View
220
Download
0
Category
Preview:
Citation preview
Perseon Corporation Case Study
Climate, Challenges, Data and Solutions
Rick Gaykowski
VP Global Regulatory Affairs
rgaykowski@perseonmedical.com
Cognizant Technology Solutions and Perseon Corporation.
HEALTHCARE PRODUCTS
Healthcare Environment Interactions
2
Investment Financial Partners Customers
OSHA
FDA
SEC
Governing Agencies
EPA
Clinical & Medical
Specialists
Distribution Partners
Legal Counsel Shareholders
& Employees
Strictly private and confidential
Fluid Environment: Data Dynamics
3 Strictly private and confidential
Global regulatory alignment: FDA & Int’l Partners
• Class I Recalls, MD-SAP, Global FDA training
Higher level of oversight:
• R-T-A, De-Novo, Section 515(i)
Enhanced market expectations:
• Risk-based approach
Increased sophistication:
• FDA Guidance, International Standards (ISO 9001:2015, ISO 13485:2016, IEC 4th Edition)
Emerging market alignment:
• FDASIA, UDI 2013/2016, CFDA Oct 2014, JPAL Nov 2014
Fluid Environment: Data Dynamics (con’t)
4 Strictly private and confidential
FDA 3-Year Strategic Priorities
Item Topic Industry Relevant
1 Regulatory Science √
2 Globalization √
3 Safety & Quality √
4 Smart Regulation √
5 Stewardship √
REGULATORY SCIENCE: “…development of tools, processes, and approaches for
achievement of safety, effectiveness, and quality…” (Paraphrase)
Fluid Environment: Data Dynamics (con’t)
5 Strictly private and confidential
FDA Guidance Documents (CDRH)
Year “Draft” Guidance Final Guidance
2016 9 3
2015 23 7
2014 17 4
2013 6 4
R-T-A: ~37% of 510(k)’s returned for inadequacy
• SI percentage within 60-days: ~97.5%
• 510(k) accepted within 90-days: ~98.5%
• Average review cycles: ~1.6
MDUFA III
(MDUFA IV Proposed – QM
Team)
Food, Drug & Cosmetic (FD&C) Industry Snapshot
6 Strictly private and confidential
0 10 20 30 40 50 60 70
Biologics 14.6%
Cosmetics 0.7%
Device 12.5%
Food 28.5%
Drug 43.7%
INDUSTRY SECTORS
642# WL’s issued in 2015
(54/month, ~3/day)
*FDA Enforcement Report, 2/24/2016
144# Recalls in 2016* 33# 483’s in 2016,
through 3/9/2016
15# WL’s issued in
February 2016
7 Strictly private and confidential
Management Responsibility
Management Review
Quality Policy Management
Representative Quality Manual
Production and Process
Controls Training
Corrective and Preventive
Action Quality Audit
Complaint Files
Device Labeling
Document Control
Inspection and Test
Equipment
Environmental Controls
Purchasing Control
Design Control Identification
and Traceability
Device Packaging
Non-conforming
product
Process Change Control
Distribution Handling Storage Design Review
Device History Record
Servicing Device Master
Record Installation
Supplier Evaluation
Label Storage Supplier
Qualification Label Integrity
Design Verification
Design Inputs Design
Outputs Design History
File
Process Validation
Acceptance Status
Design Transfer
Design Changes
Software Validation
Calibration Acceptance
Activities Quality System
Record Servicing Record
Certification to Foreign Govt.
