IATF 16949:2016
Audit Guide and Checklist
Version 2.0
Copyright 2018
SystemsThinking.Works
Second Edition
January 2018
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Table of Contents
Foreword
Introduction
1. Checklist Summary
2. An Introduction to IATF 16949: 2016
3. Context of the Organization
4. Risk Based Thinking
5. An Introduction to Process Based Auditing
6. The Process of Process Auditing
7. The Audit Report
8. Documenting Evidence
9. Identification of Actions Required
10. The Word ‘Process’ As Used by ISO
11. Risk Based Approaching ISO 9001: 2015/IATF 16949: 2016
12. Customer Oriented Processes (COPs)
13. Turtle Diagrams
14. The PDCA Cycle – Process Approach
15. Linking the Turtle and PDCA
16. This Checklist
System Assessment ISO 9001: 2015/IATF 16949: 2016
Stage 1 Assessment
Stage 2 Assessment
Questions for the Product Design Manager
Questions for the Process Design Manager
Questions for the Manager of Purchasing
Questions for the Manager(s) Responsible for the Production Process
Questions for Front Line Supervisors
Questions for the Maintenance Manager
Questions for the Manager Responsible for Tool Control
Questions for the Owner of the Quality Process
Questions for the Manager Responsible for Shipping and Receiving
Questions for the Manager Responsible for Internal Audits
Questions for the Manager Responsible for Continual Improvement Projects
Questions for the Human Resource Manager
Questions for the Information Technology Manager
Clause Reference
CSR Reference
REFERENCES
A PROCESS BASED CHECKLIST
858 QUESTIONS
584 Questions Covering
ISO 9001: 2015, IATF 16949:2016Requirements
+
188 Questions Covering
The 2017Customer Specific Requirements for
GM (26), Ford (47),FCA (35),
Volkswagen (53), PSA Group* (27)
*Added in the 2 Addition
+
71 Questions Covering
Automotive Core Tools Requirements
APQP -Control Plan/FMEA Handbook (2017)
MSA/Process Capability/PPAP
+
15 Questions Covering
CQI Requirements
+
24 Pages of Additional Resource Information 6 Pages of Reference Material and Approximately 150 Notes
to assist auditors
NEW in the 2nd Edition
1. Added Guidance for effective implementation of Context of the Organization
2. Revised and expanded explanation of Clause 5.1.1c. - Integration of QMS
3. Additional detail for MAQMSR requirements
4. Updates based upon IATF responses to FAQs as of Nov 1, 2017
5. Updates based upon IATF 2017 Sanctioned Interpretation
6. Updates and additions to the latest 2017 OEM Customer Specific Requirements
7. Added questions covering the latest 2017 FMEA Handbook (33 questions)
8. 15 Additional questions to emphasize control of Safety Related Products and Characteristics
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 its structure.
TERMINOLOGY
There is also no requirement for the terms used in an organization’s QMS to be replaced by the terms
used in ISO 9001 or IATF 16949 except where necessary for communication with customers regarding
their specific requirements. Organizations are free to use terms which suit their operations. For example:
In fact, unique terms adopted for your organization can enhance the effectiveness of the system by
eliminating old biases and criticisms born from misapplications and misunderstandings of terms used in
the past.
Consider the term ‘Non-conformance’. The ISO world has spent over 25 years making the word Nonconformance a four letter word. In many organizations the mere mention of the word can insight the
rawest of responses. If this is the case in your organization, maybe changing the term is an opportunity to
make a new start with a healthier understanding and approach.
3. CONTEXT OF THE ORGANIZATION
AN EXPLANATION AND INTERPRETATION OF CONTEXT OF THE ORGANIZATION
Consider for a moment that you have been hired to design a new ship. Your immediate question I am sure
would be what kind of ship. In other words what does it need to do? Where does it need to do its work? In
what environment?
Context of the Organization and its sister requirement Understanding Expectations of Interested Parties
is the exact same exercise. What does your organization do? What is expected of it and in what
environment is it required to work?
In addressing ‘Context of the Organization’ and ‘Need and Expectations of Interested Parties’ consider
the chart above. In determining the environment that your organization has to do its work, you must
consider a number of factors. In general, they are: Market, Legal, Facilities, Products, People and the
Community.
MARKET
First consider your market. Who are your customers? Are there many of them or just a few big ones? Is
the demand for your products growing or shrinking? Consider technological advances or consumer
trends? Are your customers close or distant? Is there a significant transportation element to shipping
your product? Is there an international element to your business (languages, customs, and laws)? How do
they affect your business? Does your business have seasonal or model year fluctuations? How often? How
significant? Who are your competitors? How many are there? Is the list growing or shrinking? Have your
competitors been around for a long time or are there new players in the game? Are you the market
leader? Follower? New guy? If you are the leader, WHY are you the leader? If you are not the leader, WHY
NOT? What are your customer’s expectations of your company? What are the expectations of owner or
shareholders?
LEGAL
Is your organization or product subject to high levels of statutory and /or regulatory scrutiny? Or low or
negligible levels? Are the significant requirements Safety, Environmental, or Security-related? Are legal
requirements - Local in nature, state or regional, national or international?
What are regulator’s expectations of your company?
FACILITIES
Does your organization have one or many sites? If more than one, are they near one another or
significantly spread out? Are they regional, national, international? Are your sites new or old? Modern or
not so modern? Do your buildings properties etc. have room to expand or have they met their limit? Are
facilities conducive to the introduction of new technologies, new transportation or methods new building
layout trends?
PRODUCT
Is your product high tech or low tech. compared to state of the art? Are your manufacturing processes
high tech or low tech. compared to best practices? Is your product simple to produce given the right
equipment or does it require considerable expertise and specialized processes? Are technologies
changing? Are product requirements changing? Are market tends moving away from your product or
toward it? Is your product high volume or low volume? High cost or low cost? Does your product have
significant cost pressures?
PEOPLE
Are the people needed to run your organization available? Nearby? Are labor costs high, low? Higher than
the competition? Lower? Are technically qualified people readily available? Is labor availability stable? Do
you have something to attract qualified people to your organization (wages, environment, culture)? Are
labor expectations changing? Are the technological requirements for the jobs currently or for the future
becoming more complex or less complex? Is the workforce, young, old, aging? Is there an expectation or
requirement that your work force will have to become more diverse? Are there expectations, today or in
the future, that cultural, ethnic, religious or sexual orientation will have an effect on your work
environment?
COMMUNITY
Consider your relationship with your community. Does the community support your company and what it
does? Be careful to consider the community and not just the political or industry representatives who may
gain from your company’s presence. Are community standards, requirements (corporate responsibility,
human rights, safety, environment, air quality, water quality, etc.) changing? Are human wants (social
norms, work environment, benefits) changing?
LINKS
Are there links between the information describing one section of the above analysis and another? For
instance, can current trends in social needs or labor migration effect future availability of technologically
competent employees? Will current or future legal requirements, transportation costs or skills
requirements have an effect of facility locations? These interactions need to be assessed.
ANALYSIS
Each question in the above review needs to be analyzed and it is a sure thing that the answers to some of
the questions will lead to new questions. An effective approach to the ‘Context of the Organization would
require an effective analysis of the information and effective actions to address issues.
An Excel based form for developing context and interrelationship of processes is available free at
https://systemsthinking.works/
4. RISK BASED THINKING
Stressed in ISO 9001:2015 is the requirement to consider risk in management thinking. While
understanding risk was implied in the 2008 version of the standard it is much more explicit in these new
standards. The IATF 16949:2016 standard goes further and requires formal ‘Risk Analysis’ which is
defined as ‘The Use of Failure Mode and Effects Analysis (FMEA) or something similar’.
INTEGRATION OF THE QMS INTO THE ORGANIZATION’S MANAGEMENT SYSTEM (5.1.1c)
To understand this requirement, consider first the conditions that describe many current QMS as well as
EMS (environmental) and OHSAS (health and safety) systems. Many systems today consist of multiple
layers of unique systems. The primary (Management System) layer is the functional operations of the
management. Typically structured around departments.
Superimposed on this system is the QMS (IATF 16949 / ISO 9001) systems, the ISO 14001 systems and
the ISO 45000 (OHSAS 18001) systems. Each managed by specific coordinators. These systems are often
organization wide.
This approach is decidedly NOT an integrated management approach.
In an integrated system and as described in IATF 16949 5.1.1c, the system is built on processes. Each
process has ONE owner. The owner has defined responsibility for the effective operation of the process.
The objectives for the process are defined and measured. In a process based, fully integrated system the
organization would look like the diagram below.
Each process in an effective process-based integrated Business Management System (BMS) would have
very specific attributes:
Identified Owner
Specific Objectives, Measurables, Targets
Productivity, Quality, Environment, Safety fully integrated into the process
Control of Statutory and Regulatory Requirements
Efficiency and Effectiveness designed in and monitored
Documented as needed
Identification and Control of Customer Expectations
Defined Interactions with other processes
Measured Performance
Records
Improvement
Management Oversight
5. AN INTRODUCTION TO PROCESS BASED AUDITING
Even though the change to process based auditing became the intended practice at the turn of the
century, many organizations and some auditors still rely on a clause-based or a shall-based audit process.
The problem with auditing ‘shalls’ or clauses is that the methodology can miss important elements of the
process. It often becomes a simple exercise in determining whether the appropriate words appear in a
document. This approach misses the intent of the standard and the potential value inherent in an effective
application of the requirements of the standards.
Process based auditing is designed to explore the interconnectivity of functions and activities within
organizations. The process approach follows both a systemic investigation of the process, a ‘Turtle
Diagram’ mindset and a PDCA (Plan – Do – Check – Act) approach. The systemic component of the audit
gathers data about the process in a method that builds from the foundation up gathering linked data as
the audit continues. At each step of this analysis the auditor follows the PDCA cycle through the process
as well as following the PDCA cycle through each component within the process. This approach covers all
activities in the process in a way that follows the process through an organized structured manner while
ensuring that all of the elements of the process are reviewed effectively.
Process auditing follows the ‘story’ of the process. Best practice process auditing uses the ‘Turtle
Diagram’ as its primary tool. It is important to note that the Turtle Diagram is not a form used for
auditing, it is process used for auditing. It is a concept and an approach. A ‘Turtle Diagram Form’ may be
used for a short time as a training aid for new auditors. But once an auditor is comfortable with the
process, the only ‘Turtle Diagram’ needed is a blank document that resides in the auditor’s brain.
Visit https://systemsthinking.works to get a free Turtle Diagram Form or purchase the Process Audit
Toolkit which includes a Turtle Diagram form and step by step instructions on how to use it for processbased audits.
6. THE PROCESS OF PROCESS AUDITING
There are 5 steps in conducting a Process Audit. Four of those steps are in ‘Preparation’.
Conducting a Process Audit
1. Determining the Scope and Objectives,
2. Checking Performance,
3. Reviewing Documentation,
4. Planning your audit,
5. Conducting your audit
Audit Preparation
Step 1 - Determine the Scope and Objectives of the Audit
What is the intent (Objective(s)) of the Audit?
To determine conformance to all or part of a standard
To determine conformance to Specific Customer Requirements
To determine conformance related to one or more product contracts
To determine systems conformance to Statutory or Regulatory Requirements
NOTE: Conformance NOT Compliance – Audits of ISO 9001 or IATF 16949 Quality Management Systems
are conformance audits and not compliance audits. Compliance audits refer to determining whether laws
are being complied with. In other words, whether the activities assessed are being conducted within or
against the law. QMS audits determine whether regulatory requirements are included within the system
and that they are being managed, but not whether the specific law is being met. QMS auditors are not
qualified to and should not make those specific determinations.
Where does the process (or processes) to be audited start? Where does it end? What is included? What is
not included? Is it an audit of the complete QMS or specific components of the system, specific contracts,
part numbers or production processes?
