Product Improvement: Inventing or introducing new product, features to reduce risk, or user friendly.Process Improvement: reduce the common causesProcess Maintenance: Reduce or eliminate special causes
Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects (errors) and minimizing variability in manufacturing and business processes. It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization ("Black Belts", "Green Belts", etc.) who are experts in these methods. Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified financial targets (cost reduction and/or profit increase).
Three areas generates nonconformance that require continuous improvements:Suppliers Quality: Returns, and Investigations Manufacturing Process: Nonconformance Reports, Deviations, Change control Customer Complaints
Common Cause: Random occurrence with limited frequency due to process variations.
Product is: a prefilled sterile Syringe with a drug Syringe component: Glass Cartridge with a rubber plunger on one end and a glass neck on the other end. Aluminum Cap consist of Aluminum Shell with a roll grove Rubber liner (proprietary rubber) Needle with a plastic cap
The CPM Suite consist of: CPM Unit: sterile environment room where is the Cartridge Processing Machine is run by two operators . The Cartridge Processing Machine is comprised of four sub-assemblies: a feeding section, a filling section, a sealing section and a needle assembly section. Before coming into the filling room, the cartridges are washed and plungered. After the plungered glass cartridge is received in the filling area it is fed onto the conveyor. filling station. The cartridges are filled ten at a time. As the cartridges move along the conveyor belt, aluminum caps (seals) are picked up. In the sealing station, the aluminum cap is crimped into the cartridge’s neck. The aluminum cap is seated on the cartridge neck, and spun on. The glass makes a number of revolutions as the spinning wheel slides under the neck of the cartridge and the aluminum cap will be crimped to the cartridge. During the crimping process, pressure is applied from the top on the cap and from the bottom on the cartridge. Needle assembly section were needles are locked on top of the aluminum cap. The cap grove is where the needle get locked. Inspection Room: The units then move to the accumulation area for light testing, labeling and packaging. All the carpuject are inspected in the light test station; where three CPM operators are arranged in serial inspection station and each carpuject will pass through each station. At this point any defective cartridge is removed during the inspection process. If defected units were detected during the MQ audit, 10 trays since the last successful audit will be 300% re-inspectedIf the suspected segment will be audited the second time by MQ. The AQL for the second audit is 0 Accept, and 1 Reject (0/1). by the CPM Operators. All units that were defective or suspected to be defective were removed. with the suspected segment will be separated and 300% re-inspected
For a particular product problem, Root Cause is the factor that, when it is fixed the problem goes away and doesn’t come back
We travel in a journey from the present to the past, to collect the action and condition that explains the observation of the Primary Effect . Accept only the facts that are only supported by evidences.
Corrective action 1: Evaluate the feasibility for using an automatic visual system to identify and remove the non-conformed units. Corrective Action 2: The MQ sample plan should be evaluated for the MQ audit frequency. The audit frequency should increase to reduce the segment size. Reducing the segment size will reduce the risk of rejecting good units. Corrective Action 3: The Cap supplier needs to identify the seal failure root cause and to ensure that the supplier corrective actions are effective. The supplier needs to evaluate if the 8-I Cap design needs reviewing to eliminate the root cause of this failure. Corrective Action 4: Cap specifications accept variation that is up to 35% for some of the cap critical attributes such as grove height and liner thickness. All the received caps are passing the receiving inspection but fail in the manufacturing process. McPherson facility should review the component specifications which are critical to manufacturing. Corrective Action 5: vendor qualification should be evaluated for its effectiveness for vendor selection and approvals, and how to manage the vendors’ material that is critical and not meeting manufacturing process. Corrective Action 6: An appropriate CAD (Communication Awareness Discussion) should be conducted with Incoming Quality personnel to be instructed on the caps inspection critical criteria, and to pay attention to inspect for “Improper seating of liner”, and other critical criteria before releasing the shipment to manufacturing. Preventive Action: Preventive Action 1: component specifications need to be tightening to match the current manufacturing process capability. Preventive Action 2: The form Packaging Material Inspection / Test Record should be revised to include the Higher and Lower specifications for each of the component measurement. The Incoming Quality inspection should record the individual samples measurements to justify the acceptance of the received shipment.
We can’t fix a problem outside of our influence such as a problem was caused by an earthquake, volcano eruption, Worker’s stick in Europe, or Transportation strike.
