Preparing and Maintaining Standard Operating Procedures

Transcription

1 SOP No. GA Supersedes SOP No. GA Effective Page 1 of 9 Original Issue 4 February 2002 Retirement 1. Significant Change(s) from Previous Version Revised Title of document, Purpose and Scope (Sections 2 and 3) Updated Standing Committees and Specialty Sections in Document Enumeration (Section 5.2) Updated Periodic Review of SOPs to occur each year in conjunction with the Annual Report (Section 5.7) Deleted Attachment 2, Document Review Form in lieu of communicating changes via (Section 5.8) Clarified document approval process and defined effective date as the date of approval by the Board Liaison (Sections 5.14 and 5.15) 2. Purpose This Standard Operating Procedure (SOP) describes the processes for preparing, reviewing, revising, distributing, and retiring SOPs that pertain to the functions of the Society of Quality Assurance (SQA). 3. Scope This SOP applies to: Members Committees Specialty Sections Council on Professional Registration Board of Directors Headquarters 4. Responsibilities 4.1 Each member of the Board of Directors (in his/her role as Board Liaison) shall approve new and revised SOPs for the Committee(s) and/or Specialty Section(s) with which s/he liaises and assure that such documents are reviewed in conjunction with Annual Reports The President of SQA shall approve all new and revised SOPs pertaining to General Administration, SQA Headquarters (HQ) and the Board of Directors.

2 Page 2 of The Executive Director or his/her HQ designee shall review all new and revised SOPs to assure compliance with SQA SOP formatting and consistency with the information provided in SQA Bylaws, policies and other procedures. 4.2 The Committee and Specialty Section Chairs, the Board Liaisons, and the Executive Director shall assure that their respective Committees, Specialty Sections, and staff members are familiar and comply with all applicable documents. 4.3 Each SQA member who serves in an elected or volunteer SQA position shall be familiar with the SOPs that apply to his/her area of responsibility by reviewing the current SOPs posted on the SQA website. 4.4 HQ shall serve as the Document Administrator and is responsible for the processes of enumerating, reviewing, finalizing, posting, filing, and retiring SOPs. 4.5 The Document Administrator and Administrative Webmaster shall be responsible to post all approved SOPs on the SQA website. 5. Procedures General Requirements 5.1 Each new SOP shall be written and saved as an electronic file at HQ. The Document Administrator shall name each file in accordance with Sections 5.2 and 5.3 below. Documents shall be prepared using the template, entitled Document Template (Attachment 1), which is located in SQA s electronic files and accessible to the Document Administrator and his/her backup. Document Enumeration All pertinent parts of the template shall be completed in sufficient detail to assure that a newly elected or volunteer member can understand the procedure. The Details of Procedure section shall be written in sufficient detail to assure that the task(s) can be performed in a consistent manner. Templates or other information referenced in the document shall be attached to the document and labeled accordingly: Attachment 1, Attachment 2, etc. 5.2 Documents shall be uniquely enumerated with a core alphanumeric designation (i.e., number) The alpha component is comprised of two letters and indicates the functional group within SQA to which the document applies. The alpha designations are as follows:

3 Page 3 of 8 Governance GA General Administration HQ Headquarters BD Board of Directors LF Learning Foundation Standing Committees AI Articles of Incorporation and Bylaws Committee BP Board of Publications ED Education Committee EM Ethics and Membership Credentials Committee EX Executive Committee FI Finance Committee HI Historical Committee IR International Relations Committee MD Membership Retention and Development Committee MP Mentoring Program Committee NO Nominating Committee PC Program Committee RP Regional Chapter Presidents Committee RR Regulatory Forum Council on Professional Registration CP Council on Professional Registration Specialty Sections AH Animal Health Specialty Section BC Beyond Compliance Specialty Section BA Bioanalytical Specialty Section CO Quality Assurance Consulting Support Specialty Section CS Clinical Specialty Section CV Computer Validation Initiatives Committee Specialty Section GL GLP Specialty Section GM GMP Specialty Section ME Medical Devices Specialty Section PV - Pharmacovigilance Specialty Section SA Scientific Archiving Specialty Section US University Specialty Section Each document shall receive a two-digit number signifying the order in which the documents were prepared. The number of the first document shall be 01 and sequentially enumerated thereafter for all documents within the group/type classification. The sequential numbers are separated from the alpha component by a dash (i.e., -01, -02, -03, etc.).

