quality management beyond the pmbok ® christopher e. maddox, pmp vice president, program management...

Quality ManagementBeyond the PMBOK®

Christopher E. Maddox, PMP

Vice President, Program Management

Legacy Pharmaceuticals International

Project Management Institute Baltimore Chapter

20 January 2011This 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.

An Opening Thought

•Review Quality Management Definitions and Tools

•Quality and Risk•The Economics of Quality•Understanding Causes and Effects•Statistical Tool Cautions and Tips

Objectives

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

WHICH IS HIGHER QUALITY?

Quality Management Definitions

Hyundai Accent Mercedes Brabus SL

WHICH IS HIGHER QUALITY?

Quality Management Definitions

“Zero to 60 in under 6 seconds”

WHICH IS HIGHER QUALITY?

Quality Management Definitions

“Better than 25 MPG”

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

•Cause and Effect Diagrams (Fishbone)•Control Charts•Flowcharting•Histogram•Pareto Chart•Run Chart•Scatter Diagram•Statistical Sampling•Inspection

PMBOK® Quality Tools and Techniques

• 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

• Define Quality and Cost– Define Acceptable Quality Level– Define Cost of Quality and Risk/Cost of Poor Quality

• Acceptable Quality Level1. What are the user requirements / specifications?2. What is needed to meet them?

• Cost of Quality and Risk/Cost of Poor Quality1. 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

The Economics of Quality

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QUALITY LEVEL - ACCEPTABLE WIDGETS

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The Economics of Quality

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QUALITY LEVEL - ACCEPTABLE WIDGETS

The Economics of Quality

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QUALITY LEVEL - ACCEPTABLE WIDGETS

POINT OF LOWEST COST

The Economics of Quality

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QUALITY LEVEL - ACCEPTABLE WIDGETS

POINT OF LOWEST COST

(Risk Averse Case)

RISK

• 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

So… what the heck is Six Sigma?

• 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 99.9997% “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

Six Sigma Quality

NU

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OF

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DEVIATION BELOW SPECIFICATION

DEVIATION ABOVE SPECIFICATION

Six Sigma Quality

NU

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ER

OF

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DEVIATION BELOW SPECIFICATION

DEVIATION ABOVE SPECIFICATION

“NORMAL” Distribution

Curve

Specification

Six Sigma Quality

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ER

OF

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RV

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S

DEVIATION BELOW SPECIFICATION

DEVIATION ABOVE SPECIFICATION

ACCEPTANCE CRITERIA

Six Sigma Quality

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DEVIATION BELOW SPECIFICATION

DEVIATION ABOVE SPECIFICATION

1σ

2σ

3σ

99.9997%

68%

95%

NOT A SIX SIGMA PROCESS!

Conforming to Six Sigma

NU

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ER

OF

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RV

AT

ION

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DEVIATION BELOW SPECIFICATION

DEVIATION ABOVE SPECIFICATION

1σ

2σ

3σ

99.9997%

68%

95%

IMPROVE PROCESS CAPABILITY

Conforming to Six Sigma

NU

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DEVIATION BELOW SPECIFICATION

DEVIATION ABOVE SPECIFICATION

1σ

2σ

3σ

99.9997%

68%

95%

WIDEN THE ACCEPTANCE RANGE

Causes and Effects of Quality Problems

• 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

Causal CircleUDEs (Tablet Compression Project)1. Tablet chipping2. Tablet hardness variation3. Coating is not uniform4. Tablets under weight5. Press force drifting during process6. Granulation density low7. Press process too slow8. Speed control past limit

1. List and Number UDEs

Causal Circle1

8 2

7

5

3

6 4

UDEs1. Tablet chipping2. Tablet hardness variation3. Coating is not uniform4. Tablets under weight5. Press force drifting during process6. Granulation density low7. Press process too slow8. Speed control past limit

2. Arrange numbers in circle

Causal Circle1

8 2

7

5

3

6 4

UDEs1. Tablet chipping2. Tablet hardness variation3. Coating is not uniform4. Tablets under weight5. Press force drifting during process6. Granulation density low7. Press process too slow8. Speed control past limit

3. Establish Relationship between UDE 1 and others

Causal Circle1

8 2

7

5

3

6 4

UDEs1. Tablet chipping2. Tablet hardness variation3. Coating is not uniform4. Tablets under weight5. Press force drifting during process6. Granulation density low7. Press process too slow8. Speed control past limit

4. Repeat for all UDEs

Causal Circle1

8 2

7

5

3

6 4

UDEs1. Tablet chipping2. Tablet hardness variation3. Coating is not uniform4. Tablets under weight5. Press force drifting during process6. Granulation density low7. Press process too slow8. Speed control past limit

5. Tabulate incoming and outgoing arrows for each

UDE IN OUT

1 5 1

2 3 3

3 3 0

4 4 1

5 2 3

6 0 5

7 0 1

8 1 4

Causal Circle1

8 2

7

5

3

6 4

UDEs1. Tablet chipping2. Tablet hardness variation3. Coating is not uniform4. Tablets under weight5. Press force drifting during process6. Granulation density low7. Press process too slow8. Speed control past limit

6. Identify drivers, outcomes, contributors

UDE IN OUT

1 5 1

2 3 3

3 3 0

4 4 1

5 2 3

6 0 5

7 0 1

8 1 4

D

D

O

O

O

C

C

DRIVER

DRIVER

DRIVER

OUTCOME

OUTCOME

OUTCOME

CONTRIBUTOR

CONTRIBUTOR

D

1. Study the system, product or process2. Brainstorm possible range of failure modes for each process step3. List potential consequences of each failure mode4. Assign Severity (SEV) scores for each failure mode5. Identify cause(s) of each failure mode6. Assign Occurrence probability (OCC) scores for each cause7. Identify controls to detect the failure modes8. Assign a detection escape (DET) score for each control9. Calculate Risk Priority Number (RPN) for each FMEA line [RPN = SEV x OCC x DET]10. Prioritize failure modes and causes based on RPN11. Determine actions to be taken on failure and plans for prevention12. Recalculate RPN based upon actions/plans and re-prioritize

Failure Mode and Effect Analysis

Failure Mode and Effect Analysis

Category 5 (Very Bad) 4 3 2 1 (Good)

Severity (SEV) Severe consequence of failure

High consequence Moderate consequence

Minor consequence Negligible consequence of

failure

Occurrence (OCC) Very high probability cause will occur

High probability Moderate probability Low probability Very low probability cause will occur

Escaped Detection (DET)

Very high probability failure will escape detection before

reaching the customer

High probability Moderate probability Low probability Very low probability failure will escape detection before

reaching the customer

Proc Step Failure Mode

Failure Effect

SEV

Cause OCC

Control DET

RPN

Action Plan pSEV

pOCC

pDET

pRPN

Matrix

Scoring

• 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

• 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

Questions? Comments?

Thank You!Chris Maddox

chris.maddox@legacypharm.com+1 443 243 2220

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.