Going Beyond Compliance To Boost Quality For Medical Devices
A Data-Driven Approach toQuality Risk Management:Going Beyond Compliance to BoostQuality for Medical DevicesWHITEPAPER
Table of ContentsIntroduction3Risk Management: Tough and Getting Tougher5Signs of a Weak Link between Risk Management andthe Quality Management System710Digital Risk Management Is the SolutionPerform Deeper Analysis: The Importance of data backed,quantifiable risk management11Choose the Best Digital Risk Managment System161.1014
IntroductionThe international medical device industryThese innovations have increased thehas enjoyed tremendous growth. This growthcomplexity in how medical devices arehas driven innovation for complex medicaldesigned and manufactured, while alsodevices that have broadened the treatmentsincreasing the diversity in usage environmentsavailable to patients with complex diagnosesof those same complex products. Alongsideand other conditions. For example, minimallythis growth and innovation has come theinvasive procedures have provided medicalincreasing reports of serious adverse events.1benefits to patients such as less bleeding,In fact, serious adverse event reports havetrauma, and scarring compared to invasiveoutpaced the medical device industry growthor open procedures and surgeries. Roboticsince 2001. Further, over half of all medicaland navigation-enabled surgeries havedevice recalls have been due to design flawsimproved trajectory and depth visualizationand manufacturing issues of medical devices.for surgeons, resulting in reduced soft tissuedamage and reduced pain for patients.Innovations in instrumentation and implantshave provided effective treatments andcorrections for complex spinal deformities.www.spartasystems.comThere has also been an increasingtransparency into comparative qualitybetween medical device manufacturers,including an increasing media focus on3
medical device quality.2 The medical deviceAlongside this integration comes the benefitsmarket rewards manufacturers who haveof fast quality decision making with proactivehigher perceived quality, such as less recallssolutions for medical device professionals.and higher achievement of benefits. “In theThis paper provides insights into the methodspast decade, an average of one company perand benefits of digitally integrating a qualityyear has seen a 10 percent drop in share pricerisk management program to the qualityafter a single, major quality event (e.g., a majormanagement system.product recall).”3 This increasing transparencyof quality has strongly influenced buyingchoices across the industry by healthcareproviders and by patients4, thus makingmedical device quality not only a regulatoryexpectation, but one that differentiates onemedical device manufacturer from another.While the contents of this paper referenceinternational standards and regulationsthat are specific to medical devices, thebasic principles of quality risk managementbeing integrated throughout the qualitymanagement system are ones that can beemployed by any manufacturer, includingTo systematically reduce harm to patientsmanufacturers of pharmaceuticals,and users, proactively detect signals anddiagnostics, and other medical products.trends, and continuously improve quality andsafety of medical devices through real worldevidence, quality risk management mustsuccessfully integrate risk communicationthroughout the quality management system.www.spartasystems.comQuality risk managementmust successfully integraterisk communicationthroughout the qualitymanagement system.4
Risk Management: Tough and Getting TougherNew regulations are bringing more scrutiny from regulators on the risk management processes formedical devices and combination products. The European Union Medical Device Regulation (EU MDR)and ISO 14971:2019 requirements are bringing the full burden of risk management to medical devices andcombination products.Risk management in the new era is a big undertaking. It spans all lifecycles of product development andmeans tracking practically every system and process in your enterprise, including: Product planning, design, and changes Regulatory submissions and labelling Manufacturing activities Post-market surveillance Clinical evaluation plans and reportsAnd to be effective, all your risk management efforts must be interconnected.Information must be handed off between departments in a way that keeps complexity from leading toconfusion. These teams include personnel from quality, regulatory affairs, clinical affairs, R&D engineers,manufacturing engineers, distribution and supply chain personnel, and many more that all speak aboutsimilar topics in different ways. It’s a lot to ask of cross-functional teams from every part of your organizationto coordinate so much data frequently enough to be useful when they are working in siloes.“Both ISO 14971 and 21 CFR Part 820 take a total life cycle approach tomanagement of risks associated with medical devices and expect thatmanufacturers will incorporate post market data into their device riskmanagement process, including new and changes to existing risks identifiedafter the device is on the market. “ – FDA5www.spartasystems.com5
