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.
Key changes to ISO 9001:2015 and 7 steps of 7Epsilon
1. Key changes in ISO 9001:2015
Risk based thinking, Organisational
knowledge and Management review
Dr. Rajesh S. Ransing, Swansea University, UK
Dr. Meghana R. Ransing, p-matrix Ltd., UK
‘7Epsilon for ISO 9001:2015’ training course slides
www.7epsilon.org
2. ISO 9001:2015
ISO 9001:2015 will be introduced in September 2015
ISO 9001:2008 will no longer be valid from September 2018
3. ISO 9001:2015 – Main Changes
Focus on continually improving a substantially redefined ‘Quality
Management System (QMS)’ rather than continually improving the
effectiveness of an existing (and may be, inadequate) QMS.
One of the most significant but subtle change is at the top most
level in the information provided for the management review and
its output (clause 9.3 in ISO 9001:2015 and clause 5.6 in ISO
9001:2008)
ISO 9001:2015 management review requires consideration to:
Trends and indicators in the information on the quality performance
The effectiveness of actions taken to address risks & opportunities
as specified in clause 6.1
New potential opportunities for continual improvement
4. 7Epsilon for ISO 9001:2015
The 7Epsilon approach:
discovers trends and indicators in the organization’s in-
process data
directly addresses risks and opportunities as defined in clause
6.1
generates possible solutions (or new potential opportunities)
for continual improvement
creates evidence on the effectiveness of actions taken to
address risks and opportunities.
provides a structured methodology for ogranisational
knowledge management
5. ISO 9001:2015 – Main Changes
2015 requires the management review to include decisions
related to:
Continual improvement opportunities and
Any need for changes to the QMS (including resource needs)
In comparison, the 2008 version (5.6.3) only required decisions
related to:
Improvement of the effectiveness of the QMS
Improvement of product with reference to customer requirements
Resource needs
6. What Vs How
ISO 9001:2015 focuses on ‘what’ needs to be done rather than
‘how’ it is done.
E.g. reference to use of statistical techniques in clause 8.1 of
ISO 9001:2008 has been dropped.
We are also expecting AS9100:2016 which will be based on
ISO9001:2015 to drop explicit references to methods such as
Design of Experiments, FMEA from the clause 8.1 of
AS9100:2009 and focus on what needs to be done.
7. ISO 9001:2015 – Main Changes
‘Organizational knowledge’ and ‘risk based thinking’ concepts
are explicitly defined
A requirement to maintain and retain ‘documented information’
Introduces 7 Quality Management Principles (QMP’s)
8. Risk - An effect of uncertainty on an expected result
Uncertainty == deficiency of knowledge
Deficiency of knowledge are opportunities for creating
additional knowledge (e.g. Tolerance limit optimization)
The effect of uncertainty manifests itself as deviation(s) from
expected results
ISO 9001:2015’s risk based thinking
9. Risk - An effect of uncertainty on an expected result
Uncertainty == deficiency of knowledge
Deficiency of knowledge are opportunities for creating
additional knowledge (e.g. Tolerance limit optimization)
The effect of uncertainty manifests itself as deviation(s) from
expected results
How is risk based thinking1 embedded in
ISO 9001:2015’s clauses and 7Epsilon?
ISO 9001:2015’s risk based thinking
1Ransing, R. S., Batbooti R, Giannetti C and Ransing M.R. An algorithm for knowledge discovery using risk based thinking and scores defined
in a p-dimensional principal component space, (under review)
13. Clause 4 Context of the Organization
Clause 4 is generalized from the QMS to Context of the
Organization. It forces you to think of internal and external
factors and conditions that can influence organization’s ability to
consistently provide products and services to customer
expectations.
Requirements of ISO 9001:2015’s clauses 4.4 (a-h), 6.1, 7.1.6,
7.2, 7.5, 10.2 & 10.3 can be easily met with 7Epsilon’s 7 Steps
to ERADICATE Defects
However, implementing 7Epsilon’s 7Steps to ERADICATE
Defects require organizations to first meet the requirements of
ISO 9001:2015’s clauses 5.1, 7.1.1, 8.1, 8.5, 9.1, 9.3 with
reference to resources, in-process data and management
commitment.
14. Risk and ISO 9001:2015 Clauses
Clause 4: The organization is required to determine inputs and
expected outputs of its processes, risks (effect of deficiency of
knowledge i.e. deviations from expected outputs), opportunities
(for additional knowledge) and plan and implement appropriate
actions to address risks and opportunities.
Clause 5: Top management must show commitment and
leadership to ensure that all aspects of Clause 4 are followed.
Clause 6: Organizations are required to take actions to address
risks and opportunities.
