You are on page 1of 132

QUALITY

MANAGEMENT
January 2014

Quality Management

1

Part 2
Tools and Techniques used in Total
Quality Management

January 2014

2

Quality Management

Tools and Techniques used in Total
Quality Management
• Tools and Techniques
• Product and Process Improvements

January 2014

Quality Management

3

Part 2.1 Tools and Techniques January 2014 4 Quality Management .

each solution to a problem is based on relevant data and appropriate analysis • Collecting and analyzing data can be difficult • Use of Total Quality tools and techniques ensure better decision making. products and services January 2014 Quality Management 5 . better solution to problems. improvement in productivity.Introduction • One of the basic principles of Total Quality is management by facts • It requires that each decision.

Overview of Total Quality Tools Basic 7 tools: • • • • • • • January 2014 The Pareto Chart Cause-and-Effect Diagrams Check Sheets Histograms Scatter Diagrams Stratification Run Charts and Control Charts Quality Management 6 .

Overview of Total Quality Tools Other tools: • • • • • • January 2014 Statistical Process Control (SPC) 5S Flowcharts Input-output diagram Failure mode and effects analysis Design of Experiments (DOE) Quality Management 7 .

Overview of Total Quality Techniques • • • • Process Capability Quality Loss Function and Robust Engineering Risk Assesment Problem Solving and Decision Making – PDCA – 8D – Kepner Traego – Six Sigma January 2014 Quality Management 8 .

Pareto charts are important because they can help an organization decide where to focus limited resources January 2014 Quality Management 9 .Pareto chart Pareto charts are useful for separating the important from the trivial.

What Frequency of Type of Interruption information do we Occurrence “see” from Machine Breakdown the Pareto? 180 Defective Production 135 No Material 63 Change-over 56 Tool Breakdown 27 Defective Material 23 Maintenance 14 No Labor 9 January 2014 Quality Management 10 . Machine Breakdown and Defective Production are the biggest contributors to production interruption.  The number of production interruptions. at an injection molding plant are recorded for one month.Pareto Chart The purpose is to separate the “vital few” from the trivial many. and the reasons for the interruption.

Pareto chart January 2014 Quality Management 11 .

Cause and Effect Diagram The purpose of the cause-and-effect diagram ( Ishikawa of fishbone) diagram is to help identify and isolate the causes of problems January 2014 Quality Management 12 .

Cause and Effect Diagram • Example of problem: • Contamination of product with iron. • Possible (primary) causes of contamination: – – – – – – Measurement Material Methods Environment Manpower Machines January 2014 5M+E Quality Management 13 .

Cause and Effect Diagram Measurements Materials Methods Iron in product Environment January 2014 Manpower Machines Quality Management 14 .

Cause and Effect Diagram Measurements Lab error Analyst Improper calibration Calculation Solvent contamination In laboratory January 2014 Quality Management At supplier 15 .

Cause and Effect Diagram January 2014 Quality Management 16 .

Cause and Effect Diagram • Can be used in any function of an organization • Example from Human Resources – Employee turnover – Possible (primary) causes of turnover: • • • • • • January 2014 Economy Performance of the Organization Organizational Culture Job Characteristics Unrealisic Employee Expectations Personal Reasons Quality Management 17 .

Cause and Effect Diagram January 2014 Quality Management 18 .

Check sheet Check sheets make it easy to collect data for specific purposes and to present it in a way that automatically converts it into useful information January 2014 Quality Management 19 .

Histogram Histograms have to do with variability. A histogram is a measurement scale across one axis and a frequency of measurements on the other. January 2014 Quality Management 20 .

Histogram Adds to 100% January 2014 Quality Management 21 .

January 2014 Quality Management 22 .Scatter diagram Scatter diagram is used to determine the correlation between two variables.

10. Project 1.What is a Correlation? • A correlation exists between two variables when they are related to one another in some way. 7. 8. January 2014 Time (Days) 14 29 26 10 18 11 34 26 24 21 Cost ($k) 80 111 76 27 55 51 150 140 80 120 QUESTION: What is the relationship between Project time and Cost? Quality Management 23 . 3. 9. 4. 2. 5. 6.

4. 6. 9. 8. 5. 7. 2. C os t of P rojec ts 150 C os t ($ k) Project 1. 10. Time (Days) 14 29 26 10 18 11 34 26 24 21 100 50 10 Quality Management 20 T im e (D a ys ) 30 24 . 3.Scatter Diagram A scatter diagram is the graphical representation of paired (x.y) data. January 2014 Cost ($k) 80 111 76 27 55 51 150 140 80 120 T ime vs .

3. Time (Days) 14 29 26 10 18 11 34 26 24 21 100 50 10 20 T im e (D a ys ) 30 As the project time increases. Quality Management 25 . C os t of P rojec ts 150 C os t ($ k) Project 1. 6. 9. 7.Scatter Diagram January 2014 Cost ($k) 80 111 76 27 55 51 150 140 80 120 T ime vs . so does the cost. 5. 4. 2. 8. 10.

