PFMEA and the Control Plan - Overview and Application

The Process FMEA and Control Plan program introduces the basic concepts behind this important tool and provides training in how to conduct an effective PFMEA. First, the course explains what a PFMEA is and how it improves the long-term performance of your products, services and related processes by addressing process related failures. The role of the PFMEA in the overall framework of Quality Management System Requirements is explained as well as the role of the PFMEA in the Advanced Product Quality Planning (APQP) process. Additionally, the differences and relationships between the DFMEA and PFMEA are well defined. With this background information, the course provides a systematic, standardized approach for completing the Process FMEA. Outputs from PFMEAs are essential inputs to Control Plans. This course pairs training on building Control Plans with PFMEAS because of this relationship. The basic format for and methodology for building, using and maintaining an effective Control Plan is presented.

What Will You Learn

By attending this seminar, participants will be able to:
  • Describe how the PFMEA can drastically improve the long-term reliability of their organization's products and processes
  • Describe the role of the PFMEA within a quality management system
  • Describe the differences and relationships between the PFMEA and DFMEA
  • Build and lead a Cross-functional Team for completing a PFMEA
  • Follow the AIAG Potential Failure Mode and Effects Analysis Reference Manual for completing a PFMEA
  • Conduct a Brainstorming Session aimed at eliminating process failures
  • Develop and use a Process Flow Diagram for use as a job aid in completing the PFMEA
  • Document of the analyses results on the standard PFMEA form
  • Use the Process Controls identified during the PFMEA as inputs to the Control
  • Create, Employ and Maintain a Control Plan

Is This Course For You

This PFMEA and the Control Plan course will provide training to a manufacturer’s process engineering, development, operations, quality and administrative personnel. These individuals are typically involved in the development and production of parts for direct use in the manufacture of automobiles or other manufactured items. Technical managers of personnel involved in the above would benefit as well.

Materials Provided

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Course Requirements

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I. Introductions
  • Instructor qualifications
  • Participant’s job roles and experience
  • Examples of process issues that lead to failures
II. Define Basic Reliability Concepts that Set the Stage for the Completion of the PFMEA
  • Identify reliability and basic quality concepts such as the Bathtub Curve, Failures and what it takes to consistently meet customer requirements
  • Analyze failures related to design weaknesses as opposed to failures related to process issues
  • Determine the difference between process failure modes and effects
III. Comprehend the Need for the PFMEA
  • Essential factors that play a significant role for a company to successfully provide quality products and services
  • Benefits to the organization its customers and employees
  • The role of the PFMEA in Quality Management System (QMS), Advance Product Quality Planning (APQP) and relationship to the Control Plan as well as other tools/techniques
IV. Identify the basic requirements for effective completion of the PFMEA
  • Cross functional team approach
  • Process Flow Diagram
  • Use of the AIAG form to guide the PFMEA
  • Analysis and problem solving
  • Follow-up and implementation
  • The FMEA as a “Living Document”
V. Explain the role of the Process Control Plan, describe the basic layout of an effective Process Control Plan and explain how to complete a Process Control Plan
  • Basic Entries
  • Effective Control Strategies
  • Effective Reaction Strategies
VI. Construct a Process Flow Diagram and use it to assure thorough analysis of the product process under review

VII. Begin a PFMEA and interpret the results (simulated data or real data, if onsite training)
  • Identification of potential failures
  • Prediction of failure modes and the severity of failures
  • Estimations of the probability of failure occurrence
  • Identification of associated risks and effects of failures
  • Identify, analyze and implement design controls
  • Calculation and interpretation of the Risk Priority Number (RPN)
  • Follow-up and implementation of recommendations
VIII. Employ the Results of the PFMEA to Begin a Process Control Plan
  • A basic template/format
  • Effective control strategies
  • Effective responses
  • Updates