15. Risk and ISO 9001:2015 Clauses
Clause 7: The organization shall provide the resources needed
to establish, implement, maintain and continually improve
Clause 4 including costs of addressing risks and opportunities
as defined in Clause 6. It will determine organizational
knowledge necessary to address risks and make it available to
the extent necessary and ensure its employees are competent
to address risks and opportunities. It will maintain documented
information as evidence.
Clause 8: Organizations shall have processes to identify risks
and opportunities in its operations and take actions to address
risks and implement control of the processes.
16. Risk and ISO 9001:2015 Clauses
Clause 9: The organization is required to monitor and measure
appropriate data and information to analyze and evaluate the
effectiveness and conformity of addressing risks and
opportunities and determine the need for new potential
opportunities for improvement. Top management is required to
review this information.
Clause 10: Occurrence of nonconformity is a deviation from the
expected results i.e. a change in the risk. This clause requires
organizations to improve by reacting to such changes in risks
by implementing corrective actions, review its effectiveness and
make changes to the quality management system (that includes
organizational knowledge) if necessary.
17. Traceability in ISO 9001:2015
• Maintaining traceability is not a technological issue.
• It is a cultural problem.
• It is a top management problem.
• in 2008 version (clause 7.5.3) is ‘product centered’.
• Monitor product status throughout product realization
• Unique identification of the product
• Traceability in 2015 version (clause 8.5.2) relates to ‘process outputs’.
• Monitor the status of process outputs throughout production
• Unique identification of the process outputs
• Process outputs include products, intermediate
parts/components
18. Traceability in ISO 9001:2015
• Traceability in 2015 version (clause 8.5.2) relates to ‘process outputs’.
• Process outputs include products, intermediate
parts/components
• Connect in-process data associated with intermediate parts to the
final product
• Traceability with the factor data (process inputs) is an implicit
requirement for organizations as it becomes necessary to satisfy the
requirements clauses 6.1, 4.4 c & g, 8.5.1 c
• The organization is required to make necessary resources available
(clauses 4.4 d, 7.1.1, 8.1 b-d, 8.5.1 e)
19. 7Epsilon’s 7 Steps to ERADICATE Defects2
2Roshan, H. M., Giannetti, C., Ransing, M. R., & Ransing, R. S. (2014, 19th - 21st May 2014). “If only my foundry knew what it knows …”: A
7Epsilon perspective on root cause analysis and corrective action plans for ISO9001:2008. UK Exchange Paper, 71st World Foundry Congress,
Bilbao, Spain
28. 7Epsilon’s 7Steps to ERADICATE Defects
1. Acquire team members knowledge about
processes, their factors, responses and causal relationships
2. Gather process knowledge codified using
Process maps, SIPOC diagrams and cause and effect diagrams
29. Process knowledge is
The understanding that Y = f(Xs)
How variability in Xs affects variability in Ys
Foundries rely on experts for process knowledge
Generic knowledge comes from experience, published literature
Foundry knowledge needs to be systematically collected,
recorded for reuse
Systematic research on process factors and how they affect
response with written descriptions
7Epsilon’s 7Steps to ERADICATE Defects
30. Objectives:
To determine trends in process settings to discover
reasons of product non-conformity / responses (e.g.
defects, material properties)
To transform in-process data into actionable
information (e.g. optimal process parameter ranges)
To provide information relating to
Opportunities for corrective actions
7Epsilon’s 7Steps to ERADICATE Defects
31. Knowledge discovery
in-process data is normally routinely collected, however, it is
a requirement of ISO 9001:2015 (clause 9.1.1, 8.5.1 c and
QMP 6 and for satisfying clause 6.1)
Perform rootcause analysis and discover correlations using
penalty matrix approach
Prioritise patterns using p-matrix software
7Epsilon’s 7Steps to ERADICATE Defects
32. Foundry example of risk based thinking
Investment casting process
Nickel based super alloy
Continual process improvement in melting sub-process
Discover product specific process knowledge
35. Risk - An effect of uncertainty on an expected result
Uncertainty == deficiency of knowledge
Deficiency of knowledge are opportunities for creating
additional knowledge (e.g. Tolerance limit optimization)
The effect of uncertainty manifests itself as deviation(s) from
expected results
7Epsilon’s penalty matrix approach3
quantifies the effect of uncertainty by penalizing deviation
from desired response and
links it with tolerance limit optimization and organizational
knowledge
ISO 9001:2015’s risk based thinking
3Ransing, 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), 514-523.
36. Embedding risk based thinking
Factor Scatter Diagram
0.01
0.015
0.02
0.025
0.03
0.035
0.04
0.045
0.05
0.055
0 10 20 30 40 50 60 70
Observations No.
%Zirconium
• Uncertainty (or deficiency of
Knowledge):
• Is top, middle or bottom
50% optimal?
