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    IATF 16949:2016 Audit Guide and Checklist 2nd Edition
    IATF 16949:2016 Audit Guide and Checklist 2nd Edition
    IATF 16949:2016 Audit Guide and Checklist 2nd Edition
    Ebook257 pages1 hour

    IATF 16949:2016 Audit Guide and Checklist 2nd Edition

    By Patrick Ambrose

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    About this ebook

    The IATF 16949:2016 Audit Guide and Checklist provides all the information necessary for an in-depth assessment of your ISO 9001:2015 / IATF 16949:2016 Quality Management System. It was written to help auditors conduct a process based audit and stresses process effectiveness as well as compliance. The evidence-based questions start with top management and flow through the path of a generic product within an organization.

    Following the 16 insightful chapters on such topics as process design, process auditing, PDCA, Turtle Diagrams, Context of the Organization and Systems Integration you can dive into the evidence-based questions. The first part of the audit examines the complete system. This includes questions about the conformity of the system to the standard along with dozens of Best Practice questions to help you better evaluate the effectiveness of the system. Questions in the second part focus on the effectiveness of the processes that are found in almost any organization, regardless of industry or sector.

    This Guide covers every requirement in both ISO 9001 and IATF plus Customer Specific Requirements (GM, FORD, FCA, VW, PSA), Core Tools (APQP (2018), FMEA (2018), Control Plans, MSA, Process Capability, and PPAP) and CQI requirements (8, 9,11, 12, 14, 15, 17, 19, 23, 24).

    The Guide includes: 584 Assessment questions, 188 questions related directly to Customer Specific Requirements, 71 Core Tools Questions and 15 Specific CQI Questions and 150 valuable notes designed to help auditors understand the intent of specific questions.

    The IATF 16949:2016 Audit Guide and Checklist offers:

    *A blend of insightful guidance and practical evidence-based questions that help take your QMS to the next level.
    *Practical advice on everything from defining processes, to evaluating training, to evaluating maintenance to measuring sales activity.
    *Help in planning and organizing process audits effectively and documenting the results in a meaningful way.
    *Additional clarity on Context of the Organization, Safety Related Products, MAQMSR, Sanctioned Interpretations and FAQs.
    *Value to organizations that want more than their money’s worth from their management systems by driving best practice.

    LanguageEnglish
    PublisherPatrick Ambrose
    Release dateApr 10, 2018
    ISBN9781370127771
    IATF 16949:2016 Audit Guide and Checklist 2nd Edition
    Author

    Patrick Ambrose

    Pat is the founder of SystemsThinking.Works and has been auditing, consulting on and teaching management systems for over 25 years. At SystemsThinking.Works he is supported by a small team with experience in quality management, project management, and six sigma in several industries including automotive, healthcare, consumer goods, and government.Pat wants to share not only ideas from his experiences in quality, auditing and management systems, but also what he’s most passionate about – critical thinking and systems thinking and how these can be applied to make organizations effective. It’s not just about getting ISO certification. It’s about thinking critically about what an organization needs and what the people responsible for making that happen need in order to make it happen.As a semi-retired grandfather of seven, SystemsThinking.Works and his ebooks are Pat’s way of putting everything he’s learned and experienced together in one place. It is there for the taking. Learn what you can and what you want. The outcomes from what you learn are up to you.

    Read more from Patrick Ambrose

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      very good audit guide pls go forward to more in other standards

    Book preview

    IATF 16949:2016 Audit Guide and Checklist 2nd Edition - Patrick Ambrose

    Foreword

    The creation of this 2nd Edition guidebook and checklist brings this guide to the most up to date list of requirements that we can offer. This book is a checklist, but it is a unique checklist. It is not just a list of questions which elicit a specific correct answer. The questions here are intended to help auditors find evidence of an effective and efficient system. The questions follow a ‘Plan, Do, Check, Act’ –‘Process Approach’ to finding evidence. Auditors are expected to gather evidence, review it, evaluate it and then determine for themselves the effectiveness of the system being audited and whether the requirements are fully met. Many of the questions require observation. Others require review of documents or records. Other questions ask the auditor to make a value judgment, (Is evidence sufficient?). In this way, auditors will have guidelines which, combined with their own knowledge and skills, will create a complete and value adding audit.

    This book could not have been written without help. I owe a great deal of thanks to many people whose questions and discussions have shaped my approach and content of this book. To all of my audit students, fellow registration auditors, colleagues and friends who have helped me, mostly unknowingly, to develop, revise and constantly expand my thinking with regard to Quality Management Systems, Auditing and management in general, Thank You!

    And finally, I would like to thank you, the purchaser and user of this book. I sincerely hope, this book will provide you and your organization with the information that you need to achieve your goals and objectives.

