How do you update and review FMEA regularly to capture changes and feedback in your Kaizen cycles?

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Failure Mode and Effects Analysis (FMEA) is a tool that helps you identify and prevent potential problems in your processes, products, or services. It helps you prioritize the risks, assign responsibilities, and take corrective actions. But FMEA is not a one-time activity. You need to update and review it regularly to capture changes and feedback in your Kaizen cycles. Kaizen is a philosophy of continuous improvement that involves everyone in your organization. Here are some tips on how to keep your FMEA current and effective in your Kaizen journey.

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1 Define the scope and frequency

Before you update and review your FMEA, you need to define the scope and frequency of your activities. Depending on the complexity and criticality of your process, product, or service, you may need to update and review your FMEA monthly, quarterly, or annually. You also need to decide which parts of your FMEA need to be updated and reviewed, such as the functions, failure modes, effects, causes, controls, ratings, actions, or results. You can use a checklist or a matrix to help you plan and track your FMEA updates and reviews.

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Timothy Milliman

Manufacturing Quality and Continuous Improvement Leader
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In order to make a solid contribution to a process FMEA, you need to understand the process really well. Any Process or Manufacturing Engineer worth their keep, should already have a mentality that considers severity, occurrence, and detection of fail modes. For this reason, I have always found PFMEA to be nothing more than a communication tool to allow people who don't know the process well where the biggest risks are. FMEA does not improve the process. That is done in problem solving events where again it is usually the process experts who make the most significant improvements. It amazes me when some people think preparing a FMEA will in itself make the process better. A process expert will already know where these biggest risks are.

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Rafael Pozos

Problem Solver | Risk Management Practitioner | Regulatory Affairs| Sr Quality Engineer| Cybersecurity| Project Manager|Deficiency Remediation| Medical Device | FDA | ISO 13485| ISO 14971| IEC 62304| Process Improvement
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As a default for this, I recommend a quarterly cadence for FMEA updates. Frequent enough to catch changes to your product, developments in the field post market, etc. but not so much that it puts an onerous burden on the organization. As your organization grows and your product or services stabilize, you can look to switching to a different frequency.

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2 Collect and analyze data and feedback

The next step is to collect and analyze data and feedback from various sources that can affect your FMEA. These sources can include customer complaints, quality audits, process performance indicators, defect reports, change requests, or suggestions from your team members. You need to use data analysis tools, such as Pareto charts, histograms, or control charts, to identify the trends, patterns, or outliers in your data and feedback. You also need to verify the accuracy and validity of your data and feedback before you use them to update and review your FMEA.

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Rafael Pozos

Problem Solver | Risk Management Practitioner | Regulatory Affairs| Sr Quality Engineer| Cybersecurity| Project Manager|Deficiency Remediation| Medical Device | FDA | ISO 13485| ISO 14971| IEC 62304| Process Improvement
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This is absolutely essential. You need to know what is happening and how often. This is another role the FMEA coordinator or facilitator can play in the organization. They are in a unique position to monitor complaints coming in as well as feedback from auditors, etc. to make the changes necessary to improve.

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3 Update and review the ratings and actions

Based on the data and feedback you collected and analyzed, you need to update and review the ratings and actions in your FMEA. The ratings are the numerical values that represent the severity, occurrence, and detection of each failure mode. The actions are the corrective or preventive measures that you take to reduce the risk of each failure mode. You need to compare the current ratings and actions with the previous ones and see if there are any changes or gaps. You also need to use a risk priority number (RPN) to rank the failure modes and prioritize the actions.

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4 Implement and verify the actions

After you update and review the ratings and actions in your FMEA, you need to implement and verify the actions. You need to assign responsibilities, resources, and deadlines for each action and monitor the progress and status of each action. You also need to verify the effectiveness of each action by measuring the results and outcomes. You can use tools, such as run charts, scatter plots, or fishbone diagrams, to evaluate the impact of each action on the failure mode, effect, cause, or control.

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5 Communicate and document the changes

The final step is to communicate and document the changes in your FMEA. You need to share the updated and reviewed FMEA with all the relevant stakeholders, such as your customers, suppliers, managers, or team members. You need to explain the rationale, benefits, and challenges of the changes and solicit their feedback and suggestions. You also need to document the changes in your FMEA using a standard format, such as a spreadsheet, a software, or a template. You need to keep a record of the history, version, and date of your FMEA for future reference.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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Rafael Pozos

Problem Solver | Risk Management Practitioner | Regulatory Affairs| Sr Quality Engineer| Cybersecurity| Project Manager|Deficiency Remediation| Medical Device | FDA | ISO 13485| ISO 14971| IEC 62304| Process Improvement
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One time, my committee and I were working on a medical device that we didn't think was susceptible to defibrillation, yet might have been. A similar device we were evaluating was susceptible due to EKG leads and failed the test for not shunting current in the event of a defibrillation shock -- rendering it ineffective. It came up because there was no warning printed on the device to remove before defibrillation. Since we knew the FDA would come after our devices without EKG leads, we used our FMEA process to quantify the risk of defibrillation to the patient with those devices, found it unacceptably high, and alerted senior leadership.

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Craig Standing

Quality Manager at Barnes Aerospace
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I really enjoyed your insight on FMEA as a tool for continuous improvement. Additionally helpful is to update Master FMEA if applicable to drive lessons learned from FMEA Kaizan. Another leg for Prevent Recurrence. Assurance to be driven into new product launches with similar technologies and risk.

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How do you update and review FMEA regularly to capture changes and feedback in your Kaizen cycles?

1

2

3

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5

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1 Define the scope and frequency

2 Collect and analyze data and feedback

3 Update and review the ratings and actions

4 Implement and verify the actions

5 Communicate and document the changes

6 Here’s what else to consider

Failure Mode and Effects Analysis (FMEA)

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