This report, prepared by Larry Coulson in behalf of the Convened Group, documents the Fermilab ES&H N&S pilot project conducted between February 27, 1995 and July 14, 1995. The pilot was charged with testing the validity and applicability of the Department of Energy Closure Process for Necessary and Sufficient Set of Standards, which we will call "the Process." (See Attachment 1.) Attachments to this report contain the key documentation and the results of the pilot. The most detailed source of documentation of the pilot is the Documentation of Record (DoR). The DoR comprises 10 appendices containing the detailed documentation, with an introduction, called the Process Documentation Guide, that describes the documentation in the appendices. The DoR Table of Contents and the Process Documentation Guide are Attachment 2 to this report. Another useful report is the Fermilab Demonstration, Response to Criteria for Judging Success of Process Demonstration, July 25, 1995, which contains the response to questions posed by the DOE Department Standards Committee to measure the success of the Fermilab pilot. The latter report, without attachments, is Attachment 3 to this report. Copies of the appendices and attachments to the above reports are available through the Director's Office at Fermilab (708-840-3211).
We intend this report for a broader audience than the other documents we reference above. We hope that this report will help guide others through the Process as currently written. We assume that the reader has an acquaintance with the Process and is using this report as a guide to its implementation. Without some prior acquaintance with the Process, we fear that many of the references will be meaningless.
The first of the eight parts of this report is this Introduction. The second part contains comments on the Process, including an explanation of the pilot organization. The third part, Implementation of the Process, describes what we did to address each section of the Process. This part should help the reader understand the interpretation chosen for each section of the Process. The fourth part contains a brief discussion of the contract modification made as a result of the pilot. The fifth part contains some general conclusions and lessons learned. The sixth part is a brief summary statement. The seventh section is a Glossary of Abbreviations, which the reader may find helpful in keeping track of the many abbreviations used in this report. Finally, there follows a series of 19 attachments, which contain the documentation to help the reader understand the details of the Fermilab pilot.
PROCESS COMMENTS AND ORGANIZATION
1. A critical element for the success of the pilot was the strong support from the entire line organization (ER, CH, BAO, and Fermilab), EH and the Department Standards Committee. Not only was there strong support and participation from all these organizations, but the working team relationship among the participants greatly facilitated the process.
2. From the beginning, the team decided to include all interested persons on the distribution list for documents as they were generated. Therefore, we sent electronic copies of meeting minutes, charters, etc. to everyone who had shown interest, including representatives of all the above-mentioned organizations. Ultimately over 40 people were on the distribution list.
3. Involvement of people and organizations outside the DOE family, peers from DOE sister labs, DOE personnel from the field office and area office, as well as Fermilab personnel, enhanced the credibility of the final product.
4. Agreement on the overall organization, responsibilities, authorities, etc. at the beginning of the Process kept the Process going smoothly. We agreed on the protocols for organization, approvals, responsibilities, and members of the Convened Group at the first and only meeting of the Extended Convened Group.
5. The Process works. We recognized that the Department Standards Committee had not specified the mechanics of the Process in great detail; but our experience showed that a strength of the Process comes precisely from the fact that the mechanics of the Process are not prescribed in great detail. Although this made starting the Process difficult, it allowed for enough flexibility for the responsible parties to implement the pilot in a way that reflected their collective judgment and experience. As a result, they felt comfortable in taking ownership of the Process and could feel confident of the results.
Attachment 4 shows the organization developed for the Fermilab pilot. The 3 boxes in the top row lists the Agreement Parties. The name within each box indicates the approval authority for that organization. Fred Bernthal is the President of Universities Research Association, Inc. (the organization that holds the contract with DOE to operate Fermilab); John O'Fallon is the Director of the High Energy Physics Division in ER; and Andrew Mravca is the Manager of the Batavia Area Office, and the Contracting Officer.
Each of these organizations had one member on the Convened Group (the Process Leader is also from Fermilab but generally represented the Process and not an organization). Larry Coulson (Process Leader) is an Assistant Director at Fermilab; Ray Stefanski is the Associate Director for Operations Support at Fermilab; Andrew Mravca; and Dave Goodwin (ER-20) represented the Resource Authority.
The Extended Convened Group included the Convened Group members plus Cherri Langenfeld (Manager, Chicago Operations Office), Wilmot Hess (Director of High Energy and Nuclear Physics in ER), Ezra Heitowit (Vice President of URA), and Ken Stanfield (Deputy Director of Fermilab). This group met only once as a decision-making body. As described above, they created the overall plan for the Pilot.
