Welcome to my Website LetsTalkQuality.com
WHAT IS NEW IN QUALITY?
AS9100:2016 (D) was released April 2016
The new AS9100:2016 is based on the Current ISO 9001:2015 standard, plus additional requirements of the Aviation, Space and Defense industry requirements. The focus of the revision is to add clarity, enhance ease of use, while addressing industry and and stakeholder needs.
ISO 9001:2015 was released Sept 2015
The deadline to comply with this new standard was Sept 14th 2018
The New ISO 9001:2015 standard has been restructured: chapters and subchapter titles as well as the order of clauses and paragraphs, were completely revised. The provision for "actions to address risks and opportunities" is one of the most significant changes to the standard. While risk based thinking was implicit in many ISO 9001:2008 provisions, the new standard calls for it explicitly, and the implications are more extensive. Risk management (RM) is common sense when it comes to issues like safety, compliance with environmental regulations, and quality. Risks of omission or failure to identify and exploit opportunities, are far less obvious and can be far more dangerous.
Here are a few links I recommend you view to help understand what this new standard brings
ISO (International Organization for Standardization)
Presented by CALISO Corp
NQA ISO 9001:2015 Transition Webinar
Bsi looks at the detail behind the ISO 9001:2015 Revision
Say goodbye to ISO/TS 16949, say hello to IATF 16949:2016
As of 2016 the ISO /TS16949 management system standard will no longer be maintained by ISO, it is solely managed and maintained by the IATF (International Automotive Task Force) as IATF 16949:2016.
Reference www.aiag.org
NEW! AS9145/Advanced Product Quality Planning (APQP)
The International Aerospace Quality Group (IAQG), the body that sets and maintains standards for the Aerospace and Defense industry, has released the new AS9145/Advanced Product Quality Planning (APQP) Standard.
APQP has been successfully implemented in the Automotive, Medical Electronics, Heavy Equipment, and other industries. It specifies the process, methods and tools to advance the planning for quality products to points much earlier in the product development process. The identification of requirements and key characteristics drives the use of design and process failure mode effects analysis (FMEA), with the intent of improving the management of design/ process risks, and minimizing process variability associated with key characteristics.
WHY BUILD A QUALITY MANAGEMENT SYSTEM?
QUALITY is not a program; it is an approach to business.
QUALITY is a collection of powerful tools and concepts that is proven to work.
QUALITY is defined by customer through their satisfaction.
QUALITY includes continuous improvement and breakthrough events.
QUALITY tools and techniques are applicable in every aspect of the business.
QUALITY is aimed at performance excellence; anything less is an improvement opportunity
QUALITY increases customer satisfaction, reduces cycle time and costs, and eliminates error and rework.
QUALITY “Performance and Profitability” are the natural consequence of an effective quality management system.
Deming believed that;
”85 percent of all quality problems were the fault of management. In order to improve, management had to take the lead and put in place the necessary resources and systems”
My name is Michael Gonzales, I am a Senior Member for the American Society for Quality and Professional Consultant for Quality Management Systems, Operations, EHS and Lean Manufacturing.
I have over 35 years of experience in Quality Management Systems development and control for Aerospace, Automotive, Commercial and FAA (AS9100, ISO 9001, TS16949, FAA), with 15+ years experience in Environmental, Health and Safety systems.
I also have strong experience utilizing process improvement tools such as Lean and Six Sigma.
It is the combination of a structured and disciplined Quality Management System with the tools of Lean/Six Sigma that will bring growth, profit and stability to an organization.
Performance and Profitability of an organization cannot be achieved without these disciplines working together. Technically, ISO 9001, AS9100 and TS16949 Quality Management Systems require Lean/Six Sigma tools. These Quality System Standards have the requirements of "Analysis and Evaluation". Using Lean to reduce waste and Six Sigma to reduce variations, your processes become measurable, stable and will continually improve.
Risk Based Thinking and Root Cause Analysis are the most powerful tools in a Quality Management System. Without being proactive (RBT) and quickly reactive (RCA), many Lean and Six Sigma tools are only capturing undesirable data without understanding the cause.
I have worked on many exciting projects over the years, and have had the honor and pleasure to work hand-in-hand with some of the best companies in the world.
I have worked with NASA, Kaiser Marquardt, Lockheed, Boeing, Pratt and Whitney, Raytheon, Meggitt, HondaJet, General Atomics, Caterpillar, Woodward, Ultramet, Turbonetics Inc. and more.
With my years of experience in various cultures, environments, projects and system requirements, I can say that Quality is often challenging and often misunderstood.
When the value of a structured Quality system is properly understood and supported, it is the ingredient that makes a good product "A Great Product, A Safe and Dependable Product". "Performance and Profitability” are the natural consequence of an effective quality management system.
-"Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for". ~Peter F. Drucker
However, Quality does not always come easy, we in "Quality" are often challenged, and are at times expected to sway, deviate, allow, settle or find the loophole to buyoff a product to meet schedule.
What is the Golden Rule for a Quality Representative?
