Leveraging ISO Certification Standards to Drive Performance How Management System Certifications can help you achieve world-class performance Andrew Porter February 23, 2017 CERTIFICATION
Agenda What are Management Systems and how do they drive improvement Some popular Management System standards: ISO 9001 Quality Management Systems AS9100 Aerospace Quality Management Systems ISO 14001 Environmental Management Systems Food Safety Systems Talk with the experts 2
Ask Yourself Some Questions How did your business do last year compared to 2015? Which measures do you rely on to know how it s going? Profit, ROI? Sales? Productivity? Quality, Lead time, On-time delivery? Customer Satisfaction? If your business improved, was it by luck or deliberate action? Did you implement significant improvements to the business? Did you have data to help you make sound decisions? Did you identify potential risks and take action to reduce them? Did you identify problems and eliminate root causes? Did you improve your supplier base? So let s agree that we re not going to rely on luck. 3
So How Do We Manage toward Success? We create a vision and a strategy to achieve the vision We create policies to convey the vision to the organization We document what we people need to do We assign resources and responsibilities We measure our progress toward the vision We identify gaps between what we re doing and what we should be doing We take action to close these gaps What we ve described here is the foundation of a management system 4
What Are Management Systems Standards? Documented practices for running a business well, typically including: Understanding the context of the organization Demonstrating leadership in the organization Planning on how to achieve desired results Providing support for the organization Performing the work to realize a product or service Measuring performance against targets Making Improvements If you re thinking this is common sense, you re starting to get it! 5
So How Does a Management System Standard Drive Continual Improvement? Management System Standards employ Plan-Do- Check-Adjust (PDCA) to drive continual improvement: 1. Decide what to do and make a plan 2. Execute the plan 3. Measure results and identify gaps 4. Make improvements and repeat Two important characteristics of PDCA: It doesn t matter where you start, you are always moving toward becoming excellent How quickly you improve is determined by how fast you cycle through these steps 6
What Else Is Included in a Management System? Requirements for: Describing your processes and how they interrelate Setting overall objectives and targets for how well you meet your policies Planning changes to your management system Performing processes to achieve high-quality results Controlling and correcting problems Determining customer satisfaction Evaluating how well the organization is functioning Making improvements 7
Management System Standards are not all the same Some are intended to be very general and broadly applicable, such as ISO 9001. Others are more specific, like Food Safety Environmental Aerospace Automotive Medical Device Worker Safety How many of you have one of these standards? 8
For example lets look at ISO 9001 Probably the most widely adopted management system standard worldwide, spanning more than 25 years It describes a Quality Management System, but truly it is a Business Management System However Despite all of the great business wisdom embedded in this standard we see organizations with systems that aren t driving improved performance Despite the improvements made to the standard over more than 25 years, these organizations management systems have hardly changed 9
Why Did We Implement Our ISO System? Sales thought it would increase customer orders Marketing thought the logo would look great on the website Quality saw it as a big power play Operations knew it would never work The President thought everyone else was doing it And of course we all wanted to improve But why didn t we improve?!! 10
Why Didn t ISO 9001 Help Us Improve? We delegated ISO 9001 to the Quality department because it seemed logical. We added more paperwork to make sure we did things the ISO way. Our ISO 9001 system was constraining us so we ignored some of the rules We created a big heavy quality manual but nobody read it. 11
Finally, Why Didn t We Improve? For most of us, we just didn t get it! This is about running our business, and we can t delegate that. This is about doing something we do every day: Plan what you do, Do it, Check your progress, and Adjust your course. It s just not that hard. 12
Is your Management System running like a Clunker or a Race Car? Clunker: Bureaucratic Meaningless measures Same problems returning over and over Long arduous management reviews that yield nothing Business performance has stalled Race Car: Simplified processes Meaningful measures Corrected problems that don t return Engaging reviews and actions that achieve measurable results Consistent improvement over time 13
What Are Some Management System Standards? Quality Management Systems: ISO 9001 Aviation, Space, and Defense Quality Mgmt. Systems: AS9100 Environmental Management Systems: ISO 14001 Food Safety Systems: GFSI, FSSC 22000, SQF, BRC Automotive Quality Mgmt. Systems: ISO/TS 16949 or IATF 16949 Medical Device Quality Management Systems: ISO 13485 Occupational Health and Safety Management Systems: OHSAS 18001 (ISO 45001 expected Dec. 2017) 14
ISO 9001 Quality Management System Standard Applies to any business and all industries Most general of all management system standards Revised in 2015: Greater emphasis on demonstrating improvement over time Fewer required documents Better aligned with Plan-Do-Check-Adjust More focus off the shop floor than in prior versions Added needs and expectations of relevant interested parties Added internal and external issues Added actions to address risks and opportunities Removed requirement for Management Representative All ISO 9001 businesses must be recertified to 2015 version by September 2018. 15
