Failure Modes, Effects and Criticality Analysis (FMECA)
Higher Reliability. Reduced Costs.
Even if your organization has an asset maintenance program to help increase productivity and optimize your assets, a shortage of expertise in the area of asset failure could send your critical risks spiraling out of control.
With Aladon’s expertise in FMECA, we can help you identify potential failure modes for a product or process, assess the risk associated with those failure modes, and carry out corrective measures to address the most critical issues.
The FMECA process is an effective tool for improving designs for products and processes—resulting not only in higher reliability, and better quality, but also increased safety, enhanced customer satisfaction and reduced costs.
FMECA can also be used to establish the need for maintenance programs (for maintainable items) and contribute to quality assurance procedures. It provides a knowledge base of failure modes (causes and mechanisms) and their associated corrective action information that is useful for future training, troubleshooting, Root Cause Failure Analysis, and RCM based maintenance programs.
FMECA is not a specific ISO requirement; however, it does satisfy the definition of Preventive Action as defined in both ISO 9001 and ISO 55001. FMECA is also not a specific requirement of ISO 31000, but it does satisfy the criteria by providing a process for managing risk.
Types of FMECA
The FMECA process is generally applied to the following:
- Design FMECA (DFMECA)
- Process FMECA (PFMECA)
- Machinery and Equipment FMECA (EFMECA)
We do FMECA typically for three reasons: (i) Improving a new design for a product or process, (ii) modifying an existing design or process (assuming there is an FMECA for the existing design or process), and (iii) using an existing design or process in a new environment, location, or application (assuming there is an FMECA for the existing design or process).
Benefits of FMECA
- Increased reliability and asset integrity (right from the start)
- Better safety and environmental integrity
- Improved compliance
- Fewer breakdowns and downtime
- Empowerment through participation
- Risk reduction
Why Perform FMECA?
The objective of an FMECA is to look for all of the potential ways a process or product can fail. A product failure occurs when the product does not function as it should or when it malfunctions in some way. A process failure occurs when the process does not deliver the intended outcome. Even the simplest processes and products have many opportunities for failure.
Failures are not limited to problems with the asset or product because failures also can occur when the operator or user makes a mistake, a failure which should also be included in the FMECA. Ways in which a product or process can fail are called failure modes. Each failure mode has a potential effect, and some effects are more likely to occur than others. The FMECA process is a way to identify the failures, effects and risks within a process or product, and then eliminate or reduce them.
About the FMECA Process
The following steps form the basic framework for performing FMECAs. Depending on the application, and whether it is applied to a new design (DFMECA), process (PFMECA) or equipment (EFMECA) some variations may exist.
- List the functions/process steps. These are from the highest ranking items and can be compared with functional requirements.
- List the potential failure modes for each function/process step. (How can this function, step or process fail?)
- List the potential effects of each failure mode. (How does this matter?)
- Agree and list the severity of the failure mode. (Impact on Safety, Regulations, Environment, Production or Operations)
- Identify the potential causes/mechanisms of each failure mode.
- Determine the occurrence – how likely each cause/mechanism is to occur.
- Identify the controls that are in place for managing this failure (Prevention as well as Detection).
- Rank the effectiveness of preventive and detection controls.
- Multiply the severity, likelihood and detection rankings to determine the Risk Priority Number (RPN).
- Sort by RPN and identify the most critical issues.
- Assign actions to persons and record action dates. Ensure roles and responsibilities are well defined.
- Following the implementation of the action plan, calculate the revised or residual RPN. Evaluate and take further action (if required).
What FMECA Achieves
The application of FMECA results in three tangible outcomes:
- Maintenance and maintenance support recommendations
- Revised operating procedures for the operators of the asset or process
- A list of areas where one-time changes must be made to the design of the asset or the way in which it is operated in order to deal with situations where the asset or process cannot deliver the desired performance in its current configuration
FMECA contributes to improved safety and environmental protection, higher plant availability and reliability, improved product quality, greater maintenance efficiency, longer useful life of costly items, better teamwork and a decision database.
The Aladon FMECA process fully complies with the SAE J1739, AIAG FMEA-4 and MIL-STD-1629A standards.