SOP No. GA-06.07 Supersedes SOP No. GA-03-14.06 Effective Date Page 1 of 8 Original Issue Date 9 January 2004 Retirement Date 1. Significant Change(s) from Previous Version No significant changes. 2. Purpose This SOP sets forth the standards and requirements for formation of Specialty Sections (SS) within the Society of Quality Assurance (SQA), and the expectations of the established SSs. 3. Scope This SOP applies to: Committees (Regulatory Forum) Specialty Sections Board of Directors SQA Headquarters 4. Responsibilities Specialty Section Membership and Operations 4.1 The primary responsibility of a SS is to investigate current issues and provide guidance to the SQA membership regarding regulatory developments and current issues of special interest. 4.2 A member of a SS shall be an Active or Affiliate member of SQA with an interest in the SS topic or issue. The SS member shall actively participate in the SS meetings and/or projects. Note: Additional SS membership requirements and responsibilities shall be included in the respective SS Operating Procedure(s). 4.3 The SS shall develop a Mission Statement and SOP(s) that describe, at a minimum, its norms, membership requirements and expectations. The Mission Statement may be included in the SOP. The SS shall submit its Mission Statement and SOP(s) to the SQA Board of Directors (Board) for approval. The SS shall review its Mission Statement and SOP(s) annually and revise as necessary.
Page 2 of 8 4.4 Each SS may have a written operating plan. This plan shall be submitted for review by the Board whenever it is changed. 4.5 Each SS shall have a written annual operating plan. This plan shall be submitted for review and approval at the January meeting of the Board. 4.6 The Board shall appoint a Board Liaison (BL) for each SS (further described in the current version of BD-02.xx). 4.7 BLs shall fulfill the responsibilities described within this document and the current version of BD-02.xx. 4.8 Each SS Chair is responsible for ensuring the effectiveness of his/her respective SS, in accordance with the requirements of this document. 4.9 In general, SS Chairs shall be responsible for the following: 4.9.1 The overall function of the SS; 4.9.2 Assuring that meetings are scheduled and conducted at appropriate intervals; 4.9.3 Guiding the activities of the SS to achieve the goals of its Mission Statement; 4.9.4 Communicating with the BL and SQA Headquarters (HQ), as necessary, indicating, for example, the needs, activities and progress of the SS; 4.9.5 Ensuring that the SS appropriately responds to the needs of the SQA membership and other SSs; 4.9.6 Identifying opportunities to coordinate efforts with other SSs and Committees; 4.9.7 Assuring that the SS works cooperatively with other SSs, Standing Committees and the Board; and 4.9.8 Providing reports to HQ. 4.10 In December of each year, SS Chairs shall recognize and thank their respective SS members for their participation in writing. 4.11 SS Chairs shall be responsible for notifying the Manager of Membership Services at HQ in a timely fashion of changes in SS membership. 4.12 Each SS shall appoint members as follows: Ad hoc representative to the Education Committee; Ad hoc representative to the Program Committee; Liaison to the Regulatory Forum; Website Communications Liaison; and Regulatory Liaison.
Page 3 of 8 4.13 Specialty Sections may identify topical subcommittees to function within the group, and a chair shall be identified and approved by the Board. 5. Procedures Formation of a Specialty Section (see Attachment 1, New Specialty Section Step-by-Step Development) 5.1 Any member of SQA may identify a topical area of interest and begin procedures to develop a SS. This person is the SS Coordinator. 5.2 The Board shall appoint from its members a Board Liaison (BL) to assist in the establishment of the new SS. Note: In some cases, a temporary ad hoc committee may be formed to explore the feasibility of forming a particular SS. The Board shall appoint a BL to assist the committee. The committee shall nominate a Chair and the Board shall approve the nomination. If the committee determines that a SS is not feasible or warranted, the ad hoc committee Chair shall report this information to the Board. The Board may disband the ad hoc committee or direct that it continue to work as an ad hoc committee until there is sufficient interest and a SS is authorized. Authorization of a Specialty Section 5.3 The SS Coordinator shall provide the following to the Board: The proposed name for the SS; The SS s Mission Statement; and A list of at least ten SQA members willing to participate in the establishment of the SS. 5.4 When the Board determines that sufficient interest and leadership exists for the SS, the Board shall authorize the SS. Note: The Board may withdraw its authorization of any SS deemed ineffective or redundant. Specialty Section Chair Appointment 5.5 SS members shall nominate a member of their SS to serve as the Chair, and the Board shall approve the nomination. 5.6 The members of the SS shall determine the length of time the Chair shall serve. 5.6.1 Term length shall not exceed three full calendar years and shall be defined in the SS s SOP.
