Soma’s consulting components and methodology.
Our program adapts to standards / regulations. Over the last few years, several industry-specific standards have evolved from the ISO 9000 framework. The best known are ISO 14000, QS-9000 and ISO/TS 16949, AS9100, and TL 9000 as well as regulations such as cGMP’s, and Sarbanes Oxley. With more companies pursuing multiple standards, the implementation approach you select should have the ability to adapt. Since the program is a process-driven methodology, it is inherently more flexible and versatile than pure standard-driven models. This allows your business management system to accommodate other standards you wish to pursue in the future without taking a step backward. Soma’s Knowledge Management System can also be tailored to follow a more common approach.
Kickoff/Mapping Session
This initial interchange gathers together all the stakeholders and serves two important purposes. First, it includes a candid discussion of individual and management responsibilities. Second, it serves as an objective study of your current business processes to determine what you have in place and what needs to be created or upgraded and documented. We identify the internal customer/supplier chain as well as the key process owners. As we go through the company needs and external regulations imposed on the company, we construct a customized Map. The Map lists all procedures related to your company, the procedure's process owner by name, the procedure's document control number, and the development status of that procedure. Armed with this information, a Soma consultant will prepare a project plan with you, which lists all of your project milestones and dates for successful completion. Once approved, the plan becomes the primary project management tool that identifies potential roadblocks and ensures things don't fall through the cracks.
Registrar Selection Assistance (If applicable due to International Standard compliance such as ISO 9001, ISO 13485, etc.)
Soma will use its familiarity with many of the leading registrars to help you choose the one that best suits your organization. We initiate the selection/recommendation process early in the project to ensure a smooth transition to the registration audit. We can also provide a whole range of registrar assistance services, including appointment scheduling, background research, mediation, and interpretation of the registrar's findings. Even if you have a preferred registrar, we can still streamline the process and reduce the demands on your resources.
Document Control System
Your documentation is only as good as the system that controls and maintains it. The Soma Consultant will work with your project manager to establish a document control system, or upgrade the existing one, for maximum effectiveness. This includes creating a review and approval process, developing a document numbering convention, selecting a document format and structure, and developing a systematic method for removing obsolete documents.
Developing Level 1 Documentation
The Quality or Environmental Manual (Level 1 document) is management's definition of the quality or environmental management system, its relationship to the requirements of the standard, and the policies that govern their application. In facilitated meetings, the Consultant helps to review and prepare the Quality or Environmental Manual with key process owners. This approach promotes speedy consensus and ensures that the final product is an accurate top-level representation of your quality or environmental management system
Developing Level 2 Procedures
Using the Business Management system Map as a to-do list, Soma conducts separate facilitated meetings to capture the content of the Level 2 procedures. In most cases, two meetings are held for each procedure - the first to draft the process, and the second to finalize it. Our objective is to promote clarity and consistency by using a format style that suits your system and your staff. Soma provides expert process recommendations and can also provide model documents to assist in filling any gaps in your procedures. The end result is a set of clear, user-friendly, easily maintained procedures that both anchors and supports your management system.
Awareness Training
Studies show a definite correlation between an employee's understanding of the standard and their active participation in the management system. For this reason, Soma feels it is vitally important to provide awareness training throughout your entire organization. Our training focuses on three areas: a summary of the Business management system implementation project, an overview of the basic requirements of the standard, and a description of the audit process. We incorporate information that is specific to your company to ensure that the training addresses the unique needs of your business. Attendees gain an understanding of the standard and how it applies to the organization and to their jobs; they also learn what to expect during an audit and how to prepare for it.
Internal Quality Auditor Training/Mentoring
Ongoing adherence to the business management systems can be effectively maintained only with regular auditing. Soma provides audit training followed by real-world experience. The classroom training teaches the how-to of the audit process and provides an in-depth study of the standard's requirements. Participants then apply their newly acquired skills in an actual audit that is supervised by the Soma Consultant. This combination of theory and practice speeds and reinforces the learning process and bolsters the confidence of your audit team for future audits.
Pre-audit/Final Audit Support
Some companies elect to have the registrar perform a pre-audit to assess their readiness for the registration audit. Soma can help you prepare for the audit and can also be present if you prefer. The final audit is normally completed within two months after the pre-audit. Again, the Soma Consultant will prepare you for this important event and can be there with you throughout the proceedings.
Quality is driven and controlled by a well-conceived management system. The basic principles of such a system include policy, defined responsibilities, documented standard practices, control of critical operations, document control, training, review audits and corrective action plans. Naturally, these principles were also the fundamental building blocks Soma used to design our implementation plan. Our system is extremely successful because we apply each of these core elements to the specific standard / regulation of interest. The flexibility of our approach also allows us to tailor our delivery to different industries.
