FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. A presentation compiled from material freely available on the WEB to introduce the concepts of QbD for beginners.
Introduction & Basics of DoE
Terminologies
Key steps in DOE
Softwares used for DOE
Factorial Designs ( Full and Fractional)
Mixture Designs
Response Surface Methodology
Central Composite Design
Box -Behnken Design
Conclusion
References
It is a graded seminar presentation of Mohammad Abuzar Shaikh Umer on the topic of quality by design (QbD) with case study on naproxen enteric coated pallets model for QbD study.by using plackette burman boxe behnken design and statistical analysis by using ANOVA.
Approaches to Experimentation
What is Design of Experiments
Definition of DOE
Why DOE
History of DOE
Basic DOE Example
Factors, Levels, Responses
General Model of Process or System
Interaction, Randomization, Blocking, Replication
Experiment Design Process
Types of DOE
One factorial
Two factorial
Fractional factorial
Screening experiments
Calculation of Alias
DOE Selection Guide
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part III in the series- deals with the concepts of critical material attributes, critical process parameters , their linage to the the critical Quality attributes of the Product and Quality Risk Management and its pivotal role in the QbD process.Concepts of control strategy are also discussed briefly.
This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
Value Stream Mapping is a key component of Value Stream Management – the process by which Lean concepts and tools are utilized to minimize waste and promote one piece flow pulled by customer demand through the entire operation.
Introduction & Basics of DoE
Terminologies
Key steps in DOE
Softwares used for DOE
Factorial Designs ( Full and Fractional)
Mixture Designs
Response Surface Methodology
Central Composite Design
Box -Behnken Design
Conclusion
References
It is a graded seminar presentation of Mohammad Abuzar Shaikh Umer on the topic of quality by design (QbD) with case study on naproxen enteric coated pallets model for QbD study.by using plackette burman boxe behnken design and statistical analysis by using ANOVA.
Approaches to Experimentation
What is Design of Experiments
Definition of DOE
Why DOE
History of DOE
Basic DOE Example
Factors, Levels, Responses
General Model of Process or System
Interaction, Randomization, Blocking, Replication
Experiment Design Process
Types of DOE
One factorial
Two factorial
Fractional factorial
Screening experiments
Calculation of Alias
DOE Selection Guide
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Technology Transfer and Scale-up in Pharmaceutical IndustryPranjalWagh1
Transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites”.
In Pharmaceutical Industry, technology transfer refers to the processes that are needed for successful progress from drug discovery to product development to clinical trials to full scale commercialization.
It is basically divided into three phases - Research Phase, Development Phase and Production Phase. The presentation elaborates on the technology transfer taking place in production phase. Production phase mainly concerns with validation studies and scale-up.
Validation studies such as performance qualification, cleaning validation and process validation is carried out by R&D department.
Scale-up involves the use of results obtained from lab studies for designing prototype of a product and pilot plant process, constructing pilot plant and further using pilot plant data for full-scale commercialization.
FDA’s emphasis on quality by design began with the recognition that increased testing does not improve product quality (this has long been recognized in other industries).In order for quality to increase, it must be built into the product. To do this requires understanding how formulation and manufacturing process variables influence product quality.Quality by Design (QbD) is a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
This presentation - Part III in the series- deals with the concepts of critical material attributes, critical process parameters , their linage to the the critical Quality attributes of the Product and Quality Risk Management and its pivotal role in the QbD process.Concepts of control strategy are also discussed briefly.
This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
Value Stream Mapping is a key component of Value Stream Management – the process by which Lean concepts and tools are utilized to minimize waste and promote one piece flow pulled by customer demand through the entire operation.
Measurement System Analysis is the first step of the Measure Phase of an improvement project. Before you can pass judgment on the process, you need to ensure that your measurement system is accurate, precise, capable and in control.
Response Surface Regression - a useful tool for data mining, historical data analysis, and identifying critical factors in your process optimization efforts.
In this session from the Institute of Validation Technology's Validation Week Europe, Kurtis Epp and John Kandl discuss how to implement QbD to all three stages of process validation.
Introduction to Design of Experiments by Teck Nam Ang (University of Malaya)Teck Nam Ang
This set of slides explains in a simple manner the purpose of experiment, various strategies of experiment, how to plan and design experiment, and the handling of experimental data.
Experimental methods are widely used in industrial settings and research activities. In industrial settings, the main goal is to extract the maximum amount of unbiased information regarding the factors affecting production process form few observations, whereas in research, ANOVA techniques are used to reveal the reality. Drawing inferences from the experimental result is an important step in design process of product. Therefore, proper planning of experimentation is the precondition for accurate conclusion drawn from the experimental findings. Design of experiment is powerful statistical tool introduced by R.A. Fisher in England in the early 1920 to study the effect of different parameters affecting the mean and variance of a process performance characteristics
Taguchi's orthogonal arrays are highly fractional orthogonal designs. These designs can be used to estimate main effects using only a few experimental runs.
Consider the L4 array shown in the next Figure. The L4 array is denoted as L4(2^3).
L4 means the array requires 4 runs. 2^3 indicates that the design estimates up to three main effects at 2 levels each. The L4 array can be used to estimate three main effects using four runs provided that the twthree-factoro factor and three factor interactions can be ignored.