What criteria will apply to this audit? ISO 9001? IATF 16949? Multiple standards? The organization’s
quality management system? Specific Customer Requirements? All of the above?
What is the purpose for the audit? Conformance to a standard? Compliance with customer or statutory
requirements? A Specific Problem investigation? Review of the status of corrective actions? Contract
adherence, completion or the effectiveness of improvement actions?
What is the physical location for the audit? One building in one city? Multiple buildings? Including
warehouses, sales offices, distribution centers, sequencing centers, design centers, etc.?
What products, product lines, commodities are included?
Step 2 - Check Performance
Look at recent management review activities. Look specifically at customer satisfaction performance,
customer complaints, and any external or internal performance measures related to the product, process,
processes or audit purpose that you will be auditing. This information will provide one of three Risk
conditions:
Performance is good – (LOW Risk) - Your audit should be focused on general conformity to specific
customer requirements, statutory or regulatory requirements, changes to employees or documentation,
changes to organization structure, policy or objectives and/or opportunities for system improvements.
Performance is poor – (HIGH Risk – known problems) - Your audit should focus on finding causal systemic
factors that could be contributing to the identified poor performance.
Performance is intermittent- The process works well most of the time but occasionally there are
significant issues. (HIGH Risk - since issues are not able to be predicted) - Your audit should focus on
finding causal systemic factors that could be contributing to the intermittent issues.
NOTE: Make a list of potential weak processes or weak functions within the related process or processes
to be audited. Consider those processes with poor performance indicated by the performance reviewed,
as well as connected processes. Often poor performance is manifested in one process but is caused by
another. For instance, poor delivery performance could be caused by issues that reside in production
scheduling, production efficiency, material handling or order make-up, pick-pack, etc.
Step 3 - Review Documents
Review the QMS (Quality Management System) documents related to the process or processes that you
will be auditing. Look specifically at parts of the process associated with the previously identified weak
(HIGH Risk) performance areas.
Remember that there is no particular need (unless this process has never before been audited and
management has requested a full document review) to check all documents to make sure that all related
clauses of the standard are covered. Not to mention that in modern quality management systems not
every clause of the standard needs to be documented and so some clauses may simply not be fully
documented.
Make a list of steps in the documentation which if done incorrectly might cause the types of negative
issues identified in your performance review. Find the appropriate questions in your checklist and make a
note of your findings. This way when you get to that question you will have your previously identified
evidence ready.
Determine whether there are any Customer Oriented Processes (COPs) within the process you will be
auditing. COPs in this context are small special micro-processes embedded in system processes which are
required only by specific customers. For instance, a specific customer may want their specified corrective
action format used – FORD 8D, FCA – 8Step, etc. (See Customer Oriented Process – Section 4 of this
document)
Add notes on the identified COPs to your checklist as a reminder during the audit.
NOTE: COPs should be a particular focus of IATF 16949 QMS audits.
Step 4 - Plan Your Audit
Allocate time to the audit. If the audit is to cover multiple processes, create a formal audit plan and bias
your time toward those processes with poorer performance (i.e. those processes which present greater
RISK to the organization).
If your audit is to cover only one process, a formal audit plan is unnecessary but still bias your time
toward those functions within the process which are most likely to be associated with the identified risk
areas.
Conducting the Audit
Step 5 - Conduct Your Audit
Consult your checklist questions making notes as you go.
As you gather data, verify and analyze that data which creates information. Refer to information gathered
and use it to evaluate and assess new data. Continue this process throughout your audit.
Follow a P-D-C-A cycle within each process, each sub-process and each activity.
7. THE AUDIT REPORT
It is important that evidence from an audit is collected and reported fairly, accurately and effectively. That
is to say that the evidence gathered and reported must be put into context. In addition to the reporting of
identified issues and positive evidence found, there should always be a summary of the audit findings
attached to each audit.
Typical information on the summary report:
1. Areas where evidence shows above average performance.
2. Areas where evidence shows that action MUST be taken to conform to the requirements of the
standard, the customer or the organization.
3. Areas where evidence shows less than ideal performance, where action should be considered to
improve performance, subject to management direction.
4. Areas other than those above where in the opinion of the assessor improvement should be a practical
expectation.
5. A synopsis of the benefits that should be expected if the actions described in 2, 3 and 4 are effectively
addressed.
Visit https://systemsthinking.works to purchase your Process Audit Toolkit which includes an Audit
Summary Report template as well as other great tools for process-based auditing.
8. DOCUMENTING EVIDENCE
One important aspect of audit reporting often overlooked is the need to report evidence. Usually evidence
of nonconformity is easily available, but evidence of conformity is often missing. It may be that auditors
believe the rule “no information means that there is nothing wrong”, but this isn’t the only requirement.
It is important that auditors record evidence of both conformity and nonconformity; however, it is NOT
required that auditors keep copies of every (or for that matter) any documents as evidence.
A simple note stating what evidence was looked at and sufficient information so that the information
could be verified if necessary is sufficient. Rather than copy a report it is enough to note that ‘The daily
report for scrap in the warehouse area dated 3/4/12 was reviewed.’ Should anyone need to verify your
findings, they can easily retrieve the report for 3/4/12. Obviously records of nonconformity require
additional detail of the specific nonconformity and the requirement that was not met.
Notes about Evidence:
Many of the questions in this guide require evidence. There are some rules regarding evidence and some
guidance may be helpful. Evidence can be something:
•Someone tells you, if they are describing their own job.
•It can be something you see / witness.
Evidence:
•Can be a document (forms, instructions, procedures, policies etc.).
•Can be a machine or gauge numbers.
BUT Importantly – Evidence:
•CAN BE VERIFIED – If someone says, “Yes I have that document.” That IS NOT evidence. If they then
give the document to you. Then it is evidence.
Evidence is NOT opinion, hearsay or assumption. Be careful that you do not take a small piece of evidence
and mentally jump to a conclusion and then describe your conclusion as evidence. For example: an
auditor sees evidence of an employee doing something contrary to their documented process. The auditor
assumes that the operator is not doing the job right because they weren’t properly trained and then
determines that there is a non-conformance because of insufficient training. Note that there is NO
EVIDENCE that the operator wasn’t trained or that it wasn’t effective. The ONLY EVIDENCE is that the
operator wasn’t doing the job as documented.
9. IDENTIFICATION OF ACTIONS REQUIRED
The ISO standard uses the term ‘NON-CONFORMITY’ which we have continued to use in this text up to
this point, but now there is an important discussion to be had. Many organizations have struggled with
the term non-conformity or non-conformance. Telling someone in the organization that they have nonconformity is comparable to telling them that their baby is ugly. It rarely elicits a positive reaction.
The problem is often simply the word. For over twenty- five years, the ISO community has worked very
hard to make the act of giving a non-conformity punishment at least and insulting and degrading
punishment at worst. Interestingly there is no requirement for issue of non-conformity in the ISO
requirement. Or rather there is a need to issue non-conformity but NOT to call it non-conformity. You have
the right to call issues requiring attention anything you want to call them. The point being, if in your
organization non-conformities are accepted with the same reaction as news of a tax assessment, maybe
there is an opportunity to change what you call them and at the same time change the internal culture
related to finding and improving systemic problem areas.
Consider problem areas under three categories:
a) ACTION REQUIRED TO ACHIEVE PERFORMANCE
An issue found that has a direct or indirect effect on performance. If the issue where resolved there would
be a noticeable positive improvement in performance.
b) ACTION REQUIRED TO ACHIEVE SYSTEM CONFORMITY
An issue found that has created a condition where a specific requirement of the applicable standard or
the procedures of the organization or a specific requirement of the customer are not being met. If this
issue is resolved, there will be conformity to the requirement. It may or may not have any influence on
performance and it may or may not have any influence on customer satisfaction.
c) ACTION REQUIRED TO ACHIEVE CUSTOMER REQUIREMENTS
An issue that has created a condition where a customer’s specified requirement has not been or may not
be complied with. If not resolved customer satisfaction will probably be affected.
You may want to classify nonconformities based on these definitions. That may lead to modified corrective
action processes based on the issue’s category. This may have a better level of acceptance than say Major
or Minor designations.
Note: The standards themselves do not require that internal quality management systems use Major
and/or Minor designation for nonconformities.
10. THE WORD ‘PROCESS’AS USED BY ISO
The many dictionary meanings of the word ‘Process’ are:
A series of things that happen and have a particular result
A systematic series of actions directed to some end
A series of actions or steps taken in order to achieve a particular end
A series of actions that produce something or that lead to a particular result
Yet none of these meanings are particularly helpful in understanding the use of the word in the context of
quality management systems. The problem is that you can have processes within processes which exist
within processes. All of which meet the criteria of the definitions above. You can also use the term to
describe very different process situations. A process can be the action of tightening a nut or arranging a
business merger. So, the question stands that when we use the word ‘process’ in the context of your QMS
and the ISO/IATF requirements, at what level and in what context are we using the word? The fact is that
the ISO/IATF standards use the term ‘Process’ in three different contexts.
Consider 3 categories of Process:
PROCESS = Management System Processes
These are the processes referred to in the beginning of the ISO 9001 standard where it says to identify
the organization’s processes and in ISO 9000 where it states that a process has an owner, has
documentation, is measured etc. These are ‘Management System Processes’. The basic Management
System Processes in generic terms include:
Note: (I’ve intentionally used very generic names because these processes have many different names
depending on the industry, profession or structure of an organization.)
Value Added Processes
The Get Work Process – The process used to bring customers or clients to the organization and to sell
them on your product or service.
The How Do We Do This Process – The process used, once we have an order, to plan how we will create or
provide what the customer wants?
The Buy Stuff Process – Procurement of the tools, equipment, materials, services, etc. needed in order to
provide our customer with what we have promised.
The Make Stuff or Do Stuff Process – Creating or providing our product or service.
Support Processes
The Facilities and Equipment Process – We certainly need a roof over our head and maybe machinery,
equipment, computers etc.
Maybe an IT Process, a Quality Process or a Transport Process.
And finally there is one other process which is really more of a basket full of small processes. It is called
Management or Administration.
Management Processes
The Management Process is actually a bucket of small processes that include: Management Review,
Management Responsibility, Management System Design, Documentation Control, Internal Audit,
Corrective Action and Continual Improvement, etc.
Virtually all businesses consist of these or a variation of these management system processes. There are
of course countless variations in structure and many different names for the processes listed. In larger
organizations one process listed could, in reality, be two or three different processes. The list above
should not stop your organization from applying creativity and imagination in the development of your
system.
PROCESS = Operational Processes
This word ‘Process’ can and often is used interchangeably with Procedures or Methods. This meaning
applies when the standard says that these must be a process for a given requirement. In other words,
there must be a described way of getting from ‘A’ to ‘B’. Depending on the requirement the process or
procedure mayor may not need to be documented.
The need for a document is sometimes specified in the standard, such as when the term ‘documented
process’ is used, but when a document is not required, the organization should consider risks related to
the lack of documentation and the most efficient and effective way of providing direction before simply
writing another procedure.
Note that operational processes can exist at various levels in the system. Creating a work order is an
operational process, but so is the process of reviewing that work order.
PROCESS = Manufacturing Processes
The term ‘manufacturing process’ has been used for a very long time. Manufacturing processes are the
processes for making things; forging, casting, molding, stamping, milling, turning, sewing, fabricating,
etc., are all manufacturing processes. When the standard is referring to the act of product realization, it
is referring to manufacturing processes. Manufacturing Processes can also exist at various levels in the
system. Manufacturing a car is a manufacturing process, but so is attaching the ‘GT’ logo on the side of
the body.
Understanding that within the ISO and IATF standards the same word PROCESS can actually refer to
three different sets of conditions may help in your understanding of the requirements and in the design
and operation of your system.
