Transcript www.3hti.com

Risk Management and
Corrective Action:
Identification, Transfer,
Monitoring, and Mitigation
Sponsored By:
3 HTi, LLC
PTC Reseller / Systems Integrator
www.3hti.com Booth # 4709
Presented by: Duane Huffman, ASQ CRE
Risk Management Overview
Rigorous Identification of Risk
Transfer of Risk Knowledge
• To Product and Process Design
• To Quality Management
Effective Monitoring of Risk
Effective Risk Mitigation
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What Is Medical Device Risk Management?
Medical Device:
Any equipment used to diagnose,
treat, or monitor patient health
Mechanical
Systems
Patient Impact
Design
Test
Operator Impact
Manufacture
Electronic
Systems
Software
Systems
Impact on others in the
environment
Deliver
Use
Impact on equipment
itself / other equipment
Service
Disposal
All systems of a medical device must be analyzed for potential risk to
patients, operators, others, and the equipment. This analysis must
consider each part of the product development lifecycle.
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Risk Management Standards
Global Harmonization Task Force SG3/N17/2008
ISO 14971
– Quantitative Risk Assessment
– Required in EU
– Guideline for “Best Practices” in US
– Recognized by FDA to obtain regulatory
approval
Standard
Description
ISO 14971
Defines risk management requirements
for safe, reliable medical devices
IEC 60601
Defines required safety standards for
electromedical equipment
ISO/TR 80002
Applies ISO 14971 to medical device
software development and
maintenance
21CFR Part 11
Defines medical device software
requirements for data security and
integrity
FDA, CDRH
– Pre-Market Approval of certain devices
requires a Risk Management File
documenting Risk Management process
– Risk Management File also used in support
of audits
21 CFR Part
820
Requires quality policies and audits,
including CAPA to investigate, correct,
and prevent nonconformances.
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Defining Risk Management: ISO 14971
Risk management is the systematic application of policies, procedures, and
practices to the task of analyzing, evaluating, controlling, and monitoring the risk
inherent in medical devices.
Standards-Driven:
Each risk must be compared to pre-defined standards of acceptability
Iterative:
Each new risk must be fed back into risk analysis, evaluation, and control
Documented:
Each step must be fully recorded for the risk management file
Continuous:
Risk management must continue through planning, design, development,
testing, manufacture, use, and disposal of medical device
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Risk Management Overview
Rigorous Identification of Risk
Transfer of Risk Knowledge
• To Product and Process Design
• To Quality Management
Effective Monitoring of Risk
Effective Risk Mitigation
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Risk Management for Medical Devices:
ISO 14971
Phase 1
Define Acceptable
Risk
Step 1. (ISO 14971) Risk Management Plan:
Define acceptable & unacceptable levels of risk
Phase 2
Identify and Analyze
Risk
Step 2. Risk Analysis:
Identify Risk
Estimate Risk Level (a quantitative process)
Phase 3
Evaluate Risk
Phase 4
Control Risk
and monitor
effectiveness
of controls
Risk
Assessment
Step 3. Risk Evaluation:
Evaluate estimated level of risk for acceptability/
unacceptability based on Risk Management Plan
Unacceptable
Risks Found?
Step 4. Risk Control:
Analyze Control Options, Implement Controls,
Evaluate Residual Risk, Risk/Benefit Analysis, Review
Effects of Controls, Review Completeness
Step 5. Overall Residual Risk
Step 6. Risk Management Report
Step 7. Production and Post-Production Monitoring
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Methods for Risk Management
Risk Management Activity
Risk/Reliability Analysis Tools
FMEA (Failure Mode & Effects Analysis)
Risk Identification & Analysis
Fault Tree Analysis
FMEA
Risk Estimation
Fault Tree Analysis
Reliability Prediction
Advanced System Modeling (OpSim)
Risk Control Measures:
- Analyze
- Implement
- Evaluate
- Risk/Benefit Analysis
- Review New Risks
- Completeness of Control Measures
FMEA & Fault Tree Analysis
Reliability Prediction
Advanced System Modeling (OpSim)
FRACAS
(Failure Reporting, Analysis, and Corrective Action System)
Production &
Post-Production Monitoring
Weibull (Life Data Analysis)
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Risk Management Overview
Rigorous Identification of Risk
Transfer of Risk Knowledge
• To Product and Process Design
• To Quality Management
Effective Monitoring of Risk
Effective Risk Mitigation
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Integrated Process
Product Lifecycle Stages:
Product Definition
Detailed Design
