How to Leverage FMEAs and Control Plans for Continuous Improvement

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.)

Failure Modes and Effect Analysis can significantly impact your quality processes. It is critical to recognize that there are significant quality risks associated with failing to implement FMEAs when introducing new products or adapting existing ones.

The overarching goal of FMEAs and control plans is to proactively identify, mitigate, and address risks before they occur, which is beneficial to every company. Detecting failures before they significantly impact your manufacturing operations allows you to reduce potential threats, improve product reliability and quality, and increase customer satisfaction.

Mitigating, eliminating, or reducing these risks also means faster production time and, as a result, a shorter turnaround time to launch a new or updated product. Incorporating FMEAs into your operations can help you save money on quality. Forestall the quality problems before they occur to keep production flowing smoothly and ensure customer satisfaction.

• Role of FMEA in advanced quality planning (AQP) and its relationship to quality function deployment (QFD) and the control plan.
• FMEA Basics. Foundation or master FMEAs save work and address known risks through reliance on product families and group technology, i.e., products that can be made by a common set of tools and operations. This makes performing a PFMEA for new parts in the same product family relatively easy.
• Seven steps of the process FMEA - 
      • Planning and preparation
      • Structure Analysis; identification of process steps (this is synergistic with a process flowchart) and process elements.
     • Function Analysis. The function of the process item is what the process is supposed to accomplish. This provides the basis for the failure effect, failure mode, and failure cause.
     • Failure Analysis; identification of failure causes, modes, and effects. The failure mode (how the failure happens) is the focus of the analysis. The failure cause (why it happens) was known previously as the failure mechanism.
    • Risk Analysis; Severity, Occurrence, Detection, and Action Priority. The Occurrence and Detection ratings are now based on the nature of the preventive and detection controls respectively as opposed to quantitative probability data that might be difficult to obtain. The Action Priority (which replaces the risk priority number) is based primarily on the Severity rating, followed by the Occurrence and Detection ratings. The Occurrence rating is so important that a 1 (best possible, the failure cause is totally disabled from creating the failure mode) will reduce the Action Priority to Low regardless of the Severity and Detection ratings. This reinforces the superiority of prevention over detection.
     • Optimization; actions to remove or mitigate risks. These can include superior prevention and/or detection controls and actions that reduce the severity rating. The result is often a lower Action Priority rating.
    • Documentation (the FMEA becomes a quality record and part of organizational knowledge). It is also important to share any lessons learned with similar processes.
• Manufacturing and occupational health and safety (OH&S) examples.
• Control plan; this can be appended to the PFMEA to create a dynamic control plan.

• Quality Managers
• Engineers, and Technicians
• Quality Assurance Personnel
• Research and Development
• Manufacturing Personnel
• Production Personnel
• Design Engineers, Design Assurance
• Everyone responsible for product realization processes. (The principles also are applicable to services, although this is not the traditional focus of PFMEA.)