Types of Relationships Positive Correlation Strong Positive Perfect Positive Negative Correlation Strong Negative Perfect Negative January 2014 Quality Management No Correlation Nonlinear Correlation 26 .

Correlation Coefficient • The correlation coefficient. January 2014 Quality Management 27 . r. no linear relationship is present. is a statistical measure of the strength of the linear relationship between two variables. • When r is close to zero. • r is always between -1 and 1 (inclusive).

4. 9. 2. 10. 5. 8. C os t of P rojec ts 1 50 C os t ($ k) Project 1.82 January 2014 Quality Management 28 . 6.Correlation Coefficient Cost ($k) 80 111 76 27 55 51 150 140 80 120 T ime vs . 7. Time (Days) 14 29 26 10 18 11 34 26 24 21 1 00 50 10 20 T im e (D a ys ) 30 r = 0. 3.

89 Strong Negative r = 1.0.Correlation Coefficient .0. just not in a linear fashion.0 Perfect Negative r = 0.52 Positive Correlation r = .1.0 Perfect Positive r = .Examples r = 0.85 Strong Positive r = . January 2014 Quality Management 29 . The variables might be related.09 No Correlation r@0 Nonlinear Correlation Note: r  0 means no linear relationship.73 Negative Correlation r = 0.

) 0.Correlation Coefficient Discussion January 2014 1.70 Quality Management 30 . is approximately (select one): a.00 b. r.) 0.05 2. is approximately (select one): a. The correlation coefficient.) 0.) 0.70 c.85 c.50 b.) 0.) -0. r. The correlation coefficient.

January 2014 Quality Management 31 . Grouping of data by common elements or characteristics makes it easier to understand the data and to draw insights from it.Stratification Stratification is a tool used to investigate the cause of a problem by grouping data into categories.

Run chart The run chart records the output results of a process over time For this reason. the run chart is sometimes called a trend chart January 2014 Quality Management 32 .

January 2014 Quality Management 33 . This weakness gave rise to the control chart.Run charts and Control charts The weakness of the run chart is that it does not tell whether the variation is the result of common causes or special causes.

Control Chart • Common Cause Variation – Routine. inherent process variation – the “steady state” variation that persists over time – Common-cause variation is the noise within the system. – Common cause variation describes variability in a process that is inherent in the design of the process – Reduction of common cause variation requires (usually) a redesign of the process January 2014 Quality Management 34 .

It is the signal within a system – Special cause variation is a variability that comes from some extraordinary event January 2014 Quality Management 35 . – Special-cause variation always arrives as a surprise.Control Chart • Special Cause Variation – Variation that demonstrates a deviation from the process’ “steady state”.

Control Chart Two different sorts of data: • Data collected by counting: – Attribute/discrete data charts – Number of wrong invoices received per day • Data collected by measurements: – Variable/ continue data charts – Percentage of alcohol in beer January 2014 Quality Management 36 .

– Range of a set of data is the difference between the largest and smallest values January 2014 Quality Management 37 .Control Chart Two different control charts: • The p-chart is used to monitor the number of (non) conforming units in a sample • The x and R chart is used to monitor a variable's data when samples are collected at regular intervals from a business or industrial process.

01481 0. n=500 invoices are sampled. 1 UCL=0.06 0.08 0.Run (p) chart Each week.3% Wk 4 – 4. P Chart of Rejcted Invoices 0.04126 P=0.2% Wk 3 – 5.10 0.03 0.5% Etc.0416 0.02 LCL=0.01 2 January 2014 4 6 8 10 12 Week 14 Quality Management 16 18 20 38 .04 0.09 0.9% Wk 5 – 2.05 _ Average = 0.06839 0.07 Proportion Wk 1 – 4% Wk 2 – 5. The percentage of invoices needing correction is plotted for 20 weeks.

Control Chart On Control chart. January 2014 Quality Management 39 . and a process average are added. an upper control limit. but a lower control limit. data are plotted just as they are on a run chart.

Control Chart • Control limits are statistical bounds that define the region within which the process naturally varies. • These bounds are computed from the data. January 2014 Quality Management 40 .

06839 LCL=0. 01481 January 2014 Quality Management 41 .0416+3 0.02679= 0.0416 – 0.052+0.053+0.0416 ( 1 – 0.02679 = 0.04+0.025)/5 UCL=0.049+0.Upper and Lower Control Limit (UCL & LCL) for p chart UCL/LCL = p = average of all p values: (0.04126 + 0.0416) 500 = 0.

