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Merging the Process Map, FMEA and Control Plan

\n\n

A Hybrid Approach

\n\n

Steve Burkhart

\n\n

hybridfmea@gmail.com

\n\n

Abstract

\n\n

This document explores the development and interaction of the Process\nMap, FMEA, and Control Plan as a single document, and outlines a novel\napproach to its creation. The ideas expressed here are the result of my\npractical experience over the years in using these documents, and my\nrecommendations for improving them for ease of use and maintenance.\nThese documents are traditionally formatted to exist as separate,\nstand-alone entities, fitting on an 8½” x 11” sheet of paper, which is\ninherently an isolating condition, creating opportunities for\ndiscontinuity and difficulty in implementation. Merging all three forms\ncan both speed their completion and act as an effective error-proofing\nmeasure, helping to eliminate inconsistency between elements.

\n\n

Keywords: Process Map, Process Flow, Failure Mode Effects Analysis\n(FMEA), Control Plan, Pre-Production Approval Process (PPAP), Advance\nProduct Quality Planning (APQP), Automotive Industry Action Group\n(AIAG)

\n\n

Introduction

\n\n

Today, many industries require the effective implementation of APQP to\nmake sure that the delivery of goods and services are planned for and\nexecuted in a way that meets their customer’s requirements for timing\nand quality. Cross-functional teams determine how specific customer\nrequirements can be met by creating a process flow chart, next the FMEA\nthat identifies the risks in product realization, and finally the\nControl Plan that demonstrates the specific measures the organization\ntakes to ensure that the risks are mitigated and that defective units\nare not delivered to the customer.

\n\n

If you are a Manufacturing Engineer or a Quality Engineer, you have\nprobably been involved with developing these documents in a team\nsetting, but often times in isolation, which is frequently the case when\ndeadlines are looming and it is “All hands on deck!” Perhaps you have\ngone into a Control Plan development meeting, with printed copies of the\nFMEA for the participants, or you had to bounce back-and-forth between\nthe electronic Process Map, the FMEA, and the Control Plan, while\nviewing them projected upon the conference room screen, unable to see\nthem all at the same time. And why is it that we live with this juggling\nact? Admit it, if this were a production setting and an operator needed\nto have multiple sources of data available simultaneously for quick\nreview, the Manufacturing Engineers and the IT folks would a have\ngraphic user interface dangling at eye level with color coded data\nfields on a touch screen. So why is it that the very people who plan and\nexecute the design and implementation of manufacturing processes,\nconstrain themselves by the size of a sheet of paper?

\n\n

You may be wondering what the size of a sheet of paper has to do with\nProcess Maps, FMEAs and Control Plans, but it is this very thing, this\nlimiting phenomenon that once shackled to our imaginations, robs us of\nthe ability to see new ways of doing things. Paper is sized for what is\nmost universally needed by the market that utilizes it. People want\npaper that when bound together is of a convenient size and weight to be\nused, carried, and stored. When computers were put into mainstream use,\nthey were used to help simplify and streamline the creation and use of\ndigital records and processes. People took their paper forms and\nduplicated them digitally. The monitors that we use to display them,\nwhile having modestly increased in size over the years, in effect have\nbeen made to replicate a “page” of useful data or images.

\n\n

Problem Statement

\n\n

We know that the FMEA must follow the steps of the Process Map, and the\nControl Plan must match the FMEA, line-by-line, otherwise we have not\ncreated a seamless plan for ensuring that the requirements of the\ncustomer are met. Knowing all of this, why are these three documents\nseparate documents? By separating them, but requiring 100% agreement, we\nare knowingly accepting the risk that we are sowing the seeds of\ntrouble. Have you ever had an auditor find a specific failure mode in\nyour FMEA that had no corresponding line in the Control Plan? Have you\never noticed that all of the steps of a particular Process Map were not\nquite reflected in the FMEA? How about discovering that because of\nunrealistic time constraints, under-staffing, or a combination of both, the FMEA was just a rough summary of the main processes,\n and the Control\nPlan was a gaping breach in the wall, ignoring many significant steps\nand risks? More times than I care to admit, I have seen desperate people\ndo desperate things, creating three separate documents that could not\ntalk to each other, but they were honestly able to say, “The FMEA (or\nControl Plan) is done!”