Preventive Maintenance
Recognized International
Standards Technical File
Essential Requirements
Checklist
Quality Planning
Objective Reference
Evidence of Conformity
Contamination Control
Normative Reference
510 (k) Submission
Adverse Event Product Recall Field
Correction
Quality System Certification
Establishment Distribution
UDI and GUDID
Device Listing
Elements of excellence
11 Strictly private and confidential
• Excellence in everything we do, each time, every time
• Execution and ‘Attention to Detail’ orientation
• Upgrade capability with greater strength & experience
• Utilize leading-edge tools without inhibition
I N E S S E N C E , T H E R E S H O U L D B E A D N A C H A N G E
Competent Authority Expectations
13 Strictly private and confidential
Subject to global oversight
Required to investigate complaints
Required to review customer feedback for unanticipated trends
Expected to make improvements to
prevent patient harm
Required to report serious events
Global Perspective
15 Strictly private and confidential
FOR GLOBAL REACH… …EACH OF US MUST WEAR
A ‘GLOBAL FACE’
16 Strictly private and confidential
Risk
iden
tifi
cati
on
Management avo
idan
ce
index
resource
analysis
knowledge
event
monitor
imp
lem
enta
tio
n
project re
du
ctio
n
method
con
tro
l
residual
severity
cost
remediation
usability
risk/benefit
Time Is Money
18 Strictly private and confidential
Total of Open Complaints Aging
Owner Regulatory Review 0-29 Days New 30-59 Days at Risk Grand Total
Fiber 1 1
OPS QA SLC OBQ 1 1 2
Fiber 4 4
OPS QA YOK Review in Progress 2 2
OBQ 2 1 3
Fiber 27 27
RA Review in Progress 1 1
Safety Complaint 25 42 67
Service Review in Progress 138 2 140
Fiber 2 2
Grand Total 173 76 249
Lumenis Fiscal Week #45 33 34 35 36 37 38 39 40 41 42 43 44 45
Report Week Beginning Date 11-Aug 18-Aug 25-Aug 1-Sep 8-Sep 15-Sep 22-Sep 29-Sep 6-Oct 13-Oct 20-Oct 27-Oct 3-Nov
Report Week Ending Date 17-Aug 24-Aug 31-Aug 7-Sep 14-Sep 21-Sep 28-Sep 5-Oct 12-Oct 19-Oct 26-Oct 2-Nov 9-Nov
13-wk
Average
New Service Complaints 68 60 57 51 65 50 74 64 65 73 60 78 65 64
73.91% 74.07% 59.38% 68.00% 66.33% 67.57% 70.48% 59.81% 63.73% 73.74% 63.16% 71.56% 59.09% 72.93%
New Fiber Complaints 0 6 2 6 4 3 3 9 4 2 2 3 0 3
0.00% 7.41% 2.08% 8.00% 4.08% 4.05% 2.86% 8.41% 3.92% 2.02% 2.11% 2.75% 0.00% 3.87%
New LightSheer Duet Service Complaints 17 8 20 16 20 16 17 15 19 14 26 20 23 18
18.48% 9.88% 20.83% 21.33% 20.41% 21.62% 16.19% 14.02% 18.63% 14.14% 27.37% 18.35% 20.91% 20.30%
New Out of Box Quality Issues 3 0 0 0 0 0 2 3 5 0 2 1 1 1
3.26% 0.00% 0.00% 0.00% 0.00% 0.00% 1.90% 2.80% 4.90% 0.00% 2.11% 0.92% 0.91% 1.49%
New LightSheer Duet Adverse Events 0 0 1 1 4 0 0 0 1 1 0 0 1 1
0.00% 0.00% 1.04% 1.33% 4.08% 0.00% 0.00% 0.00% 0.98% 1.01% 0.00% 0.00% 0.91% 0.79%
New Array LaserLink Complaints 0 0 0 0 0 0 2 4 1 0 0 0 0 1
0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 1.90% 3.74% 0.98% 0.00% 0.00% 0.00% 0.00% 0.62%
New LightSheer Desire Complaints 0 1 0 0 2 1 0 0 0 0 0 2 6 6
0.00% 1.23% 0.00% 0.00% 2.04% 1.35% 0.00% 0.00% 0.00% 0.00% 0.00% 1.83% 5.45% 6.85%
New LightSheer Infinity Complaintss 0 2 1 0 0 1 2 0 1 2 1 0 2 1
0.00% 2.47% 1.04% 0.00% 0.00% 1.35% 1.90% 0.00% 0.98% 2.02% 1.05% 0.00% 1.82% 1.05%
New M22 Complaints 4 2 15 0 3 3 5 11 6 7 4 4 11 6
4.35% 2.47% 15.63% 0.00% 3.06% 4.05% 4.76% 10.28% 5.88% 7.07% 4.21% 3.67% 10.00% 6.59%
New ReSurFX Complaints 0 2 0 1 0 0 0 1 0 0 0 1 1 0
0.00% 2.47% 0.00% 1.33% 0.00% 0.00% 0.00% 0.93% 0.00% 0.00% 0.00% 0.92% 0.91% 0.53%
Total New Complaints Received 92 81 96 75 98 74 105 107 102 99 95 109 110 88
96% 91% 83% 99% 95% 93% 93% 89% 93% 91% 95% 94% 82% 100%
Closed Complaints Total 0 0 200 251 396 75 50 128 159 73 93 101 113 126
Remaining Total Open (WIP) 681 729 650 491 217 227 299 279 228 250 256 266 249 371
