What is Process Failure Mode & Effects Analysis (PFMEA)?

What Is Process Failure Mode and Effects Analysis (PFMEA)?

A análise do modo de falha e dos efeitos do processo (PFMEA) é uma ferramenta essencial nas indústrias em que a fiabilidade do processo e a qualidade do produto são críticas. Envolve uma análise detalhada das etapas do processo para descobrir potenciais pontos de falha e avaliar os seus efeitos no processo global. Esta análise inclui:

• Identificação de modos de falha: Determinar como um processo pode falhar em cada etapa.
• Avaliação dos efeitos: Avaliar as consequências de cada falha no processo e no produto final.
• Priorização de riscos: Atribuir um número de prioridade de risco (RPN) com base na gravidade, ocorrência e deteção de cada modo de falha.
• Implementing Actions: Develop and implement strategies to reduce or eliminate high-risk failure modes. 

While a failure mode and effects analysis (FMEA) identifies equipment failures and potential breakdowns, a PFMEA looks at the manufacturing process as a whole. Portions of the process examined could include purchasing raw materials, storage, manufacturing, assembly, packaging, and shipping.

A PFMEA é uma abordagem sistemática utilizada para identificar e avaliar potenciais falhas num processo de fabrico ou comercial. O objetivo da PFMEA é melhorar os processos, identificando os modos de falha, avaliando o seu impacto e implementando acções correctivas para reduzir os riscos. Ao examinar cada etapa de um processo, a PFMEA ajuda as organizações a aumentar a fiabilidade, melhorar a qualidade e evitar defeitos antes que estes ocorram.

O processo PFMEA é colaborativo, envolvendo equipas multifuncionais que trazem perspectivas diversas para identificar potenciais problemas de forma abrangente. Esta colaboração garante que todos os modos de falha possíveis são considerados e tratados de forma eficaz.

PFMEA vs FMEA

Embora a PFMEA seja um tipo específico de Análise dos Modos e Efeitos de Falha (FMEA), é importante compreender as diferenças e semelhanças entre a PFMEA e a FMEA.

FMEA: A FMEA é uma metodologia alargada utilizada para identificar potenciais modos de falha, tanto em projectos de produtos como em processos. Engloba vários tipos, incluindo a FMEA de projeto (DFMEA) e a FMEA de processo (PFMEA).

• Aplicação: Aplicado tanto ao desenvolvimento de produtos como aos processos de fabrico para melhorar a fiabilidade e a qualidade.
• Foco: Pode ser utilizado para analisar projectos de produtos (DFMEA) e processos (PFMEA).

PFMEA: A PFMEA centra-se especificamente na identificação e resolução de potenciais falhas nos processos de fabrico ou comerciais. O seu objetivo é melhorar a fiabilidade e a eficiência do processo.

• Aplicação: Utilizado principalmente em ambientes de fabrico e produção para garantir que os processos são robustos e isentos de defeitos.
• Foco: Concentra-se nas etapas e operações do processo, identificando os modos de falha que podem afetar o fluxo do processo e a qualidade do produto.

Design FMEA and Process FMEA: Key Differences

• Âmbito: A DFMEA centra-se na conceção dos produtos e dos seus componentes, enquanto a PFMEA diz respeito aos processos utilizados para fabricar os produtos.
• Objetivo: A DFMEA visa melhorar a conceção e a fiabilidade do produto, enquanto a PFMEA visa otimizar a fiabilidade e a eficiência do processo.
• Fase de aplicação: A DFMEA é normalmente realizada durante a fase de conceção e desenvolvimento do produto, enquanto a PFMEA é aplicada durante o desenvolvimento e fabrico do processo.

Tanto a DFMEA como a PFMEA são parte integrante do sistema de gestão da qualidade de uma organização, trabalhando em conjunto para garantir que tanto os projectos de produtos como os processos de fabrico são robustos, fiáveis e satisfazem as expectativas dos clientes.

Importance of PFMEA in Risk Assessment

As a proven process to identify, assess, and mitigate potential process failures, PFMEA is an essential component of your risk mitigation strategy. That’s because it allows you to:

• Uncover potential failure modes that could significantly impact development and production costs, health and safety issues, and more
• Analyze potential failures and rank criticality to prioritize solutions
• Determine production process improvements to reduce failures and enhance productivity
• Implement mitigation strategies, including a blend of corrective actions and preventive actions
• Adopt a continuous improvement approach across processes

This powerful quality risk assessment tool can save time and money while improving safety and customer satisfaction.

