1. Overview of
Risk Management
Remediation
440-315-3353, rpizzuto@ppreconsulting.com
Russell Pizzuto

2. QSR
Medical
Devices
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 Pizzuto
President
PPRE Consulting LLC
32310 Seneca Drive
Solon, Ohio 44139
440-315-3383
rpizzuto@ppreconsulting.com
pg. 2

3. QSR
Medical
Devices
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

4. QSR
Medical
Devices
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 Commitments
Gains Approval of Remediation Plan

5. QSR
Medical
Devices
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

6. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
COMPLEX REMEDIATION EVOLVES
Takes 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

7. QSR
Medical
Devices
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 1/25/2014
X Incorrect: Incorrect RP
Reviews need cross-functional signatures
It Didn’t Happen If It Isn’t Documented!

8. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk Management Process
What To Expect
What is Required

9. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
ISO 14971
Consensus
Standard
INTERNATIONAL
STANDARD
ISO
14971
Second edition
2007-03-01
Medical devices — Application of risk
management to medical devices
Dispositifs médicaux — Application de la gestion des risques aux
dispositifs médicaux
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

10. QSR
Medical
Devices
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

11. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Lifecycle Management–
Ongoing Feedback
Project
Initiation
Mfg.
Commercial’n
Ongoing
Production
Business
Case
Requireme
nts
Regulation
s
Mkt
Analysis
Design
Ideas
Idea
s
Idea
s
Proj
.
Research &
Developme
nt
Gatin
g
Parallel Work & Project Management
Market
Research
Develop
Post Market
Data
Complain
ts MDRs
MADE
Audits
483’s
Design
Change
Process
Improve
ment
CAPA’s
Device Lifecycle

12. QSR
Medical
Devices
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

13. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk
Managem
ent Plan
Risk Management Plan
8.0 PRODUCT LIFE CYCLE AND DESIGN PHASES RISK MANAGEMENT
8.1 Risk management shall be carried out for the entire life cycle of the oxygen cylinder assembly.
8.2 TABLE ONE shows the steps in the risk management process required during the design control
development phases, the corresponding deliverable and the function responsible for the deliverable
as outlined in the Product Development Process Road Map of CP04-003
TABLE ONE - DESIGN PHASES RISK MANAGEMENT
Risk Management
Element
Purpose Deliverable
Design Control
Development
Phase
Responsibility
Device Description and
Intended Use
The intended use defines what medical
purpose the device within the product
category is used for, the patient
population for which it is intended, the
environment in which it is intended to be
used and characteristics of typical users.
Risk Management
Plan
Concept &
Feasibility
Stage(S1)
Engineering,
Marketing, Product
Risk Management,
Regulatory, Quality
The device description and intended use
shall align with the User Requirement
Specification (URS) for the specific
device.
Risk Management
Report
Pre-production (S4)
Engineering,
Marketing, Product
Risk Management,
Regulatory, Quality
Identification of
Characteristics Related
to Safety
Characteristics related to safety define
potential hazards with the intended use
of the device, and non-intended uses.
Initial Product
Risk Analysis
Planning (S2)
Development (S3a)
Engineering, Product
Risk Management,
Quality
Risk Management Plan
To describe the risk management
activities, requirements for reviews,
responsibility for risk management
activities and criteria for risk
acceptability.
Risk Management
Plan
Planning (S2)
Prototype (S3b)
Product Risk
Management,
Engineering, Quality,
Regulatory
Hazard Identification
To identify foreseeable hazards
associated with a device in normal and
fault conditions. Detailed analysis of
each risk to health identified shall be
performed. Where applicable, additional
activities should be performed at the
subsystem level in order to document
any mechanism of failure.
Hazard Analysis
Planning (S2),
Development (S3a),
Prototype (S3b),
Pre-production (S4)
Product Risk
Management,
Engineering, Quality,
Regulatory
Risk Estimation
Estimate risk based on the Severity and
Probability of the hazard leading to a
harm.
Hazard Analysis
Planning (S2),
Development (S3a),
Prototype (S3b),
Pre-production (S4)
Product Risk
Management,
Engineering, Quality,
Regulatory
Risk Evaluation
Determine if risk mitigation action is
required for risk acceptability.
Hazard Analysis
Planning (S2),
Development (S3a),
Prototype (S3b),
Pre-production (S4)
Product Risk
Management,
Engineering, Quality,
Regulatory
Risk Control Option
Analysis
Identify risk control measures for
reducing risk to an acceptable level.
N/A
Planning (S2),
Development (S3a),
Prototype (S3b),
Pre-production (S4)
Product Risk
Management,
Engineering, Quality,
Regulatory
Hazard Analysis
Planning (S2),
Development (S3a),
Prototype (S3b),
Pre-production (S4)
Product Risk
Management,
Engineering, Quality,
Regulatory
 Lifecycle Phases
 Responsibilities
& Deliverables
Plan
Controls
Report
Feedback
Assessment

14. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Risk
Manageme
nt Plan
Plan
Controls
Report
Feedback
Assessment
 Risk Review
Requirements
Risk Management Plan
11.0 RISK MANAGEMENT ACTIVITIES
11.1 The following Risk Review Matrix will be followed at a minimum.
Product Life Cycle
Phase
Risk Item(s) reviewed
Check appropriate field
Risk Review
by Team
Peer Risk
Review
Risk Review
according to
CP14-013
Concept &
feasibility stage (S1)
1. User Requirement
Specification
2. Traceability / IO Matrix
Planning (S2)
1. Risk Management Plan
2. Product Category Risk
& Hazard Analysis
3. Member Roster
4. Traceability / IO Matrix
5. Core Team & Peer
Team Risk Reviews
Development (S3a)
1. Risk Management Plan
2. Product Category Risk
& Hazard Analysis
3. Member Roster
4. Traceability / IO Matrix
5. Core Team & Peer
Team Risk Reviews
Prototype (S3b)
1. Risk Management Plan
2. Product Category Risk
& Hazard Analysis
3. Member Roster
4. Traceability / IO Matrix
5. Core Team & Peer
Team Risk Reviews
Pre-production (S4)
1. Risk Management Plan
2. Product Category Risk
& Hazard Analysis
3. Member Roster
4. Traceability / IO Matrix
5. Core Team & Peer
Team Risk Reviews
6. Risk Management Report
Production (S5)
1. Risk Assessment for
Product Malfunctions &
Quality Issues
Post-Production
1. Risk Assessment for
Product Malfunctions &
Quality Issues
12.0 RISK MANAGEMENT FILE (RMF) MAINTENANCE
12.1 The Risk Management Plan (RMP), a Product Category Risk and Hazard Analysis, and other

15. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Severity
High Death / Serious
Med
Non-serious
Non-permanent
Low
No medical
intervention
Probability
High Nearly Inevitable
Med Unusual
Low Not probable
Plan
Controls
Report
Feedback
Assessment

16. QSR
Medical
Devices
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
Detail
P(U)
S(
U)
R(U)
HID-1
Biolo
gical
-
expo
sure
to
bioh
azar
d
Airstream
contamination
by particulate
Airstream
components
Personal
injury -
minor
airway
reaction
H M
Unaccept
able
HID-2
Biolo
gical
-
expo
sure
to
bioh
azar
d
Airstream
contamination by
vapor or gas
Airstream
components
Personal
injury -
minor
airway
reaction
H M
Unaccept
able
HID-5
Elect
roma
gneti
c -
elect
rical
shoc
k
External
component failure
- Insulation system
breakdown
o hole in side of
cabinet
o cabinet
insulation
breakdown
Cabinet
Personal
injury -
death
death M H
Unaccept
able
HID-6
Elect
roma
gneti
c -
elect
rical
shoc
k
Internal component
failure
- Internal insulation
breakdown
o double
insulation
system
Electron/electri
cal
components
Personal
injury -
death
death L H ALARP
HID-7
Elect
roma
gneti
c -
elect
rical
shoc
k
Line cord damaged
Design:
- Line cord
damaged
User Error:
- Inadequate or
overly
complex
instructions
and or warnings
Line cord
Personal
injury -
death
death M H
Unaccept
able
0 50 100
Unusabl…
Battery -…
DC…
Heat
Fuse
Melt
AC…
Compre…
O2 Flow
Burning…
Noise
Sieve Bed
other
Field Use Data
Plan
Controls
Report
Feedback
Assessment

17. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
0 5 10 15
Heat
Bulge or…
Burning…
DC Adapter
AC/Char…
Fuse
Battery…
Insufficie…
Noise
Shock
Sparktota
l
201
2
201
1
201
0
200
9
Operational -
Thermal - high
temperature -
Mechanical -
acoustic energy -
Discomfort
Electromagnetic - low
voltage electrical shock –
Discomfort
Potential for Thermal
Event Fire – Burn or
Death
Adverse Events
0 50 100
Unusabl…
Battery -…
DC…
Heat
Fuse
Melt
AC…
Compre…
O2 Flow
Burning…
Noise
Sieve Bed
other
Operationa
l
- Loss of
function
-
Discomf
ort
Ther
mal
-
Burn
Customer
Complaints
 Time Consuming Process
 Identify Hazards
 Calculate Probability
Plan
Controls
Report
Feedback
Assessment

18. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Hazard
ID
Hazard
Category
Hazard
Category
Detail
System/
Subsystem/
Component
Harm
Category
Harm
Category
Detail
P(U
)
S(U
)
R(U)
HID-1
Biological -
exposure to
biohazard
Airstream
contamination
by particulate
Airstream
components
Personal
injury -
minor
airway
reaction
H M Unacceptable
HID-2
Biological -
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

19. QSR
Medical
Devices
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
Detail
S(U
)
P(U
)
R(U)
HID-1
Biological -
exposure to
biohazard
Airstream
contamination
by particulate
Airstream
components
Personal
injury -
minor
airway
reaction
H M Unacceptable
HID-2
Biological -
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
#remediationwe

20. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Hazard
ID
Hazard
Category
Hazard
Category
Detail
System/
Subsystem/
Component
Harm
Category
Harm
Category
Detail
P(U
)
S(U
)
R(U)
HID-1
Biological -
exposure to
biohazard
Airstream
contamination
by particulate
Airstream
components
Personal
injury -
minor
airway
reaction
H M Unacceptable
HID-2
Biological -
exposure to
biohazard
Airstream
contamination by
vapor or gas
Airstream
components
Personal
injury -
minor
airway
reaction
H M Unacceptable
Probability + Severity = Risk
Probability
Severity
Risk Level
Plan
Controls
Report
Feedback
Assessment

21. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
Hazards, Harms and Unmitigated Risks
DESIGN
CONTROLS
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
Inhalat
ion -
irritati
on
H 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
Disco
mfort
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 Left
Pg 11 - Left Side Note 7
Pg 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
Feedbac
k
Assess
ment

22. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
RISK
REPOR
T
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
Assessme
nt

23. QSR
Medical
Devices
Overview of Risk Management Remediation © PPRE Consulting LLC - 2015
ONGOING
RISK
MANAGEM
ENT
Parallel Work & Project Management
Project
Initiation
Mfg.
Commercial’n
Ongoing
Production
Business Case
Requirements
Regulations
Mkt Analysis
Design
Ideas
Pr
oj.
Research &
Development
Gatin
g
Market
Research
Develop
Idea
s
Ideas
QUALITY MANAGEMEN
Lifecycle Management
Post Market Data
Complaints
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 products
Plan
Controls
Report
Feedbac
k
Assessm
ent