# Open Complaint-Related CAPA's in TrackWise 0 0 0 0 0 0 0 0 0 0 0 0 0 0
# Complaint Open >60 days 31 31 31 31 31 31 31 34 50 51 53 54 72 41
# Complaints at ACCEPT >30 Days 0 0 0 0 0 0 0 3 0 1 4 10 1 1
# New Adverse Events 2 1 3 3 6 10 1 7 4 6 8 8 8 5
# Open Adverse Event Cases 22 17 13 7 9 19 18 20 16 12 19 19 23 16
# Closed Adverse Event Cases 2 6 7 9 4 0 2 5 8 10 1 8 4 5
Average Age of Open Complaints (Days) 40 54 43 44 60 71 52 56 66 64 65 66 69 58
Average Age of Closed Complaints (Days) 0 0 49 45 25 26 22 17 12 11 13 12 12 19
Basic Fundamental Rules
22 Strictly private and confidential
Stay in-bounds
Use proper and tested equipment
Apply discretion and good judgement
Buddy-system (don’t do it alone)
Proper provisions
Different Needs and Expectations
25 Strictly private and confidential
• Notable global complaint activity >750/week
• Interfaces: SAP, Enovia PLM, S-Max, SFDCom
• Significant data migration (>5,000 complaint
records imported)
• Active IT Department oversight
LASER COMPANY Complaint PMS Centric
MW ABLATION COMPANY Business Overview Need
• Small global installed base
• Low complaint rates
• Sales/Installed Base/Trunk Stock/PMS tracking
expectations
• Incorporating Quality Metrics
1
2
Situational Analysis
26 Strictly private and confidential
LASER COMPANY 1 • Cap. Eq/Dispos, large install base
• Class I/II/III portfolio, multiple sectors
• M&A conglomerate, six Notified Bodies
• SW linkage (SAP, Enovia, S-MAX, SFDCom)
• US-only data, moderate growth
• Global compliance sensitivity
• Portfolio expansion
• Data capture, application, utilization
• Establish “Agility-Risk-Compliance” balance
Deployment Highlights
27 Strictly private and confidential
LASER COMPANY 1
Complaints CAPA Reports and
Documentation
FUNCTIONALITIES IMPLEMENTED
• Non-Safety
Complaints
• Safety
Complaints
• Manual & Fiber
Complaints
• Reportability
• Product CAPA
• Process CAPA
• Supplier CAPA
• SCAR/NCMR
• Product
Investigations
• Service
Documentation
• Integrations built with ServiceMax Cases and Work Orders
• MedVantageTM configuration & customization completed
within stipulated timelines
• Minimal to no issues identified during UAT
• Validated the entire instance including IQ and OQ
documentation
• 24x7 Product Support and Assistance is being provided
DEVELOPMENT AND SUPPORT
User Adoption
28 Strictly private and confidential
LASER COMPANY 1
• Over 9,500 complaint records as of December 2015
• Complaints are entered by Communications Centers
in the EU, UK, USA and Japan
• Data sliced by product family, region, with drill down
to specific customers & installed product
• Audit trail documentation of all decisions and
actions
• Electronic storage of all related event documentation
• Valuable global trend data helped improve
product performance across markets
• Accurate picture of unique customer
experiences
• Sales advantage with additional resources
• Compendium of clinical experience data
• Eliminated e-mail table-tennis
BUSINESS BENEFITS
USER ADOPTED PROCESSES
Results
33 Strictly private and confidential
LASER COMPANY 1
Time savings Global complaint database Product performance data
Immediate data availability (cloud-based)
Improved & broadened QMS Analytics
B E T T E R Q U A L I T Y D E C I S I O N S , B E T T E R B U S I N E S S D E C I S I O N S
Situational Analysis
34 Strictly private and confidential
MW ABLATION COMPANY 2 • Operating history of 35-years
• Class III, PMA legacy technology
• Flat/negative growth
• ‘Institutionalized’ QMS – Class III
• Emerging Class II technology for cancer
• Asset divestiture, team-rebuild, QMS re-cast,
• Agility-oriented, data-centric, risk-based,
compliance-driven
Streamlined Customer Interactions through MedVantageTM
36 Strictly private and confidential
MW ABLATION COMPANY 2
ASSETS
SERVICE
COMPLAINT
TREATMENT
CAPA
MATERIAL BOM
SALES ORDERS
ACCOUNT
Data connectivity
37 Strictly private and confidential
MW ABLATION COMPANY 2 • Customer/User Facility database
• Disposable-accessory sales mix
• Procedure/Case details
• Trunk stock movement
• Install base solidification
• Serialized component BOM data
• Complaints/Investigations/Vigilance
