Total Quality Management and a Process-Based Approach

In a process-based Quality Management System, the organization defines respective processes and how they interact with each other. Each process needs to have resources with authority, ie., process owners.

This blog will describe the responsibilities of process owners within the Quality Management System.

ISO 9001:2015 tells us that processes need to be monitored for effectiveness and efficiency and acted upon if the process is not performing to expectation. The standard goes further to require that an organization actively manage risks and opportunities of respective processes. Though ISO 9001:2015 does not specifically call out the role of a process owner, the standard does ask for authority and resources be available for processes. However, IATF 16949:2016 is more prescriptive and requires top management to identify process owners who are responsible for managing the processes, going further to set a requirement of competence of process owners.

So, what is the role of the process owner in practical terms? (Example work instruction for process owners.)

The process owner describes the process, completes the SIPOC or other process description tool, and further sets requirements of the process and process steps via procedures, work instructions and perhaps templates/forms.

The process owner actively nurtures his/her process. Most often a process owner is assigned a process because they are the key leader in that respective area or program. For example, the Purchasing Manager is often the process owner for the factory purchasing process. With that, the process owner has a vested interest in ensuring the process is healthy, performing well and that risks are being mitigated effectively.

The process owner defines key performance indicators enabling the monitoring of effectiveness and/or efficiency of his/her process. And then the process owner goes on to monitor the actual measures at perhaps a monthly rhythm, taking action when any actuals are off target.

The process owner assesses risk & opportunity in his/her process. This can be done in many ways. Most common is a factory-level risk & opportunity register that is reviewed at a regular cadence, where higher risk items are addressed with actions to reduce the risk level. The FMEA is an excellent tool for assessing risk in a process and can be used for each process of the Quality Management System.

The process owner reports out on process performance at the regular Management Reviews, including those actions that have been taken to mitigate off-target KPIs or high-risk items or perhaps to leverage opportunities.

Finally, ISO 9001:2015 asks us to continuously improve our processes and overall Quality Management System. The process owner takes active steps to improve process performance, which should, of course, be documented.