A Steering Committee was created within Fermilab to advise the Process Leader on aspects of the Process that directly involved Fermilab. Members of the Steering Committee included Larry Coulson, Ray Stefanski, Bruce Chrisman (Associate Director for Administration), Don Cossairt (Head of the ES&H Section), Tim Miller (Deputy Head of the ES&H Section), Hans Jostlein (Standards Manager), and Kathy Williams (Manager of the QA Office).
The Identification Team, created by the Convened Group, consisted of 15 members including the Process Leader. One member each came from CEBAF, ANL, BNL, and BAO. Two members each came from SLAC and CH. The remaining members were Fermilab personnel. In general, senior personnel were chosen for their technical knowledge of accelerator activities, including ES&H aspects, and their ability to work in a team environment. The Identification Team broke into technical groups (by functional area), called Focus Groups ,to analyze issues and select standards. The Focus Groups had access to Subject Matter Experts as required.
The protocol for confirmation required presentation and defense of the draft set of standards to Fermilab first, and the Convened Group second. The Fermilab ES&H Policy Advisory Committee (ESHPAC), which advises the Director on ES&H Policy matters, primarily carried out the Fermilab review.
A Confirmation Panel, created to support the Convened Group in its challenge of the draft set, provided peer involvement at the confirmation stage. The Confirmation Panel included high-level operational and ES&H personnel selected from DOE and non-DOE laboratories with a history of accelerator based physics research.
IMPLEMENTATION OF THE PROCESS
This section follows the outline of the Process. Paragraph labels and headings are those used in the Process. We discuss the interpretation and implementation of each part of the Process, for the Fermilab pilot.
We agreed on the following definitions at the Extended Convened Group meeting.
The Customer Organization is BAO.
The Responsible Organization is URA.
The Agreement Parties include URA, ER , BAO. This is in keeping with the suggestion to establish the approval authority as low in the organization as possible.
The Resource Authority is ER.
The Convened Group identified Stakeholders in a document called the Stakeholder Participation Plan. This plan defines stakeholders and indicates the level of involvement of each. (See Attachment 5).
Operational and Technical Experts were largely ES&H professionals, physicists, engineers and other line supervisors at Fermilab. We also tapped expertise at sister labs for participation on the Identification Team and the Confirmation Panel. Three local industrial companies participated by providing personnel to discuss their experiences with external regulation and regulatory bodies. In addition, the Safety Director of the Laboratory of Nuclear Studies at Cornell presented to the Identification Team his experience with safety issues and regulation by outside regulators.
1. INITIATING THE NECESSARY AND SUFFICIENT CLOSURE PROCESS
Initiation of the Fermilab pilot was somewhat different from that envisioned in the Process protocol document. Fermilab was selected by representatives of the Department Standards Committee and ER as a likely candidate to conduct the pilot for two important reasons: Fermilab is a single purpose laboratory and it is classified as a low hazard facility. It was anticipated that it would be easier to conduct the pilot at Fermilab than at a multipurpose or a higher risk lab. In a letter to Andrew Mravca, Wilmot Hess proposed that Fermilab conduct the pilot. Fermilab agreed, and sent a proposal to the Department Standards Committee. The Department Standards Committee accepted the proposal on 2/24/95. A kickoff meeting at Fermilab on 2/27/95 launched the pilot. Representatives of ER, EH, CH, BAO and Fermilab participated. The kickoff acquainted Fermilab managers and other Lab personnel with the Process and showed the support of the line organization and EH. We hoped that this would allay skepticism about the prospects for success of the pilot. As required by the Department Standards Committee's protocol for the pilots, the head of the ER program office, Martha Krebs, and the head of EH, Tara O'Toole, officially sanctioned the pilot. DoR Appendix A displays these letters.
The Responsible Organization, Fermilab, appointed Larry Coulson to be the Process Leader.
2. PRODUCING A NECESSARY AND SUFFICIENT SET OF STANDARDS
Process Element 1. Defining the Work and the Hazards
 Acquisition of relevant information on the work performed at Fermilab was obtained as follows:
A. Through the Convened Group meetings, the Process Leader solicited information on the initial conditions (A through F shown in paragraph ) from ER and BAO. The group agreed that the hazard (issue) identification survey to be conducted by Fermilab would supply the best "bottoms up" information. (See D. below.)
B. Operational and technical experts provided much of the information collected by the survey conducted by Fermilab. Experts were also part of the Identification Team and the Confirmation Panel as previously described. More than 30 Subject Matter Experts assisted the Identification Team.
