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AS9100:2016 Transition

AS9100 Rev D was released in October 2016. Important changes include an increased emphasis on strategic planning elements and risk-based thinking, as well as a dramatically “Osterized” structure – with 10 clauses rather than 8.There are things you can begin doing now to smooth the transition for your organization and suppliers.

Come learn insider’s perspectives from Ray Hanson, an Axeon Sr. Instructor and member of the Technical Committee (TC176 SC2) tasked with the evolution of ISO 9001. In this 1-day class you will receive detailed insights into the implications of the changes and a transition road map to guide your efforts.

 

5-Day Transition Week Pricing

 

• $600 off of 5-Day Transition Week Package

 

• If Payment or PO is received within 7 days of confirmed registration

 

5-Day Transition Week Package - $3540

Transition Week

 

Transition Week is a powerful combination of classes designed to prepare you and your company for the transition to the new standards.

 

This package includes the following courses:

2-Day Root Cause Corrective and Preventive Action

2-Day Risk Management Principles and Practices

1-Day Early Transition Course

 

The new ISO standards are coming, and we all know it. But just because you know something is coming, doesn’t mean you have all of the answers you need. The truth is, we don’t have all of the answers either, but most of the important changes have been established and many of the questions on your mind have answers.

 

With the changes coming to Root Cause and Corrective Actions, and the increased requirements for Risk Management throughout the entire organization, a simple transition course is not enough for most customers. Knowing what the changes are, isn’t the same thing as being able to implement them in your organization. These classes, along with a firm foundation in ISO, will give you all the knowledge and skills you need to make the transition to the new standard. You will also spend time in class learning strategic planning skills that will assist you in creating your company’s customized transition plan.

3- Day AS9100 Rev D Internal Auditor- $1395

3 Day AS9100:2016 Rev D Internal Auditor Class

With Live Audits

Days: 3 • CEU Hrs: 2.4

Time: Day 1 7:30 a.m.- 4:30 p.m.

Day 2 7:30 a.m.- 4:30 p.m.

Day 3 7:30 a.m.- 4:30 p.m.

Audience: Beginner to Advanced

Overview: 

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 Rev D standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Who Should Attend

Individuals who will perform audits to AS9100:2016 Rev D Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 Rev D registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the AS9100:2016 Rev D Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Fully understand and interpret the AS9100:2016 Rev D requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

 

Agenda

Day 1

Part 1:  Introductions and Self-Assessment

  1. Course requirements
  2. How to get the most from this experience
  3. Networking with class mates (industry professionals)
  4. Self-assessment of audit skills and internal audit programs Exercise #1

Part 2:  Quality Terminology and Definitions

  1. Quality industry vernacular from AS9100:2009, ISO 19011
  2. Differentiating between Verification and Validation
  3. Understanding Corrective and Preventive Actions
  4. How to converse with external auditors
  5. Terminology Exercise #2

Part 3:  Requirements of AS9100:2009

  1. Demystifying the AS9100:2016 Rev D standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of AS9100:2016 Rev D to quality events
  5. Audit Case Studies

Part 4:  The Audit Process:  Roles and Duties 

  1. Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
  2. Qualifying Auditors
  3. Duties of the IA staff
  4. Exercise #8: Preparing to be audited-

Day 2

Part 5:  The Audit Process:  Performing the Audit Process

  1. Audit Tools – checklists, process maps, findings, reports
  2. Conducting Audit Interviews Exercise #9
  3. Exercise #10 with Morgan Case Studies

Part 6:  The Audit Process:  Audit Skills and Techniques

  1. Audit Interviewing techniques
  2. Continual improvement techniques
  3. Process Auditing methods
  4. Developing a “continual improvement” attitude in the organization
  5. Exercise #11 Writing Audit Findings
  6. Exercise #12 Evaluating the effectiveness of Audits
  7. Exercise #13 Application of Process Auditing techniques
  8. Review written NCRs and OFIs

Day 3

Part 7:  The Audit Process:  Finalizing the Audit

  1. Developing an Audit Schedule
  2. Conducing Audits- Live Audit
  3. Writing Non-Conformities
  4. Prepare a PEAR form
  5. Writing the audit report
  6. Exercise #14 Writing and audit report
  7. Exercise #15 Writing Non-Conforming Reports
  8. Exercise #16 Conducting a Closing Meeting

