Functional Safety Management (ISO 26262)
Most Automotive OEMs are starting to require ISO 26262 for the new vehicles they
are designing. ISO 26262, which is the Functional Safety Analysis standard comprised
of 10 parts, was published November 14, 2011.
It is widely being used by European and US Automotive companies. It is being adopted
by many Tier One automotive organizations who are finding ISO 26262 conformance
a requirement in their Request for Quotes. ISO 26262 requires that suppliers for
sub systems, hardware, and software, as well as Semiconductor components meet ISO
26262 requirements. Customers for Electronics including PCB and semiconductors are
also being required to be ISO 26262-compliant.
The integration of software with hardware was highlighted in the Toyota sudden acceleration
incident. Most Automotive CEOs and Boards have taken the concept of functional safety
to heart and see newly developed electronics and electronic controls, software,
and sensors as fraught with risk to their organizations and have been encouraging
the use of risk mitigation steps with the implementation of ISO 26262 and the Automotive
It is clear ISO 26262 is here to stay. Omnex has a number of training, discovery
analysis/assessment and software offerings to help you implement ISO 26262.
Click here to see how Omnex can assist with
Implementation Support and/or Assessments.
Training and Workshops
This is a period of unprecedented change in the Automotive industry because there
has been a large turn over in personnel from 2009 with a large influx of new people
in 2010 and 2011 when the Automotive industry and the economy picked up. All these
new employees need to be trained. Automotive Companies are also focusing on their supply chains as
new suppliers and supply chains are getting stretched.
ISO 26262 a functional safety standard is one of the latest changes in the in the
Automotive Industry that is being driven due to a fundamental change in technology.
Mostly it is being felt in the Electric Car Industry that has significant safety
risk due to the immaturity of the electric car technology, but it is also present
in the regular automobile industry as hardware and software complexity increases.
This webinar can help you understand ISO 26262.
In fact, here are the Key Changes Omnex is seeing in the Automotive Industry as
Click here for more information regarding the Automotive Industry.
Functional Safety Requirements (ISO 26262)
ISO/TS 16949:2009 and Customer-Specific Requirements
Automotive/Production Core Tools (APQP, FMEA, PPAP, SPC, MSA)
(This course is broken into modules, allowing specialists to only attend the training
relevant to their responsibilities)
(Five-day training course that teaches the linkages of DFMEA with DVP&R to Process
Flow, PFMEA, Control Plan, to Work Instructions with a standard industry case study,
or Omnex can develop a customized case study working within your organization. This
course can be broken into modules, allowing specialists to only attend the training
relevant to their responsibilities.)
Implementing APQP with Collaborative Tools EAPQP
AQuA Pro Software and Project Planner for APQP including linked DFMEAs, DVP&R (test
plans), Process Flow, PFMEA, Control Plans, Risk Based Controls including work instructions
and quality checklists
Disciplined Problem Solving (8D)
Effective Problem Solving (EPS)
Integrated Management Systems
Integrated Management Systems (IMS) is the integration of QMS,
EMS, OHSAS and other regulations / standards and requirements into a single management
system. IMS fosters the approach that an organization should establish one integrated
system that is best for the business and not set up separate, often duplicate, processes
or documentation to satisfy each management standard. IMS contains company-wide
processes that conform to various management system standards such as AS9100, ISO/TS
16949, ISO 22000, ISO 9001, ISO 14001, and OHSAS 18001 but are primarily established
in support of the business goals.
At Omnex, integration means developing common organizational processes based on
standardized work flows, conducting integrated risk analysis (using FMEAs and Control
Plans for quality, environmental and health and safety risks) and conducting integrated
audits. At Omnex, we are continuing to pioneer ever more effective and efficient
ways of defining, implementing and auditing integrated management systems.
Integration and standardization not only reduce confusion and redundancy in the
workplace, but cost an estimated 50% less to implement and most importantly cost
50% less to maintain. Furthermore, the cost for registration is reduced by as much
Omnex has been implementing integrated management systems since the 1990s, beginning
with the integration of QS-9000 and ISO 14001 in the Americas for Yazaki. Since
then, we have integrated ISO 9001, ISO 14001 and OHSAS 18001 for organizations around
the world including General Motors and TRW. Lately, we have integrated ISO 9001
and Food Safety Management Systems including an implementation where Food Safety,
Quality (ISO 9001), Environmental (ISO 14001), and Health and Safety (OHSAS 18001)
were integrated into one management system. Omnex recently helped Swiss Colony a
100 year-old Food Catalog and Bakery implement FSMS and QMS standards in a record
six months that included QOS/BOS and Phase Gate New Product Development methodologies
and 8D Problem Solving techniques.
Omnex provides training for top management in the understanding and integration
of multiple integrated management systems, as well as the worlds only lead auditor
course in Integrated Management Systems (ISO 9001, ISO 14001 and OHSAS 18001).
Click here for
more information on Omnexs approach to Integrated Management Systems
Omnex Methodologies and Practices
Omnex offers training for each of the different methodologies as shown in this link.
Keep in mind, some of these methodologies may be known by different names within
Omnex specializes in the following methodologies:
Click here to view Omnex Training and Workshop Offerings.
Omnex can help you conduct an ISO/TS 16949 or ISO 26262 Analysis (or Assessment)
or conduct a Best-In-Class assessment to assist your company in making
process improvements that result in efficiency and savings.
Omnex will conduct a Discovery Analysis during an initial assessment. Omnex will
study your current processes to see the gaps in the systems as well as review Best-In-Class
practices depending on the scope of the assessment. Omnex assessments always focus
on savings and improvements within the organization. The last day of the assessment
centers around feedback and planning with the customer team. An implementation plan,
team, and next steps are completed as a part of the Discovery. Of course, this can
also be conducted at the beginning of an implementation, when the standard is revised
or when the customer is ready for an overhaul of their systems.
Further implementation support for ISO 26262 includes the following:
ISO 26262 Project Implementation Support
Omnex can assist in establishing processes for safety-related activities
Functional Safety Manager
Omnex will provide full-time or half-time support as your acting Functional Safety
Manager Provide coaching and implementation to existing personnel
Assess internal process, the system, hardware, software, manufacturing to identify
best methods to implement ISO 26262 integrated with ISO TS 16949 and APQP management
Product Safety Assessment with respect to achieving a required ASIL
Review existing records for compliance to ISO26262 and adequacy for required ASIL.
Assist in developing additional work products as required.
Omnexs core strengths are spelled out in the 12 methodologies in which
we specialize. Each of these practices are Best In Class practices that
can be implemented based on the needs of a specific organization in any industry.
Let us know how we can help you!