Compliance Solutions (Life Sciences) Ltd, E-Mail: Elindsay .

Edwin LindsayPrincipal ConsultantCompliance Solutions (Life Sciences) Ltd,Tel: 44 (0) 7917134922E-Mail: elindsay@blueyonder.co.ukCompliance Solutions (Life Sciences) Ltd

There were no guidelines/ regulationsThere was no trainingNo ProceduresNo InspectorsCompliance Solutions (Life Sciences) Ltd

Inform All staff of the outcomeCompliance Solutions (Life Sciences) Ltd

Most Common Deadly Sins of Non-ComplianceInadequate Change ControlInadequate ValidationInadequate follow-upRepeat violationsInadequate TrainingInadequate/Deficient controlsCompliance Solutions (Life Sciences) Ltd

Most Common Deadly Sins of Non-ComplianceInadequate Failure Investigations (NonConformances and CAPA)Failure to Follow ProceduresInadequate Internal AuditsInadequately staffed Quality departmentsCompliance Solutions (Life Sciences) Ltd

Quality Lessons for AllDeficiencies occur / mistakes happenKey is to have systems in place that:Investigates root causesAssures complete and systematic correctionDocuments and validates changesCompliance Solutions (Life Sciences) Ltd

What does all this mean to me?Document allactionsUse equipmentcorrectlyFollowinstructionscarefullyTake time todo it rightfirst timePERSONNELDon t takeShort-cutsYou, Me, EveryoneTake trainingseriouslyCompliance Solutions (Life Sciences) LtdAdmit errors &mistakes

What Is a Gap Analysis?A way to compare current conditions and practicesin order to identify gaps and areas in need ofimprovement with regards to compliance to therelevant standardsFormal means to identify and correct gaps betweendesired levels and actual levels of performanceUsed by organizations to analyze certainprocesses of any division of their companyCompliance Solutions (Life Sciences) Ltd

Developing An Improvement PlanCURRENTSITUATIONGAPIMPROVEMENTPLANBEST PRACTICESWhat s possibleCurrent Systemand PracticesWhat simportantWhat theweaknessesare1. Assess currentsituationCompliance Solutions (Life Sciences) Ltd3. Develop aplan to closegapBusinessStrategy(StrategicLevers)2. Determinepriorities based onstrategy & BestPractices

Gap analysisMethodologyWhat type of information?Who will collect information?Where from?How will the information be collated?Where will it be stored?Who will evaluate and analysed?How will information be disseminated?Who will disseminate?Compliance Solutions (Life Sciences) Ltd

Gap Analysis ToolPhase 1: Identify GapsPhase 2: Fill GapsCompliance Solutions (Life Sciences) Ltd

Gap Analysis ToolIdentify Gaps:Make a list of requirements, this is usually in the form ofquestions.Review of all current practices, written or otherwiseReview nceCompliance Solutions (Life Sciences) Ltd

Gap Analysis ToolIdentify Gaps:Three answers are possible for each question:Yes organization has met one of requirementsNo points to a gapN/A question is not applicable to situationCompliance Solutions (Life Sciences) Ltd

Gap Analysis ToolIdentify Gaps:Each time NO is answered, there is a column to help organization identifywhich processes need to be fixed-Quality Management ProcessInternal Communications ProcessDocument Control ProcessRecord Keeping ProcessTraining ProcessInternal Audit ProcessManagement Review ProcessMeasuring and Monitoring ProcessNonconformance Management ProcessContinual Improvement ProcessCompliance Solutions (Life Sciences) Ltd

Gap Analysis ToolFill Gaps:The Gap Analysis questions are turned into action statementsThese action statements formulate remedial actions which will fill in the gapsDevelop plans to address the gapsThese remedial actions are used to fill the gaps that are foundAll remedial actions must be assigned a Remedial Action NumberJob responsibilities are then given out to make sure that the remedial actionsare carried outCompliance Solutions (Life Sciences) Ltd

