On April 3, SecondMuse hosted the Risk Management & Assembly Workshop with guest speaker Michael Fornasiero of Empire State Development at CEBIP in Stony Brook, Long Island.  This is the 6th M-Corps event in the workshop series, and the 4th collaboration event with Futureworks, our NYC-focused hardware incubator funded by NYCEDC.

In framing risk management, Michael focused the content of the workshop on Failure Mode & Effects Analysis (FMEA) methodology. In addition, Michael facilitated  breakout exercises to allow participants a chance to take their new knowledge to the page – allowing startup founders time to identify key functions, failure modes, effects, mechanisms, controls, and analysis. Through the use of these activities, participants were ready to take a stab at filling out an FMEA template for their product.

With the FMEA highlights listed below (and a review of Mike’s incredible presentation), you can utilize the FMEA template to analyze your manufacturing process, reduce your risk,  and make important changes before production. This will save you time and money – things startups have little of!

FMEA: From Almost Certain to Almost Impossible
So what is Failure Mode & Effect Analysis exactly? FMEA is a methodology designed to analyze and discover the characteristics of a product or process that lead to failures, which impact performance, safety, or customer satisfaction. Basically, if you haven’t done your FMEA, you’re likely to get into headache-inducing or business-killing trouble. These methods can help product designers and manufacturers determine potential failure modes of systems, the effects those failures may have on the system, how to correct (or at least mitigate), and of course, develop documentation for design and engineering improvements.

There are three main types of FMEA:

  • Design – Focuses on failure modes caused by design which may impact a customer, and requires evaluation and validation to address manufacturability, assembly, service, and end-of-life.
  • Process – Focuses on process deficiencies. Addressing these may aid in the development of control plans as you head toward assembly and begin to tackle safety concerns. Bonus round: Process FMEA feeds the design community information to improve manufacturing.
  • Machinery – Focuses on the machines themselves to improve both design and process as well as reduce breakdown, production loss, lead time changes, and operating costs.

While multiple resources are available online such as the US Government and the Ford FMEA Handbook (every engineer seems to have a copy in their library) to help  identify the formats and standards and how to apply them.

Getting Started: Foundations for Success
While this methodology seems complex, there are straight-foward ways your team can address failure modes.  FMEA is best utilized when the whole team understands the path forward for your product, so be sure to include all of your staff.

Your team must prepare for this exercise with a clear set of requirements, principles, and a set scope of what you plan to accomplish. Some of these may include regulatory and certification concerns, performance benchmarks, safety data sheets, and validation criteria.

The use of language to describe failure modes is very important. By using How, What or Will, and Why verbs in the process, you can focus on the reasons you are product or process is failing, the effects of those failures, and what you can do to fix them. Be specific when defining each step in the process using verbs and nouns. Avoid using words like “allow”, “facilitate”, and “provide” because they are vague. For example, you must consider the component (what failed), the mode of failure (an adjective) and the cause of the failure (the why) – “Bearing seized due to lack of lubrication”.

FMEA in Action: Functions, Failure Modes, Effects, and Mechanisms

Start with identifying Functions. Functions must be measurable and represent a design intent, engineering requirements, or customer requirements. By outlining the function clearly, you can understand the requirements. Examples of Functions you may identify include Basic Functions (primary purpose of product, see your requirements and specs), Interface, Reliability (product life), Product Appeal, Ergonomic & Human Interaction Functions, Design for Manufacturing or Assembly, Legal & Regulatory, safety (during manufacture and use), Installation, Inventory and Fulfillment.

Additional tools related to functions include:

  • Boundary Diagrams – Images that map out functions and interactions that occur.
  • Process Flow Diagrams – Use Excel or Powerpoint to create a diagram that includes purpose, characteristics, and graphics to help leverage your team’s knowledge.
  • Function Trees – Place a mission on the left and build out functions to the right– as the tree grows,  you may identify pathways of failure that compromise customer satisfaction.

Failure Modes – “How”
There are four types of Product Failure Modes to determine how a Product Fails.

  1. No Function: Part/System/Process is totally non-functional
  2. Partial/Over Function/Degraded Over Time: Degraded performance. Meets some of the functional requirements, but does not fully comply with all attributes or characteristics.
  3. Intermittent Function*: Complies but loses some functionality or fails often due to external impacts such as environment.
  4. Unintended Function*: Interaction of several properly functioning elements creates unintended outcomes or consequences. (*Type 3 & 4 Failure Modes are often difficult to capture in the initial FMEA.)

There are four categories of Process Failure Mode that will help you identify how a process fails:

  1. Manufacturing: Dimensions (tolerance), surface finish, etc.
  2. Assembly: Relational, missing part, misorientation
  3. Receiving/Inspection: Accept bad purchased parts, reject good purchased parts
  4. Testing/Inspection: Accept bad process parts, reject good process parts

As you work through the “How”, your team will find yourself looking into Failure Effects  that show you “What or Will” happen to the product or process. As you evaluate these, consider what the failure mode will have an effect on. Operation? Function? Status of subcomponents, assembly, or system? Performance? Safety? Compliance? Any of these factors could also affect noise, erratic operation, leaks, repairs, improper fitting/attachment, damage and wear.  

Failure Mechanisms – “Why”

As you begin to understand more about the failure modes, ask questions about why, how, and what was overlooked– what can be learned to ensure improvement of product or process?  At a minimum, focus on identifying first level causes – the immediate causes of failure. Some examples of failure mechanisms include fatigue, fracture, seal failure, electrical overload, excessive heat/cold, etc. Why would this product fail in this manner?

Criticality, Controls, and Analysis
As you reach the end of your FMEA, begin to look into design flaws that may be causing major failures. You can determine and rank Severity, Occurrence, and Detection for each Failure Mode to help prioritize fixes and establish effective controls. By using these methods, you can prevent the Failure Cause from occurring– reducing the rate of occurrence though prevention should be the focus as it will drive continuous and permanent improvements.

You should aim to detect the Failure Cause or Failure Effect through analytical or physical methods before the product is released from production or before the part is released from a process step. Control Detection is almost always more costly and ineffective than adjusting a design or process around prevention.

Actions, Responsibility and RESULTS!
Finally, why is it important to document the FMEA process and create actionable items, responsible parties, and results? Because actions give us the opportunity to improve the product or process! Through these actions, you can:

  • Revise design geometry or tolerances
  • Revise material specifications
  • Design experiments or other problem solving techniques to refine solutions
  • Develop or revise test plans
  • Adjust redundant systems, warning devices, failure to appropriate modes (ex. fail to off)
  • Validate function or performance through simulation

When assigning responsibilities, place action with appropriate team members and do not overload them. Document actions as they are taken, take pictures of every step, and document dates of effective change. As you note these changes, update the Action Results as this will demonstrate how risk has changed and will highlight new areas of focus.