Integrated Systems Health Management for Intelligent Systems
Integrated Management Systems
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Transcript of Integrated Management Systems
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Dennis Arter, FASQ
October 2013
Management Systems Integration: Big Q or little q?
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Eras of management
Control era (product) 1925-1975
Define characteristics and inspect to those characteristics (form, fit, function)
Assurance era (process) 1975-2000
Define processes to achieve results and make sure those processes are being followed. (Say what you do and do what you say)
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Eras of management
Management era (system) 2000-2012
Develop organization systems to achieve results and provide resources to achieve success.
Integration era (whole) 2012-2018
Combine quality, environment, safety, security into a holistic view. More emphasis on risk management.
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Plan Do
CheckAct
Back to Basics
From our Quality history
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PDCA means
Plan
Identify item or service characteristics (form, fit, function)
Define methods, material, and machines to make or deliver that product
Define the systems in which the product is made or delivered
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PDCA means
Do
Provide people, equipment, material and infrastructure to make or deliver the product
Follow the defined methods
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PDCA means
Check
Measure progress in achieving defined products, processes, and systems
This can be through inspection, audit, customer satisfaction, SPC, or any number of such tools
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PDCA means
Act
Reduce differences between desired and actual states
Make things better and smarter
Note: Deming (PDSA) and Six Sigma (DMAIC) are versions of this.
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Good and evil
Some systems promote Good
Quality management tries to achieve excellence, efficiency, satisfaction, delight.
Financial management tries to improve efficiency.
Human resource management tries to maximize people resources.
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Good and evil
Some systems prevent Evil
Environmental management tries to prevent harm to the planet.
Safety management tries to prevent harm to people.
Security management tries to keep bad guys away.
Financial management tries to protect assets
Note: These can also save resources if done right.
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Bring things together
Material Ideas
People Machines
Make it
Deliver it
Evaluate itChange
Quality management model
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Acceptable?
EffectsChange
No
PollutantsSources
Conditions
Evaluate
Avoid
Transfer Mitigate
Take Action
Environmental Management model
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Safety management model
Acceptable?
Barriers
EffectsChange
No
EnergySources
Conditions
Evaluate
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Security management model
Acceptable?
Barriers
TargetChange
No
Threat
Monitor
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Recent initiatives
ISO 19,011:2011, Management systems – Guidelines for auditing management systems
ISO 17,021:2012, Conformity assessment auditing
ISO Annex SL:2012, Proposals for management system standards
ISO 9001:2015, Quality management systems – requirements
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Common elements
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
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Emerging trends
Access to information
Global market
Sustainability
Climate change
Business continuity
Social conditions
Triple bottom line: People, Profit, Planet
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Social responsibility
1. Consider social and environmental effects of operations when making decisions.
2. Be accountable for social and environmental effects of operations.
ISO 26,000:2010, Guidance on social responsibility, released in Dec 2010.
Not meant for conformity assessment use.
Big in Europe and Asia; not N. America
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General risk model
1. Define risk
Quantitative (What is out there?)
Qualitative (How bad is it?)
2. Judge risk
Risk effects analysis (What happens?)
Acceptable and unacceptable risk (Worth it?)
3. Provide countermeasures (ATM)
Avoid (physical and admin)
Transfer (buy insurance or sell to Moldova)
Mitigate (process design)
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Risk issues
Good or evil
Quality profession emphasis on making better
Risk professions emphasis on preventing evil
Is it actually increasing?
Attention to risk concepts is increasing every day
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Future: Big Q?
Quality heart and soul
Environmental brain
Safety shoes
Security skirt
Sustainable energy
Low carbon emissions
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Future: or little q?
Quality is part of the stew
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Let’s have a conversation
Preserve emphasis on goodness
Big Q or little q
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Thank You
Dennis Arter, the Auditguy
Kennewick, Washington, USA
Mail: [email protected]
Web: http://auditguy.net
Blog: http://auditguy.blogspot.com
Twitter: @Auditguy
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Reference
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Quality
ISO 9000 family and spin-offs
ISO 9001:2008 is quite mature.
Current emphasis is on processes and how they form systems. No big changes expected.
Most of the world sees quality as conformity assessment (registration/certification).
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Quality
Medical device and pharmaceutical
Device is mature. FDA 21 CFR 820 (Quality System Requirements) and ISO 13,485:2003 apply.
Pharma moving towards harmonization, with FDA 21 CFR 210 as the start.
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Quality
Food safety
ISO 22,000:2006 (HACCP and ISO 9001 and GMP)
British Retail Consortium (BRC codes)
Safe Quality Food 2005 (SQF) is quite mature
Consolidation effort by Global Food Safety Initiative
Consumer interest strong and getting stronger
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Environment
ISO 14001:2004, Environmental management systems -- Requirements and rest of family.
Quite mature and merging with 9001.
Expect much more activity on labeling and claims of conformance.
ISO 50,001:2011, Energy management systems
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Occupational safety
Still pretty reactive and lacking maturity of other systems. (Lawyers?)
OHSAS 18,001:2007 (Requirements) developed by ISO and ILO. Not much interest in No. America.
Responsible Care and Process Safety Management (21 CFR 1910) for chemical industry in USA.
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Information security
ISO 27,001:2005 (Info Security). Started out as BS 17,799.
ISO 13,335:2004 (IT/MIS Security) available for free.
Identity theft and password capture are huge revenue generators for bad guys.
Cyber-warfare is being developed (StuxNET worm). Zero Day thriller novel recently released.
Governments and multi-nationals interested in registration/certification.
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Business security
NFPA 1600:2007 on Disaster Planning, Emergency Response, and Business Continuity used by US Dept. of Homeland Security.
ISO 22301:2012 Societal security - Business continuity management systems - Requirements
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Supply chain security
Supply chain risk (sole source, lean, safety, terrorism)
ISO 28,001:2007 Security management systems for the supply chain used for registration
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Risk management
ISO 31,000:2009 says that Risk management:
1. Creates and protects value
2. Is an integral part of all organizational processes
3. Is part of decision making
4. Explicitly addresses uncertainty
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Risk management
ISO 31,000:2009 says that Risk management:
5. Is systematic, structured and timely
6. Is based on best available information
7. Is tailored
8. Takes human and cultural factors into account
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Risk management
ISO 31,000:2009 says that Risk management:
9. Is transparent and inclusive
10. Is dynamic, iterative and responsive to change
11. Facilitates continual improvement of the organization
See also ISO 14,971:2001 (Risk management for medical devices)
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CSR is not SR. Focus is on business
Some national standards being developed, especially in Eastern Europe, but not ISO
Conformity assessment, with government encouragement
Used in USA as shorthand for green and corporate charity
No ISO movement (that I am aware of)
Corporate social responsibility