Developing The Action PlanGAP - INTENDED VS. IMPLIED STRATEGY1. Identify performance gaps relative654to categories321-3-2-1012GAP2. Identify strategy gaps andassociated practicesPlanTask 13. Examine individual practices withlow performance & highimportance in large gapcategories & strategiesTask 2Task 3Task 4Assessment CategoryBusiness & Product StrategyProduct & Pipeline ManagementTechnology ManagementManagement LeadershipEarly InvolvementProduct Development TeamsOrganizational EnvironmentProcess ManagementProcess ImprovementUnderstanding the CustomerRequirements & Specifications Mgt.Development Process IntegrationSupplier/Subcontractor IntegrationProduct LaunchConfiguration ManagementDesign AssuranceProject & Resource ManagementDesign for ManufacturabilityProduct Cost ManagementRobust DesignIntegrated Test Design & ProgramDesign for Operation & SupportProduct DataDesign AutomationSimulation and AnalysisComputer-Aided ManufacturingCollaborative Tools & TechnologyKnowledge 4.25.76.14.73.55.23.84.62.94.2Weighted Total4.5BEST PRACTICES GAP4. Look for logical relationships &precedence among practices5. Develop the action plan & gainconsensus to the plan024681012Bigger gap indicates greater improvement opportunityCompliance Solutions (Life Sciences) Ltd

How to effectively approach the project?Steering committee and task forceDiagnosis of an existing systemExecution planTrainingPlanning, DocumentingImplementationAudits and reviewPossible changesCompliance Solutions (Life Sciences) Ltd

PlanningPrioritize development projectsDon t overload resourcesRapidly staff the project according to planCapture and document requirements and specifications completelyTightly manage requirementsPlan concurrent developmentLearn to work with partial informationPlan and coordinate requirementsResolve problems quicklyCreate a comprehensive, realistic project planCompliance Solutions (Life Sciences) Ltd

PlanningObtain personnel's commitment to the project planCommunicate project plans and responsibilitiesIdentify project staffing requirementsPlan development resource requirementsAllocate and manage resourcesStandardize where possibleAll review the plan on a regular basisCompliance Solutions (Life Sciences) Ltd

Summary of Gap AnalysisGaps can be found in any process of anorganization s operationsGap Analysis is one of the best procedures to helplead an organization to not only improve theirprocesses, but recognize which processes are inneed of improvement.Compliance Solutions (Life Sciences) Ltd

The danger or probability ofloss/error.Compliance Solutions (Life Sciences) Ltd

What is Risk Management?The culture, processes and structures that aredirected towards the realization of potentialopportunities and the effective management ofadverse effectsComplianceSlide22 Solutions (Life Sciences) Ltd

What is risk?Many Definitions:It is widely accepted that the concept of risk has two components& Consequences:ChanceHow likely is the scenario to happen?If it does happen, what are the consequences?Key Considerations:The probability of occurrence of harm, (chance, possibility, uncertainty,etc.)The consequences or severity of that harm, (injury, cost, supply issues,etc.)Compliance Solutions (Life Sciences) Ltd

Risk Assessment.How do we reduce the chance of errors occurring?Examination of process and develop safety barriers tominimise chance of error.Understand why risk needs to be managed and what therisk is.Understand where risk comes from and how peopleprocess informationCompliance Solutions (Life Sciences) Ltd

Risk Management ProcessCompliance Solutions (Life Sciences) Ltd

Recognition in Riskstart by identifying what may happenEvent

Risk Prioritisationidentify causes and consequencesRisk AnalysisCauses andConsequencesContributory FactorsEventstart putting barriers in place Risk Measures (Barriers)Safety Related Systems: IT ,Safety Systems: Other TechnologiesExternal Risk Reduction Measures

Risk ManagementRisk AnalysisCauses andConsequencesContributory FactorsEventas you go on, add more barriers Risk Measures (Barriers)Safety Related Systems: IT ,Safety Systems: Other TechnologiesExternal Risk Reduction Measures

