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Making SOPs Fit for Human Use

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Making SOPs Fit for Human Use

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A presentation given by Ximedica Co-Founder Aidan Petrie at the MD&M East conference in Philadelphia, May 2012. His talk explored the recent re-design of Ximedica's standard operating procedure paperwork, and how streamlining document control can significantly conserve time and resources. SOP's are used internally for clinical, regulatory, and quality-control purposes as well as externally by the FDA and potential auditors.

A presentation given by Ximedica Co-Founder Aidan Petrie at the MD&M East conference in Philadelphia, May 2012. His talk explored the recent re-design of Ximedica's standard operating procedure paperwork, and how streamlining document control can significantly conserve time and resources. SOP's are used internally for clinical, regulatory, and quality-control purposes as well as externally by the FDA and potential auditors.

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Making SOPs Fit for Human Use

  1. 1. Standard Operating Procedures Fit for Human Use
  2. 2. Agenda: The background behind Ximedica’s decision The process of re-designing The results and benefits
  3. 3. Applying usability to Standard Operating Procedures for improved compliance. 3
  4. 4. The value of re-designing SOPs: Defined methods Improved training Ensuring alignment with FDA requirements + ISO Able to evolve with the organization Providing situational awareness 4
  5. 5. Ximedica is a medical and healthcare firm focused on helping our clients bring innovative products to market. RESEARCH DETAILED IMPLEMENTATION + INNOVATION DEVELOPMENT + LAUNCH 5
  6. 6. RESEARCH DETAILED IMPLEMENTATION + INNOVATION DEVELOPMENT + LAUNCH Product/platform strategy Designing and developing Pilot manufacturing new product offerings 2nd gen product refinement Supply chain strategy Regulatory strategy + User research + concept submission Global sourcing testing Tech. feasibility assessments User observation and human 6 factors studies Formative studies
  7. 7. 140+ personnel with diverse backgrounds and roles RESEARCH DETAILED IMPLEMENTATION + INNOVATION DEVELOPMENT + LAUNCH Product/platform strategy Designing and developing Pilot manufacturing new product offerings 2nd gen product refinement Supply chain strategy Regulatory strategy + User research + concept submission Global sourcing testing Tech. feasibility assessments User observation and human 7 factors studies Formative studies
  8. 8. Before: Written for/by Content Experts Difficult to maintain and update Not reflective of current processes Siloed awareness across different functions Very long, lots of duplicate information Diverse format styles 8
  9. 9. Re-architected for: - Ease of use - Accuracy - Simplicity Team: Time to completion: Information Architects 1.5 years Human Factors Engineers Content Experts Regulatory Executive Sponsors 9
  10. 10. 1. Deconstructed into elements Purpose Scope Definitions Responsibilities Reference Documents Record Retention Procedure Process Revision History Approval Methods Appendix 10
  11. 11. 2. Re-architected 11
  12. 12. 3. Removed redundancy Definitions Definitions Definitions Definitions Definitio Definitions Definitions Definitions Definitions Definitions Defin Definitions Definitions Definitions Definitions Definitions Defin Definitions Definitions Definitions Definitions Definitions Defin Reference DocumentsDocuments Document Documents Documents Documents Documents Documents Do Documents Documents Documents Documents Documents Do Documents Documents Documents Documents Documents Do StakeholdersStakeholders Stakeholders Stakeholde Stakeholders Stakeholders Stakeholders Stakeholders Stakeho Stakeholders Stakeholders Stakeholders Stakeholders Stakeho Stakeholders Stakeholders Stakeholders Stakeholders Stakeho Process DetailsDetails Details Details Details Deta Details Details Details Details Details Details Details Details De Details Details Details Details Details Details Details Details De Details Details Details Details Details Details Details Details De 12
  13. 13. 4. Created a repeatable framework 1 Purpose 5 Process Flow 2 Scope 6 Procedure 3 Definitions 7 Reference Documents, 4 Stakeholders Attachments, Appendices 13
  14. 14. 5. Emphasized front page All the high level information was included on the cover. Information hierarchy; top of page guides your eye Company process serves as iconic graphic Predominant header Location in process gives user context Footer reinforces title, gives most current revision and page number 14
  15. 15. 6. Using images/charts whenever possible 15
  16. 16. 7. Re-wrote concisely, in common language when possible “ Ximedica’s Product Development Process consists of 6 phases. It is a “ flexible process allowing for specific activities to occur as needed. 16
  17. 17. 8. Referenced the process 17
  18. 18. The results: - Reduced time spent reading - Easier to understand - Easier to train on - Decreased frustrations - Easier to update - Shared view across process - Additional perceived informational value 18
  19. 19. Project team and phase activities Phase One Phase Two Team: Team: - Information Architect - All department VPs - All department VPs - Selected staff members - COO + CIO as advisory board - COO + CIO as advisory board - Content Experts Activities: - Deconstructed existing structure and ctivities: content - Removed redundant content VPs and select staff assigned to develop content for specific SOPs - Optimized format and content - Created a standard SOP template Reformat and move content into - Created detailed visual diagram of template Ximedica’s development process Refined clarity of content and alignment with corporate goals 19 Test against process
  20. 20. Benefits Before After Number of pages to read 12 - 27 6 - 18 pages per SOP: pages Time spent to read: 30-45 minutes 10-15 minutes Targeted for FDA, Auditors Inclusive for all potential Audience: audiences; FDA, Auditors, current and new hires Technical Specs locked in Accessible to all specifications: licensed files with users to view, print, limited access and transfer efficiently 20
  21. 21. The newly designed SOPs are better organized, more concise, and easier to follow than most procedures I review. The process flow shows what the procedure is doing and what phase of the process it is linked to. The details at the end provide an appropriate level of instruction and information to be useful for readers. - Recent Auditor 21
  22. 22. Thank you. Aidan Petrie Chief Innovation Officer, Co-Founder apetrie@ximedica.com www.ximedica.com 22

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