5 Places to Use a FMEA in Your Quality Process

Before any road trip, it makes sense to check your tire pressure along with levels of engine oil, windshield wiper fluid, and coolant.

By doing so, you can avoid some of the most common problems that could leave you stranded on the side of the road.

This is the essential idea behind failure mode and effects analysis (FMEA), a risk management tool prevalent throughout manufacturing.

To dig deeper into how FMEAs work and how companies can use them to mitigate risk, this article explores:

• The basics of FMEAs and how they relate to risk management as a whole
• Five places to use a FMEA within your quality process
• How to use FMEA tools in the QMS to monitor and manage risk more effectively

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What Is an FMEA?

A failure mode and effects analysis (FMEA) is a structured method for identifying possible failure points in a product or process. FMEA is used in industries such as medical device, pharmaceutical, automotive and aerospace manufacturing to proactively identify risks and prevent problems.

FMEA involves analyzing:

• Ways a product or process could fail
• The potential effects of those failures
• The likelihood and ability to detect failures
• Controls to prevent or mitigate product failure

How to Create an FMEA

On a high level, creating an FMEA involves seven key steps.

Steps in creating a FMEA

FMEA and the Risk Management Process

FMEA is a central component of risk management in manufacturing, which broadly involves four key steps aligned with the Plan-Do-Check-Act process.

On the surface, FMEA largely mirrors the risk management process as a whole. That said, there are some key differences in terms of their scope and application:

• Scope: FMEA involves a detailed, technical approach to preventing product and process failures, while risk management looks at a much broader range of financial, operational, and strategic risks.
• Application: FMEA is used at specific points in the process such as product development and process design, while risk management is an ongoing process that involves high-level decision-making.

With that in mind, let’s look at five places where manufacturers should consider incorporating FMEA into their processes to get the most from this valuable tool.

1. Product Design (DFMEA)

The most common place to use FMEA is at the product design stage. Called a design FMEA (DFMEA), this type of FMEA is conducted early on in product development to minimize the risk of design flaws.

FMEA is essential here considering that a large proportion of recalls and product safety failures are the result of product design issues.

Let’s look at a quick example of how an FMEA works. Say you’ve recently updated the design of a consumer electronic device. Your DFMEA would help you identify potential failure modes in the new model, such as:

• Component compatibility issues: How might updated components might lead to malfunction or performance problems?
• Overheating issues: Could the design change affect airflow or cooling functions, potentially causing the device to overheat?
• Software issues: Does the device’s updated hardware introduce any potential software errors?
• Battery life: How could the design changes increase power demands and potentially reduce battery life?
• Assembly problems: Do any physical design changes impact alignment during assembly of the product?

2. Process Design (PFMEA)

Engineers use a process FMEA (PFMEA) to identify and mitigate risks within production processes themselves. Failure modes focus on how a specific process could fail and how that failure would affect the end product.

PFMEA is useful anytime you’re introducing a new technology or updating a process, such as part of a continuous improvement or change control initiative.

An example here would be a PFMEA analyzing assembly of a surgical instrument, identifying failure modes such as:

• Improper sterilization during packaging
• Component misalignment during assembly
• Incorrect calibration
• Seal integrity problems

When creating a PFMEA, sources of risk can be identified by looking at what is called the 6M’s of manufacturing.

Using the 6M’s to build your PFMEA

3. Root Cause Analysis

While people typically think of FMEA as a risk management exercise used at the design phase, it’s also useful in the context of root cause analysis. There are two reasons why:

1. It gives you a pre-defined list of your most likely failure points
2. It helps you determine whether your preventive and detective controls are actually effective for those failure modes.

 For an example of how this works, think about what you would do if your phone stopped charging. First you might examine the charger itself to see if the cord is frayed, looking next to see if the connection point is damaged. From there, you might clean the charging port of any lint or debris before ordering a new charger or seeking additional support.

4. Corrective Action

Revisiting your FMEA after a corrective action is important for several reasons:

• Capturing new failure modes: If your corrective action involved a new process or material, this may introduce new risks that need assessment.
• Validating corrective action effectiveness: Updating the FMEA helps validate whether your corrective action was effective at reducing risk to acceptable levels.
• Regulatory compliance: In some regulated industries, keeping FMEAs updated and current is a compliance requirement.
• Preventing recurrence: Updating the FMEA helps prevent similar issues from occurring or reoccurring by building the lessons learned from corrective action into risk management activities.

As you update your FMEAs, focus on steps such as:

• Reassessing failure modes: In some cases, a corrective action may lead to the discovery of a new failure mode that wasn’t considered previously. For those that did appear on the FMEA, you may need to update its severity, occurrence, and/or detection ratings.
• Documenting new controls: New process improvements and controls should be documented in the FMEA for future assessments, and for recalculating your RPN.
• Reevaluating the risk ranking: Based on new information on failure modes, controls, and RPN you may need to readjust your risk ranking to prioritize new or remaining risks.

5. Complaint Management

Similar to corrective actions, customer complaints can provide valuable insight into where your FMEAs might have gaps. This is because they offer real-world data on failures in the field, allowing you to:

• Identify unexpected failure modes: By revealing issues experienced by customers, complaints can point to risks that emerge under real-world conditions that haven’t been fully evaluated.
• Reevaluate severity ratings: You may discover that the real-life impact of a given failure mode is higher than you originally thought. This would then warrant a higher severity rating and thus higher priority corrective actions.
• Update occurrence ratings: Real-world data on how often a particular failure actually occurs in the field may lead you to update its occurrence rating, impacting RPN.
• Improve detection controls: Customer complaints can sometimes spotlight shortcomings in existing detection methods. If your customers are finding defects before you do, that may lead you to implement stronger detection controls such as increased quality control checks.

FMEA Tools in the QMS

Too often, manufacturers will complete a FMEA, then file it away and largely ignore it. Using FMEA tools integrated in an automated quality management system (QMS) helps avoid this problem by allowing you to leverage FMEA tools at different points in the quality process.

Examples include:

• Linking FMEAs to corrective actions to track risk mitigation activities
• Integrating FMEA into workflows for complaints, corrective actions, and change control
• Making it simple to access FMEAs as part of the root cause analysis process

Centralized reporting and dashboards also allow you to monitor risk across the organization, while maintaining thorough documentation of your risk management efforts.

Conclusion

Rather than a one-time exercise, a FMEA should be a living document that is revisited at multiple points along the quality chain. In doing so, manufacturers ensure that FMEAs are robust and are an accurate reflection of the current risk picture.

A flexible QMS with built-in FMEA tools is vital to this effort, allowing you to leverage risk-based thinking for root cause analysis, corrective action, complaint management, and more.

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About the Author

Stephanie Ojeda is Director of Product Management for the Life Sciences industry at AssurX. Stephanie brings more than 15 years of leading quality assurance functions in a variety of industries, including pharmaceutical, biotech, medical device, food & beverage, and manufacturing.