Presented by Duane Huffman ASQ CRE Sponsored By 3 HTi LLC PTC Reseller Systems Integrator www3hticom Booth 4709 What Is Medical Device Risk Management Medical Device Any equipment used to diagnose ID: 810777
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Slide1
Risk Management and Corrective Action: Identification, Transfer, Monitoring, and Mitigation
Presented by: Duane Huffman, ASQ CRE
Sponsored By:3 HTi, LLCPTC Reseller / Systems Integratorwww.3hti.com Booth # 4709
Slide2Slide3What Is Medical Device Risk Management?
Medical Device:
Any equipment used to diagnose,
treat, or monitor patient
health
Mechanical
Systems
Electronic
Systems
Software
Systems
Patient Impact
Operator Impact
Impact on others in the environment
Impact on
equipment
itself
/ other
equipment
Design
Use
Deliver
Disposal
Service
Manufacture
Test
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.
Slide4Risk Management Standards
Global Harmonization Task Force - SG3/N17/2008
ISO 14971Quantitative Risk AssessmentRequired in EUGuideline for “Best Practices” in US
Recognized by FDA to obtain regulatory approval
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
Standard
Description
ISO 14971
Defines risk management requirements
for safe, reliable medical devices
IEC 60601
Defines required safety
standards for electromedical equipmentISO/TR 80002Applies ISO 14971 to medical device software development and maintenance
21CFR Part 11Defines medical device software requirements for data security and integrity21 CFR Part 820
Requires quality policies and audits, including CAPA to investigate, correct, and prevent nonconformances.
Slide5Defining 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
Slide6Slide7Phase 4
Control Risk
and monitor effectivenessof controls
Phase 3
Evaluate Risk
Phase 2
Identify and Analyze
Risk
Phase 1
Define Acceptable
Risk
Risk Management for Medical Devices:
ISO 14971
Step 7. Production and Post-Production Monitoring
Step 3. Risk Evaluation:
Evaluate estimated level of risk for acceptability/ unacceptability based on Risk Management Plan
Step 2. Risk Analysis:
Identify RiskEstimate Risk Level (a quantitative process)
Step 1. (ISO 14971) Risk Management Plan: Define acceptable & unacceptable levels of risk
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
Risk
Assessment
Unacceptable Risks Found?
Slide8Methods for Risk Management
Risk Management Activity
Risk/Reliability Analysis ToolsRisk Identification & Analysis
FMEA (Failure Mode & Effects
Analysis)
Fault Tree Analysis
Risk Estimation
FMEA
Fault
Tree Analysis
Reliability Prediction
Advanced System Modeling (OpSim)
Risk Control Measures:
Analyze
Implement Evaluate
Risk/Benefit Analysis Review New Risks Completeness of Control MeasuresFMEA & Fault Tree Analysis
Reliability PredictionAdvanced System Modeling (OpSim)
Production & Post-Production Monitoring
FRACAS (Failure Reporting, Analysis, and Corrective Action System)Weibull
(Life Data Analysis)
Slide9Slide10Software Tools /
Relationships
Integrated Process
Outputs
Product Lifecycle Stages:
Inputs
D
P
Control Plans
Functions
Process Sequence
BOM
Effect = Effect
Severity = Severity
Cause = Mode
DFMEA Effect =
Risk Matrix Cause
DVP
Requirements
Production Planning
Detailed Design
Product Definition
Complaints
Slide1111
Integrated Risk Management
Hazard Analysis
Hazards
Hazardous Situations
Risks
Causes
Controls
Parameter Diagrams
Functional Inputs
Functional Outputs
Hazards
Controls
Functional Hierarchy
Identify primary systems and functions
Establish Project
Define Acceptable Risk
Identify Intended Use
Harms
Hazard / Harm Tree
Generate DVP (Test Plan) against Functions / Risks
Risk Matrix
Complaints System
Requirements
Slide1212
D
Design FMEA and Test Plan
DVP
Windchill / Relex BOM Integration
DFMEA
Slide1313
PFMEA, Control Plans, Work Instructions
P
PFMEA to Control Plan
DFMEA to PFMEA
Dashboard Metrics to track performance
Slide14Slide15Audit quality
processes
Nonconforming
Product
Identify CAPA
procedures
Design
Controls
Quality Management in Medical Devices:
21 CFR 820
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
21 CFR 820.22
Establish audit procedures to ensure compliance with quality policy ,
Include responsibility, results of re-audit, audit report, and review
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
Document Control
21 CFR 820.40Document approval and distribution activities Apply Change control
21 CFR 820.90
Control of nonconforming product, segregation & dispositionNonconformity review and disposition authority
Document rework and reevaluation
Maintain Complaints files
21 CFR 820.198- Receive, review, and evaluate complaints – including verbal complaints
- Document procedures for processing, evaluating for reporting to FDA
Slide16Nonconformance Management
►
Storyboard Overview
Intake
Investigation
Start
Evaluation
Disposition Plan
End
2
.
0
3
.
0
4
.
0
1.
0
Quality
MRB Review
5
.
0
Disposition
6
.
