Is FMEA The Right Risk Management Method For Your Medical Device?

FMEA medical device (Failure Modes & Effects Analysis)

An important quality assurance function is assessing risk for the critical characteristics of a disposable medical device, throughout its lifecycle. This is true for any disposable medical device product where compliance is required with either the US FDA, the EU (requiring CE mark), ISO-14791 quality standard, or even to demonstrate cGMP compliance.

In order to establish a process for conducting and documenting risk analysis, all manufacturing risks associated with production processes must be documented, detailed and when possible solved proactively. This is the purpose of Failure Modes & Effects Analysis (FMEA medical device), a method that helps medical device manufacturers identify, break down, control and review the risks associated with product development and manufacturing.

Is FMEA The Right Risk Management Method To Use?

Quality assurance is an integral part of the manufacturing of disposable medical devices. It has a considerable impact on manufacturers, suppliers, practitioners, and patients. Ensuring that the right method is in place to carry out risk analysis associated with quality is essential. FMEA is one method, but there are other steps that organizations can take as well. Like any other method, FMEA has certain downsides and limitations.

It’s important to note that FMEA doesn’t necessarily cover every aspect of risk management. Risk management entails the use of policies, procedures, and practices to identify, evaluate, and control risk. FMEA is narrower in its scope, focusing specifically on identifying possible failures. While this is undoubtedly an essential part of any effective risk management approach, it doesn’t cover all essential functions.

FMEA is an effective tool for identifying and evaluating failure mode risks, but there are other potential risks that must be evaluated as well. Risk management must confront an extensive range of hazards, harm, and risks while assessing their probability, acceptability, and controls. FMEA is an integral part of this process but not the only step that needs to be implemented.

FMEA Will Not Cover Everything In The ISO-14791 Standard

While many steps in an FMEA are similar to the risk management standards included in ISO-14791, there are also some key differences. FMEA doesn’t include risk management planning, which is an important step. ISO-14791 also includes more focus on residual risk, along with including production and postproduction info. While the core of FMEA and ISO-14971 are very similar, manufacturers should pay close attention to the areas in which they differ.

FMEA is highly effective in determining failure mode prioritization, serving as an important step in any process to resolve those risks.

However, it doesn’t focus on the correction or elimination of those risks. Instead, an FMEA serves to inform other planning activities and methods for risk management.

An FMEA should be a part of a larger risk management system such as ISO-14971. This ensures that risk management doesn’t stop at identifying and evaluating but also includes practical measures for mitigating and controlling risks. ISO-14971 contains multiple additional process steps focused on control, risk acceptability, and reviews that aren’t included in an FMEA.

Common FMEA Mistakes

When implementing an FMEA, there are several common mistakes that organizations can make. The first is not starting their FMEA early enough. An FMEA can have the most impact when implemented as early in the design process as possible when meaningful changes can still be made. Taking on too large a scope is another common mistake made, as organizations quickly find themselves overwhelmed if they aren’t focused on specific equipment or processes.

When done the right way, an FMEA is a valuable tool that serves as part of the foundation of risk management. Organizations should focus on properly handling their FMEA and ensuring that they include input from operators, customers, and suppliers. An FMEA should be focused enough that the specific area can be explored in fine detail, identifying and evaluating failure modes thoroughly to deliver the most useful information for risk management.

Preparing For An FMEA Process

As in every analysis process, it is critical to have good quality inputs in an FMEA, in order to expect actionable results that will actually help safeguard the disposable medical device. That is why an important first step to conducting an effective FMEA is gathering the correct information that will go into the FMEA process. 

Firstly a timeline with all the exact phases of new product development must be established. Secondly every phase should have its own tasks, with responsibilities assigned for every task involved. Finally for every task or process function there need to be an analysis of the risks regarding failure modes and effects, as well as causes and corrective or preventive actions that need to be taken, in order to minimize risk.

Conducting FMEA for Medical Device

Any FMEA process begins with a risk assessment of the general medical device manufacturing process. Although every medical device developer has their own exact way of documenting and conducting FMEA, following are the most critical steps and information that every FMEA for medical device should include.

1. Know Your Process

To initiate the FMEA requires a detailed description of the process. The items mentioned below need to be documented for every process step, providing a basis for the whole FMEA.

• Process Function: A detailed description of every operation in a concise way that clearly indicates the purpose of this process step. 
• Potential Failure Mode: A description of how a specific operation can potentially fail to meet requirements or design intent, assuming the incoming materials or parts were received according to specifications.
• Potential Effects of Failure: The effects a failure can have on the subsequent operations of the process, including the next or subsequent operations, all the way to the impact it may have to the final customer.
• Potential Causes of Failure: A description assigned to show how each failure mode could occur. Since the goal is to identify, correct, and control the cause of failure, it is important to avoid ambiguous phrasing and be specific in describing the potential causes of failure.

2. Prioritize Risk

• Risk Severity: Indicates the seriousness a failure mode effect can have to the subsequent operation.
• Probability of Occurrence: Indicates the estimated frequency (or the likelihood) in which a specific failure can occur. Historical or other empirical data can be taken into account to assess probability of occurrence, when available. 
• Probability of Detection: Indicates how probable it is for a failure mode to be identified or detected in case it occurs. When estimating probability of detection, factors such as quality checks frequency and sampling size need to be taken into consideration.
• Risk Priority Number: In terms of FMEA for medical device, estimating the risk means calculating the risk priority number. This is done by taking into account the risk severity, probability of occurrence, and probability of detection of every failure mode. Once the risk priority number has been calculated for every step, the failure modes are ranked in order of criticality. This way it is evident where effort should be given first to take corrective or preventive actions and reduce risk.

3. Take Action

Current Process Controls

In every process step mentioned above, the process controls currently in place need to be clearly stated since it is those that serve to detect, prevent, and ultimately limit or even eliminate the effects of a failure mode. These include both IPCs (in process controls) during an activity, as well as post process controls such as batch release scheme sampling controls.

Recommended Actions

The recommended actions can be defined according to each failure mode’s risk priority number and process controls. These can be both preventive or corrective actions, with the goal to reduce the overall risk of each failure mode, which ultimately means one or more of either: decrease risk severity; decrease the probability of occurrence, and lastly increase the likelihood of detection.

The Disposable Medical Device Specialists

Quasar has over 30 years of experience in the development and mass production of disposable and reusable medical devices. Quasar is an expert with FMEA medical device methodologies. Working with us grants you access to an established Quality Assurance system with our world-class medical device development infrastructure and mass production facilities.