Quando realizar a PFMEA

A PFMEA can be time consuming. Due to its in-depth nature, it often requires a significant number of working hours and involves pulling team members from many departments.

Conducting a PFMEA for every process throughout the company doesn’t usually need to be performed regularly. But in some instances, performing a PFMEA can significantly reduce risks and improve processes. Examples include:

• When there’s a failure: A PFMEA should be completed when there’s a failure, especially when it’s impactful and your company wishes to avoid similar failures in the future.
• Quando há uma mudança no equipamento: Por exemplo, é necessária uma PFMEA se várias máquinas na linha de produção tiverem sido substituídas por modelos mais recentes. Neste caso, a sua equipa pode ter de ajustar os horários de manutenção, o inventário de peças sobresselentes e as expectativas de tempo de produção para retomar com sucesso as operações com o novo equipamento.
• When there are process changes: A PFMEA should also be completed when new processes are introduced or current processes are significantly changed.
• After quality issues: If a process has experienced quality issues, PFMEA can be used to analyze the root causes and implement corrective actions to prevent recurrence.
• Compliance requirements: In industries with stringent regulatory requirements, PFMEA ensures that processes meet safety and quality standards.

By using PFMEA in these scenarios, organizations can proactively manage risks, enhance process reliability, and maintain high safety and quality standards.

Indústrias que utilizam habitualmente a PFMEA

A PFMEA é amplamente utilizada em várias indústrias onde a fiabilidade do processo e a qualidade do produto são fundamentais. Eis algumas das indústrias que normalmente implementam a PFMEA:

• Indústria automóvel:
  • A PFMEA é amplamente utilizada para garantir a fiabilidade e a segurança dos processos de fabrico automóvel. Desde as linhas de montagem até ao fabrico de componentes, a PFMEA ajuda a identificar e a reduzir os riscos que podem conduzir a defeitos ou falhas nos veículos.
    • Aplicação comum: Os fabricantes de automóveis utilizam a PFMEA para analisar processos como a montagem de motores, a aplicação de tintas e a soldadura, garantindo uma produção de alta qualidade e sem defeitos.
• Indústria aeroespacial:
  • A indústria aeroespacial conta com a PFMEA para manter padrões rigorosos de qualidade e segurança na produção de componentes e sistemas de aeronaves. A PFMEA ajuda a identificar potenciais falhas de processo que podem comprometer o desempenho e a segurança das aeronaves.
    • Aplicação comum: Os fabricantes do sector aeroespacial utilizam a PFMEA para analisar processos como o fabrico de pás de turbinas, o fabrico de materiais compósitos e a montagem de aviónica, assegurando que cada passo do processo cumpre os mais elevados padrões.
• Indústria farmacêutica:
  • A PFMEA é fundamental na indústria farmacêutica para garantir a consistência e a qualidade dos processos de fabrico de medicamentos. Ajuda a identificar e a controlar os riscos que podem afetar a eficácia e a segurança dos produtos farmacêuticos.
    • Aplicação comum: As empresas farmacêuticas utilizam a PFMEA para analisar processos como a compressão de comprimidos, o enchimento estéril e a embalagem, assegurando que cada passo cumpre os requisitos regulamentares rigorosos e as normas de qualidade.
• Indústria eletrónica:
  • A indústria eletrónica utiliza a PFMEA para melhorar a fiabilidade e a qualidade dos processos de fabrico de componentes e dispositivos electrónicos. A PFMEA ajuda a identificar potenciais falhas no processo que podem afetar o desempenho e a durabilidade do produto.
    • Aplicação comum: Os fabricantes de produtos electrónicos utilizam a PFMEA para analisar processos como a montagem de PCB, a soldadura e os testes, garantindo produtos electrónicos fiáveis e de alta qualidade.
• Indústria de alimentos e bebidas:
  • A PFMEA é utilizada na indústria alimentar e de bebidas para garantir a segurança e a qualidade dos processos de produção. Ajuda a identificar potenciais perigos e a implementar controlos para evitar a contaminação e garantir a consistência do produto.
    • Aplicação comum: As empresas do sector alimentar e de bebidas utilizam a PFMEA para analisar processos como a mistura, a cozedura e a embalagem, garantindo que cada passo cumpre as normas de segurança alimentar e os requisitos de qualidade.