There is not a simple answer or a standard approach. However, when challenged...you need to remember your "Reputation will last longer than your position". You are making decisions based on Objective Evidence (Purchase Order requirements, Contract requirements, Terms and Conditions, Blueprints, Non Disclosure Agreements, and the established Quality Management System requirements).
Remember, with every decision and action, you are representing three entities:
-The Customer
-The Company (Owner/Stockholders and Employees)
-Your Reputation and integrity
So, what is the big deal in a poor judgment call?
If you are aware of a conflict in a requirement and Accept it even with direction or permission from your boss or higher, you have not only compromised your position, you can be accountable as an individual if the action violates Customer/Regulatory/Statutory requirements. Financial consequences (Fines), Criminal charges (Possible time served in jail), and not to mention Your reputation and integrity is tarnished for life.
Some people do what they feel they have to “to keep their job”
While others do what they feel they have to “to do their job”.
-Michael Gonzales
So, with that said I can suggest you pay attention to the dialogue used in the movie 300 (2006) with Gerard Butler.
"Choose your next words carefully, Leonidas. They may be your last as king."
So, how does a successful system work? What is needed? It is simple...a Dedicated Team that all work together with one goal in mind...Team Success.
Respect and understand each persons position. Most of the time the problem is not the process or hardware, it is the lack of understanding and lack of Team focus.
TOGETHER we stand, TOGETHER we fall, TOGETHER we win, and winners take ALL. TC Volleyball Team
There is nothing more rewarding to meet or exceed all requirements and deliver a product on time "Right, the First Time". This can only be achieved through attention to detail, devotion to excellence, TEAM focus, communication and keeping the End User In Mind (Customer).
----------------------------------------------------------
I truly like the quotes from Jehangir Ratanji Dadabhoy Tata. and Henry Ford
“Productivity and efficiency can be achieved only step by step with sustained hard work, relentless attention to details and insistence on the highest standards of quality and performance.” - J. R. D. Tata
---------------------------------------------------------
"The Success of Teamwork"
Coming together is a beginning...Keeping to together is progress... Working together is success,
~Henry Ford~
---------------------------------------------------------
QMS Training & Consulting
$120 per hour + travel/expenses
Certification Training offered:
Consulting
Email me at: Mike@LetsTalkQuality.com
Where Compliance is more than a √ box
AS9100:2016 (D) was released April 2016
The new AS9100:2016 is based on the Current ISO 9001:2015 standard, plus additional requirements of the Aviation, Space and Defense industry requirements. The focus of the revision is to add clarity, enhance ease of use, while addressing industry and and stakeholder needs.
ISO 9001:2015 was released Sept 2015
The deadline to comply with this new standard was Sept 14th 2018
The New ISO 9001:2015 standard has been restructured: chapters and subchapter titles as well as the order of clauses and paragraphs, were completely revised. The provision for "actions to address risks and opportunities" is one of the most significant changes to the standard. While risk based thinking was implicit in many ISO 9001:2008 provisions, the new standard calls for it explicitly, and the implications are more extensive. Risk management (RM) is common sense when it comes to issues like safety, compliance with environmental regulations, and quality. Risks of omission or failure to identify and exploit opportunities, are far less obvious and can be far more dangerous.
Here are a few links I recommend you view to help understand what this new standard brings
ISO (International Organization for Standardization)
Presented by CALISO Corp
NQA ISO 9001:2015 Transition Webinar
Bsi looks at the detail behind the ISO 9001:2015 Revision
Say goodbye to ISO/TS 16949, say hello to IATF 16949:2016
As of 2016 the ISO /TS16949 management system standard will no longer be maintained by ISO, it is solely managed and maintained by the IATF (International Automotive Task Force) as IATF 16949:2016.
Reference www.aiag.org
NEW! AS9145/Advanced Product Quality Planning (APQP)
The International Aerospace Quality Group (IAQG), the body that sets and maintains standards for the Aerospace and Defense industry, has released the new AS9145/Advanced Product Quality Planning (APQP) Standard.
APQP has been successfully implemented in the Automotive, Medical Electronics, Heavy Equipment, and other industries. It specifies the process, methods and tools to advance the planning for quality products to points much earlier in the product development process. The identification of requirements and key characteristics drives the use of design and process failure mode effects analysis (FMEA), with the intent of improving the management of design/ process risks, and minimizing process variability associated with key characteristics.
WHY BUILD A QUALITY MANAGEMENT SYSTEM?
QUALITY is not a program; it is an approach to business.
QUALITY is a collection of powerful tools and concepts that is proven to work.
QUALITY is defined by customer through their satisfaction.
QUALITY includes continuous improvement and breakthrough events.
QUALITY tools and techniques are applicable in every aspect of the business.
QUALITY is aimed at performance excellence; anything less is an improvement opportunity
QUALITY increases customer satisfaction, reduces cycle time and costs, and eliminates error and rework.
QUALITY “Performance and Profitability” are the natural consequence of an effective quality management system.
