Use a Process Approach to Avoid Quality Management System Nonconformances

A well-designed process, e.g. for product realization, should prevent quality nonconformances and, if any occur, make it easy to resolve them. A good process follows the SIPOC (Supplier, Input, Process, Output, Customer) model. Application of failure mode effects analysis (FMEA) concepts to each step of the process should identify potential variation sources and other potential failure causes, and remove them proactively. FMEA is synergistic with the control plan that shows, for each step of the process, how process and product characteristics are controlled. It is also vital to pay attention to handoffs and interfaces between processes because these are often sources of trouble. Inadequate corrective and preventive action (CAPA) is a leading source of quality management system audit findings, and the webinar will use a good off-the-shelf CAPA process, AIAG's Effective Problem Solving, to illustrate the process approach.

ISO 9001:1987 warned, "Technical specifications may not in themselves guarantee that a customer’s requirements will be consistently met if there happen to be any deficiencies in the specifications or in the organizational system to design and produce the product or service." It is also known that a bad process will usually beat a good worker because skill, diligence, and judgment can go only so far to make up for a deficient process. 

A well-designed process, on the other hand, leaves no doubt as to what is to be done, when, how, by whom, and why. When each step is straightforward and includes controls to prevent all known trouble sources, the process should deliver the desired outcomes.

• Quality Managers
• Quality Personnel
• Engineers
• Technicians
• Manufacturing Personnel
• Anyone with responsibility for the QMS (ISO 9001:2015, with some concepts carrying over into IATF 16949)