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Risk Management Remediation Overview
- 1. Overview of Risk Management Remediation 440-315-3353,rpizzuto@ppreconsulting.com Russell Pizzuto
- 2. QSR Medical Devices Overview of RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement Remediation © PPRE Consulting LLC - 2015 Risk Management Process What To Expect What is Required
- 9. QSR Medical Devices Overview of RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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 RiskManagement 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
Editor's Notes
- #18 Print the presentation and go up to leah with it and say leah can you please look at this with your people and come up with as many questions as possible? Specifically in Russ’s section? If we get to a point that we reach the end and only at 36 mins we need a pipeline of questions to plant and ask presenters at the end. KC IS BEGGING