PART I Six Sigma Background PART II Six Sigma in the Lab PART III Six Sigma in Method Development and Validation PART IV Workshop

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1 Alice Krumenaker Process Manager Merial Ltd ASQ CQPA, CMQ/OE, CSSGB IVT METHOD VALIDATION CONFERENCE July 2010 PART I Six Sigma Background PART II Six Sigma in the Lab PART III Six Sigma in Method Development and Validation PART IV Workshop 1

2 It is not enough to do your best; you must know what to do, and the do your best. ~W. Edward Deming~ 2

3 Six sigma is a highly disciplined process that focuses on delivering near-perfect products and services consistently. CSSBB 2007 Primer Quality Council of Indiana Motorola pioneered the use of six sigma in manufacturing Resulted in significant cost savings Use of six sigma methodology spread to other functions 3

4 Six sigma level = 3.4 defects per million opportunities (DPMO) or 3.4 ppm DMAIC approach to problem solving: D Define M Measure A: Analyze I: Improve C: Control 4

5 Define: Clarify the project Create a project charter State goals Outline financial benefits Document process and scope Communication plan Identify milestones Measure: Clarify the project Confirm current process Identify process inputs and outputs Collect data and establish metrics Make quick win improvements, if possible (remove obvious inefficiencies) 5

6 Analyze: Clarify the project Analyze data and review process Identify root cause of problem Update project plan and charter Improve: Use the data to resolve inefficiencies and bottlenecks Review possible solutions Outline and pilot revised process Develop implementation plan 6

7 Control: Complete project Develop implementation plan Document and implement new process Compare results of original and new processes Transition to process owner Audit results Master Black Belts: Mentor Black Belts and monitor projects Black Belts: Lead process improvement project Green Belts: Assist Black Belts or lead small scare projects with supervision from Black Belt 7

8 Sponsors: Executives Who support the six sigma initiatives from a business perspective Champion: Members of upper level management who provide resources and lead implementation Process Owner: Coordinates process and monitors progress; may be trained as Yellow Belts Financial Savings Reduce Lead Time Remove Waste and Inefficiencies 8

9 Time Consuming Resource Drain Projected Financial Benefits May Not Occur Yes! Six sigma techniques are successfully used in service functions as well as manufacturing 9

10 If you can t describe what you are doing as a process, you don t know what you re doing. ~W. Edward Deming~ 10

11 Six Sigma tools: Identify the steps in a process Identify gaps and inefficiencies Make the process more predictable Reduce cycle time and rework Start Small: If six sigma is not currently being used in your lab, don t try to make sweeping, department wide changes 11

12 Process Identification: Have others explain the process and observe them if possible Draw the steps to the process and analyze Use the information to streamline process Integration into current process: Revise procedures related to the process Train on new process Develop metrics to evaluate and improve 12

13 Method development varies with the test material how can six sigma help? There are common elements in developing methods. The steps used may be made more predictable. Steps for method validation are documented in compendia and guidelines. What is the benefit to incorporating six sigma? Reduced cycle times for validation will provide a method for filing or transfer more quickly. 13

14 Won t incorporating six sigma techniques add more work and require more resources? Any time a change is made to a process, there are potential delays and additional work, but this is not typically true after usage becomes more common. Increases in efficiency save money and require fewer resources Financial benefits typically are the best selling point 14

15 Tools used in each of the Five Stages: Define Measure Analyze Improve Control Define Stage: Voice of the Customer Pareto Chart Process Mapping Failure Mode and Effects Analysis (FMEA) 15

16 Measure Stage: Trend Chart Statistical Process Control (SPC) Analyze Stage: Fishbone Diagram 5 Whys Histogram 16

17 Improve Stage: Brainstorming Error Proofing Corrective Action Matrix Control Stage: 5S FMEA CHECK Process 17

18 Examples of six sigma tools used successfully in the lab Mistake proofing: color-coding HPLC lines to prevent mixups 5S: removing clutter and reorganizing supplies to make work more efficient Process mapping: Identify and remove inefficiencies Full Scale Six Sigma projects are not always considered acceptable for labs May be viewed as interfering with ongoing projects 18

19 Kaizen may be a good match for the lab environment Japanese technique for process improvement Incremental continuous improvement Kaizen blitz focused, short-term improvement event Typically completed in 2 weeks or less 19

20 Kaizen blitz: Pros: Projects are completed quickly so it isn t likely to delay timelines Quick results generate enthusiasm Kaizen blitz: Cons: Management support is vital In depth training is not usually done may not be a clear understanding of how to continually improve 20

21 Define: Interview department members (Voice of the Customer): How do they view the process? Affinity diagram: Participants use Post It notes to outline the steps of the process Define: Map the process: Use the information obtained from the department members to create a chart with the process steps 21

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23 Analyze: Use the info from the Define stage to identify what data will be collected Pareto Chart good tool to show problem areas Analyze: 5 Whys Plot data using trend (or run) chart Histogram Use statistical analysis 23

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25 Improve: Take the results from the Analyze stage and use it to find a solution to the problem Improve: Brainstorming: Introduce the results of Analyze to process users for their ideas on how to improve the project Mistake Proofing (Removing opportunities for error) or 5S (Reorganizing workspace of efficiency) may be other ways to resolve the problem 25

26 Improve: Create a new process map or make an outline of the revised process Test the new process before putting in into place Control: Transition the new process to the system owners (Analysts will take over from improvement team leader) Monitor new process: Are improvements still effective? Is it time for new improvements? 26

27 While developing an analytical method for the assay of an active ingredient in a challenging product, several formulation changes occurred. Each formulation change resulted in changes to the method. Once the final formulation was identified, the method validation was started Passing results could not be obtained on a precision study There was a variety of possible causes, but similar situations occurred in the past so department management decided to make this a six sigma project 27

28 Define: What steps would you use to define the project? What tools would you use? Project and scope: Measure: How would you use the information from the Define stage? Are you able to identify metrics? What tools would you use? 28

29 Analyze: How would you use the data from the Measure stage? What tools would you use? What would you identify as the item that needs to be improved? Improve: How would you use the data from the Analyze stage? Who should be involved in the Improve stage? After a revised process is identified, what are your next steps? 29

30 Control: Once you ve tested your new process, what are your next steps? Do you think there is another stage after the Control stage is complete? Is there an end to the Control stage? QUESTIONS? 30

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