Critical Checks for Pharmaceuticals and Healthcare: Validating Your Data Inte...Minitab, LLC
Watch online at: https://hubs.ly/H0hswm60
Organizations in the pharmaceutical and health sectors are being asked by regulators to:
- Apply more complete methods to validate analytical techniques and measurement systems, known as Data Integrity
-Monitor and evaluate the performance of production processes, otherwise called Statistical Process Control (SPC)
In this presentation you will learn how to:
-Improve the precision and accuracy of analytical techniques, using Minitab's tools for Gage R & R, Gage Linearity and Bias studies and Design of Experiments
-Select the relevant control charts and capability analyses for data that does and does not follow the normal distribution
The presentation will explain how data integrity and process monitoring are critical to each other for regulatory compliance. If the data is not healthy, the evaluation of the process could also be incorrect.
You will finish with the confidence to use more sophisticated statistical techniques, in particular for data integrity.
Upfront Thinking to Design a Better Lab Scale DoEplaced1
Presentation Given at AIChE 2009 and the Dynochem User meeting. Discussion on using mechanistic modeling to support DoE investigations and QbD initiatives for single reaction steps.
Using recycled concrete aggregates (RCA) for pavements is crucial to achieving sustainability. Implementing RCA for new pavement can minimize carbon footprint, conserve natural resources, reduce harmful emissions, and lower life cycle costs. Compared to natural aggregate (NA), RCA pavement has fewer comprehensive studies and sustainability assessments.
Welcome to WIPAC Monthly the magazine brought to you by the LinkedIn Group Water Industry Process Automation & Control.
In this month's edition, along with this month's industry news to celebrate the 13 years since the group was created we have articles including
A case study of the used of Advanced Process Control at the Wastewater Treatment works at Lleida in Spain
A look back on an article on smart wastewater networks in order to see how the industry has measured up in the interim around the adoption of Digital Transformation in the Water Industry.
Student information management system project report ii.pdfKamal Acharya
Our project explains about the student management. This project mainly explains the various actions related to student details. This project shows some ease in adding, editing and deleting the student details. It also provides a less time consuming process for viewing, adding, editing and deleting the marks of the students.
Sachpazis:Terzaghi Bearing Capacity Estimation in simple terms with Calculati...Dr.Costas Sachpazis
Terzaghi's soil bearing capacity theory, developed by Karl Terzaghi, is a fundamental principle in geotechnical engineering used to determine the bearing capacity of shallow foundations. This theory provides a method to calculate the ultimate bearing capacity of soil, which is the maximum load per unit area that the soil can support without undergoing shear failure. The Calculation HTML Code included.
NO1 Uk best vashikaran specialist in delhi vashikaran baba near me online vas...Amil Baba Dawood bangali
Contact with Dawood Bhai Just call on +92322-6382012 and we'll help you. We'll solve all your problems within 12 to 24 hours and with 101% guarantee and with astrology systematic. If you want to take any personal or professional advice then also you can call us on +92322-6382012 , ONLINE LOVE PROBLEM & Other all types of Daily Life Problem's.Then CALL or WHATSAPP us on +92322-6382012 and Get all these problems solutions here by Amil Baba DAWOOD BANGALI
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Online aptitude test management system project report.pdfKamal Acharya
The purpose of on-line aptitude test system is to take online test in an efficient manner and no time wasting for checking the paper. The main objective of on-line aptitude test system is to efficiently evaluate the candidate thoroughly through a fully automated system that not only saves lot of time but also gives fast results. For students they give papers according to their convenience and time and there is no need of using extra thing like paper, pen etc. This can be used in educational institutions as well as in corporate world. Can be used anywhere any time as it is a web based application (user Location doesn’t matter). No restriction that examiner has to be present when the candidate takes the test.
Every time when lecturers/professors need to conduct examinations they have to sit down think about the questions and then create a whole new set of questions for each and every exam. In some cases the professor may want to give an open book online exam that is the student can take the exam any time anywhere, but the student might have to answer the questions in a limited time period. The professor may want to change the sequence of questions for every student. The problem that a student has is whenever a date for the exam is declared the student has to take it and there is no way he can take it at some other time. This project will create an interface for the examiner to create and store questions in a repository. It will also create an interface for the student to take examinations at his convenience and the questions and/or exams may be timed. Thereby creating an application which can be used by examiners and examinee’s simultaneously.
Examination System is very useful for Teachers/Professors. As in the teaching profession, you are responsible for writing question papers. In the conventional method, you write the question paper on paper, keep question papers separate from answers and all this information you have to keep in a locker to avoid unauthorized access. Using the Examination System you can create a question paper and everything will be written to a single exam file in encrypted format. You can set the General and Administrator password to avoid unauthorized access to your question paper. Every time you start the examination, the program shuffles all the questions and selects them randomly from the database, which reduces the chances of memorizing the questions.
HEAP SORT ILLUSTRATED WITH HEAPIFY, BUILD HEAP FOR DYNAMIC ARRAYS.
Heap sort is a comparison-based sorting technique based on Binary Heap data structure. It is similar to the selection sort where we first find the minimum element and place the minimum element at the beginning. Repeat the same process for the remaining elements.
Forklift Classes Overview by Intella PartsIntella Parts
Discover the different forklift classes and their specific applications. Learn how to choose the right forklift for your needs to ensure safety, efficiency, and compliance in your operations.
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1. Operational Excellence
Evolutionary Operation
Operational Excellence
Introduction
3/4/2017 Ronald Morgan Shewchuk 1
• The experimental designs we have explored thus far may be considered
revolutionary in nature.