02 LCL=0.01481 0.01 2 4 6 8 10 12 Week 14 16 18 20 When the process randomly fluctuates within the control limits.09 0.03 0.10 Upper Control Limit 1 0. or in statistical control.07 UCL=0.05 _ P=0. January 2014 Quality Management 42 . it is impacted only by common causes of variation and considered stable.08 Within Control Limits Proportion 0.04 Lower Control Limit 0.Control (p) Chart P Chart of Rejcted Invoices 0.73% of all the points will fall between the control limits.06839 0. If the process is in control . 99.06 0.0416 0.

02 LCL=0.08 Proportion 0.0416 0.01481 0.06 0.04 0.06839 0. Special Cause Variation Variation that demonstrates a deviation from the process’ “steady state”.Control (p) Chart .09 0.03 0. January 2014 UCL=0.01 2 4 6 8 10 12 Week Quality Management 14 16 18 20 43 .05 _ P=0. inherent process variation – the “steady state” variation that persists over time.10 1 0. P Chart of Rejected Invoices P Chart of Rejcted Invoices 0.07 Common Cause Variation Routine.

Run (x) Chart Range Range of Daily Production Cost per Week Week Number January 2014 Quality Management 44 .

both for the process averages (x) and for the ranges (R) January 2014 Quality Management 45 . an upper control limit. we need to establish a lower control limit.Control Chart To construct a Control chart.

0 + ( 0 .0 4.4 9.577  6 .0 8.282 2.0 8.000 0.7 ) = 1 .0 4.0 6.0 1.0 6.1 16.Control (x – R) Chart UCL = 8.0 8.1 Subgroup Size (n) 2 3 4 5 A2 1.0 3.577  6 .0 5.2 8.0 Quality Management UCL UCL LCL LCL x x x x = X + A2 R = 5 .267 2.0 2.0 10.0 6.000 D4 3.0 2.0 .0 8:30 7.0 7.0 2.0 3.574 2.0 1. 6.0 LCL 0.0 X chart Compute and plot the control limits for the “Averages” chart.880 1.0 3.0 2.577 D3 0.000 0.0 LCL 0.114 46 .0 5.0 9:30 10:00 10:30 11:00 9.0 3.0 4.0 6.0 UC L 8.0 6.0 8.729 0.0 2.7 ) = 8 .0 3.6 3.6 4.( 0 .0 4.0 LCL = 1.023 0.0 8.000 0.0 7.0 9:00 5.9 = X .0 4.0 2.0 R 4.0 Sample # 1 2 3 4 5 Average Range January 2014 8:00 10.0 6.0 1.6 8.0 4.A 2R = 5 .0 2.6 5.0 4.0 10.0 R chart UC L 12.9 10.0 5.0 6.0 9.

0 6.0 6.0 LCL = 1.000 D4 3.1 16.6 4.Control (x – R) Chart UCL = 8.000 0.0 10.0 2. 6.0 1.0 9:00 5.0 6.0 7.114 x 6.0 1.0 5.0 5.729 0.0 3.0 8:30 7.0 X chart Compute and plot the control limits for the “Range” chart.0 3.0 6.0 2.0 6.0 6.2 8.574 2.0 4.0 6.0 1.7 = 14 LCL 9:30 10:00 10:30 11:00 9.0 3.267 2.0 8.0 4.0 10.0 LCL = D3R LCL = 0 x 6.0 2.114 47 .880 1.0 3.0 2.0 UCL = 14 UC L 12.0 4.0 Sample # 1 2 3 4 5 Average Range January 2014 8:00 10.000 0.0 R 4.0 UC L 8.577 D3 0.0 7.0 2.0 Quality Management Subgroup Size (n) 2 3 4 5 A2 1.0 LCL = 0 0.0 4.6 8.0 3.9 10.0 2.0 8.000 0.6 5.4 9.0 LCL 0.0 8.0 2.023 0.0 4.6 3.7 = 0 UCL = D4R UCL = 2.0 4.0 4.0 9.0 8.282 2.0 R chart 8.0 5.

the plotted data stays between the upper control limit and lower control limit while varying about the center line or average.Control Chart • As long as the variation is the result of common causes such as statistical variation only. January 2014 Quality Management 48 .

Overview of Total Quality Tools Other tools: • • • • • • January 2014 Statistical Process Control (SPC) 5S Flowcharts Input-output diagram Failure mode and effects analysis Design of Experiments (DOE) Quality Management 49 .

Overview of Total Quality Techniques • • • • Process Capability Quality Loss Function and Robust Engineering Risk Assesment Problem Solving and Decision Making – PDCA – 8D – Kepner Traego – Six Sigma January 2014 Quality Management 50 .

the quality of a finished article is ensured by end of line inspection of the product.Statistical Process Control (SPC) • Traditionally. traditionally. • Each article (or a sample of articles from a production lot) may be accepted or rejected according to how well it meets its design January 2014 Quality Management 51 . in mass-manufacturing.

