Refine current tolerance limits of process factors to sustain the continual process improvement effort. Embed ISO 9001:2015’s Risk based thinking. Compile organisational knowledge using modified process FMEA table.
The document discusses methods for discovering product-specific process knowledge to improve quality in the foundry industry. It proposes using statistical techniques like principal component analysis and penalty matrices on in-process data to determine optimal tolerance ranges for factors like percentage of carbon, iron, and aluminum. This helps reduce defective castings from 2-3% to below 1% by minimizing deviations from expected results. The methods also align with requirements for risk-based thinking and documenting organizational knowledge in the ISO 9001:2015 standard.
7Epsilon - World Foundry Congress 2014 presentationMeghana Ransing
Optimise your foundry process for defect/waste reduction using 7Epsilon Continual Improvement. Use in-process data to make small adjustments to your process in order to achieve continual process improvement.
7Epsilon projects satisfy the requirements of Clause 8 of ISO 9001:2008 quality standard. 7Steps of 7Epsilon refine Six Sigma's Measure, Analyse, Improve and Control steps.
Organisational knowledge management for defect reduction in foundries - to sa...Meghana Ransing
A novel framework for creation, storage and reuse of product specific process knowledge is presented and reviewed
- satisfies clause 7.1.6 requirement of ISO 9001:2015
- ensures sustainability of knowledge transfer across its staff.
- takes into consideration theoretical perspectives of organisational knowledge management
- addresses the challenges in its practical implementation.
7Epsilon Risk Based Thinking - ASQ International Conference on Quality Stand...Meghana Ransing
Learn how to use risk based thinking to trigger innovation and develop organizational knowledge in a connected enterprise environment. These slides are based on the presentation given at the ASQ International Conference on Quality Standards, Pittsburgh, USA. November 14-15, 2016.
AS 9100:2016 and ISO 9001:2015 - Clause 9.3 Management Review : What's New?Meghana Ransing
This presentation gives a holistic overview of key changes in AS9100:2016 and ISO9001:2015. The authors prepared these slides for an invited presentation at the 14th World Conference on Investment Casting held in Paris at the Le Palais des Congrès between 17th and 20th April 2016.
7Epsilon - World Foundry Congress 2014 presentationMeghana Ransing
Optimise your foundry process for defect/waste reduction using 7Epsilon Continual Improvement. Use in-process data to make small adjustments to your process in order to achieve continual process improvement.
7Epsilon projects satisfy the requirements of Clause 8 of ISO 9001:2008 quality standard. 7Steps of 7Epsilon refine Six Sigma's Measure, Analyse, Improve and Control steps.
Organisational knowledge management for defect reduction in foundries - to sa...Meghana Ransing
A novel framework for creation, storage and reuse of product specific process knowledge is presented and reviewed
- satisfies clause 7.1.6 requirement of ISO 9001:2015
- ensures sustainability of knowledge transfer across its staff.
- takes into consideration theoretical perspectives of organisational knowledge management
- addresses the challenges in its practical implementation.
7Epsilon Risk Based Thinking - ASQ International Conference on Quality Stand...Meghana Ransing
Learn how to use risk based thinking to trigger innovation and develop organizational knowledge in a connected enterprise environment. These slides are based on the presentation given at the ASQ International Conference on Quality Standards, Pittsburgh, USA. November 14-15, 2016.
AS 9100:2016 and ISO 9001:2015 - Clause 9.3 Management Review : What's New?Meghana Ransing
This presentation gives a holistic overview of key changes in AS9100:2016 and ISO9001:2015. The authors prepared these slides for an invited presentation at the 14th World Conference on Investment Casting held in Paris at the Le Palais des Congrès between 17th and 20th April 2016.
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The operations science pioneered through Factory Physics provides practical concepts to analyze and optimize supply chain operations. This presentation covers basic approaches for operations science to enhance your world, with all its variability in product mix, demand, people and processes. You will get applications of the science to apply immediately.