C. The resource authority, ER, agreed that the pilot would be conducted within existing resource limits. The resources to conduct the pilot would come partially from delaying some reports to DOE. The resources for the Laboratory mission (HEP) were not an issue in this pilot. The group decided that, although resources would fluctuate, future resource availability would not play a role in this pilot.
D. The Convened Group defined Stakeholder involvement in the Stakeholder Participation Plan. The DoR, Appendix D, documents the involvement of stakeholders.
 The Process Leader organized all the collected information into a binder issued to each Identification Team member when the work of the Identification Team began.
 The primary source of information for the definition of work at Fermilab was a survey of management, supervisors, and ES&H professionals. The survey form includes questions A though F, some other questions, and a checklist of potential ES&H issues. Attachment 6 displays the survey forms. This information, collected from each of the 77 sub-organizational units at Fermilab, provided a characterization of all the work currently being done at the Lab. The DoR, Appendix C, contains the collected data. In addition to this survey, the Process Leader assembled other sources of information that were felt to be of importance in characterizing the work and hazards at the Lab--e.g. accident records, occurrence reports. Attachment 6 also documents the other sources of information.
The information from all these sources was formulated into 151 ES&H issues that were provided as a starting point to the Identification Team for analysis to produce the N&S set of standards. The DoR, Appendix E, displays this initial list of issues. Nearly everyone who reviewed this list agreed that, with only a few exceptions, the same list would characterize many light industrial companies. The obvious conclusion is that there are very few unique ES&H issues at Fermilab. Fermilab has mostly standard industrial hazards.
 Although the Process allows for re-evaluating the definition of the work if advised by the Identification Team, the team found no re-evaluation necessary.
Process Element 2. Creating the Team(s)
The Extended Convened Group named the members of the Convened Group as described above. The Extended Convened Group decided that it was appropriate for the Convened Group to consist of one representative of each of the agreement parties. We have earlier provided the membership of the Extended Convened Group and Convened Group, also included as Attachment 7.
The Convened Group followed the guidance in the Process as closely as possible. The Convened Group documented their decisions and the protocols for the pilot in the pilot Charter. (See Attachment 8.) The Convened Group carried out specific responsibilities as follows:
 The pilot Charter and the Identification Team Charter, Attachment 9, defined the criteria for selection of Identification Team members. The primary criterion for the Identification Team members was knowledge of the work activities at a research accelerator. Another criterion was work experience in an external regulatory organization such as OSHA or EPA. We agreed that a Fermilab person with technical expertise in the appropriate functional ES&H area should lead each of the Focus Groups of the Identification Team, so members from Fermilab were also selected on this basis.
 The Process Leader solicited biographies of candidates for the Identification Team from Fermilab, BAO, CH, and four sister labs (SLAC, ANL, CEBAF, and BNL). The Convened Group reviewed the biographies and selected the team members. Attachment 10 contains the names of the team members and a summary of their credentials.
The Convened Group approved a list of Confirmation Panel candidates from five sister labs and one non-DOE accelerator lab The Process Leader solicited the Confirmation Panel members from that list. The Confirmation Panel included the ES&H Managers from SLAC, LBNL, ANL, and the Deputy ES&H Manager from BNL. The Project Manager of CEBAF and the Safety Director of The Laboratory of Nuclear Studies, which operates the Cornell Electron Storage Ring accelerator at Cornell University, were also panel members. Attachment 10 contains the list of Confirmation Panel participants.
Process Element 3. Defining and Agreeing to Protocols and Documentation Requirements
 The Convened Group defined the protocols and documentation in the pilot Charter (Attachment 8). Of particular importance was the specification of the approval protocols, and resolution of differing opinions. The Extended Convened Group agreed that the approval would be by the Agreement Parties: President of URA, ER, and the Contracting officer, in that order. The process for resolving differing opinions followed the authority hierarchy--i.e. problems not resolved by the Identification Team would be referred to the Convened Group, problems not solved by the Convened Group would be referred to the Extended Convened Group. We defined no further appeal mechanism.
 The Convened Group left most decisions about the documentation of the Identification Team work to the Identification Team. The pilot Charter contains all decisions made by the Convened Group regarding documentation requirements.
The minutes of the meetings, contained in the DoR, Appendices E, F, and H, record Identification Team decisions about protocols and documentation.
Process Element 4. Identifying the Necessary and Sufficient Set of Standards
The Identification Team began its analysis on the 151 issues prepared as previously described. During their deliberations, some issues were deleted or combined with others and some issues were added, based on the Identification Team's professional judgment. Attachment 11 displays the final list of 172 issues. The Identification Team used the following process for the analysis of each issue:
1. The Identification Team determined if a standard is needed for each issue identified (either presented to them or identified by them).
