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Quality Management Beyond the PMBOK ® Christopher E. Maddox, PMP Vice President, Program Management Legacy Pharmaceuticals International Project Management.

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Presentation on theme: "Quality Management Beyond the PMBOK ® Christopher E. Maddox, PMP Vice President, Program Management Legacy Pharmaceuticals International Project Management."— Presentation transcript:

1 Quality Management Beyond the PMBOK ® Christopher E. Maddox, PMP Vice President, Program Management Legacy Pharmaceuticals International Project Management Institute Baltimore Chapter 20 January 2011 This Presentation © 2011 Christopher E. Maddox. For use only by PMI members for non-profit educational purposes without express written consent of the copyright holder. Dilbert cartoons © United Features Syndicate and are used under Fair Use doctrine for educational purposes.

2 An Opening Thought

3 Review Quality Management Definitions and Tools Quality and Risk The Economics of Quality Understanding Causes and Effects Statistical Tool Cautions and Tips Objectives

4 QUALITY “the degree to which a set of inherent characteristics fulfill requirements” GRADE “category assigned to products or services having the same functional use but different technical characteristics” Quality Management Definitions PMBOK ® Guide 4ed p190

5 WHICH IS HIGHER QUALITY? Quality Management Definitions Hyundai AccentMercedes Brabus SL

6 WHICH IS HIGHER QUALITY? Quality Management Definitions “Zero to 60 in under 6 seconds”

7 WHICH IS HIGHER QUALITY? Quality Management Definitions “Better than 25 MPG”

8 QUALITY ASSURANCE “The process of auditing the quality requirements and the results from quality control measurements to ensure appropriate quality standards and operational definitions are used” QUALITY CONTROL “The process of monitoring and recording results of executing the quality activities to assess performance and recommend necessary changes” Quality Management Definitions PMBOK ® Guide 4ed p189

9 Cause and Effect Diagrams (Fishbone) Control Charts Flowcharting Histogram Pareto Chart Run Chart Scatter Diagram Statistical Sampling Inspection PMBOK ® Quality Tools and Techniques

10 Quality management ALWAYS involves assessment of risk Risks to consider –Risk related to poor quality (scrap, recalls, reputation, liability, etc) –Risk related to sampling/inspection error Complete elimination of risk is impractical in terms of time and cost; risk-based mitigation strategies are at the heart of effective QM Understanding risks is the first step towards prevention of quality problems Quality and Risk

11 Define Quality and Cost –Define Acceptable Quality Level –Define Cost of Quality and Risk/Cost of Poor Quality Acceptable Quality Level 1.What are the user requirements / specifications? 2.What is needed to meet them? Cost of Quality and Risk/Cost of Poor Quality 1.What is the cost of compliance (process, QA, QC)? 2.What is the cost and risk of poor quality (scrap, returns, etc)? Quality, Risk and Cost

12 The Economics of Quality 95%100% QUALITY LEVEL - ACCEPTABLE WIDGETS COST OF PROCESS / QA / QC Per 1000 WIDGETS $ 0 $ 100

13 The Economics of Quality 95%100% COST OF PROCESS / QA / QC Per 1000 WIDGETS $ 0 $ 100 COST OF SCRAP / RETURN / RECALL Per 1000 WIDGETS $ 0 $ 100 QUALITY LEVEL - ACCEPTABLE WIDGETS

14 The Economics of Quality 95%100% COST OF PROCESS / QA / QC Per 1000 WIDGETS $ 0 $ 100 COST OF SCRAP / RETURN / RECALL Per 1000 WIDGETS $ 0 $ 100 QUALITY LEVEL - ACCEPTABLE WIDGETS POINT OF LOWEST COST

15 The Economics of Quality 95%100% COST OF PROCESS / QA / QC Per 1000 WIDGETS $ 0 $ 100 COST OF SCRAP / RETURN / RECALL Per 1000 WIDGETS $ 0 $ 100 QUALITY LEVEL - ACCEPTABLE WIDGETS POINT OF LOWEST COST (Risk Averse Case) RISKRISK

16 Investing in Quality –FIRST invest in capable processes –NEXT invest in Quality Assurance –LAST invest in Quality Control Consider in your Risk Assessment… –Cost of lost customers –Cost of lost reputation –Cost of liability Accepting less than Six Sigma Quality may not be sufficient to mitigate your risks! The Economics of Quality

17 So… what the heck is Six Sigma?

18 A measure of process capability The simple definition –A process capable of producing not more than 3.4 defects per 1,000,000 opportunities –That’s % “Good” The slightly-more-complex definition –Acceptance range of the process is 3 standard deviations (SD, Sigma or σ) of the process’ normal distribution on either side of the desired specification point Six Sigma Quality

19 NUMBER OF OBSERVATIONS DEVIATION BELOW SPECIFICATION DEVIATION ABOVE SPECIFICATION

20 Six Sigma Quality NUMBER OF OBSERVATIONS DEVIATION BELOW SPECIFICATION DEVIATION ABOVE SPECIFICATION “NORMAL” Distribution Curve Specification

21 Six Sigma Quality NUMBER OF OBSERVATIONS DEVIATION BELOW SPECIFICATION DEVIATION ABOVE SPECIFICATION ACCEPTANCE CRITERIA

22 Six Sigma Quality NUMBER OF OBSERVATIONS DEVIATION BELOW SPECIFICATION DEVIATION ABOVE SPECIFICATION 1σ1σ 2σ2σ 3σ3σ % 68% 95% NOT A SIX SIGMA PROCESS!