11. RISK BASED APPROACHING ISO 9001:2015 / IATF 16949:2016
All systems, processes and activities have inherent risks. Risks are the effects of unexpected conditions
acting upon a process. The concept of risk-based thinking which has always been implicit in ISO 9001 is
in the new 2015 edition in a much more explicit format. Risk-based thinking is found in the requirements
for establishing, implementing, maintaining and improving the quality management system. IATF
16949:2016 has also embraced risk based thinking but has also included a requirement for ‘Risk
Analysis’.
The level of risk in terms of the organization’s ability to meet its objectives and customer expectations
will vary considerably from organization to organization and within organizations from process to
process. Consequently the robustness of the process for determination of risk and the product, service or
system controls applied will vary.
“Risk-based thinking” therefore, means considering risk qualitatively (and, depending on the
organization’s context, quantitatively) when defining the degree of formality needed to plan and control
the quality management systems as well as its component processes and activities.
Rules Related to Risk Based Thinking
1. Risk recognition, evaluation and mitigation must be a priority and responsibility of the organization’s
leadership (not delegated).
2. Don’t shoot the messenger (Employees will not identify risks if they do not perceive an open
environment to share risk information – reward for identifying risks would be good).
3. Have a formal and repeatable set of risk management processes (such as FMEA).
4. Participants must be trained and competent in risk assessment practices.
5. Risks must be determined, assessed, and reviewed and acted upon at regular intervals.
6. Risk considerations must be a central focus of management reviews.
7. Risk assessment working groups and review activities must be promptly scheduled when there is
evidence of negative effects from known or unexpected risks.
8. Risk mitigation activities must be assigned only to staff with authority to implement and maintain
mitigation actions.
9. Risk based approaches must never be outsourced.
10. The organization must consider risks that extend beyond cost, schedule, and technical performance
(Considered - cross-program, social, political and economic impacts).
11. Identified risks must be clearly defined. Use ‘Condition-If-Then’ protocol.
12. Approaches to formal risk management (SARA for Share Avoid Reduce Accept | A-CAT for "Avoid,
Control, Accept, or Transfer").
13. IATF aligns ‘RISK ANALYSIS’ with FMEA (Failure Mode and Effects Analysis).
(Note that formal ‘Risk Management’ is not required by ISO 9001 while ‘Risk Analysis’ and by extension
‘Risk Management’ is a requirement of IATF 16949).
Risk Identification
Evaluation of product and environmental factors, organizational factors, culture and, project management
considerations and concerns applied to product or project deliverables, assumptions, constraints, cost or
resources.
Risk Analysis
An assessment to identify the range of possible outcomes and their associated risks. The FMEA process
achieves this result. Other methods include:
Qualitative Risk Analysis
A determination of the probability and impact of occurrence for each identified risk assessed.
Risk Probability
High – Greater than X% probability of occurrence.
Medium – Between Y% and X% probability of occurrence.
Low – Below Y% probability of occurrence.
Impact
High – May greatly impact cost, schedule or performance.
Medium – May slightly impact cost, schedule or performance.
Low – Little impact on cost, schedule or performance.
Detailed Risk Analysis
An analysis of high priority risks using qualitative analysis.
Qualitative Analysis
Qualitative analysis is a securities analysis that uses subjective judgment based on unquantifiable
information, such as management expertise, industry cycles, strength of research and development, and
labor relations.
Risk Response Planning
For each major risk, apply monitoring and a plan for one of:
Avoidance – Elimination of the threat.
Control – Identify ways to reduce the potential impact of the risk.
Acceptance – Nothing will be done.
Transfer – Make another party responsible for the risk (Buy insurance, outsourcing, etc.).
For each risk, describe the plan for implementation and monitoring of the chosen approach: Risk
Monitoring, Controlling, and Reporting.
Maintain a Top 10 Risk List with constant monitoring until risks are eliminated or further information
prompts additional controls.
(For further information on Risk based auditing, refer to ISO 3100.)
12. CUSTOMER ORIENTED PROCESSES (COPs)
COPs the Theory
Again in the ISO world we use the same term with multiple meaning. In this case only two, but it has been
enough to create its own share of misunderstandings. In the ISO documentation we talk about COPs,
MOPs and SOPS. The gist of the text is that everything an organization does, should be a requirement of
the customer COP – Customer Oriented Process, something management needs done – MOP Management Oriented Process or something we need to do in order to support COPs or MOPs. These are
Support Processes. But someone’s idea of simplicity is to call them SOPs – Support Oriented Processes
(Because cops and mops didn’t sound ridiculous enough on their own). Anything that an organization is
doing which is not a COP a MOP or a Support Process is, therefore, in all likelihood not necessary and
should be discarded.
The theory of COPs, MOPs and SOPs is relevant enough and an organization should ensure that they are
not doing work that has no customer. But that really is as far as it goes.
My personal thinking is that organizations should probably do a COPs, MOPs, SOPs review occasionally,
maybe once every five or ten years. It would take that long for an unneeded process to creep into the
system. But then there is COPs the requirement.
COPs the Practical Requirement
The second COPs is an invention of the automotive sector who on occasion come up with some good
ideas. The COPs concept except for the duplication of the ISO term is one of those good ideas. COPs in
this context are unique customer requirements that require your organization to input ‘Micro Processes’
to comply with the unique needs of that one customer into your management and manufacturing
processes.
In the normal business relationship the customer orders a product and we provide it. But in modern
business it isn’t always that cut and dried. Often during the process of creating or providing the product
the customer introduces specific requirements. They may want you to use their software portal for
communications, their format for quotes, their specific corrective action steps or labeling standards. They
may have specific requirements such as: no wooden pallets, no cardboard packaging etc.
During delivery operations, they may ask for special labels, stamps or other identification for various
internal reasons. All of these are examples of COPs. Each COP if not identified, understood and effectively
implemented and managed is an opportunity to dissatisfy your customer. For this reason, COPs as used
here need to be identified in each process and have specific controls in place to ensure that these specific
customer requirements are met.
13. TURTLE DIAGRAMS
The Turtle Diagram
The turtle diagram was first introduced into ISO 9001 auditing at the turn of the century. Its purpose was
to provide registration auditors with a tool that would help them transition from clause or shall-based
auditing to a process-based approach. Auditors focused on the automotive sector were the first to receive
this training.
The turtle is a generic diagram used to effectively describe a process. It has a similar but simplified
structure to the Cause and Effect Diagram created by Professor Kaoru Ishikawa in the 1960s. The Turtle
diagram as the name suggests resembles a Turtle with a large center Process (Shell) with a head, a tail
and four legs.
The standard Turtle includes: the head and tail – (INPUT and OUTPUT), the body (The PROCESS FLOW)
and four legs - Clockwise from the top right – EQUIPMENT/MATERIALS, PEOPLE, MEASUREMENT and
DOCUMENTATION.
At Systemsthinking.works, we add another leg, The COP (Customer Oriented Process) – This in our
opinion completes the Turtle so that it effectively covers all aspects of a process.
The beauty of the turtle is that on one diagram you can fully and completely describe any process. It is
important, however, to understand that the Turtle Diagram isn’t an actual document. The Turtle is a
concept, an idea. Documentation of the elements of the Turtle on the Turtle itself is ineffective at best.
This has been the experience of almost everyone who has ever tried to use the Turtle as a document.
There simply isn’t sufficient room in the small rectangles that make up a turtle to effectively describe the
intended inputs.
Many auditors and many more consultants have tried to present the turtle as a necessary document for
describing an organization’s processes. It isn’t. But that doesn’t mean that the Turtle isn’t an excellent
approach to an effective and efficient definition and description of a process. Using the idea of the turtle
while generating documentation in some other format combines the value of the turtle concept with the
detail and completeness necessary for an effective analysis and description of the process.
The sequence of questions in this checklist follows the turtle approach in combination with the PDCA
process approach.
14. THE PDCA CYCLE – PROCESS APPROACH
The standard PDCA cycle consists of a Planning stage, a Doing stage, a Checking Stage and an Acting
Stage. Also known as the Deming Cycle, or the Shewhart cycle, the ‘Plan, Do, Check, Act’ Cycle can be
used as an important guide in the development of an effective QMS as well as a bases for the Audit or
assessment of a process. The PDCA cycle consists of;
Planning – Determining objectives, intended outcomes or expectations of a product, process or system
and the development of a strategy (Plan) to achieve the intended result.
Doing – Refers to the implementation of the plan, conformance to procedures, effective application of
inspections and tests.
Checking – Refers to inspection, measurement or test evaluations and determination of effectiveness.
Act – Refers to; continuation of the process, modification of the process, corrective Action or
Improvement of the process.
A more detailed picture of the PDCA process is shown below:
This diagram fills in the blanks that often get missed in the design or analysis of processes. The process
starts with the customer (internal or external) and the customer’s requirements. These requirements
become a part of the INPUT to the PDCA process.
Other components of the input include statutory and regulatory requirements and requirements of the
management of the organization.
All requirements and their associated risks must be considered in the ‘Plan’ part of PDCA. The amount
and complexity of documentation, amount and duration of training to ensure competence of people, the
type and extent of technology and equipment needed and the amount of verification and validation
necessary to monitor the activities within the process. All are part of the planning component of the
process. The ‘Plan’ is then implemented.
The ‘Do’ component is a function of how well the implementation is planned, how well it is implemented
and how well the process performs over time.
As well as evaluation of the activities performed within the process, there is a need to evaluate the
effectiveness of the process in achieving its goals. This is the ‘Check’ phase of the PDCA cycle. There is
an important link between Policy, Objectives, Performance Measurement, Targets for those
measurements, and effective Monitoring and Management of the Performance.
Finally, there is the ‘Act’ phase. Based on the results of ‘Check’ing and analysis, the OUTPUT of the
process- either it proceeds to its designated destination or it does not. If output requirements are not met
(Rejected),there are several alternative actions. The output can be rejected (Scrapped) or the output can
be rejected and modified (Corrected) in order to achieve the intended output. If the output is (Rejected),
then modifications to the process are required. This information is fed back to the planning phase and the
process is modified. If the output is acceptable, there still may be opportunities to improve the output or
the process. Opportunities for Improvement are also sent back to the ‘Planning” phase.
The process either continues as designed, is corrected and then continues, or is improved and then
continues in the PDCA cycle.
15. LINKING the TURTLE and PDCA
Effective auditing is a process of linking the components of the ‘Turtle Diagram’ with the PDCA cycle. The
methodology is quite simple. For each stage of the ‘Turtle’ follow the PDCA cycle. First, follow the
‘Measurement’ leg of the ‘Turtle’ using PDCA. How are the measurements for the process planned? How
are measurements and targets determined? Who determines the targets? Are they linked to objectives?
Secondly, determine whether measures have been implemented as planned and are they being applied
effectively? Third, is the applicability and effectiveness of the measures being used being evaluated? And
finally, is there evidence that the measures are being modified, changed or revised when appropriate?
Continue the same PDCA cycle for People, Equipment, Input, Documentation, Customer Oriented
Processes when you come across them and the process flow itself of course as well as the output. In
short, Measurement-PDCA, People-PDCA, Equipment-PDCA, Input-PDCA, Documentation-PDCA, COPSPDCA, Process Flow-PDCA, Output-PDCA, NEXT PROCESS.
16. THIS CHECKLIST
Structure of this Checklist
This checklist is designed to take a theoretical journey through your organization following the product
and a ‘Turtle Diagram’ ‘PDCA’, PROCESS BASED methodology. The checklist starts with management and
from there generally follows the route of a generic product through the organization. As the journey is
taken, the checklist captures the appropriate requirements of the ISO 9001:2015 standard as well as the
requirements of IATF 16949:2016, Customer Specific Requirements for FORD, GM, FCA, VW, and CQI
Requirements.
The Questions
Each question is numbered. Stage 1‘Audit Planning’ is numbered starting at #1. The Stage 2assessment
checklist starts again at question #1 and covers the complete Quality Management System (QMS). The
Stage 2 assessment covers 14 specific processes.