Exemplo de PFMEA

Para compreender o processo da PFMEA, considere o seguinte exemplo de uma PFMEA numa fábrica:

Uma equipa de produção efectua uma revisão completa de um processo específico na linha de produção. Durante a revisão, descobrem uma potencial falha: Existe o risco de um produto químico específico necessário para a produção se esgotar. Se isso acontecer, a produção será interrompida.

The importance of having the required amount of this chemical is very high, so the team decides to rank its severity as a 10. Due to the short shelf life of the chemical, this shortage has occurred several times over the past few years, so the team ranks the occurrence at a 5. Detection can be challenging because having the chemical on hand doesn’t necessarily mean that it’s usable, so the team ranks that at a 6, resulting in an RPN of 300.

Em conjunto, a equipa analisa as necessidades da empresa, o prazo de validade do produto químico e as dificuldades de o adquirir, e determina que pode prever com sucesso o volume de produto químico que precisa de encomendar semanalmente. Em seguida, a equipa pode criar encomendas automatizadas, uma melhor gestão de inventário ou outros processos para garantir que nunca haverá falta deste produto químico crítico.

Potential Failure Modes in Processes

Failure modes refer to the ways in which an asset or material could malfunction, break down, or otherwise fall short of achieving its intended purpose.

In order to take the right corrective actions, you need to know what type of failure you’re experiencing, what caused it, and the impact to your operation.

Types of Failure Modes and Their Causes

Process failure modes may be inherent in your materials or equipment (such as a manufacturing defect), develop over time, or result from process or operator issues. No matter the type, cause, or effect, you’ll lose time, money, and energy to any of these failure modes.

Raw Material Failure Modes

Issues with your production materials can cause failure at any point during production may result from:

• Contamination and impurities
• Poor composition
• Inconsistent quality
• Incompatibility with other raw materials or equipment on your production line

Design Failure Modes

Even with the best materials, processes, and employees, design flaws like these can ruin your final product:

• Incorrect measurements
• Failure to account for variations in production
• Missed steps during design
• Improper documentation
• Poor quality control measures

Environmental Failure Modes

The environment inside and outside of your facility has serious implications for production. Environmental factors that can lead to failure include:

• Pests
• Produtos químicos
• Inconsistent or extreme temperatures
• Inconsistent or extreme humidity

Asset Management Failure Modes

Improper equipment maintenance and asset management problems can lead to failure and breakdowns caused by:

• New or unusual vibrations
• Overheating
• Parts failure
• Infrequent inspections
• Insufficient preventive maintenance
• Overreliance on corrective maintenance

Operator Failure Modes

Human errors are a major contributor to manufacturing failures. Causes of operator failure include:

• Inadequate training
• Insufficient or absent retraining
• Failure to document and/or follow proper procedures
• Carelessness
• Insufficient quality control measures

Effects of Common Failure Modes

Across types and causes, failure modes have similar potential effects for internal and external customers, employees, business operations, and even the environment. Potential effects include:

• Products with incorrect sizing, deformities, inadequate packaging, durability issues, or limited functionality
• Unexpected downtime and production delays
• Potential damage to assets and equipment on the production line
• Possible health and safety risks for employees and/or external customers
• Environmental impacts, including wasted materials, unsustainable practices, and pollution

Benefícios da PFMEA

By performing a PFMEA, manufacturers can identify current or potential process issues. The benefits of performing a PFMEA can include reduced downtime, increased outputs, increased reliability, improved customer satisfaction, and improved employee safety. A PFMEA is most successful when failures are identified and then prevented or reduced through new procedures, policies, or other steps that reduce the likelihood of occurrence. A PFMEA should be continually used and improved (or updated) as needed. As your team continues making process improvements, you should see a reduced impact from failures across the manufacturing floor, including decreased downtime and quality improvements.