    Sincerely,

    Pat Ambrose

    INTRODUCTION

    There is one important consideration that the management of your organization should make before choosing to use the checklists included in this Guide. They must carefully consider their objectives regarding your IATF 16949 / ISO 9001 Quality Management System. If what they are looking for is the easiest way to get and keep their IATF registration, or if their aim is to take the paperclip and bubble gum approach – i.e. identify the exact wording changes and modify the documentation, THIS IS PROBABLY NOT THE BOOK FOR YOU. Neither is this book and the checklists in it simply a regurgitation of IATF Customer expectations. The questions included in this checklist are designed to promote best practices. This checklist is for organizations with a desire to get their money’s worth and more out of their systems. The questions strive to provide a value-added, effective and efficient quality management system that will provide customers with conforming products, effective supplier systems performance and effective supplier/customer relations while providing your organization with an efficient and cost-effective system.

    This book does not promote bureaucracy or endless procedures. The questions and notes provided are intended to assess whether your system is first and foremost ‘Effective’.

    Certainly, you have the option and I would expect that you will skip or delete questions that are of no value to your organization. I would also expect that you will modify questions or even add additional questions of your own. I welcome your participation in this effort to get the maximum value from this resource.

    Pat Ambrose

    1. CHECKLIST SUMMARY

    2. AN INTRODUCTION TO IATF 16949:2016

    With this new International Standard, some of the structure and terminology in TS 16949: 2009 and ISO 9001:2008 has been changed to improve alignment with other management systems standards. Basic Changes include:

    TS (Technical Specification) is now IATF (International Automotive Task Force)

    The combined format has become two distinct but linked documents (See FAQ answer below)

    The adoption of the HLS (standardized ‘High Level Structure’) (ISO and IATF)

    An explicit requirement for risk-based thinking (ISO and IATF)

    Reinforced application of the process approach (ISO and IATF)

    Fewer prescribed requirements (ISO)

    More detailed and better defined requirements (IATF)

    Less emphasis on documents (ISO)

    Clearer document requirements (IATF)

    Inclusion of customer specifics into some requirements (IATF)

    A requirement to define the boundaries of the QMS (ISO and IATF)

    Emphasis on organizational context (ISO and IATF)

    Emphasis on the needs and expectations of interested parties (ISO and IATF)

    Increased leadership requirements (Active Participation) (ISO and IATF)

    Greater emphasis on the achievement of desired outcomes to improve customer satisfaction (Performance Measurement) (ISO and IATF)

    IATF FAQ - Why are there two manuals (IATF 16949:2016 and ISO 9001:2015)?

    ANSWER - The IATF and ISO were not able to reach a licensing agreement to publish IATF 16949 with the ISO 9001 in an integrated document.

    Major Differences in Terminology between Previous and New Standards:

    Additional IATF CHANGES

    Scope: The new scope includes accessory parts made for the OEMs and stresses customer requirements and product with embedded software.

    Embedded Software Note

    Organizations designing or working with products with ‘EMBEDDED SOFTWARE’ require more detailed and more stringent controls including a software development assessment methodology, prioritized risk assessments and inclusion of software development assessment in the scope of the internal audit process. (See - 8.3.2.3, 8.3.3.1, 8.3.4.2, 8.4.1.2, 8.4.2.3.1, 10.2.6 IATF and also - ‘Automotive SPICE’ reference 1)

    IATF Sanctioned Interpretation – Customer Requirement -All requirements specified by the customer (e.g., technical, commercial, product and manufacturing process-related requirements, general terms and conditions, customer-specific requirements, etc.). Where the audited organization is a vehicle manufacturer, vehicle manufacturer subsidiary, or joint venture with a vehicle manufacturer, the relevant customer the vehicle manufacturer, their subsidiaries, or joint ventures.

    Accessory Parts – parts either electronically or mechanically connected to the vehicle such as truck bed liners, floor mats, sound systems, sunroofs or spoilers – Aftermarket accessories are not included in the scope.

    Other New or Changed Definitions

    Challenge (Master) Part – parts of known specification used to calibrate/validate error-proofing devices or check fixtures.

    Special Status – result of a notification by a customer of a classification assigned to a supplier because one or more customer requirements are not being satisfied due to significant identified issues.

    Production Shutdown – a condition where manufacturing processes are idle. Time span can be a few hours to a few months.

    Trade-Off Process – methodology using trade-off curves to establish technical or economic relationships between alternatives.

    IMPORTANT NOTES:

    FORMAT

    It is important to recognize that the changes in the structure and terminology used in the latest standard do not need to be reflected in the documentation of your organization’s quality management system. The structure of clauses is intended to provide a coherent presentation of requirements rather than a model for documenting an organization’s QMS (Quality Management System). There is no requirement and no intention for the structure of an organization's quality management system documentation to mirror that of either the ISO 9001 or IATF 16949 standards. As a matter of fact, the intent is for your systems to be designed around your manufacturing and your management processes. In this regard, every organization’s IATF system should be unique in

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