What You Need From Risk Management Reduce harm to patients using your products Detect signals and identify trends for effectiveroot cause analysis and decision making Resolve process and product deviations andnonconformances quickly Expedite approvals and market authorization Improve quality and safety continuously Comply with standards and regulations Ensure acceptable quality Minimize the resources required for all of theaboveDo These Sound Familiar?The constantly evolving expectations of risk management over the years have resulted in manymanufacturer’s developing a complex, ineffective risk management processes. These changes span overthree decades and include the European Directives (MDD, AIMDD, IVDMDD), ISO 14971-1:1998, ISO 14971:2000,ISO 14971:2007, and EN ISO 14971:2012 with content deviations. Most recently, the EU MDR and ISO 14971:2019have added to the burden of manufacturers staying on top of changing regulatory expectations for medicaldevice risk management.Compliance with the EU MDR and ISO 14971:2019 from planning to production and post-product informationcollection requirements will take a lot of resources and will fail to deliver high quality if your company relieson outdated risk management methods.Old, manual ways of doing risk management are simply not good enough anymore—they will consume toomany resources, slow down decision making, and not deliver the quality improvement and risk reduction thatyou need to compete.HERE ARE SOME OF THE HALLMARKS OF RISK MANAGEMENT THAT JUST ISN’T GOOD ENOUGH TO KEEP UP:Standalonefailure modesand effectsanalysis thatare trackedin manualrecordsystems suchas Word orExcelwww.spartasystems.comRisk scoring indifferent partsof the productlifecycle issubjective orundefined,leading me fromquality, R&D,operations,supply chain,distribution,clinical, andregulatoryaffairs staffRisk reviewis donequarterlyor monthlyinstead ofcontinuoussignal analysisand trenddetectionRisk analysisis linkedmanually tothe qualitymanagementsystem—orit isn’t linkedat allRisk analysis,analysis,evaluation,control,review, andpost-marketdecisionmaking allstart fromscratch foreach newproduct andprocess6
Signs of a weak link between Risk Management andthe Quality Management SystemUsing Different Risk Terminology across the Quality Management SystemThe medical benefits associated with use of amedical device include an inherent degree of risk,and the core of risk management is ensuring thatpatients and users have the freedom from thoserisks that are considered to be unacceptable.To do this, the Risk Management process includesdata and inputs from many various highlyspecialized teams. But effective risk managementis hard to do when different teams use differentterms or different standards for the exact sameproblem. This makes it difficult for teams that aretasked with relating complaints and CAPA withrisk management data as part of understandingsignificance and spotting signals and trends to actquickly when a significant failure occurs or occursunacceptably frequently.www.spartasystems.comIf the terminology that your risk managementteam uses to describe what failures are and howsevere they are is different than the terminologyyour complaint handling team uses, you may thinkyou need to take action when you really don’t. Orworse, you may not take corrective action, or issuea product recall, when you really need to.It’s vital to use consistent severity and occurrencedefinitions to ensure that residual risks in yourrisk management file align with how they aredocumented in your post-market surveillanceprocesses. If you can do that, it becomes veryeasy to determine if an observed risk has alreadybeen evaluated for acceptability in the existing riskmanagement file.7
Not Using Consistent and Precise NumbersWithout quantitative occurrence rates, you cannotevaluate trends to identify if you need to take correctiveaction to reduce risk.All too often, a risk management file will use vaguedescriptors for expected or acceptable failurefrequencies, such as “remote” or “frequent,” without anyquantitative numbers or rates. This leaves the teamsconducting post-market surveillance scrambling todetermine whether the actual (observed) risks areacceptable or not acceptable. Are the frequencies of therisks that they’re seeing the same as those consideredacceptable in the risk file, or not?If risk management doesn’t make decision makingeasy once the product is launched, what’s the point ofit? How do you justify taking a risk-based approach ifyour risk management file doesn’t give you sufficientinformation and decision-making criteria to actuallymanage risk when real world evidence is received?If the prediction in a risk file is a precise failurefrequency of 1 in 100 times at a precisely definedseverity, and post-market surveillance reveals afrequency of 1 in 250 times at that severity, then itis instantly clear that no immediate correction orcorrective action is needed. This doesn’t just lead tofaster action on patient safety, it saves staff time andother resources.COMPLIANCE CORNER: EU Medical Device Regulation(Regulation EU 2017/745) – Annex 1 GSPR 2 Evaluate theimpact of information from the production phase and,in particular, from the post-market surveillance system,on hazards and the frequency of occurrence thereof, onestimates of their associated risks, as well as on the overallrisk, benefit-risk ratio and risk acceptability; and if necessary,amend control measures.www.spartasystems.com8