Each question looks for evidence that ISO 9001:2015 / IATF 16949:2016requirements or more specifically
a portion of a requirement has been effectively achieved. Questions DO NOT simply follow a standard
clause by clause format. The questions follow the natural flow of the processes and therefore the clause
numbers which are referenced for each question do not follow in any order. Some questions cover the
requirements or components of requirements from several clauses in the two standards. Some questions
are in themselves checklists of requirements.
Some questions are followed by (BP). These questions denote Best Practice and therefore, are over and
above the general need and are optional as to whether an organization chooses to use them.
Questions from Automotive Customer Specific Requirements are designated with reference to the specific
requirement.(i.e.: GM (GM Specific), FORD (Ford Specific) FCS (Fiat-Chrysler Specific), VW-(Volkswagen
Specific). NOTE: some customer specific requirements are NOT in the form of a question since the
requirement is conformance to the customer expectation as written.
Specific requirements related to CQIs are again not necessarily in the form of questions, but rather point
out specific CQI requirements or requirements to apply CQIs.
Some questions cover specific Automotive CORE TOOLs requirements (APQP, DFMEA, PFMEA, Control
Plans, MSA, Process Capability and PPAP.
NOTES: Are provided to assist the auditor in the understanding and intent of the standards. They
consider or describe a best practices perspective.
SYSTEM ASSESSMENT
ISO 9001:2015 / IATF 16949:2016
INTRODUCTION
Every organization is a unique entity with its own history, culture and belief systems. To the extent that
this culture does not negatively affect the organization’s ability to satisfy its customers and achieve its
objectives, the Quality Management System (QMS) should reflect that culture.
EXAMPLE of the format of the questions
Audit Guidance
1. If during your audit, if a document or record is mentioned by the interviewee – ask immediately to see
the document – review it for legibility, availability, proper use and completeness. Once satisfied that the
document does the function that was described both efficiently and effectively, document your evidence
and return the document to the person being interviewed. Be sure to document enough information about
the document that if necessary you could retrieve the same document i.e. revision date, date completed,
document name, author etc.
2. Always look first at performance. Look for evidence of poor performance, intermittent performance or
performance that does not meet specific customer requirements. Look for customer complaint data or
insufficient coverage of statutory or regulatory requirements.
NOTES are provided for auditor guidance and added detail where it may be helpful.
STAGE 1 ASSESSMENT
READINESS REVIEW – ASSESSMENT PLANNING
Review of Documentation and Performance
Review of Documentation
NOTE: A matrix showing where requirements of the standard with linkages to the QMS may be created but
IS NOT A REQUIREMENT. Such a matrix can be found at the back of this book.
NOTE: There is no specific requirement for the format or structure of the Quality Manual (hard copy,
electronic, flow chart format, bullets, etc.). If a series of documents is used there is however a requirement
for list of relevant documents that make up the manual. However, an electronic file folder which contains all
documents that make up the manual will automatically provide such a list.
NOTE:
IATF – FAQ – Does the customer requirements cover ALL customers including non-IATF and Tier 1s? Do
requirements go beyond ‘Customer Specific Requirements (CSRs)?
ANSWER – A document is required as part of the Quality Manual and the organization’s scope and includes:
•All direct customers (IATF OEMs, non-IATF OEMs, tier-1, tier 2 etc.)
•Does not need to consider the tier 1’s OEM if the OEM is not a direct customer.
•Organizations are not expected to turn the customer specific requirements into a CSR format such as
provided by IATF OEMs.
IATF Sanctioned Interpretations – 7.5.1.1 - QMS Documentation
The Quality Manual shall include, at a minimum, the following:
d. (The words - i.e. Matrix) has been changed to – for example, a table, a list or a matrix) indicating where
within the organization’s quality management system their customer-specific requirements are addressed.
NOTE: In the past, organizations have met this requirement as it was previously defined by using a general
‘Process Map’. The current requirement suggests to us that a more comprehensive approach is needed. For
some ideas, take a look at the SystemsThinking.Works Process Audit Toolkit or for those wishing to get more
value from their process interaction analysis there are exercises included with the purchase of the Systems
Thinking & 9001 eBook available at https://systemsthinking.works.
NOTE:
IATF–FAQ– What is considered evidence of conformity to statutory and regulatory requirements (8.4.2.2,
8.6.5)? Did the intent of this clause change from TS 16949?
ANSWER – The organization is expected to have an approach to; Research, Identify, Maintain copies, Review,
Understand and Assure Compliance with statutory and regulatory requirements of products, for the country
in which they are manufactured, for their destination country and the end user country. Compliance is
intended to be designed into business processes and manufacturing processes including control of supplier
compliance. While the new wording is more explicit the requirement has not changed from the TS
requirement.
IATF – FAQ – (8.6.5) What is the expectation for a supplier to maintain current knowledge of statutory and
regulatory requirements of international customers? How are these requirements met if they are not
communicated by the customer?
ANSWER – The does not require the organization to maintain a list of international requirements. They are
required to review audits or periodically check that the process is robust and assures compliance to the
latest requirements for product destinations communicated by the customer.
IATF – FAQ – (5.3.1) Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
IATF – FAQ – (8.7.1.7) What is the intent of ‘render unusable’? How is this controlled? Does it apply to
component or semi-produced product?
ANSWER – Render Unusable – ensure that nonconforming final product as shipped to the customer CANNOT
find its way into the unofficial aftermarket, or be accidentally shipped to a customer. Product cannot be
useable OR repairable. The organization is expected to develop effective control of nonconforming product
and to verify its effectiveness. This process can be subcontracted and applies to product that has gone
through the organization’s process and in ready to ship.
IATF – Sanctioned Interpretation - (6.1.2.3) – cyber-attacks on information technology has been
added.
NOTE: Good performance is usually an indicator of sufficient documentation. Poor performance may have
many causes but insufficient documentation is certainly one.
NOTE: Highly trained people may need different types, amounts and detail in their documentation. The
documentation should be appropriate for the needs of those using it.
Creation and Revision of Documents
NOTE: Identification may include a date, signature, reference number, file number, etc. The method must
ensure that, when there is an identifiable risk that the wrong version of a document can create a problem for
the organization or the customer, the current document cannot be confused with a previous of subsequent
version of the same document or record.
NOTE: While any medium can be used (i.e. paper, electronic, audio, video etc.) there are times when a
specific format is required for a specific document. This may be a customer requirement such as FMEA or
Control Plan format or format could be determined by the organization. When specific format is required, it
must be controlled and used as defined.
Control of Documents
NOTE: Readily available is dependent upon the situation. Having a recipe readily available for a Master Chef
has a different expectation than having a defibrillator readily available to a Paramedic.
NOTE: Access can mean permission to view information; permission to have a document under personal
control; or to have the authority to use or modify a document.
NOTE: Unless otherwise specified by the customer or regulatory requirements
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered.
NOTE: The organization determines whether a document of external origin needs to be controlled. However,
the auditor must make an independent determination of risk associated with NOT controlling the document
before acceptance of the organization’s process.
NOTE: If there are identified issues found during the above review, try to identify which management
processes may contain either evidence of the effect of the issue or evidence of causal factors for the
existence of the issue. In planning for Stage 2, consider using more of your available time on these identified
processes. Based on the number and potential severity of the issues found, you may need to increase the
planned time for the Stage 2 audit.
Review of Performance
REVIEW OF MOST RECENT MANAGEMENT REVIEW MEETING INFORMATION. SPECIFICALLY, DATA
SHOWING THE PERFORMANCE OF THE ORGANIZATION AND ITS PROCESSES.
End of Stage 1 Assessment
STAGE 2 ASSESSMENT
QUESTIONS FOR TOP MANAGEMENT
It is very important that the most senior management of the organization’s site is active and takes a
leadership role in the development and ongoing success of the QMS. Depending on the organization and its
structure top management may be a single individual or a small group. But it is important that senior
management is that person or group that has the power to delegate authority and provide resources for the
development and on-going success of the QMS (See General clause 1.1 of ISO 9001:2015).
In the vast majority, if not all, automotive manufacturing environments, ‘Top Management’ is the single
individual who commands the top management position at the manufacturing site. This may be the Owner,
the President, the General Manager, the Operations Manager or the Plant Manager depending on the size
and structure of the organization. It is ineffective and usually unacceptable to define ‘Top Management’ as
the management team
Leadership
NOTE: For sites associated with a larger corporate entity the corporate policies may be directed from a
corporate headquarters. At the site there must be evidence of their existence and the effective application
within the site.
NOTE: See Supplier - Social Responsibility and Anti-Corruption Requirements Web-Guide
https://web.fsp.ford.com/gtc/docs/hrandwc.pdf.
Context of the Organization
NOTE: External Context relevant to the strategic objectives of the organization can include:
•legal or regulatory exposure,
•technological development,
•competition,
•market fluctuations and changes,
•cultural considerations (consider employees, the community and customers),
•social and economic impacts,
•environmental concerns, (flora and fauna, business and social environments)
Considerations should include international, national, regional and local contexts to the extent that they
apply.
NOTE: Internal Context relevant to the strategic objectives of the organization can include:
•roles, responsibilities and authority,
•financial and capital resource issues,
•cultural considerations (consider employees, the community and customers, suppliers),
•conformance and compliance to industry standards to which the organization subscribes,
•contractual agreements,
•products and services that the organization currently provides or is planning to provide
•introduction (launch) of future offerings.
Expectations of Interested Parties
NOTE: While the ISO standard defines interested parties as ONLY those who are relevant to the QMS and
ONLY those needs relevant to the QMS. It may well be difficult to make this distinction. Therefore, it would
benefit the organization to err on the side of a more robust and inclusive interpretation.
NOTE: When the Specific Requirements of (Customer) interested parties are included within a process they
are sometimes referred to as Customer Oriented Processes (COPs). These are typically sub processes
included within a process to ensure that a specific requirement has been met. For example, there may be a
requirement for a specific safety label to be affixed to shipments of certain materials and not others. The
organization may need specific process steps to be applied to the shipping process to ensure that when these
special labels are required, they are properly applied.
Customer Satisfaction
NOTE: The purpose for determining customer perception is to find out and evaluate the customer’s views
and opinions of the organization. Customer perception can be determined through the use of surveys,
customer provided performance evaluations (score cards), market analysis, benchmarking, customer awards,
compliments, warranty claims, dealer reports, contact feedback sheets, etc. The essence of determining
customer perception is to determine where your organization stands with respect to the three qualities –
(Expected Quality, Comparative Quality and Quality of Delight) (See Reference #3 for more detail about the
three qualities).
NOTE: Incidents of premium freight should be evaluated on four (4) levels.
Premium Freight occurrences from your supplier to your organization – supplier’s fault.
Premium Freight occurrences from your supplier to your organization – your organization’s fault. Premium
Freight occurrences from your organization to your customer – your organization’s fault.
Premium Freight occurrences from your organization to your customer – your customer’s fault.
Each situation has different causal factors for events and therefore requires different actions to control
performance.
NOTE: Most all Sr. Management is responsible for Product Quality in one way or another.
Determining the Scope
NOTE: The Scope of the QMS includes, all subjects covered in clauses 4.1 and 4.2 as well as
•remote locations (remote sites (4.3.1)),
•products covered by the system,
•standards included,
•industry codes of practice to which the organization subscribes,
•requirements of relevant interested parties (CUSTOMER SPECIFIC REQUIREMENTS).
If the organization produces or provides product with embedded software that too should be included in the
scope of their QMS. If the organization uses outsourced testing or prototype processes, the type and extent
of control of such processes must also be included in the scope of the QMS.
NOTE: The requirement for documenting exclusions in the Scope no longer exists in the ISO 9001 standard
but only clauses related to Product Design (8.3) can be excluded in the IATF standard and the exclusion still
is required in the Scope. Other Clauses can still be ignored if they don’t apply – such as the requirement for
Appearance Items (8.6.3) – but only if the requirement does not exist for your organization (i.e. - you are not
designated as a manufacturer of Appearance Items). In any case justification is required for any clause not
covered.
