Risk Management Research 2016 ISO 14971:2016
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Transcript of Risk Management Research 2016 ISO 14971:2016
Risk Management within Medical Devices
MScSED - Module: MCT626
Researcher: Niamh St John LynchAdvisor: Dr Owen MolloyDate: 04 May 2016
Experience
Qualifications / Experience
Quality Manager J&J, Boston Scientific, Beckman
Coulter / Danaher, Merit Medical, Bioniche / Mylan, Phardiag / Menarini Group
20 Years in IT, Pharmaceutical and Medical Devices
BSc Cognitive Science (Hons)MSc NeuropharmacologyCertified to ISO 14971:2016
Certified to ISO 13485:2016Certified to GMP/GDP/RP
Niamh Lynch (nee St John)
Contents
BackgroundDefinitionsIntroductionProblem OverviewResearch QuestionLiterature ReviewResearch MethodologyConclusion
Requirements Relevance?
Background
Risk management is central to all Medical Device manufacturers and with the changes to ISO 14971:2012 and more recently ISO 13485:2016
All Medical Device companies need to review their approach
ISO 14971 Risk Management
Risk PlanRisk Analysis
Risk Evaluation
Risk ControlEffectiveness
MonitoringRisk
AcceptabilityRisk Report Risk Benefit
Analysis
ISO 14971:2012
Risk PlanRisk Analysis
Risk Evaluation
Risk Control Effectiveness monitoring of
controlsRisk Report
ISO 14971:2007/20
09
Risk AnalysisRisk
EvaluationRisk Control
ISO 14971:2001
Risk Assessment
Only
ISO 14971-1:1998
21 CFR Part 820 required for
device modification
includes Design Control and Validation including
labelling and packaging
QSR 1996
Medical Device
AmendmentClass III medical
devices to go through PMA
FDA GMP 1976
Definition of Risk
“the combination of the probability of occurrence of harm and the severity of that harm” Q9 (2006)
Definition of Risk Management
“the systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk”, Q9 (2006).
Why Perform Risk Management?
Reduce Risk to Patients
Reduce Risk to Business reduce cost
Risk management attempts to identify, measure, mitigate or control risks, which as we defined above, are the opportunity for loss or injury in order to protect the public from harm arising from new medical devices or changes to existing medical devices
What is a Medical Device? Medical Device - “Any instrument, apparatus, implement, machine,
appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for human beings for one or more of the specific purpose(s) of the following:
Diagnosis, prevention, monitoring, treatment or alleviation of disease; Diagnosis, monitoring, treatment, alleviation of or compensation for
an injury; Investigation, replacement, modification, or support of the anatomy
or of a physiological process; Supporting or sustaining life Control of conception Disinfection of medical devices Providing information for medical purposes by means of in vitro
examination of specimens derived from the human body; and which does not achieve its primary intended action or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”
Problem Overview
Patient Harm, Injury and Death continue to occur
Product Recalls and Failures continue Risk Management System Requirements
require ‘robust’ risk techniques Risk Management Systems continue to be
difficult to maintain Risk Management Systems are for the most
part, not integrated within it’s QMS FMEA is main tool used in Medical Devices –
not robust enough to identify all risk
Literature Review
Lit Review Demonstrates:
FMEA is the tool of choice for manufacturing, manufacturing services and suppliers to the industry.
Ref. Dumbrique, R. (2010). Implementation of Risk Management in the Medical Device Industry. Master’s Theses Paper 3855. San Jose State University. SJSU Scholar Works
Research Question Two key questions :
Do Medical Device companies continue to rely heavily on Failure Modes and Effects Analysis (FMEA) as the primary tool for risk assessment
(ref. Lopez, et al (2010), Kamm (2005) and Lu Gan (2012)?
Does the FMEA adequately support Risk Management throughout the full lifecycle of the Product Development Process to meet relevant Medical Device standards, ISO 13485:2016 and ISO 14971:2012?
Failure Modes Effects Analysis
FMEA LimitationsSome of the limitations of the FMEA listed by McDowall (2005 and Gan, 2011) include:Components can be tedious and difficult to analyze
when part of complex systemsCompound failure effects cannot be analyzedCost and time consuming, unless carefully controlled Successful completion requires expertise, experience
and good team skills Incorporating all possible factors influencing the
system, such as human errors can result in lengthy analysis, difficult to manage.
Data redundancies can be a problem and is time consuming
How Can Technology Help?
A software risk management tool is proposed to overcome these significant problems within the industry.
The aim for the software tool suggested is to streamline the process, create efficiencies within the Quality Management System (QMS), reduce real risk to the business and ensure compliance to the relevant regulatory standards and authorities.
Research Methodology
A combination of methodologies are required to conduct this research:
Content AnalysisLiterature Review Data Surveys for current statusExperimental Research & Development relevant
architectural design
Useful Websites
ASQ: http://www.asq.org FDA: http://www.fda.gov ; http://www.21cfrpart11.com ICH: http://www.ich.org IEE: http://www.iee.org ISPE: http://www.ispe.org/gamp/ BSI: http://www.bsi-global.com NIST: http://csrc.nist.gov/publications/nistpubs/index.html WHO: http://www.WHO.org EU: http://ec.europa.eu GHTF: http://ghtf.org now http://www.imdrf.org
Q&A
Go Raith Maith Agat
Thank You