Risk Management and FMEA Tool Example

Risk Management and FMEA Approach

We walk through the use of the Failure Mode Effects Analysis (FMEA) tool used as a risk register that we can use for our project risk management. Using this approach we can uncover, assess, and plan our risk response actions in one sheet. That includes identify our control or mitigating actions and ascertain the amount of influence or degradation of risk has theoretically happened as a result of our work. The tool is also set up with specific metric and values to identify when the risk is imminent, and a specific person to monitor this particular risk as we know if everybody is responsible, then nobody is responsible. There is even a column for the monitoring.

The template is a downloadable and is found by clicking this link https://www.valuetransform.com/downloads/


FMEA Flashback!

By Jon M Quigley

We have discussed the Failure Mode Effects technique a few times in the past.  Though Failure Mode Effects and analysis seems to be a powerful tool, the problem is you do not know if the FMEA is effective and perhaps you will never know.  The Failure Mode Effects Analysis tool, theoretically, allows us to critique the product before we test.  How do we prove something did not happen because of a well conducted FMEA?  I have seen failures arise in testing and post launch.  In both instances I found it difficult to believe we missed the issue in the development or testing work as the failure seemed obvious.  I would later discover the FMEA was either missing or performed with a check box mentality, both of which are poor execution and not necessarily a testimonial of the apropos of the technique.  Of course this is only anecdotal evidence.

For me the real benefit is when we … Continue reading

Manufacturing Quality Assurance Activities

Manufacturing plays a BIG Role in Product Quality

We have spent some energy on the development of the product design, discussing the sorts of activities we will undertake to assure the product quality.  A quality design without the ability to produce the desired quality product is one-half of the solution.  Therefore, just like our design specific activities we have actions we take to mature the manufacturing line, assess the capability, and continue to grow the line capability.

Manufacturing Quality Activities

A few examples of the types of activities that happen during the manufacturing are[1]:

Packaging Process Failure Mode Effects Analysis Floor Plan Layout Process Flow Chart Work Station Instructions Poke Yoke Gage Repeatability and Reproducibility Run at Rate Trial Production Runs Measurement System Analysis Process (Production) Verification Control Charts Manufacturing Activity and Quality and Risk

Each of these activities has a particular objective or risk mitigating benefit.  Packaging ensures we can deliver the product from the point of … Continue reading

Asking for More Late in the Project

Asking for more…

Recently, I overheard a project manager discussing the use of a quality tool for their project. The project is well underway. Can you guess the tool under discussion?  It was the DFMEA or Design Failure Mode Effects Analysis.  There are a couple of things wrong with starting the discussion at this point, but let’s start with the FMEA itself.

Project and FMEA

The DFMEA (also has a cousin for manufacturing processes called the PFMEA) are a couple of the tools from the APQP (Advanced Product Quality Planning) suite. The FMEA provides a structured review or critique of the proposed product design or in the event of the of the PFMEA the manufacturing processes. I will not go into details on the structure of the FMEA, if you are interested give us a call. We can coach your team. It is sufficient to know that this is a well structured and planned activity.  We draw upon … Continue reading

Fundamentals and the FMEA

We have recently had a discussion on what it takes to quality assure software. The discussion focused on FMEA and the role it plays in quality assurance.  The discussion began to sound as if the FMEA was the panacea for poor quality. There is no silver bullet.

To be sure the FMEA (which is essentially a design review) helps, but is not the only thing we can or should do to secure the quality of the software product.  Like many things, you get out what you put into it.  A poorly executed FMEA (the amount of time, rigor, and skill that we put into it) will produce poor results and likely be a time consuming activity with little return.

While FMEA’s are typically more focused upon the hardware (DFMEA) or process (PFMEA) the tool can also be used on Systems level and even Software application.  We have even turned the FMEA methodology into a Project Management Risk Evaluation tool (see … Continue reading

FMEA to the nth degree

We have been on a bit a tear (or rant) about FMEAs. We suggest the FMEA documentation is part of the core of a design process. The ultimate approach we have seen is that of Michael Anleitner (The Power of Deduction: Failure Modes and Effects Analysis for Design, Quality Press, 2010), which uses functional analysis system technique (FAST) among others to greatly amplify the capability of the FMEA to eliminate mistakes before they happen.

Another way to improve our likelihood of proceeding without failure on a variety of fronts is to use the FMEA approach rigorously in all areas: purchasing, accounting, manufacturing, engineering, human resources, and any other department we may have. If it works for manufacturing, why wouldn’t we expect it to work in other venues? We can even develop an FMEA for FMEAs, since many of the drawbacks are well known.

We at Value Transformation LLC use a variety of tools, some of them quite simple to use, … Continue reading

FMEA and Design Reviews

We submit that a Failure Mode and Effects Analysis (FMEA) review is a form of design review. After all, one of the purposes of a design review is to try and remove defects before they appear in the product and that is the entire rationale for the FMEA in the first place. Yet, most of the time, the design reviews we have attended did not even attempt to review the product or module FMEAs, thus limiting the value gained from the design review.

We must ask ourselves, what is the purpose of a design review? Do we sit there like zombies and rubber stamp approve the spiffy slide show we just attended or do we put some teeth in the review and start asking the hard questions nobody wants to deal with.

Of course, a design review can also include schedule and cost considerations in addition to the quality issues. The FMEA review doesn’t eliminate that and we should add … Continue reading

Lessons Learned and the FMEA

We addressed the issue of the modular FMEA in a previous blog. We also suggest that the FMEA in its various guises is also a great place to capture lessons learned. In the medical, aerospace, automotive, and food industries, some kind of FMEA is a required document. Since we already must create these documents, why not leverage our work into a tool for capturing everything we have seen happen to a specific module. For example, with gauge-driving stepper motors, we could capture all failure modes seen to date. Every time a new failure mode we didn’t anticipate occurs, we can update the modular FMEA so we don’t lose the knowledge we should have gained from this negative experience—not to mention, we pull something positive out our impromptu and unexpected investment in fixing the problem

We can also apply this approach to services. We have rarely seen a service FMEA mentioned in the literature, but we see no reason why most … Continue reading

Modular FMEA

A modular FMEA is a modification of the standard Failure Mode and Effects Analysis tool into meaningful components. For example, we can select “stepper motor” as a component of a typical instrument cluster used in the dashboards of truck and autos. We would then create our FMEA to deal with all issues related specifically the stepper motor.

How would we expand our FMEA to include the entire instrument cluster? We do this by creating a more difficult version of the FMEA called the System FMEA or SFMEA. A system FMEA is really an analysis of failure modes related to the inputs and outputs of the component systems (subsystems) of the larger concept. By the time we get to the dashboard itself, we should have a hierarchy of component and systems level FMEAs that cover the entire product.

Why do the modular FMEA? A modular FMEA allows us to transfer selected modules to the next product, a product which may only … Continue reading

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