Standard Operating Procedures. Fit for Human Use

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1 Standard Operating Procedures Fit for Human Use

2 Agenda: The background behind Ximedica s decision The process of re-designing The results and benefits

3 Applying usability to Standard Operating Procedures for improved compliance. 3

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 Ximedica is a medical and healthcare firm focused on helping our clients bring innovative products to market. RESEARCH + INNOVATION DETAILED DEVELOPMENT IMPLEMENTATION + LAUNCH 5

6 Ximedica is a medical and healthcare firm focused on bringing innovative products from concept to market. RESEARCH + INNOVATION Product/platform strategy 2 nd gen product refinement User research + concept testing User observation and human factors studies DETAILED DEVELOPMENT Designing and developing new product offerings Regulatory strategy + submission Tech. feasibility assessments Formative studies IMPLEMENTATION + LAUNCH Pilot manufacturing Supply chain strategy Global sourcing 6

7 RESEARCH + INNOVATION 140+ personnel with diverse backgrounds and roles DETAILED DEVELOPMENT IMPLEMENTATION + LAUNCH Product/platform strategy 2 nd gen product refinement User research + concept testing User observation and human factors studies Designing and developing new product offerings Regulatory strategy + submission Tech. feasibility assessments Formative studies Pilot manufacturing Supply chain strategy Global sourcing 7

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 Re-architected for: - Ease of use - Accuracy - Simplicity Team: Information Architects Human Factors Engineers Content Experts Regulatory Executive Sponsors Time to completion: 1.5 years 9

10 1. Deconstructed into elements Purpose Scope Definitions Responsibilities Record Retention Reference Documents Procedure Process Approval Methods Revision History Appendix 10

11 2. Re-architected 11

12 3. Removed redundancy Definitions Definitions Definitions Definitions Definitio Definitions Definitions Definitions Definitions Definitions Defini Definitions Definitions Definitions Definitions Definitions Defini Definitions Definitions Definitions Definitions Definitions Defini Reference Documents Documents Document Documents Documents Documents Documents Documents Do Documents Documents Documents Documents Documents Do Documents Documents Documents Documents Documents Do Stakeholders Stakeholders Stakeholders Stakeholde Stakeholders Stakeholders Stakeholders Stakeholders Stakeho Stakeholders Stakeholders Stakeholders Stakeholders Stakeho Stakeholders Stakeholders Stakeholders Stakeholders Stakeho Process Details Details 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 4. Created a repeatable framework 1 Purpose 5 Process Flow 2 Scope 6 Procedure 3 4 Definitions Stakeholders 7 Reference Documents, Attachments, Appendices 13

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 6. Using images/charts whenever possible 15

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 8. Referenced the process 17

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 Project team and phase activities Phase One Phase Two Team: - Information Architect - All department VPs - COO + CIO as advisory board Team: - All department VPs - Selected staff members - COO + CIO as advisory board - Content Experts Activities: - Deconstructed existing structure and content - Removed redundant content - Optimized format and content - Created a standard SOP template - Created detailed visual diagram of Ximedica s development process Activities: - VPs and select staff assigned to develop content for specific SOPs - Reformat and move content into template - Refined clarity of content and alignment with corporate goals - Test against process - Advisory board approved content - Final approval and signoff - Company-wide training on new SOPs 19

20 Benefits Before After Number of pages to read per SOP: pages 6-18 pages Time spent to read: minutes minutes Audience: Targeted for FDA, Auditors Inclusive for all potential audiences; FDA, Auditors, current and new hires Technical specifications: Specs locked in licensed files with limited access Accessible to all users to view, print, and transfer efficiently 20

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 Thank you. Aidan Petrie Chief Innovation Officer, Co-Founder 22

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