Deming believed that;
”85 percent of all quality problems were the fault of management. In order to improve, management had to take the lead and put in place the necessary resources and systems”
My name is Michael Gonzales, I am a Senior Member for the American Society for Quality and Professional Consultant for Quality Management Systems, Operations, EHS and Lean Manufacturing.
I have over 35 years of experience in Quality Management Systems development and control for Aerospace, Automotive, Commercial and FAA (AS9100, ISO 9001, TS16949, FAA), with 15+ years experience in Environmental, Health and Safety systems.
I also have strong experience utilizing process improvement tools such as Lean and Six Sigma.
It is the combination of a structured and disciplined Quality Management System with the tools of Lean/Six Sigma that will bring growth, profit and stability to an organization.
Performance and Profitability of an organization cannot be achieved without these disciplines working together. Technically, ISO 9001, AS9100 and TS16949 Quality Management Systems require Lean/Six Sigma tools. These Quality System Standards have the requirements of "Analysis and Evaluation". Using Lean to reduce waste and Six Sigma to reduce variations, your processes become measurable, stable and will continually improve.
Risk Based Thinking and Root Cause Analysis are the most powerful tools in a Quality Management System. Without being proactive (RBT) and quickly reactive (RCA), many Lean and Six Sigma tools are only capturing undesirable data without understanding the cause.
I have worked on many exciting projects over the years, and have had the honor and pleasure to work hand-in-hand with some of the best companies in the world.
I have worked with NASA, Kaiser Marquardt, Lockheed, Boeing, Pratt and Whitney, Raytheon, Meggitt, HondaJet, General Atomics, Caterpillar, Woodward, Ultramet, Turbonetics Inc. and more.
With my years of experience in various cultures, environments, projects and system requirements, I can say that Quality is often challenging and often misunderstood.
When the value of a structured Quality system is properly understood and supported, it is the ingredient that makes a good product "A Great Product, A Safe and Dependable Product". "Performance and Profitability” are the natural consequence of an effective quality management system.
-"Quality in a product or service is not what the supplier puts in. It is what the customer gets out and is willing to pay for". ~Peter F. Drucker
However, Quality does not always come easy, we in "Quality" are often challenged, and are at times expected to sway, deviate, allow, settle or find the loophole to buyoff a product to meet schedule.
What is the Golden Rule for a Quality Representative?
There is not a simple answer or a standard approach. However, when challenged...you need to remember your "Reputation will last longer than your position". You are making decisions based on Objective Evidence (Purchase Order requirements, Contract requirements, Terms and Conditions, Blueprints, Non Disclosure Agreements, and the established Quality Management System requirements).
Remember, with every decision and action, you are representing three entities:
-The Customer
-The Company (Owner/Stockholders and Employees)
-Your Reputation and integrity
So, what is the big deal in a poor judgment call?
If you are aware of a conflict in a requirement and Accept it even with direction or permission from your boss or higher, you have not only compromised your position, you can be accountable as an individual if the action violates Customer/Regulatory/Statutory requirements. Financial consequences (Fines), Criminal charges (Possible time served in jail), and not to mention Your reputation and integrity is tarnished for life.
Some people do what they feel they have to “to keep their job”
While others do what they feel they have to “to do their job”.
-Michael Gonzales
So, with that said I can suggest you pay attention to the dialogue used in the movie 300 (2006) with Gerard Butler.
"Choose your next words carefully, Leonidas. They may be your last as king."
So, how does a successful system work? What is needed? It is simple...a Dedicated Team that all work together with one goal in mind...Team Success.
Respect and understand each persons position. Most of the time the problem is not the process or hardware, it is the lack of understanding and lack of Team focus.
TOGETHER we stand, TOGETHER we fall, TOGETHER we win, and winners take ALL. TC Volleyball Team
There is nothing more rewarding to meet or exceed all requirements and deliver a product on time "Right, the First Time". This can only be achieved through attention to detail, devotion to excellence, TEAM focus, communication and keeping the End User In Mind (Customer).
----------------------------------------------------------
I truly like the quotes from Jehangir Ratanji Dadabhoy Tata. and Henry Ford
“Productivity and efficiency can be achieved only step by step with sustained hard work, relentless attention to details and insistence on the highest standards of quality and performance.” - J. R. D. Tata
---------------------------------------------------------
"The Success of Teamwork"
Coming together is a beginning...Keeping to together is progress... Working together is success,
~Henry Ford~
---------------------------------------------------------
QMS Training & Consulting
$120 per hour + travel/expenses
Certification Training offered:
- 8D Root Cause Investigation and Corrective Action (16hrs)
- ISO 9001:2015 Internal Auditing (24hrs)
- Mechanical Blueprint Reading (16hrs)
Consulting
- Introduction to Quality Management
- Supplier Control and Auditing
- ISO 9001:2015 Internal Auditing
- AS9100 Internal Auditing
- Root Cause Failure Investigation / FRACAS
- EHS Regulatory Auditing
Email me at: Mike@LetsTalkQuality.com
Where Compliance is more than a √ box