How do you prevent risks in your processes using failure mode and effects analysis?

?? How do you prevent risks in your processes? Complete a Failure Mode & Effects Analysis, shortened to FMEA! What is a FMEA & why should you care? It’s one of the most underused & misunderstood tools I have come across over the years, & yet it truly is one of the most important. A FMEA helps identify many (ideally most) of the ways in which your entire process could fail or parts (steps) within it. A FMEA compliments Agile software projects as well projects within Operations. Completing this should ideally be a group exercise, involving SMEs & be led by an experienced facilitator who is well versed on how to create a FMEA. This usually is an afternoon workshop. You can download free FMEA templates online. ?? Like to support this

Failure Mode and Effects Analysis (FMEA) identifies potential failures by assessing their causes, impacts, and likelihood. Prioritize high-risk areas, implement corrective actions, and monitor results. Continuous improvement and team collaboration reduce process risks and enhance reliability.

The FMEA tool allow you to optimise the reliability of a process by identifying mistakes and malfunctions at an early stage. This methodology can be used for products, services as well as process or means of production. The different stage are : - define the objective of the analysis - set up a working groupe - carry out a fonctionnal analysis of the system - list possible failures mode - study the effect of each possible failure on the system - attribute to each failure a level of severity, frequency and probability of non detection to obtain a criticality index - define actions plan to improve the criticality index - repeat the analysis as the project progresses

Failure Mode and Effects Analysis (FMEA) is a systematic approach used to identify, evaluate, and prioritize potential failures in a process or product design and their effects on operations or outcomes. The primary goal of FMEA is to preemptively address risks by pinpointing areas where failures could occur, assessing the impact of those failures, and implementing corrective actions to mitigate or eliminate them. Using FMEA helps organizations improve reliability, enhance quality, and reduce costs associated with process failures, ensuring a proactive approach to risk management.

FMEA is a structured method used to evaluate potential failures in a process, product, or service by answering three key questions: What can go wrong? How likely is it to happen? What are the consequences? This approach allows you to rank risks based on their severity, occurrence, and detection, and calculate a Risk Priority Number (RPN) for each failure mode. Higher RPNs indicate more urgent needs for improvement. By using FMEA, you can prevent defects, reduce costs, and enhance customer satisfaction, making it an essential tool for risk management.

Before you actually begin the FMEA take them through an example so they know what each column means. I've seen many times that when you ask how big an impact an event would be they answer: "that would never happen". Or if you are trying to get them to assess how likely something is to happen they focus instead on the fact that the event would have a significant negative impact. Their previous experiences make it difficult to take the questions at face value. I also use 1-4-7-10 scoring to avoid every score ending up in the middle.

Prework is our friend. Do not begin with a cold start. Create a warm start by asking participants to review supporting documents (e.g., process maps, past performance data including defects and complaints). Then have the participants evaluate each process step and ask: * What could go wrong and * What is the impact This prework gets the team off to a warm start in identifying potential failure modes and effects. Makre sure the team knows what we are trying to achieve and how we will do it with FMEA. For Rookies, consider offering training. ? Finally, I have found that it is not a good idea to lock participants in a room (or in a virtual conference) for 8 hours. By hour 5, you may beat them into a sense of group think.

The most important in a FMEA is to select the right SME (Subject Matter Experts). FMEA is not an individual exercise but a group exercise.

Preparing for FMEA involves assembling a cross-functional team with diverse expertise related to the process or product being analyzed. Start by clearly defining the scope and objectives of the FMEA, ensuring all team members understand the process stages or product components to be evaluated. Gather relevant data, such as historical failure records, design specifications, process maps, and customer feedback, to provide a comprehensive foundation for the analysis. Additionally, prepare necessary tools and templates, like FMEA worksheets, to systematically document findings and actions.

It makes a difference having a facilitator who: 1) is sufficiently versed in the technical aspects of the problem; and 2) actively listens to all the voices in the room. For first pass analysis, fishbone is hard to beat.

I recommend not to use 1 to 10 but rather 1 3 6 9 , this gives more differences between each category. The definition of each category is important

Conducting FMEA involves identifying potential failure modes, their causes, and their effects on the process or product. For each failure mode, the team assesses three factors: the severity of the failure’s impact, the likelihood of occurrence, and the detectability before the failure reaches the customer. These assessments are usually scored on a scale, typically from 1 to 10. Document each failure mode and its corresponding scores on the FMEA worksheet. Encourage thorough discussion among team members to ensure all potential issues are identified and evaluated accurately.

Após mapear o processo observamos qual o modo de falha que poderá ocorrer nas etapas . O modo de falha é a anula??o total ou parcial da fun??o primária do processo. Exemplo: Atualizar a planilha do excel. O primeiro passo será ligar o computador e o modo de falha será: Computador n?o ligou. Depois identificamos os motivos que fez ocorrer o modo de falha. Pergunte: Por que o computador n?o ligou? Existem várias causas associadas...falta de energia, problemas de hardware, software, etc...Analisamos em seguida as consequências que ir?o existir com a falha e depois pontuamos através de um score o grau de severidade, a frequência e se é fácil detectar a falha ou n?o. Por fim multiplicamos os indicadores para encontrar o RPN e priorizar as a??es.

