risk management remediation overview
TRANSCRIPT
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Russell Pizzuto has 40 year of experience in engineering and management with 13 years in medical device design, manufacturing and regulatory compliance. He has developed hundreds of products for fortune 500 companies. As Global Director of Engineering for a major medical products manufacturer with teams in USA, Europe, China and Mexico he delivered Class I and Class II medical device projects.
For the last few years he has served as President of PPRE Consulting, specializing in Product, Project and Regulatory Engineering. He holds a Medical Device certificate from the Regulatory Affairs Professionals Society (RAPS), has work on the FDA’s Hospital Bed Safety Work Group and served as an expert witness in Hospital Bed Safety litigation. Mr. Pizzuto has most recently focused on helping clients under FDA legal action, to bring their Design Control and Risk Management Systems into compliance.
Russell PizzutoPresidentPPRE Consulting LLC32310 Seneca DriveSolon, Ohio [email protected]
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QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Client / Consult Team Consultants – with relevant expertise
Client’s Management Team
Client’s Subject Matter Expert – SME
Client’s Cross-functional Support
Client Engagement Very Important
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Strong & Engaged Steering Committee Decision Makers: Listen - Guide – Direct
Members Functional Leaders – Work stream Owners
Sub-team Project Owners
Lead Consultants
Reports to Upper Management
Ensure Resource CommitmentsGains Approval of Remediation Plan
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
STRONG& ENGAGED STEERING COMMITTEE
•Timely and Effective Decision Makers• Identify Gaps - Remediation Plans• Resource Management & Project Oversight
– Business Decisions• Cultural Change
• Ongoing Communication of Importance• Communication of Plans, Process & Results• Manage Resistance to Change
Weak Leadership = Ad Hoc Decisions Wavering / Inconsistent / Ineffective
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
COMPLEX REMEDIATION EVOLVESTakes Longer Than Envisioned•Everyone is Learning - Underestimate Effort•Unknown Unknowns at Start
• New processes, resources & time; magnitude of gaps • FDA expectations • ISO 14971 – How to tailor to company & culture
•Balancing • Compliance Alternatives• Complex vs. Practical, Productive Compliance
Risk Avoidance = delays & unproductive processes
Initial Process – Use & Improved
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
OLD RECORDS: A FREQUENT PROBLEM
“Objective Evidence” must be signed and dated
Corrections must be:• Signed and dated• Crossed out legibly
Correct: Correct RP 1/25/2014X Incorrect: Incorrect RP
Reviews need cross-functional signatures
It Didn’t Happen If It Isn’t Documented!
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk Management ProcessWhat To Expect
What is Required
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
ISO 14971 Consensus Standard
Medical Electrical Equipment Part 1: General requirements for basic
safety & essential performance
IEC 60601-1 3rd Edition
• Clause 4.2
A risk management process
according to ISO 14971 shall
be performed
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Starts Early in Product Development
Concept(Project Inputs)
Planning(Design Inputs)
Development Part 1
(Design Outputs)
Development Part 2 (Design
Verification)
Pre-product(Design
Validation)
S5 Production
Risk Plan Initial Risk
Assessment
Ongoing Risk
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Lifecycle Management– Ongoing Feedback
ProjectInitiation
Mfg.Commercial’n
Ongoing Production
Business Case
Requirements
Regulations
Mkt Analysis
Design
Ideas
Ideas
Ideas
IdeasIdea
s
Proj.
Research &Developme
nt
Gating
Parallel Work & Project Management
MarketResearch
Develop
Ideas Post Market
DataComplaints MDRs
MADE
Audits483’s
Design Change
Process Improve
ment
CAPA’s
Device Lifecycle
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk Management Plan
Risk Controls / Mitigation
Risk Management Report
Production and Post-production Information / Feedback
Risk Assessment Hazards Harm Probability
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk Management Plan
Lifecycle Phases Responsibilities
& Deliverables
Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk Management Plan
Plan
Controls
Report
Feedback
Assessment
Risk Review Requirements
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
SeverityHigh Death / Serious
MedNon-serious Non-permanent
LowNo medical intervention
Probability
High Nearly Inevitable
Med Unusual
Low Not probable Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Preparation • Historical - Risk Analysis
• Field use data
• Databases search (Maude…)
• New design concept
• Clinical studies
Hazard ID
Hazard Category
Hazard Category
Detail
System/ Subsystem/ Component
Harm Category
Harm Category
DetailP(U) S(U) R(U)
HID-1
Biological - exposure to biohazard
Airstream contamination by particulate
Airstream components
Personal injury - minor
airway reaction H M Unaccepta
ble
HID-2
Biological - exposure to biohazard
Airstream contamination by vapor or gas
Airstream components
Personal injury - minor
airway reaction H M Unaccepta
ble
HID-5
Electromagnetic - electrical shock
External component failure - Insulation system breakdown o hole in side of cabinet o cabinet insulation breakdown
Cabinet Personal injury - death
death M H Unacceptable
HID-6
Electromagnetic - electrical shock
