Embed Size (px)
DESCRIPTION
Aidan Petrie, Chief Innovation Officer and Co-Founder Ximedica
Citation preview
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 compliancefor improved compliance.
3
The value of re-designing SOPs:
Defined methods
I d t i iImproved training
Ensuring alignment with FDA requirements + ISO
Able to evolve with theAble to evolve with the organization
P idi it ti lProviding situational awareness
4
Ximedica is a medical and healthcare firmXimedica is a medical and healthcare firm focused on helping our clients bring
innovative products to market.
RESEARCH DETAILED IMPLEMENTATIONRESEARCH + INNOVATION
DETAILED DEVELOPMENT
IMPLEMENTATION + LAUNCH
5
RESEARCH DETAILED IMPLEMENTATIONRESEARCH + INNOVATION
DETAILED DEVELOPMENT
IMPLEMENTATION + LAUNCH
Product/platform strategy Designing and developing new product offerings
Pilot manufacturing
2nd gen product refinement
User research + concept testing
U b ti d h
new product offerings
Regulatory strategy + submission
Tech. feasibility assessments
Supply chain strategy
Global sourcing
User observation and human factors studies Formative studies
6
RESEARCH DETAILED IMPLEMENTATION
140+ personnel with diverse backgrounds and roles
RESEARCH + INNOVATION
DETAILED DEVELOPMENT
IMPLEMENTATION + LAUNCH
Product/platform strategy Designing and developing new product offerings
Pilot manufacturing
2nd gen product refinement
User research + concept testing
U b ti d h
new product offerings
Regulatory strategy + submission
Tech. feasibility assessments
Supply chain strategy
Global sourcing
User observation and human factors studies Formative studies
7
Before:
Written for/by Content Experts
Difficult to maintain and update
Not reflective of current processesNot reflective of current processes
Siloed awareness across different f tifunctions
Very long, lots of duplicate information
Diverse format styles
8
Ease of seR hit t d f - Ease of use- Accuracy
Re-architected for:y
- Simplicity
Team: Time to completion:Team:Information ArchitectsHuman Factors EngineersC t t E t
Time to completion: 1.5 years
Content ExpertsRegulatoryExecutive Sponsorsp
9
P1. Deconstructed into elements
Purpose Scope DefinitionsResponsibilities
R f D tReference DocumentsRecord RetentionProcedure Process
Record Retention
A l M th dRevision History
Approval Methods Appendix10
2. Re-architected
11
Definitions3. Removed redundancy
D fi iti D fi iti D fi iti D fi itiDefinitions Definitions Definitions Definitions DefinitioDefinitions Definitions Definitions Definitions Definitions DefinDefinitions Definitions Definitions Definitions Definitions DefinDefinitions Definitions Definitions Definitions Definitions Defin
Reference DocumentsDocuments DocumentDocuments Documents Documents Documents Documents Do
Definitions Definitions Definitions Definitions Definitions Defin
StakeholdersDocuments Documents Documents Documents Documents Do
Stakeholders Stakeholders Stakeholde
Documents Documents Documents Documents Documents Do
StakeholdersStakeholders Stakeholders StakeholdeStakeholders Stakeholders Stakeholders Stakeholders StakehoStakeholders Stakeholders Stakeholders Stakeholders StakehoStakeholders Stakeholders Stakeholders Stakeholders Stakeho
Details Details Details Details DetaDetails Details Details Details Details Details Details Details De
Stakeholders Stakeholders Stakeholders Stakeholders Stakeho
Process DetailsDetails Details Details Details Details Details Details Details DeDetails Details Details Details Details Details Details Details De
12
1 5P
4. Created a repeatable framework12
56
Purpose
ScopeProcess FlowProcedure
34
7DefinitionsStakeholders
Reference Documents, Attachments, Appendices
13
5. Emphasized front page
All the high level information was included on the coverwas included on the cover.Information hierarchy; top of page guides your eye
Company process serves as iconic graphic
Predominant headerPredominant header
Location in process gives user context
Footer reinforces title gives mostFooter reinforces title, gives most current revision and page number
14
6. Using images/charts whenever possiblepossible
15
7. Re-wrote concisely, in common language when possiblelanguage 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
8. Referenced the process
17
The results:
- Reduced time spent reading- Reduced time spent reading- Easier to understand- Easier to train on- Decreased frustrations- Easier to update
Shared view across process- Shared view across process- Additional perceived informational value
18
Project team and phase activitiesPh O Ph TPhase One Phase Two
Team: All department VPs
Team: Information Architect - All department VPs
- Selected staff members- COO + CIO as advisory board- Content Experts
- Information Architect- All department VPs- COO + CIO as advisory board
Activities:- Deconstructed existing structure and
Activities:- VPs and select staff assigned to
d l t t f ifi SOPcontent- Removed redundant content- Optimized format and content
develop content for specific SOPs- Reformat and move content into
template- Refined clarity of content and alignment
- Created a standard SOP template- Created detailed visual diagram of
Ximedica’s development process
y gwith corporate goals
- Test against process- Advisory board approved content
Final approval and signoff- Final approval and signoff- Company-wide training on new SOPs
19
Before AfterBenefits
Number of
Before After
pages to read per SOP: 12 - 27
pages6 - 18 pages
Time spent to read: 30-45 minutes 10-15 minutes
Audience:Targeted for FDA, Auditors Inclusive for all potential
audiences; FDA, Auditors, current and new hires
Technical specifications:
Specs locked in li d fil ith
Accessible to all t i i t
current and new hires
specifications: licensed files with limited access
users to view, print, and transfer efficiently
20
Th l d i d SOP b ttThe newly designed SOPs are better organized, more concise, and easier t f ll th t d I ito follow than most procedures I review. The process flow shows what the procedure is doing and what phase of the process it isdoing and what phase of the process it is linked to. The details at the end provide an appropriate level of instruction andappropriate level of instruction and information to be useful for readers.
R t A dit- Recent Auditor
21
Thank you.Aidan Petrie
www.ximedica.com
Chief Innovation Officer, Co‐Founder
Thank you.
22
![Operating Procedures 1 G2 - OPERATING PROCEDURES [6 Exam Questions - 6 Groups] G2APhone operating procedures; USB/LSB utilization conventions; procedural](https://img.pdfslide.us/doc/110x75/56649e4d5503460f94b4351a/operating-procedures-1-g2-operating-procedures-6-exam-questions-6-groups.jpg)