Detailed insight of Strategy Deployment in an Organization encompassing: Vision, Mission & Quality Policy, Goals and Objectives & its importance, SMART Objectives, Target & Requirement of Objectives in ISO 9001:2015 Standard
PECB Webinar: Corrective Action or Preventative Action - The new risk based m...PECB
The webinar covers:
• How the concepts of corrective and preventive action change in the new version of the standard
• Understanding risk-based thinking approach
• Understanding the new risk based methodology for ISO 9001:2015
Presenter:
This webinar was presented by Jason Teliszczak, PECB Certified Trainer and CEO/Founder of JT Environmental Consulting, Inc.
Link of the recorded session published on YouTube: https://www.youtube.com/watch?v=NSNIgSYNgSI
This presentaiton on Overall Equipment Effectiveness, Down Time Analytics and Assett Utilization was developed by me and a coleague during my tenure at ISS. Presentation was given to the Chattanooga, TN Chapter of the SME.
Risk Management Requirements Implementation in ISO 9001:2015 Clauses including Objects and Subjects of Control as well as recommended regulatory document (if provided in the Standard)
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Implementing a Test Dashboard to Boost QualityTechWell
You are responsible for addressing quality problems that are plaguing your product and having an adverse impact on the business. Have you been challenged to provide a simple mechanism for quantifying and tracking key performance indicators selected by your organization. The ultimate goal is an approach that will enable the cross-functional team to identify problem areas so they can take corrective action. Where do you start? Attend this session to learn how you can develop a quantifiable approach to assessing testing effectiveness and addressing quality. Scott Acker shows you a solution he developed, deployed, and managed to effectively leverage various types of data to support analyzing, tracking, and reporting changes in testing and quality over time. Discover how to drive communication and collaboration improvements across the entire cross-functional team and boost quality efforts.
Pharmaceutical 6 Sigma and QbD May 2005 Ball State UniversityAjaz Hussain
Pharmaceutical product and process quality – what is the current “sigma”?
Challenges in moving towards “6-sigma” levels?
What are the steps necessary for the pharmaceutical continuous improvement journey in the 21st Century?
I am writing this document to help out managers, who think AS9100 is a very complicated system to install, implement and follow. They have an apprehension that it requires tons of documentation and record keeping.
I will be bringing the basic outlines of how to implement a QMS (Quality Management System) from scratch, which adhere to AS9100 Rev C requirements in a very basic manner. This document alone cannot be used to implement the AS9100 Rev C; the aim of this document is to familiarize the managers about the basics of implementation of AS9100 Rev C. I have used many illustrations and also used project management concept to implement AS9100 Rev C.
QMS Effectiveness: Tracking and Trending Quality Data - OMTEC 2017April Bright
What measurements are useful, and which metrics’ baseline makes sense to show the effectiveness of your quality management system? This presentation takes an ISO 13485 and 21 CFR, Part 820 approach to deciding what measurements are important, how trending makes an impact on risk-based decision-making, and why management review is just one of the ways to discuss and document your Quality Data activities.
Maximizing Use of Your Supplier Scorecard - OMTEC 2018April Bright
Supplier scorecards provide a comparative look at suppliers and a heightened understanding of internal challenges within your organizations. Orthopaedic device companies rely on scorecards to monitor the performance of suppliers that are an extension of their own operations. The right elements in the scorecard (e.g. weighted factors of quality, delivery, cost, responsiveness, SCAR, CAPA, etc.) will strengthen your confidence, control and relationship with your suppliers while simultaneously providing essential indicators to drive positive change.
Analyze and Optimize Your Supply Chain Operations for Higher Performance - OM...April Bright
The operations science pioneered through Factory Physics provides practical concepts to analyze and optimize supply chain operations. This presentation covers basic approaches for operations science to enhance your world, with all its variability in product mix, demand, people and processes. You will get applications of the science to apply immediately.
Detailed insight of Strategy Deployment in an Organization encompassing: Vision, Mission & Quality Policy, Goals and Objectives & its importance, SMART Objectives, Target & Requirement of Objectives in ISO 9001:2015 Standard
PECB Webinar: Corrective Action or Preventative Action - The new risk based m...PECB
The webinar covers:
• How the concepts of corrective and preventive action change in the new version of the standard
• Understanding risk-based thinking approach
• Understanding the new risk based methodology for ISO 9001:2015
Presenter:
This webinar was presented by Jason Teliszczak, PECB Certified Trainer and CEO/Founder of JT Environmental Consulting, Inc.
