Using FMEA to Manage Risk Under IATF 16949
Although FMEA’s have long been a part of IATF 16949, now that IATF 16949 is meant to be implemented as an adjunct to ISO 9001, the mandate to apply risk-based thinking (RBT) also applies to automotive quality management systems using this standard. While ISO 9001 has essentially replaced the concept of preventive action, IATF 16949 keeps this concept but focuses it on the Quality Management System (QMS) planning stage (as they have with the older TS 16949 standard’s concept of contingency planning). In other respects, the new automotive standard fully embraces RBT, allowing more expansive approaches so accomplish it. FMEA is still a key risk management tool – now more than ever.
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What is FMEA?
FMEA stands for Failure Mode Engineering Analysis. FMEA is a type of risk assessment that uses a step-by-step approach to identify potential failures in a design, process or a product or service. This identification allows for analysis to prevent or reduce future failures. It is a tool typically used by Engineering and/or Quality that identifies and quantifies risk associated with potential product and process failures. This shows how to analyze product or a process to mitigate risk. FMEA also helps to redesign the processes so that the possibilities of failures are eliminated. (FMEA is embedded within the Six Sigma methodology and it can help detect errors in the development of processes or services, thus reducing development time and costs.)
“Failure modes” refers to the ways in which something can fail. “Effects analysis” refers to the scrutinizing of the consequences of each of those failures. FMEA is a preventative action, meant to be implemented before a process or product is designed, modified or applied in a new way. It’s also wise to use FMEA periodically throughout the life of a product, process or service.
Learn more about FMEA with this tutorial:
Definition of a Process FMEA
Process Failure Mode and Effects Analysis
- Analytical technique typically lead by process responsible engineer
- Means to ensure that potential failure modes and their causes are considered and addressed
- Manufacturing, assembly, engineering team summarizes items that could go wrong as a process is developed. It formalizes the mental discipline that should be used in planning any manufacturing process.
Objectives of a PFMEA
- Identify steps of product realization, their requirements & purpose
- Identify potential (product & process) related failure modes.
- Assess the effects of failures on the customer
- Identify manufacturing assembly process causes & process variables on which to focus controls.
- Prioritize controls for occurrence reduction or detection of the failure conditions.
Objectives of a PFMEA-continued
- Rank the list of failure modes for corrective/ preventive actions.
- Document the analysis of:
- Inputs to the PFMEA from the Design FMEA, Manufacturing Process Flow, and list of product characteristics
- Results of investigations in related activities
- Provide basis for Continual Improvement in Product & Process
Process FMEA development step in Advanced Product Quality
Inputs to Process FMEA
- SAE, AIAG FMEA Reference Manual or customer specific requirements
- Characteristics Matrix
- Design Matrix
- Design FMEA
Customer & Process Related Inputs:
- Warranty information
- Customer Complaints and Returns Data
- Results of Corrective or Preventive Actions
- Process Flow Document
- PFMEA for similar products or processes
- Internal data: scrap, failures, rejects, test results
The Process FMEA examines each operation
- by identifying potential product-related process failure modes, which can be quality related or reliability related
- assessing potential effects of failure
- identifying process control variables for prevention and/or detection of failure conditions
- suggesting recommended actions for improving controls or eliminating causes
Outputs of a FMEA
- a list of potential process/part failure modes
- a list of potential significant process characteristics
- Input to a control strategy to effectively manage the risk
- a list of process improvement actions
Recommended Actions to Reduce Risk
Error-Proofing Control Functions
- regulatory control methods
- regulatory warning methods
- contact methods
- fixed value methods
- motion step methods
Reduce or Eliminate Occurrence
- product redesign
- process redesign
- error-proofing Control Systems
- source inspection
Recommended Actions to Reduce Risk Continued
Improve the control:
- successive check
- self check
Reduce severity ranking
- Design in product and/or process change
Keys to FMEA Team Success
- Support by management
- Scope not too large
- Objectives well defined
- Objectives considered relevant and significant
- A measurable for success identified
- Team sized for the task
- Time allotted for analysis and improvement
- Effective training
- Activity integrated with organization’s development process
- Input information and data are available
What Does FMEA Accomplish?