\n\n

Solution Approach

\n\n

What if each line of the Process Map was shared by the corresponding\nlines of the FMEA and Control Plan? Yes, that does seem like too much\ninformation all in one place. At first blush, your assessment would be\nthat there is no way to do that, because the row would run too far off\nthe right side of the monitor, requiring too much horizontal scrolling,\nand in order to see the entire form, the zoom level would have to be so\nhigh that the text would appear nearly microscopic. According to the\nstandard AIAG formats, that would be the case, but if we were both\ncreative and selective with the data we chose to display and the manner\nin which we displayed it, I believe there is a method to merge the\nProcess Map, FMEA and Control Plan, so that they are effectively usable\non one screen, and if so desired, able to be printed as one effective\ndocument.

\n\n

There are many benefits to this type of arrangement. You would\nimmediately notice that you would not have to refer back and forth\nbetween multiple documents when working in this format. This would\nespecially be a blessing when creating the FMEA and the Control Plan,\nbecause the “source material” needed to proceed is right there in-line\nfor you to reference. Another benefit is that it delivers on the\nrequirement for consistency throughout all three documents; as long as\neach line is complete, you know that you have delivered something\nseamless; this is a huge advantage over other methods! If you were to\nutilize this convention, gone would be the days of needing to have two\nor three separate documents open at the sametime in order to perform a\nline-by-line check.

\n\n

Here are the typical column headings used in most FMEAs and Control\nPlans:

\n\n

• Operation Number

\n\n

• Process Function

\n\n

• Process Failure Mode

\n\n

• Potential Effects of Failure

\n\n

• Severity

\n\n

• Class

\n\n

• Potential Causes of Failure

\n\n

• Occurrence

\n\n

• Current Process Controls

\n\n

• Detection

\n\n

• RPN

\n\n

• Machine, Device, Tool, Jig for manufacture

\n\n

• Characteristic Number

\n\n

• Product CharacteristicProcess Characteristic

\n\n

• Special Characteristic Class

\n\n

• Sample Size

\n\n

• Sample Frequency

\n\n

• Control Method

\n\n

• Reaction Plan

\n\n

• Recommended Actions

\n\n

• Responsibility and Target Completion

\n\n

• Actions Taken

\n\n

• Severity

\n\n

• Occurrence

\n\n

• Detection

\n\n

• RPN

\n\n

You may be wondering what is wrong with that list. I tucked the Control\nPlan (sans “Part/Process Number” and “Process Name/Operation\nDescription”) right in the middle of the FMEA. In order to merge the\nthree documents, it is useful to remove redundant columns, but not\nmandatory. When using this hybrid document format to complete the FMEA,\nit may be advantageous to use the spreadsheet “hide” function to remove\nthe Control Plan from view, and then “unhide” it to complete the Control\nPlan. Also, this gets the FMEA improvement section out of the way while\nworking on the Control Plan.

\n\n\n

\n\n\n

Control Plan Visible

\n\n\n

\n\n\n

Control Plan Hidden

\n\n

The benefits to this hybrid format are readily apparent to anyone who\nhas had to create and maintain separate documents before. Begin the\nProcess Flow by populating the “Operation Number” and “Process Function”\ncolumns with the FMEA. Create the FMEA by inserting additional rows\nwithin the Process Flow. Create the Control Plan by reading across the\nFMEA, ensuring that the controls you establish are specific to the\nfailure modes identified within that same line.

\n\n

Conclusions

\n\n

No special software is needed to implement this method; use your\nfavorite spreadsheet program
It is more difficult than the standard methods, to have logical\ndiscontinuity between elements
Editing and building a completed document is streamlined because:\n
- You can copy and paste whole lines, or entire operations
- No switching is needed between documents
\n
The completed document prints conveniently in landscape view on\n11”x17” paper
Auditing is simple and straightforward

\n\n

I hope that this out-of-the-box approach to Process Maps, FMEAs and\nControl Plans is helpful to you and to your organization.

\n\n

References

\n\n

AIAG Production Part Approval Process

\n\n

www.aiag.org

\n\n

\n\n","tocStructure",[],"publicChapterContent","nextChapter","sections",[],"routes/_store+/_layout","routes/_store+/_readers+/_layout","actionData","errors"]

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