Vamos analisar mais detalhadamente os principais benefícios da execução de uma Análise dos Efeitos dos Modos de Falha do Processo:

Enhanced Process Reliability: PFMEA helps identify and address potential process failures, reducing the likelihood of unexpected breakdowns and disruptions. Running PFMEA ensures smooth and consistent operations, minimizing downtime and production delays.

Improved Product Quality: By identifying failure modes that could impact product quality, PFMEA helps implement corrective actions to prevent defects. PFMEA leads to high-quality products that meet customer expectations and regulatory standards.

Cost Savings: Proactively addressing potential failures through PFMEA can prevent costly rework, scrap, and warranty claims, reducing overall production costs and increasing profitability.

Risk Mitigation: PFMEA systematically identifies and prioritizes risks, allowing organizations to implement effective controls and mitigation strategies. This minimizes the impact of process failures on operations and product quality.

Compliance With Standards: PFMEA helps ensure compliance with industry standards and regulatory requirements by identifying and addressing potential process risks — avoiding fines, legal issues, and reputational damage associated with non-compliance.

Improved Communication and Collaboration: PFMEA involves cross-functional teams, fostering collaboration and communication across different departments. This enhances problem-solving capabilities and ensures that all perspectives are considered in the analysis.

Continuous Improvement: PFMEA promotes a culture of continuous improvement by regularly reviewing and updating the analysis based on process changes and new information, which keeps processes optimized and responsive to evolving business needs.

Customer Satisfaction: By ensuring high-quality products and reliable processes, PFMEA contributes to increased customer satisfaction and loyalty. A strong reputation for quality and reliability leads to repeat business and positive word-of-mouth.

A computerized maintenance management system, or CMMS, can help your team manage these improvements by providing maintenance scheduling, inventory management, and workflows, and giving your team the tools they need to improve processes across your plant. To learn more about CMMS solutions, read our blog post or try a free demo of the award-winning eMaint CMMS.

Drawbacks of PFMEA

Maintenance teams sometimes overlook PFMEA or dismiss it as an administrative process. That’s a misunderstanding of the PFMEA meaning. Done right, PFMEA is one of the most valuable maintenance metrics around. However, getting it right means overcoming its built-in challenges. Here are some of the typical drawbacks of PFMEA.

Time and Resource Intensive: PFMEA requires in-depth analysis and documentation. Ideally, it should be performed at regular intervals; this can feel like a considerable burden, especially for lean maintenance teams.

Requires Significant Data: PFMEA assessments need high-quality data to be accurate. The PFMEA example worksheet asks for historical data, asset failure modes, maintenance records, and more. Depending on your maintenance program, you may not have access to all that data.

Potentially Subjective: Depending on how you implement it, PFMEA can be subjective — heavily based on the hunches and theories of your maintenance crew. That subjectivity might lead to inaccurate results and missed failure modes, and it might be why some teams prefer FMEA vs PFMEA.

Establishing a strong single source of maintenance data will correct most of the above challenges. With the right data, PFMEA is a reliable and valuable maintenance metric — and your CMMS can help.

Your CMMS acts as a central repository for work order histories, condition monitoring data, and other key information necessary to calculate PFMEA correctly. Beyond that, a CMMS makes it easier to calculate a range of maintenance metrics, so you have a full picture of facility-wide asset health.

How To Run PFMEA: A Step-by-Step Guide

PFMEA works by analyzing at each process and determining how it could go wrong. Those working on the PFMEA will name all the effects that could occur if that failure happens. For each process, the failures are ranked on:

• Severity – The impact of the failure, with 1 being least impactful and 10 being most impactful
• Occurrence – The likelihood of the failure happening, with 1 being very unlikely and 10 being highly likely or certain
• Detection – The chance that the failure will be detected, with 1 being easily detected and 10 being extremely difficult to detect

Usually, the PFMEA is completed in a spreadsheet. Then, the three numbers are multiplied together to produce a risk priority number (RPN):

RPN = Gravidade x Ocorrência x Deteção

Once the potential failures have been discovered and their severity ranked, the process of failure mitigation can begin. Often, it makes the most sense to try to avoid or reduce the risks for the higher RPN numbers first. In a PFMEA for manufacturing companies, the effects can include anything from inability to manufacture, slowed manufacturing, inability to meet production goals, end-user dissatisfaction, and everything in between.

