements depends on the purpose of the standards set. • If the standards set is intended to be used to identify contractual requirements, the set must be incorporated into the contract. Information on the use of standards sets for this purpose is described in the ISM DEAR clause. • If, under existing contract provisions on safety standards and requirements, the N&S Closure Process is used to identify standards to implement existing contractual requirements, no contract recognition of these implementing standards is necessary. Q8 How do we know that the contractors won’t choose a minimal set of standards? A8 Application of the N&S Closure Process does not allow a contractor “to chose” the WSS set. No single party to the N&S Closure Process can control it to the degree that a set unacceptable to the other parties. DOE-HDBK-1148-2002 A-8 The N&S Closure Process is a participative process which focuses on understanding the particular work to be accomplished and the hazards associated with that work, and subsequent identification of standards through the collective qualification of teams. The participative, iterative process among qualified teams leads to agreement on the appropriate – not minimal – set of standards that when implemented, provides reasonable assurance of adequate protection. Also, the N&S Closure Process calls for appropriate confirmation and specific approval of the application of the Process as well

as the set of standards. Documentation, subject to review, that justifies the standards set is a strong additional incentive to identify the controlling standards with care. A principal guard against minimal standards is the focus on understanding the work and its hazards preliminary to identifying controlling standards and justifying, on the record, that the standards are adequate. The N&S Closure Process closely joins the understanding of the work and its hazards with knowledge of appropriate controls. Q9 Will the documentation for WSS sets be standardized in the future? A9 The documentation of a WSS set is inherently tailored to the Work it addresses and the local contract in which those standards are to be implemented. From the present experience of more than four years there is little evidence that documentation expectations can be standardized beyond the basic requirements stated in Process Element 3, “Defining and Agreeing to Protocols and Documentation Requirements.” The Convened Group defines the specific requirements for this documentation and may include additional documentation requirements to suit the specific application of the Process. Q10 How will the Department know what’s going on? A10 As with all aspects of its commitment to ISM, the Department is a party to the Process in all applications requiring Department agreement on the set of standards. Specific Department elements will be Agreement Parties and Resource Authorities, and other DOE headquarters and field elements may participate as appropriate. DOE-HDBK-1148-2002 A-9 Q11 How does EH get involved in the Process? A11 EH elements have participated in the Process as Convened Group Members, Technical Operational Experts, or as Confirmation Team members depending on the situation. However, as a matter of EH policy, EH independent oversight elements do not participate. EH oversight may assess whether specific applications of the Process have been conducted in accordance with the Manual (M 450.3), and whether the agreed upon requirements are adequately implemented. Q12 How do we assure consistency in the Work Smart Standards sets of standards across the complex? A12 The Department’s Integrated Safety Management goal is to achieve consistent and excellent protection of workers, the public, and the environment. Because the work, work definitions, expected hazards, and conditions of work vary widely across the complex, the standards necessary to achieve this goal must also vary from place to place. Consistent adequacy of tailored protection controls demands consistent, excellent management of the Department’s work, dedication of its employees, and a willingness to accept the responsibility that this entails. It is recognized that when applying the N&S Closure Process that fidelity to the requirements and the underlying logic given in DOE M 450.3-1 are important to the integrity and thus the acceptance of the Process as a legitimate means of standards identification. The Department Standards Committee, on behalf of Department line management, oversees Process applications and promotes a high standard of Process fidelity as the most important Process contribution to consistency in adequate protection. Q13 Will the sets of standards be similar for similar facilities? A13 Similar facilities are likely to identify similar, but not identical, sets of standards. Differences in physical plant or process, organizational structure, management policies,

work force capabilities, and political factors are all potential sources of differences in DOE-HDBK-1148-2002 A-10 sets of standards. Similarity is often a more meaningful basis in the comparison of safety performance outcomes. Q14 If the Work Smart Standards set incorporates external standards, who interprets those requirements? A14 Existing contracts (and Orders) contain or reference external standards, such as laws, regulations and consensus standards, that may require interpretation. The incorporation of external standards into WSS sets does not require a change from the existing policies or practices regarding interpretation. In general, the chain of authority for the interpretation of standards used by contractors is: contractor line management, Department line management, the sources of the standard (regulatory or consensus organization), and the courts. Under