• We purposely chose high and low levels for the input factors that were expected to
make a large change in the output response variable.
• This allowed us to observe changes in the output variable that were not due to
random noise and which permitted mapping of the total response surface.
• Incurring a “bad” result in the output response variable is not considered Faustian
but rather, a natural part of the discovery process.
• There are situations, however, where a reduction in the response variable,
throughput or quality level cannot be tolerated.
• Process improvements in these situations are best deployed through the technique
of Evolutionary Operation.
• Evolutionary Operation (EVOP) was developed by George Box and first published in
his 1957 article Evolutionary Operation: A Method for Increasing Industrial
Productivity in the Journal of Applied Statistics.
2. Operational Excellence
Evolutionary Operation
Operational Excellence
Introduction
3/4/2017 Ronald Morgan Shewchuk 2
• As with many experimental designs, EVOP pre-dates the advent of personal
computers.
• The underlying statistic fundamentals of EVOP have been established for many
years.
• Personal computers, with their associated software programs, simply facilitate the
analysis of the underlying statistics.
• Dr. Box developed a simple worksheet method by which two-level full factorial
experiments with center points are conducted in phases as part of routine
production operations.
• The objective is to nudge the operating parameters along the pathway of steepest
ascent of the response variable without any interruption to the process or any
increase in defective product.
• This nudging process may be visualized as in Figure 9.23 where the boxes
represent individual 22 full factorial experiments.
3. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.23 Successive 22 Full Factorial Experiments Conducted in EVOP
3/4/2017 Ronald Morgan Shewchuk 3
A
B
0.80.70.60.50.40.30.20.10.0
1.75
1.50
1.25
1.00
0.75
0.50
>
–
–
–
–
–
< 70
70 75
75 80
80 85
85 90
90 95
95
Yield
Contour Plot of Yield vs A, B
95
90
85
80
75
70
4. Operational Excellence
Evolutionary Operation
Operational Excellence
Introduction
3/4/2017 Ronald Morgan Shewchuk 4
• Of course, we do not know the surface topography of the response variable, if we
did it would be elementary to dial-in the optimum factor settings.
• Thus, we set the center point of our first experiment at the current operating
conditions and measure the response variable at the high and low tolerances of
the two input factors.
• We must conduct a sufficient number of replicates to ensure that our conclusions
about the direction of steepest ascent are statistically significant and not the result
of random process noise.
• This is not a problem since replicates result in good production lots which we need
to meet market demand.
• Replication is continued within successive cycles until a new optimum corner point
has been validated.
• This milestone represents the conclusion of the first phase of the EVOP.
• The second phase of the EVOP thus begins with its center point at the optimum
corner point identified in phase one.
5. Operational Excellence
Evolutionary Operation
Operational Excellence
Introduction
3/4/2017 Ronald Morgan Shewchuk 5
• The process is continued until the response variable is maximized.
• It is important to recognize that the topography of a response variable is not etched
in stone.
• The response variable surface is influenced by noise factors such as variations in
supplied raw materials, ambient environment, uncontrolled process conditions, etc.
• Consequently, practitioners of EVOP have found it useful to perpetually continue
Evolutionary Operation experiments to account for these noise variables which
move the response variable maxima.
• It is typical for EVOPs to be limited to two factors although the technique can easily
be extrapolated to three or more factors.
• In the latter case, it is best to use a statistical software package to analyze the EVOP
phase results to reduce the chance of transcription errors.
• We will demonstrate the use of Evolutionary Operation to optimize the process of
producing biodiesel in Case Study XVI. The analysis of this case study will be
facilitated by the 22 EVOP Worksheet as shown in Figure 9.24.
6. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.24 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 6
EVOP 2
2
Worksheet
Process:
+1 d b
Cycle n: 1
Factor B 0 z
Phase:
-1 a c
Response:
f(5,n): - -
-1 0 +1
Factor A
Treatment Combination z a b c d
1. Previous Sum Previous Sum of Std Dev
2. Previous Average Previous Avg Std Dev
3. New observation New Std Dev = Range·f(5,n)
4. Difference (2 - 3) Difference Range
5. New sum (1 + 3) New Sum of Std Dev
6. New average: (5 / n) New Avg Std Dev
Date
Time
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = For Averages and New Effects: 2 s-bar / SQRT(n) =
For Change in Center Effect: 1.78 s-bar / SQRT(n) =
B = (b + d - a - c)/2 =
Statistical Significance:
AB = (a + b - c - d)/2 =
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 =
(zero and Max(Effect)) =
Cycle # f(5,n)
Max Point = 1 - -
2 0.30
(zero and Min(Effect)) = 3 0.35
4 0.37
Min Point = 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
7. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 7
Case Study XVI: Optimization of Biodiesel Production Yield by EVOP
Kuwat Pramana is beaming with pride. His small Indonesian start-up company is successfully producing biodiesel from the
transesterification of palm oil. It has been a long, hard road building the reaction, purification and filling plant followed by
the process equipment commissioning and yield ramp. Over several months, Kuwat and his operators have been able to
sustain production yields of 89%. Kuwat can now begin paying back the loan which he received from the Economic
Development Administration in Jakarta to build his facility.
Indonesia has an abundant supply of crude palm kernel oil, the primary raw material used in the transesterification reaction.