PFMEA follows a structured methodology to systematically identify and address potential failures in a process. Here’s how to conduct a PFMEA in eight stages:

Step 1: Choose a Process and Assemble a Cross-Functional Team

Select a process to analyze, and with it, a cross-functional team of people involved in that process. The team members should be knowledgeable enough to give insightful input. They should have access to historical data and hands-on experience that can assist with completing the PFMEA.

Step 2: Map Out the Process in Question

As a team, perform a process review. Start by mapping out the entire process, breaking it down into individual steps or operations. This provides a clear understanding of the process flow and highlights critical points where failures could occur.

Step 3: Identify Potential Failure Modes

For each process step, identify all possible ways the process could fail to meet specifications or performance criteria.

• Exemplo: Num processo de pintura, um modo de falha pode ser a adesão incorrecta da tinta devido à contaminação da superfície.

Step 4: Assess the Effects of Failures

Determinar os efeitos potenciais de cada modo de falha no processo e no produto final. Considerar o impacto na qualidade, segurança, desempenho e satisfação do cliente.

• Exemplo: Uma má aderência da tinta pode levar à rejeição do produto, ao aumento dos custos de retrabalho e à insatisfação do cliente.

Step 5: Assign Severity, Occurrence, and Detection Rankings

Rate each failure mode based on its severity (impact), occurrence (likelihood), and detection (ability to detect before it reaches the customer).

• Exemplo: Um modo de falha com elevada gravidade, elevada ocorrência e baixa deteção seria prioritário para acções corretivas.

Step 6: Calculate Risk Priority Number (RPN)

Calculate the RPN by multiplying the severity, occurrence, and detection ratings. Calculate the RPN by multiplying the severity, occurrence, and detection rankings. This numerical value helps prioritize which failure modes need the most attention.

• Exemplo: Se um modo de falha tiver uma classificação de gravidade de 8, uma classificação de ocorrência de 6 e uma classificação de deteção de 3, o RPN será 144 (8 x 6 x 3).

Step 7: Develop and Implement Corrective Actions

Together, identify changes in processes, employee education, maintenance, or other areas that help address and reduce the likelihood and/or impact of the high-risk failure modes discovered. These actions could involve process redesign, additional controls, or enhanced testing procedures.

• Exemplo: Para resolver a má aderência da tinta, as acções podem incluir a melhoria dos procedimentos de limpeza da superfície ou a implementação de um processo de inspeção de qualidade mais robusto.

Step 8: Review and Monitor

Rever continuamente os resultados da PFMEA e monitorizar a eficácia das acções implementadas. Atualizar a PFMEA conforme necessário para refletir as alterações no processo ou novos modos de falha.

• Vantagem: Assegura que a PFMEA permanece relevante e eficaz na prevenção de falhas ao longo do tempo.

Seguindo estes passos, as organizações podem implementar eficazmente a PFMEA para identificar e mitigar os riscos nos seus processos, aumentando a fiabilidade e a qualidade globais.

PFMEA Risk Evaluation and Mitigation Strategies

What strategies and techniques can you use during the PFMEA process? Learn more about effective ways to carry out each stage of the PFMEA process.

Process Mapping Techniques: Process Flow Diagrams and PFMEA Worksheets

To illustrate each stage of your manufacturing processes, you can use a process flow diagram (PFD). It shows all inputs (raw materials, efforts, funds), outputs (end products), and stages (what your team and assets do) in detail.

PFDs are helpful because they make it easy to see every component of your process at a glance. And that’s critical when identifying risks in the next stages of the PFMEA process.

Next, PFMEA worksheets guide you through the remaining steps of the process. For each process step, you’ll assess potential failure modes, effects, causes and contributing factors, current actions, RPN, and recommended actions. The more comprehensive your worksheet, the more strategic your solutions can be.

Root Cause Analysis: Techniques To Identify Failure Modes

Root cause analysis (RCA) is the overarching process of exploring failures by defining the problem, gathering data, identifying contributing factors, identifying the cause, implementing the right corrective actions, and monitoring for improvements. Here are some popular techniques to perform RCA.