the practices established by the ISM DEAR clause, the contract, that includes explicit DOE approved provisions for safety management, becomes both the operational and regulatory basis for interpretation of the integrated set of requirements for safe work. Thus, the contract agreement processes established by the DEAR clause address all the various interpretive situations that might be encountered during the life of the contract. Of course, where requirements are grounded in law or regulation the contract defers its interpretive authority to the source agency. Q15 Is there a preference for applying the N&S Closure Process at the site level or the activity level? A15 Application of the Process at the site level and the activity level are not mutually exclusive. The Process can be applied at any level where the Department and the contractor must agree on the standards to be applied. This clearly includes the contract requirements, and may include any site level and activity level work controls that require Department approval prior to the authorization of work Q16 Who is going to make sure that the standards are used appropriately? A16 The contractor must plan work in keeping with the DOE-approved ISM system to meet all applicable contractual requirements and subordinate commitments. Department line DOE-HDBK-1148-2002 A-11 management will review the contractor’s ISM plan and selected work plans and the contractor’s implementation of those plans. Under ISM principles the Department depends on aggressive self-assessment by the contractor in combination with its own management reviews and independent oversight assessments. Performance incentives encourage effective self-assessment and self-improvement but if these are unsuccessful, the Department will expand its own line management and independent oversight. Q17 What has to be in the authorization agreement called for in the ISM DEAR clause? A17 An authorization agreement establishes the conditions for the authorization of work. The details of a specific agreement are locally tailored to factors such as agency risk exposure, threat to mission completion or safety performance trends that might impede that standards-based work plan. It should define limiting conditions of normal operations, approval conditions that may not be changed without prior Department approval, and conditions that may be acceptably changed by the contractor with only subsequent notice to the Department. Q18 How do DOE and the contractor come to agreement called for by the ISM DEAR clause?

A18 There are many ways for the Department and the contractor to come to agreement. Each time a contract or a work authorization is signed, an agreement has been reached. The N&S Closure Process is used by the Department and contractor line management as a mechanism to focus on the work and hazards and on planning as the basis for achieving adequate protection. The agreements called for in the ISM DEAR clause are considered to be anchored in the Annual Program and Budget guidance process and therefore include both relatively fixed (e.g., infrastructure standards) and dynamic components. Q19 How long will it take to develop a set of standards? A19 Clearly, there is not a definitive answer to this question, because applications of the Process will vary widely in scope and complexity. The level of effort required for contract DOE-HDBK-1148-2002 A-12 requirements will, equally clearly, be greater than that required to insert boilerplate, one- site-fits-all requirements. However, this added effort in defining necessary and sufficient sets of contract requirements and a focus on work planning involving necessary and sufficient work controls will save the enormous effort that used to be devoted to stove- piped implementation plans and assessments of compliance with inappropriate requirements which added little to the level of protection. Q20 How can the Confirmation team approach its responsibility to determine whether the proposed Work Smart Standards set is “feasible”? A20 The confirmation test that the Work Smart Standards set is “feasible” is a process safeguard against adopting standards that those responsible for implementation might not reasonably be expected to achieve. Feasibility focus is not on the ability of the standards to guide performance (i.e. “adequacy”), but rather on a potential future failure to achieve standards-based and safe work. Such failures could occur if management systems and processes are not capable of delivering work based on the WSS set or if resources are not sufficient to design and perform the work consistent with the WSS set. The N&S Closure Process requires the Identification and Confirmation Teams to assess both the adequacy and feasibility of the standards set. The agreed upon definition of the work and the institutional implementing assumptions about how that work will be carried out are first developed as a description of initial conditions by the Convened Group during Process Element 1: Defining the Work and Hazards. The requirements for describing both work objectives and a relationship of those work objectives to some organized system for the delivery of that work are equally important to the ultimate utility of the WSS set. By starting with the Convened Group’s core of guidance, the Identification Team is reasonably expected to further refine the definition of work, hazards and controls in a way that integrates implementability and technical sufficiency to provide for adequate protection. In the N&S Closure Process Element 4: Identifying the Necessary and Sufficient Set of Standards, relevant knowledge of the work and the available mechanisms of performance are brought to bear to achieve an adequate and feasible WSS set. The requirement that the Identification Team confirm and document implementing DOE-HDBK-1148-2002 A-13 assumptions serves to address issues of feasibility in going from the pre-WSS situation