• An advantage of SPC over end of line inspection is that it allows early detection and prevention of problems. rather than the correction of problems after they have occurred January 2014 Quality Management 52 .Statistical Process Control (SPC) • In contrast. SPC use statistical tools to observe the performance of the production process in order to predict significant variations which may result in the production of a sub-standard article.

Statistical Process Control (SPC) • Statistical Process Control (SPC) is a statistical method of separating variation resulting from special causes from natural variation in order to eliminate the special causes. • It is used to monitor processes and indicate when they get out of control • It can be applied to any process January 2014 Quality Management 53 .

• Use a sampling frequency that captures normal changes in the process (changes in material. 2 hr.. operators. (Depending on the process and purpose of the study. • The data within a subgroup should be collected close together in time (for example..Collecting Data for an SPC Chart • At least 20 subgroups of about n=5 data are required. or longer). 30 min.).. January 2014 Quality Management 54 .. etc. 1hr. 5 consecutively produced parts) • Longer time intervals are used between subgroups. these time intervals could be 15 min.

........Collecting Data for an SPC Chart Measure 1 Time 08:00 Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 2 09:00 3 10:00 4 11:00 5 12:00 6 13:00 x R January 2014 7 14:00 . 20 03:00 x= R= Quality Management 55 .

Creating a SPC Chart • Calculate the UCL and LCL – In case of variable data also for the Range • Create a SPC chart with time intervals on the horizontal axis and x or p on the vertical axis – In case of variable data create additional chart for Range • Plot the UCL and LCL on the chart • Start collecting data from the process • Generally. the average and range are monitored simultaneously. so that the entire system can be evaluated January 2014 Quality Management 56 .

SPC (X Bar and R) Chart X Bar Control Chart – Average Daily Production Costs by Week Range of Daily Production Cost per Week January 2014 Quality Management 57 .

Interpretation of SPC charts January 2014 Quality Management 58 .

Interpretation of SPC charts • Out of Control Conditions: • If one or more points falls outside of the upper control limit (UCL). either above or below . see section A • If two out of three successive points fall in the area that is beyond two standard deviations from the mean. either above or below .see section D • If eight or more points fall on either side of the mean .see section E January 2014 Quality Management 59 .see section B • If four out of five successive points fall in the area that is beyond one standard deviation from the mean.see section C • If there is a run of six or more points that are all either successively higher or successively lower . or lower control limit (LCL).

Interpretation of SPC charts January 2014 Quality Management 60 .

design. or service => PROCESS CAPABILITY January 2014 Quality Management 61 .73% of the products are good? • No. product. it only means that the process is under statistical control • To determine if the process is producing only good products we need to understand the relation between control limits and product specification • A specification is an explicit set of requirements to be satisfied by a material.SPC and Process Capability • Does it mean that if all results on an SPC chart are within Control limits at least 99.

Normal Distribution
• The central limit theorem states that under certain
(fairly common) conditions, the sum of many random
variables will have an approximately normal
distribution
U p p e r C o n tr o l L im i t

L o w e r C o n tr o l L im i t
January 2014

Quality Management

62

Properties of the Normal Distribution

68% of parts will fall
between
+/- 1 standard deviations
from the mean
January 2014

95% of the parts will fall
between
+/- 2 standard deviations
from mean
Quality Management

99.73% of the parts will fall
between
+/- 3 standard deviations
from mean
63

Standard deviation (Sigma)

January 2014

Quality Management

64

Standard deviation (Sigma) The standard deviation of a statistical population is the square root of its variance January 2014 Quality Management 65 .

and take the square root: • This is the population standard deviation. and square the result of each: • Next compute the average of these values. it is equal to the square root of the variance. January 2014 Quality Management 66 .Example • Consider a population consisting of the following eight values: 2 4 4 4 5 5 7 9 • These eight data points have the mean (average) of 40:8 =5 • To calculate the population standard deviation. first compute the difference of each data point from the mean.

"parent" population. drawn from some larger. then we should have used 7 (which is n − 1) instead of 8 (which is n) in the denominator of the formula. • If they instead were a random sample. and then the quantity thus obtained would have been called the sample standard deviation January 2014 Quality Management 67 .Population vs sample standard deviation • The formula is valid only if the eight values we began with form the complete population.

Capable process January 2014 Quality Management 68 .Process capability • Process capability shows the relationship between the natural process limits (the control limits) and specifications • Process in (statistical) control vs.

LSL USL  Specification limits are decided by people.Specification Limits LCL UCL Specification Limits are applied to individual measurements.  Control limits are determined by the data (voice of the process). January 2014 Quality Management 69 .

0 LSL 1.m.0 1.0 0.5 1.5 1.) 20 Frequency 15 10 5 After Modified Collision Sensor Installed BETTER CAPABILITY 0.0 1.5 1.m.5 70 .5 USL Cut Dimension (mm) Histogram of Dimension B (m.5 2.Process Capability Improvement Cut Dimension (mm) Histogram of Dimension B Initial State: POOR CAPABILITY 25 Frequency 20 15 10 5 0 0.5 2.0 2.5 LSL 2.0 A fter 2.) 16 14 After Auto Clamp Installed HIGH PROCESS CAPABILITY! 12 Frequency 0 10 8 6 4 2 0 January 2014 Quality Management 0.0 0.5 USL Cut Dimension (mm) Histogram of Dimension B (m.0 2.0 0.