• Service Work Orders
• Product updates based on ECO changes
• CAPA
Performance based data
38 Strictly private and confidential
MW ABLATION COMPANY 2 • Procedures by anatomical area
• Customer adoption, utilization, trends
• Patient outcomes, product performance
• By device
• Complaints by type, product group, Country, severity
• Sales by Region, Country, Rep
• Case planning, inventory allocation & tracking
I N S T A N T L Y S C A L A B L E A N A L Y T I C S
Sales dashboards from MedVantageTM (SFDC)
39 Strictly private and confidential
MW ABLATION COMPANY 2
Disposable Complaints by Reported Problem
41 Strictly private and confidential
MW ABLATION COMPANY 2
Results
44 Strictly private and confidential
MW ABLATION COMPANY 2
Product movement overview Product Quality Performance Sales Rep Performance
Complaint, PMS data Immediately Available
Reporting
B E T T E R Q U A L I T Y D E C I S I O N S , B E T T E R B U S I N E S S D E C I S I O N S
Lesson: Share the Vision of “Regulatory Science”
46 Strictly private and confidential
• Ensure key decision-makers understand the reason behind change
• Assure end-users are included in the planning and implementation
• Describe the expectations for improvement
• Process improvement requires change
• Embrace constructive change
Lesson: Document Existing Processes
47 Strictly private and confidential
• Identify areas for improvement and focus on them
• Create a ‘safe environment’, for openness, honesty and creativity
• Capture entire in-situ work flow from start to end
• Broken processes are still processes, they should not be ignored
• Inter-functional connections are essential (OPS-Sales-Cust Service-
QA-Finance-R&D-Adm)
Lesson: Benefits of Proper Codes
48 Strictly private and confidential
• A well designed reported event, cause and remediation codes is essential
• Reported problem codes
• Identified cause codes (HVPS, attenuator, Use Error etc.)
• Action codes (repair, replace, dispose)
• Granularity results in fact based decisions
A N A L Y T I C S P O W E R C O M E S F R O M B E T T E R U S A G E O F C O D E S
Lesson: Horizontal – Vertical Data Application
49 Strictly private and confidential
• Use ‘cockpit/dashboard’ reports to create routine visibility
• Integrate data into leadership meetings for early awareness to avoid surprises
• Efficient feeder into meaningful Management Review
• QSIT/cGMP-QSR/ISO Oriented
• Snapshot, SME development, audit team training
• Effective ‘school-yard’ tool for compliance audits
• Audit-Ready Posture: Unannounced, pre-announced, directed, ad hoc, etc.
• Planning, Inventory flow, traceability, PMS advantages
4 Panel Orientation Approach (Sample)
51 Strictly private and confidential
Issues
Actions/Decisions Risks
Analysis
This section includes facility based metrics such as complaint rates or
audit based metrics such as number non-conformances. Section changes
depending on quality system element being discussed.
This section is typically populated by trends noted from the analysis
section or other business areas of concern.
• Description of Issue #1
• Description of Issue #2
• Actions recommended or implemented to address Issue #1.
• Actions recommended or implemented to address Issue #2.
Risk of Issue #1
Patient Risk, Business Risk, Compliance Risk
Risk of Issue #2
Patient Risk, Business Risk, Compliance Risk
Overall criticality of the parameter
Internal Audits
52 Strictly private and confidential
Issues
Actions/Decisions Risks
Analysis
No issues identified
• All essential elements audited
• Process review & streamlining where applicable
No risks identified
Low Criticality
Goal Result Trend
Total Audits Scheduled 5 5
Total Open Audits 1 1
Total Closed Audits 5 5
% Completed vs Scheduled 100% 100%
Number of Nonconformances 0 0
2015 Post Market Complaints
53 Strictly private and confidential
Issues
Actions/Decisions Risks
Analysis
• Significant Distributor response time for return
• Complaints open over 90 days.