of the organization to a post-Process state of WSS conformance. As stated in Chapter III of the Manual, “Planning and performing work in accordance with the approved set of standards requires an adequate system for managing the work.” Properly developed WSS sets will document assumptions about the specific “system for managing the work” into which the care and implementation of the new standards set will be entrusted. Such documentation serves primarily to inform those within that “system” what considerations the Process applications had in mind when settling to closure on a particular WSS set. During Process Element 5: Confirming the Necessary and Sufficient Set of Standards, the Confirmation Team examines how well the Convened Group and the Identification Team in working to closure on the proposed WSS set have anticipated and addressed the conditions in the receiving (i.e. implementing) organization. This is done to provide the Approval Parties assurance that the existing “system for managing the work” can “get there” (to WSS conformance) “from here” (the prevailing condition of the organization). It is critical to recognize that, as with the “adequacy” of protection test, the Confirmation Team is not expected to develop a fully independent assessment of “feasibility.” Rather the evidence of feasibility should come primarily from the documented work of the Convened Group and the Identification Team to assure that the WSS set is understandable both in terms of protection and its context for implementation. This point simply restates the recognition that a WSS set must address both technical and management considerations and takes it one step further by requiring that the managerial aspects of the proposed set be grounded in the specific local conditions of an existing management system. As with adequacy confirmation, there can be no explicit limits upon the ability of the Confirmation Team to assess the credibility of the implementing assumptions and other elements of the set that address feasibility for implementation. The Convened Group and Identification Team will necessarily apply some presumed effectiveness of the receiving management system’s ability to take the WSS set and then develop the needed system or upgrade the existing management system to the new set of standards. To the extent that documentation of the Process application makes clear what was assumed about the management system; what level of capability was DOE-HDBK-1148-2002 A-14 assigned to that system; and what evidence upon which the expectation of competence was established, the Confirmation Team might have a relatively simple task of confirming feasibility. Conversely, to the extent that the work is radically different, the organization for implementation non-existent or immature in its capabilities, or that some proposed standards are more challenging to meet than prior performance levels achieved by the management system, the Confirmation Team may need to dig deeply into the credibility of the implementation assumptions made by the Convened Group and the Identification Team. In order to prevent the Confirmation Team from exceeding the process-intended scope of the WSS set feasibility determination, confirmation protocols might stress that the burden of proof for feasibility is ultimately and necessarily on the earlier steps in the Process. There is a recognition in the Process that the Confirmation Team is dependent

to some significant degree upon the knowledge, relevant experience and collective work of both the Convened Group and the Identification Team. By selecting a Confirmation Team membership with equal or stronger credentials, there is an expectation that such a group can draw upon both the tangible and intangible parts of its own collective experience to more or less rapidly determine if the proposed WSS set is feasible. If the Confirmation Team is inclined to conclude that it needs to do a separate assessment of implementing organization capability, this inclination is best viewed as a failure on the part of the Convened Group and the Identification Team to make clear how they concluded the set was feasible and the set should be returned to those groups for further work. In this sense the Confirmation Team’s role is analogous to that of judge and jury in a trial, it is the prosecutor’s job to develop both the facts (i.e. standards for adequate protection), and the case for the conclusions it suggest be drawn from the facts (i.e. that the standards can reasonably be implemented.) Q21 What is the significance of the finding that the N&S Closure Process has been correctly implemented; that is applied with “fidelity”? How can fidelity confirmation to be approached? A21 Process fidelity verification relates to the confidence that others who were not directly involved in standards identification, ought to have in the results of the Process. The DOE-HDBK-1148-2002 A-15 basis for depending upon fidelity as a measure of Process effectiveness is the demonstration that the Process requirements draw plentifully upon the recognized DOE Integrated Safety Management concepts, plus the fact that application of such concepts has demonstrated its value in numerous other high technology, high hazard industries. The N&S Process Elements follow the logic of the Core Functions of ISM. Through frequent iteration among the various intermediate closure points, the Process elements progressively develop an agreed upon and integrated expression of work, hazards, and controls that always starts from and returns to the need to Do Work Safely. The structure