Laura Halleck of Quality Support Group, Inc.

Failure Mode and Effects Analysis (FMEA) is an analytical methodology used to ensure that potential problems have been considered and addressed throughout the product and process development process. Part of the evaluation and analysis is the assessment of risk. FMEA is the most commonly used risk analysis method in the automotive and aerospace industries, and helps manufacturers and suppliers to predict and prevent failures in both the product development and part production processes.

In the Automotive industry, OEMs (US and Europe) have harmonized their regional FMEA manuals into an international guide on Failure Mode and Effects Analysis (FMEA). The revised handbook represents the culmination of a four-year project updating the FMEA process for automotive suppliers. The project was a joint effort between OEMs and Tier 1 supplier members of the Automotive Industry Action Group (AIAG) and Verband der Automobilindustrie (VDA), Germany’s association for automotive manufacturers and suppliers. The result is one common foundation for FMEAs across all global automotive sectors represented by AIAG and VDA.

In addition to making it easier for suppliers to meet their customers’ needs during the FMEA development process, the handbook features major changes such as a new process for FMEA development – the 7-Step Approach. Important changes include the following:

• Totally revised Severity, Occurrence and Detection Tables.
• The Action Priority (AP) methodology and Tables to replace RPN.
• New Form Sheets (spreadsheet users) and Software Report Views (software users).
• Change point highlights from both the AIAG 4th edition FMEA Manual and the VDA Volume 4 FMEA Manual.

Biography:

Laura Halleck;  Senior Quality Management Systems Consultant;  Quality Support Group, Inc.

Laura has over 20 years of experience in manufacturing engineering, quality engineering, quality assurance and process improvement (Six Sigma) for the Automotive, Electronic, and Aerospace and Defense Industries. Her background includes quality system development and implementation, supplier quality management, and internal and second party audits to the following standards: ISO 9001, AS9100, IATF 16949, ISO 13485, ISO 14001.

Laura specializes in guiding organizations through quality management systems certification and maintenance, including gap assessments, systems implementation, training and internal auditing. Her training specialties also include Root Cause Analysis, Corrective Action, 8D Structured Problem Solving, Automotive Core Tools (APQP, PPAP, MSA, SPC, FMEA, and Control Plan), and Aerospace APQP and PPAP per AS9145.

Laura is a PECB Certified IATF 16949, AS9100, and ISO 9001 Lead Auditor and Trainer and has also obtained certification as a Six Sigma Black Belt.

Laura received an M.B.A. from the University of Massachusetts Lowell, an M.S. in Industrial & Systems Engineering from Georgia Institute of Technology and a B.S. in Industrial & Management Engineering from Rensselaer Polytechnic Institute.

Certificates

ISO 14001 2015 Internal Auditor

IATF 16949 2016 Lead Auditor

ISO 9001 Lead Auditor

Certified Trainer

AS9100 Lead Auditor

 ISO 13485 Overview