Quality management professionals in the manufacturing sector know all too well how failure modes and effects analysis (FMEAs) and control plans can positively impact your operations, reduce the cost of poor quality, and decrease the number of defects in your product and processes. But, the concept can be challenging to convey to company stakeholders who may not have as deep of an understanding. So what exactly is FMEA, and how can you leverage it to create a control plan to commit to continuous improvement?
What Are FMEAs?
Failure Mode and Effect Analysis (FMEA) is a continuous improvement mechanism used to identify all possible or actual defects, errors, risks, or failures in a product, process, or service. Once these failures have been identified, they are ranked by the gravity of their consequences, frequency of occurrence, and ease of detection, and, thus, assigned a Risk Priority Number (RPN). In short, the higher the risk, the higher the priority when it comes to resolving the issues.
FMEA should first be implemented during the earliest possible design stages of a product or process and then continuously throughout any redesign processes. The goal of FMEA is to identify critical issues as early on in the development lifecycle as possible to make them easier to mitigate and overcome — this also includes anticipating potential problems. When you can predict what might go wrong with a product, you can plan to address it before it affects your stakeholders and improve its long-term performance and reliability.
What Are Control Plans?
A control plan is an end output of the FMEA process. It’s a written document that contains critical information on how you intend to control, or avoid, the identified risks from the FMEA, starting with those that have the highest priority (as identified by their RPN).
The elements of a control plan include part information, process steps, methods of control, measurements, inspections, and quality checks. Control plans, like many of your quality records, are a living document that you will revise and edit over time as you refine your quality processes or change your product or process, including its characteristics, specifications, design, control methods, or integrated systems. At their core, control plans allow your company to reduce production waste and maintain consistency, so identified issues don’t snowball into something more detrimental.
Where Do FMEAs and Control Plans Fit into the APQP Process?
Advanced Product Quality Planning (APQP) is a structured process to ensure quality and customer satisfaction from conception through manufacturing. APQP is important because it provides a framework for developing, producing, and maintaining quality products that satisfy the consumer.
APQP has five key phases:
- Product Planning and Quality Program Definition
- Product Design and Development
- Process Design and Development
- Product and Process Validation
- Product Launch, Assessment, and Improvement
Of those five phases, FMEAs apply directly to Phase 2 and Phase 3. In Phase 2, Design Failure Mode and Effects Analysis (DFMEA) is used, which ensure defects are addressed, root causes are identified, and preventative actions are in place for the product design and development phase.
In Phase 3, Process Failure Mode and Effects Analysis (PFMEA) is used, which addresses the potential failure modes in production processes to ensure everything is in place for productivity, efficiency, and consistent quality. As mentioned above, once the defects from the DFMEA and PFMEA are identified, a control plan can be created and implemented to fix those identified issues.
Why Use FMEAs?
While it may be clear that FMEAs can have significant benefits to your quality processes, it is worth noting that there are major quality risks to not implementing FMEAs as you introduce new products or adapt existing ones.
The overarching goal of FMEAs and control plans is to proactively identify, mitigate, and address risks before they happen, which every company can benefit from. Having the ability to catch failures before they have a significant impact on your manufacturing operations means that you can reduce potential threats, improve product reliability and quality, and increase customer satisfaction. Mitigating, eliminating, or reducing these risks also means quicker production time, and thus, a faster turnaround to launch a new or updated product.
Furthermore, implementing FMEAs in your operations can substantially reduce the cost of quality. Rather than waiting until your system breaks down completely, fixing failure points incrementally as they are identified or anticipated can eliminate the risk of a complete assembly or production shutdown.
FMEAs can also improve safety. The ability to identify and anticipate parts that may become outdated or are at the end of their natural lifecycle can mean less risk and safer equipment for your employees who use or service the equipment.
FMEA/Control Plan Software
Manual methods of tracking revision histories to living documents make APQP a cumbersome task, especially for quality managers that simply do not have the time to track down improperly filed documents from several years ago. In an ideal scenario, changes to one APQP document should trigger an alert that reminds you to revisit the subsequent or previous steps in the APQP cycle.
That’s where having a streamlined and automated solution for your APQP processes is beneficial. FMEAs and control plans improve when you can manage all the necessary APQP documents (flow diagrams, FMEAs, and control plans) in one holistic enterprise quality management solution.
Think of a scenario where your company adds new machinery to the shop floor. If you have a sound APQP software in place, you will be able to anticipate the changes you need to make to FMEAs and control plans to accommodate updated production processes.
Since APQP is a continuous process that contains various elements, having a centralized location for your processes provides you the benefit of having a broader, enterprise-wide perspective on quality. IQS provides a solution to the APQP puzzle by offering process flow software, FMEA software, and control plan software solutions. As a result, using these modules within our enterprise quality management software (EQMS) can allow for reduced risk, increased productivity, and reduced costs while meeting your quality standards. Contact IQS today to learn more or to request a demo of our EQMS.