Risk Management Training
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Risk management involves determining the probability and impact of process failures and mitigating risks likely to occur with severe impacts. An acceptable risk is determined by evaluating options and consequences to select the most acceptable one. Risk severity is the probability of an event multiplied by its potential negative impact. Ways to deal with risk include proactive risk management to reduce probabilities and impacts, and reactive crisis management with constrained options. The CAPA system connects to risk management by using risk assessments to prioritize CAPAs and elevate issues. An annual product review examines manufacturing, quality, and post-market records over the previous year to support management decisions.
Risk Management Training
- 1. Risk ManagementQuality Improvement Consulting, LLC
- 2. What Is Risk Risk may be defined as the possibility of suffering damage or loss.
- 3. PossibilityThe possibility is characterized by three factors:probability, or likelihood, that loss or damage will occur. The expected time of occurrence.The magnitude of the negative impact that can result from its occurrence.
- 4. What Is Risk Management ?A Determination of the probability of occurrence of a process failure & the negative effect or impact if it does.Putting in place preventive actions to mitigate those risks that are determined to be most likely to happen and will have a server impact to the process.
- 5. What Is Acceptable RiskA decision process that:Specifies the objectives to measure the desirability or lack thereof
- 6. Defines possible options, including no action
- 7. Identifies the consequences of each option and likelihood of occurrence
- 8. Specifying the desirability of consequences
- 9. Analyzing the options and selecting the “most acceptable” optionThe Seriousness of a RiskThis can be determined by multiplying the probability of the event actually occurring by the potential negative impact to cost, schedule, or performance: Risk Severity = Probability of Occurrence x Potential Negative Impact
- 10. Potential Risk Scenarios Scenario 1. Probability of occurrence is high and the potential impact is very low.Scenario 2. Probability of occurrence is low and the potential impact is very high.Scenario 3. Probability of occurrence is low and the potential impact is very low.Scenario 4. Probability of occurrence is high and the potential impact is very high.
- 11. Ways to Deal With RiskProactive approach: Risk ManagementAnalyzes future project events and past projectsIdentify potential risksTaking measures to reduce their probability and or impactReactive approach: Crisis ManagementResource-intensiveAvailable options constrained or restricted by events.
- 12. Systems of FeedbackDesign feedbackManagement ReviewRisk ManagementCustomer ComplaintsCAPA EscalationAcceptable Risk
- 14. Why Risk as Part of CAPA System?What is the impact of risk to the CAPA system?What hurdles will you encounter?
- 15. CAPA : Connecting RiskManagement and TrendingCritical questions that drive into the CAPA process and determine the depth of investigation/priority of CAPA:Is this a new or unknown problem?Has the severity increased? Decreased?Has the frequency of occurrence increased?Have the causes of the problem been confirmed?Are there new causes of the problem that have inadequate or no mitigation?
- 16. Key DefinitionsNonconformance (NC)• Any noncompliance with the requirements of the Quality System (product and non-product).Correction• Repair, rework, or adjustment related to the disposition of an existingnonconformity. Corrections are typically one-time fixes.Corrective Action (CA)• Action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence.Preventive Action (PA)• Action taken to eliminate the cause of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence and improve quality trends.
- 17. CAPA ProcessProblem Identification (Risk Assessment)Failure Investigation(Root Cause Analysis)CAPA PlanApproval andDisseminationImplementation(Change Control)Follow-up for Effectiveness Not EffectiveEffectiveClosure
- 18. Inputs and Triggers -InternalAcceptance activitiesCalibration and Maintenance recordsDesign Control systemManagement Reviews/Annual Product ReviewsNonconformance's (product and non-product)Packaging and Labeling materialsQuality AuditsReturned productsRisk Management documentsService and Installation recordsSix Sigma/Process Excellence programsSPC monitoringAnd more…
- 19. Inputs and Triggers-ExternalCustomer complaintsCustomer feedbackExternal Quality Audit reportsISO/AS 9100/ feedbackProduct warrantyRecalls/field actionsIdentification of any other condition/issue that does not comply with:Your own Quality System and/orISO/AS standards (e.g., ISO 9001, AS 9100 etc.)And more…
- 20. Inputs and Triggers- IssuesInputs not clearly defined or establishedTrigger thresholds not establishedFocus on reactive metrics (Nonconformances, Complaints, Audit Observations)Data not easily retrievableData not easy to analyze for trends
- 21. Root Cause Analysis-IssuesPoor/lack of technical skills to conduct root cause analysisPoor/lack of writing skills in documenting root cause analysisPoor/little business knowledge in conducting root cause analysis across processes, systems, product lines, and Quality Systems
- 22. Preventive Actions- IssuesWhen everything is corrective, how can the organization assign resources to address Preventive Action?Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action).CAPA metrics tend to focus on closure rates, cycle time, number of open CAPAs, etc. Preventive Actions are, in most cases, longer-term solutions across processes, systems, product lines, and Quality Systems and will take more time to close.
- 23. From Corrective to PreventiveClearly define inputs and establish thresholdsImplement predictive metrics/indicatorsRoutinely review and act on sources of product and quality dataMake data reporting available and easy to users and management
- 24. From Corrective to PreventiveRisk ManagementEstablish elevation mechanisms to CAPAUse a risk assessment process to allow prioritization of CAPAs and elevation to ManagementUse a risk assessment process that allows CAPAs for Preventive ActionLink CAPA to Risk Management documentation (e.g., Design Control documents)Make data reporting available and easy to users and management
- 25. From Corrective to PreventiveRoot Cause AnalysisEstablish clear roles and responsibilities for conducting investigationIncrease technical skills on root cause analysis toolsImprove writing skillsUse team approach to conduct investigation to increase business and technical knowledge
- 26. From Corrective to PreventivePreventive ActionImplement predictive metrics/indicatorsRoutinely review and act on sources of product and quality dataUse a risk assessment process that allows CAPAs for Preventive ActionImprove linkage between CAPA into Design ControlsTake a holistic view of issuesCan it link to other Quality Systems, product lines, systems, and/or processes?
- 27. From Corrective to PreventiveManagement Support and OversightEnsure Management oversight and commitmentAlign CAPA with company, departmental, and individual goals and objectivesCreate rewards and recognition programsEstablish joint partnership between business/system owner and Information Technology for continuous improvement effortsAlign metrics from departmental to corporate level
- 28. Annual Product Review - RequirementsWritten records subject to this review include, but are not limited to, the following: Manufacturing and quality records from lots or batches of products manufactured within the previous year, including:– receiving inspection– in-process– final release testing results– deviations– investigations– change control records– quality system trends
- 29. Annual Product Review - RequirementsPost market quality records such as:– Customer complaints– Adverse events– Field actions– Product corrections– Regulatory submissions– Returned or salvaged products
- 30. Conclusions - Annual Product ReviewCovers the product cradle to grave. Presents management a view of product and process behavior over time.Is influenced by all aspects of the Quality System - including in process and release testing.Supports decisions related to design control, process validation and control as well as user drift.Identifies trends/opportunities across mfg lines or sites.