Siloed or Periodic Trend ReviewsA long-standing practice for many medical devicemanufacturers is to have a recurring review boardmeeting, whether it is captured within ManagementReview, or a product specific meeting, to collect dataand analyze trends of products through complaintrates or nonconformance rates. Quality teams waituntil those board meetings to collect data. If thesereview boards are quarterly, how long is an adversetrend occurring before it is brought to the attention ofsubject matter experts and management? In this gapof data collection and analysis, whether it is a monthor a quarter, time is being wasted to react to thesetrends. Furthermore, the reviews of these trends arelimited in scope due in part to data managementlimitations, analysis limitations, and resourcing ofquality teams, resulting in less data being availableto make critical decisions on quality and safety.If these describe your risk management effortstoday, your efforts are not sufficient—and they maybe hindering your ability to manage risks of yourproducts as effectively as possible.Many companies are capable today of doing riskmanagement just well enough to stay compliantmost of the time, fending off warning letters andadverse audit findings but keeping their headsabove water. but they will be outcompeted bycompanies with effective, digital risk management.Effective risk management process locks downcompliance and adds significant quality decisionmaking value, while consuming far fewerresources.ASK YOURSELF: How can existingdata be used to better understandexisting risk profiles and improvenew products? What is the value ofidentifying an adverse trend early andimplementing risk control? Or worse,what is the impact of failing to identifya safety signal when one truly doesexist? These consequences canrange from business impact ofcostly manufacturing rework, tocompliance and brand impactsfrom a safety related recall.www.spartasystems.com9
Digital Risk Management Is the SolutionWE’RE IN THE ERA OF BIG DATA.At its heart, risk management is a big data problem and the informationrevolution has solved it. The solution is a digital risk management systemthat goes beyond minimal compliance, has automated ties to existingquality management processes, uses consistent qualitative and quantitativedescriptors, provides automatic signal and trend detection, and enablesproactive and predictive risk management.A digital risk management system overcomes all ofthose challenges and enables continuous qualityimprovement that can set you apart from thecompetition.A digital risk management system is a centralized,enterprise-wide collaborative space for cradleto-grave risk management records and activities.A good digital risk management solution will offercloud storage and reliability, and will comply with21 CFR Part 11 and EU GMP Annex 11.With an automated digital risk managementsystem, you can: Lower risk Increase efficiency and reduce costs Improve patient safety Increase quality-led responsiveness in yourmanufacturing, supply chain, and distributionecosystemsThe following pages discuss its key features.DIGITAL RISKMANAGEMENT IS ANENTIRELY DIFFERENT WAYTO MANAGE RISK THANTRADITIONAL PROCESSES.www.spartasystems.com10
Perform Deeper Analysis: The importance ofdata-backed, quantifiable risk managementA digital risk management system doesn’t just get through the usual risk management activitiesfaster and with fewer resources, it enables risk management that is more effective for the safetyof the end user and patient.Identify Signals and Adverse Trends across the Quality Management SystemA digital risk management system achievesrisk management efficiency and enablesbetter decision making by standardizing riskmanagement terminology across the QualityManagement System. Instead of requiringstaff to collect and analyze information from aspreadsheet or separate files, subject matterexperts can utilize their time for deeper analysisin a centralized location. Let’s take a closer look athow this is possible.There are multiple processes within the qualitymanagement system that impact, or are impactedby, risk management activities: complaints,nonconformances, deviations, corrective andpreventive actions (CAPAs), and change controlto name a few. Complaints and nonconformancesare sources of real-world data that can be used toimprove existing risk evaluations, while CAPAs andchange control can be used as pathways to drivepost-market risk reduction, but all these activitieshave a risk management link that triggers timely“The first step is to establish asystem to collect and reviewrelevant production andpostproduction information. Thissystem must include appropriatemethods for the collection andprocessing of data, which caninclude statistical methods fortrend analysis. “ – BSI6decision making.www.spartasystems.com11