4 Page 4 of 8 Revision Designation 5.3 In addition to the core alphanumeric designation, all documents shall be assigned a revision number (i.e., suffix) that is separated from the core alphanumeric designation by a decimal point. The suffix for the first version (i.e., the original document) shall be.00. For each subsequent revision, the suffix is increased by one (e.g.,.00 to.01). Document Enumeration Example 5.4 GA indicates that the document is the first (01) General Administration (GA) procedure and that it is the original document (.00). The fourth revision to it would be designated as GA Preparation of a New Document 5.5 A new document shall be prepared when a new procedure is identified and deemed necessary for description or consistency of practice. 5.6 When a person (as described in Section 4.1) determines that it is appropriate to prepare a new document, such person shall obtain an electronic copy of the Document Template (Attachment 1) from the Document Administrator as well as the new document number designation. At that time, the Document Administrator shall assign the number and shall add the number and draft title in italic font to the Master Document Index for tracking purposes. Periodic Review 5.7 SOPs may be reviewed at any time, but periodic reviews shall occur each year. Committee and Specialty Section Chairs shall review their SOPs near the end of the year and make revisions as needed in conjunction with their Annual Report that is submitted in December for the next year s January Board meeting. The Document Administrator shall send the Annual Report template to Committee and Specialty Section Chairs in November of each year. SOPs shall be reviewed by the end of each year and edited as necessary, and the Chair will sign off on the Annual Report that the process has taken place. Headquarters shall be responsible reviewing for the Headquarters and General Administration SOPs, and the Board shall be responsible for the Board SOPs. 5.8 If a reviewer recommends changes to an SOP, their Board Liaisons and/or the Executive Director (for Board SOPs) shall review the edits to ensure the accuracy, clarity, and adequacy of the document. Their review shall be documented in an to the reviewer, indicating whether the revised SOP: 1) is acceptable as written (no additional revisions) 2) should be revised further (and itemize the recommended changes) The SOP shall be reviewed further as changes are made/discussed until the Board Liaison and/or Executive Director approve(s) a final revised version.

5 Page 5 of 8 Document Retirement 5.9 Reasons for retirement may be that the subject matter no longer pertains to SQA, it has been incorporated into another procedure, or a new procedure has superseded it. If a reviewer and Board Liaison/Executive Director recommend retirement of an SOP: Document Revision The Executive Director, with the Document Administrator, shall determine the retirement date The Document Administrator shall remove the original from the current document file and assure that it is deleted from the website. The retirement date shall be recorded on the original document and in the Master Document Index. Note: Document titles and the respective retirement dates shall remain on the Master Document Index indefinitely The Document Administrator shall electronically archive the original document in HQ s files If an SOP requires revision, the reviewer shall edit the SOP to incorporate the revisions. Section 1 of the SOP, entitled Significant Change(s) from Previous Version, shall include the Section number affected by the revision and a brief description of the change(s) for each revision. Note: The reviewer shall utilize the Track Changes tool when electronically editing the SOP. When editing the SOP, electronically or otherwise, the reviewer shall indicate the exact wording intended for the revised document Upon completion, revised electronic (or paper) copy of the document shall be forwarded to the Board Liaison/Executive Director for review, as described in 5.8 above. Document Approval 5.12 Approvals are generally achieved by either of the methods described below: When possible, both the Executive Director or the HQ designee and the Board Liaison will hand-sign the original SOP. Note: Hand-signing would most likely occur at a face-to-face Board of Directors meeting If hand signing is not possible, written approval shall be obtained (e.g., via or minutes), and the SOP shall include the phrase Approval on File.

6 Page 6 of When the SOP has been approved, the Document Administrator shall denote the effective date on the document. The effective date is the date of final approval by the Board Liaison or Executive Director (for Board SOPs). The Document Administrator shall type the phrase Approval on File in place of the signatures of the Executive Director/HQ designee and Board Liaison in the electronic version of the document as well as the review and approval dates Headquarters (or the Document Administrator) shall file the original electronic document, the scanned version of the hand-signed document, if available, and the Board Liaison s approval in the appropriate SOP file on the SQA server at Headquarters Headquarters (or the Document Administrator) shall advise the Administrative Webmaster to post the new SOP as a PDF to the website. Processes for HQ Administration 5.14 The electronic originals of all current and historical documents, the scanned version of hand-signed documents, and approval s shall be maintained in the files at HQ. The files shall be organized by alpha component and document type (see Sections and under Document Enumeration ) The Document Administrator shall update the Master Document Index each time a document is issued or revised. Note: The original Master Document Index shall list all current, superseded and retired documents and shall be retained in the files at HQ. The web-posted Master Document Index shall list only current documents. 6. Other Documents to Consider None. SOP Reviewed by: Approval on File Alison Cockrell SQA Executive Director SOP Approved by: Approval on File Melissa Eitzen RQAP-GLP SQA President

7 Page 7 of 8 ATTACHMENT 1: Document Template SQA e-logo SOP No. AA-##.## Supersedes SOP No. AA-##.## Effective Page 1 of # Original Issue Retirement Title of SOP 1. Significant Change(s) from Previous Version This is a new SOP. OR Itemize with a brief description. 2. Purpose Briefly describe the purpose of the SOP. 3. Scope Briefly describe the scope, or to whom the SOP applies. When listing the SQA groups to whom the SOP applies, the following titles shall be used: SQA Members Committees Specialty Sections Council on Professional Registration Board of Directors SQA Headquarters 4. Responsibilities Describe in detail the Responsibilities the SOP addresses. 5. Procedures Describe in detail the Procedures the SOP addresses.

8 Page 8 of 8 6. Other Documents to Consider List other documents that should be considered or referenced, or that may be affected if the document is revised or retired. List specific documents by document number; if no others are impacted, indicate None.. SOP Reviewed by: Signature Name SQA Executive Director or HQ Designee SOP Approved by: Signature Name SQA Board Liaison