YOU ARE AT THE STATE FAIR WHERE YOU PAY TO TAKE A SHORT JOYRIDE IN A - PowerPoint PPT Presentation

YOU ARE AT THE STATE FAIR WHERE YOU PAY TO TAKE A SHORT JOYRIDE IN A SMALL AIRPLANE • Your pilot is new at the airport and has a straight A average in flight school. This pilot “knows everything”. But this pilot has never flown this specific aircraft before. Do you want them to take you on this flight? Or do you want someone with demonstrated skills AND experience in this particular aircraft? The pilot will follow a detailed procedure, is that ok?

ISO9001:2015 NAVIGATING THE TRANSITION FROM 2008

WILL KITCHEN SOLUTION STRATEGIST WITH EXECUTIVE KPI • 11 years in metals manufacturing for the automotive supply chain (ISO 9000:1994, Alcoa Internal Auditor) • 6 years in chemical manufacturing for the electronics supply chain (ISO 9001:2000, RMP, PSM) • 6 years manufacturing inks/coatings, plastics and food packaging (ISO 9001:2008, HACCP, SQF, AIB, 21CFR174-179) • 2 years manufacturing dietary supplements (ISO 9001:2015, FSSC 22000, 21CFR110 and 21CFR111) • ASQ Certified manager of quality / operational excellence, Six sigma black belt • ISO internal auditor, HACCP and GMP certified, Food safety officer, Regulatory Director (FDA, USDA, EPA, WSDA, SWCAA, OSHA) • Preventive Controls Qualified Individual (FSMA – the new regulatory requirements)

PRODUCTS/MARKETS

ISO: THE EVOLUTION International Standard for Quality Control • ISO9000:1987 • Emphasis placed on conformance with procedures • ISO9000:1994 • The rise of preventive actions (from beneath sheaths of documents) • ISO9001:2000 • Process management emphasized at the heart of the standard • ISO9001:2008 • Minor amendments and consistency adjustments • ISO9001:2015 • Revised to follow the common structure for management system standards •

KEY FEATURE CHANGES • Integrates with existing management system standards using the 10 clause structure – all ISO management systems will look the same • More compatible with services and non-manufacturing sectors • Concept of preventive action now addressed through risk identification and mitigation • “Documented information” replaces “document and record” • Increased emphasis on seeking opportunities for improvement

BENEFICIAL CHANGES • Enhanced leadership involvement in the management system • Risk-based thinking • Simplified language? • Aligning the QMS with the strategy of the organization

As per ISO 9000, the definition of Context of STICKY CLAUSES the Organization is “business environment“, “combination of internal and external factors and conditions that can have an effect on an • Organization and context organization's approach to its products, services and investments and interested • Interested parties Parties“. • Risk and opportunities • Knowledge, competence, and innovation • Controlled conditions and documented information • Measuring customer satisfaction and alignment

POTENTIAL BENEFITS TO THE USER Per ISO/TC 176/SC 2/N1282: • Focus on achieving planned results • Improved risk control • Improved customer satisfaction • Customer retention and loyalty • Improved Image and Credibility

The common structure and ISO 9001:2015 additions 4 Context of 9 Performance 5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement organization Evaluation 9.1 Monitoring, 8.1 4.1 5.1 6.1 7.1 measurement, 10.1 Understanding Leadership and Risks and Operational planning Resources analysis and General and control context commitment opportunities evaluation 10.2 7.2 4.2 6.2 5.2 9.2 Nonconformity Competence Interested parties Planning Policy Internal audit and corrective action 7.3 5.3 9.3 10.3 Awareness 4.3 Organizational Management Continual Scope roles, review improvement responsibilities 7.4 Communication and authorities 4.4 QMS 7.5 Documented information 10

The common structure and ISO 9001:2015 additions 8 Operation 8.1 Operational planning and control 11

Plan Do Check Act 4 9 5 6 7 8 10 Context of Performance and Leadership Planning Support Operation Improvement organization Evaluation 7.1 9.1 10.1 4.1 5.1 8.1 6.1 Resources Monitoring, General Understanding context Leadership and Operational planning and Actions to address risks measurement, analysis commitment control and opportunities and evaluation 7.1.2 4.2 People 5.2 10.2 Nonconformity and Interested parties Policy See next slide 6.2 corrective action 9.1.2 7.1.3 Quality objectives and Customer satisfaction Infrastructure 4.3 planning 5.3 Scope Organizational roles, 7.1.4 10.3 responsibilities and 6.3 9.1.3 Environment for the Continual improvement authorities 4.4 Planning of changes Analysis and evaluation operation of processes QMS 9.2 7.1.5 Internal audit Monitoring and measuring resources 9.3 Management review 7.1.6 Organizational knowledge 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 12

SECTIONS 2015 2008 0 – Introduction 0 - Introduction 1 – Scope 1 - Scope 2 – Normative References 2 – Normative Reference 3 – Terms and Definitions 3 – Terms and Definitions 4 – Context of the Organization 4 – N/A (the spirit of this requirement was in 1.1 and 4.1) 5 – Leadership 5 – N/A (5.1-5.5.1) 6 – Planning 6 – N/A (5.4.1, 5.4.2) 7 – Support 7 – N/A (6.1-6.4, 7.6, 4.2.3, 4.2.4) 8 – Operation 8 – N/A (7.1-7.5, 8.2, 8.3) 9 – Performance evaluation 9 – N/A (8.1, 8.2, 8.4, 5.6) 10 – Improvement 10 – N/A (8.3, 8.5)

MAJOR CHANGES • The context of the organization must be determined • The internal and external issues relevant to the organization • The needs and expectations of interested parties must be determined. • Refers to customers and other stakeholders • There is a requirement for adopting a process approach • Many organizations already have process-based systems, this is more for service based industries

MAJOR CHANGES (CONTINUED) • Requirement for a risk-based approach replaces preventive action • Implies the need for risk assessment and risk management activities • Documented information replaces procedures and records • There is no longer a specific requirement for having a quality manual • The organization determines what must be documented • The term "goods and services" replaces "products", and "provider" replaces "supplier" • This broadens the applicability of the standard • You don't have to run back and do a search and replace

WHAT WE RAN INTO • Challenges getting upper management engaged (managing up) • Understanding the language (context of the organization, etc) • The gray areas – open to interpretation • Auditor discussions and engagement • Upper management engagement

PREPARE FOR THE CONVERSION • Educate yourself and the organization • Download and review the standard – compare sections • ISO 9001 Correlation Matrices are online at www.iso.org/tc176/sc02/public • Identify the gaps between your current system and the new requirements • Prepare an implementation plan with appropriate timelines • Provide appropriate training and awareness across your organization • Talk to your certification body about transitioning at your next audit Deadline for implementation: September 2018 – after this, your ISO9001:2008 certificate is no longer valid

THANK YOU! • I hope you have enjoyed our discussion! • If you are looking for assistance during your conversion process, feel free to contact me at willkitchen@executivekpi.com I can help: • Handle transitions using a team based approach • Provide audit readiness preparation for GFSI food safety schemes • Sit in on audits if needed to provide support and guidance • Be your PCQI representative for FSMA • More information at www.executivekpi.com