• Is there any interaction
with other factor ranges?
37. Embedding risk based thinking
Response Scatter DiagramFactor Scatter Diagram
• Deviation from expected results
(or desired response values) is
the effect of Uncertainty on an
expected result
• ISO 9001: 2015 defines this as
Risk
-0.01
0.03
0.07
0.11
0.15
0.19
0.23
0.27
0 10 20 30 40 50 60 70
Observations No.
%Shrinkage
0.01
0.015
0.02
0.025
0.03
0.035
0.04
0.045
0.05
0.055
0 10 20 30 40 50 60 70
Observations No.
%Zirconium
• Uncertainty (or deficiency of
Knowledge):
• Is top, middle or bottom
50% optimal?
• Is there any interaction
with other factor ranges?
38. Embedding risk based thinking
Response Bubble Diagram
• 7Epsilon penalises3 deviation
from expected results (or
desired response values)
• ISO 9001: 2015 terms this as
changes in risks and requires
organizations to address risks
to achieve improvement.
-0.01
0.03
0.07
0.11
0.15
0.19
0.23
0.27
0 10 20 30 40 50 60 70
Observations No.
%Shrinkage
100 Penalty Values
0 Penalty Values
3Ransing, 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), 514-523.
Factor Scatter Diagram
0.01
0.015
0.02
0.025
0.03
0.035
0.04
0.045
0.05
0.055
0 10 20 30 40 50 60 70
Observations No.
%Zirconium
39. Embedding risk based thinking
Response Bubble Diagram
• 7Epsilon penalises3 deviation
from expected results (or
desired response values)
• ISO 9001: 2015 terms this as
changes in risks and requires
organizations to address risks
to achieve improvement.
-0.01
0.03
0.07
0.11
0.15
0.19
0.23
0.27
0 10 20 30 40 50 60 70
Observations No.
%Shrinkage
100 Penalty Values
0 Penalty Values
3Ransing, 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), 514-523.
0.01
0.015
0.02
0.025
0.03
0.035
0.04
0.045
0.05
0.055
0 10 20 30 40 50 60 70
Observations No.
%Zirconium
Top 50%
Main Effects Bubble Diagram
Bottom 50%
• Transfer the response
penalty values on all factor
scatter diagrams.
• Actions to address risks as
required in the clause 6.1 are
discovered
41. Analyse p-matrix reports
Hypotheses on causation are established using knowledge
acquired in Step 2
Hypotheses are potential solutions (or actions as in clause
6.1.2 a)
New tolerance limits proposed and
corrective action plan is outlined or collect more in-process
data or conduct one or more design of experiments
7Epsilon’s 7Steps to ERADICATE Defects
42. Prior to the 7Epsilon Quality Control Meeting
• Every team member designs his/her version of a
corrective action plan for confirmation trial by
– observing penalty matrices (i.e. potential corrective
actions)
– Comparing trends with published literature for further
insights into factor – response relationships (clause
7.1.6 b)
– Using your domain knowledge (clause 7.1.6 a)
• Turns insight into actionable information
43. 7Epsilon Quality Control Meeting
• Review ALL suggestions
• The final corrective action plan for validation trial is agreed
• Perform a trial demonstrating reduction in the variation of
response values
• Discover new process knowledge
• Record feedback and results from the confirmation trial
• Create a preventive actions plan
• Newly gained product specific process knowledge is
reused.
44. Generating possible solutions…
Generate possible solutions or new potential
opportunities for continual improvement by discovering
trends and indicators in the organization’s in-process
data
Presentations 6 - 7:.
1. create p-matrix input file and Output report – layout (6)
2. Interpret p-matrix report – single response (7)
45. Confirmation trials are carried out to validate the hypotheses
and create new product specific process knowledge
Optimal ranges for all the process variables (X) are determined
New product specific process knowledge is created in the form
of
list of values with their new specification ranges
7Epsilon’s 7Steps to ERADICATE Defects
46. Potential additional knowledge discovered
Process
Parameter
Minimum
Value
Maximum
Value
Optimal Range Optimal Values
Niobium 0.656 0.893 Middle 50% > 0.77 & < 0.827
Carbon 0.086 0.113 Top 75% > 0.095 & < 0.113
Iron 0.057 0.2 Top 50% > 0.114 & 0.2
Aluminium 3.059 3.306 Top 25% > 3.24 & < 3.306
Zirconium 0.019 0.05 Top 50% > 0.026 & < 0.05
Boron 0.007 0.012 Bottom 50% > 0.007 & < 0.009
Aluminium
+Titanium
6.204 6.527 Top 75% < 6.299 & < 6.527
Cobalt 7.714 8.028 Bottom 50% < 7.714 & < 7.847
Nitrogen 11.4 38.95 Top 50% < 23.75 & < 38.95
47. New knowledge obtained stored in knowledge repository in
tabular form so that it can reused in Step 2
This is specific for a given part and process and becomes part
of the organizational knowledge
7Epsilon’s 7Steps to ERADICATE Defects
48. Product Specific Process Knowledge3
Organizational knowledge for a given product is
i. the actionable information
ii. in form of optimal list of measurable factors and their
ranges
(Niobium: 0.77% – 0.827%; Aluminium: 3.24% - 3.306%
Zirconium: 0.026% – 0.05%; Carbon: 0.095% – 0.113%;)
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)
3Ransing, 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), 514-523.