LSL USL Cp Index Demonstrates Potential Capability Cp = (USL – LSL)/ 6s Cp = 1 3s LSL USL 3s  Cp is the ratio of Total Tolerance to the 6s Process Spread. Cp =1. Quality Management 71 .  It shows how capable the process would be if it were perfectly centered.33  Cp = Potential Capability USL 4s LSL 4s Cp = 2 6s January 2014 6s This is a “Six Sigma” process.

Cp = Cpk.33 Cp = 2 Cpk = 2 January 2014 Quality Management Cpk takes into account any offcentering that actual occurs.USL – Avg. 72 . Cpk = 3s USL LSL Cpk Index Demonstrates Actual Capability Cp = 2 Cpk = 1. When process is centered.

Process Sigma Level .Table PPM Sigma Level 3.5 sigma shift. it would probably exhibit 2.5 Sigma capability in the long term.  For example: if a process exhibits 4 Sigma capability in the short term. January 2014 Quality Management 73 .4 6 233 5 6210 4 66807 3 308538 2 691462 1  Six Sigma “thinking” employs a 1.

January 2014 Quality Management 74 .Process Performance Index (Pp and Ppk) • Process Performance Index basically tries to verify if the sample that you have generated from the process is capable to meet the requirements • It differs from Process Capability (Cp & Cpk) in that Process Performance only applies to a specific batch of material. • An example of this is for a short preproduction run.

Process Control and Capability • Examples of process control and capability • Three different production processes January 2014 Quality Management 75 .

35 _ _ X=1.1916 3 6 9 12 15 Sample 18 21 24 27 30 U C L=0.30 1.1 0.4 0.3022 1.1917 0.2 0.4127 Sample Mean 1.40 1.3 _ R=0.0 LC L=0 3 January 2014 6 9 12 15 Sample 18 Quality Management 21 24 27 30 76 .Process Control and Capability Process In Control (Stable) Xbar-R Chart of Nugget Diameter U C L=1.4053 Sample Range 0.20 LC L=1.25 1.

08 E xp.26 1.Process Control and Capability Process Is Capable (Cpk > 1.90 O bserv ed P erformance P P M < LS L 0.80000 Target * USL * S ample M ean 1.00 1.00 PPM > USL * P P M Total 0.01 C C pk 2.62 * 2.00 PPM > USL * P P M Total 0.00 PPM > USL * P P M Total 0.00 January 2014 1. O v erall P erformance P P M < LS L 0. Within P erformance P P M < LS L 0.44 1.08320 S tD ev (O v erall) 0.00 Quality Management 77 .67) Process Capability of Nugget Diameter LSL P rocess D ata LS L 0.80 E xp.01 C PU * C pk 2.30220 S ample N 150 S tD ev (Within) 0.06 * 1.01 O v erall C apability Pp PPL PPU P pk C pm 0.06 * 2.08138 W ithin Ov erall P otential (Within) C apability Cp * C PL 2.

0 727.5 _ _ X=725.55 15 10 _ R=7.Process Control and Capability Process In Control (Stable) Xbar-R Chart of Preform Length U C L=730.5 720.25 725.85 Sample Mean 730.64 2 4 6 8 10 12 14 Sample 16 18 20 22 24 20 Sample Range U C L=17.69 5 0 LC L=0 2 January 2014 4 6 8 10 12 14 Sample 16 Quality Management 18 20 22 24 78 .0 722.0 LC L=719.

33 P P M Total 8333.4 P P M Total 13481.0 P P M > U S L 13481.Process Control and Capability Process Is Not Capable (Ppk < 1.69 P pk 0.83 PPL 1.00 P P M > U S L 8333.20479 O v erall C apability Pp 0.21482 S ample N 120 S hape 1.67) Process Capability of Preform Length Calculations Based on Weibull Distribution Model LSL USL P rocess Data LS L 700.00000 S ample M ean 708.69 E xp.67064 S cale 7.84297 Threshold 701.4 O bserv ed P erformance P P M < LS L 0.22 PPU 0.00000 Target * USL 720. O v erall P erformance P P M < LS L 0.33 700 January 2014 704 708 712 716 Quality Management 720 724 79 .

029480 0.002468 0.029 _ _ X=0.026634 2 4 6 8 10 12 14 Sample 16 18 20 22 24 0.Process Control and Capability Process Not In Control (Not Stable) Xbar-R Chart of Strip Caster Thickness Special Cause Sample M ean 0.031 1 0.0045 0.0060 Sample Range U C L=0.028 0.0000 LC L=0 2 January 2014 4 6 8 10 12 14 Sample 16 Quality Management 18 20 22 24 80 .027 LC L=0.030 U C L=0.0030 _ R=0.028057 0.005218 0.0015 0.