• Proactive Customer Service follow-up
• Improve existing database and trending capability
• Software enhancement initiative
• Regulatory compliance risk
• Lack of data for product improvement
Medium Criticality
Complaint Management Center Goal Result Trend
Aware to Close (Days) 30 Days 77
Number Open Complaints 3 3
Avg Age of Open Compl. <30 Days 55
Adverse Events Received N/A 0
# MDRs Filed Late 0 0
Purchasing Controls/Logistics
54 Strictly private and confidential
Issues
Actions/Decisions Risks
Analysis
• Vendors: Delays resulted from changes in customer expectations.
• Shipments: Customs delays resulting from customer communication issues
• Failure to use customer’s shipping account with carrier.
• Vendors: Better account for time required for approvals and
communication between issuance of PO and delivery date.
• Shipments: Establish better communication channels to clearly
communicate requirements by Custom Offices.
• Retrain personnel to review orders for shipping instructions and
communicate with customer when questions exist.
• Customer satisfaction risk
• Financial risk
Medium Criticality
On-Time Delivery/Issues Goal Result Trend
Vendors 95% 94.8%
Shipments 95% 99%
Issues 95% 98.5%
CAPA
55 Strictly private and confidential
Issues
Actions/Decisions Risks
Analysis
• Timely CAPA completion
• Management Changes
• Resources
• Quarterly CAPA Committee review
• Emphasize Cross-functional review of CAPA’s by CAPA Committee
• Process review & streamlining
• External Audit visibility
• Regulatory Noncompliance Vulnerability
2015 Goal Result Trend
Total Open CAPAs 0 1
CAPA Extension Requests 0 1
CAPA Extensions Closed 0 2
Overdue CAPAs 0 0
CAPAs Deemed Ineffective 0 0
Aging CAPAs (Avg Days @ Phase
Investigative Phase 30 Days 30
CAPA Phase 90 Days 164
Verification Phase 14 Days 14
Low Criticality
QMS Effectiveness
56 Strictly private and confidential
QMS Area Internal Audit Findings External Audit Findings Findings/Open
Design Control 0 0 Risk Management
Internal Audit 0 0 On-Schedule
CAPA 1 0 Closure consistency
Records, Documents, Change Control 1 0 SOP consistency, Comprehensive review
Infrastructure 2 0 Calibration, Pest Control
Work Environment 1 0 No impact on product.
Purchasing 1 0 Drawing consistency
Vendor Control 0 0 Rating & Outsourcing audit frequency
Post-Market Surveillance 0 0 Annual product review, Competition,
Complaint Handling 0 0 Trend details, Regional breakout for EU
Labeling 0 0 Expiry Date: Bar-coding vs. print gaps
Training 0 0 SOP refinement, process overhaul
Perseon Project Dashboard (Illustrative)
57 Strictly private and confidential
Metric Goal
Approved Supplier Listing 100% Cleared
On-Time Delivery per production schedule ≥ 95%
IQA Acceptance Rate ≥92.5%
First Pass Yield (CEA – Probes) ≥ 85%
First Pass Yield (Perseon – Generators) ≥ 80%
Complaint/MDR Rate 2%/0.2%
ECO Incorporation Efficiency < 1 week
Notification of NCMR/CAR issues in CEA Production Within 72 hours
Re-occurrence of closed CAR/SCAR/NCMR issues <5%
SCARS reported for workmanship issues 0
Failure to follow MPI’s/ training 0 Occurrences
Adherence to Quality Plan requirements 100% Compliance
Employee Retention Rate 90%
Summary Scoring Indicators
58 Strictly private and confidential
SECTOR PERSEON - SLC
IQA
Production
Complaints
Internal Audits
External Audits
Supplier Audits
CAPA
Design Control
Staffing/Resources
ECO's
Training
New RA Issues
Calibration
Environmental Control
Preventive Maintenance CEA
Regulatory Submissions
What was the root cause?
67 Strictly private and confidential
• Flight 4590 was loaded 810 kg over limit
• Flight 4590 fuel was unbalanced
• Competitor Airline Mechanic cut corners
• Titanium Strap; not approved for temporary repairs
• Strap not installed properly
• Competitor plane loses strap during take-off
• No FOD walk as required by SOP’s
Summary…
68 Strictly private and confidential
EMPHASIS ON QMS CHECKS
GATHER, ANALYZE AND APPLY MEANINGFUL DATA
USE PROPER AND TESTED TOOL/ EQUIPMENT
APPLY DISCRETION & GOOD JUDGEMENT
BUILD & DEVELOP YOUR TEAM
REQUIREMENT VS. PRUDENT BUSINESS CONDUCT
1 2 3
6 5 4
Recommended