Process variation and continuous improvements
Download as PPTX, PDF4 likes3,722 views
The document discusses various continuous improvement tools and techniques: 1) It describes process components and characteristics, process variations and causes, and process improvement methodologies. 2) It then provides a fruit pizza recipe including ingredients and directions. 3) Finally, it discusses tools for nonconformance investigation such as root cause analysis, which aims to identify and eliminate the true root causes of process failures through a systematic approach.
Process variation and continuous improvements
- 2. Tarek Elneil Contact Information September 12Tarek Elneil 2 email: telneil@msn.com Tel: 805-876-4356
- 3. Main Points September 12Tarek Elneil 3 What is a Process Process Components &Characteristics Process Variations and Causes Process Improvement Methodologies
- 4. 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-inch pizza pan. Bake until firm to touch, about 11 to 15 minutes. Cool. In a medium bowl, blend cream cheese and sugar. Spread the baked cookie with the cream cheese mixture and decorate with sliced fruit. In a small bowl, combine melted white chocolate with chocolate syrup. Top the pizza with remaining berries and chocolate mixture. Slice and serve immediately. 5/20/2013 4 http://www.foodnetwork.com/recipes/paula-deen/fruit-pizza-recipe/index.html Ingredients Directions
- 5. 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-inch pizza pan. Bake until firm to touch, about 11 to 15 minutes. Cool. In a medium bowl, blend cream cheese and sugar. Spread the baked cookie with the cream cheese mixture and decorate with sliced fruit. In a small bowl, combine melted white chocolate with chocolate syrup. Top the pizza with remaining berries and chocolate mixture. Slice and serve immediately. 5/20/2013 5 http://www.foodnetwork.com/recipes/paula-deen/fruit-pizza-recipe/index.html Input : Bill Of Material (BOM) Output : Master Batch Record Machine Measurement Environment Material Chef Method
- 6. Process Variation May 2011Tarek Elneil 6 Measurement Machine Environmental (Mother Nature) Material Method
- 7. Types of Process Variation Tarek Elneil 7 Variations in process input cause the variations in the process output (Products) There are three basic kinds of variation: Common cause variation: is variation inherent to the process. It is due to the interface of the different components of the process input Structural variation: is variation due to differences among parallel parts of the process Special (Assignable) cause variation: is variation due to sources outside the process, due to changes in the process input
- 8. Common Variation Not all parts are created equal Any population under control follows the Normal Curve characteristics: Probability of the population variation from the Mean 68 % within + 1 within + 2 within + 3 2012 8 Tarek Elneil 1 2 3
- 9. Process Improvements Reduce the process common cause variation throughout incremental improvements steps to identify, and eliminate the causes of defects (errors) and minimizing process variability September 2012 9 Tarek Elneil
- 10. Investigating (Special Cause) May 2011 Tarek Elneil 10
- 11. Nonconformance Improvement Systems 11 September 2012Tarek Elneil Nonconformance Improvement SCAR CAPA Customer Complaints
- 12. Major Steps of Quality Investigation Tarek Elneil 12 Define the problem Evaluate the failure Failure risk assessment Investigate failure causes Select and implement effective solutions Ensure the solution effectiveness
- 13. Problem Definition’s Elements Define 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 there is 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?
- 14. Problem Evaluation It help to answer 3 questions 1. Should we continue with the investigation? 2. How much time should we spend on the investigation? 3. How much resources (people and money) should we utilize 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
- 15. Nonconformance Evaluation Safety FreqCostRevenue Env. Start Yes No No No StopNoNo Yes Yes Yes Yes Assemble Team Investigate Root Cause(s) Implement CA’s Control Phase No Result Acceptable? Share Yes No
- 16. Risk Assessment September 2012Tarek Elneil 16 Risk assessment attempts to answer the following fundamental 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 consequence of the risk or that reduce the probability of the risk?