Fault Tree Analysis

Fault tree analysis is a visual tree-inspired map of the relationships that can lead to potential system failure. Start with your failure event at the top of the tree and add branches for each potential cause and contributing factor. Create sub-branches for related factors and new branches for unrelated ones. This in-depth failure analysis is helpful for complex and high-risk failures.

Cause-and-Effect Diagrams

Cause-and-effect diagrams such as fishbone diagrams, also known as Ishikawa diagrams, are another visual representation of potential failure modes. Similar to fault-tree analysis, these diagrams place potential failures at one end of the diagram as a fish head, then build out a skeleton of fish bones for related causes.

The Five Whys

The Five Whys or 5Y method lets teams get to the root of potential failure modes through inquisitive questioning. Start with the most obvious layer, then continue to ask, “Why?” For example:

The machine failed unexpectedly.

Why? The bearings on the asset wore out prematurely.

Why? There wasn’t enough lubrication.

Why? Lubricant in the pump ran out.

Why? We missed the previous inspection and preventive actions.

Why? Emergency maintenance takes precedent, removing resources from preventive maintenance.

By continuing to ask “Why,” you’ll reach the root of the problem. That way, you’ll strategically implement the right solution.

Techniques To Interpret RPN Values

Once you’ve calculated RPNs, you must decide on your thresholds for prioritization. This essential step lets you assess the importance of resolving each potential failure mode relative to other potential failures.

Higher RPNs represent higher potential risk, but what is “high”? This depends on several factors, including:

• Indústria
• Risk tolerance
• Key performance indicators (KPIs)
• Budgets
• Recursos

Use your collective RPN data to design the right thresholds. You’ll typically categorize RPNs as high risk, moderate risk, and low risk. But, as you might imagine, categorizing 90% of your failure modes as “high risk” doesn’t help you prioritize. So, choose RPN thresholds that prioritize the most critical failure modes while leaving room to deprioritize lower-risk issues.

Techniques To Determine the Right Corrective Actions

Next, you must assign the appropriate corrective actions for each failure. Weigh possible actions with respect to feasibility, efficiency, cost, and effectiveness.

In other words, the right solution is one that you can implement realistically, quickly, and at a reasonable cost relative to the potential cost of failure. Finally, it should also resolve the issue as completely as possible, without additional measures.

5 Common Mistakes in PFMEA Analysis

Done right, PFMEA can save organizations substantial time, money, and effort. But to reap the benefits, you must avoid these common mistakes:

1. Oversimplification. Simply going through the motions isn’t enough to gain substantial insights or drive noticeable change. Your entire team must be on board and committed to the process.
2. Lack of communication. Cross-functional collaboration is particularly essential to identify causes and select appropriate corrective actions. Equipment operators don’t have the same insights that engineers do, and vice-versa. To understand problems and implement effective solutions, teams must communicate and work together.
3. Outdated or siloed documentation. Paper records make interdepartmental communication more difficult. It’s also much more challenging to adopt a continuous improvement approach to PFMEA without dynamic records and trending data analysis. Use the right tools, such as CMMS, to improve documentation and communication.
4. Poor risk assessment and prioritization. Improperly ranking or prioritizing potential failures invalidates everything you could stand to gain from PFMEA. Full team buy-in, dedication, and cross-functional collaboration can prevent you from making this mistake.
5. Ineffective monitoring and improvement strategies. PFMEA isn’t a one-time process. To properly eliminate failure modes that cost you time and money, it’s essential to develop robust plans, carefully monitor your updates, and adjust your approach.

Best Practices for PFMEA Implementation

PFMEA should be a part of your team’s larger quality management systems. To implement this process efficiently and effectively, take the following measures.

Within your team, clearly communicate and document which team members are part of the process and what they’re responsible for.

Within your processes, establish clear scenarios signaling the need for PFMEA — for example, when new quality issues arise or processes change. Also, create standardized documentation (workflows, checklists, etc.) to simplify the process, as well as a system to track and monitor improvements.

Finally, within your broader plant management strategy, use PFMEA as one tool for problem solving — but emphasize preventive strategies for operational excellence. Other quality solutions such as statistical process control (SPC) can help you control, monitor, and improve production.

How eMaint Supports PFMEA Management

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