Review and Examination for Certificate

 

 

2-Day Root Cause Corrective Action and Preventive Action Course- $1295

2-Day Root Cause Analysis, Corrective Action and Preventive Action Training

 

Schedule

Day 1: 7:30 am – 4:30 pm

Day 2: 7:30 am – 4:30 pm

Root Cause & CAPA 

This course teaches attendees how to use a simple 8-step approach to correcting and preventing problems or nonconformities that exist anywhere in their organization. It can help to satisfy quality management system requirements for planning and establishing a process for corrective action.

Learning Objectives

Learn the process for completing a formal corrective action request. You’ll learn how to describe a problem, conduct causal analysis and what information is needed in order to ensure a corrective action is complete and effective.

A great course for anyone learning to deal with corrective actions for the first time or if you just need a refresher to calibrate your knowledge and build more confidence in your abilities.

Who Should Attend

Any employees that will conduct a corrective action or participate as a team member, as well as any individual who would like to gain an in depth understanding of the 8-step approach for CAPA’s.

 

Agenda

 

Day 1

  • Overview of Root Cause & Corrective/Preventive Action
  • 8-Step Closed-Loop Process
  • Typical Problems with Root Cause Analysis
  • Why most problem solving models don’t get to the root cause, and a solution
  • How analytical and creative thinking must be both separated and integrated
  • Difference between content and process thinking
  • Responsibilities for Root Cause and Corrective/ Preventive Action
  • Quality, Design, Frontline Management, Supervisors, Worker
  • Step 1: Assigning a corrective action team leader
  • Step 2: Describing the problem
  • Activity #1 – Detailed problem descriptions
  • Step 3: Containing the problem
  • Activity #2 – Containment Potential
  • Step 4: Identifying the root cause or causes
  • System, process, & product causes
  • Root cause/data analysis tools (flow charts, histograms, Pareto charts, Paynter charts, control charts, run charts, etc.)
  • Data Collection
  • Population versus sampling; options for sampling
  • Check sheets, graphs, and tables for discrete data collection
  • Surveys, interviews, and field observation for opinions or less precise data
  • Activity #3 – “5 why” method
  • Activity #4 – Ishikawa or Cause & Effect Diagram
  • Activity #5 – FMEA (Failure Modes Effect Analysis)
  • Step 5: Verifying the root cause or causes
  • Step 6: Implementing corrective actions
  • Step 7: Verifying corrective action effectiveness
  • Step 8: Closing the corrective action report
  • Preventing recurrence
  • Acknowledging the improvement

 

Day 2

Application of Closed-Loop Root Cause & Corrective/Preventive Action Tools

  • Step 1: Assigning a corrective action team leader
  • Step 2: Describing the problem
  • Step 3: Containing the problem
  • Step 4: Identifying the root cause or causes
  • Step 5: Verifying the root cause or causes
  • Step 6: Implementing corrective actions
  • Step 7: Verifying corrective action effectiveness
  • Step 8: Closing the corrective action report

 

Review & Exam

 

2-Day Risk Based Thinking and Risk Management ISO 31000 & 14971 Training - $1295

2-Day Risk Based Thinking and Risk Management

ISO 31000 & 14971

Risk Management for ISO 9001:2015, AS9100:2016 and ISO 13485:2016

 Quality Risk Management Principles and Practices

This class will teach participants to turn Risk Assessment into a well-organized systematic approach that targets and then reduces risk to the organization, customers and stakeholders. While Risk Management is a requirement for Aerospace and Medical Device Manufacturers, these same techniques can be used regardless of the products or services offered by your organization.

 

Who should attend

  • Anyone who needs to develop and implement a comprehensive Risk Management
  • Program meets requirements for ISO 14971 and ISO 31000
  • Any organization that needs a formal, disciplined approach to the identification, assessment and management of Risk
  • Quality Managers
  • Engineering Managers
  • Internal and external auditors
  • Design Teams
  • Management Representatives
  • Project Teams
  • Anyone who needs to understand the difference between Risk Identification, Risk
  • Assessment and Risk Management and how to put these important tools to work for your organization.