It’s a tricky one. In an example below, what would you prioritise? Risk 1 = 8 (Severity) x 6 (Occurrence) x 2 (detection): RPN = 96 Risk 2 = 6 (Severity) x 8 (Occurrence) x 2 (detection): RPN = 96 Here your mitigation action priority would be for risk 1 even if RPN is same due to high severity (impact). This is called “Action Priority”.

Risk Priority Numbers (RPNs) are calculated by multiplying the scores of severity, occurrence, and detectability (RPN = Severity x Occurrence x Detectability). This numerical value helps prioritize which failure modes require the most immediate attention. Higher RPNs indicate higher risk and necessitate urgent action. Once RPNs are calculated, rank the failure modes from highest to lowest. This prioritization guides the team in focusing on the most critical issues first, ensuring resources are allocated efficiently to mitigate significant risks.

To calculate and prioritize RPNs in Failure Mode and Effects Analysis (FMEA), start by rating the severity, occurrence, and detection of each failure mode. Multiply these ratings to obtain the RPN, which indicates the risk level associated with each failure mode. Record and calculate RPNs using an FMEA worksheet or spreadsheet, then sort them from highest to lowest. Focus your improvement efforts on the failure modes with the highest RPNs, as they represent the greatest risks and should be addressed first to prevent issues in your processes.

O RPN é o produto de outros 3 indicadores do FMEA que s?o utilizados para prioriza??o das falhas: RPN = Severidade x Frequência x Detec??o. Um indicador de RPN alto sinaliza a necessidade de prioriza??o de uma a??o de melhoria. Mas também é necessário observar se um RPN baixo possui um grau de severidade alto, pois a nota da severidade é dada pelo cliente e mesmo que haja uma frequência baixa e maior facilidade de detec??o, o cliente irá demonstrar a sua insatisfa??o com a falha ocorrida.

Deepak K asks a great question: we see the same RPN with different SEV and OCC ratings. It is indeed more than just reacting to the magnitude of the RPN. Rather, we should explore what I call the story of the RPN (with a scale of 1 to 10): RPN = 1000: we face almost certain loss of our customers almost every time and there is nothing that we can do about it. YIKES! OCC = 10, DET = 1: the cause is going to happen, and we will most certainly detect it. End result: Hidden Factory. DET = 10: guaranteed escaped defects. No worries, our customers will find them for us. SEV = 10: even if we scored OCC and DET low, let’s make certain that this will not happen, and if it does, we can catch it. Ensure that when this occurs, it is TRANSPARENT!

Thumb rule, don’t change severity rating in post recommended actions RPN. Your occurrence can reduce and detection can increase due to mitigation/ recommendations implemented.

A implanta??o de melhorias deve seguir algumas características importantes. 1- Utilize uma planilha de 5w2h para elaborar um plano de a??o no menor nível de detalhe possível junto com os envolvidos. 2- Defina os responsáveis em executar dentro do nível detalhado das a??es. 3- Entreviste os responsáveis de cada a??o para que eles possam definir prazos realistas. 4- Fa?a uma conex?o dos prazos das a??es em uma linha de tempo e crie um caminho crítico. Exemplo: Automatizar um processo fabril n?o poderá ter um único responsável. Esta a??o deverá ser desmembrada e responsabilizada desde o momento da cota??o de maquinário, tendo como responsável a área de compras até os treinamentos e partida da máquina pelo time de RH e produ??o.

After identifying and prioritizing failure modes, develop action plans to address the most critical risks. Assign responsibilities for implementing corrective actions, establish timelines, and set measurable goals for each action. Regularly monitor the progress of these actions and evaluate their effectiveness in reducing RPNs. Update the FMEA document to reflect changes and improvements. Continuous monitoring ensures that the implemented solutions are effective and sustainable, allowing for adjustments as necessary to maintain process reliability and quality.

Failure Mode and Effects Analysis (FMEA) helps prevent risks in processes through a structured approach. To do so: 1. Identify Failure Modes: List potential failure modes for each process step. 2. Assess Effects: Analyze the impact of each failure on the process and end product. 3. Determine Causes: Identify root causes for each failure mode. 4. Prioritize Risks: Calculate a Risk Priority Number (RPN) using severity, occurrence, and detection ratings to focus on the most critical risks. 5. Implement Actions: Develop and implement corrective actions for high-priority risks. 6. Review and Monitor: Continuously monitor the process and update the FMEA as needed. This systematic approach enhances process reliability and safety.

When implementing FMEA, consider integrating it into the broader quality management system to ensure it becomes a standard practice rather than a one-time activity. Encourage a culture of continuous improvement by regularly revisiting and updating FMEAs to reflect changes in processes, products, or customer requirements. Utilize software tools designed for FMEA to streamline the documentation and analysis process. Finally, ensure that all stakeholders, including management and operational staff, are engaged in the FMEA process to foster collaboration and buy-in, which is crucial for successful risk management and implementation of corrective actions.