And finally, complete your FMEA education by adding two manuals to your library: the Potential Failure Mode & Effects Analysis manual and the FMEA for Tooling & Equipment manual, your indispensable guides to identifying potential failures before they occur.

Certification by AIAG in APQP/PPAP verifies an individual's proficiency in product quality planning and control plan guidelines, and PPAP submittal requirements as defined in the APQP and PPAP reference manuals.


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The AIAG guideline and the new AIAG & VDA manual both list three cases for the application of the FMEA tools. However, the new manual goes into more detail describing the scope of each FMEA and also includes more detail in describing the third case for FMEA. The cases are as follows:

The AIAG & VDA manual goes into more detail than the previous standard in describing the various circumstances upon which a DFMEA or PFMEA review may be required. The manual indicates that the review can be initiated by design changes, process changes, product recalls, quality issues, non-compliance to regulatory requirements, functional requirement changes, or changes to either the Hazard and Risk Assessment or Threat Analysis and Risk Assessment, and/or lessons learned. There are indeed many circumstances or events that may indicate the need to perform an FMEA exercise.

There are two primary approaches in the application of FMEA. They are the Design FMEA which focuses the analysis on the product functions and the Process FMEA which analyzes the steps in a process. This can be a manufacturing process, or an office of operational process as well. If you really think about it most everything that you do can be described as a process. The AIAG & VDA FMEA manual includes information on both the Design and Process FMEAs but also the FMEA-MSR which is described as a supplemental FMEA for Monitoring and System Response. There is too much information within the manual to cover here. Therefore, our primarily focus will be the DFMEA structure and process along with a review of the new FMEA-MSR methodology.

The new AIAG & VDA FMEA manual introduces a seven-step systemic approach that views the resulting FMEA as a record of the technical analysis. While reviewing the seven steps you will discover that included within many of the steps are tools that we have been employing for robust FMEA development for years. These tools are now imbedded into the seven-step methodology. In addition, the manual encourages organizations to develop foundation FMEAs upon which to build a robust Design and Process risk analysis process. Furthermore, the seven-step approach also includes some new content and a new approach to evaluating and managing recommended actions among other changes. The seven-step approach is as follows:

The new manual includes valuable detailed information regarding topics that should be reviewed and considered early in project planning phase prior to any FMEA activities. The purpose of this discussion is to ensure that you achieve the best results and benefit from the FMEA. The planning stage generally includes determining the scope of the project, the type of FMEAs to be completed (Concept, System, Sub-system, Component, etc.), setting the boundaries of the FMEA analysis and defining the basis for the structural analysis step. The 5Ts of FMEA development must also be taken into consideration during the planning and preparation step. The following is a list of the 5Ts along with a brief description of each topic.

The FMEA team should include members from different disciplines who have the subject matter knowledge and experience to obtain the greatest benefit. The AIAG & VDA manual provides a great deal of information and insight regarding the team members and their various roles and responsibilities.

The seven-step process outlined in the manual clearly identify the tasks and deliverables at each phase of the FMEA development. The team should also be prepared to share information with management at various times during the process.

There are many different software tools on the market that can be used for FMEA development. In some cases, organizations develop their own internal software. In addition, there is always the traditional form-based exercise utilizing the standard spreadsheet method. The manual provides an example of both a software and a spreadsheet developed FMEA.

One of the major changes with the new AIAG-VAD FMEA manual is that the Risk Priority Number or RPN has been eliminated. It has been replaced by the AP or Action Priority process. Where RPN considers severity, occurrence and detection rankings equally SOD which correlates to the new AP system considers first the severity then the occurrence values and so on. The AP tables included in the new manual take all 1000 variations of S, O and D into consideration. The tables assign one of three suggested rankings for each action based upon the S, O and D values. The AP rankings are as follows:

An additional FMEA methodology has also been included in the AIAG-VDA manual. The FMEA-MSR is used to evaluate a systems ability to maintain a safe state of operation and or compliance to applicable regulatory requirements during customer operation. The focus of the FMEA-MSR is the monitoring systems ability to identify faults/failures and the effectiveness of the systems response.

Gregory F. Gruska, a Fellow of the American Society for Quality (ASQ), is presently the COO of Omnex Systems and a principal consultant in performance excellence and Six Sigma Master Blackbelt for Omnex Engineering and Management, Inc. Greg is on the writing committee for the FMEA, SPC, and MSA manuals for AIAG.

When your customer requires a PPAP, they will frequently note a submission level. The exact elements that need to be submitted to the customer will depend on the part and the requirements in the purchase order. According to the AIAG PPAP manual, all elements should be completed. The PPAP levels indicate which documents need to be submitted to the customer, and which can simply be retained by the manufacturer.


Level 1 - Part Submission Warrant (PSW) only

Level 2 - PSW with product samples and limited supporting data

Level 3 - PSW with product samples and complete supporting data

Level 4 - PSW and other requirements as defined by the customer

Level 5 - PSW with product samples and complete supporting data available for review at the supplier's manufacturing location

Prior to adopting a computer-aided quality (CAQ) management system, Schlote was using a heterogeneous information technology (IT) environment on its shop floor along with a number of standalone solutions subject to a relatively high error rate due to the manual and unstructured creation and modification of documents. There was no universal standard at Schlote, so each plant and location was responsible for its own organization.

A large number of standards, methods and systems also needed to be observed and applied on a day-to-day basis. Using manual methods made it almost impossible to comply with standards such as the International Organization for Standardization (ISO) 9000, ISO 14001 and TS 16949/Automotive Industry Action Group (AIAG). And it was nearly impossible to manually apply risk management, continuous improvement process (CIP) and statistical process control (SPC). 006ab0faaa

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