- 17. Nonconformance Investigation Y LCL UCL Tarek Elneil17
- 18. Nonconformance Investigation September 2012Tarek Elneil 18 Nonconformance should be investigated when Identified Cause have exceeded the expected frequency limits Special (Assignable )Cause has unexpectedly occurred Which have significant impact on the product, safety, cost or any established criteria
- 19. Nonconformance Investigation September 2012Tarek Elneil 19 Kepner Trego: investigate the changes that probably caused the failure. Root Cause Analysis: investigate the actions and condition that caused the failure
- 20. 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 2012 20 Tarek Elneil
- 21. Problem Analysis - When Is Is Not When was the deviation observed first (clock and calendar time)? How many objects have the deviation? What is the size of a single deviation? How many deviations are on each object? When else could the deviation have been observed first, but was not? How many objects could have the deviation, but don’t? What other size could a deviation be, but isn’t? How many deviations could there be on each object, but are not?
- 22. Problem Analysis Evaluate Possible Causes Examine possible causes against the IS and IS NOT specification 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 NOT information? Which possible cause has the fewest, simplest, and most reasonable assumptions?
- 23. Real Case Study On 10/6 the MQ (Manufacturing Quality) light test audit rejected a segment of 12,422 units for a bad seal 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 rejected May 2011 23 Tarek Elneil
- 24. The Product Components Cartridge Liner /Septum Aluminum shell Needle Roll Grove Plunger DrugAluminum Cap 24 Tarek Elneil
- 26. Kepner Trego Investigation Is It was in CPM (Cartridge Processing 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 Shift September 12 26 Tarek Elneil
- 27. Tarek Elneil27 VIS-Seal Deficiencies, Pr oduct Code AB84T, LotNo.A x1234 ENVIRONMENT MEASURES METHODS MATERIALS MACHINE PEOPLE N/A Carpujects in disarray at accumulation area Poor lighting for inspection tests Distractive environment for personnel N/A Batch records consistent Consecutive inspections by same personnel MQ Audit AQL correct QES not set correctly for alert limits SOPs clear? Capper parts worn out Bad plungers Bad seal caps Bad glass vials Capper not spinning at correct rpm Lack of procedural understanding Human error Personnel error Training current Lack of Quality oversight Plungers not set correctly Capper pivots arms defective Worn capper parts Cap seal set up not correct Seal crimper not set correctly N/A N/A N/A N/A N/A
- 28. Problem Analysis Evaluate Possible Causes Test possible causes against the facts, use Contradiction Matrix to sort 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 NOT information? Which possible cause has the fewest, simplest, and most reasonable assumptions?
- 29. Contradiction Matrix Why To determine relationships between facts obtained in the Define Phase and the likely causes of a problem obtained during the Measure Phase of a problem solving effort. Allows us to focus on the most likely causes of the problem. Effective tool for sorting the few likely causes from many possible causes. What A matrix that compares the likely causes, obtained during a brainstorming session, in the left column with the facts of a problem in the upper row. How Complete the IS/IS NOT and Distinction & Changes Matrices along with a timeline of process changes. Prepare a Cause & Effect diagram during the Measure Phase of the problem solving process. Conduct a Change Point Analysis (CPA) of existing process output data, and note any significant changes. Construct the Contradiction Matrix and fill in all cells where know information exists. Leave cells blank where unknown information exists. Place an “A” in cells where assumptions for a contradiction can be made. Strike any rows where an obvious contradiction exists. X - FACT contradicts CAUSE A - Assumptions made; need data to verify O - FACT supports CAUSE BLANK- Need more data X - FACT contradicts CAUSE A - Assumptions made; need data to verify O - FACT supports CAUSE BLANK- Need more data FACTS CAUSES #1 #2 #3 #4 #5 A X X X B O O O O C X X D O A
- 30. What is Root Cause Analysis (RCA)? September 2012Tarek Elneil 30 Root Cause is the fundamental breakdown or failure of a process which, when resolved, prevents a recurrence of the nonconformance Root Cause Analysis is a systematic approach to investigate, identify and eliminate the true root causes of the process failure
- 31. Uses facts to narrow the search to identify and eliminate the root cause Present RCA Methodology May 2011Tarek Elneil 31 Evidence! Evidence! CAUSES CAUSES CAUSES Past Why? Why? Why?
