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 ASIL levels.

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 current trends:

• Functional Safety Standards (ISO 26262)
• Management System Standards (ISO/TS 16949) and Auditing.
• Trends in APQP Collaborative Solutions and the Strategic Implications
• New Machine FMEA
• Risk Management and Integrated Management Systems
• Social Responsibility Standards
• Disciplined Problem Solving

Click here for more information regarding the Automotive Industry.

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 as 33%.

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 Stage 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 the industry.

Omnex specializes in the following methodologies:

• Quality/Business Operating System (QOS/BOS)
• Stage Gate Risk-Based New Product Development Process
• Integrated Management Systems
• Quality/Business Management Systems
• Environmental Management Systems (ISO 14001) including Social Responsibility (ISO 26000), Energy Management (ISO 50000) and Sustainability
• Audit Processes and Methods
• Disciplined Problem Solving
• Lean and Six Sigma
• Functional Safety
• Business Excellence
• Supply Chain Practices and Outsourcing
• Software: Enterprise-wide Integrated Management Systems and MediniAnalyse

Implementation Support

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:

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!