The price of palm oil is driven by demand from the food and cosmetics industries. Kuwat has calculated that he must
operate at yields above 88% to ensure that his operation remains profitable. The higher the yield, the quicker he can repay
his loan and reduce his interest expenses.
The transesterification process consists of reacting the crude palm kernel oil with methanol in the presence of a base
catalyst, sodium hydroxide. Glycerine is produced as a by-product of the reaction. Reactant purity, mixing time, reaction
temperature, catalyst type, catalyst concentration, and mass ratio of methanol to oil have been identified as key factors
affecting biodiesel yield. Kuwat has decided to hold all factors constant and use the technique of Evolutionary Operation to
optimize production yield through incremental changes in methanol to oil mass ratio (factor A) and sodium hydroxide
catalyst concentration (factor B) within the reactor. Phase 1 through phase 3 experiments are captured in the EVOP 22
Worksheets of Figures 9.25 through 9.35.
8. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 8
Case Study XVI: Optimization of Biodiesel Production Yield by EVOP
We begin at phase 1, cycle 1 using a new 22 EVOP worksheet. The names of the factors to be optimized are entered in cells
F14 and B7 for factor A and factor B respectively. The biodiesel process is currently operating at a methanol to oil ratio of
0.32 and a catalyst concentration of 0.92 wt % NaOH. These values are entered as the zero point of phase one in cells F11
and D6 respectively. Kuwat does not wish to “upset the apple cart” so he decides with his team that the maximum change in
MeOH : Oil Mass Ratio will be 0.02 units and the maximum change in wt% NaOH will be 0.03%. The high (+1) and low (-1)
values of the factors are entered in the appropriate cells in the worksheet. We now have a game plan to conduct phase one
experiments. The first experiment is conducted at the current factor conditions, point z. The date and time that the
experiment is begun is entered in cells C24 and C25 respectively. The production yield resulting from these factor settings is
entered in the “new observation” line of the table. Rows one and two are left blank for the first cycle of any phase. Rows 4,
5 and 6 are calculated fields based upon rows 1, 2 and 3. Factor settings are next changed to those of point a in the design
box and another batch of biodiesel is produced at these settings. The measured production yield is entered in the new
observation field for treatment combination a. This process is continued for points b, c and d within the design box
concluding phase one cycle one. The average yield for these first five batches of biodiesel is 88.8% which is above Kuwat’s
breakeven point. The maximum yield was obtained at point b and the minimum at point a.
9. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.25 Case Study XVI Phase 1, Cycle 1 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 9
EVOP 2
2
Worksheet
Process: Biodiesel
+1 0.95 d b
Cycle n: 1
Factor B 0 0.92 z
Catalyst Conc (wt % NaOH) Phase: 1
-1 0.89 a c
Response: Yield
0.30 0.32 0.34 f(5,n): - -
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum Previous Sum of Std Dev
2. Previous Average Previous Avg Std Dev
3. New observation 89.0 86.8 90.8 88.4 88.9 New Std Dev = Range·f(5,n)
4. Difference (2 - 3) Difference Range
5. New sum (1 + 3) 89.0 86.8 90.8 88.4 88.9 New Sum of Std Dev
6. New average: (5 / n) 89.0 86.8 90.8 88.4 88.9 New Avg Std Dev
Date Nov 25 Nov 25 Nov 25 Nov 25 Nov 25
Time 07:00 10:00 13:00 16:00 19:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = For Averages and New Effects: 2 s-bar / SQRT(n) = 0
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 0
B = (b + d - a - c)/2 =
Statistical Significance:
AB = (a + b - c - d)/2 =
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 =
(zero and Max(Effect)) =
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Enter Factor Names
Enter Factor Starting,
High and Low Values
Leave Blank
on Cycle 1
Enter Date and Time
Experiment Begun
Block Pt of
Max New Avg
Block Pt of
Min New Avg
10. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 10
Case Study XVI: Optimization of Biodiesel Production Yield by EVOP
Cycle two is a replicate of cycle one. The objective is to generate enough data points to detect a statistically significant signal
that a preferred operating condition exists within the design box. Previous sums and average yields are linked to the new
sums and average yields of the previous cycle. The previous sum of the standard deviation and the previous average
standard deviation are left blank for cycle two. New observations at the five treatment combinations are entered in line
three. This permits the calculation of a new average standard deviation. Since this standard deviation is only based upon ten
data points it is not recommended to make any changes in operating conditions based upon cycle two.
11. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.26 Case Study XVI Phase 1, Cycle 2 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 11
EVOP 2
2
Worksheet
Process: Biodiesel
+1 0.95 d b
Cycle n: 2
Factor B 0 0.92 z
Catalyst Conc (wt % NaOH) Phase: 1
-1 0.89 a c
Response: Yield
0.30 0.32 0.34 f(5,n): 0.30
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 89.0 86.8 90.8 88.4 88.9 Previous Sum of Std Dev
2. Previous Average 89.0 86.8 90.8 88.4 88.9 Previous Avg Std Dev
3. New observation 88.0 90.4 88.8 90.6 88.7 New Std Dev = Range·f(5,n) 1.67
4. Difference (2 - 3) 1.0 -3.6 2.0 -2.2 0.2 Difference Range 5.57
5. New sum (1 + 3) 177.0 177.2 179.6 179.0 177.6 New Sum of Std Dev 1.67
6. New average: (5 / n) 88.5 88.6 89.8 89.5 88.8 New Avg Std Dev 1.67
Date Nov 25 Nov 26 Nov 26 Nov 26 Nov 26
Time 22:00 01:00 04:00 07:00 10:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 0.96 For Averages and New Effects: 2 s-bar / SQRT(n) = 2.36
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 2.10
B = (b + d - a - c)/2 = 0.26
Statistical Significance:
AB = (a + b - c - d)/2 = 0.03
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = 0.52
(zero and Max(Effect)) = -1.27
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = -0.06 3 0.35
4 0.37
Min Point = z 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Copied from New sum and
New average from Cycle 1
Leave Blank
on Cycle 2
Cycle 2 Std Dev is not
reliable - don't make
any decisions based
upon Cycle 2
12. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 12
Case Study XVI: Optimization of Biodiesel Production Yield by EVOP
Cycle three is the third replicate in phase one. Previous sums and averages of the yields are linked to the new sums and new
average yields of the prior cycle. The previous sum of the standard deviation and the previous average standard deviation
are linked to the new sum of the standard deviation and the new average standard deviation of cycle two. The maximum
new average yield is observed at point b while the minimum is observed at point z. The difference between the new average
yield at point b versus point z is 4.03. This value is above the standard error limit of 2.35 for changes in center effect
indicating that we have received a signal that point b represents a better operating condition than point z. But let’s be sure
about this conclusion. We are producing good product without affecting throughput rate or increasing impurities. There is
no harm to seek confirmation.
13. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.27 Case Study XVI Phase 1, Cycle 3 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 13
EVOP 2
2
Worksheet
Process: Biodiesel
+1 0.95 d b
Cycle n: 3
Factor B 0 0.92 z
Catalyst Conc (wt % NaOH) Phase: 1
-1 0.89 a c
Response: Yield
0.30 0.32 0.34 f(5,n): 0.35
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 177.0 177.2 179.6 179.0 177.6 Previous Sum of Std Dev 1.67
2. Previous Average 88.5 88.6 89.8 89.5 88.8 Previous Avg Std Dev 1.67
3. New observation 84.9 88.0 94.5 91.6 88.8 New Std Dev = Range·f(5,n) 2.89
4. Difference (2 - 3) 3.6 0.6 -4.7 -2.1 0.0 Difference Range 8.27
5. New sum (1 + 3) 262.0 265.2 274.1 270.6 266.4 New Sum of Std Dev 4.56
6. New average: (5 / n) 87.3 88.4 91.4 90.2 88.8 New Avg Std Dev 2.28
Date Nov 26 Nov 26 Nov 26 Nov 26 Nov 27
Time 13:00 16:00 19:00 22:00 01:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 2.18 For Averages and New Effects: 2 s-bar / SQRT(n) = 2.63
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 2.35
B = (b + d - a - c)/2 = 0.79
Statistical Significance:
AB = (a + b - c - d)/2 = 0.36
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = 1.89
(zero and Max(Effect)) = -4.03
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = -1.06 3 0.35
4 0.37
Min Point = z 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Copied from New sum and
New average from Cycle 2
Copied from New Sum and
New Avg from Cycle 2
Absolute value of -4.03
exceeds Error Limit of 2.35.
A signal has been received
that point b is better than
point z.
14. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 14
Case Study XVI: Optimization of Biodiesel Production Yield by EVOP
Cycle four represents the fourth replicate. New observations are entered in line three. Point b is observed to represent the
maximum new average yield while point a represents the minimum. The difference between the new average yield at point
b versus point z is 4.01. This value is above the standard error limit of 2.00 calculated for the change in center effect
confirming the signal that point b represents a better operating condition than point z. Kuwat and his team decide to move
the standard operating conditions of the reactor to a MeOH : Oil Mass Ratio of 0.34 and a Catalyst Concentration of 0.95%
NaOH. These conditions will serve as the zero point of phase two. The twenty batches of phase one have been produced at
an average biodiesel yield of 88.9%.
15. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.28 Case Study XVI Phase 1, Cycle 4 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 15
EVOP 2
2
Worksheet
Process: Biodiesel
+1 0.95 d b
Cycle n: 4
Factor B 0 0.92 z
Catalyst Conc (wt % NaOH) Phase: 1
-1 0.89 a c
Response: Yield
0.30 0.32 0.34 f(5,n): 0.37
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 262.0 265.2 274.1 270.6 266.4 Previous Sum of Std Dev 4.56
2. Previous Average 87.3 88.4 91.4 90.2 88.8 Previous Avg Std Dev 2.28
3. New observation 88.7 83.8 92.6 89.1 85.0 New Std Dev = Range·f(5,n) 2.19
4. Difference (2 - 3) -1.3 4.6 -1.3 1.1 3.8 Difference Range 5.92
5. New sum (1 + 3) 350.6 349.0 366.7 359.7 351.5 New Sum of Std Dev 6.76
6. New average: (5 / n) 87.7 87.2 91.7 89.9 87.9 New Avg Std Dev 2.25
Date Nov 27 Nov 27 Nov 27 Nov 27 Nov 27
Time 04:00 07:00 10:00 13:00 16:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 3.24 For Averages and New Effects: 2 s-bar / SQRT(n) = 2.25
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 2.00
B = (b + d - a - c)/2 = 1.19
Statistical Significance:
AB = (a + b - c - d)/2 = 0.56
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = 1.21
(zero and Max(Effect)) = -4.01
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 0.42 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Copied from New sum and
New average from Cycle 3
Copied from New Sum and
New Avg from Cycle 3
Absolute value of -4.01
exceeds Error Limit of 2.00.