030 5 0 0.034 81 .028 Thickness Quality Management 0.032 0.022 0.Process Control and Capability Process Is Not Capable (Cpk will be calculated after special cause is eliminated.) Histogram of Strip Caster Thickness 20 Frequency 15 LSL= 0.024 10 USL= 0.020 January 2014 0.030 0.026 0.024 0.

• Create control chart and assess stability. and verify measurement system • Determine appropriate sub grouping. – If special cause(s) present. then remove the special cause(s). and collect data in time order. collect new data. (Apply problem solving: KT.Process Control and Capability • Determine what to measure.) January 2014 Quality Management 82 . 8D. etc.

and collect new data. – Compute Cpk or Ppk. PPM. (Note: Cpk/Ppk > 1. evaluate process capability. – If not capable.67 is often the goal. then reduce variation (conduct DOE if needed).Process Control and Capability • Once stable.) • Establish preventive maintenance (needed to maintain stable & capable condition). – Check for normality. – Make histogram. January 2014 Quality Management 83 .

and therefore predictable • Common Capability Indices: – Cp. and for processes that have not yet been stabilized). Cpk (used when data is normal and process is in control) – Pp.Process Control and Capability • A process is in statistical control when it is stable over time. January 2014 Quality Management 84 . Ppk (used for non-normal data.

Process Control and Capability
• If we produce a product in a stable and
capable process it means that almost all parts
are produced within the tolerance limits
(99,9777% with Cpk of 1,67)
• Does that mean that all those products have
same quality?

January 2014

Quality Management

85

Quality Loss Function (Taguchi)
• Taguchi showed that "loss" in capabilities did not
begin only after exceeding these tolerances, but
increased as described by the Taguchi Loss
Function at any condition exceeding the nominal
condition
• The customer wants a target value
– => any deviation will cause loss

• The quality loss function attempts to measure
quality as loss due to deviation from target
• Highest quality system is the one which has the
least functional variability
January 2014

Quality Management

86

Quality Loss Function
The quality loss function is quantitative evaluation of
loss caused by functional variation of a product
LSL

January 2014

USL

Quality Management

87

Another approach • Robust Engineering January 2014 Quality Management 88 .Quality Loss Function • Quality Loss Function approach aims at improving Quality by reducing the functional variation of a product.

January 2014 Quality Management 89 .Robust Engineering • Robustness is the state where technology. product or process performance is minimally sensitive to factors causing variability (in user’s environment and manufacturing) at the lowest cost.

Robust Engineering • Robust Engineering is prevention.  How to reduce variability in product function.  How to reduce cost. • Robust Engineering focuses on …  How to prevent failures. January 2014 Quality Management Applicable in: •Electronic •Mechanical •Chemical •Software Engineering Systems 90 .

Robust Engineering All failures and defects are caused by 3 types of noise:  Various usage conditions •End-user/ Environmental conditions •Neighboring subsystems  Deterioration or wear (degradation over time)  Individual difference (manufacturing imperfections) How can we prevent problems due to these types of noise factors? January 2014 Quality Management 91 .

Robust Engineering Countermeasures against Noise 1. Control/ eliminate Noise (reactive) (standardization. the less money we spend on the others. Tolerance design) 3. Compensate effect of Noise (feedback control. feed-forward control) 4. Ignore 2. January 2014 Quality Management 92 . control charting. Error Proofing. Minimize effect of Noise (proactive) (Robust optimization – Parameter Design) $$$ The more we can do #4.

Robust Engineering • Quality Loss Function approach aims at improving Quality by reducing the functional variation of a product. while • Robust Engineering approach aims at improving Quality by minimizing the sensitiveness of a product to factors causing variability (noise) January 2014 Quality Management 93 .Quality Loss Function vs.

Robust Engineering Quality Loss Function Quality Loss Robust Engineering 0 Value Target January 2014 Quality Management 94 .Quality Loss Function vs.

January 2014 Quality Management 95 .5S • 5S is the name of a workplace organization methodology • It describes how to organize a work space for efficiency and effectiveness by identifying and storing the items used. and sustaining the new order. maintaining the area and items.

Seiton. effective response.Separate and Scrap – Sort useful form useless • 2S – Straighten – Everything in its place • 3S – Scrub – Workplace and equipment clean • 4S – Standardize – Select the best practice • 5S – Sustain – Make sure rules are followed By organizing the workplace. January 2014 Quality Management 96 . unstable or wasteful situations become visible earlier.5S (Seri. allowing for a quick. Shitsuke) • 1S . Seiso. Seiketsu.

Purpose of 5S A structured system to make abnormalities stick out These abnormalities can then be addressed January 2014 Quality Management 97 .

