RISK MANAGEMENT (05) – FMEA GENERAL OVERVIEW

Rami.Azulay January 26th, 2020 Posted by Rami Azulay( ) ISO 14971, Requirements Management Tool

In this post, we will be sharing the basic information that you as a medical device manufacturer should know about Failure Mode and Effect Analysis (FMEA).

What is FMEA?

FMEA stands for Failure Mode and Effect Analysis. One can describe as a continuous quality process that helps to identify potential manufacturing and design errors. Furthermore, FMEA helps to determine the effects of these errors before they actually happen. As a result, if a medical device company suspects vulnerability in their system or process, FMEA is an inductive and proactive way to logically get to the root cause of the problem and develop solutions. In simple terms, it is a way to estimate what could go wrong and develop a prevention plan. FMEA can be simplified as follows;

Failure Mode: The stage of contemplating what is wrong with a product? Or how a processor device can fail?

Effect: What will be the result of the failure in the product or process? How would it impact a patient, the company and overall performance?

Analyze: Discover the root cause of the failure as well as the chances of it occurring before there is an actual incident.

Firstly, below are the 9 major advantages of a comprehensive FMEA.

Advantages of FMEA

  1.   An effective FMEA will lead to improved quality, upper reliability, and enlarged safety.
  2.   It makes it easier to develop ideas and concepts that will help improve similar processes and designs
  3.   Using FMEA will allow companies to improve both manufacturing and design efficiencies.
  4.   It allows for proper documentation of Corrective Action implementation that led to improvements.
  5.   It helps to remove or eliminate the possibility of late changes and the crisis it brings.
  6.   It reduces the chances of repeating similar of the same mistakes in the long-term.
  7.   It helps to lower the cost and time need for system development.
  8.   It allows for co-operations between co-workers at all levels. As a result, there is a better exchange of ideas and teamwork.
  9.   Companies get the benefit of improving their market competitiveness and overall image.

 FDA Endorsement

In several industries, one of the most efficient ways to analyze reliability problems in the early stage of product development is through FMEA. Due to FMEA, manufacturers can act proactively toward reducing or removing potential failure.

One of the tools that the FDA endorses to help manufacturers deal will medication errors is FMEA. It is worth noting that prevention is always better than cure.

 The Origins of FMEA

We can trace the history of FMEA back to NASA in the 60s when the organization was concerned about the safety and reliability of space program hardware. Since that time, any industries with a reputation for high-cost or high-risk makes use of FMEA. As of today, the FMEA method is commonly used in the medical device and pharmaceutical industries.

FMEA method is an effective way to identify potential errors, failures and problems in the design, systems, processes and service before customer consumption. Making it easier to implement and document corrective actions. In the ICH Quality Rick Management Q9 guide, FMEA is the primary tool listed for Quality Risk Assessment.

 The ICH Quality Risk Management Q9 Guide

According to Section 1.12 of the ICH manual, FMEA is;

  • FMEA (IEC 60812) opens an opportunity to evaluate various modes of potential failure and predict the possible effects it will have on product performance.
  • Once failure modes are determined, it is possible to use risk reduction to reduce, remove or control likely failures. However, it works when there is a proper understanding of the process and product development.
  • With the help of FMEA, a company can break down the analysis of complex processes into gradual steps methodically. It is a tool that allows for the summarizing of crucial failure modes, the factors responsible for the failure and their possible effects.

In determining the use of FMEA, it is possible to use FMEA to prioritize risks, while monitoring the effects of various control measures. Likewise, it can be used in various equipment and manufacturing facilities. Similarly, it can be used to pinpoint high risk and critical requirements in various system and process development cycles.

The relative risk score is the output of an FMEA process and it is used to rank various failure modes by their potential risk threat.

 Application of FMEA in the Pharmaceutical Industry

The most popular risk management methodological term is FMEA. As a result, it features in numerous instances. For example;

  1.  When it comes to drug substances and products, it can be used to define the design space for their manufacturing processes. During the design phase, FMEA can help outline design options, select the best one, as well as improve the design and processes.
  2.  It helps with the setup of both the manufacturing and design of equipment. Also, it aids the optimization and improvement of qualification and maintenance plans for equipment. If a device, process or system can fail then you can apply FMEA to it.

 What can FMEA do for you?

Below are some of the benefits of applying the FMEA method in your manufacturing processes;

  • It will assist you in discovering and analyzing likely failures mores ahead of time.
  • You will be able to quantify the effects of those potential failures.
  • It will help you estimate the probability of having the failure modes occur.
  • Using FMEA, you will be able to identify as well as prioritize corrective actions that will result in the reduction or removal of the potential failure threat.
  • It is a valid way of documenting and implementing plans that will reduce risks in a system.

Therefore, we can summarize that effective FMEA helps to enhance the safety, quality, and reliability of a developmental process. In doing so, the company will be able to save time and money while ensuring customer satisfaction.

So, with FMEA, you can create time to handle other pressing activities while saving cost and time on risk management.

When to Perform FMEA?

FMEA can be conducted at the following times;

  1.   When you start a new product cycle.
  2.   When there is an update in the current design, system or processes.
  3.   There is a change in the operating parameters of a system.
  4.   A current process or design is been used for something different.
  5.   There are new regulations governing a design, process, system or product use.
  6.   When customer feedback point to a problem.
  7.   When analyzing failures in an existing system or process.

Therefore, make it a rule to systematically and periodically perform FMEA throughout the life cycle of a system, design or product. That way, there is a way to track updates, improvements and threats to the process. It is crucial to deal with RISK NOW rather than face FAILURE later.

 


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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