23 Conforming to Six Sigma NUMBER OF OBSERVATIONS DEVIATION BELOW SPECIFICATION DEVIATION ABOVE SPECIFICATION 1σ1σ 2σ2σ 3σ3σ % 68% 95% IMPROVE PROCESS CAPABILITY

24 Conforming to Six Sigma NUMBER OF OBSERVATIONS DEVIATION BELOW SPECIFICATION DEVIATION ABOVE SPECIFICATION 1σ1σ 2σ2σ 3σ3σ % 68% 95% WIDEN THE ACCEPTANCE RANGE

25 Causes and Effects of Quality Problems

26 Ishikawa (Fishbone) Diagram –Featured in the PMBOK ® - a basic tool of investigating defects –Qualitative but not quantitative –Does not always help determine causality Other Tools –Causal Circle explores cause-effect relationships of undesirable effects (UDEs) – suited to complex systems –Failure Mode and Effect Analysis (FMEA) systematically analyzes and prioritizes potential failures, consequences and preventative/corrective actions. Cause and Effect of Quality Problems

27 Causal Circle UDEs (Tablet Compression Project) 1.Tablet chipping 2.Tablet hardness variation 3.Coating is not uniform 4.Tablets under weight 5.Press force drifting during process 6.Granulation density low 7.Press process too slow 8.Speed control past limit 1. List and Number UDEs

28 Causal Circle UDEs 1.Tablet chipping 2.Tablet hardness variation 3.Coating is not uniform 4.Tablets under weight 5.Press force drifting during process 6.Granulation density low 7.Press process too slow 8.Speed control past limit 2. Arrange numbers in circle

29 Causal Circle UDEs 1.Tablet chipping 2.Tablet hardness variation 3.Coating is not uniform 4.Tablets under weight 5.Press force drifting during process 6.Granulation density low 7.Press process too slow 8.Speed control past limit 3. Establish Relationship between UDE 1 and others

30 Causal Circle UDEs 1.Tablet chipping 2.Tablet hardness variation 3.Coating is not uniform 4.Tablets under weight 5.Press force drifting during process 6.Granulation density low 7.Press process too slow 8.Speed control past limit 4. Repeat for all UDEs

31 Causal Circle UDEs 1.Tablet chipping 2.Tablet hardness variation 3.Coating is not uniform 4.Tablets under weight 5.Press force drifting during process 6.Granulation density low 7.Press process too slow 8.Speed control past limit 5. Tabulate incoming and outgoing arrows for each UDEINOUT

32 Causal Circle UDEs 1.Tablet chipping 2.Tablet hardness variation 3.Coating is not uniform 4.Tablets under weight 5.Press force drifting during process 6.Granulation density low 7.Press process too slow 8.Speed control past limit 6. Identify drivers, outcomes, contributors UDEINOUT D D O O O C C DRIVER OUTCOME CONTRIBUTOR D

33 1.Study the system, product or process 2.Brainstorm possible range of failure modes for each process step 3.List potential consequences of each failure mode 4.Assign Severity (SEV) scores for each failure mode 5.Identify cause(s) of each failure mode 6.Assign Occurrence probability (OCC) scores for each cause 7.Identify controls to detect the failure modes 8.Assign a detection escape (DET) score for each control 9.Calculate Risk Priority Number (RPN) for each FMEA line [RPN = SEV x OCC x DET] 10.Prioritize failure modes and causes based on RPN 11.Determine actions to be taken on failure and plans for prevention 12.Recalculate RPN based upon actions/plans and re-prioritize Failure Mode and Effect Analysis

34 Category5 (Very Bad)4321 (Good) Severity (SEV)Severe consequence of failure High consequenceModerate consequence Minor consequenceNegligible consequence of failure Occurrence (OCC)Very high probability cause will occur High probabilityModerate probabilityLow probabilityVery low probability cause will occur Escaped Detection (DET) Very high probability failure will escape detection before reaching the customer High probabilityModerate probabilityLow probabilityVery low probability failure will escape detection before reaching the customer Proc StepFailure Mode Failure Effect SEVSEV CauseOCCOCC ControlDETDET RPNRPN ActionPlanpSEVpSEV pOCCpOCC pDETpDET pRPNpRPN Matrix Scoring

35 Fishbone: Beware that correlation ≠ causality (use Causal Circle for complex systems) Control Charts: Look for off-center trends; plot a distribution if you have enough data Pareto Charts: Beware that all items must be a direct cause of the defect or you can draw invalid conclusions Scatter Plots: Do these in Excel and you can easily plot trend lines, derive formulas and R-squared values Statistical Sampling: Subject to errors; know how to calc margin of error so you can create a valid sampling plan PMBOK ® Statistical Tool Cautions & Tips

36 Understand what quality is, and who defines it Good quality management is dependent on good risk management Understanding economics of quality is a competitive advantage Process capability is the most important factor in quality and usually the most cost effective in the long run Knowing cause, effect & failure mode is the only way to anticipate and investigate failure and continuously improve Understand what tools and statistics are telling you Quality is profitable unless it is just a buzzword – then it costs! Summary

37 Questions? Comments?

38 Thank You! Chris Maddox This Presentation © 2011 Christopher E. Maddox. For use only by PMI members for non-profit educational purposes without express written consent of the copyright holder. Dilbert cartoons © United Features Syndicate and are used under Fair Use doctrine for educational purposes.


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