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Making SOPs Fit for Human Use
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Standard Operating Procedures 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.
Transcript of Making SOPs Fit for Human Use
Standard Operating ProceduresFit for Human Use
Agenda:
The background behind Ximedica’s decision
The process of re-designing
The results and benefits
Applying usability to
Standard Operating Procedures
for improved compliance.
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Defined methods
Improved training
Ensuring alignment with FDA requirements + ISO
Able to evolve with the organization
Providing situational awareness
The value of re-designing SOPs:
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RESEARCH + INNOVATION
DETAILED DEVELOPMENT
IMPLEMENTATION + LAUNCH
Ximedica is a medical and healthcare firm focused on helping our clients bring
innovative products to market.
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RESEARCH + INNOVATION
DETAILED DEVELOPMENT
IMPLEMENTATION + LAUNCH
Product/platform strategy
2nd 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
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RESEARCH + INNOVATION
DETAILED DEVELOPMENT
IMPLEMENTATION + LAUNCH
Product/platform strategy
2nd 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
140+ personnel with diverse backgrounds and roles
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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
Before:
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- Ease of use- Accuracy- Simplicity
Team:Information ArchitectsHuman Factors EngineersContent ExpertsRegulatoryExecutive Sponsors
Time to completion: 1.5 years
Re-architected for:
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PurposeScope
Responsibilities
Definitions
Reference Documents
Procedure Process
Approval Methods
Record Retention
AppendixRevision History
1. Deconstructed into elements
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2. Re-architected
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Stakeholders
Definitions3. Removed redundancy
Reference Documents
Definitions Definitions Definitions DefinitionsDefinitions Definitions Definitions Definitions Definitions DefinitionsDefinitions Definitions Definitions Definitions Definitions Definitions
Documents DocumentsDocuments Documents Documents Documents Documents DocumentsDocuments Documents Documents Documents Documents Documents
Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders
Details Details Details Details DetailsDetails Details Details Details Details Details Details Details DetailsDetails Details Details Details Details Details Details Details Details
Definitions Definitions Definitions Definitions Definitions Definitions
Documents Documents Documents Documents Documents Documents
Stakeholders Stakeholders Stakeholders Stakeholders Stakeholders
Details Details Details Details Details Details Details Details Details
Process Details
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1
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Purpose
Scope
Definitions
Stakeholders
Process Flow
Procedure
Reference Documents, Attachments, Appendices
4. Created a repeatable framework
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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
5. Emphasized front page
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6. Using images/charts whenever possible
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“Ximedica’s Product Development Process consists of 6 phases. It is a flexible process allowing for specific activities to occur as needed.
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7. Re-wrote concisely, in common language when possible
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8. Referenced the process
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- Reduced time spent reading- Easier to understand- Easier to train on- Decreased frustrations- Easier to update- Shared view across process- Additional perceived informational value
The results:
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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
Project team and phase activitiesPhase One Phase Two
Team: - All department VPs- Selected staff members- COO + CIO as advisory board- Content Experts
Team: - Information Architect- All department VPs- COO + CIO as advisory board
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Number of pages to read per SOP:
Time spent to read: 30-45 minutes 10-15 minutes
Technical specifications:
Specs locked in licensed files with limited access
Accessible to all users to view, print, and transfer efficiently
12 - 27 pages
6 - 18 pages
Before After
Audience:Targeted for FDA, Auditors Inclusive for all potential
audiences; FDA, Auditors, current and new hires
Benefits
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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
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