5S example January 2014 Quality Management 98 .

Flowchart A flowchart is a picture of the separate steps of a process in sequential order High level flowchart January 2014 Quality Management 99 .

Flowchart Detailed flowchart January 2014 Quality Management 100 .

The Input-Process-Output (IPO)
Diagram
• IPO Diagrams are “high-level” process maps.
– Input: Substance(s) that enter the system.
– Process: Actions taken upon or using the
input.
– Output: Tangible item(s) that result from
the processing, and exit the process.

January 2014

Quality Management

101

IPO - High Level Process Maps
“Hire Employee”

INPUTS

PROCESS

OUTPUTS

Post Position
• Personnel Request Form
• Candidates for the
position
• Resumes

Review Resumes
Select Candidates

• Person placed in position
• Rejected candidates
• Closed-out PR Form

Interview
Make Offer

January 2014

Quality Management

102

Risk Assessment
• Risk assessment is the determination of
quantitative or qualitative value of risk related
to a concrete situation and a recognized threat
• Quantitative risk assessment requires
calculations of two components of risk (R):,
the magnitude of the potential loss (L), and
the probability (p) that the loss will occur
• Total Risk: R = L x p
January 2014

Quality Management

103

Both in the production phase and usage phase • Producer and/or distributor has a moral and legal responsibilty for the risks in usage phase. health. January 2014 Quality Management 104 . In the first line these are safety risks (danger to human life.Risk Assessment • Important problem of products are risks which are caused by bad or insufficent quality. property). .

Risk Assessment Damage occurence Area of extreme risks often possible seldom not probable small January 2014 medium big Quality Management catastrop hic Potential damage 105 .

and others who make products available to the public are held responsible for the injuries those products cause. • Although the word "product" has broad meaning. distributors.Product liability • Product liability is the area of law in which manufacturers. January 2014 Quality Management 106 . retailers. product liability as an area of law is traditionally limited to products in the form of tangible personal property. suppliers.

and these dangers are present regardless of how well the product is manufactured and designed for its intended purpose. – Design defects occur where the product design is inherently dangerous or useless (and hence defective) no matter how carefully manufactured • Failure to warn – Failure-to-warn defects arise in products that carry inherent nonobvious dangers which could be mitigated through adequate warnings to the user. – Manufacturing defects are those that occur in the manufacturing process and usually involve poor-quality materials or poor workmanship • Design defect.Product liability Types of liability: • Manufacturing defect. January 2014 Quality Management 107 .

o odpovědnosti za škodu způsobenou vadou výrobku January 2014 Quality Management 108 . 59/1998 Sb.Product liability European Union: European Union Directive 85/374/EEC Czech Republic Zákon č.

Risk management • In design and development – – – – DFMEA Design verification Design validation Prototyping and testing • In production – – – – – PFMEA SPC Poka Yoke Final product inspection / Product audit (Quick) Problem Solving January 2014 Quality Management 109 .

especially ones that affect the customer. Failures are any errors or defects. or a product or service. in which something might fail. January 2014 Quality Management 110 . and can be potential or actual. • “Effects analysis” refers to studying the consequences of those failures. • “Failure modes” means the ways. or modes.FMEA • Failure modes and effects analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design. a manufacturing or assembly process.

January 2014 Quality Management 111 . • Failure modes and effects analysis also documents current knowledge and actions about the risks of failures. • FMEA is used during design to prevent failures. • Ideally. starting with the highest-priority ones. FMEA begins during the earliest conceptual stages of design and continues throughout the life of the product or service. for use in continuous improvement.FMEA • The purpose of the FMEA is to take actions to eliminate or reduce failures.

FMEA • Failures are prioritized according to – how serious their consequences are • (severity) – how frequently they occur • (occurrence) – how easily they can be detected • (detection). January 2014 Quality Management 112 .

the failure may result unsafe operation and possible injury) Detection • • • • • • • Rating 1 2 3 4/5/6 7/8 9/10 January 2014 Meaning Certain .Occurrence • • • • • • Rating 1 2/3 4/5/6 7/8 9/10 Meaning No known occurrences on similar products or processes Low (relatively few failures) Moderate (occasional failures) High (repeated failures) Very high (failure is almost inevitable Severity • • • • • • • Rating 1 2 3 4/5/6 7/8 9/10 Meaning No effect Very minor (only noticed by discriminating customers) Minor (affects very little of the system.fault will be caught on test Almost Certain High Moderate Low Fault will be passed to customer Quality Management 113 . customers angered. customers are dissatisfied) Very high and hazardous (product becomes inoperative. noticed by average customer) Moderate (most customers are annoyed) High (causes a loss of primary function.

FMEA process RPN (Risk Priority Number) = S x O x D January 2014 Quality Management 114 .

FMEA example January 2014 Quality Management 115 .