Quality Policy
NOTE: It is neither required nor intended that employees should be able to recite the Quality Policy. It is
important that everyone in the organization is able, in their own words to describe what the Policy says and
what it means as it relates to their job own functions.
QMS Structure
NOTE: See ISO clause 7.2 for competence requirements
NOTE: The Process Approach includes: PLAN – Establish performance objectives based upon customer as
well as organizational expectations, RISK – Determine the risks associated with the organizations ability to
achieve the performance objectives, DO – Implement the process steps with risk management steps included,
CHECK – Review and analyze actual performance against the targets, ACT – Take action where objectives
are not met and consider opportunities to improve where objectives are being met. (SEE ISO clause 0.3)
NOTE: Identification of where ISO and IATF requirements are covered within the QMS is considered an
additional benefit. BUT this is not a requirement.
Note: The processes identified here should be the Management System Processes as well as Product
Manufacturing Processes, needed to provide the organization with the means of achieving their goals and
objectives as identified through defining their Organization’s Context (4.1) and the requirements of
interested parties (4.2). Externally provided processes or components of processes must be included
(8.5.1.1) as well as external processes directed by the customer (8.4.1.3)
NOTE:
IATF FAQ - What is the scope of clause 4.4.1.2 – Product Safety?
ANSWER - This clause focuses on product and manufacturing process characteristics that affect the safety
AND/OR performance of the final assembly. These characteristics may not be directly addressed in
regulatory/statutory requirements, but may be defined by the customer.
IATF Sanctioned Interpretation – Product Safety –
The organization shall have documented processes for the management of product-safety-related products
and manufacturing processes, which shall include but not be limited to the following, where applicable:
NOTE: Special approval of safety related requirements or documents may be required by the customer or the
organization’s internal processes.
NOTE: Often organizations use a Process Map to achieve the three questions above, however this is not a
requirement and other means can be used. The increase in the defined requirements probably will require at
least additional documentation to support the process map.
See an alternative method at www.systemsthinking.works – free tool kit.
NOTE: IATF 16949 requires that organizations pay particular attention to processes where products
identified as safety related are produced. Processes that include Customer Oriented Processes (COPs) should
also get additional consideration.
IATF FAQ – Answer – 4.4.1.2 -This clause focuses on product and manufacturing process characteristics that
affect the safety AND/OR performance of the final assembly. These characteristics may not be directly
addressed in regulatory/statutory requirements, but may be defined by the customer.
IATF Sanctioned Interpretation – Product Safety –
The organization shall have documented processes for the management of product-safety-related products
and manufacturing processes, which shall include but not be limited to the following, where applicable:
NOTE: Special approval of safety related requirements or documents may be required by the customer or the
organization’s internal processes.
(Deleted text) Removed to clarify special approval review
NOTE: These processes may be related to Product Design, APQP, Production or Outsourced activity. They
may also require special attention to assignment of responsibility and authority.
IATFFAQ – Answer – 4.4.1.2 - This clause focuses on product and manufacturing process characteristics that
affect the safety AND/OR performance of the final assembly. These characteristics may not be directly
addressed in regulatory/statutory requirements, but may be defined by the customer.
IATF Sanctioned Interpretation – Product Safety –
The organization shall have documented processes for the management of product-safety-related products
and manufacturing processes, which shall include but not be limited to the following, where applicable:
NOTE: Special approval of safety related requirements or documents may be required by the customer or the
organization’s internal processes.
(Deleted text) Removed to clarify special approval review
Note: What gets measured gets done. Effective performance measurement is a cornerstone of a successful
organization.
NOTE: Don’t forget non-manufacturing processes.
IATF Sanctioned Interpretation – (6.1.2.3) Contingency Planning
The organization shall:
Prepare contingency plans for continuity of supply in the event of any of the following:
- Cyber-attacks on information technology systems (added) – Rationale-Organizations need to address the
possibility of a cyber attack that could disable the organization's manufacturing and logistics operations,
including ransom-ware. Organizations need to ensure they are prepared in case of a cyber-attack.
NOTE: Instructions for registering for the portal and assistance with its use can be found at
https://fcagroup.esupplierconnect.com.
Objectives
NOTE: Consider risks related to the size of the organization, the complexity of processes, process
performance, interaction between processes, personnel competence and skills in performing specific tasks,
lack of sufficient documentation (too much or too little), equipment availability and reliability, effective
communications ((between supervision and functions, between management and staff, between one process
and another (consider top down and bottom up communications).
NOTE: Some notes on effective performance measurement.
•Performance measurements work best when they work in pairs. Consider if there is only one measurable
and it measured quality what would happen? Chances are the quality would be very good, but productivity
may slow to a crawl. Hence, we measure quality and productivity.
•Combining measurements into formulae is often ineffective. Because causal factors are hidden in the
formula, deficiencies when they are identified will require further analysis in order to determine cause.
Simple one activity-one measurement is much more effective. This usually means many more measurable,
but in a modern software based world this is a simple problem to address.
•Reading and analyzing measurements is often negatively affected by formats that are too complex. Where
possible charts provide the best information, but complex charts and multiple random colors make analysis
of charts more time consuming. Simple charts with one measurement with a simple RED (Bad)/YELLOW
(Marginal)/GREEN (Good) color scheme makes analysis simple and quick.
•Spreadsheets are often less effective as performance measurements because they don’t show trends.
•Finally consider the difference between operational measurements i.e. the measure of things and time vs
business measurements i.e. the measure of money. While measurements obviously must monitor the financial
wellbeing of the organization, this is the best done by the finance department using business measurements.
In an operational environment, direct measurement of activities, things and time is often more effective.
Management Review
NOTE: There is no requirement for a meeting called ‘Management Review’. Because of this
misunderstanding many organizations have found themselves with a redundant, non-value adding extra
meeting. The requirement is for a meeting that does management review, not a meeting called management
review.
This meeting might be called a ‘Monthly Performance Meeting’ a ‘Staff Meeting’, a ‘Key Performance
Indicator Meeting’, an ‘Operations Meeting’ etc. In addition, the requirements of the management review
meeting may be accomplished in multiple meetings provided that Senior Management is involved in the
meetings and records are kept. Also, all management review requirements need not be covered in every
meeting. Meeting requirements can be staggered through the year based on the importance and necessity of
frequent reviews.
Design of the Management Review process is and should be specific to the needs and expectations of the
organization and its customers, it should provide senior management with the information that they need for
the effective management of the organization’s performance.
NOTE: Not all activities have to be on the agenda of every meeting. Different activities listed may be handled
on different frequencies or in different meetings. The important point is that each item is reviewed at a
frequency that will effectively provide timely feedback to management.
Changes
NOTE: Simple pass/fail records are NOT Acceptable.
Responsibility, Authority, and Accountability
NOTE: Accountability is NOT included in the ISO 9001 2015 requirement. We have included it here for
clarification. There is a great deal of literature stating that responsibility and accountability are
interchangeable and that therefore there is no need for both words. This makes for a great discussion for
academics and theorists, but for the purposes of this guidebook we are going to take a much more
pedestrian viewpoint. We take responsibility for actions and accountability for results. Everyone can be
responsible for satisfying the customer, but can everyone be accountable for the level of customer
satisfaction achieved? In the view of this document, everyone can be responsible, but everyone can’t be
accountable.
Resources
NOTE: 3rd Party Certification to OHSAS 18001 and eventually ISO 45001 can be recognized as meeting
some of the above requirement.
NOTE: Consider ‘throughput time’ as a measurement of material flow. (The time from when material arrives
as raw material until that same material leaves the facility as finished goods).
Consider sales per square foot as a measure of value-added use of floor space.
Human Resources
NOTE: Are there the right number of people with the right skills, competence and training?
Support Equipment
NOTE: Total Productive Maintenance (TPM) is a system of maintaining and improving the integrity of
production and quality systems through the machines, equipment, processes, and employees that add
business value to an organization.
Jishu Hozen (a Pillar of TPM) is a Japanese word that means autonomous maintenance. “Jishu” loosely
translated, means – independence, autonomy. “Hozen” when translated to English means – preservation,
integrity or conservation.
Kobetsu Kaizen (a Pillar of TPM)is a Japanese word for focused improvement, which means prioritising the
most important losses and eliminating them. These are individual improvements and focus on losses, (which
losses and when).
Key Themes of TPM; Autonomous Maintenance, Visual Controls, 6s, Predictive Technologies, Reliability
Centered Maintenance (RCM), Mistake Proofing, Set-up Reduction, Understanding downtime losses (OEE,
Loss Tree, etc.), Return equipment and workplace to “ideal conditions”, Workshops, and Kaizen - small
continuous improvements.
Overall Equipment Effectiveness (OEE) is a term coined by Seiichi Nakajima in the 1960s to evaluate how
effectively a manufacturing operation is utilized. It is based on the Harrington Emerson way of thinking
regarding labor efficiency. The preferred OEE calculation is the three OEE factors:
OEE – (Availability X Performance X Quality).
Measurement Equipment
NOTE:
IATF - FAQ – Are MSA studies required for each individual gage?
ANSWER – No – instruments with the same characteristics (range, resolution, etc.) can be grouped and
sampled (gage families).
NOTE: Be careful with your choice of families. Vernier micrometers, dial micrometers and digital
micrometers are not equal.
Operations Planning
NOTE: Product requirements include customer specified requirements, statutory and regulatory
requirements and other requirements identified by the organization.
Summary Notes:
QUESTIONS FOR THE PRODUCT DESIGN MANAGER
Design of Product
NOTE: This section is applicable to organizations that create new products for offer to customers. New
products can include the development of new hardware, new software, new services, new recipes, etc. An
organization is not considered responsible for the design of products when the requirements of the product
or service are wholly defined by the customer or other interested party. In the automotive industry, the
customer and supplier often cooperate in the development of new product. The automotive industry
considers an organization that can participate in a concurrent design/manufacturability effort as Design
Responsible and the organization should then include Clause 8.3 in their Quality Management System.
Specific processes and procedures etc., should focus on those aspects and functions within the requirements
that are provided by the organization and their links to customer and /or the organization’s design center.
NOTE:
IATF – FAQ – (5.3.1) Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: Are there the right number of people with the right skills, competence and training?
IATF FAQ – Answer – 4.4.1.2 -This clause focuses on product and manufacturing process characteristics that
affect the safety AND/OR performance of the final assembly. These characteristics may not be directly
addressed in regulatory/statutory requirements, but may be defined by the customer.
IATF Sanctioned Interpretation – Product Safety –
The organization shall have documented processes for the management of safety-related products and
manufacturing processes, which shall include but not be limited to the following, where applicable:
NOTE: Special approval of safety related requirements or documents may be required by the customer or the
organization’s internal processes.
(Deleted text) Removed to clarify special approval review
NOTE: Refer to https://web.qpr.ford.com/sta/SREA.html
APQP Product Design
NOTE: One approach for considering design alternatives is the use of ‘Trade-Off Curves’. See Reference 2.
NOTE: Adhere to customer designated special characteristics (8.2.3.1.2, 8.3.3.3 IATF).
DFMEA
NOTE: The APQP/PPAP Evidence Workbook is available at https://web.qpr.ford.com/sta/APQP.html.
NOTE: FORD 8.3.4.3 - The organization is responsible for the quality of the parts it produces and for any
subcontracted services, including sub-tier suppliers specified by Ford Motor Company without a Multi-Party
Agreement. This applies to all phases of product development, including prototypes. Individual Statements of
Work may specify alternate responsibilities.
See GPDS for additional information on prototype programs on Ford Supplier Portal.
NOTE: Request form and submittal through - fordtool@ford.com
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered?