Link of the recorded session published on YouTube: https://www.youtube.com/watch?v=NSNIgSYNgSI
This presentaiton on Overall Equipment Effectiveness, Down Time Analytics and Assett Utilization was developed by me and a coleague during my tenure at ISS. Presentation was given to the Chattanooga, TN Chapter of the SME.
Risk Management Requirements Implementation in ISO 9001:2015 Clauses including Objects and Subjects of Control as well as recommended regulatory document (if provided in the Standard)
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
Implementing a Test Dashboard to Boost QualityTechWell
You are responsible for addressing quality problems that are plaguing your product and having an adverse impact on the business. Have you been challenged to provide a simple mechanism for quantifying and tracking key performance indicators selected by your organization. The ultimate goal is an approach that will enable the cross-functional team to identify problem areas so they can take corrective action. Where do you start? Attend this session to learn how you can develop a quantifiable approach to assessing testing effectiveness and addressing quality. Scott Acker shows you a solution he developed, deployed, and managed to effectively leverage various types of data to support analyzing, tracking, and reporting changes in testing and quality over time. Discover how to drive communication and collaboration improvements across the entire cross-functional team and boost quality efforts.
Pharmaceutical 6 Sigma and QbD May 2005 Ball State UniversityAjaz Hussain
Pharmaceutical product and process quality – what is the current “sigma”?
Challenges in moving towards “6-sigma” levels?
What are the steps necessary for the pharmaceutical continuous improvement journey in the 21st Century?
I am writing this document to help out managers, who think AS9100 is a very complicated system to install, implement and follow. They have an apprehension that it requires tons of documentation and record keeping.
I will be bringing the basic outlines of how to implement a QMS (Quality Management System) from scratch, which adhere to AS9100 Rev C requirements in a very basic manner. This document alone cannot be used to implement the AS9100 Rev C; the aim of this document is to familiarize the managers about the basics of implementation of AS9100 Rev C. I have used many illustrations and also used project management concept to implement AS9100 Rev C.
Innovation is achieved when product specific process knowledge is discovered ...Meghana Ransing
WFC 2014 UK Exchange Paper: 7Epsilon case study on Conchoidal Fracture to satisfy requirements of ISO 9001:2008 as well as clause 6-1-2 and 7-1-6 of ISO 9001:2015.
This document will help you to understand the risk based thinking approach that has been introduced to the new revision of QMS ISO 9001:2015 as well as assist the organizations that tends to move toward implementing the new standard.
the first step is to understand what is the definition of risk! when we are going to apply this term, what are things to considered? if you thinking of establishing a specially designed procedure or form related to this term what are the main categories you should considered and how? what are the modules you shall use? ... etc.
Therefore, This document will answer ,at least, most of these questions.
Best of luck, Eng. Akram Malkawi, Amman, eng.karam@outlook.com/Mob. +962795705076
This Guide-Book is prepared after as a results of a years of experience and efforts. The book will help you to understand the ISO 9001:2008 standard. not that only, but also you will be able to establish as well as implement QMS within your organization and getting certified. no need for external consultations, save your money and let the whole world know how to go on with Quality Management Systems. Please do not stop sharing it. It is for FREE and not allowed to copy, edit or sell.
Author: Eng. Akram Malkawi
Amman-Jordan
Mob. +962-781-501940
email. kmalkawi@gmx.us
A system of Daily Management (based on the work of Luftig & Warren International) that enables management of the day-to-day operation of departments or cells at the lowest possible level by the process owner. It provides the means to improve performance on an ongoing basis and lock in the hard won gains.
Key changes to ISO 9001:2015 and 7 steps of 7EpsilonMeghana Ransing
This presentation highlights key changes to the upcoming ISO 9001:2015 quality standard and describes how '7 steps of 7Epsilon' satisfy its various requirements on risk based thinking, organisational knowledge and management review.