It is crucial to use the improvement tools in the correct way to achieve your objectives fast and effective. Preventive Action: (Problem Solving, Quality Continuous Improvements) Action to eliminate the cause of a potential nonconformity or other undesirable situationFMEA : Failure Mode and Effects AnalysisCorrective Action: (Problem Solving, Nonconformance Root Causes: Action to eliminate the cause of a detected nonconformity or other undesirable situation
Which approach we select depends on the organization culture and the investigator qualifications. The failing of any of the quality improvement initiative can be contributed to two major types of failure:Investigator failureFailing to identify the root causesFailing to select an effective corrective actionOrganizational failureFailing to recognize the or accept the corrective action Failing to eliminate or mitigate cause conditionsIn this case study you will see both types of failures
Main PointsSeptember 12Tarek Elneil3 What is a Process Process Components &Characteristics Process Variations and Causes Process Improvement Methodologies
Fruit Pizza Recipe Pizza Dough: 1 package store bought sugar cookie dough Toppings: 8 ounces softened cream cheese 1 cup confectioners sugar 1 large peach, sliced 1 large green apple, sliced 1 large orange, sectioned 1/2 pint fresh strawberries, sliced 6 ounces fresh blueberries 6 ounces fresh raspberries 1/2 cup white chocolate chips, melted 1/2 cup chocolate syrup Preheat oven to 350 degrees F. Flatten cookie dough onto a 6-inchpizza pan. Bake until firm totouch, about 11 to 15 minutes. Cool. In a medium bowl, blend creamcheese and sugar. Spread the baked cookie with thecream cheese mixture and decoratewith sliced fruit. In a small bowl, combine meltedwhite chocolate with chocolate syrup.Top the pizza with remaining berriesand chocolate mixture. Slice andserve immediately.5/20/20134http://www.foodnetwork.com/recipes/paula-deen/fruit-pizza-recipe/index.htmlIngredients Directions
Process Structure Pizza Dough: 1 package store bought sugar cookie dough Toppings: 8 ounces softened cream cheese 1 cup confectioners sugar 1 large peach, sliced 1 large green apple, sliced 1 large orange, sectioned 1/2 pint fresh strawberries, sliced 6 ounces fresh blueberries 6 ounces fresh raspberries 1/2 cup white chocolate chips, melted 1/2 cup chocolate syrup Preheat oven to 350 degrees F. Flatten cookie dough onto a 6-inchpizza pan. Bake until firm totouch, about 11 to 15 minutes. Cool. In a medium bowl, blend creamcheese and sugar. Spread the baked cookie with thecream cheese mixture and decoratewith sliced fruit. In a small bowl, combine meltedwhite chocolate with chocolate syrup.Top the pizza with remaining berriesand chocolate mixture. Slice andserve immediately.5/20/20135http://www.foodnetwork.com/recipes/paula-deen/fruit-pizza-recipe/index.htmlInput : Bill Of Material (BOM) Output : Master Batch RecordMachineMeasurementEnvironmentMaterialChefMethod
Process VariationMay 2011Tarek Elneil6MeasurementMachineEnvironmental(Mother Nature)MaterialMethod
Types of Process VariationTarek Elneil7 Variations in process input cause the variations inthe process output (Products) There are three basic kinds of variation: Common cause variation: is variation inherent to theprocess. It is due to the interface of the differentcomponents of the process input Structural variation: is variation due to differencesamong parallel parts of the process Special (Assignable) cause variation: is variation due tosources outside the process, due to changes in theprocess input
Common Variation Not all parts arecreated equal Any population undercontrol follows theNormal Curvecharacteristics: Probability of thepopulation variationfrom the Mean 68 % within + 1 within + 2 within + 320128Tarek Elneil123
Process Improvements Reduce the processcommon causevariation throughoutincrementalimprovements steps toidentify, and eliminatethe causes of defects(errors) and minimizingprocess variabilitySeptember 20129Tarek Elneil
Major Steps of Quality InvestigationTarek Elneil12 Define the problem Evaluate the failure Failure risk assessment Investigate failure causes Select and implement effective solutions Ensure the solution effectiveness
Problem Definition’s ElementsDefine the process input (X) and desired output (Y)qualitatively and quantitatively What: Primary Effect What object (or group of objects) has the failure? What failure type does it have? What do we see, hear, feel, taste, or smell that tells us thereis a failure? When: Relative Time of the Primary Effect Where: Relative Location in System, Facility, or Component Significance: Why you are working on this problem?