Following is some background information on each of these standards and a brief description of how the program adjusts for each.
ISO 14000
The voluntary development of ISO 14000 was intended to establish a universally accepted code of practice that addressed environmental concerns. Businesses that implement an Environmental Management System (EMS) elevate their status to that of good corporate citizen and confirm their environmental stewardship. While waste reduction and pollution prevention are noble endeavors, businesses are also acutely aware of the tremendous potential for financial gain. By integrating activities like planning, documentation and measurement into daily business operations, it is possible to achieve the dual goals of pollution prevention and profit growth. Soma is the experienced partner you need to formulate your environmental policies and objectives. We help to identify the environmental aspects and impacts of your company’s activities, products and services, and assist with federal, state and local regulatory requirements. We can even develop your emergency planning and response program.
TS 16949 (QS-9000)
In 1994 the Big Three auto makers (Chrysler, Ford and General Motors), along with certain truck manufacturers, announced QS-9000, a quality standard that incorporates ISO 9000 in its entirety, with certain customer-specific elements added to address the needs of the automotive environment. At first, the requirement for QS-9000 compliance was limited to the Tier 1 suppliers, but there was strong support for making it mandatory for the entire automotive supplier chain. The main thrust of QS-9000 was to establish within the automotive supplier community a continuous quality improvement mentality that emphasized defect prevention and waste reduction. Soma is active in helping organizations to implement this standard.
AS9100
May 1997 saw the introduction of a new standard, which focuses on the unique needs of the aerospace industry. A consortium of industry leaders, including Boeing, McDonnell Douglas, Lockheed Martin, Northrop Grumman, and Pratt & Whitney were part of the steering committee that drafted this consensus standard. Its sponsors include the Aviation/Space and Defense Division of the American Society for Quality (ASQ). AS9000 is consistent with the quality requirements of NASA, FAA and DoD and as a result, has replaced the SAE ARD9000 standard. It is also aligned with similar industry initiatives in the
TL9000
Similar to the automotive and aerospace industries, all of the major players in the telecommunications industry adopted the ISO 9000 standard and added additional requirements to form TL 9000. The TL 9000 standard contains common requirements relevant to all companies and additional requirements that apply depending on the type of product provided: hardware, software, and services. What distinguishes TL 9000 from other industry specific standards is the requirement to use metrics. TL 9000 requires companies to establish metrics on specific performance indicators and to benchmark their performance against other suppliers. Gaining registration to TL 9000 is provided through third-party audits conducted by accredited registrars and is virtually identical to the process for ISO 9000 and QS 9000 registration.
Customer service is one of Soma's greatest strengths and our post-registration support is a prime example. Achieving registration is quite an accomplishment and we want to help you get the word out .
The Journey of Continuous Improvement
By now, we hope you understand that we are committed to your success and that we view each undertaking as a partnership. It is important to realize that registration is the first step of a long journey in continuous improvement. We want you to be comfortable knowing that Soma is a full-service organization that stands ready to provide all the quality improvement training to keep your quality practices up to date and performing at peak efficiency. Our services include compliance evaluation, Level 1, 2 and 3 documentation, process improvement, SPC and a variety of organizational training seminars.
At the heart of every successful quality system is a well-planned documentation system and well-written procedural documents. These documents represent the control an organization has over its business processes and, if not carefully crafted, can have a dramatic negative effect on the health of an organization. Regardless of what stage you're at in the process of documentation development, you can benefit from Soma's expert assistance. We are ready to do any or all of the following:
Ø Audit your procedures to ensure compliance with the standard.
Ø Design a sensible document control system that is easy to manage and maintain.
Ø Evaluate your quality manual (Level 1), operating procedures (Level 2) and work instructions (Level 3) for compliance, readability, logical flow and cohesiveness .
Ø Write your Level 1, 2 and 3 documentation, thereby saving valuable company time and resources.
Ø Works for ISO 9001, ISO 14001, TS 16949, AS 9100, etc.
This form is to be used by companies that are committed to pursuing registration and would like to find out how Soma services will be beneficial to that process. By providing this information, we will have a better understanding of your organizational needs and be able to offer a customized solution. If you have a general interest in Soma products and services, please use the information request form.
The difficulty businesses face today is not identifying their problems but designing and implementing solutions. Soma’s Process Improvement Consulting (I cubed - Dashboard) was developed to meet this need while significantly reducing the cycle time of business improvement. Speed is the key to business success and Soma has lapped the competition when it comes to service delivery. Our comprehensive process improvement methodology addresses how a company’s processes should work – not just employee training or workflow automation.
Our approach is to:
Ø Design efficient business operations
Ø Measure your organization and process performance
Ø Deploy useful information technology
Ø Manage cost structures
Ø Comprehensively solve critical business issues
Integration, Inspiration & Integrity