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Overview of Risk Management Remediation 440-315-3353, [email protected] Russell Pizzuto

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Page 1: Risk Management Remediation Overview

Overview of Risk Management

Remediation

440-315-3353, [email protected]

Russell Pizzuto

Page 2: Risk Management Remediation Overview

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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Page 3: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 4: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 5: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 6: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 7: Risk Management Remediation Overview

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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!

Page 8: Risk Management Remediation Overview

QSRMedicalDevice

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Overview of Risk Management Remediation © PPRE Consulting LLC - 2015

Risk Management ProcessWhat To Expect

What is Required

Page 9: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 10: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 11: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 12: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 13: Risk Management Remediation Overview

QSRMedicalDevice

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Overview of Risk Management Remediation © PPRE Consulting LLC - 2015

Risk Management Plan

Lifecycle Phases Responsibilities

& Deliverables

Plan

Controls

Report

Feedback

Assessment

Page 14: Risk Management Remediation Overview

QSRMedicalDevice

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Overview of Risk Management Remediation © PPRE Consulting LLC - 2015

Risk Management Plan

Plan

Controls

Report

Feedback

Assessment

Risk Review Requirements

Page 15: Risk Management Remediation Overview

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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

Page 16: Risk Management Remediation Overview

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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

Page 17: Risk Management Remediation Overview

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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

Page 18: Risk Management Remediation Overview

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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

Page 19: Risk Management Remediation Overview

QSRMedicalDevice

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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

Page 20: Risk Management Remediation Overview

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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

Page 21: Risk Management Remediation Overview

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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

Page 22: Risk Management Remediation Overview

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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

Page 23: Risk Management Remediation Overview

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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