Understanding The ISO/TS 16949:2002 Standard

0.2 Process Approach  

This Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a QMS, to enhance customer satisfaction by meeting customer requirements. 

For an organization to function effectively, it has to identify and manage numerous linked activities. Any activity, using resources and managed in order to enable the transformation of inputs into outputs, can be considered a process. Often the output from one process directly forms the input to the next. 

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.   

Process Approach:   Key Explanation Points and Tips:  

Þ           The process approach is the foundation upon which your QMS must be developed. Let’s understand some basics about processes.   

Þ            Figure 1 - All work generally involves a process - things go in (inputs); get worked upon (conversion); and come out differently (output). The value-adding conversion activity within a process transforms inputs into outputs, e.g. takes raw materials (the input) and manufactures (the value-adding conversion activity using various resources) a product (the output). 

Þ            Process inputs and outputs can be tangible (raw materials or finished product) or intangible (information – e.g. computerized drawing or specification). 

Þ           Figure 2 - All process has a supplier and a customer. These suppliers and customers may be internal processes or external to your organization. Each process must have an accountable owner, i.e., having defined responsibility and authority to operate, control and improve their process. 

Þ            All processes require the use of resources, e.g. – people, equipment, materials, technology etc. These resources can be used as inputs (raw materials or information such as a customer specification) as well as for the value-adding conversion activity (e.g. use of machinery, equipment, computers, technology, people, etc.) to transform raw material (input) into finished product (output). 

Þ            All processes must meet (customer, organizational and applicable regulatory) requirements. The performance of all processes can be monitored and measured. Gather performance data that can be analyzed to determine process effectiveness and whether any corrective action or improvement is needed. 

Þ            An organization’s processes may be grouped or categorized in many ways. One logical way would include the following:  

Þ      Customer Oriented Processes (COP’s) - These are product realization processes (see clause 7) that determine customer requirements (inputs), design, make and deliver product (outputs) to customers and determine customer satisfaction. These processes generally have the greatest degree of interaction with external customers. COP’s include - marketing and sales; design and development; production; shipping; packaging; servicing/ warranty; customer satisfaction; etc., whether performed onsite or off-site. 

Þ      Support Oriented Processes (SOP’s) – These processes provide the necessary resources to COP’s to facilitate product realization. These processes generally have the greatest degree of interaction at an operational level with COP’s and to a lesser degree with other internal QMS processes. SOP’s include - human resources; information technology; purchasing and receiving; laboratory; maintenance; tooling; facility management; etc, whether performed onsite or off-site. See clause 6 and 7. 

Þ      Management Oriented Processes (MOP’s) - These processes provide the commitment, leadership, resources, review and decision-making by top management (see clause 5).  These processes generally interact with all QMS processes at the QMS planning and review level. MOP’s include – business planning; management review; quality planning; resource planning; communication, etc., whether performed offsite or on-site.  

Þ      Quality Management Processes (QMP’s) to document, measure, analyze and improve all processes – These processes provide quality management support to and interact with all QMS processes. QMP’s include - document control; records control; monitoring and measurement of processes and product; internal audits; control of nonconforming product; corrective and preventive action; continual improvement; etc whether performed onsite or off-site. See clause 4 & 8. 

Þ      Outsourced Processes (OP’s) – These are COP’s or SOP’s that are performed by a function or organization outside the ownership or managerial control of your facility. They may be performed onsite or off-site. These processes include - heat treating; painting; welding, calibration; testing; sort; HR; etc.