The high profile recall of the Samsung Note 7, after a series of battery failures and fires, demonstrates the damage that can be caused when a product fails to meet the customer’s expectations. Although most problems attract less publicity, many organisations are struggling to deliver projects on time, – or achieve targets for cost, quality and delivery, because they failed to anticipate, prevent, detect or mitigate problems that are discovered late in development or after product launch. So what is Failure Mode Effects Analysis?
It’s a particular form of risk assessment, developed to address this problem by:-
Analysing how a product or process may fail to satisfy the design requirements, and assess the unintended harm, loss or injury that may be caused when it fails
Investigating and documenting the potential causes of product or process failure
Evaluating the existing controls intended to prevent, detect and mitigate the potential causes of failure – avoiding any actual harm
Identifying and prioritising actions required to improve the product or process design, reducing or eliminating the possibility of failures that may disrupt the manufacturing supply chain, cause customer complaint – or result in a product recall and litigation
As a project progresses from concept design – through development – and into production the cost of change escalates rapidly, and it may become more difficult to acknowledge that the design or process in not ‘fit for purpose’ in its current form. By identifying potential problems early in the development cycle, the FMEA reduces the need for late changes, accelerating the development process and improving initial product quality.
Failure Modes Effects Analysis can be applied at several stages of development, using a common approach to achieve subtly different objectives:-
The System FMEA (S-FMEA) is used to develop the product specification, ensuring that the design concept satisfies all legal and market requirements, and that various component systems are correctly specified. The System FMEA also identifies ‘acceptance criteria’ for components and subsystems and the need for fail-safe devices to give the user adequate warning of known ‘failure conditions’.
The Design FMEA (D-FMEA) examines how the proposed design could fail to satisfy the specification and satisfy the user requirements. The outputs from the D-FMEA may include recommendation to change or improve the design, or the use of ‘controls’ to prevent and detect ‘errors in the design’ – so that are identified as early as possible in the development process.
The Process FMEA (P-FMEA) examines how variation, errors or omissions in the manufacturing process could cause the product to fail or disrupt the manufacturing supply chain. This may prompt changes to the product design to simplify and error proof the process – or the introduction of ‘controls’ to prevent and detect unintended changes and variation in the manufacturing operations. The Process FMEA therefore drives the creation of an effective process control plan – and minimises scrap and rework in the manufacturing operations
The purpose of the FMEA’s is to identify necessary improvements in the specification, product design and production process, avoiding costly project delays, scrap and rework that may be caused when problems are discovered late in the development process – or after the product is on sale.
What is the most effective way to utilise FMEA?
The most effective FMEA’s are performed by a cross functional team, with knowledge and understanding of the operating environment, customer requirements, design methods and manufacturing process. However, FMEA teams also need to tap into the unconscious knowledge of the organisation, and use the tactile knowledge of people who know the product and process as they explore different scenarios. An impartial moderator can be a great benefit, and team members must resist the temptation to ‘justify the status-quo’ rather accepting the challenge to ‘find a better way’
A well-executed FMEA may identify opportunities for improvement, not only in the particular product or process under considerations – but also in the design methods’ and standards that are adopted in all areas of the business
To discover how FMEA’s can improve your business, why not attend one of our public courses – or arrange an in-house course for your team. FMEA training course information.
About the Author
Phil delivers FMEA training for Bywater clients in the UK and Europe, is passionate about ‘getting value’ out the quality improvements tools and techniques – minimising the risk of product recalls. He is highly experienced and works with vehicle manufacturers and component suppliers to identify and investigate problems in design and manufacturing – helping them develop and improve their design and manufacturing process.