Risk Management ActivitiesRisk AnalysisCauses andConsequencesContributory FactorsEventRisk ManagementActivitiesProcesses, proceduresto maintain and verifythat risk measures are inplace and effective Risk Measures (Barriers)Safety Related Systems: IT ,Safety Systems: Other TechnologiesExternal Risk Reduction Measuresconstantly ensure barriers are maintained

Risk Management ActivitiesRisk AnalysisCauses andConsequencesContributory FactorsEventRisk ManagementActivitiesProcesses, proceduresto maintain and verifythat risk measures are inplace and effective Risk Measures (Barriers)Safety Related Systems: IT ,Safety Systems: Other TechnologiesExternal Risk Reduction Measures

A Risk DefinitionRisk is the combination of the probability of occurrence ofharm and the severity of that harmRisk Probability x SeverityRisk (P x S)Risk can be Quantified or QualifiedRisk (4 x 3) 12Risk (Moderate x Major) UnacceptableCompliance Solutions (Life Sciences) Ltd

What about Detection?Are Detection Controls not taken into account?Is Risk Not (Probability x Severity x Detection)?Risk Priority Number (P x S x D) often used, especially in FMEA,FMECAAdvantage simple concept, easy to use and understandCommentThere is much confusion about where to consider detection controlsduring Risk Assessment .Compliance Solutions (Life Sciences) Ltd

Probability of Occurrence LevelsProbabilityThis Means The Failure ModeFrequentis Very Likely to Occur, 20%Probablewill Probably Occur, 5Occasionalshould Occur at Some Time, Infrequently, 0.1RemoteUnlikely to Occur in Most Circumstances 0.1%20%5%Note: These levels are arbitrary and for illustrative purposes onlyCompliance Solutions (Life Sciences) Ltd

Severity LevelsSeverityThis Means the Failure Mode May Result in .CriticalVery Significant Non-Compliance with GMP orPatient InjuryMajorSignificant Non-Compliance with GMP orPatient ImpactMinorMinor Infringement of GMPNo expected Patient ImpactNote: These levels are arbitrary and for illustrative purposes onlyCompliance Solutions (Life Sciences) Ltd

Risk TableFailure ModeMinorSeverityAcceptance bleOccasionalRemoteNote: These criteria are arbitrary and for illustrative purposes onlyCompliance Solutions (Life Sciences) Ltd

Risk TableAcceptance CriteriaFailure ModeMinorSeverityFrequentUnacceptable IntolerableIntolerableProbableUnacceptable tableCompliance Solutions (Life Sciences) LtdMajorSeverityCriticalSeverity

Acceptance Criteria NotesRed MeansThe Risk is Intolerable. Eliminate the Hazard or build insystems/controls to ensure the effects of the hazard arenot realised (e.g. redundant systems)Amber MeansThe Risk is Unacceptable. The Risk must be Reducedor Controlled to an acceptable levelGreen MeansThe Risk is Acceptable. No Reduction or New Controlsare RequiredCompliance Solutions (Life Sciences) Ltd

Detection LevelsDetectionThis Means.HighHigh Likelihood that Controls will Detect the FailureMode or its EffectsMediumMedium Likelihood that Controls will Detect theFailure Mode or its EffectsLowLow Likelihood that Controls will Detect the FailureMode or its EffectsNoneDetection Controls are AbsentNote: These levels are arbitrary and for illustrative purposes onlyCompliance Solutions (Life Sciences) Ltd

What is FMECA?Failure Mode, Effects & Criticality AnalysisA Risk Assessment tool based around Failure Modes(A Failure Mode is a way in which a process can fail toprovide the anticipated result)FMECAIdentifies potential Failure Modes in a system, facility,process or productPrioritises the Failure Modes in accordance with their riskPuts controls in place to address the most serious concerns

Human FactorsHowever, around 80% of accidents areattributable to human factorsWhat are the contributing factors in theimages in the next two slides?

What Caused the ProblemIs it the donkey s fault?Is there something wrong with the designof the cart?

What Caused the ProblemIs this a problem caused by thedesign of the plane?Why did this happen when this issomething these people do manytimes everyday?