Summary Notes:
QUESTIONS FOR THE PROCESS DESIGN MANAGER
Design of Process
IATF – FAQ – 5.3, 5.3.1 -Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
IATF – FAQ – 5.3, 5.3.1 - Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: Are there the right number of people with the right skills, competence and training?
IATF Sanctioned Interpretation – Product Safety –
The organization shall have documented processes for the management of safety-related products and
manufacturing processes, which shall include but not be limited to the following, where applicable: NOTE:
Special approval of safety related requirements or documents may be required by the customer
APQP – Advanced Product Quality Planning
Select a product development project APQP that has just recently been completed or is very close to
completion. Select a second project which covers processes or products not covered by the first sample.
Audit the two projects and the two managers at the same time.
CONTROL PLAN
PFMEA
NOTE: Specific quantitative values for characteristics are optional on the FMEA Form.
NOTE: Team should assume that the Product Design is correct. Identified potential Design issues should be
reported to the design authority.
NOTE: This is only identified in the standard as a product design requirement, however the need for
engineering proficiency in specific core tools and engineering skills is self-evident and therefore it is added
here for engineers involved in manufacturing processes as well.
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)
NOTE: There may or may not be product or process special characteristics identified by the customer or
design process, but there should always be special characteristics in the manufacturing process which
should be identified by the organization. These special characteristics are the inherited knowledge which
allows the organization to be efficient, effective and competitive at their chosen business. Loss of special
characteristic knowledge through employee turnover or attrition could have significant negative effects on
the organization’s performance.
IATF Sanctioned Interpretation – 8.3.3.3 Special Characteristics –
a) documentation of special characteristics in the product and/or manufacturing documents (as required),
relevant risk analysis (such as Process FMEA), control plans and standard work/operator instructions;
special characteristics are identified with specific markings and are documented in the manufacturing
documents, which show the creation of, or control required for these special characteristics.
NOTE: Adhere to customer designated special characteristics (8.2.3.1.2, 8.3.3.3 IATF)
IATF Sanctioned Interpretation – 8.3.3.3 Special Characteristics –
b)documentation of special characteristics in the product and/or manufacturing documents (as required),
relevant risk analysis (such as Process FMEA), control plans and standard work/operator instructions;
special characteristics are identified with specific markings and are documented in the manufacturing
documents, which show the creation of, or control required for these special characteristics.
NOTE: Supplier Engagement Process is available at
https://web.qpr.ford.com/sta/GPDSSupplierEngagement.html
Schedule A is available through https://web.qpr.ford.com/sta/APQP.html
NOTE:
Global Phased PPAP - available through https://web.qpr.ford.com/sta/Phased_PPAP.html
Q1https://web.qpr.ford.com/sta/Q1.html.
Service Part Deviation SREA process found via https://web.srea.ford.com/ through the Ford Supplier Portal.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered.
Summary Notes:
QUESTIONS FOR THE MANAGER OF PURCHASING
Purchasing
IATF – FAQ – 5.3, 5.3.1 Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
IATF Sanctioned Interpretation – 8.4.2.1 – Outsourced process control
Where characteristics or components “Pass through” the organization’s quality management system
WITHOUT validation or control, the organization shall ensure that the appropriate controls ARE IN PLACE at
the point of manufacture.
NOTE: Includes both controls required of the supplier and controls applied by the organization upon receipt
of the product. Includes; sub-assembly, sorting, rework, calibration and test services.
IATF FAQ – Answer- (8.4.2.2, 8.6.5) The organization is expected to have an approach to: Research, Identify,
Maintain copies, Review, Understand and Assure Compliance with statutory and regulatory requirements of
products, for the country in which they are manufactured, for their destination country and the end user
country. Compliance is intended to be designed into business processes and manufacturing processes
including control of supplier compliance.
IATF Sanctioned Interpretation – 8.4.2.1 – Outsourced process control
Where characteristics or components “Pass through” the organization’s quality management system
WITHOUT validation or control, the organization shall ensure that the appropriate controls ARE IN PLACE at
the point of manufacture.
NOTE:
IATF – FAQ – (8.4.2.3.1) Define ‘Embedded Software’? What is the requirement where the organization does
not develop the ‘embedded software’ and does not have expertise to evaluate it?
ANSWER – Formal definition is TBD. Embedded software is specialized for a particular hardware that it runs.
If an organization is not responsible for design and development of ‘embedded software, then they are
responsible to ensure that the supplier has validated the software functionality and that there are records
showing that customer requirements have been met.
NOTE: Ref. IATF Sanctioned Interpretation (8.4.2.3) – Using a risk based model:
The organization shall:
1. Require ISO 9001 certification as the minimum requirement
2. Based upon performance and risk, move supplier organizations through the following process:
a. ISO 9001 Certification – Unless authorized by the customer
b. ISO 9001 Certification plus MAQMSR
c. ISO 9001 Certification plus IATF 16949 compliance through 2nd Party assessment
d. IATF 16949 3rd Party Certification
NOTE: The minimum acceptance level of a supplier’s QMS may be compliance to ISO 9001 through 2nd
party audit if authorized by the customer.
NOTE: There may be alternative methods specified and agreed to by the customer.
NOTE: Customer specifics often identify unique controls for very small suppliers.
NOTE :(MAQMSR Minimum Automotive Quality Management System Requirements (See MAQMSR
Reference (4) for a full list of clauses)
Contents
1. Control Plans
2. Process Approach
3. Performance Measurement
4. Internal Auditing
5. Control of Nonconforming Product
6. Part Approval
7. Management Responsibility
8. Risk Management
9. Safety
NOTE: System requirements are often contained in a customer provided supplier quality manual, customer
portals, similar documents or by contract. These documents provide detailed requirements for inspection,
documentation, testing, statistical analysis, packaging, employee qualifications, quality systems or standards
to which suppliers are expected to conform, supplier roles in corrective action processes, supplier roles in
continual improvement processes and expectations for customer verification of product or verification of
supplier systems at the supplier’s premises.
NOTE: Product may originate in China, be shipped to the U.S., be processes and shipped to Mexico where it
may be further processed and then sent to Australia. Statutory and regulatory requirements for all four
countries may apply.
IATF FAQ – (8.4.2.2, 8.6.5) Answer - The organization is expected to have an approach to; Research, Identify,
Maintain Copies, Review, Understand and Assure Compliance; with statutory and regulatory requirements of
products, for the country in which they are manufactured, for their destination country and the end user
country. Compliance is intended to be designed into business processes and manufacturing processes
including control of supplier compliance.
IATF FAQ – (8.4.2.2, 8.6.5) Answer –Clause does not require the organization to maintain a list of
international requirements. They are required to review audits or periodically check that the process is
robust and assures compliance to the latest requirements for product destinations communicated by the
customer.
NOTE: Acceptable alternatives include:
•Receipt and evaluation of supplier provided statistical data.
•Traditional receiving inspection.
•2nd or 3rd party assessment at the supplier site (only if linked to records of product conformance at
production.
•Other methods specifically accepted by the customer.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered?
QUESTIONS FOR THE MANAGER(S) RESPONSIBLE FOR THE PRODUCTION PROCESS
Provision of Products or Services
NOTE: Provision of products or services, previously referred to as product or service realization is the
process of transforming raw material and customer expectations into finished products. The standard
requires documentation which describes the requirements of the product and documentation that describes
the steps in the process required to transform input into output. The amount of documentation, the format of
the documentation and the amount of detail required in the documentation should be determined by the
complexity of the product, the complexity of the process, customer specific requirements and the
competency levels of the people doing the work.
Product descriptions are generally in the form of drawings, blueprints, specifications, diagrams, agreements,
contracts, etc.
Process descriptions are in the form of PFMEAs, Control Plans, process flow diagrams, travelers, work
instructions, or work orders.
IATF – FAQ – 5.3, 5.3.1 -Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: Post-delivery activities can include warranty services, guarantees, return policies, rebate processes,
environmental clean-up after construction, service contracts, recycling services or disposal services.
Depending on the complexity of the post-delivery activity, any or all of the requirements of clause 8.5.1 could
apply. Where post-delivery activities include compliance to statutory or regulatory requirements, there
should be steps to ensure that the applicable requirements are reviewed and understood and that there is a
process to monitor changes to those requirements.
IATF – FAQ – 5.3, 5.3.1 - Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: The process description documentation includes documents such as: operator instructions, work
instruction, inspection instructions, set-up instructions, work cell layouts, 5S layouts and processes, daily
maintenance, packaging instructions, labeling instructions, material handling instructions, etc.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process, then
should control of the revision or version of that document be seriously considered?
Summary Notes:
QUESTIONS FOR FRONT LINE SUPERVISORS
CONDUCT A MANUFACTURING PROCESS / PRODUCT AUDIT
1. Select a production line or process. Selected Process should be based on previously gathered evidence of
process performance where performance concerns were identified. i.e.- Customer Complaints, Returned
Parts, High Scrap Rates, Scheduling Issues, Poor Delivery Performance, New Launch, etc.
2. Review the Control Plan for Content and consistency with the PFMEA
3. Use the following questions to assess each operation of the selected manufacturing process.
4. Assess each shift on which the process occurs, including weekend and continental shifts.
5. NOTE: All Manufacturing Processes must be audited during a three-calendar year cycle. This should also
be a consideration. NOTE: NOT ALLPRODUCTS need to be audited but ALL MANUFACTURING PROCESSES
must be audited.(9.2.2.3, 9.2.2.4 IATF)
6. IMPORTANT: Consider doing the Product Audit as described below concurrent with the Process audit.
IATF – FAQ – 5.3, 5.3.1 - Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: While the standard requires control of the process ONLY when control of the product cannot be done,
best practice is to always control the process and use controls on product as a validation if necessary.
Effective use of statistical process control could in most cases negate the need for, or at least reduce the
dependence on product inspection.
NOTE: Particular attention should focus on situations where misidentification can cause product
nonconformity. Pay close attention to organizations producing various products where there is a possibility
that products can be mixed. Consider: Left vs Right, Front vs Rear, Top vs Bottom as well as products that
look very similar.
NOTE: Product can be identified by a part or serial number molded, etched into the part or on a label
attached to the part. Identification can be on the container holding the product or identification can be
inherently obvious through its location, packaging, or position in the production steam. Potential
nonconformities include: product left on tables which could be erroneously assumed to be an acceptable
product; boxes or containers of parts with no identification; parts stored without identification; parts left on
or around machines; unidentified files.
NOTE: When there are customer complaints, product returns, product or process changes, the PFMEA and
Control Plan are required to be updated. Verify the last issue and ensure that the documents have been
effectively revised.
NOTE: This requirement is not only a manufacturing or production issue. It included paperwork such as
instructions, set-up sheets, quality alerts, documents or records from different jobs, being mixed,
misidentified or misfiled.
NOTE: The extent of operator instructions (Work Instructions) necessary is a function of employee
competence, complexity of the task and risks associated with potential errors.
PRODUCT AUDIT
INSTRUCTIONS: - Cover the next question for each operation identified on the control plan. If inspections
are conducted by an inspector or quality technician as well as the operator, have them do the same check
and confirm the answers to the three questions given. NOTE: Have the operators and inspectors conduct the
inspections while you observe. DO NOT do the inspections yourself. However, you must be competent to do
the checks in order to evaluate whether the inspection is being done correctly. (See Internal Auditor
Competency Requirements)
QUESTIONS:
Ask the operator or person (s) responsible for physical inspection or test of the product to inspect a product –
Witness their work and answer these questions:
1. Has the person demonstrated their ability to correctly inspect or test the product and correctly interpret
the result?
2. Is there evidence that the inspection/test method used will effectively distinguish a good product from a
bad product?
3. Does evidence provided show that current products being produced at the work station are compliant to
product and customer requirements?