Signal has been confirmed -
point b is better than point z.
Move center point operating
conditions to point b for
Phase 2.
16. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 16
Case Study XVI: Optimization of Biodiesel Production Yield by EVOP
Phase two starts with a clean worksheet and a new starting point on the DOE mountain. Remember that we have no idea of
the topography of the yield with respect to factor A and factor B. We are defining a small experimental box
and illuminating the corner points with a penlight to see which corner we should jump to. Phase two, cycle one begins with
the factor settings as shown in Figure 9.25E. The first set of yield observations from the five experiments are entered in line
three. The new sums and averages for these yields are linked to the second cycle, line one and two respectively. The second
cycle yield observations allow the calculation of the standard error limits but as in phase one, we make no decisions based
upon cycle two on account of the uncertainty in the standard deviation. We proceed to cycle three and enter the yield
observations for the five treatment combinations. The maximum new average yield is observed at point b while the
minimum is observed at point a. The difference between the new average yield at point b versus point z is 3.00. This value is
above the standard error limit of 2.55 for changes in center effect indicating that we have received a signal that point b
represents a better operating condition than point z. We could proceed to confirmatory cycles but Kuwat and the operators
are excited about the improvements and would like to change the standard operating conditions of the reactor to point b
and proceed to phase three. The fifteen batches of phase two have been produced at an average biodiesel yield of 90.2%, a
slight improvement over the average yield of 88.9% obtained in phase one.
17. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.29 Case Study XVI Phase 2, Cycle 1 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 17
EVOP 2
2
Worksheet
Process: Biodiesel
+1 0.98 d b
Cycle n: 1
Factor B 0 0.95 z
Catalyst Conc (wt % NaOH) Phase: 2
-1 0.92 a c
Response: Yield
0.32 0.34 0.36 f(5,n): - -
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum Previous Sum of Std Dev
2. Previous Average Previous Avg Std Dev
3. New observation 90.8 89.0 92.4 90.2 90.8 New Std Dev = Range·f(5,n)
4. Difference (2 - 3) Difference Range
5. New sum (1 + 3) 90.8 89.0 92.4 90.2 90.8 New Sum of Std Dev
6. New average: (5 / n) 90.8 89.0 92.4 90.2 90.8 New Avg Std Dev
Date Nov 28 Nov 28 Nov 28 Nov 28 Nov 28
Time 07:00 10:00 13:00 16:00 19:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = For Averages and New Effects: 2 s-bar / SQRT(n) = 0
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 0
B = (b + d - a - c)/2 =
Statistical Significance:
AB = (a + b - c - d)/2 =
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 =
(zero and Max(Effect)) =
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Enter zero point factor
values from point b,
phase 1, cycle 4.
Adjust high and low
values accordingly.
Leave Blank
on Cycle 1
Enter Date and Time
Experiment Begun
Block Pt of
Max New Avg
Block Pt of
Min New Avg
18. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.30 Case Study XVI Phase 2, Cycle 2 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 18
EVOP 2
2
Worksheet
Process: Biodiesel
+1 0.98 d b
Cycle n: 2
Factor B 0 0.95 z
Catalyst Conc (wt % NaOH) Phase: 2
-1 0.92 a c
Response: Yield
0.32 0.34 0.36 f(5,n): 0.30
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 90.8 89.0 92.4 90.2 90.8 Previous Sum of Std Dev
2. Previous Average 90.8 89.0 92.4 90.2 90.8 Previous Avg Std Dev
3. New observation 86.6 86.6 92.3 93.0 91.7 New Std Dev = Range·f(5,n) 2.11
4. Difference (2 - 3) 4.2 2.4 0.1 -2.8 -0.9 Difference Range 7.02
5. New sum (1 + 3) 177.4 175.6 184.7 183.2 182.5 New Sum of Std Dev 2.11
6. New average: (5 / n) 88.7 87.8 92.4 91.6 91.3 New Avg Std Dev 2.11
Date Nov 28 Nov 29 Nov 29 Nov 29 Nov 29
Time 22:00 01:00 04:00 07:00 10:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 2.47 For Averages and New Effects: 2 s-bar / SQRT(n) = 2.98
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 2.65
B = (b + d - a - c)/2 = 2.10
Statistical Significance:
AB = (a + b - c - d)/2 = -1.36
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = 1.64
(zero and Max(Effect)) = -3.65
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 0.92 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Copied from New sum and New
average from Phase 2, Cycle 1
Leave Blank
on Cycle 2
19. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.31 Case Study XVI Phase 2, Cycle 3 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 19
EVOP 2
2
Worksheet
Process: Biodiesel
+1 0.98 d b
Cycle n: 3
Factor B 0 0.95 z
Catalyst Conc (wt % NaOH) Phase: 2
-1 0.92 a c
Response: Yield
0.32 0.34 0.36 f(5,n): 0.35
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 177.4 175.6 184.7 183.2 182.5 Previous Sum of Std Dev 2.11
2. Previous Average 88.7 87.8 92.4 91.6 91.3 Previous Avg Std Dev 2.11
3. New observation 92.7 86.0 94.3 89.5 87.0 New Std Dev = Range·f(5,n) 2.86
4. Difference (2 - 3) -3.9 1.8 -2.0 2.2 4.2 Difference Range 8.17
5. New sum (1 + 3) 270.1 261.6 279.1 272.7 269.5 New Sum of Std Dev 4.97
6. New average: (5 / n) 90.0 87.2 93.0 90.9 89.8 New Avg Std Dev 2.48
Date Nov 29 Nov 29 Nov 29 Nov 29 Nov 30
Time 13:00 16:00 19:00 22:00 01:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 3.45 For Averages and New Effects: 2 s-bar / SQRT(n) = 2.87
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 2.55
B = (b + d - a - c)/2 = 2.39
Statistical Significance:
AB = (a + b - c - d)/2 = -0.27
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = 0.17
(zero and Max(Effect)) = -3.00
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 2.84 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Absolute value of -3.00
exceeds Error Limit of 2.55.