The most valuable Helpful PDF file that extremely can boost your ability to understand well the New version of QMS in accordance to ISO 9001:2015 as well as ease the documentation transition process toward ISO 9001:2015
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This project concentrates on removing rivet height variation in process of rivet production at a production unit in Bangalore. Here, we apply six sigma methodology to improve the process.
Predictive Business Process Monitoring considering Reliability and RiskAndreas Metzger
This presentation presents techniques and experimental results for considering prediction reliability and risk during predictive business process monitoring. Considering reliability and risk provides additional decision support for proactive process adaptation.
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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
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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.
In this paper study of Gas Tungsten Arc Welding
(GTAW) process used for Aerospace application, the
material used is Maraging steel (MDN250).The weld
defects are a major concern leading to rework, higher costs
and thus affecting the delivery schedule of the job. The
process starts with Welding of long seams and circular
seams in the job, and subsequently carrying out the NDT to
find any defects during welding. A number of defects are
being observed in the welding Process. Defects in welding
may be found out in two methods, i.e. by Radiographic
Tests and by Ultrasonic Tests. The paper deals with an
application of Six Sigma DMAIC (Define–MeasureAnalyze-Improve-Control)
methodology in an industry
which provides a framework to identify, quantify and
eliminate sources of variation in an operational process in
question, to optimize the operation variables. Six Sigma
improves the process performance of the critical
operational process, leading to better utilization of
resources, decreases variations & maintains consistent
quality of the process output.
six sigma DMAIC approach for reducing quality defects of camshaft binding pro...Niranjana B
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Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
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Speakers:
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👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
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Epistemic Interaction - tuning interfaces to provide information for AI support
Refine current tolerance limits of process factors to sustain the continual process improvement effort. Embed ISO 9001:2015’s Risk based thinking. Compile organisational knowledge using modified process FMEA table.
1. CIE45
International Conference on Computers & Industrial Engineering
28-30th October 2015, Metz / France
CIE45 Conference, 28-30 October 2015, Metz / France
Mr Raed S. Batbooti, Dr. Rajesh S. Ransing and Dr. Meghana R. Ransing1
College of Engineering, Swansea University, Swansea SA1 8EN, UK
1p-matrix Ltd, Swansea SA2 8PP, UK
HOW TO DISCOVER AND EMBED PRODUCT SPECIFIC PROCESS
KNOWLEDGE INLINE WITH ISO9001:2015 REQUIREMENTS
2. CIE45 Conference, 28-30 October 2015, Metz / France
-Foundry industry loses 2-3% of casting produced as defective components.
Problem Statement
-Lead to increase in the cost of productions.
-Produce tonnes of wastes.
Goal for In-process Quality Improvement
Reduce deviation from expected results in any process.
Optimise tolerance limits.
3. CIE45 Conference, 28-30 October 2015, Metz / France
-Foundry industry loses 2-3% of casting produced as defective components.
Problem Statement
Why?
Defects
-Lead to increase in the cost of productions.
-Produce tonnes of wastes.
Goal for In-process Quality Improvement
Reduce deviation from expected results in any process.
Optimise tolerance limits.
4. CIE45 Conference, 28-30 October 2015, Metz / France
-Foundry industry loses 2-3% of casting produced as defective components.
Problem Statement
Why?
Goal for In-process Quality Improvement
Reduce deviation from expected results in any process.
Optimise tolerance limits.
Defects
-Lead to increase in the cost of productions.
-Produce tonnes of wastes.
Variation in Factor in-process data
(Tolerance limits)
Variation in Response in-process data
(or Deviation from expected Results)
5. CIE45 Conference, 28-30 October 2015, Metz / France
Transfer the penalty onto factor
diagrams
Penalise Deviation from expected
Results (www.7epsilon.org)
The discovery of tolerance adjustment opportunity of %Carbon is in line with
the risk based thinking requirements (Clause 6.1) of ISO9001:2015
Knowledge discovery using quality
correlation algorithm[1]
0 Penalty Values
100 Penalty Values
[1] Ransing R. S. , Batbootia Raed S. , Giannettia C. , Ransing M.R. 2015. A quality correlation algorithm to reduce the occurrence of
No-Fault-Found defective batches, Computers & Industrial Engineering, under review.