2. If a standard is needed, a Fermilab Identification Team Document (FITD) was filled out. This form documented adherence to the requirements of the Process. In particular, it provides documentation of , , , and  in Process Element 4.
Attachment 12 shows a flow chart of the analysis process and an example of the FITD. More than 30 Subject Matter Experts, mostly drawn from Fermilab's pool of professional engineers, scientists, and ES&H personnel, assisted the Focus Groups in this analysis.
The expectations of BAO, ER, and URA for the pilot were primarily to use industrial solutions for industrial problems. In other words, if an identified issue is similar to that faced by industry and an industrial standard exists (e.g. OSHA, EPA, etc.) then that standard should be chosen. If no industrial solution exists or if it is inadequate, then another external standard is sought (e.g. consensus standard, DOE Order, etc.). Only if a satisfactory solution is not available from those choices should an internal (Fermilab) standard be chosen.
In order to help the team members better understand the consequence and experience of using industrial standards, the team asked several local industries and two university research facilities to participate. Three local industrial firms sent representatives to join in a panel discussion on industrial regulation and regulators. AMOCO Research Center, Amersham, and NALCO participated. The Safety Director of the particle accelerator at Cornell also visited the team and discussed his experience with ES&H at a high energy accelerator that is not subject to DOE regulations. The safety director for the accelerator facility at the University of Illinois (also not regulated by the DOE) sent a copy of the ES&H program developed for that facility for the Identification Team to review. The interactions with the representatives of facilities using outside regulation proved very insightful to the Team members.
Attachment 13 contains the final set of FITDs for all 172 issues, and Attachment 14 contains the final list of issues with corresponding standards citations. Some standards (e.g. OSHA 1910) had many sections referenced. In some of these cases the Identification Team decided to accept the entire standard for the sake of simplicity, even though some parts of it were not necessary for the set.
The Identification Team reached consensus on a set of standards. Attachment 15, the Team Report, contains these standards. The Identification team made no recommendations for redefinition of work or for developing new standards.
Process Element 5. Confirming the Necessary and Sufficient Set of Standards
The pilot Charter called for a two-step confirmation process. First, Fermilab was invited to review and comment on the draft set. The pilot Charter defines the protocols for this process, and DoR Appendix G contains the documentation of that review.
The Charter called for the final confirmation process to be a presentation and oral defense of the draft set by the Identification Team to the Convened Group. A peer group, the Confirmation Panel, assisted the Convened Group. The Convened Group also invited the Extended Convened Group to participate in the confirmation.
The Convened Group held the confirmation meeting on July 12, 1995. Attachment 16 shows the people participating. DoR Appendix I shows the minutes of the confirmation meeting, issues raised, and the resolution of those issues. During the meeting, three issues were raised that were significant enough to need resolution after the meeting. The Convened Group resolved all issues before approval of the N&S set of standards by the Agreement Parties.
Process Element 6. Approving the Necessary and Sufficient Set of Standards
Approval of the N&S set occurred on July 14, 1995. Attachment 17 contains the approval documents.
The DOE/URA contract was modified on July 14, 1995, as a result of the N&S Pilot (see Attachment 18). The contract modification replaced the existing list of applicable ES&H DOE Orders with a modified list of applicable orders and the "N&S" list of Standards.
The new contract no longer contains the orders for Quality Assurance, Conduct of Operations, Self-Assessment, and Maintenance Management. These management orders have historically been associated with the ES&H activities of laboratories. These orders are important because they affect the implementation of the N&S set.
The Convened Group asked the Identification Team to make recommendations about management systems to the Convened Group. However, the Identification Team could not reach consensus on the best management systems to use as "standards." Members of the team held views that reflected the management systems of their home institutions. Therefore, the Process Leader referred these issues to the Convened Group for resolution as per protocol in the Pilot Charter. The Convened Group discussed these issues with the Identification Team, the Confirmation Panel, and members of the Extended Convened Group present at the confirmation. It was noted that many of the selected standards explicitly addressed QA for ES&H--e.g. CFR 835.102, ASME Pressure Vessel Code, and the Handbook for Sampling & Sample Preservation of Water and Wastewater (EPA-600/4-82-029). The conclusion of the Convened Group was unanimous--the referenced orders do not add value and are not necessary; therefore the contract should not include them.
The following clause was inserted into the contract:
1,b,(3). (Fermilab will) Continue to maintain management systems that ensure that the agreed-upon standards are implemented.