for reaching agreement is robust, with multiple, explicit, and semi-independent levels of definition (Process Leadership and Convened Group), analysis (Teams) and verification (Confirmation Team and Approval Parties). The ISM Guiding Principles of clear roles and responsibilities, demonstrated team competence, tailoring, and balancing of priorities are all explicitly incorporated in Process Manual requirements. Process documentation is required for both WSS set components and for records of decision- making that support the justification of WSS set as adequate and feasible; thus the N&S Closure Process ensures that readiness for operations proposed to be authorized, on the basis of the identified standards and implementing assumptions, can in fact be reached. Throughout the Process application, Line Management bears the lead responsibility for the WSS set, its development, and its justification of adequacy. With elaborate process logic detail, and frequent reference to performance attributes that must be addressed in order to make the WSS set both adequate and feasible, the N&S Closure Process manual requirements self-define the elements of demonstrating fidelity to the Process. However, precisely because the N&S Closure Process is built on ISM principles, “fidelity”

can rarely be deduced from a simple verification checklist. It is a matter of practical experience that Convened Group understanding (or “profound knowledge” in the words of W. Edwards Deming) about the kind of safety management system needed to embody the ISM principles is a predictor for achieving evident demonstration of Process fidelity. Manual requirements provide many effective lines of inquiry for Confirmation Teams and Approval Parties to test this understanding. DOE-HDBK-1148-2002 A-16 Q22 What lessons were learned at LLNL from following the N&S Process? A22 Lessons learned from the LLNL N&S Process application are summarized below, and are also reflected in the body of the N&S Handbook. The N&S Process should include all ES&H aspects of the performance and management of work. Work activities are performed within the total programmatic and safety environment of the institution. Selection of safety standards is best done based on the hazards associated with the work and an understanding of the management philosophy and processes. Also, standards for the management of safe work are often critical first line elements for creating a safe work environment and should be considered in selecting a complete WSS set. Since the N&S Process is an integral part of ISM, the activities should be initiated at the same time. ISM and the N&S Process have a synergistic relationship. Standards identification is a key step in the ISM work functions. Similarly, having a strong foundation in the principles and functions of ISM will allow the N&S Closure Process to proceed more efficiently and provide a context for the selection of both technical and management standards. Complete documentation supporting justification of adequacy of proposed standards should be provided to the Confirmation Team. The N&S Process identifies various types of documentation and the responsible party as a normal part of the Process. A complete and integrated set of documents describing and documenting the Process is necessary before confirmation to permit the Confirmation Team to understand and evaluate the Process. This information should be provided to the Confirmation Team 3-5 weeks before their site visit to allow adequate time for review. Confirmation Team members should make a separate visit to tour facilities and become familiar with the site. The Confirmation Team needs to have adequate information, understanding and first hand experience of typical work environments and their safety systems. A separate visit allows sufficient dedicated time for site familiarization and a helpful background for review of documentation prior to the confirmation visit. DOE-HDBK-1148-2002 A-17 The entire safety management system should be described to the Confirmation Team so they can assess the feasibility of the WSS Set. The Confirmation Team needs to clearly understand the nature of the entire safety management system. This is needed to build confidence in the current safety system and proposed ISM system before they can take on the task of assessing the feasibility of the WSS Set. A list of the complete set of proposed standards should be given to the Confirmation Team. The Confirmation Team should be given the full set of ES&H standards so they can evaluate both the completeness and adequacy of the final product. Interested Parties need to be identified early in the Process (e.g., DOE/HQ, DNFSB) and

kept up to date. The N&S Process can result in significant changes to the way LLNL performs work safely. Interested Parties must be identified early in the Process and kept informed throughout the Process to ensure that they understand the potential changes, their ramifications and to be better prepared to continue their relationship with LLNL. Top management engagement throughout the entire Process is a key success factor. Laboratory and DOE Oakland Operations Office top management must be continually engaged to ensure the success of the Process. Their continued involvement by attending Convened Group and Standards Identification Team meetings clearly demonstrated to all the importance of the Process to safety at LLNL. Management is also then in a better position to provide the necessary resources and eliminate barriers to progress. The N&S Process requires a transition from an expert based system to a standards based system. LLNL works to manuals that have been maintained by safety subject matter experts based on their extensive experience at LLNL and knowledge