 

What you will learn

  • The components of risk management that can be applied to any organization, regardless of their products or customers
  • How to design a risk management structure for your organization that gets results
  • A means for demonstrating to customers and stakeholders the potential risks associated with products or processes and provide assurance that these have been effectively managed
  • Tools used for Risk Assessment such as FMEA and FMECA
  • How to quantify risk as the first step in establishing priorities for your organization

 

Day 1 Agenda

  • Risk terminology and theory from ISO 14971,ISO 13485, and ISO 31000
  • History of risk management and relationship with Corrective and Preventive Actions
  • Requirements of ISO 14971
  • Design of framework for managing risk
  • 4.3.2 Establishing risk management policy
  • Integration into organizational processes
  • Establishing internal communication and reporting mechanisms
  • Establishing external communication and reporting mechanisms
  • Implementing risk management
  • Implementing the framework for managing risk & risk management process
  • Continual improvement of the framework
  • Communication and consultation
  • Establishing the internal and external context
  • Establishing the context of the risk management process
  • Defining risk criteria
  • Risk assessment
  • Risk identification
  • Risk analysis
  • Risk evaluation
  • Risk treatment
  • Selection of risk treatment options
  • Preparing and implementing risk treatment plans
  • Monitoring and review
  • Recording the risk management process
  • Exercises B.1 – B.6 internal & external framework, risk treatment, risk monitoring, risk policy, risk analysis
  • Additional Requirements for ISO 31000

 

Day 2 Agenda

  • Guidelines from ISO 14971/31000 Risk Assessment Techniques – Risk Management
  • Selection of risk assessment techniques
  • Selection of techniques
  • Availability of Resources
  • The Nature and Degree of Uncertainty
  • Complexity of risk
  • Application of risk assessment during life cycle phases
  • Types of risk assessment techniques
  • Flow charts and process mapping
  • Brainstorming
  • Risk Checklists
  • Delphi Method
  • Process FMEA
  • Design FMEA
  • Fault Tree Analysis (Event Tree Analysis)
  • HAZOP & HACCP
  • Cause & Effect with 5-Whys & 7-M
  • Preliminary hazard analysis
  • Risk Ranking and Filtering
  • Case Studies with application
  • Organization’s Risk Procedures and Tools
  • Case Studies from Organization’s Risk Analysis, Treatment and Monitoring
  • Risk Applications in the Aerospace organization
  • Internal Audit
  • Training
  • CAPA System
  • Supplier Selection & Control
  • Outsourcing – Special Processes
  • Facilities and Equipment
  • Design & Development
  • Production and Process Controls
  • Process Validation and Re-Validation
  • Servicing
  • Design FMEA Case Study
  • Various Risk Case Studies
  • Organization’s Case Studies
  • Statistical Methods
  • Test

 

2-day AS9100 Rev D Internal Auditor- $1295

 2 Day (18 Hr) AS9100:2016 Rev D Internal Auditor Class

Live online or Onsite Only

Days: 2 • CEU Hrs: 1.9

Time: Day 1 7:30 a.m.- 5:30 p.m.

Day 2 7:30 a.m.- 4:00 p.m.

Audience: Beginner to Advanced

 

Overview: 

This course prepares you to perform internal QMS audits using industry-proven techniques and to apply proper interpretation of the ISO standard to real life audit situations. You’ll follow the full audit process including: audit tools and preparation, opening meetings, audit interviews, closing meetings, and reporting.  This is a very practical class that is not “bogged-down” with academic discussions of quality topics that have limited utility for class attendees.

This Internal Audit class makes extensive use of activities and case studies to help you fully understand the requirements of quality system auditing to the AS9100:2016 standard. Since people “lock” new understanding into long-term memory much better when they apply it, lecture time is held to a minimum providing you time to grasp and then practice your newly acquired skills in simulated real-life audit situations.

Who Should Attend

Individuals who will perform audits to AS9100:2016 Standards or Quality Management Systems, individuals assisting their organizations toward AS9100:2016 registration, or individuals who are frequently audited should attend this training. Quality directors, managers, engineers, auditors, ISO coordinators, laboratory quality professionals, and anyone engaged in quality audits will benefit from this training.