FMEA example January 2014 Quality Management 116 .

FMEA cycle January 2014 Quality Management 117 .

Types of FMEA • Process: analysis of manufacturing and assembly processes • Design: analysis of products prior to production • Concept: analysis of systems or subsystems in the early design concept stages • Equipment: analysis of machinery and equipment design before purchase • Service: analysis of service industry processes before they are released to impact the customer • System: analysis of the global system functions • Software: analysis of the software functions January 2014 Quality Management 118 .

• DOE allows multiple factor adjustments simultaneously • It reduces the number of tests needed to find an optimal situation by factor 10 • It also shows which factors are critical and which are not January 2014 Quality Management 119 .Design of Experiments • Design of experiments (DOE) is a sophisticated method for experimenting with complex processes for the purpose of optimizing them.

It is about continual improvement. put another way. the discrepancy between the current and the desired state of affairs. January 2014 Quality Management 120 .Problem Solving and Decision Making • A problem is a situation in which what exists does not match what is desired or. • Problem solving in a total quality setting is not about putting out fires.

Recommended tools:        January 2014 Cause-and-effect diagrams Flowcharts Pareto charts Run charts Histograms Control charts Scatter diagrams Quality Management 121 .Problem Solving and Decision Making • Securing reliable information is an important part of problem solving and decision making.

PDCA Identify and analyze the problem. Standardize the solutions January 2014 Develop and implement the solution Evaluate the actual results (measured and collected in "DO" above) and compare against the expected results (targets or goals from the "PLAN") to ascertain any differences Quality Management 122 . Set a measurable goal . Identify root cause(s) of the problem Request corrective actions on significant differences between actual and planned results .

8D methodology (TOPS) January 2014 Quality Management 123 .

• D1: Team: – Establish a team of people with product/process knowledge. and how many (5W2H) for the problem. how.8D methodology • D0: Problem Awareness: – Plan for solving the problem and determine the prerequisites. where. January 2014 Quality Management 124 . when. why. what. • D2: Defining the Problem: – Specify the problem by identifying in quantifiable terms the who.

January 2014 Quality Management 125 .8D methodology • D3: Contain : – Define and implement containment actions to isolate the problem from any customer – Verify effectiveness of actions • D4: Diagnose (Define and verify root causes) : – Identify all applicable causes that could explain why the problem has occurred. – Identify why the problem has not been noticed at the time it occurred. – All causes shall be verified or proved by experimentation and statistical data. not determined by fuzzy brainstorming.

• D8: Closure: – Recognize the collective efforts of the team. operation systems. practices. and procedures to prevent recurrence of this and all similar problems.8D methodology • D5: Action (Choose and verify permanent corrective actions) – Verify that the correction will actually solve the problem – Evaluate the degree of problem reduction or elimination • D6: Verify – Verify the effectiveness of the corrective actions • D7: Prevent (Take Preventive Measures): – Modify the management systems. January 2014 Quality Management 126 .

8D and FMEA • The Failure Modes in a FMEA are equivalent to the problem statement or description in an 8D. • Causes in a FMEA are equivalent to potential causes in an 8D. • Effects of failure in a FMEA are problem symptoms in an 8D. January 2014 Quality Management 127 .

 Ask "Why this problem happened?" to discover its underlying problem then ask "Why?" again to go deeper by another level until you reach the root cause.Diagnose the problem Basic 5 times Why The intent of asking "Five times Why“ is to assure that the root causes and not symptoms are corrected.  The "Five-Why Process" was introduced at Toyota to find solution to manufacturing problems. but this approach can be applied to any other area as well. Continuous January 2014 Improvement Quality Management 128 .

5 times Why Why did the machine stop? A fuse in the machine has blown Why did the fuse blow? Circuits overloaded Why did the circuit overload? The bearings have been damaged and locked up Why have the bearings been damaged? There was insufficient lubrication Why was there insufficient lubrication? The oil pump on the machine is not circulating enough oil Why is the pump not circulating enough oil? Pump intake is clogged with metal shavings Why is the intake clogged with metal shavings? There is no filter on the pump intake Asking "why" repeatedly. so problems can be solved permanently. directs the focus towards real causes. possibly more than five times. Continuous January 2014 Improvement Quality Management 129 .

systems or processes are not performing as expected. machinery.  The PA process describes the problem with a clear Problem Statement and Problem Specification (“IS / IS NOT”).  When people. Continuous January 2014 Improvement Quality Management 130 . problem analysis provides a structured process to identify and verify the cause.D4 – Use Problem Solving Tools to Diagnose the probable Root Cause “Problem Analysis (PA)“ is used to find the true cause of a positive or negative deviation.

IS / IS NOT Continuous January 2014 Improvement Quality Management 131 .

for problem solving and process improvements is Six Sigma January 2014 Quality Management 132 .Six Sigma • The most complex and sophisticated methodology. within Total Quality.