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Process Approach

The respond to a customer request, the organization has to be concerned with processes within the organization. A work process is a series of operations/steps or activities that transform input into intermediate output at each step until the final output that meets the customer specified requirements. A common term to remember the structure of a process is SIPOCSuppliers, Input, Process, Output and Customers. The process approach using the SIPOC model creates processes that will produce products and services that conform to customer specified requirements. Understanding and improving process capability is superior to inspecting and sorting the final output.

 

The process approach recognizes that the products and services an organization provides to its customers are the result of processes linked together, from inputs to outputs – the chain of customers. All outputs have customers and all inputs have suppliers. Unfortunately, in practice an individual operator can only visualize the next process and the ultimate end users as customers. Unless and until the alignment and integration of the processes to form the functional system is visualized, the potential of the process approach cannot be released.

 

It is the responsibility of management to identify processes needed to produce and deliver the products or services to satisfy the requirements of the customer and other interested parties (suppliers, employees and other affected parties). Other crucial considerations that should be given due emphasis include the associated support processes as well as the desired outputs, process steps, activities, flows, control measures, training needs, equipment, methods, information, material and other resources.

 

In the ISO 9001 Clause 4.1 “General Requirements” (a) requires organization to determine the processes needed for QMS and their application throughout the organization. The requirements for the core business processes of the organization are defined under ISO 9001 Clause 7 “Product Realization”.

 

The product realization processes have to be supported by other supporting processes such as processes for managing information, training, finance-related activities, infrastructure and service maintenance activities, marketing activities, and other relevant supporting activities. The Note 1 in ISO 9001 Clause 4.1 clearly states that processes for QMS should include processes for management activities, provision of resources, product reliasation and measurement, analysis and improvement”

 

Fundamental to process approach is process management. Process management is founded on the concepts of process-oriented thinking, customer focus, and the importance of management variation. Process management is the term used to describe activities undertaken to operate and maintain processes in order for them to achieve planned resulted for the customers and the organization. It encompasses the key activities of:

 

 

Organization has to undertake periodic review of process performance to ensure consistency to the quality plan. The review on the performance of the processes and the actions taken to improve them are specified in the requirements for management review as defined in ISO 9001 Clause 5.6 “Management Review”.  The review of the processes covers:

 

 

Decisions and actions from the review include those that affect improvement of the effectiveness of QMS and its processes, improvement of products related to customer requirements, and change in resources needed.

 

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In order to consistently meet customer requirements, a high degree of standardization must exist in the processes. Standardization fosters organizational learning, provide the baseline for future improvements, enables employees to learn new job quickly, and improve the consistency of the process output. Standardization is not only on incoming materials, parts and the outputs, but also include the processes, operations, methods, measurements, and controls. It ensures repeatability of the process and consistency in quality. Organization will achieve dramatic improvement in product and service quality as well as significant cost saving through standardization activities.

 

The Standardize-Do-Check-Act (SDCA) cycle is the planning activity behind the standardization of processes. To establish a standard process, it has to start with Standardize step, where a trial standard is developed based on the current knowledge of those who do the work. The desired and standard outcomes are also determined here. In the Do step, the trial standard is tested in operation. The results of the trial are compared to the desired outcomes in the Check step. The Act step then makes the decision to accept the standard or revise the standard and thus go through the SDCA cycle again, until the final decision to accept the standard for practice.

 

Applying the Principle of Process Approach in ISO 9001

Applying The Principle of Process Approach In ISO 9001

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