Polaris

SOP# SITE-001.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. The Department Head for each Department will determine which activities requireSOPs and will assign the responsibility for writing the initial version.B. All SOPs will include:1. Brief, informative title.2. The SOP number on every page.3. Effective date of the SOP on every page.4. Dated approval signatures for the SOP’s Author, Department Head, and QualityAssurance (QA) representative.5. Revision history.6. Scope of the SOP (i.e., a statement which describes the personnel, projects, andsituations to which the SOP applies).7. Description of the procedure (i.e., a detailed description of all tasks to beconducted under the SOP, including when they are to be accomplished, where,and by whom). Each step in the procedure should be numbered. All new orunusual terms should be defined. If an abbreviation is associated with a term, itshould be placed in parentheses following the word. If specific forms orequipment are to be used, they should be specified. Copies of the applicableforms should be attached to the SOP in the Attachments section.8. References (i.e., citations of any applicable regulations, guidelines, publications,or other SOPs). Copies of the references do not need to be attached to the SOP.9. Attachments (i.e., copies of any forms, checklists, charts, and/or tables that will beused in executing the SOP). The Attachments section should begin with a list ofthe attachments that are included in the SOP. Attachments should be identified byletter.C. Review and Approval of SOPs1. The Author will circulate the draft SOP to the Author’s department members forreview and comment.2. The Department Head will perform the final review and edit of the SOP and willsubmit the final versions to QA for review.3. After completing its final review, QA will reconcile all questions and/orsuggested revisions with the Author prior to issue.4. The final version of each SOP must be approved by the Department Head and adesignated member of the QA Department before issuance. QA will obtainoriginal signatures on the SOP cover sheet before releasing the final versions ofan SOP.SITE-001.doc© 2004 by CRC Press LLC