Problem EvaluationIt help to answer 3 questions1. Should we continue with the investigation?2. How much time should we spend on theinvestigation?3. How much resources (people and money) should weutilize to investigate and solve the problem? Example of significance statement: Potential loss of $1500 worth of Raw Materials Twice this month 2 weeks delay in customer order
Nonconformance EvaluationSafety FreqCostRevenue Env.StartYesNo No No StopNoNoYes Yes Yes YesAssemble TeamInvestigateRoot Cause(s)Implement CA’s Control PhaseNoResult Acceptable?ShareYesNo
Risk AssessmentSeptember 2012Tarek Elneil16Risk assessment attempts to answer the followingfundamental questions: what can happen and why (by risk identification)? what are the consequences? what is the probability of their future occurrence? are there any factors that mitigate the consequenceof the risk or that reduce the probability of the risk?
Nonconformance InvestigationSeptember 2012Tarek Elneil18 Nonconformance should be investigated when Identified Cause have exceeded the expectedfrequency limits Special (Assignable )Cause has unexpectedly occurredWhich have significant impact on theproduct, safety, cost or any established criteria
Nonconformance InvestigationSeptember 2012Tarek Elneil19 Kepner Trego: investigate the changes thatprobably caused the failure. Root Cause Analysis: investigate the actions andcondition that caused the failure
Kepner Trego Methodology Problem analysis: Corrective Action Things were OK; they’re not now. What’s changed? Something distinguishes what is a problem and what is not. Who was involved? Who was not? Why was it important? Why is it unimportant?September 201220Tarek Elneil
Problem Analysis - WhenIs Is Not When was the deviationobserved first (clock andcalendar time)? How many objects have thedeviation? What is the size of a singledeviation? How many deviations areon each object? When else could thedeviation have beenobserved first, but was not? How many objects could havethe deviation, but don’t? What other size could adeviation be, but isn’t? How many deviations couldthere be on each object, butare not?
Problem AnalysisEvaluate Possible Causes Examine possible causes against the IS and IS NOTspecification explain both the IS and IS NOT information? What assumptions have to be made? Determine the most probable cause Which possible cause best explains the IS and IS NOTinformation? Which possible cause has the fewest, simplest, and mostreasonable assumptions?
Real Case Study On 10/6 the MQ (Manufacturing Quality) light testaudit rejected a segment of 12,422 units for a badseal during the second light test audit in the CPM line. What: Light Test Audit When: 10/6 Where: CPM line Significance: 12,422 units were rejectedMay 201123Tarek Elneil
The Product ComponentsCartridgeLiner /SeptumAluminum shellNeedleRoll GrovePlungerDrugAluminum Cap24Tarek Elneil
Kepner Trego Investigation Is It was in CPM (CartridgeProcessing Machine) Line Product A4D Failed Light Test Leaking Cap A1st and A2nd Shift Is Not Line 1,2 or 3 Product B1C Sterility Labeling B1 and B2 ShiftSeptember 1226Tarek Elneil
Tarek Elneil27VIS-SealDeficiencies, Product CodeAB84T, LotNo.Ax1234ENVIRONMENTMEASURESMETHODS MATERIALSMACHINE PEOPLEN/ACarpujects in disarray at accumulationareaPoor lighting for inspectiontestsDistractive environment forpersonnelN/A Batch records consistentConsecutive inspections by samepersonnelMQ Audit AQL correctQES not set correctly for alertlimitsSOPs clear?Capper parts wornoutBad plungersBad seal capsBad glass vialsCapper not spinning at correctrpmLack of procedural understandingHuman errorPersonnel errorTraining currentLack of Quality oversightPlungers not set correctlyCapper pivots armsdefectiveWorn capper partsCap seal set up notcorrectSeal crimper not setcorrectlyN/AN/AN/AN/AN/A
Problem AnalysisEvaluate Possible Causes Test possible causes against the facts, use Contradiction Matrix tosort out the facts and the causes The facts from the IS and IS NOT The causes from the Fishbone diagram Determine the most probable cause Which possible cause best explains the IS and IS NOTinformation? Which possible cause has the fewest, simplest, and mostreasonable assumptions?
