General Requirements | Omnex
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4.1 General Requirements

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Process Focus

This requirement in ISO 9001:2008 and ISO/TS 16949:2009 requires organizations to go beyond QS-9000. They have to identify the processes within their hierarchical organizational structure. The organizational structure and the chain of command follow Fredrick Winslow Taylor's theory of "specialization". It is what we call in the automotive industry - organizational silos or Chimney's. (See picture).

Products are "realized" by processes. ISO/TS 16949:2009 would force QS-9000 registered organizations to identify the "product realization" processes and the "support" processes. These processes provide for the product and are responsible for satisfying the customer.

Two ISO 9001:1994 paradigms need to be discarded at this stage. One is that the organization can scope out processes not required by the elements of ISO/TS 16949:2009. 1.2 Application in ISO 9001:2008 and ISO/TS 16949:2009 is careful to point out that only processes that do not "affect the organization's ability or responsibility to provide product that meets customer and applicable regulatory requirements" can be scoped out. "Requirements" are defined as "need and expectation". In other words, an organizational entity or a process can only be scoped out if it does not affect customer expectations. Now, it is questionable if organizations can scope out R&D Centers or Sales offices. Furthermore, ISO/TS 16949:2009 has defined 7.3 Design and Development as product and process design. No organizations implementing ISO/TS 16949:2009 can exclude 7.3 Design and Development from process design.

Two, ISO 9001:2008 and ISO/TS 16949:2009 clearly state that the organization needs to maintain control of the outsourced processes that "affect product conformity." Organizations will need to include outsourced processes in their process map including heat treating or plating or any component of an assembly manufactured by a supplier.

Organizations need to go beyond the elements of ISO/TS 16949:2009 when creating the process map. Telltale signs to auditors are process maps that only include elements related to the standard. Inherently, a "process focus" is different from a "departmental" focus. Worse yet is the compliance-driven approach of many companies who implemented QS-9000 with procedures solely based upon elements of the standard.

Business Circles

Omnex recommends that organizations study four types of processes for inclusion in the process map - ISO/TS 16949:2009 Processes, Product Realization Processes, Support Processes and Business Processes. ISO/TS 16949:2009 processes inherently fulfill the requirements of the standard. The Product Realization Processes include product ideation, research & development, marketing input, design & development all the way through to delivery of product and post delivery services. The Support Processes aid the overall organization -these include operations like training, purchasing, and document control. The Business Processes are those processes that differentiate you from your competitor and those that help fulfill "customer needs and expectations." The Business Processes are the most important processes for the success of a business. Of course, there is overlap in the four types of processes. In fact a picture of the relationship between the four types of processes is shown in the attached figure. By definition, Product Realization and Support Processes are exclusive. In other words, a process can either be a support process or a product realization process. ISO and Business Processes can be both product realization or support processes.

After studying the different processes, the organization can create a process map that "identifies the processes" in the organization. The process map also can show the "sequence and interaction" of these processes. The figure of a process map was included in the first series article of this series in May 2001 volume of the Informed Outlook.

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