A signal has been received
that point b is better than
point z. Move center point
operating conditions to point
b for Phase 3.
20. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 20
Case Study XVI: Optimization of Biodiesel Production Yield by EVOP
Phase three, cycle one begins at a MeOH : Oil Mass Ratio of 0.36 and a Catalyst Concentration of 0.98% NaOH. The high (+1)
and low (-1) values of the factors are as shown in Figure 9.32. Yield observations at the five treatment combinations are
entered into line three. Similarly, yield observations are entered in cycle two for line three. Cycle three yield observations
result in point b being identified as the new average maximum. The difference between the new average yield at point b
versus point z is 3.89. This value is above the standard error limit of 1.40 for changes in center effect indicating that we have
received a signal that point b represents a better operating condition than point z. But notice that the yield for point a is the
same as point z. This causes Kuwat and the team some concern so they decide to continue at the current operating
conditions to cycle four. Point b is validated in cycle four as the new average yield maximum at 95.8%. The difference
between the new average yield at point b versus point z is 4.53. Since this value is above the standard error limit of 1.34 for
changes in center effect, point b represents a better operating condition than point z. The reactor operating conditions
should be moved to a MeOH : Oil Mass Ratio of 0.38 and a Catalyst Concentration of 1.01% NaOH in phase four. The twenty
batches of phase three have been produced at an average biodiesel yield of 92.5%, a significant improvement over the
average yield of 88.9% obtained in phase one.
21. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.32 Case Study XVI Phase 3, Cycle 1 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 21
EVOP 2
2
Worksheet
Process: Biodiesel
+1 1.01 d b
Cycle n: 1
Factor B 0 0.98 z
Catalyst Conc (wt % NaOH) Phase: 3
-1 0.95 a c
Response: Yield
0.34 0.36 0.38 f(5,n): - -
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum Previous Sum of Std Dev
2. Previous Average Previous Avg Std Dev
3. New observation 92.4 90.8 93.5 91.7 92.4 New Std Dev = Range·f(5,n)
4. Difference (2 - 3) Difference Range
5. New sum (1 + 3) 92.4 90.8 93.5 91.7 92.4 New Sum of Std Dev
6. New average: (5 / n) 92.4 90.8 93.5 91.7 92.4 New Avg Std Dev
Date Dec 1 Dec 1 Dec 1 Dec 1 Dec 1
Time 07:00 10:00 13:00 16:00 19:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = For Averages and New Effects: 2 s-bar / SQRT(n) = 0
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 0
B = (b + d - a - c)/2 =
Statistical Significance:
AB = (a + b - c - d)/2 =
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 =
(zero and Max(Effect)) =
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Enter zero point factor
values from point b,
phase 2, cycle 3.
Adjust high and low
values accordingly.
Leave Blank
on Cycle 1
Enter Date and Time
Experiment Begun
Block Pt of
Max New Avg
Block Pt of
Min New Avg
22. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.33 Case Study XVI Phase 3, Cycle 2 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 22
EVOP 2
2
Worksheet
Process: Biodiesel
+1 1.01 d b
Cycle n: 2
Factor B 0 0.98 z
Catalyst Conc (wt % NaOH) Phase: 3
-1 0.95 a c
Response: Yield
0.34 0.36 0.38 f(5,n): 0.30
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 92.4 90.8 93.5 91.7 92.4 Previous Sum of Std Dev
2. Previous Average 92.4 90.8 93.5 91.7 92.4 Previous Avg Std Dev
3. New observation 91.9 88.5 96.3 90.2 92.7 New Std Dev = Range·f(5,n) 1.55
4. Difference (2 - 3) 0.5 2.3 -2.8 1.5 -0.3 Difference Range 5.16
5. New sum (1 + 3) 184.3 179.3 189.8 181.9 185.1 New Sum of Std Dev 1.55
6. New average: (5 / n) 92.1 89.6 94.9 91.0 92.6 New Avg Std Dev 1.55
Date Dec 1 Dec 2 Dec 2 Dec 2 Dec 2
Time 22:00 01:00 04:00 07:00 10:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 1.84 For Averages and New Effects: 2 s-bar / SQRT(n) = 2.19
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 1.95
B = (b + d - a - c)/2 = 3.44
Statistical Significance:
AB = (a + b - c - d)/2 = 0.51
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = -0.10
(zero and Max(Effect)) = -2.78
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 2.51 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Copied from New sum and New
average from Phase 3, Cycle 1
Leave Blank
on Cycle 2
23. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.34 Case Study XVI Phase 3, Cycle 3 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 23
EVOP 2
2
Worksheet
Process: Biodiesel
+1 1.01 d b
Cycle n: 3
Factor B 0 0.98 z
Catalyst Conc (wt % NaOH) Phase: 3
-1 0.95 a c
Response: Yield
0.34 0.36 0.38 f(5,n): 0.35
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 184.3 179.3 189.8 181.9 185.1 Previous Sum of Std Dev 1.55
2. Previous Average 92.1 89.6 94.9 91.0 92.6 Previous Avg Std Dev 1.55
3. New observation 90.3 90.3 96.4 92.1 92.9 New Std Dev = Range·f(5,n) 1.17
4. Difference (2 - 3) 1.8 -0.7 -1.5 -1.1 -0.3 Difference Range 3.34
5. New sum (1 + 3) 274.6 269.5 286.2 274.0 278.0 New Sum of Std Dev 2.72
6. New average: (5 / n) 91.5 89.8 95.4 91.3 92.7 New Avg Std Dev 1.36
Date Dec 2 Dec 2 Dec 2 Dec 2 Dec 3
Time 13:00 16:00 19:00 22:00 01:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 2.12 For Averages and New Effects: 2 s-bar / SQRT(n) = 1.57
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 1.40
B = (b + d - a - c)/2 = 3.45
Statistical Significance:
AB = (a + b - c - d)/2 = 0.63
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = 0.63
(zero and Max(Effect)) = -3.89
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 1.68 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Copied from New sum and New
average from Phase 3, Cycle 2
Copied from New Sum and
New Avg from Cycle 2
Absolute value of -3.89
exceeds Error Limit of 1.40.