of related safety areas. With the implementation of the WSS set of standards, the subject matter experts will need to improve their knowledge of the current standards and be prepared to propose modifications of the WSS set based on improvements of existing standards. The N&S Process requires a commitment to formality and rigor for an organization such as LLNL. The management of a N&S Process where a wide variety of work and DOE-HDBK-1148-2002 A-18 hazards, including nuclear, are involved requires a commitment to extensive review and complete documentation following the requirements outlined in DOE Manual 450.3.1. The N&S Process is a manpower intensive activity which can create operational resource conflicts unless managed properly. Assigned program staff, Assurance Managers, ES&H Subject matter experts and line managers are major contributors to the N&S Process. A careful assessment of day-to-day ES&H Program needs has to be balanced with N&S Process support. ISMS also adds another demand on their time. There are different kinds of workers who all need to be included in the N&S Process. The N&S Process should include all types of workers in the identification of work and characterization of the hazards. Upper, mid and first level supervisors as well as hands on technicians and crafts workers should be included in the N&S Process in order to benefit from their various perspectives and experience. The selection of standards to manage work safely is based on the work and the broad experience of its managers. Safety standards can be selected based on the work and its associated hazards. The selection of standards to manage work safely is not only based on a knowledge of the work, but also the broad experience of managers who understand the institutional philosophies and complexities of managing work safely at LLNL. In fact, it was our experience that in some management areas broad managerial experience was more important than detailed knowledge of the work. Local Standards were developed to build on, add to and quantify information in existing DOE Orders and consensus standards. Over the years, research and development activities at LLNL on the many and complex national needs has resulted in LLNL performing unique work and developing special expertise in dealing with certain hazards.

In moving from an experience based to a standards based ES&H system, LLNL needed to develop and codify local standards controlling the unique work and hazards to supplement the existing body of consensus and DOE standards. Also, in several more common areas, e.g., ergonomics and the use of HEPA filters, we found that adequate national standards were not available. DOE-HDBK-1148-2002 A-19 As a part of the N&S Process OAK and LLNL Staff with similar technical qualifications developed and demonstrated a common understanding of the work and associated hazards. The process of selecting the standards brought together DOE OAK and LLNL staff to understand the work, its hazards and the available standards. This common understanding was clearly demonstrated in several internal reviews held prior to confirmation where the reviewers could not readily determine whether the presenters were from LLNL or DOE/OAK. The N&S Process leads to a better understanding of requirements and expectations by the various participants. The N&S Closure Process required participation by the workers, as well as DOE and LLNL program managers and ES&H professionals and required them to focus on the work and the hazards. This common focus, with its exchange of information and experience regarding the work and the standards to provide adequate safety resulted in a shared understanding of requirements and expectations by all involved. Readiness for Confirmation is multifaceted: (a) Required N&S Process elements and the appropriate documentation should be reviewed. The Confirmation Team expects to understand the context, including the implementation of the N&S Closure Process, in which the standards were selected. Careful documentation of how the Process was implemented is critical to meeting this expectation. (b) The Convened Group and the Standards Identification Team need to have evaluated the feasibility of the set and be prepared to articulate this to the Confirmation Team. The Confirmation Team is asked to confirm the adequacy and feasibility of the set of standards. Understanding the assumptions and agreements made in determining the adequacy of a standard together with an understanding of the LLNL management system constitute the minimum elements necessary for the Confirmation Team to assess feasibility of the WSS set. Although not required by the N&S Closure Process, internal reviews in preparation for the confirmation process were very useful. DOE-HDBK-1148-2002 A-20 Confirmation Team Co-Chairs should visit the site several weeks before confirmation, review the schedule and documentation and develop a strategy to follow during the Confirmation Team visit. For a large N&S Process the Confirmation Team Co-Chairs should visit the site and become familiar with the documentation, review the schedule for presentations and tours and meet with key staff. These interactions will permit the Co- Chairs to develop an effective and efficient strategy for the full team s visit. The Change Control Process for the WSS set and ISM implementation should be integrated and an organization identified to administratively manage the set. The WSS set is an integral part of the ISM process and any changes to the set need to be implemented in a timely manner. By having a combined Change Control Board, the selection and revision of standards will be fully integrated with their implementation to assure the maintenance of an adequate safety system at LLNL.

