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

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

Feb 07, 2023 127 likes •309 views

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

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SLIDE 1

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?

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SLIDE 2

ISO9001:2015

NAVIGATING THE TRANSITION FROM 2008

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SLIDE 3

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)
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SLIDE 4

PRODUCTS/MARKETS

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SLIDE 5

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
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SLIDE 6

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
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SLIDE 7

BENEFICIAL CHANGES

  • Enhanced leadership involvement in the management system
  • Risk-based thinking
  • Simplified language?
  • Aligning the QMS with the strategy of the organization
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SLIDE 8

STICKY CLAUSES

  • Organization and context
  • Interested parties
  • Risk and opportunities
  • Knowledge, competence, and innovation
  • Controlled conditions and documented information
  • Measuring customer satisfaction and alignment

As per ISO 9000, the definition of Context of the Organization is “business environment“, “combination of internal and external factors and conditions that can have an effect on an

  • rganization's approach to its products,

services and investments and interested Parties“.

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SLIDE 9

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
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SLIDE 10

10

The common structure and ISO 9001:2015 additions

4 Context of

  • rganization

5 Leadership 6 Planning 7 Support 8 Operation 9 Performance Evaluation 10 Improvement

4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 6.1 Risks and

  • pportunities

6.2 Planning 7.1 Resources 9.1 Monitoring, measurement, analysis and evaluation 10.1 General 10.3 Continual improvement 7.3 Awareness 7.4 Communication 7.5 Documented information 7.2 Competence 9.2 Internal audit 9.3 Management review 8.1 Operational planning and control 5.2 Policy 5.3 Organizational roles, responsibilities and authorities 10.2 Nonconformity and corrective action

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SLIDE 11

11

8 Operation

8.1 Operational planning and control

The common structure and ISO 9001:2015 additions

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SLIDE 12

12

Do Check Act Plan

4 Context of

  • rganization

5 Leadership 6 Planning 8 Operation 9 Performance and Evaluation 10 Improvement

4.1 Understanding context 4.2 Interested parties 4.3 Scope 4.4 QMS 5.1 Leadership and commitment 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning 9.1 Monitoring, measurement, analysis and evaluation 10.2 Nonconformity and corrective action 10.3 Continual improvement 5.3 Organizational roles, responsibilities and authorities 9.2 Internal audit 9.3 Management review 8.1 Operational planning and control 5.2 Policy 6.3 Planning of changes 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation See next slide

7 Support

7.1 Resources 7.3 Awareness 7.4 Communication 7.5 Documented information 7.2 Competence 7.1.4 Environment for the

  • peration of processes

7.1.5 Monitoring and measuring resources 7.1.2 People 7.1.3 Infrastructure 7.1.6 Organizational knowledge 10.1 General

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SLIDE 13

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)

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SLIDE 14

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

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SLIDE 15

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
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SLIDE 16

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
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SLIDE 17

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

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SLIDE 18

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