A signal has been received
that point b is better than
point z.
24. Operational Excellence
Evolutionary Operation
Operational Excellence
Figure 9.35 Case Study XVI Phase 3, Cycle 4 - 22 EVOP Worksheet
3/4/2017 Ronald Morgan Shewchuk 24
EVOP 2
2
Worksheet
Process: Biodiesel
+1 1.01 d b
Cycle n: 4
Factor B 0 0.98 z
Catalyst Conc (wt % NaOH) Phase: 3
-1 0.95 a c
Response: Yield
0.34 0.36 0.38 f(5,n): 0.37
-1 0 +1
Factor A
MeOH : Oil Mass Ratio
Treatment Combination z a b c d
1. Previous Sum 274.6 269.5 286.2 274.0 278.0 Previous Sum of Std Dev 2.72
2. Previous Average 91.5 89.8 95.4 91.3 92.7 Previous Avg Std Dev 1.36
3. New observation 90.7 89.3 97.1 95.3 94.4 New Std Dev = Range·f(5,n) 1.79
4. Difference (2 - 3) 0.9 0.6 -1.7 -4.0 -1.7 Difference Range 4.85
5. New sum (1 + 3) 365.2 358.8 383.3 369.3 372.4 New Sum of Std Dev 4.51
6. New average: (5 / n) 91.3 89.7 95.8 92.3 93.1 New Avg Std Dev 1.50
Date Dec 3 Dec 3 Dec 3 Dec 3 Dec 3
Time 04:00 07:00 10:00 13:00 16:00
Effects: Error Limits: n = cycle number
A = (b + c - a - d)/2 = 2.69 For Averages and New Effects: 2 s-bar / SQRT(n) = 1.50
For Change in Center Effect: 1.78 s-bar / SQRT(n) = 1.34
B = (b + d - a - c)/2 = 3.45
Statistical Significance:
AB = (a + b - c - d)/2 = 0.06
For Averages: Difference (2 - 3) > 2 s-bar / SQRT(n)
Effect of Change in Center*: For New Effects: A, B, AB > 2 s-bar / SQRT(n)
For (zero & Effect): (zero & Effect) > 1.78 s-bar / SQRT(n)
(a + b + c + d - 4z)/5 = 1.14
(zero and Max(Effect)) = -4.53
Cycle # f(5,n)
Max Point = b 1 - -
2 0.30
(zero and Min(Effect)) = 1.61 3 0.35
4 0.37
Min Point = a 5 0.38
6 0.39
* If negative, center is near maximum 7 0.40
* If positive, center is near minimum 8 0.41
9 0.41
Manual Entry Field 10 0.42
11 0.42
Calculated Field 12 0.43
Calculation of Averages
Calculation of Std Deviation
Table of f(5,n)
Copied from New sum and New
average from Phase 3, Cycle 3
Copied from New Sum and
New Avg from Cycle 3
Absolute value of -4.53
exceeds Error Limit of 1.34.
Signal has been confirmed -
point b is better than point z.
Move center point operating
conditions to point b for
Phase 4.
25. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 25
• It has taken nine days and fifty-five batches to cause a yield increase of 3.6%.
• The key point of this improvement process was that no defective batches were
produced and no reduction in throughput was incurred.
• Consequently, the improvement came without cost.
• If there were other response variables which Kuwat was interested in, such as the
concentration of a specific impurity, separate EVOP worksheets would be carried
through for these response variables.
• Decisions about changes in operating conditions would have to be justified against
all response variables.
• Evolutionary Operation is well suited to processes with constraints on their output
response due to market demands or constraints on their input factors due to design
limitations.
• In the latter case it is better to avoid input limitations which constrain output
responses through the judicious use of Design for Lean Six Sigma.
Summary
26. Operational Excellence
Evolutionary Operation
Operational Excellence
3/4/2017 Ronald Morgan Shewchuk 26
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