key changes to iso 9001:2015 and 7 steps of 7epsilon

Key changes in ISO 9001:2015 Risk based thinking, Organisational knowledge and Management review

Dr. Rajesh S. Ransing, Swansea University, UKDr. Meghana R. Ransing, p-matrix Ltd., UK

‘7Epsilon for ISO 9001:2015’ training course slides

www.7epsilon.org

ISO 9001:2015

ISO 9001:2015 will be introduced in September 2015

ISO 9001:2008 will no longer be valid from September 2018

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

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


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

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.


‘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)

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





How is risk based thinking1 embedded in ISO 9001:2015’s clauses and 7Epsilon?


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)

ISO 9001:2015 – Quality management system


No requirement to improve the QMS

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.

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.

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.

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.

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

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)

7Epsilon’s 7 Steps to ERADICATE Defects2

Step1: Establish Process Knowledge

Step2: Refine Process Knowledge

Step3: Analyse in-process data

Step 4: Develop new hypotheses or potential solutions

Step 5: Innovate

Step 6: Corrective actions

Step 7: Building Aspiring Teams and Environments

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

ISO 9001:2015’s Clauses & 7Epsilon’s 7 Steps

Step1: Establish Process Knowledge (Clause 4.4 a)

Step2: Refine Process Knowledge (Clauses 4.4 b, c & g)

Step3: Analyse in-process data using penalty matrices (Clauses 4.4 f, h & 6.1.1 b)

Step 4: Develop hypotheses for new product specific ‘process knowledge’ (Clauses 4.4 f, 6.1.2 a, 7.1.6)

Step 5: Innovate using rootcause analysis and conducting confirmation trials (Clauses 4.4 f, 6.1.2 b2 & 10.2.1b2 )

Step 6: Corrective actions and update process knowledge (Clauses 4.4 f, g; 6.1.2 b1 & 6.1.1 c; 7.1.6,10.2.1c-e )

Step 7: Building Aspiring Teams and Environments by monitoring performance (Clauses 4.4 d, e; 7.2, 7.5, 10.2.2, 10.3)






Step 6: Corrective actions and update process knowledge (Clauses 4.4 f, g; 6.1.2 b1 & 6.1.1 c; 7.1.6,10.2.1c-e )








Step 6: Corrective actions and update process knowledge (Clauses 4.4 f, g; 6.1.2 b1 & 6.1.1 c, 7.1.6,10.2.1c-e )



7Epsilon Approach

Embeds all 7 Quality Management Principles (QMP’s)

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


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



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



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



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

Sample Shrinkage and Chemistry data for Ni based alloy





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


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.

Embedding risk based thinking

Factor Scatter Diagram

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• Uncertainty (or deficiency of Knowledge): • Is top, middle or bottom

50% optimal? • Is there any interaction

with other factor ranges?


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

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• Uncertainty (or deficiency of Knowledge): • Is top, middle or bottom

50% optimal? • Is there any interaction

with other factor ranges?


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.

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Factor Scatter Diagram

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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.

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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

Interactions Bubble Diagram

Penalty Matrix

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% Boron

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7Epsilon’s Unique Penalty Matrix approach implements risk based thinking …


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


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

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.

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)

Step 5: Innovate using rootcause analysis and conducting confirmation trials (Clauses 4.4 f, 6.1.2 b2 & 10.2.1 b2)

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


Potential additional knowledge discovered

Product specific process knowledge

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

Step 6: Corrective actions and update process knowledge (Clauses 4.4 f, g; 6.1.2 b1 & 6.1.1 c, 7.1.6, 10.2.1 c-e )

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


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)


Step 7: Building Aspiring Teams and Environments by monitoring performance (Clauses 4.4 d & e, 7.2, 7.5, 10.2.2, 10.3)

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


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.

Organizational knowledge and 7Epsilon

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

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 REPOSITORYdpsace@7Epsilon

Generic Foundry Process Knowledge

Academia (Published Literature)Thesis

Supplier InformationTrade associations reports/data

Product Specific Foundry Process Knowledge

Process mapping diagramsList of factors/responses

Product Specific Factor Ranges

Knowledge Storage

Process Engineer/Operators/Students/

Academics

Knowledge Transfer/ApplicationKnowledge 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

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Creation( Combination)

Knowledge Creation

(Externalisation)

Re-use product generic and product specific process knowledgeKnowledge 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

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’.

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

key changes to iso 9001:2015 and 7 steps of 7epsilon

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