Contradiction MatrixWhy To determine relationships between factsobtained in the Define Phase and the likelycauses of a problem obtained during theMeasure Phase of a problem solving effort. Allows us to focus on the most likely causes ofthe problem. Effective tool for sorting the few likely causesfrom many possible causes.What A matrix that compares the likelycauses, obtained during a brainstormingsession, in the left column with the facts of aproblem in the upper row.How Complete the IS/IS NOT and Distinction &Changes Matrices along with a timeline ofprocess changes. Prepare a Cause & Effect diagram during theMeasure Phase of the problem solving process. Conduct a Change Point Analysis (CPA) ofexisting process output data, and note anysignificant changes. Construct the Contradiction Matrix and fill in allcells where know information exists. Leave cellsblank where unknown information exists. Placean “A” in cells where assumptions for acontradiction can be made. Strike any rows where an obvious contradictionexists.X - FACT contradicts CAUSE A - Assumptions made; need data to verifyO - FACT supports CAUSE BLANK- Need more dataX - FACT contradicts CAUSE A - Assumptions made; need data to verifyO - FACT supports CAUSE BLANK- Need more dataFACTSCAUSES#1 #2 #3 #4 #5A X X XB O O O OC X XD O A
What is Root Cause Analysis (RCA)?September 2012Tarek Elneil30 Root Cause is the fundamental breakdown or failureof a process which, when resolved, prevents arecurrence of the nonconformance Root Cause Analysis is a systematic approach toinvestigate, identify and eliminate the true rootcauses of the process failure
Uses facts to narrow the search toidentify and eliminate the root causePresentRCA MethodologyMay 2011Tarek Elneil31Evidence!Evidence!CAUSESCAUSESCAUSESPastWhy?Why?Why?
How to Use RCASeptember 2012Tarek Elneil32 Investigate an incident or series of incidents Attempt to understand the underlying causes of theincident(s) Generate effective corrective actions to prevent ormitigate incident(s) reoccurrence
Root Cause Analysis PrincipalsSeptember 2012Tarek Elneil33 Symptoms = Effects: are the signs or results of afailure but not the root cause Causes levels: First level causes: the direct lead to a problem High level causes: is called the root cause Cause and Effect Roles Causes and Effects are the same thing Causes and Effects are part of an infinite continuum ofcauses Each effect has at least two causes; Action and Condition effect & causes exists at the same point in time and space
Solution Criteria Solution Selection Criteria Prevent recurrence Comply with requirements Be within the span ofcontrol, or sphere ofinfluence Does not create otherproblems Meet organizational goalsand objectives Will save money in thelong run (cost less toimplement than theproblem reoccurrence)SpanofControlOutside of InfluenceSphere of InfluenceSeptember 2012Tarek Elneil34
Corrective Actions Recommended Evaluate the feasibility for using an automatic visual system toidentify and remove the non-conformed units Reduce the MQ Audit segment size Review the component specifications which are critical tomanufacturing A vendor qualifications program should be evaluated Implemented Management was satisfied with the Supplier correctiveactions, and decided no more corrective actions are required No effectiveness check is needed because there is no correctiveactionMay 201135Tarek Elneil
Previous Failure InvestigationCorrective Actions A CAD (Communication Awareness Discussion)session was conducted with all CPM line personnelfor failing to identify a possible unit closure defect. Personnel were reminded of the need to pay moreattention to detail!May 201136Tarek Elneil
Solution Matrix Develop Solution Matrix Challenge all solution ideas in the list against criteriafor viable solutionsSolutions Criteria Meet OurGoalsEffective Comply WithinControlS1 Y N N NS2 Y Y Y YS3 N Y Y YS4 Y Y Y NS5 N N N NSeptember 2012Tarek Elneil37
Six Sigma, RCA, Problem Analysis (K.T.)July 2012Tarek Elneil38Function Six Sigma RCA Problem AnalysisUse •Proactive : Reduceprocess variation•Reactive: Identify,reduce or eliminateroot causes•ReactivePhases •Define•Measure•Analyze•Improve•Control•Problem Definition•Risk Assessment•Analyze•Corrective Action•Effectiveness•Problem Definition•Identify possiblecauses•Evaluate possiblecauses (Hypothesis)• Confirm true causeDefinitionToolsInput Output, ParetoChart , FlowchartWhat, When, Where,SignificanceIs, Is Not AnalysisAnalysis Tools Fishbone Diagram,FMEA, 5 “Whys”Identify the CausesActions and ConditionsContradiction MatrixSolutionSelectionSelection Matrix,Force Field Analysis,BrainstormingEliminate root causeconditionsDecision Analysis(DA)
Nonconformance Investigation FailuresJuly 201239Tarek ElneilAny organization has two choices to treat their nonconformance. They canchoose between treating the symptom, or eliminating the root causes.Approach Treating Symptom Eliminating Root CausesCause Errors are often a result of workercarelessnessErrors are the result of defects in thesystem. People are only part of theprocessCorrective Actions train and motivate workers to bemore carefulneed to find out why this ishappening, and implement mistakeproofs so it won’t happen againJustification don’t have the time or resources toreally get to the bottom of thisproblemfailure to eliminate the root causeswill results in the reappearance ofthe same problem but in differentforms