Complaint Handling and Trending At Stryker Orthopaedics · The hip joint is a ball-and-socket...
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March 8 – 10, 2011 Hyatt Regency Cincinnati, OH Complaint Handling and Trending At Stryker Orthopaedics Richard Campos Senior Reliability Engineer Stryker Orthopaedics [email protected] John Lynch Reliability Engineer Stryker Orthopaedics [email protected]
Transcript of Complaint Handling and Trending At Stryker Orthopaedics · The hip joint is a ball-and-socket...
March 8 – 10, 2011Hyatt RegencyCincinnati, OH
Complaint Handling and TrendingAt Stryker Orthopaedics
Richard CamposSenior Reliability EngineerStryker [email protected]
John LynchReliability EngineerStryker [email protected]
Our Company
Stryker – A broad based global leader in medical technologies
Founded 1941 by Dr. Homer StrykerCompany went public in 1979
18,000 employees $7.3B sales in 89 countries for 2010$4.3B worldwide sales of orthopaedic implants in 2010
Diversified businesses• Joint reconstruction of knees, hips, shoulders• Operating room equipment• Medical beds and stretchers• Craniomaxillofacial• Endoscopy• Trauma• Spine
Broad Product Range
Joint Replacement
The hip joint is a ball-and-socket joint, formed by the femoral head at the upper end ofthe thigh bone, and the rounded socket, or acetabulum, in the pelvis.
An artificial joint is a medical option available torelieve pain and restore quality of life to patients withjoint degeneration or arthritis.
JOHNNY BENCH
System Overview
Integrated data handling, risk management, and analytics
Data
Triggers Analysis
Data
Triggers Analysis
Complaint Handling
Why do we investigate complaints
• We want to improve our products for our users and patients
• Regulations
What is a complaint?
• Any written, oral, or expression of dissatisfaction relative to the identity, quality, durability, reliability, safety, effectiveness, performance, or appearance
• Voice of Customer - A customer has had an unsatisfactory experience with our product
Where do we monitor complaints?
Intake Tools Required
•Best practices
•SOPs
•Forms
•Hotline
•Expedited device returns
Data Management Tools Required
• Validated database• 3rd party solution•Company specific solution
•Key Attributes•Time Bases•Event types•Root Cause types
Voices of Customer (VOC)
“Packaging damaged”
“Discrepancy noted in blister”
“Stem moved in packaging”
“Contents rattling in box”
“Damaged blister”
“Failed pre-op inspection”
“Blister does not look right”
“Dent on inner blister”
Translating VOC to Event Types
“Packaging damaged”
“Discrepancy noted in blister”
“Stem moved in packaging”
“Contents rattling in box”
“Damaged blister”
“Failed pre-op inspection”
“Blister does not look right”
“Dent on inner blister”
User mishandling
Shipping damage
Shipping damage
Shipping damage
Shipping damage
User mishandling
Shipping damage
Shipping damage
Categorization of complaints
User mishandling
Shipping damage
Shipping damage
Shipping damage
Shipping damage
User mishandling
Shipping damage
Shipping damage
Data
Triggers Analysis
Risk Management and Trending
Value Stream
ANALYSIS
Hazard & Harm lists
EVALUATION
Acceptability criteria
CONTROL
Effective Measures
REPORT
Controlled Documents
POST / PRODUCTION
Surveillance
Risk Management Process
Plan Do
CheckAct
PRODUCT 1
Plan Do
CheckAct
PRODUCT 2
Product Complaint Trending
1Scope the Complaints
2Scope Sales
3Estimate the complaint rate
4Compare to acceptable rate
5Communicate to Stakeholders
Corrective Action
What is the issue?
What is the valid statistical rate ?
How many patient exposures?
What was the risk assessment at product launch?
How are the findings effectively communicated?
Scoping Complaints
Examples:
For implantable devices, timebase on the implantation dateFor corrective action effectivity, timebase on the production date
Pareto the issue
• By supplier, tool, batch, distributor, shipper• By product line, brand, family, specific item• By region, country, facility, user, patient • By failure mode, hazard, harm (severity)
Timebase the issue
• Choice of date affects sales association (event, surgery, production…)• Choice of binning affects sample size (monthly, quarterly …)
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Scoping Sales
Product Association
• Determine optimal product association
Example:
Reusable Medical
InstrumentMedical
Uses
# units shipped # implants soldPareto the issue
• By bulk complaint to sales
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23
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Timebase reminder
• Match timebase chosen for complaint scoping
Complaint Rate Estimation
Valid Statistical Technique
Linear regression• Y = cumulative complaints• X = cumulative sales
s1
c1
c1+c2
s1+s2
Cumulative Sales
Cum
ulat
ive
Com
plai
nts
Speed = Rise over Run
The Speed at the second data position is
(c1+c2) - c1 c2= = Complaint Rate
(s1+s2) - s1 s2
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2
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Compare to Acceptable Rate
O5
O4
O3
O2
O1S0 S1 S3 S4 S5
None LimitedIntervention
RequiredPermanentImpairment
Death
S2
Temporary orReversible
High
Moderate
Low
Remote
Negligible
Example of documented Risk Assessment
Review Product Risk Management files
• Risk Tables, Fault Trees, FMEAs• Determine risk ratings for subject issue• Compare rate and severity to risk ratings
Is this a new risk?If known, is there residual risk?
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2
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Acceptable occurrence
Acceptable Severity
Communicate to Stakeholders
Executive Issue Summary
• Issue description• Associated products• Harms and Hazards• Supply chain scope• Statistical method• Statistical results• Risk reassessment• Action request
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Let’s drive an example
Hip Stem Packaging Damage
PETG double blister package, sealed with Tyvek lids and retaining foam
Causal associations
Double blister break: Readily detected and replacedInner blister break: Sterility not compromised
Product Complaint Trending
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Scope the Complaints
VOC Damaged Hip stem PETG Package Blisters
Database 95 % Coded events as Damaged Package
Timebase Binning by Production Date
Pareto 98% complaints from 1 Product Family
Harms Minor delay in surgery
Product Complaint Trending
Scope the Sales
Association Hip stem sales
Timebase Binning by Production Date
Pareto 76 % from Region1 (worst case distribution path)
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45
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Product Complaint Trending
Estimate the Complaint Rate
Technique Linear regression for Region 1
Fit quality 99% adjusted R-square
Residuals Normal, independent, homogeneous
Cumulative Sales
Cum
ulat
ive
Com
plai
nts
Product Complaint Trending
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2
34 5 Risk Re-assessment
and Communication
Action is Needed !
Occurrence: Trend rate
Severity: Event details
So How did We Do ?
The Package was redesigned to secure the stem for the
most stringent distribution pathThe Risk reduction was
Effective
Complaints level off
Cum
ulat
ive
Com
plai
nts
Cumulative Sales
Conclusion
Our integrated processes effectively reduce patient and user risk
Pillars• Complaint Handling• Risk Management• Trending
Supporting pillars• Corrective Action system• Decision makers
Thank You for your Attention
Any Questions ?