For example, medical device manufacturers havehigh volumes of complaint records that eachidentify reported failures and harms. This is thevery same type of information that is assessed inthe risk management files. A risk managementprocess that is digitally integrated with thecomplaints process allows for the sharing of thatrelevant information, including failure modes andharms. Not only can a complaint record be linkedwith the appropriate risk file, pre-determinedcategories of complaint type and severity fromthe risk management file can indicate as towhether the reported complaint has identified anew risk that is not identified in the current riskmanagement file, among other instances thatrequires a review of the risk management file: New hazards or hazardous situations New harms or greater than expected severityof riskFurther, a combination of similar complaints mayindicate an adverse trend, and because a digital riskmanagement solution can allow you to correlatecomplaint to residual risks in the risk managementfile, the comparison between expected frequenciesversus observed frequencies of risks becomesthat much easier to determine if action is requiredor not. An increase in the same type of failuremode for a product may breach the acceptedprobability of a hazardous situation occurring, whilean increase in a single type of harm may breachthe accepted probability of harm as documentedin the risk management file. In either case, theproper personnel are able to take a deeper lookat these adverse trends as soon as possible andtake timely action to reduce risk. Earlier, this paperdiscussed recurring review boards that analyzedtrends. So instead of waiting for a quarterly meeting,adverse trends can be flagged more efficiently forappropriate staff to review. Higher than expected P1, P2, and Occurrence ofHarm values Breaches of statistical techniques that includeautomatic central tendency and control chartsevaluating raw number, or rates, of complaintsand quality events of a specific time periodCOMPLIANCE CORNER: ISO 14971:2019 Section 10.3The manufacturer shall review the informationcollected for possible relevance to safety,especially whether previously unrecognizedhazards or hazardous situations are present or anestimated risk arising from a hazardous situation isno longer acceptable;www.spartasystems.com12
Digital Integration of Top-Down and Bottom-Up Risk AnalysisDigital risk management provides incredible advantages by not only providing risk analysistools such as hazards analysis and failure mode and effects analyses (FMEA), but by linkingthose complex analyses to establish a complete, holistic risk management workflow.FMEAs can include analyses of the manufacturingprocess (pFMEA), design (dFMEA), and use (uFMEA)of a medical device and they systematicallyevaluate consequences of those single fault failuremodes, along with the occurrence and detectabilityof those consequences7. This is often referred to asa “bottom-up” risk analysis as each process step,part, or procedure is evaluated in progressive levelsof the functional system8.FMEAs, however, are founded on the principle thata harm can only occur if there is first a failure inthe process, design, or use of a product. Both ISO14971:2019 and EU MDR have made it clear that therisks associated with a medical device also needto be identified in normal conditions (i.e. no-faultconditions), this is because hazardous situations (andultimately a harm) can occur even where there areno faults.This is where the Hazard Analysis supplementsthe FMEA, and further complies with ISO 14971and EU MDR. The Hazard Analysis identifieshazards and hazardous situations, associatedharms and occurrences, and resulting risk control,verification, and evaluation of risk activities. Theprobability of the hazardous situation occurring(P1), probability of a hazardous situation leadingto a harm (P2), and the probability of occurrenceof harm (P P1*P2), along with the severity ofharm are documented on the Hazard Analysis.Further, the outputs of the FMEA can be linked tothe Hazard Analysis by identifying which failuremodes are causing which hazards and hazardoussituations, thus the Hazardous Situation becomesa “top-down” analysis as it first identifies the riskwww.spartasystems.comon the end user or patient at the highest systemlevel, and then drills