CSTAR CCB Charter.doc

CSTAR Change Control Board (CCB) Charter

CSTAR Change Control Board Charter This document describes the purpose, authority, membership, operating procedures, decision-making process, and communication methods of the Change Control Board (CCB) for two key Center IT systems: the CDRH Ad hoc Reporting System (CARS) and the Center Tracking System (CTS). Collectively, these systems are known as “CSTAR,” or “Center Submission Tracking and Reporting.”

1 Purpose

The CSTAR CCB has been established for the following purposes:

· Enables employees from each CDRH office, who are interested in improving the Center’s IT systems, to come together as a user group each month.

· Provides status updates related to activities that have been approved by the CDRH Information Management Steering Committee (IMSC).

· Offers the opportunity for voting members to review, prioritize, and assign Change Control Requests (CCRs)—that are within the CCB’s scope of authority—to release(s).

· Promotes the discussion of ideas, suggestions, and problems along with their associated risks, solutions, and trade-offs.

· Requires attendees to communicate CCB decisions back to the affected groups and individuals within their offices.

2 Scope of Authority

The diagram in Figure 1 shows the relationship of the CSTAR CCB with the Center’s management, the Information Management Steering Committee (IMSC), functional area representatives, and FDA’s Office of Information Management (OIM). Budget authority resides with the Office of the Center Director (OCD). The Business Information Solutions (BIS) team within OCD serves as the liaison between OIM and the Center’s business units and coordinates all planning, funding, and contracting aspects of IT systems. The IMSC establishes the high-level priorities, recommends funding requests, and provides executive-level oversight of CDRH’s IT investments. Functional area sponsors include subject matter experts and organizational advocates who work with OIM and BIS to define detailed requirements for approved enhancements in each subsystem of CTS plus CARS. OIM also establishes and maintains FDA-wide standards related to IT (e.g., security, tools, development processes, etc.) to which all CDRH systems must adhere. Finally, OIM provides the government employees and contract staff needed to design, develop, test, deploy, and maintain CARS and CTS. Figure 1 shows some of the important interactions that occur between these organizational entities.

Note: OIM refers to both FDA OIM employees and contractors on the CARS and CTS development teams.

Figure 1: CCB Context

The authority of the CSTAR CCB is limited to reviewing, approving, and prioritizing operations and management (O&M) changes (e.g., bug fixes, minor enhancements, etc.) within the existing CARS and CTS applications. All changes are subject to budget constraints and approval by the Center’s IT management group. Any request that adds significant new functionality or requires major system changes would be considered a development, modernization, and enhancement (DME) task. Only the IMSC can approve major development tasks to implement CCRs that are categorized as DME.

When a newly submitted CCR exceeds the threshold for an O&M request or requires Center-level review, OIM will notify CDRH’s Business Information Solutions (BIS) team. The BIS team will work with the requesting program office to initiate a more formal IT Project Request, which will be evaluated and prioritized by the IMSC. These major CCRs will not be presented to the CSTAR CCB until approved by the IMSC.

Otherwise, the CSTAR CCB will be made aware of minor changes to the database and/or underlying software configuration (e.g., adding a new consult type, changing the values that appear for Interactive Review Log contact types, etc.). OIM will notify CCB members of these changes and will wait at least three (3) business days before implementing them. The CCB will let OIM know within that time if the proposed changes should be discussed at an upcoming meeting. If the CCB does not request that action be deferred until a general discussion, OIM will make the change as requested.

3 Membership

The CSTAR CCB is chaired by a business representative. The CCB Chair will run for a 12-month period. Upon completion of the term, if the Alternate Chair is from a program office, the Alternate CCB Chair will assume the Chair’s responsibilities automatically, and a new Alternate CCB Chair will be selected. A member of the Business Information Solutions (BIS) team will preside over CCB meetings or activities that the CCB Chair (or Alternate CCB Chair) cannot attend or perform.

The CCB Chair is responsible for ensuring that each office is represented by engaged voting members who cast their decisions in a timely manner. All CCB activities are facilitated by a partnership among the CCB Chair, the CeSub development teams within OIM, and the BIS team within OCD. Votes may not be cast by the CCB Chair, OIM, or BIS.

The following table identifies the current CCB voting members. The Office Director or his or her designee will select each office’s primary and alternate voting members. The voting members should be knowledgeable about the CARS and CTS applications and should understand what improvements are needed to help their offices perform their work. This table will be updated as existing members leave and new ones join. Although offices may have more than one representative, each office has only one vote. The primary voting member is responsible for soliciting input and representing the collective feedback of its office. The alternate voting member may cast the official vote when the primary is unavailable.

4 Operating Procedures

Configuration Change Requests. CCRs may be submitted by end users or OIM staff/contractors through the General Issue Entry (GENIE) system, ERIC, JIRA, or a CCB member. OIM will collect, track, and report on CCRs to facilitate discussions during CCB meetings.

Meetings. The CCB will meet on a monthly basis. The CCB Chair may also convene special meetings to discuss issues requiring a decision before the next monthly meeting. OIM will distribute an agenda prior to the meeting. Everyone is welcome to attend any of the CSTAR CCB meetings as a non-voting guest.

Activities. CCB meetings will typically include an update on major activities, a summary of CCRs addressed in any recent system releases, a quick review of CCRs currently being implemented according to prior CCB decisions (sometimes including demonstrations), and a more extensive review of CCRs that are candidates for future releases. CCB voting members are expected to solicit input from the organizations they represent and rank all unapproved CCRs outside of meetings. CCB voting members will discuss their rankings and reach consensus on the overall CDRH priority of a CCR. As needed, working groups for areas of special interest may be formed. These need not be limited to members of the CCB. No decisions by working groups will be binding.

OIM Support. To support this process, OIM government employees and contract staff will analyze submitted CCRs and estimate the level-of-effort (LOE) required to implement them. OIM will also clarify CCRs and present alternative solutions when needed. OIM will store CCB-related artifacts (e.g., CCR lists, rankings, etc.) in a Traction workspace. OIM will notify CCB members of proposed changes that do not require a significant amount of time to make and wait three business days for any request to defer the change until it can be discussed at an upcoming meeting.

5 Decision-Making Process

The CSTAR CCB will reach agreements primarily through consensus. At least 75% of the voting CDRH offices must vote for any decisions to be binding. With at least 75% participation, the CCB Chair may ask for official votes during a meeting—whether or not consensus has been reached. Otherwise, voting may also take place in Traction. Decisions require a simple majority of votes. The CCB Chair cannot overrule collective votes, but he or she will break ties. Issues will be escalated to the IMSC, if needed.

When a CCR list is provided for review and prioritization, the CCB will be responsible for voting. Voting will allow for prioritization of each need. The group will discuss what O&M CCRs will be implemented in the application releases of CARS and CTS. It is important to have OIM and BIS as parties to this discussion. The next version release list will be based on this prioritized list and our discussions.

6 Communicating Status

The CSTAR CCB will communicate status to stakeholders in these ways:

· OIM will prepare a status presentation in advance of each CCB meeting.

· OIM will take meeting minutes to capture all CCB discussions and decisions (e.g., votes by office, CCR release assignments).

· OIM will store CCB-related artifacts in the CDRH Business Information Solutions workspace in Traction.

· OIM will update the JIRA issue tracking system to communicate CCB decisions to the implementation staff.

· OIM will make use of Traction outside of regularly scheduled meetings to facilitate communication and collaboration with all of CDRH.

7 Document History

January 11, 2011

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