Functions
Inputs
Software Tools /
Relationships
Production Planning
Process Sequence
BOM
DFMEA Effect =
Risk Matrix Cause
D
Effect = Effect
Severity = Severity
Cause = Mode
P
Outputs
Complaints
Requirements
DVP
Control Plans
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Integrated Risk Management
Establish Project
Define Acceptable Risk
Identify Intended Use
Risk Matrix
Functional Hierarchy
Identify primary systems and functions
Parameter Diagrams
Functional Inputs
Functional Outputs
Hazards
Controls
Hazard Analysis
Hazards
Hazardous
Situations
Harms
Risks
Generate DVP (Test Plan)
against Functions / Risks
Complaints System
Causes
Controls
Requirements
Hazard / Harm Tree
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11
D
Design FMEA and Test Plan
Acquire BOM from Windchill
Pull BOM from Windchill
Reliability Analysis
Windchill / Relex
BOM Integration
Predict Reliability against BOM
DFMEA
Failure Modes
Effects
Causes
DVP (Test Plan)
Test Plan against DFMEA /
Product BOM]
Identified issues fed back to
design for product improvements
DFMEA
DVP
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P
PFMEA, Control Plans, Work Instructions
Process Sequence
Acquire Routing / Process Sequence
Pull from DFMEA
Map related DFMEA data to PFMEA
DFMEA to PFMEA
PFMEA
Failure Modes
Effects
Causes
PFMEA to Control
Plan
Control Plans
Generate Control Plans tied to PFMEA
Dashboard Metrics to
track performance
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Risk Management Overview
Rigorous Identification of Risk
Transfer of Risk Knowledge
• To Product and Process Design
• To Quality Management
Effective Monitoring of Risk
Effective Risk Mitigation
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Quality Management in Medical Devices:
21 CFR 820
Audit quality
processes
21 CFR 820.22
- Establish audit procedures to ensure compliance with quality policy ,
- Include responsibility, results of re-audit, audit report, and review
Design
Controls
21 CFR 820.30
- Establish design and development process
- Include design Inputs, outputs, V&V, change, transfer
- Establish and Maintain Design History File for each product
Document
Control
21 CFR 820.40
-Document approval and distribution activities
-Apply Change control
Nonconforming
Product
21 CFR 820.90
-Control of nonconforming product, segregation & disposition
-Nonconformity review and disposition authority
-Document rework and reevaluation
Identify CAPA
procedures
21 CFR 820.100
- Identify causes of non-conformances and other quality problems
- Document actions taken to correct and prevent their recurrence
- Verify and document the effectiveness of the CAPA process
Maintain
Complaints files
21 CFR 820.198
- Receive, review, and evaluate complaints – including verbal complaints
- Document procedures for processing, evaluating for reporting to FDA
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Nonconformance Management
► Storyboard Overview
2.0
Evaluation - Define Investigation
and Disposition activities
1.0
Rapid Nonconformance Capture
Quality
Start
1.0
Intake
3.0
2.0
Investigation
Evaluation
6.0
3.0
Investigation
Perform Disposition
4.0
Disposition Plan
5.0
MRB Review
5.0
MRB Review
4.0
Disposition Plan
6.0
Disposition
End
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Complaints & Customer Feedback
2.0
► Storyboard Overview
1.0
Evaluate, Triage, Define Follow-up
Activity Plan
Complaint Intake
Quality
Start
1.0
Intake
2.0
Evaluation
3.0
Execute Activity Plan
A. Return Product Analysis
B. General Follow-up
C. Regulatory Safety Reporting
4.0
3.0
Execute Activity Plan
Review Final Codification and
Escalate to CAPA
4.0
Review
End
© 2013 PTC
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Management Review Reporting
► Storyboard Overview
If you want to run a report again
you can save the criteria in a saved
report
1.0
Access Master Pages for any
Quality Records
2.0
Quality
Start
1.0
Access Master Page
2.0
4.0
Save Report
Review Reports
Schedule Saved Reports or
Setup Data Monitors to look for
critical conditions
3.0
3.0
Setup Data Monitor
4.0
Review Reports
End
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Product / Process Quality and the PDS
A sample workflow across PDS roles and processes…
Receive Adverse
Event
Quality/Regulatory
• Complaints & Nonconformances
• Design Validation & Postmarket Study
Winchill
Quality
Solutions
Initiate CAPA /
Perform RCA
Validate Change
Monitor
Effectiveness
• Corrective / Preventive Actions
A Closed-Loop Process
Create Action
Plan
Confirm Design
Changes
Windchill
PDMLink
Engineering
• Change & Configuration Mgmnt
• Detailed Design
Make Product
Design Changes
Close Change
Request
Windchill
MPMLink
Manufacturing
Make Process
Design Changes
• Manufacturing Process Mgmnt
© 2011 PTC