DOE-HDBK-1148-2002 B-1 APPENDIX B ACTIONS AND ASSIGNED RESPONSIBILITIES FOR STAKEHOLDER INVOLVEMENT IN THE N&S PROCESS AT THE SAVANNAH RIVER SITE NOTE: This Savannah River Site (SRS) example which demonstrates considerable outreach to stakeholders and interested parties was developed to support the SRS Pilot project to validate the Necessary and Sufficient Closure Process. Since that time, the use of the term "Stakeholder" has been modified. The SRS example includes DOE, contractor and public groups under the general category of stakeholder. The Pilots and subsequent WSS Applications have clarified that the term "Stakeholder" should be limited to involvement of non- DOE or contractor groups. Public interest groups or unions are examples of stakeholders. The definition of "Stakeholders" provided in the Glossary is consistent with the provisions of the Federal Advisory Committee Act which establishes controls for participating in Federal policy- making bodies. DOE and contractor personnel groups that are involved in the identification, approval or implementation of standards should be included as participants in the N&S Closure Process. The Defense Nuclear Facilities Safety Board, due to their legislative mandate, are included as Interested Parties. DOE-HDBK-1148-2002 B-2 STAKEHOLDER INVOLVEMENT Approval Authorities The WSRC-ER and DOE-SR approval authorities for the set of N&S standards for this pilot were stakeholders because they are responsible for the set of standards and its implementation. Communications with the approval authorities were through WSRC-ER and DOE-SR process team members and the steering committee. Project Manager and Operations Manager The WSRC-ER Project Manager and Operations Manager were stakeholders because they are responsible for safe installation and operation of the treatment unit and supporting structures. The Operations Manager represents the workers who will eventually operate the F/H Groundwater Water Treatment Units; these operators are not yet identified. Communications with the Project Manager and Operations Manager were through the WSRC-ER process team leader and by the members of the standards identification/confirmation teams. These continual communications lead to better definition of the project scope, schedule, and operational requirements. Both the Project Manager and Operations Manager were involved in design decisions throughout the F/H Groundwater Remediation project (Ref. 22, 5/5/95). A presentation of the set of site design and safety documentation N&S standards was made to the Project Manager and Operations on July 13 (Ref. A1). Engineering The various engineering organizations within WSRC were stakeholders because they can affect and may be affected by the results of this process. Other engineering organizations that can affect the outcome include the design engineers that are responsible for using the identified standards in the project design and other engineering organizations that may want to implement this process in the future on their facilities/activities. Communications with the engineering organizations were through the WSRC-ER process team leader and by the members of the standards identification/confirmation teams. For example, several of the standards for the electrical scope of F/H Groundwater Remediation were discussed with the Power Engineering DOE-HDBK-1148-2002 B-3

Department, as they are the custodians of most of the power lines at SRS. Their input provided the ER N&S standards identifiers with a better understanding of site requirements and commercial practices (Ref. A2). Environment, Safety, Health, and Quality Assurance Various Environment, Safety, Health, and Quality Assurance (ESH-QA) organizations within WSRC and DOE are stakeholders because they may affect or be affected by the results of this process. ESH&QA is responsible for the SRS approach to a standards-based program, in response to DNFSB recommendation 90-2. The Standards/Requirements Identification Document is the SRS response to 90-2. The WSRC-ER process team leader is also the ER S/RID point of contact and ensured that SRS S/RID requirements determined to not be N&S as a result of this F/H Groundwater Remediation N&S pilot are identified as such (REF. 41, A3). Department of Energy - Headquarters Various