END OF MANUFACTURING PRODUCT AUDIT
END OF MANUFACTURING PROCESS AUDIT
GENERAL MANUFACTURING PROCESS QUESTIONS
NOTE: Product can be considered Identified if its identity is inherently obvious. For instance if material in a
bin waiting for processing is identified and processed material in a bin next to it is identified, then in most
cases material on a table between the two, even though it is not specifically identified is considered to be
inherently obvious.
NOTE: In many organizations, lack of specific identification that material is not acceptable is evidence of
identification that it is acceptable. For this reason, material that is not confirmed to be acceptable must be
identified as unacceptable until such time as acceptability is verified.
NOTE: Consider returnable packaging, tools and fixtures, raw materials, prototypes, drawings and
specifications, buildings, other intellectual property and personal property. Controls should cover loss,
damage, deterioration, loss of confidentiality and should include when and how to inform the owner of the
property.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered?
Summary Notes:
QUESTIONS FOR THE MAINTENANCE MANAGER
IATF – FAQ – 5.3, 5.3.1 - Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: While ‘Downtime’ and ‘Uptime’ are common measures, more modern measures are OEE (Overall
Equipment Effectiveness – (Availability X Performance X Quality)), MTBF (Mean Time between Failures) and
MTTR (Mean Time to Repair). Organizations that want to improve their maintenance performance should
consider these measures.
Note that, in order to achieve effective MTBF and MTTR, there are a number of other initiatives which
should be tracked and managed, including: TPM (Total Productive Maintenance), Effective Preventive
Maintenance activities, Effective Predictive Maintenance activities, Quick Die Change Methods, a Precision
Maintenance Program, Defect and Failure True (DAFT) Cost methods, Accuracy Controlled Enterprise (ACE)
Procedures, Visual Factory Technologies.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered?
Summary Notes:
QUESTIONS FOR THE MANAGER RESPONSIBLE FOR TOOL CONTROL
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered?
Summary Notes:
QUESTIONS FOR THE OWNER OF THE QUALITY PROCESS
IATF – FAQ – 5.3, 5.3.1 - Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: Often quality performance measures address the measurement of other processes. Part of the quality
function is often to monitor and report on the performance of other processes, but the requirement here is to
determine whether the quality function has measures of its performance. The quality process is not
responsible for producing good parts or bad parts and they are not responsible for on-time or late delivery.
These are not measures of the effectiveness of the quality process.
Receiving Inspection
Calibration
Haptic or kinesthetic communication recreates the sense of touch by applying forces, vibrations, or motions
to the user.[1] This mechanical stimulation can be used to assist in the creation of virtual objects in a
computer simulation, to control such virtual objects, and to enhance the remote control of machines and
devices (telerobotics). Haptic devices may incorporate tactile sensors that measure forces exerted by the
user on the interface.
MSA (Measurement System Analysis)
Process Capability
Quality Laboratory Activities
NOTE:
IATF – FAQ – When can non -ISO 17025 CERTIFIED equipment manufacturers for calibration?
ANSWER – Customer approval is required before the use of equipment manufacturers in this instance.
Manufacturer must have defined methodology for maintaining, adjusting and calibrating the equipment.
IATF – FAQ – Is inspection and test equipment at final assembly considered an internal lab?
ANSWER – No – In-line equipment is not considered a internal laboratory.
Layout Inspection and Functional Testing
Nonconforming Product
IATF Sanctioned Interpretation – 8.7.1.1 has removed rework from needing customer
authorization prior to further processing. Requirement still applies to use-as-is and for repair, if
sub components of nonconforming product are reused.
NOTE: Disposition can include:
•Use-as-is – This disposition would generally require approval from the customer in the form of a waiver or
deviation.
•Rework – This disposition requires a rework instruction that describes the work to be done and inspection
after the rework is done by someone other than the person who did the rework.
•Repair – This disposition requires the conditions of both of the above dispositions – Customer approval,
repair instructions and re-inspection.
•Scrap – The organization must ensure that scrapped material is mangled or mutilated such that it cannot be
used for its original purpose.
NOTE: Repair vs Rework.
•Rework is a process which brings the material back to its original expected condition.
•Repair is a process which modifies the material so that it simulates the original condition and does not
deviate from the performance as intended(e.g. a hole drilled undersize can be REWORKED by re-drilling the
hole to the correct size. A hole that is drilled oversized can be REPAIRED by plugging the hole with a similar
material and re-drilling the hole to the correct size).
NOTE:
IATF – FAQ – (8.7.1.7) What is the intent of ‘render unusable’? How is this controlled? Does it apply to
component or semi-produced product?
ANSWER – Render Unusable – ensure that nonconforming final product as shipped to the customer CANNOT
find its way into the unofficial aftermarket, or be accidentally shipped to a customer. Product cannot be
useable OR repairable. The organization is expected to develop effective control of nonconforming product
and to verify its effectiveness. This process can be subcontracted and applies to product that has gone
through the organization’s process and in ready to ship.
Monitoring, Measurement and Evaluation
NOTE: FORD CS 8.6.6 for ongoing process capability, see Table ‘A’ of Ford Customer Specifics – see
reference
NOTE: Statistical process control on product characteristics without continuous manufacturing process
controls is not appropriate or sufficient for Critical Characteristics.
Reaction to Nonconformity
Final Approval
NOTE: Post-delivery activities can include warranty services, guarantees, return policies, recycling services,
or disposal services. Depending on the complexity of the post-delivery activity, any or all of the requirements
of clause 8.5 could apply. Where post-delivery activities include compliance to statutory or regulatory
requirements there should be steps to ensure that the applicable requirements are reviewed and understood
and that there is a process to monitor changes to those requirements.
Field Returns
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process, then
should control of the revision of that document be seriously considered?
Summary Notes:
QUESTIONS FOR THE MANAGER RESPONSIBLE FOR SHIPPING AND RECEIVING
NOTE: Shipping and Receiving may each have an identified Owner. However, SHIPPING can only have ONE
owner and RECEIVING can only have ONE owner. If Ownership for shipping and receiving are separate,
identify both owners and if issues are identified identify whether the problem exists in one or the other or
both areas.
IATF – FAQ – 5.3, 5.3.1 - Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: Are there the right number of people with the right skills, competence and training?
NOTE: IATF FAQ – Answer –(8.4.2.2, 8.6.5) Clause does not require the organization to maintain a list of
international requirements. They are required to review audits or periodically check that the process is
robust and assures compliance to the latest requirements for product destinations communicated by the
customer.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process, then
should control of the revision of that document be seriously considered?
Summary Notes:
QUESTIONS FOR THE MANAGER RESPONSIBLE FOR INTERNAL AUDITS
IATF – FAQ – 5.3, 5.3.1 - Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: Are there the right number of people with the right skills, competence and training?
Internal Audit
NOTE: For years, organizations have relied on a pre-determined matrix to show their planned intervals.
Almost inevitably these matrix-based systems have been ineffective and usually deteriorate to a process used
only to show external auditors that there is a system in place. A more effective system is described in the
systemsthinking.works Process Audit Toolkit.
NOTE: There is no requirement for all products to be audited. The requirement is for all manufacturing
processes to be audited. Products need to be audited at various stages of the manufacturing process which
negates the opportunity to use just dock audits or just layout activities. Also; normal daily inspector auditing
doesn’t apply since that is one of the processes being assessed in a product audit.
2nd Party Audits
Layered Process Audits – CQI-8 2nd ED
NOTE: It is recommended that the LPA owner NOT be the Quality Manager. The recommendation is for the
Manufacturing Manager to hold this function. (3.1 CQI-8)
NOTE: The planning team should consist of (Operations Manager, Production manager, HR Manager,
Engineering Manager, Maintenance Manager, Sales Manager, Finance Manager, Quality Manager,
Purchasing Manager, Materials Manager, etc.) (3.2 CQI-8)
NOTE: LPA does not replace Internal Auditing or 3rd Party Auditing (3.3 CQI)
NOTE: Measures of activities (You did the audit) are much less effective than measures of results (reduction
in repeat issues).
NOTE: Assess audits from various levels.
NOTE: SEE CQI-8 for suggested templates
Other CQI Audits – CQI-9, CQI-11, CQI-12, CQI-15, CQI-17, CQI-23
Auditor Competence
NOTE: Formal opening and closing meetings are not required for audits of a single system process or
manufacturing process.
IATF Sanctioned Interpretation – Internal Auditor Competency
The organization shall have a documented process(es) to verify that internal auditors are competent, taking
into account any requirements defined by the organization and/or customer-specific requirements. For
additional guidance on auditor competencies, refer to ISO 19011. The organization shall maintain a list of
qualified internal auditors.
Quality management system auditors shall be able to demonstrate the following:
minimum competencies: (At a minimum) manufacturing process auditors shall demonstrate technical
understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (such
as PFMEA) and control plan. (At a minimum) product auditors shall demonstrate competence in
understanding product requirements and use of relevant measuring and test equipment to verify product
conformity. If the organization’s personnel provide the training to achieve competency, documented
information shall be retained to demonstrate the trainer’s competency with the above requirements.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process, then
should control of the revision of that document be seriously considered?
Summary Notes:
QUESTIONS FOR THE MANAGER RESPONSIBLE FOR CONTINUAL IMPROVEMENT PROJECTS
NOTE:
IATF – FAQ – (5.3.1) Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
NOTE: Are there the right number of people with the right skills, competence and training involved in the
process?
Improvement
NOTE: Improvement should show up on charts, databases, or reports as improved product quality, improved
process performance, improved system performance, improved customer satisfaction, or improved business
performance.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
Summary Notes:
QUESTIONS FOR THE HUMAN RESOURCES MANAGER
NOTE: Consider government subsidies for new hires, apprenticeship programs or specific skills
requirements (licenses, certifications, professional designations etc.).
NOTE: A particularly important HR functions is the initial orientation of new employees. Consider that if you
don’t do a good job of communicating to a new employee the values and culture of your organization, what
you will be hiring will be their previous employer’s worst habits.
NOTE: It is neither required nor intended that employees are able to recite the Quality Policy. It is important
that everyone in the organization, in their own words what the Policy says and what it means to their job
functions. An important auditor question is whether the employees believe that top management believes in
the Quality Policy. For employees, actions speak much louder than words.
NOTE: Effective actions can include, Training, Mentoring, Shadowing etc.
NOTE: Consider whether there is a mismatch between training plans and the organization’s strategic plan.
IATF FAQ – Answer – 4.4.1.2 -This clause focuses on product and manufacturing process characteristics that
affect the safety AND/OR performance of the final assembly. These characteristics may not be directly
addressed in regulatory/statutory requirements, but may be defined by the customer.
IATF Sanctioned Interpretation – Product Safety –
The organization shall have documented processes for the management of safety-related products and
manufacturing processes, which shall include but not be limited to the following, where applicable:
NOTE: Special approval of safety related requirements or documents may be required by the customer or
the organization’s internal processes.
(Deleted text) Removed to clarify special approval review
IATF Sanctioned Interpretation (7.2.3) If the organization’s personnel provide internal auditor
competency training, documented information shall be retained to show the trainer’s competency
with the requirements above.
See IATF Sanctioned Interpretation (7.2.3) Oct 2017
NOTE:
IATF – FAQ – (5.3.1) Are responsibilities assigned to functional positions, specific titles or individuals?
ANSWER – Responsibilities are assigned to roles/ positions.
IATF FAQ – Answer 4.4.1.2 - This clause focuses on product and manufacturing process characteristics that
affect the safety AND/OR performance of the final assembly. These characteristics may not be directly
addressed in regulatory/statutory requirements, but may be defined by the customer.
IATF Sanctioned Interpretation – Product Safety –
The organization shall have documented processes for the management of safety-related products and
manufacturing processes, which shall include but not be limited to the following, where applicable:
NOTE: Special approval of safety related requirements or documents may be required by the customer or
the organization’s internal processes.
(Deleted text) Removed to clarify special approval review
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: If an undetected change to an external document could have a detrimental effect on the process then
control of the revision of that document should be seriously considered?