Page 4 of 8 5.6.2 Regardless of the length of the term, it shall commence on 1 January and end on 31 December. Note: When determining the length of the Chair s term, the SS members shall specify if their first Chair shall serve only a partial year (i.e., from the time of the SS s authorization to 31 December) or continue to serve one or two years beyond that time. The Chair shall notify the BL of the SS s decision. 5.7 The SS members shall nominate a Vice-Chair and submit the nomination to the Board for approval. At the conclusion of the Chair s term of office, the Vice- Chair shall assume the role of Chair. Reports 5. 8 The Chair of each SS shall prepare reports following the criteria outlined in this SOP. The reports shall clearly identify those activities performed in conjunction with SQA s Strategic Plan, and shall document when an objective of the Strategic Plan is completed. The reports shall be submitted to the SS BL and HQ. 5.8.1 Semi-Annual Report Each SS Chair shall submit a Semi-Annual Report on or about 1 July each year. This report shall contain: the SS activities during the preceding six months; the special issues, challenges and successes of the SS; the SS s plans for the next six months; and a description of how the SS has addressed specific issues related to the Strategic Plan. Note: The Board shall distribute this report to members during the Annual Business Meeting. 5.8.2 Year-End Report Each SS Chair shall submit a Year-End Report on or about 31 December each year. This report shall summarize the twelve month activity during the Chair s term and shall include the current SS roster. 5.9 By 1 October of each year, each SS may submit an estimate of anticipated special program expense to HQ for distribution to the Board and the Finance Committee. 5.10 SSs may meet and/or communicate via e-mail, teleconferences or in face-to face meetings, as appropriate. Each meeting shall have written meeting minutes that shall be distributed to the SS BL and HQ.
Page 5 of 8 Interactions with the Education and Program Committees 5.11 On behalf of the SSs, the Ad hoc representatives to the Education Committee shall provide guidance to and/or speakers for the Education Committee and assist with SQA training within their field(s) of expertise. SS members may provide training, workshops and symposia. The Program Committee Liaison shall ensure that SSs provide a Session Chair(s) for session(s) at the SQA Annual Meeting, and shall assist in providing the expertise and/or speakers for all sessions within the SS s area of interest. Upon request, SSs shall be provided meeting space during the SQA Quarterly and/or Annual Meetings. The SS Chairs shall assure that relevant activities are coordinated through the Ad hoc representatives to the Education and Program Committees, as appropriate. Interactions with the Regulatory Forum (RF) 5.12 SS Chairs shall ensure that Members of the respective SS understand the functions of the RF; Members are aware that each may attend the RF; and Projected SS member attendance to the RF is communicated to the RF Chair. Note: It is suggested that the Chair schedule the location a SS meeting to coincide with the Annual Meeting or the meeting of the RF. Note: While attendance by SS members at the RF is encouraged and valued, logistics, such as room size, could limit the number of total attendees. Therefore, the Chair should coordinate SS attendance in order to ensure adequate representation at and reporting to the RF. 5.13 The Liaison to the RF shall communicate to and/or update the RF membership on the SS s projects and activities, hot topics and regulatory activities that impact the SS s area of interest (see the SOP of the Regulatory Forum). 5.14 SSs are encouraged to establish Regulatory Liaisons with the appropriate agencies in accordance with the current versions of RR-01.xx and GA-03.xx. Interactions with the SQA Website and Newsletter 5.15 The SS Chair shall ensure that the SS s Website Communications Liaison provides HQ, at a minimum, with the following for posting to the SQA website: Specialty Section Pages Required Mission Statement