FMEA helps companies identify and prioritize failures according to how serious their consequences are, their frequency, and the ease with which they can be detected. The purpose of conducting an FMEA is to take action to reduce or eliminate each potential failure. FMEA documents existing knowledge and actions companies are already using in their continuous improvement process and can be used to prevent potential failures with future processes and products. The results of a risk analysis are documented in an FMEA worksheet where they are used to help plan preventative measures, resulting in the production of safer automotive systems.
Resources for interpreting and documenting risks:
Where FMEA Can be Applied…
FMEA can be applied to other specific areas such as planning, testing/evaluating concepts, improving in-field reliability, software functioning and security, hazard analysis, human factors and service-based analysis, business processes and more. Preferably FMEA is used throughout the life cycle of the product or service.
The advantages of FMEA typically far outweigh the time and energy it consumes to pursue the process, including:
- Improving the overall quality, reliability and safety of a product/service/process
- Approaching the problem to prevent rather than correct later
- Reducing the cost of quality of product/service and system development time frames
- Catching potential errors early in the product life cycle
- Reducing warranty costs
- Improving company brand image and in turn share/ownership value
(See FMEA courses available for only $69 for full 8-hour course)
There are three major types of FMEAs:
Source: Effective FMEAs by Carl Carlson, John Wiley and Sons, publisher.
Similarly, the effects of this type of analysis is used to anticipate the effect of a given failure. Here’s an example using a component of a construction tool, in this case A pile driver which a typically large scale-device used to force support shafts/girders/poles into the ground, often as a foundational support for buildings, highways, bridges or similar structures.
|Pile driver main plunger|
|To provide vertical force to insert the desired object into soil at the desired depth and angle with the desired positional retention over time.|
|Main plunger contact facing with driven element cracks or fractures.|
|The plunger shaft no longer contacts the driven element correctly causing damage to the element or the plunger shaft|
|Plunger shaft jams and can no longer provide vertical movement|
|No elements (poles/girders/support shafts) can be driven into the ground|
|The driven element is deflected from the desired angle.|
Buy FMEA-related resources:
- FMEA-4 – (2008)
Potential Failure Mode and Effects Analysis (4th Edition)
- IAQG Core Tools Forms on CD – 2008
Supplier Forms for APQP, PPAP, FMEA, etc., Version 5.0
FMEA is a living document that can be constructed, adapted and modified in a variety of different ways. Below is a summary of the steps included in an FMEA analysis:
- Select a process to analyze.
- Identify individuals from all departments with specific knowledge of processes, products and client needs to brainstorm potential failure modes.
- Describe the process and/or product in detail.
- Identify all potential failures. This includes all of the components, systems, processes and functions that could potentially fail to meet the quality or reliability standard and the potential causes.
- Identify all the potential consequences of each failure.
- Assign a severity rating (S) to each failure according to the significance of the impact it has. Severity is often ranked on a scale from 1 to 10, one being insignificant and 10 being catastrophic.
- Identify all possible root causes of each failure. Some companies use cause analysis tools in addition to the knowledge and experience of their staff.
- Assign each cause an occurrence rating (O). This is often rated on a scale of 1 to 10, with 1 being rare and 10 being inevitable.
- For each cause, identify current process controls that are in place to prevent these failures from impacting customers.
- For each control, assign a detection rating (D) to determine how well the controls are able to detect the cause or failure mode once they have occurred, but before a customer is affected. This is typically rated on a scale of 1 to 10, with 1 meaning the problem will be detected with absolute certainty and 10 meaning the control will most likely never detect the problem.
- Determine a risk priority number (RPN) based on the rankings (SxOxD) for each potential failure and rank them.
- Plan and implement changes to address the failures based on the RPN identifications.
- Measure and document the success of each process change.
Continuous improvement is a key element of the FMEA process in recording observed data and results regarding the potential for, and actual, failures. This process can be used as an input for the continuous improvement mandated by IATF 16949.
- FMEA Risk-Management Software
- FMEA Risk-Management Training
- Risk Management Exercise
- IATF 16949 Suggested Problem-Solving Skills
- ISO 31000 Risk Management Principles and Guidelines
FMEA database software can help companies easily manage the FMEA process. Sunday Business Systems’ FMEA software makes it easy to develop an efficient Quality Management System (QMS) and implement risk-based thinking required by IATF 16949. This collaborative, intuitive program helps companies identify and address failure modes and visualize data from each FMEA analysis.