1. Fermilab to maintain adequate management systems, and
2. The Batavia Area Office to audit Fermilab's management systems.
Attachment 19 provides further details.
CONCLUSION AND LESSONS LEARNED
We conclude that the N&S Process works well as designed. We faithfully followed the sequence of steps for the N&S Closure Process, contained in the Charter for the pilot and in the Identification Team Charter. These documents provided an entirely satisfactory mechanism for getting the work done.
We also concluded that the role of the Process Leader is a critical and exacting one. The Process Leader's effective coordination of a complicated mix of working and advisory groups (the Convened Group, Extended Convened Group, Steering Committee, Identification Team, Focus Groups, and Focus Group Leaders) is vital to the successful implementation of the N&S Process.
We present below a collection of "lessons learned" from the implementation of the N&S Pilot Process at Fermilab; we hope that these remarks will help organizations that are planning their own N&S Process in the future:
* Time and Hard Work: A successful N&S Process requires a lot of hard work by highly qualified and highly motivated people. In particular, the Identification Team phase of the work required significantly more time and effort than the Process Leader had anticipated. If we count the time of all the persons (Fermilab, BAO, CH, ER, Department Standards Committee and outside persons) involved in meetings, preparation, follow-up, communication, travel, etc., we estimate that the pilot took about 90 person-months of effort. Fermilab effort was about 24 person-months. The direct cost to Fermilab (travel, facilitation, meeting rooms, materials, etc.) was about $50 K.
* Careful Organization: Careful organization of each step of the process, including faithful implementation of all of the prescribed formalities of the process, is very important. In the Fermilab Pilot Process, this organizational effort helped to prevent misunderstandings and contributed to assuring continued buy-in by all interested parties as work progressed. The efforts of the Process Leader to assure that all interested parties were kept informed throughout the process were most worthwhile.
* Facilitator: The participation of a management consulting firm in the Fermilab N&S Process was helpful, especially in its role as a process facilitator at the outset of the Identification Team's initial two week period of concentrated work in mid-May. The facilitator introduced several concepts (the use of flip charts, ground rules, specific goals, pre-determined breaks, role playing- devil's advocate, a common understanding of the meaning of consensus, etc.) that proved very useful in keeping the Team and Focus Groups focused on the issues, the process, and the final objective.
* OSH Issues: The scope of the work of the Occupational Safety and Health (OSH) Focus Group was too broad. Over 100 of the ES&H hazard issues identified by the workers at Fermilab were in the OSH area. The assessment of these issues by at least two separate Focus Groups would probably have made a more effective arrangement.
* Boundary Conditions: Thoughtful consideration by the Process Leader, throughout the duration of the Identification Team work, of "boundary conditions" is important. It is not always clear what constitutes an ES&H issue, or if one should include a closely related topic associated with a particular ES&H issue. Examples of this are property loss prevention in the fire safety area, or safeguards and security considerations in the emergency response area.
* Involvement of Contract Lawyers: Although we solicited some comments from legal counsel early on, during the negotiations for the contract modification it became clear that more participation by the lawyers during the Identification Team process would have facilitated the final stages of the process.
The Fermilab Pilot exercised the Process. The Pilot followed the Process scrupulously, and found it very useful for the intended purpose. A set of N&S standards was selected, approved and incorporated into the DOE/URA contract. We propose no changes to the Process. We recommend use of the Process by the other DOE laboratories. We feel that lack of resolve or vision of those involved would constitute the only barrier to success.
REPORT ON THE
FERMILAB PILOT N&S CLOSURE PROCESS
GLOSSARY OF ABBREVIATIONS
ANL Argonne National Laboratory
BAO Batavia Area Office (DOE) [Since renamed the Fermi Group]
BNL Brookhaven National Laboratory
CEBAF Continuous Electron Beam Accelerator Facility
CH Chicago Operations Office (DOE)
DOE Department of Energy
DoR Documentation of Record
DSC Department Standards Committee (DOE)
EH Office of Environment Safety and Health (DOE)
EPA Environmental Protection Agency
ER Office of Energy Research (DOE)
ES&H Environment Safety and Health
ESHPAC ES&H Policy Advisory Committee (Fermilab)
FRMI Fermi Group (DOE) [Formerly the Batavia Area Office]
FITD Fermilab Identification Team Document
HEP High Energy Physics
LBNL Lawrence Berkeley National Laboratory
N&S Necessary and Sufficient
OSH Occupational Safety and Health
OSHA Occupational Safety and Health Administration
QA Quality Assurance
SLAC Stanford Linear Accelerator Center
URA Universities Research Association