Question

Hu Chan Lee Inc wants to implement a structured approach to discovering potential failures that may exist within the design of a product or process. For this approach to be implemented a whole quality design system needs to be implemented. They are looking for a consultant who would help them with such an approach and its technicalities in implementing it as a quality system. What would you suggest to the firm and how will it be implemented? Give details and elaborate upon how this particular approach came into existence, its scoring system, how to construct and its benefits to similar firms.

Its a case study and Hu Chan Lee is a hypothectical company

Answer 1

There are numerous high-profile examples of product recalls resulting from poorly designed products and/or processes. These failures are debated in the public forum with manufacturers, service providers and suppliers being depicted as incapable of providing a safe product. Failure Mode and Effects Analysis, or FMEA, is a methodology aimed at allowing organizations to anticipate failure during the design stage by identifying all of the possible failures in a design or manufacturing process.

Developed in the 1950s, FMEA was one of the earliest structured reliability improvement methods. Today it is still a highly effective method of lowering the possibility of failure.

What is Failure Mode and Effects Analysis (FMEA)

Failure Mode and Effects Analysis (FMEA) is a structured approach to discovering potential failures that may exist within the design of a product or process.

Failure modes are the ways in which a process can fail. Effects are the ways that these failures can lead to waste, defects or harmful outcomes for the customer. Failure Mode and Effects Analysis is designed to identify, prioritize and limit these failure modes.

FMEA is not a substitute for good engineering. Rather, it enhances good engineering by applying the knowledge and experience of a Cross Functional Team (CFT) to review the design progress of a product or process by assessing its risk of failure.

There are two broad categories of FMEA, Design FMEA (DFMEA) and Process FMEA (PFMEA).

Design FMEA

Design FMEA (DFMEA) explores the possibility of product malfunctions, reduced product life, and safety and regulatory concerns derived from:

• Material Properties
• Geometry
• Tolerances
• Interfaces with other components and/or systems
• Engineering Noise: environments, user profile, degradation, systems interactions

Process FMEA

Process FMEA (PFMEA) discovers failure that impacts product quality, reduced reliability of the process, customer dissatisfaction, and safety or environmental hazards derived from:

• Human Factors
• Methods followed while processing
• Materials used
• Machines utilized
• Measurement systems impact on acceptance
• Environment Factors on process performance

Design FMEA Worksheet

Process FMEA Worksheet

Why Perform Failure Mode and Effects Analysis (FMEA)

Historically, the sooner a failure is discovered, the less it will cost. If a failure is discovered late in product development or launch, the impact is exponentially more devastating.

FMEA is one of many tools used to discover failure at its earliest possible point in product or process design. Discovering a failure early in Product Development (PD) using FMEA provides the benefits of:

• Multiple choices for Mitigating the Risk
• Higher capability of Verification and Validation of changes
• Collaboration between design of the product and process
• Improved Design for Manufacturing and Assembly (DFM/A)
• Lower cost solutions
• Legacy, Tribal Knowledge, and Standard Work utilization

Ultimately, this methodology is effective at identifying and correcting process failures early on so that you can avoid the nasty consequences of poor performance.

Late Failure Mode Discovery

Early Failure Mode Discovery

When to Perform Failure Mode and Effects Analysis (FMEA)

There are several times at which it makes sense to perform a Failure Mode and Effects Analysis:

• When you are designing a new product, process or service
• When you are planning on performing an existing process in a different way
• When you have a quality improvement goal for a specific process
• When you need to understand and improve the failures of a process

In addition, it is advisable to perform an FMEA occasionally throughout the lifetime of a process. Quality and reliability must be consistently examined and improved for optimal results.

How to Perform Failure Mode and Effects Analysis (FMEA)

FMEA is performed in seven steps, with key activities at each step. The steps are separated to assure that only the appropriate team members for each step are required to be present. The FMEA approach used by Quality-One has been developed to avoid typical pitfalls which make the analysis slow and ineffective. The Quality-One Three Path Model allows for prioritization of activity and efficient use of team time.

FMEA Relationship to Problem Solving

The Failure Modes in a FMEA are equivalent to the Problem Statement or Problem Description in Problem Solving. Causes in a FMEA are equivalent to potential root causes in Problem Solving. Effects of failure in a FMEA are Problem Symptoms in Problem Solving. More examples of this relationship are:

• The problem statements and descriptions are linked between both documents. Problem solving methods are completed faster by utilizing easy to locate, pre-brainstormed information from an FMEA.
• Possible causes in an FMEA are immediately used to jump start Fishbone or Ishikawa diagrams. Brainstorming information that is already known is not a good use of time or resources.
• Data collected from problem solving is placed into an FMEA for future planning of new products or process quality. This allows an FMEA to consider actual failures, categorized as failure modes and causes, making the FMEA more effective and complete.
• The design or process controls in an FMEA are used in verifying the root cause and Permanent Corrective Action (PCA).
• The FMEA and Problem Solving reconcile each failure and cause by cross documenting failure modes, problem statements and possible causes.

FMEA Example

This FMEA Example has one item with a progression through multiple recommended Actions. With each instance, the revised RPN has improved. The final RPN of 10 indicates the issue has been mitigated successfully. The new state should be captured as Standard Work.

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