49. Continually monitor performance and maintain accountability (4.4 e)
Ensure sustainability of this initiative with adequate resources (4.4 d)
The organisation specific 7Epsilon process knowledge repository can
also be used to train operators and process engineers (7.2)
Store knowledge in repositories such as DSpace (7.5, 10.2.2, 10.3)
7 Epsilon Knowledge
repository
7Epsilon’s 7Steps to ERADICATE Defects
50. Organizational knowledge4 and 7Epsilon
4Giannetti, C., Ransing, M. R., Ransing, R. S. et.al (2015) “Organisational
knowledge management for defect reduction and sustainable development in
the foundry industry”, International Journal of Knowledge and Systems
Science (IJKSS), 6(3), 18-37, July-September 2015.
52. Knowledge Retention and Reuse
Preserve and continuously develop process knowledge by compiling a
library of case studies
Store case study for reference and access in D-Space.
Continuously update the proprietary ‘actionable information’ or
‘knowledge’ by
Capturing industry specific product, design and in-process data
and
Comparing it with the published literature
Most effective way of retaining expertise
Reuse Data by maintaining traceability on product characteristics,
design and in-process data across sub-processes, product types and
supply chain
53. 7Epsilon Knowledge Repository1
Refine process knowledge by
compiling explanations for
factor response relationships
Process factors detailed
description (influence of factors
on response)
Analyze In-process data
Penalty Matrix reports
Co-linearity index
Develop hypotheses for new
product specific process
knowledge
Innovate using rootcause
analysis and conducting
confirmation trials
Corrective actions and
update process knowledge
Correction or
Prevention Action Plan
List of Factors and their product
specific optimal ranges
KNOWLEDGE REPOSITORY
dpsace@7Epsilon
Generic Foundry Process
Knowledge
Academia (Published Literature)
Thesis
Supplier Information
Trade associations reports/data
Product Specific Foundry Process
Knowledge
Process mapping diagrams
List of factors/responses
Product Specific Factor Ranges
Knowledge Storage
Process Engineer/
Operators/Students/
Academics
Knowledge Transfer/Application
Knowledge Creation
(Internalisation)
Enhanced Search
(using shared vocabulary)
Knowledge
Retrieval
Establish process knowledge
Cause Effect Diagrams, SIPOC,
Process Maps, FMEA,
Factor Response Lists,
Build Aspiring Teams and
Environments by monitoring
performance
Store product specific process knowledge
Literature Review
7ΕPSILON ERADICATE STEPS
CULTUREOFINNOVATIONKNOWLEDGEDISCOVERY
KNOWLEDGERETENTION
ANDREUSE
Knowledge
Creation
( Combination)
Knowledge
Creation
(Externalisation)
Re-use product generic and product specific process knowledge
Knowledge Retrieval
Knowledge creation
( Combination)
Knowledge Retrieval
Knowledge Storage
1Roshan, H. M., Giannetti, C., Ransing, M. R., & Ransing, R. S. (2014, 19th - 21st May 2014). “If only my foundry knew what it knows …”: A
7Epsilon perspective on root cause analysis and corrective action plans for ISO9001:2008. UK Exchange Paper, 71st World Foundry
Congress, Bilbao, Spain
54. Conclusions
Implementing 7Epsilon is the easiest option to satisfy the
challenging requirements of ISO 9001:2015 on risk based
thinking (clause 6.1), organizational knowledge (clause 7.1.6),
quality management system (clause 4.4) and improvement
(clauses 10.2 and 10.3).
Penalty matrix approach naturally creates the necessary ‘risk
based thinking’ environment.
A knowledge repository can be used to maintain and retain
‘documented information’ as well as ‘organizational knowledge’.
55. Identification and planning of one scenario for a
7Epsilon in-process quality improvement project
Transforming in-process data into reusable formats
using foundry specific
− traceability,
− data collection and retrieval methods,
− volume of data collection and time taken.
Contact 7Epsilon team at www.7epsilon.org
Conclusions
Swansea University and p-matrix Ltd. accepts no responsibility or liability for any use of or reliance on this presentation or its contents