Internal component failure - Internal insulation breakdown o double insulation system
Electron/electrical
components
Personal injury - death
death L H ALARP
HID-7
Electromagnetic - electrical shock
Line cord damaged Design: - Line cord damaged User Error: - Inadequate or overly complex instructions and or warnings
Line cordPersonal injury - death
death M H Unacceptable
Unusable / Shut Down
Fuse
Burning Smell
0 20 40 60
Field Use Data
Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Heat
Bulge or Melt
Burning Smell
DC Adapter
AC/Charging Adapter
Fuse
Battery Charge Insuffi-cient
Insufficient O2
NoiseShockSpark
total
2012
2011
2010
2009
2008
Operational - loss of function - Discomfort
Thermal - high temperature - Skin Burn
Mechanical - acoustic energy - Discomfort
Electromagnetic - low voltage electrical shock – Discomfort
Potential for Thermal Event Fire – Burn or Death
Adverse Events
Unusable / Shut Down
Battery - Short Run/No Charge
DC Adapter
Fuse
AC Adapter
Compressor Power Fitting
Burning Smell
Sieve Bed
other
0 20 40 60
Operational - Loss of function - Discomfort
Thermal - Burn
Customer Complaints
Time Consuming Process Identify Hazards Calculate Probability
Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Hazard ID
Hazard Category
Hazard Category
Detail
System/ Subsystem/ Component
Harm Category
Harm Category
DetailP(U)S(U) R(U)
HID-1Biological - exposure to biohazard
Airstream contamination by particulate
Airstream components
Personal injury - minor
airway reaction H M Unacceptable
HID-2Biological - exposure to biohazard
Airstream contamination by vapor or gas
Airstream components
Personal injury - minor
airway reaction H M Unacceptable
Identify Hazards
Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk Assessment: Harms and Hazards – Determine Harm
Hazard ID
Hazard Category
Hazard Category
Detail
System/ Subsystem/ Component
Harm Category
Harm Category
DetailS(U)P(U) R(U)
HID-1Biological - exposure to biohazard
Airstream contamination by particulate
Airstream components
Personal injury - minor
airway reaction H M Unacceptable
HID-2Biological - exposure to biohazard
Airstream contamination by vapor or gas
Airstream components
Personal injury - minor
airway reaction H M Unacceptable
Medical Professional On Team
Harms
Plan
Controls
Report
Feedback
Assessment
#remediationwebinar
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Hazard ID
Hazard Category
Hazard Category
Detail
System/ Subsystem/ Component
Harm Category
Harm Category
DetailP(U
)S(U
) R(U)
HID-1Biological - exposure to biohazard
Airstream contamination by particulate
Airstream components
Personal injury - minor
airway reaction H M Unacceptable
HID-2Biological - exposure to biohazard
Airstream contamination by vapor or gas
Airstream components
Personal injury - minor
airway reaction H M Unacceptable
Probability + Severity = RiskProbability
Severity
Risk Level
Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Hazards, Harms and Unmitigated Risks
DESIGNCONTROLS
Risk After Design Mitigation Labeling Mitigation Risk After Design and Labeling Mitigation
Hazard ID HAZARD System/
Subsystem/ Component HARM P(
U)S(U)RISK
P(DM)
S(DM) R(DM)
Residual Risk vs. Benefit
Analysis Required?
LABELING CONTROLS
P(M) S(M) R(M)Residual Risk
vs. Benefit Analysis
Required?
HID - 3 Biological
Particulates, gas, vapors contaminating the delivered gas
System Personal injury - minor
Inhalation - irritati
onH M Unacceptable
Meets the requirements of 93/42/EEC (MDD) and 97/23/EC (PED) related to appropriate material selection, Design Verification & Process Control
L M ALARP No L M ALARP No
HID - 4 Choking Ingestion of small particles of material
System Personal injury - major Death M H Unacceptable Meets the filtration requirements for ISO
10524-3:2005 L H ALARP (2) No L H ALARP (2)
Further residual risk mitigation
considered but risk vs. benefit doesn't
warrant further action
HID - 5 Deterioration of Function
Mechanical Failure - dropping, shock, handling
System No injury Discomfort M M ALARP
Meet requirements of 93/42/EEC (MDD) for mechanical failure resulting from dropping, shock or handling
L M ALARP No Warning: Pg 8 - Lower LeftPg 11 - Left Side Note 7Pg 14 - Lower left warning, Note 2
L M ALARP No
HZ 8
Fire User Error – Placed near source of heat
System Personal injury - major Death H M Unacceptable Heat sensor shuts down system L M Acceptable No pg 22 - 2nd paragraph?
Inspected every 5 years? L M Acceptable No
Each Hazard Must Have Controls
Risk Controls Priority Order
• Inherent safety by design
• Protective measures
• Information for safety
Mitigate Risks
• Acceptable Levels
OR
• Positive Risk Benefit Analysis
Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
RISK REPORT
Risk Report – Documents• Risk Plan is Implemented
• Design and Manufacturing Risks
• Overall Residual Risk is Acceptable Line by Line - If not acceptable
• Prove medical benefit outweigh risk
• Production & Post-production Feedback Plan
Controls
Report
Feedback
Assessment
QSRMedicalDevice
s
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
ONGOING RISK MANAGEMENT Parallel Work & Project Management
ProjectInitiation
Mfg.Commercial’n
Ongoing Production
Business CaseRequirements
RegulationsMkt Analysis
Design
Ideas
Proj.
Research &Development
Gating
MarketResearch
Develop
Ideas Idea
sIdeas
Ideas
Ideas
QUALITY MANAGEMEN
Lifecycle Management
Post Market DataComplaints MDRs MADE
Audits, 483’s
Design Change
Process Improvement
CAPA’s
Post Market Quarterly Review• Update new risks• Update probability of occurrence
Effects on similar productsPlan
Controls
Report
Feedback
Assessment