Understanding The ISO/TS 16949:2002 Standard 

0.2 Process Approach (Continued) 

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.  

When used within a quality management system, such an approach emphasizes the importance of: 

a)    understanding and meeting requirements 

b)    the need to consider processes in terms of added value 

c)    obtaining results of process performance and effectiveness, and 

d)    continual improvement of processes based on objective measurement. 

Key Explanation Points and Tips: Process Approach  

Þ            Your QMS is made up of a network of value-adding processes that link, combine and interact with one another to collectively provide product or service (See Figure 2). These processes are inter-dependent and can be defined by complex interactions. For example, any of the COP processes, could interact with some or all of the MOP’s, SOP’s; QMP’s. Also note that resources (SOP’s) and QMP’s may also be applied to all other processes.  

Þ            Interactions between processes generally have the following characteristics: 

Þ      Typically involve the flow of information (data, discussion, decisions, documents, etc.) or physical item (materials, product, supplies, resources, etc.). 

Þ      May take place between internal organizational processes; within a specific process; or with external organizations (customers, suppliers, outsourcers, regulatory bodies, Certification body (CB, etc.). 

Þ      May take place in many ways (e.g. human, computer, automated, etc. Interaction between processes may take place sequentially or concurrently between several processes.  

Þ      Interaction between processes may take place at any process stage – as an input, output, process activity or resources needed for the process.  

Þ           Probably the root cause of many QMS process nonconformities could be traced to breakdown in the communication or interaction between processes. For example the sales function fails to notify the packaging function of a customer’s special packaging specification and the product is packaged and delivered in the organizations default mode). Therefore to control the interaction between and within processes, we need to identify and control: 

Þ      What is being communicated; who is communicating it; who is receiving it; how is it being communicated; how will the data or item being communicated be used; frequency and timeliness of data or item being communicated, etc. 

Þ      The controls should address the method of interaction or communication; its completeness, reliability and quality; frequency; timeliness; approval; understandability and usability of the data or item being communicated. Additionally, the responsibilities of the transmitter and receiver must be clearly defined. 

Þ            Therefore, in general, in order to plan and implement your QMS using the ‘Process Approach’, you must: 

Þ      Identify the processes needed for the QMS (see listing above)  

Þ      Determine their sequence and interaction (show the sequence and interaction of your COP’s). There are many ways to document this, e.g., a flowchart or a process map.  

Þ      Determine the application of QMS processes throughout the organization (show how MOP’s; SOP’s and QMP’s are applied to each COP and to each other). There are many ways of documenting this. A popular way is through graphical representation, e.g. process maps.  

Þ      Determine (plan) the criteria, methods, information, controls and resources needed for each QMS process. These include: 

Þ      Identify the internal/external customer-required output.  

Þ      Describe the process activity that produces the output.  

Þ      Identify the resources needed for the process activity.  

Þ     Identify the inputs for the process – information, materials, supplies, etc.  

Þ      Define the process methods, procedures, forms etc., that may be needed to produce the output.  

Þ      Define the controls to prevent or eliminate risk of errors, omissions, or nonconformities in the process activity. These controls may come from the TS 16949 standard; customer; regulatory and your own organizational requirements (more details provided in clause 4.1). 

Þ      Interaction – with sources that provide the inputs (internal process or external supplier); uses the output (internal process or external customer); or provide the resources (internal support process) to perform the process activity.  

Þ      Implement your QMS according to your plan. 

Þ      Monitor, measure and improve each QMS process and its interaction with other processes. Performance indicators to monitor and measure process performance may come from the TS 16949 standard; customer; regulatory and your own organizational requirements. Performance indicators may relate to the process output as well as the process activity.  

Þ      Performance indicators for process output must focus on meeting customer and regulatory requirements. Performance indicators for process activity should focus on measuring process effectiveness and efficiency. See clause 5.4.2 for quality objectives. 

Þ            It is useful to point out that while we do need to identify all QMS processes and describe their interaction, not all identified QMS processes need to be documented or documented in the detail described above. Review notes on clause 4.1 General Requirements in conjunction with the above notes on the process approach, for more insight on process documentation. 

Þ            For those interested in gaining a deeper insight into understanding and implementing the process approach, study the ISO guidance document on the concept and use of the process approach for management systems - Document: ISO/TC 176/SC 2/N544R2(r), issued 13 May 2004 on the ISO website. Also review the AIAG/IATF guidance on the automotive approach to QMS processes on the IAOB website. 

Keep in mind that the above notes and references are guidance documents and the manner and detail of application and documentation of the ‘process approach’ will vary from organization to organization,  due to a variety of factors such as size and complexity of the organization; products, processes; customers; etc. See clause 4.1 for more details on applying the process approach.