Prerequisites

There are no required prerequisites.  This course is routinely taught to quality novices and life-time professionals. All attendees are required to bring their own copy of the AS9100:2016 Quality Management Standard Requirements to this training course. These will not be provided for you. We strongly advise you bring a “paper” copy.

Course Objectives

  • Prepared to conduct a solo internal audit at successful course completion
  • Fully understand and interpret the AS9100:2016 requirements.
  • Apply the proper interpretation of the standard in actual audit situations.
  • Understand process auditing tools leading to substantive quality system improvements
  • Tailor an audit interview based on the requirements of the standard and obtain audit evidence from this interview.
  • Follow-up and resolve “audit trails that present themselves during the audit interviews
  • Conduct audits that result in real improvements to the quality system
  • Plan and execute the entire audit process including: audit preparation, opening meetings, auditing, closing meetings, and reporting.

 

 

Agenda

Part 1:  Introductions and Self-Assessment

  1. Course requirements
  2. How to get the most from this experience
  3. Networking with class mates (industry professionals)
  4. Self-assessment of audit skills and internal audit programs Exercise #1

Part 2:  Quality Terminology and Definitions

  1. Quality industry vernacular from AS9100:2016, ISO 19011
  2. Differentiating between Verification and Validation
  3. Understanding Corrective and Preventive Actions
  4. How to converse with external auditors
  5. Terminology Exercise #2

Part 3:  Requirements of AS9100:2016

  1. Demystifying the AS9100:2016 standard
  2. Interpreting and cross-referencing the quality standard
  3. Analyzing audit findings
  4. Audit exercises for application of AS9100:2016 to quality events
  5. Exercise #3-#7: Short case studies in quality events

Part 4:  The Audit Process:  Roles and Duties 

  1. Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
  2. Qualifying Auditors
  3. Duties of the IA staff
  4. Exercise #8: Preparing to be audited

Part 5:  The Audit Process:  Performing the Audit Process

  1. Audit Tools – checklists, process maps, findings, reports
  2. Conducting Audit Interviews Exercise #9
  3. Exercise #10 Quality event case studies

Part 6:  The Audit Process:  Audit Skills and Techniques

  1. Audit Interviewing techniques
  2. Continual improvement techniques
  3. Process Auditing methods
  4. Developing a “continual improvement” attitude in the organization
  5. Exercise #11 Writing Audit Findings
  6. Exercise #12 Evaluating the effectiveness of Audits
  7. Exercise #13 Application of Process Auditing techniques

 

Part 7:  The Audit Process:  Finalizing the Audit

  1. Writing the audit report
  2. Opening and Closing Meetings
  3. Exercise #14 Writing and audit report
  4. Exercise #15 Writing Non-Conforming Reports
  5. Exercise #16 Conducting a Closing Meeting

Review and Examination for Certificate

 

1-Day Transition for ISO 9001:2015, ISO 13485:2016, AS9100:2016 Course $950

9001:2015 , 13485:2016, & AS9100:2016 Transition

Who Should Attend

Those responsible for planning and executing the transition from ISO 9001:2008 to ISO 9001:2015, including Management Representatives and Quality Managers, or anyone desiring an up-to-date awareness of the changes that will be impacting new or existing ISO 9001:2008-based Quality Management Systems, including ISO 13485 and AS9100.

Course Objectives

  • Understand the key changes to ISO 901:2015, AS9100 Rev D (2016), and ISO 13485:2016
  • Understand the development and implications of Annex SL
  • Learn how the new format and structure of 2015 sub-clauses compares to those of 2008
  • Provide tools, techniques and tips to address the new requirements for strategic planning, risk management, the context of the organization, etc.
  • Become aware of new requirements in documentation

Agenda

 

Day One

 

  • New Requirements of ISO 9001:2015, ISO 13485:2016, and AS9100:2016
  • Comparison of the Structure and Sequence of ISO 9001:2015 to ISO 9001:2008
  • Implications of Appendix 4
  • Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
  • Risk-based Elements of 6.1, 7.5.1, and 8.1
  • Action Plan Elements of 6.2
  • Differences in Documentation and Other Requirements
  • Timetable for Transition of Certification to ISO 9001:2015 and AS9100:2016
  • Individualized Transition Road Map