- 32. How to Use RCA September 2012Tarek Elneil 32 Investigate an incident or series of incidents Attempt to understand the underlying causes of the incident(s) Generate effective corrective actions to prevent or mitigate incident(s) reoccurrence
- 33. Root Cause Analysis Principals September 2012Tarek Elneil 33 Symptoms = Effects: are the signs or results of a failure 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 of causes Each effect has at least two causes; Action and Condition effect & causes exists at the same point in time and space
- 34. Solution Criteria Solution Selection Criteria Prevent recurrence Comply with requirements Be within the span of control, or sphere of influence Does not create other problems Meet organizational goals and objectives Will save money in the long run (cost less to implement than the problem reoccurrence) Span of Control Outside of Influence Sphere of Influence September 2012Tarek Elneil 34
- 35. Corrective Actions Recommended Evaluate the feasibility for using an automatic visual system to identify and remove the non-conformed units Reduce the MQ Audit segment size Review the component specifications which are critical to manufacturing A vendor qualifications program should be evaluated Implemented Management was satisfied with the Supplier corrective actions, and decided no more corrective actions are required No effectiveness check is needed because there is no corrective action May 2011 35 Tarek Elneil
- 36. Previous Failure Investigation Corrective Actions A CAD (Communication Awareness Discussion) session was conducted with all CPM line personnel for failing to identify a possible unit closure defect. Personnel were reminded of the need to pay more attention to detail! May 2011 36 Tarek Elneil
- 37. Solution Matrix Develop Solution Matrix Challenge all solution ideas in the list against criteria for viable solutions Solutions Criteria Meet Our Goals Effective Comply Within Control S1 Y N N N S2 Y Y Y Y S3 N Y Y Y S4 Y Y Y N S5 N N N N September 2012Tarek Elneil 37
- 38. Six Sigma, RCA, Problem Analysis (K.T.) July 2012Tarek Elneil 38 Function Six Sigma RCA Problem Analysis Use •Proactive : Reduce process variation •Reactive: Identify, reduce or eliminate root causes •Reactive Phases •Define •Measure •Analyze •Improve •Control •Problem Definition •Risk Assessment •Analyze •Corrective Action •Effectiveness •Problem Definition •Identify possible causes •Evaluate possible causes (Hypothesis) • Confirm true cause Definition Tools Input Output, Pareto Chart , Flowchart What, When, Where, Significance Is, Is Not Analysis Analysis Tools Fishbone Diagram, FMEA, 5 “Whys” Identify the Causes Actions and Conditions Contradiction Matrix Solution Selection Selection Matrix, Force Field Analysis, Brainstorming Eliminate root cause conditions Decision Analysis (DA)
- 39. Nonconformance Investigation Failures July 2012 39 Tarek Elneil Any organization has two choices to treat their nonconformance. They can choose between treating the symptom, or eliminating the root causes. Approach Treating Symptom Eliminating Root Causes Cause Errors are often a result of worker carelessness Errors are the result of defects in the system. People are only part of the process Corrective Actions train and motivate workers to be more careful need to find out why this is happening, and implement mistake proofs so it won’t happen again Justification don’t have the time or resources to really get to the bottom of this problem failure to eliminate the root causes will results in the reappearance of the same problem but in different forms
Editor's Notes
- #4: 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
- #10: 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.[4] 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.[4] 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).[4]
- #12: Three areas generates nonconformance that require continuous improvements:Suppliers Quality: Returns, and Investigations Manufacturing Process: Nonconformance Reports, Deviations, Change control Customer Complaints
- #19: Common Cause: Random occurrence with limited frequency due to process variations.
- #25: 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
- #26: 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
- #31: For a particular product problem, Root Cause is the factor that, when it is fixed the problem goes away and doesn’t come back
- #32: 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.
- #36: 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.
- #38: 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.
- #39: 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
- #40: 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