Summary Notes:
QUESTIONS FOR THE INFORMATION TECHNOLOGY MANAGER
NOTE: For organizations with Embedded Software, there is an additional requirement in this section.
NOTE: There was a time when IT was considered an add-on to systems, but in today’s modern organizations,
IT is an important integral activity. As a result, IT must have all of the components of a process in order to
ensure effective operation and control.
NOTE:
IATF - FAQ – Are MSA studies required for each individual gage?
ANSWER – No – instruments with the same characteristics (range, resolution, etc.) can be grouped and
sampled (gage families).
Embedded Software
Where IT is involved in the development, implementation, approval or management of processes with
Embedded Software
NOTE: This may be an area of responsibility assigned to a different process and process owner, in which
case the questions should be addressed there.
Automotive SPICE (Software Process Improvement and Capability) ISO/IEC 15504 – is a set of technical
standards documents for the computer software development process and related business management
functions. It is a framework for designing and assessing software development processes. If implemented
effectively, it leads to better processes and better product quality. It also helps to improve the cooperation
among complex supply chains and between globally distributed development and engineering centers.
NOTE: Access can mean permission to view information or permission to have a document under personal
control or authority to use or modify a document.
NOTE: In determining the need for control of an external document, consider this question. Would an
undetected change to the external document have a detrimental effect on the process? If there would be a
potential negative effect, then control of the revision of that document should be seriously considered?
Summary Notes:
CLAUSE REFERENCE
CSR REFERENCE
(CSR) Customer Specific Requirements used:
1. Ford – March 2017
2. GM – November 2017
3. VW – September 2017
4. FCA - October 2017
5. PSA Group – February 2017
REFERENCES
1. SPICE
Automotive SPICE - ISO/IEC 15504 - Software Process Improvement and Capability Determination
(SPICE), is a set of technical standards documents for the computer software development process and
related business management functions. It is a framework for designing and assessing software
development processes. If implemented effectively, it leads to better processes and better product quality.
It also helps to improve the cooperation among complex supply chains and between globally distributed
development and engineering centers. SEE ALSO- VDA
Automotive SPICE® (Software Process Improvement and Capability Determination)
2. TRADE-OFF CURVE EXAMPLES
A formal method to allow designers to explicitly make trade-off decisions is presented. The methodology
can be used when an engineer wishes to rate the design by the weakest aspect, or by cooperatively
considering the overall performance, or a combination of these strategies. The design problem is
formulated with preference rankings, similar to a utility theory or fuzzy sets approach. This approach
separates the design trade-off strategy from the performance expressions. The details of the
mathematical formulation are presented and discussed, along with two design examples: one from the
preliminary design domain, and one from the parameter design domain.
3. THREE QUALITIES
The 3 Qualities diagram is used to determine your organization’s progress toward customer satisfaction.
By plotting on the chart, your best estimate of where you currently stand and where your ideal position
would be, you can determine what strategies and actions are required in order to achieve your goals.
On the ‘Three Qualities Diagram the two axes of the graph represent ‘Quality’ and ‘Development over
Time’.
The first dotted line represents the development of ‘Expected Quality.’ This is the quality for which you
receive no thanks or recognition. To meet ‘Expected Quality’ you simply need to meet the customer’s
basic expectations.
‘Comparative Quality’ is the comparison of the quality level that you provide as compared to that provided
by your direct competitors. ‘Quality of Delight’ occurs when you provide a product, service or value that
is greatly appreciated, but was not expected by your customer.
Obviously your organization has to meet the Expected Quality requirements and ideally you want to be
better than your competitor at satisfying your customer. Your organization would probably like to
constantly delight your customer, but providing unexpected quality is a high risk venture and it is usually
high cost. Therefore constantly achieving ‘Quality of Delight’ is unrealistic.
Therefore, the question that needs to be asked is; “Where, in that space that meets the customer’s
‘Expected Quality’ and is ‘Better than Your Competition’ and is approaching ‘Quality of Delight’, is your
organization?” “Where in that space, do you need to be?”
4. MAQMSR - (MINIMUM AUTOMOTIVE QUALITY MANAGEMENT SYSTEM REQUIREMENTS
FOR SUB-TIER SUPPLIERS)
REQUIRED CONTENTS
CONTROL PLANS
•8.5.1.1 Control Plan
•8.5.1.2 Standardized work – Operator Instructions / visual aids
•8.5.1.3 Verification of Job Set-Ups
•8.5.2 (8.5.2.1) Identification and Traceability
•8.5.1.4 Verification after shutdown
•8.5.6.1.1 Temporary change of Process Controls
PROCESS APPROACH
•Identified Product Realization System
•Processes and sub-processes defined
•Processes and their interactions and linkages; identified, implemented and controlled
•Processes are monitored for effectiveness.
PERFORMANCE
•9.1.2.1 Customer Satisfaction
•8.6.4 Verification of externally provided products or services
•8.4.2.4 Supplier Monitoring
•8.5.1.5 Total Productive Maintenance
•10.2.3 Problem Solving
•10.2.4 Error Proofing
•10.2.5 Warranty Management
•10.2.6 Customer Complaints and field failure test analysis
INTERNAL AUDITING
•9.2.2.2 QMS Audits Focused on compliance to MAQMSR 2nd Ed
•9.2.2.3 Manufacturing process audits
•9.2.2.4 Product Audits
•9.2.2.1 Internal Audit programme
•7.2.3 Internal Auditor Competency
•requirement for a documented process may be waived if audits are conducted under the guidance of a
qualified customer 2nd party auditor.
•scope of auditor competency is limited to MAQMAR and ISO 9001 2015.
CONTROL OF NON-CONFORMING PRODUCT
•8.7.1.2 Control of Nonconforming Product
•8.7.1.3 Control of Suspect product
•8.7.1.4 Control of Reworked product
•8.7.1.5 Control of Repaired product
•8.7.1.6 Customer Notification
•8.7.1.1 Customer Authorization for concession
PART APPROVAL
•8.3.4.4 Product Approval Process
•7.5.3.2.2 Engineering Specifications Process Effectiveness and Efficiency
•8.4.2.2 Statutory and Regulatory requirements
•8.4.2.3.1 Software related products and Embedded Software
•9.1.1.1 Monitoring and Measurement
•7.1.5.1.1 MSA
•7.1.5.2.1 Calibration
•8.5.6.1 Change Control
MANAGEMENT RESPONSIBILITY
•5.1.1.2 Process Effectiveness and Efficiency
•6.2.1 / 6.2.2 / 6.2.2.1 Organizational Objectives
•5.3.2 /5.3.2 Responsibility and Authority
Customer Representative
Of or product requirements
Of or corrective action
•9.3.1.1/9.3.2.1/9.3.3.1 Management Review
•5.1.1.1 Corporate Responsibility
RISK MANAGEMENT
•6.1.2.1 Risk Analysis
•6.1.2.2 Preventive Action
•6.1.2.3 Contingency Plans
SAFETY
•4.4.1.2 Product Safety (NOTE: VWAG Customer Requirement)
5. ORGANIZATIONAL KNOWLEDGE – The Learning Organization
A learning organization is the business term given to a company that facilitates the learning of its
members and continuously transforms itself. The concept was coined through the work and research of
Peter Senge. Learning organizations develop as a result of the pressures facing modern organizations and
enables them to remain competitive in the business environment. Peter Senge stated in an interview that
a learning organization is a group of people working together collectively to enhance their capacities to
create the results that they really care about.
There are a number of other related hypotheses: consider Systems Thinking, Personal Mastery, Shared
Vision and Team Learning, Michael J. Marquardt - Building the Learning Organization: – A Systems
Approach to Quantum Improvement - McGraw-Hill, 1996, 220 (242) pages. OnLine - A Book Summary by
Jyrki J.J. Kasvi (30735p)
Excerpt: The new species of organizations is called a learning organization, and it possesses the
capability to: Anticipate and adapt more readily to environmental impacts. Accelerate the development of
new products, processes, and services. Become more proficient at learning from competitors and
collaborators expedite the transfer of knowledge from one part of the organization to another. Learn more
effectively from its mistakes. Make greater organizational use of employees at all levels of the
organization. Shorten the time required to implement strategic changes. Stimulate continuous
improvement in all areas of the organization.
6. HAPTIC TECHNOLOGY
Haptic or kinesthetic communication recreates the sense of touch by applying forces, vibrations, or
motions to the user. This mechanical stimulation can be used to assist in the creation of virtual objects in
a computer simulation, to control such virtual objects, and to enhance the remote control of machines and
devices (telerobotics). Haptic devices may incorporate tactile sensors that measure forces exerted by the
user on the interface.
7.SHUT DOWN
COLD START- To start running a process from the very beginning, without being able to continue the
processing that was occurring previously when the system was interrupted. Usually after several hours
since the last operation.
WARM START - To start running a process where the operating conditions have been maintained while
actual operation was interrupted. Usually for only a few hours from the last operation.
HOT START - To start running a process where the operating conditions have been maintained while
actual operation was interrupted. Usually for only a few minutes from the last operation.
8. TPM – Total Productive Maintenance
Total Productive Maintenance (TPM) is a system of maintaining and improving the integrity of production
and quality systems through the machines, equipment, processes, and employees that add business value
to an organization.
Jishu Hozen (a Pillar of TPM) is a Japanese word that means autonomous maintenance. “Jishu” loosely
translated, means – independence, autonomy. “Hozen” when translated to English means – preservation,
integrity or conservation.
Kobetsu Kaizen ( a Pillar of TPM)is a Japanese word for focused improvement, which. means prioritising
the most important losses and eliminating them. These are individual improvements and focus on losses,
(which losses and when).
Overall equipment effectiveness (OEE) is a term coined by Seiichi Nakajima in the 1960s to evaluate how
effectively a manufacturing operation is utilized. It is based on the Harrington Emerson way of thinking
regarding labor efficiency. The preferred OEE calculation is the three OEE factors:
Availability X Performance X Quality.
9. TEMPORARY CHANGES
Temporary change processes such as alternative methods, planned repair or salvage operations must be
covered on FMEAs and must have specific operator instructions, adequate gauging and inspection
method. There should also be additional quality control procedures for effective quality management.
Product produced under a temporary change must be treated as a unique LOT with appropriate controls.
10. MEASUREMENT GUIDELINES
1. Identify the Audience
a. Are your measurements understandable and relevant to the people who are tasked with the
performance?
2. Identify the appropriate language (Operational / Business)
a. Banks, owners, shareholders, need business measurements. Operators, engineers, supervisors,
mechanics, need operational measurements. Business language is the language of $$$Dollars.
Operational language is the language of things and time.
3. Measure the Right Thing
a. Measures should accurately address the desired outcome. Good performance means the process is
achieving its basic purpose. Bad performance should be evident in the negative effect on the
organization’s business. Does a measure which shows that audits are completed on time provide evidence
that the management system is effective, or that the audits were robust and meaningful?
4. Measurements Work In Pairs
a. One measure is never sufficient. There is always a way to achieve a measure by doing something else
that can actually cause a negative effect. There should always be a counteracting measure that addresses
this risk (Quality – Delivery). If we focus totally on quality, delivery will likely suffer unless we focus on
both.
5. Display Measurements Effectively
a. Charts are better than spread sheets or score cards. Neither spread sheets, nor score cards effectively
show trends.
b. Bigger is better. Color is better. Standard colors (RED, YELLOW, GREEN) are better. Highly visible is
better.
c. One performance measure on one chart.
d. Up equals better – down equals worse. OR down equals better – up equals worse
6. Analyze Performance Measurements Effectively
a. Are the performance measures driving the activity and results that will benefit the organization? If they
are simply driving activity, they are not valuable.
7. Use Layers of Measurement
a. 4 key measured objectives of the organization may have four connected measures for each process,
which may each have four measured performance criteria within the process to support the key
measures.
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