Page 6 of 8 Link to a database-generated list of Specialty Section leadership (including the BL) and members Meeting teleconference schedule with telephone number Description of current activities and future plans SOPs and/or documents pertaining to the Specialty Section Minutes Midyear and End-of-Year Reports to the Board (These may be included on a Minutes and Reports page.) Reports shall include accomplishments in support of the Strategic Plan. Optional Goals Statement Annual and Three-Year Plans Hot topics References and/or Links page listing resources relevant to the particular SS 5.16 Each SS shall provide quarterly Newsletter articles and periodic position papers for posting on the SQA website. Interacting with Regulatory Agencies 5.17 The SS Regulatory Liaison shall work with the Regulatory Communications Coordinator to facilitate responses to questions from the SQA membership about regulatory issues that are within the SS s area of expertise (see the Regulatory Communications Coordinator SOP). 6. Other Documents to Consider AH-01.xx GA-03.xx RR-01.xx SOP Reviewed by: Alison Cockrell SQA Deputy Executive Director Date SOP Approved by: Greg Furrow SQA President Signature on File 17 September 2014 Date
Page 7 of 8 ATTACHMENT 1 New Specialty Section Step-by-Step Development STEP I Identification of Need for a Specialty Section Any member of SQA may identify the need for a Specialty Section. If a member feels that there is a regulated area that is not being adequately addressed, s/he shall determine if interest exists by speaking with members and/or nonmember colleagues. This may be accomplished by identifying a core group of SQA members to gather feedback on the idea and to determine where a new Specialty Section might fit. Many Specialty Sections involve regulatory areas that cross over between the US (e.g. EPA, FDA, USDA) and other international regulatory agencies. Consideration should also be given at this time as to the proposed name of the Specialty Section and the proposed nominees for the position of Chair, Vice-Chair and other Specialty Section Liaisons (see list in Step IV below). STEP II Contact SQA Contact the SQA Board of Directors for initial approval and to identify a Board Liaison. The Board Liaison shall answer questions and provide insight into the Specialty Section s formation. At this time the Specialty Section may be identified as an Ad hoc Committee. STEP III Notification to Membership Request that SQA Headquarters send out an e-mail to the full database of members asking if anyone would like to join the new Specialty Section. The e-mail shall be drafted by the person(s) who originally requested that the Specialty Section be formed. The Board Liaison shall approve the e-mail prior to distribution. Compile the responses. Once the responses have been compiled, submit the contact information to SQA Headquarters so that when the Specialty Section is formally approved, the information can be added to each individual s SQA profile. STEP IV Initial Meeting (e.g. Teleconference, Face-to-Face) Arrange for a face-to-face meeting or contact SQA Headquarters to set up an initial teleconference with all interested individuals. At this time, a Chair and Vice-Chair shall be identified and the following liaisons shall be established: Program Committee Liaison: Coordinate with the Program Committee to identify and set up sessions at the Annual Meeting.
Page 8 of 8 Education Committee Liaison: Coordinate with the Education Committee about conducting any training outside of the Annual Meeting or at the Preconference Training workshops. The Education Committee Liaison may also be called on to help provide speakers for a training session. Regulatory Forum Liaison: This person sits on the Regulatory Forum Council and is the link between the Regulatory Forum and the Specialty Section. This person may also be the Regulatory Liaison to the government agency. Webmaster Liaison: This person will coordinate and monitor the Specialty Section page on the SQA website. A Mission Statement shall be drafted for approval by the Board of Directors. STEP V Official Request Upon completion of steps I - IV, a formal request shall be made to the Board of Directors for approval as a Specialty Section. STEP VI Secondary Meeting During this meeting, individuals shall be identified to write the Specialty Section SOP(s), identify areas of importance and identify goals to be accomplished in the coming year. These goals may include items such as developing sessions for the SQA Annual Meeting (all Specialty Sections are expected to Chair and organize at least one session), identifying key issues for white papers, establishing workshops with regulators and identifying the need(s) for training.