The table below shows the process breakdowns (presented in FMEA style) that occur if the corrective action system isn’t tightly linked to the FMEA system:
Failure Mode | Effect | Cause |
Problem reports or CARs are classified with the wrong causal codes (problems’ reasons) and/or wrong symptom codes (problems’ characteristics). | Data analysis is inaccurate, leading to lack of confidence in the data and minimal resource allocation. | Code lists are often developed by a brainstorming group, but are seldom correlated to real problems by doing careful analysis of historical data. Code lists are a mess (too many, not well organized, hard to find, redundant, too broad, etc.). |
New failure modes aren’t added to the FMEA when a new problem occurs and is documented in the corrective action system. | Repeated problems happen due to lack of prevention. Lessons learned aren’t effectively implemented even though the information is readily available. | The FMEA is undervalued as a planning and prevention tool. It’s difficult to access the FMEA document—people don’t want to take the time. |
Existing failure modes aren’t updated when a new symptom of the problem manifests itself. | Containment and impact assessments are often incomplete. Because people don’t know all of the symptoms they should be looking for, some things are missed. | There’s no easy way to search for and find a failure mode correlated to a specific problem. In other words, there’s no existing link. |
Containment and impact assessments are often flawed because people don’t know all of the symptoms they should be looking for. | Containment and impact assessments are often flawed because people don’t know all of the symptoms they should be looking for. | Difficult accessibility to FMEAs—there is no easy way to find an existing failure mode that is correlated to a specific problem. In other words, there’s no existing link. |
FMEA occurrence and detection rankings are only guesses. | Data analysis is flawed, which could lead to bad decisions. FMEA isn’t credible, leading to no decision and failure to implement continuous improvement. | There isn’t an easy or objective way (based on real data) to measure the actual occurrence of a failure mode pinpointed to a specific cause. |
Not assessing both the occurrence cause (why it happened in the first place) and the escape cause (how the problem got out the customer or next process) during root cause analysis. | Incomplete problem analysis will result in ineffective or incomplete corrective actions and ultimately lead to repeat failures. | Corrective action system hasn’t been adapted or kept pace with new FMEA methodology requiring both prevention and detection aspects of control. |
The net negative effects include:
- Inaccurate data analysis
- Higher costs because of repeated failures that could be prevented
- Compliance risk because of the dead FMEA syndrome
- Unhappy customer because of repeated quality problems or late deliveries
- Poor credibility for FMEA based on the problems above and perpetual cycle of these effects
There are many opportunities for companies to bring their FMEA’s to life and it isn’t a difficult task as it might seem. The list below is a practical guide to help companies jump-start this seemingly daunting task.
- Develop or purchase an automated software system that automates and tightly integrates the FMEA and corrective action processes.
- Take time with planning and development of casual codes and symptom codes based on detailed analysis of actual historical data of your actual problems. Avoid developing “could be” problem codes.
- Build a database to associate symptom codes to the data in the FMEA “Effects” column.
- Build a database to associate both occur cause code and escape cause codes to the FMEA “Cause” column.
- Have a mechanism to easily look-up and link existing failure modes and associated symptom and causal codes directly to the CAR within the corrective action system.
- Ensure there’s a positive mechanism to trigger an action to develop a new FMEA in case a matching failure mode isn’t found when a problem happens.
The system must have analytical mechanisms to quantify the actual data of problem occurrences associated with a specific failure modes/cause combination so that the occurrence rating and detection ratings are based on real data.
The FMEA is a tool designed to quantify the risk and plan the prevention of problems. To be effectively implemented, there must be a very tight connection to the corrective action system so that the failure mode information is accurate. The cost and frustration savings are enormous when the FMEA lives in thinking and practice.
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