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Process Quality with
Windchill Quality Solutions and PLM
Benefits:
BOM
Windchill Quality Solutions:
Manage Process Quality
Windchill PDM & Process Modules:
Leverage core PLM
Engineering
Calculations
Customer
Experience
Management
Service Manuals /
Instructions
Change
Management
CAPA
Training Records
Nonconformances
Regulatory
Submissions
Automatic flow-down of
CAPAs through PDS
CAPAs can be initiated from
other PDS sources
© 2006 PTC
Supply Chain
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Risk Management Overview
Rigorous Identification of Risk
Transfer of Risk Knowledge
• To Product and Process Design
• To Quality Management
Effective Monitoring of Risk
Effective Risk Mitigation
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Windchill Quality Solutions: Process Workflow
Initiate New
Request
Record Data
Sources
Customer Experience
Management
Risk Analyses
• Identify Risks requiring Corrective Action
• Issue Capture through Call Center with
History Lookup
• Escalate Risk to a Problem
• Warranty and Repair Tracking
• Route to Approvals
• Customer Support and Quality
Investigations
Identify Product
Involved
Evaluate, Assign
Issue
Determine Need
for CAPA
Investigate Root
Cause
• Ad Hoc Reporting, Reports and Watchdogs
CAPA
• Access Related Quality Inputs
• Identify Root Cause
Plan, Perform
Corrective Action
• Create & Approve CAPA Action Plan
Send ECRs to PLM System
Verify Corrective
Action
• Confirm and Verify Effectiveness
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CAPA (Closed Loop)
1.0
2.0
Submit CAPA Request
Start
1.0
2.0
Storyboard: Key Topics
3.0
Review Data & Interrogate Lessons
Learned. Determine if meets criteria for
Preventive Action or Corrective Action
3.0
Root Cause Analysis
CAPA Request
CAPA Review
Root Cause
Investigation
4.0
CAPA Plan
Verify Effectiveness
7.0
4.0
5.0
Implement
Implement Actions
5.0
CAPA Plan
6.0
Confirm
6.0
Confirm
7.0
Verify Effectiveness
End
© 2008 PTC
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Unique Device Identification
► Storyboard Overview
UDI Creator applies final edits
to refines UDI submission then
submits for approval
1.0
Collection of Products & key UDI
attributes from Disparate systems –
Automatic bulk Creation of UDI Objects
& Initiation of Workflows
2.0
Product
“Specs”
Regulatory Affairs
Home
Grown
Systems
Start
Doc &
Labeling
Systems
1.0
Collection of Data
PLM
Systems
ERP
Systems
MDM
Systems
2.0
Creation
3.0
E-Signature and
review/approval workflows
Review & Approvals
e-signature
Revision control and data
stewardship
4.0
FDA Submission
5.0
3.0
5.0
Generate HL7 SPL, submit to
FDA Electronic Submissions
Gateway (ESG) – Monitor
Acknowledgments
4.0
Ongoing Change &
Configuration Mgmt
End
© 2013 PTC
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What is eMDR in Windchill CEM?
Addressing the FDA Proposed Ruling in Windchill CEM (Customer Experience Mgmt)
• FDA rule that all Medical Device Records
(MDRs) be submitted electronically
– The proposed rule was published in the Federal
Register on August 21, 2009
– Mandated at the end of 2011 (+ 1 yr grace period)
– Ruling will become effective one year after final
rule publishes in the Federal Register
• What is an MDR?
– Reporting of device-related adverse events by
manufacturers, importers, users (hospitals, etc.)
– Traditionally performed by 3500A MedWatch form
sent via email or fax
• How does Windchill CEM handle it?
– eMDR Regulatory Reporting engine maps CEM
fields to eMDR report; routes for review, editing,
and approval; submits electronically to FDA and
stores received messages with record
© 2008 PTC
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Surgisense specializes in the design, development, testing, manufacturing, and
marketing of innovative new technologies for medical devices. Surgisense
focuses on developing the next generation of “smart” sensing surgical
instruments and medical devices to further enhance surgery, patient care, and
patient safety.
Business Drivers:
FDA Compliance for Medical Device
Solution: Windchill Quality Solutions
Documents Backbone - Manage & Control all key documents AKA Document Control
Products Backbone - Provide Control of Product information AKA Design Control, DHF,
DMR, BOM and BOO
Quality Backbone – Quality Activities & Processes interact with the Anchor Points for
Products and Processes
3 HTi, LLC, the authorized PTC reseller implemented Windchill Quality Solutions
and Creo Design Software to streamline Surgisense product development process.
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Thanks for Your Time
For More Information:
3 HTi, LLC www.3hti.com
[email protected]
866-624-3HTi
609-303-3400
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