First Let s Clear The Air. What have you heard about ISO 9001? It s a paperwork nightmare It keeps us from getting real work done Why do we do it this way? Because ISO SAYS SO! ISO 9001 is simple. People make it difficult. Don t be difficult 16
The new standard aligns better with Plan-Do-Check-Act 17
Outline Of The New Standard Quality Management System 4. Context of the Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement External and Internal Issues Leadership Commitment Risks and Opportunities People Planning Monitor & Measure Corrective Action Needs and expectations of interested parties Customer Focus Quality Objectives Infrastructure Determine and Review Product Requirements Customer Satisfaction Continual Improvement Scope of the QMS Quality Policy Plan how to achieve Quality Objectives Suitable work environment Design & Development Analysis & Evaluation QMS Map Organization Chart Plan Changes to the QMS Calibration Suppliers and Vendors (Purchasing) Internal Audit Process Maps Organizational knowledge Competence, Awareness, Communication Control of Production -ID/Traceability; -Customer property; -Preservation; -Post-delivery activities; -Change control Management Review Documented Information Product Release Requirement Largely Unchanged New Requirement Non-conforming outputs
The philosophy has shifted from Do this to Did you improve? Although some requirements have been eliminated, more focus is placed on performance improvement The first question is did you improve? If not, then did you: Create meaningful measures? Set appropriate targets? Take actions when you missed targets? Determine if the actions were effective? 10.3 Continual improvement The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system. 19
AS9100 Aerospace Quality Management System Standard Applies to suppliers to aviation, space, and defense industries Based on ISO 9001:2015 with added requirements for: Specific terms: e.g. counterfeit part, critical items, key characteristics, Adds requirement for the Management Representative (dropped by ISO 9001) Positive recall for calibrated instruments Awareness of the importance of ethical behavior Operational Risk Management Configuration Management Product Safety Prevention of Counterfeit Parts Quality and On-time Delivery must be measured and acted upon Incorporates a stage-gate design and development process Tighter control of suppliers and outsourced processes Tighter control of production, equipment, tools, and software programs Companies should consider a joint certification with ISO 9001. 20
ISO 14001 Environmental Management System Standard Applies to any business and all industries System for managing actual and potential environmental risk and compliance obligations Revised in 2015: Organizational strategy and EMS are integrated Increased accountability of leadership through integrated decision making and increased environmental manager interaction with top management Consideration of life cycle issues for risks and opportunities Rethink impact as both organization effect on the environment and how organization is affected by the environment Environmental risks and opportunities in the supply chain Proactively consider external reporting on environmental issues Specify exactly how compliance is evaluated and recorded stronger emphasis on the requirement for continual improvement All ISO 14001 certified businesses must be recertified to 2015 version by September 2018. 21
Example Certifications & Standards for Sustainable Practice Unique Standards for Specific Needs/Expectations Several frameworks exist to build additional unique customer and market credentials Alliance for Water Stewardship International Water Stewardship Standard Water risk, performance management and certification OHSAS 18001 or ISO 45001 (coming in December) Occupational Health and Safety Environmental, Social and Governance (ESG) and Corporate Social Responsibility (CSR) Social Accountability 8000 (SA 8000) Supplier Ethical Data Exchange (SEDEX) SEDEX Member Ethical Trade Audit (SMETA), The Sustainability Consortium (TSC) Aspect Specific Carbon Carbon Disclosure Project (CDP) & GHG Protocol Water Carbon Disclosure Project Water (CDP Water) & CEO Water Mandate Waste Zero Waste to Landfill Other Financial, Sector, Facility and Practice Standards and Certifications 22
Food Safety System Standards Global Food Safety Initiative (GFSI) FSSC/ISO 22000 SQF BRC Food Safety Modernization Act (FSMA) HACCP - Hazard Analysis and Critical Control Points Third Party Audits 23
Why become certified? Because your competition is certified Because your customers ask for it Because you want to create consistent and sustained improvement in your organization Because capital markets respect it Because certification systems now leverage your strategic and operational management systems 24
What the Roadmap to Improve? 1. Form an implementation team Cross functional, 3-7 persons 2. Review the standard Identify gaps in your current system and actions to close gaps 3. Simplify your current system Create simple process documents Reduce the number of procedures Make your Quality Manual less than 20 pages Complexity is your enemy. Any fool can make something complicated. It is hard to make something simple. Richard Branson 25
What the Roadmap to Improve? 4. Add what s needed to meet requirements Gaps identified when reviewing the standard 5. Rationalize measures and targets Develop meaningful measures and reasonable targets 6. Perform an internal audit to the new standard Bring in an outsider with fresh eyes to review your system 7. Recertify with your Registrar 26
Want to learn more? There are people stationed around the room to answer questions on specific standards. Consider asking them: How much do I need to document? How do I. What is the hardest part of certification? What if the auditor is unreasonable? 27