0.11
0.105
0.1
0.095
0.09
% C
ISO 9001:2015, Risk Based Thinking and 7Epsilon
6. Product Specific Process Knowledge
Organizational knowledge for a given product is [2]
i. the actionable information
ii. in form of optimal list of measurable factors and their
ranges
(%C: 0.093-0.112, % Iron: 0.095-0.2,% Aluminium: 3.145-3.306)
iii. in order to meet desired business goals (process
responses)
(e.g. minimize defect rates, porosity scores or rework time
etc and/or maximize mechanical properties)
CIE45 Conference, 28-30 October 2015, Metz / France
[2] Giannetti, C., Ransing, R.S., Ransing, M.R., Bould, D.C., Gethin, D.T., Sienz, J. 2014. A novel variable selection approach based on
co-linearity index to discover optimal process settings by analysing mixed data, Computers & Industrial Engineering, 72 (217-229), pp.
7. Reusing organisational product specific process knowledge via
process FMEA tables (This step is inline with the clause 7.1.6
of ISO9001:2015)
CIE45 Conference, 28-30 October 2015, Metz / France
.%C in range (>0.09 & < 0.093) & (>0.112 & <0.12) has been identified
as a root cause for high incidence of % Shrinkage defect.
.A new tolerance limit is suggested > 0.093 & < 0.112 to prevent the
occurrence of the failure.
FMEA table
Incorrect
Percentage of C
% Shrinkage
% C in the range
(0.09-0.093) or
(0.112-0.12)
Keep % C in
the range
(0.093-0.112)
8. • Mathematical Formulation to discover product
specific process knowledge.
CIE45 Conference, 28-30 October 2015, Metz / France
9. CIE45 Conference, 28-30 October 2015, Metz / France
Root Case Analysis of Defects
- Co Linearity Index [3]
1-Data pre-treatment.
- Penalty matrices.
- Robust standardization
- MFA transformation
2- Apply PCA on covariance matrix resulted
before step (1).
3- Estimate the loading matrix based on the
following equation.
4- Evaluate the correlation matrix from
for p principal components, where the inner
product of ith and jth row vectors of Ls
represents the correlation between variable
i and j. After that co-linearity index can be
plotted by plotting angles and length of the
loading vectors.
X=
Response Factors
- PROVIDE NOISE FREE CORRELATIONS.
- % Co Correlated positively with response penalty.
Co-Linearity Index for Nickel based alloy
[3] Ransing, R.S., Giannetti, C., Ransing, M.R., James, M.W. 2013. A coupled penalty
matrix approach and principal component based co-linearity index technique to discover
product specific foundry process knowledge from in-process data in order to reduce
defects., Computers in Industry, 64 (5), pp. 514-523.
10. CIE45 Conference, 28-30 October 2015, Metz / France
Predicting Optimal Ranges
PCA Scores Projection
. This approach will help engineers to
refine current tolerance limits of process
factors to sustain the continual process
improvement effort.
.The present work give un constrained
ranges compared with penalty matrix,
which produce ranges constrained by
quartiles.
11. CIE45 Conference, 28-30 October 2015, Metz / France
Scores projection
on each variable
Corresponding
tolerance limit
13. CIE45 Conference, 28-30 October 2015, Metz / France
7Epsilon for ISO9001:2015
[4] Roshan, H.M., Giannetti, C., Ransing, M.R., Ransing, R.S. 2014. “If only my foundry knew what it knows …”: A 7Epsilon perspective on root
cause analysis and corrective action plans for ISO9001:2008, Proceedings of the 71st World Foundry Congress, Bilbao, Spain 19th - 21st May 2014.
14. CIE45 Conference, 28-30 October 2015, Metz / France
Conclusion
. A new approach has been proposed to predict the optimal process settings for
correlated variables by using the analogue between loading and scores of principal
component analysis.
. This approach will help engineers to refine current tolerance limits of process
factors to sustain the continual process improvement effort.
.The present work give un constrained ranges compared with penalty matrix,
which produce ranges constrained by quartiles.
. Embeds ISO9001:2015’s Risk based thinking
. Modified process FMEA table helps compiling organisational knowledge.