0
Evaluation - Define Investigation and Disposition activities
2
.0
Investigation
3
.0
Disposition
Plan
4
.0
MRB Review
5
.0
Rapid Nonconformance Capture
1
.0
Perform
Disposition
6
.0
Slide17Complaints & Customer Feedback
►
Storyboard Overview
Intake
Execute Activity Plan
Start
Evaluation
Review
End
2
.
0
3
.
0
4
.
0
1.
0
© 2013 PTC
Quality
Complaint Intake
1
.0
Evaluate, Triage, Define Follow-up Activity Plan
2
.0
Execute Activity Plan
Return Product Analysis
General Follow-up
Regulatory Safety
Reporting
3
.0
Review Final Codification and Escalate to CAPA
4
.0
Slide18Management Review Reporting
►
Storyboard Overview
Access Master Page
Setup Data Monitor
Start
Save Report
Review Reports
End
2
.
0
3
.
0
4
.
0
1.
0
Quality
Access Master Pages for any Quality Records
1
.0
If you want to run a report again you can save the criteria in a saved report
2
.0
Schedule Saved Reports or Setup Data Monitors to look for critical conditions
3
.0
Review Reports
4.0
Slide19Windchill
MPMLink
WinchillQuality
Solutions
Windchill
PDMLink
Product / Process Quality and the PDS
A sample workflow across PDS roles and processes…
©
2011
PTC
Engineering
Manufacturing
Quality/Regulatory
Change & Configuration Mgmnt
Manufacturing Process Mgmnt
Design Validation & Postmarket Study
Corrective / Preventive Actions
Complaints & Nonconformances
Detailed Design
Receive Adverse Event
Initiate CAPA / Perform RCA
Validate Change
Make Product Design Changes
Make Process Design Changes
Close Change Request
Confirm Design Changes
Monitor Effectiveness
A Closed-Loop Process
Create Action Plan
Slide20Process Quality with
Windchill Quality Solutions and PLM
Benefits:
© 2006 PTC
CAPA
Customer Experience Management
Regulatory Submissions
Supply Chain
Nonconformances
Change Management
Service Manuals / Instructions
Training Records
BOM
Engineering Calculations
CAPAs can be initiated from other PDS sources
Automatic flow-down of CAPAs through PDS
Windchill PDM & Process Modules:
Leverage core PLM
Windchill Quality Solutions:
Manage Process Quality
Slide21Slide22Issue Capture through Call Center with History Lookup
Warranty and Repair Tracking
Customer Support and Quality Investigations
Windchill Quality Solutions: Process Workflow
Verify Corrective Action
Initiate New Request
Record Data Sources
Identify Product Involved
Evaluate, Assign Issue
Determine Need for CAPA
Investigate Root Cause
Plan, Perform Corrective Action
Customer Experience Management
CAPA
Risk Analyses
Access Related Quality Inputs
Identify Root Cause
Create & Approve CAPA Action Plan Send ECRs to PLM System
Confirm and Verify Effectiveness
Identify Risks requiring Corrective Action
Escalate Risk to a Problem
Route to Approvals
Ad Hoc Reporting, Reports and Watchdogs
Slide23CAPA (Closed Loop)
© 2008 PTC
Storyboard: Key Topics
Submit CAPA Request
1
.0
Root Cause Analysis
3
.0
CAPA Request
CAPA Review
Root Cause Investigation
1
.0
2
.0
3
.0
CAPA Plan
4
.0
End
Implement
5
.0
Confirm
6
.0
Verify Effectiveness
7.
0
Start
Implement Actions
5
.0
4
.0
Verify Effectiveness
7
.0
Confirm
6
.0
Review Data & Interrogate Lessons Learned. Determine if meets criteria for Preventive Action or Corrective Action
2
.0
CAPA Plan
Slide24Revision
control and data stewardship
5
.0
Unique Device Identification
►
Storyboard Overview
Collection of Data
Review & Approvals
e-signature
Start
Creation
FDA Submission
End
Ongoing Change
&
Configuration
Mgmt
Regulatory Affairs
2
.
0
3
.
0
4
.
0
1.
0
5
.
0
PLM
Systems
ERP
Systems
Home Grown Systems
MDM
Systems
Doc & Labeling
Systems
Product “Specs”
Collection
of Products &
key UDI attributes
from Disparate
systems – Automatic bulk Creation of UDI Objects & Initiation of Workflows
1
.0
© 2013 PTC
UDI Creator applies final edits
to refines UDI submission then submits for approval
2
.0
Generate HL7 SPL,
submit
to FDA Electronic Submissions Gateway (ESG
) – Monitor Acknowledgments
4
.0
E-Signature and review/approval workflows
3
.0
Slide25What is eMDR in Windchill CEM?
Addressing the FDA Proposed Ruling in Windchill CEM (Customer Experience Mgmt)
© 2008 PTCFDA rule that all Medical Device Records (MDRs) be submitted electronicallyThe 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
Slide26Surgisense 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 DeviceSolution: Windchill Quality SolutionsDocuments
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.
Slide27Thanks for Your Time
For More Information:3 HTi, LLC
www.3hti.cominfo@3hti.com866-624-3HTi 609-303-3400