down to find the lowersystem level faults that cause those risks.Process FMEAs, for example, have been arisk analysis tool used by manufacturers fordecades. However, many manufacturers are notsystematically including the effects of processfailures into the evaluation of the overall residualrisk. This link between the Hazard Analysisand FMEA is difficult to implement when theseanalyses live in different documents that aremanually maintained by different teams. Further,this link is even more difficult to maintain throughthe constant manufacturing changes thatcompanies implement to drive efficiency.By digitally integrating failure modes from the FMEAto hazards/hazardous situations in the HazardAnalysis, engineers can now trace a top-levelhazard down to the specific failure or failures thatcaused the hazard, allowing for effective root causeidentification and risk control activities that reducerisk to the end user and patient. Furthermore, theselinks can be maintained during the post-marketlifecycle phase of a product.COMPLIANCE CORNER: ISO 14971:2019 Section 5.4The manufacturer shall identify and document knownand foreseeable hazards associated with the medicaldevice based on the intended use, reasonablyforeseeable misuse and the characteristics related tosafety in both normal13
Proactively Manage Risk for New ProductsData-driven risk management during the design and manufacturing developmentprocess allows for safer new or next generation products.A top-of-the-line digital risk managementsystem allows you to efficiently and effectivelygather risk insights.New product development teams can deriveinsights from relevant complaints,nonconformances, and CAPAs. The analysisinto historical performance of manufacturingprocesses and designs and the ultimate insightsfrom that data are hindered by the vast amount ofdata available, coupled with the fast pace of newproduct development projects and short projecttimelines. Leveraging historical risk knowledgebecomes a business value when it leads toshortened time to market by utilizing real worldevidence that focuses risk control activities onwhere it’s necessary.A holistic review of these sources of data, withoutthe need for burdensome data gathering byexperts, allows new product development teamsto efficiently and effectively establish design andmanufacturing process inputs to make for a safernew product based on lessons learned fromprevious products’ post-market surveillance.Furthermore, project teams can save time andresources when building a risk analysis for similarnew products, or product line extensions, withthe ability to leverage portions of an existingrisk analysis into a new risk analysis. The systemidentifies failure modes of process, design, or usefrom the risk registry that are common to the newor enhanced product under consideration.What is the value of identifying systematicmanufacturing nonconformance across multipleproduct lines and international sites? What is thevalue of identifying common use or techniqueerrors across similar product lines? The use ofthese digital technologies allows for insights fromdata across product lines, across manufacturingplants, and across divisions of a business. Theseinsights drive risk reduction activities that includenewer products having:1. Inherently safe design and manufacture2. Protective measures in the design andmanufacture3. Information for safety for usersCOMPLIANCE CORNER: EN ISO 13485:2016 Section 7.3.3.cInputs relating to product requirements shall includeapplicable output(s) of risk management.www.spartasystems.com14
The Use of Artificial IntelligenceWhen the clues to a problem are hidden in massive data sets, there is no substitutefor a powerful system that leverages artificial intelligence to categorize events and findcorrelations.The application of Artificial intelligence, in thecontext of medical device risk management, is notto replace human involvement (i.e. autonomousintelligence). PricewaterhouseCoopers9 modelon the types of artificial intelligence are key here,and the application of Artificial Intelligence formedical device risk management can be classifiedas Assisted and Augmented Intelligence. AssistedIntelligence helps humans perform tasks faster, andAugmented Intelligence helps humans make betterdecisions.With the vast amount of data available throughoutthe QMS that is used in the risk managementprocess, the applications of auto-categorizationand autocorrelation can augment and assistquality teams. Auto-categorization can suggestclassifications of complaints and quality eventsacross the QMS. Autocorrelation can rapidly searchthrough all available current and historical data toinstantaneously identify correlations, trends, andpatters that may have been previously invisible toquality personnel.For example, in a standalone complaints process,incoming complaints are reviewed to determinecomplaint classification, reported severity, anda determination on regulatory reporting (e.g.Medical Device Reporting to the FDA). However,the complaint handling unit would not identifyunacceptable risks, and instead, days or weeksgo by until the complaint is forwarded to a subjectmatter expert who can then review the relevantrisk file and make a determination on acceptability.By applying auto-categorization to a complaintrecord, the identification of a high or unacceptablewww.spartasystems.comrisk as compared to the risk management filecan be done prior to a complaint record beingreviewed, thus allowing for prioritization of thesespecific complaint records.On the same example of complaints, byautomatically correlating similar complaint recordstogether, an AI-enabled risk management solutioncan make a disposition on whether the frequenciesare an expected or adverse trend as compared tothe risk management file accepted frequencies.Both auto-categorization and auto-correlationsupport human decision-making on productquality and patient safety by getting throughminor, less severe issues faster and uncoveringurgent, more sever issues sooner.This is crucial because the volume of complaintsand other quality records is constantly growing.In fact, 66% of quality leaders indicated “sufficientstaffing/resourcing” is a top quality systemchallenge10. You can achieve a much higherlevel of quality and patient safety when you canact without delay. And it saves engineers fromperforming individual root cause analyses andinvestigations for every failure, saving considerableresources.66%of quality leaders indicated“sufficient staffing/resourcing” isa top quality system challenge15
Choose the Best Digital Risk Management SystemThe best risk management systems increase patient safety, enable higher quality, and require fewerresources. And by flagging issues faster and more reliably, they reduce harm.Sparta Systems’ TrackWise Digital Risk Management is such a system. As a comprehensive riskmanagement solution that effectively integrates with the TrackWise Digital Quality Suite, it is best in class andgoes beyond achieving compliance.It enables a systematic approach for risk analysis, evaluation, control, review, and post-market decisionmaking that is fundamental in managing the risks of pharmaceutical products, combination products, andmedical devices. It also features a robust data model that digitally integrates the top-down and bottom-uprisk assessment methodologies, as well as provides an overall residual risk visualization on a risk matrix thatis kept up to date with information received throughout the QMS and TrackWise Digital . And it makes thedevelopment, implementation, and maintenance of a risk management program in accordance with ICH Q9,ISO 14971, and EU MDR that is less time and resource intensive.REGULATORY COMPLIANCE IS THEFOUNDATION OF RISK MANAGEMENT, BUTNOT ITS HIGHEST LEVEL OF ACHIEVEMENT.www.spartasystems.com16
Footnoteshttps://www.mckinsey.com/ /media/McKinsey/dotcom/client e business case for medical device loadhttps://www.mckinsey.com/ /media/McKinsey/dotcom/client e business case for medical device Food-and-Drug-67IEC 60812:2018 https://webstore.iec.ch/publication/263598ISO 24971:2020, in-2020-5-key-trendsREV1:210723the solutions, analytics, and expertise that speed up quality and compliance. Companies in life sciences, consumer products,Sparta Systems, a Honeywell Company, is the world’s premier provider of cloud and on-premises quality managementdiscrete manufacturing and more, rely on Sparta. Learn why at www.spartasystems.comsoftware. For nearly three decades, companies in the life sciences have relied on Sparta for the innovative tools, analyticsand expertise that speed up quality and compliance.1.888.261.5948 1.609.807.5100 sales@spartasystems.com www.spartasystems.comSparta Systems 2000 Water View Drive Suite 300 Hamilton, NJ 08691 USA www.spartasystems.com
medical devices and combination products. The European Union Medical Device Regulation (EU MDR) and ISO 14971:2019 requirements are bringing the full burden of risk management to medical devices and combination products. Risk management in the new era is a big undertaking. It spans all lifecycles of product development and
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Page 1 of 9 Rapid Regulatory Courses in HealthStream Getting Started Tip Sheet Please note: Everyone is required to take two compliance trainings titled: Rapid Regulatory Compliance: Non-clinical I Rapid Regulatory Compliance: Non-clinical II Depending on your position at CHA, you may have more courses on your list. One must complete them all.File Size: 1MBPage Count: 9Explore furtherRapid Regulatory Compliance: Clinical II - KnowledgeQ .quizlet.comRapid Regulatory Compliance: Clinical I - An HCCS .quizlet.comRapid Regulatory Compliance: Non-clinical II-KnowledgeQ .quizlet.comThe Provider Compliance Tip fact sheets are now available .www.cms.govRapid Regulatory Compliance - Non-Clinical - Part Istudyres.comRecommended to you b
