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  1. 1. Guidance for Preparing Standard Operating Procedures Sherri-Lynne Almeida, Dr.PH, MSN, M.Ed, RN, CEN, FAEN
  2. 2. Introduction <ul><ul><li>Overview </li></ul></ul><ul><ul><li>A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end result. </li></ul></ul>
  3. 3. Introduction <ul><ul><li>Purpose </li></ul></ul><ul><ul><li>detail the work processes </li></ul></ul><ul><ul><li>document the way activities are to be performed </li></ul></ul><ul><ul><ul><li>facilitate consistent conformance </li></ul></ul></ul><ul><ul><ul><li>support data quality </li></ul></ul></ul>
  4. 4. Introduction <ul><ul><li>Purpose </li></ul></ul><ul><ul><li>intended to be specific to the organization </li></ul></ul><ul><ul><li>assist that organization to maintain their quality control and quality assurance processes and ensure compliance </li></ul></ul>
  5. 5. Introduction <ul><ul><li>Benefits </li></ul></ul><ul><ul><li>development and use of SOPs promotes quality through consistent implementation of a process or procedure within the organization </li></ul></ul><ul><ul><li>reduced work effort, along with improved data comparability, credibility, and legal defensibility </li></ul></ul>
  6. 6. Introduction <ul><ul><li>Writing Style </li></ul></ul><ul><ul><li>concise, step-by-step, easy-to-read format </li></ul></ul><ul><ul><li>information presented should be unambiguous and not overly complicated </li></ul></ul><ul><ul><li>active voice and present verb tense should be used </li></ul></ul><ul><ul><li>should not be wordy, redundant, or overly lengthy </li></ul></ul>
  7. 7. SOP Process <ul><ul><li>Preparation </li></ul></ul><ul><ul><li>written by individuals knowledgeable with the activity and the organization's internal structure </li></ul></ul><ul><ul><li>written with sufficient detail so that someone with limited experience with or knowledge of the procedure, but with a basic understanding, can successfully reproduce the procedure when unsupervised </li></ul></ul>
  8. 8. SOP Process <ul><ul><li>Review & Approval </li></ul></ul><ul><ul><li>reviewed by one or more individuals with appropriate experience </li></ul></ul><ul><ul><li>approved by the State Council </li></ul></ul><ul><ul><li>signed by the President </li></ul></ul>
  9. 9. SOP Process <ul><ul><li>Frequency of Revisions & Reviews </li></ul></ul><ul><ul><li>need to remain current </li></ul></ul><ul><ul><li>procedures are changed, SOPs should be updated and re-approved </li></ul></ul><ul><ul><li>systematically reviewed on a periodic basis to ensure that the policies and procedures remain current and appropriate, or to determine whether SOPs are even needed </li></ul></ul><ul><ul><li>review date should be added to each SOP that has been reviewed </li></ul></ul>
  10. 10. Checklists <ul><li>Many activities use checklists to ensure that steps are followed in order. </li></ul><ul><ul><li>SOPs should describe how the checklist is to be prepared or on what it is to be based. </li></ul></ul>
  11. 11. SOP General Format <ul><li>Should be organized to ensure ease and efficiency in use and to be specific to the organization. </li></ul>
  12. 12. SOP General Format <ul><li>Title Page </li></ul><ul><ul><li>Title that clearly identifies the procedure/activity </li></ul></ul><ul><ul><li>Date of issue and/or revision </li></ul></ul><ul><ul><li>Name of the association </li></ul></ul><ul><ul><li>Signatures and signature dates of those individuals who prepared </li></ul></ul>
  13. 13. SOP General Format <ul><li>Table of Contents </li></ul><ul><ul><li>Quick reference </li></ul></ul><ul><ul><li>Denotes changes or revisions made only to certain sections of a SOP </li></ul></ul>
  14. 14. SOP General Format <ul><li>Text </li></ul><ul><ul><li>Purpose of the work or process </li></ul></ul><ul><ul><li>Define any specialized or unusual terms either in a separate definition section or in the appropriate discussion section </li></ul></ul><ul><ul><li>Clearly worded </li></ul></ul><ul><ul><li>The use of diagrams and flow charts help to break up long sections of text </li></ul></ul>
  15. 15. SOP General Format <ul><li>Types </li></ul><ul><ul><li>May be written for any repetitive technical activity, as well as for any administrative procedure </li></ul></ul>
  16. 16. Examples <ul><li>In states where Chapters exist, State Councils will be composed of representatives from each Chapter within the State in accord with Bylaws and Procedures . </li></ul>
  17. 17. TENA SOPs
  18. 18. Examples <ul><li>Each State Council shall coordinate the individual State Delegation to the ENA General Assembly in accord with Procedures. </li></ul>
  19. 19. Examples <ul><li>Each Chapter has the responsibility to provide representation for active participation at the respective State Level in accord with Procedures. </li></ul>
  20. 20. Examples