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Software & Analysis: FMEAs for the Medical Industry: Which FMEA Type Should I Use?

January 4, 2012
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Failure modes and effects analysis is a process to be used and not a form to be filled out.

With the demand for reduced costs in the medical industry, there is an increased interest in the use of the failure modes and effects analysis (FMEA). Unfortunately, most people are not aware of the various FMEA types available for use and their purpose.

It is important to understand that the FMEA is a process to be used and not a form to be filled out. There are four basic FMEA process types that can significantly improve a company’s ability to provide their customers with high quality, reasonably priced medical products and services. The four FMEA process types are: system FMEA, design FMEA, process FMEA for manufacturing and process FMEA for service delivery.

System FMEA

The system FMEA process should be used by personnel responsible for the definition of design requirements that will be provided to the product designers. The main objective of the system FMEA process is to identify any design requirements that if left unchanged would result in customer requirements not being met and as a result expose the patient to injury and/or the company to unacceptable financial risks.

When determining the risk of not meeting customer requirements, 17 different categories of requirements must be considered. The system FMEA is the most important of all FMEAs when it comes to product design since there is no way of preventing an improperly designed product from getting to the customer if the requirements it was designed to are incorrect.

The output of the system FMEA process is used to:

Define the current injury risk to the patient and/or financial risk to the company due to the current design requirements.

Identify improvement actions to be attempted to improve problem design requirements.

Estimate the market share loss if non-safety related problem design requirements are not changed.

Evaluate whether or not the remaining risk to the patient and/or company due to the current design requirements is acceptable and the design requirements should be released for design.

Assess the impact of proposed design requirement changes.

Identify the labeling claims that must be written based on the current state of the design requirements.

Assist in troubleshooting field problems.

Train product designers.

Design FMEA

The design FMEA process should be used by designers of the product. The main objective of the design FMEA process is to identify any design product characteristic specifications-such as ingredient concentrations-or software code (if a programmable device is involved) that if left unchanged could expose the patient to injury and/or the company to unacceptable financial risks.

The output of the design FMEA process is used to:

Define the current injury risk to the patient and/or financial risk to the company due to the current product characteristic specifications or software code.

Identify improvement actions to be attempted to improve the product characteristic specifications.

Evaluate whether or not the remaining risk to the patient and/or financial risk to the company due to the current product characteristic specifications or software code is acceptable and the specifications should be released for manufacturing.

Assess the impact of proposed product characteristic specification and/or computer code changes.

Estimate the cost of proposed characteristic specification changes.

Troubleshoot field problems.

Train product designers.

Process FMEA for Manufacturing

The process FMEA for manufacturing processes should be used by personnel responsible for the manufacture of the product. The main objective of the process FMEA process is to identify any process weaknesses that if left unchanged could expose the patient to injury, manufacturing worker to injury and/or the company to unacceptable financial risks.

When determining the risk of using the current manufacturing process including the supplier base, the process must be examined for 10 different categories of process weakness.

The output of the process FMEA process is used to:

Define the current injury risk to the patient, injury risk to the manufacturing worker and/or financial risk to the company due to the current process.

Identify improvement actions to be attempted to reduce or remove process weaknesses.

Evaluate whether or not the remaining risk to the patient, manufacturing worker and/or financial risk to the company due to the current process design is acceptable and the process should be released for manufacturing.

Create documentation detailing steps that must be taken for optimized manufacturing.

Assess the impact of proposed process changes.

Assess the impact of proposed product characteristic specification changes on the process.

Estimate the cost of proposed product characteristic specification changes.

Troubleshoot manufacturing problems.

Troubleshoot field problems.

Train manufacturing personnel.

Process FMEA for Service Delivery

The process FMEA for service delivery process should be used by personnel responsible for the delivery of medical services. The main objective of the process FMEA process is to identify any process weaknesses that if left unchanged could expose the patient to injury, service provider to injury and/or the company to unacceptable financial risks.

When determining the risk of using the current service delivery process including the service consumable supplier base, the process must be examined for nine different categories of process weakness.

The output of the process FMEA process is used to:

Define the current injury risk to the patient, injury risk to the service provider and/or financial risk to the company due to the current process.

Identify improvement actions to be attempted to reduce or remove process weaknesses.

Evaluate whether or not the remaining risk to the patient, service provider and/or financial risk to the company due to the current service delivery process design is acceptable and the service delivery process should be released for use.

Assess the impact of proposed service delivery process changes.

Assess the impact of proposed service consumable product characteristic specification changes on the service delivery process.

Create documentation detailing steps that must be taken for optimized service delivery.

Troubleshoot service delivery problems.

Train service delivery personnel.

Pulling It All Together

Every company can experience significant improvements in the quality of the medical products and services that they deliver through the use of the FMEA process. When used correctly, the FMEA process can become the cornerstone of a company’s product and/or service development system. When performed correctly, the FMEA process will also support and enhance any improvement processes such as Six Sigma or lean manufacturing that may exist within the company. Q

Tech Tips

There are four basic FMEA process types that can significantly improve a company’s ability to provide their customers with high quality, reasonably priced medical products and services:

System FMEA

Design FMEA

Process FMEA for manufacturing

Process FMEA for service delivery

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