Instructor Profile

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.

Process failure mode effects analysis (PFMEA) is part of advanced quality planning (AQP) or advanced product quality planning (APQP), whose purpose is to plan quality into the product realization process. It seeks to anticipate trouble in advance, in the form of failure modes, failure causes (also known as failure mechanisms), and failure effects. It then seeks to implement controls that prevent the generation of nonconforming products, or at least detect and stop them before they can reach an internal or external customer. It is required by the IATF 16949:2016 standard for automotive quality management systems (clause 8.3.5.2 (g)) and is highly recommended for ISO 9001 users.

This is a 90-minute overview of AIAG/VDA’s newest approach to process failure mode effects analysis, with additional information on (1) the role of FMEA in advanced quality planning (AQP), and (2) the control plan that can be appended to a PFMEA to create a dynamic control plan.

(Design FMEA will not be addressed, except for its role in AQP, due to time limitations and because some manufacturing organizations do not have a design in the scope of their quality management systems.)

Workplace safety is more than an ethical and legal obligation to employees and other stakeholders. ISO 45001:2018 is a standard for occupational health and safety (OH&S) management systems. Its effective implementation and use support occupational safety, and can help the organization not just meet but exceed the requirements of OSHA. 

This webinar will provide an overview of ISO 45001's main requirements as well as generally-accepted, easily understood, and highly effective ways to put them into practice. These include workplace safety committees, worker-initiated corrective and preventive action for hazards, job safety analysis, error-proofing, and lockout-tagout.