How can you identify and assess manufacturing risks?

Failure Mode and Effects Analysis (FMEA) is crucial for mission success. For instance, in spacecraft assembly, a propulsion system malfunction could risk maneuverability, endangering the entire mission. FMEA assesses severity, occurrence likelihood, and detection difficulty, guiding mitigation strategies like redundant systems or enhanced maintenance. FMEA benefits space missions by proactively identifying issues pre-launch, optimizing resources, enhancing system reliability, and minimizing mission risks and costs. It ensures potential failure modes are anticipated, evaluated, and mitigated, safeguarding the success of missions exploring the cosmos.

Create an effective FMEA and use it to build a control plan. This requires enlisting the right subject matter experts. From process, to reliabilityto product engineers. Invest in training the people working on the line a listen to their inputs.

Identifying and assessing manufacturing risks involves a comprehensive analysis of factors such as supply chain disruptions, equipment failures, and regulatory changes. Conduct a thorough risk assessment by evaluating historical data, engaging key stakeholders, and employing industry-specific expertise. Utilize risk management tools to identify potential vulnerabilities and prioritize them based on impact and likelihood. Regularly review and update risk assessments to adapt to changing circumstances, fostering a proactive approach to mitigate and manage manufacturing risks effectively.

I would suggest that the first step would be to identify the critical processes in your product (i.e. active area implants to form transistors and local/global metal connections in the I.C.). Once you have identified those critical processes, then you can begin to assess the risks and how to mitigate them.

Identifying and assessing manufacturing risks involves these factors. Analyzing the entire manufacturing process, supply chain, and technology. Evaluating environmental factors, quality control, and human factors. Considering financial risks, technology cybersecurity, and contingency planning. Using tools like FMEA for systematic risk assessment. Regularly monitoring and reviewing risks with stakeholder involvement. This process helps organizations proactively mitigate risks and enhance overall resilience.

The foundation for managing manufacturing risks lies in the clarity of product requirements. Beyond functional and regulatory aspects, delve into the realm of customer needs and feedback. By synthesizing these elements, you not only set benchmarks for evaluation but also create a dynamic framework that aligns your product with evolving expectations throughout the manufacturing journey.

Além do que já foi mencionado, incluiria também a análise do ambiente interno e externo, visando identificar lacunas no âmbito estratégico e, também, análise e retro-alimentação das não conformidades (implícito na FMEA), benchmarking e lições aprendidas.

If you did a good job defining expectations of your product, maybe using QFD (Quality Function Deployment), or DFM (Design for Manufacturability), one of the most powerful tool to address designs and manufacturing risks is DFMEA. Using Risk Priority Number and best assessment of severity ocurrente and detection, you might, from the very early stages, identify risks and opportunities as well as the best way to reduce those with a correct control plan and ensuring manufacturability trough error proofing or poka yokes. Per my experience, DFMEA and its reflection on control plans, might be enough to address main risks. Final stage would be error proofing and automation to reduce variation.

FMEA and DFM are two tools that have been helpful in my recent experiences. We also use a Process Safety What If Analysis to brainstorm potential risks and assess them in operations. Identifying risks is key as you won’t be able to develop proper prioritization and mitigation plans if you are blind to certain manufacturing or operations risks.

There is an efficient way to identify and, most importantly, ADDRESS potential risks in manufacturing. The theory is fine. But the problem is that when you hit a wall, you're alone! The way out: PRAGMATIC SOLUTIONS. Here is how I reduced many risks: A. Create a software simulation of the main manufacturing flow. Use what you have: a spreadsheet or advanced software. B. FIRST, apply INFINITE(maximum) capacity to every resource. C. Take the TOP risk on your list (machine failure, lack of personnel, supplying). D. Simulate it in a FINITE capacity. Now you have ONE Constraint you need to focus on. E. Focus your risk management on THAT constraint until you have both: - real-time identification measures - a solution or workaround for every case.

Moving beyond defining product requirements, the subsequent phase involves a comprehensive exploration of potential manufacturing risks. From materials to personnel, utilize diverse tools like FMEA, FTA, or risk matrices for a nuanced risk analysis. The aim is to not just list risks but to delve into their intricacies—understanding causes, consequences, and likelihoods—laying a foundation for proactive risk mitigation throughout the manufacturing journey.

Considerar todos os potenciais modos de falha, endereçando ao fatores de causa (6M) de ishikawa contribui para que consigamos mapear os riscos

Again I go back to a rigorous FMEA. Part of that is determining an RPN (risk priority number) to each process. This incorporates severity, probability, and detection. Pareto the results and focus improvement efforts on the top 5 or 10 depending on yor resources for improvement.

Beyond risk identification, the pivotal third step involves a meticulous evaluation of each risk's impact and probability during the manufacturing process. Assess the potential harm or loss, ranging from defects to customer dissatisfaction, and quantify the likelihood of occurrence. Employ numerical scales, qualitative ratings, or visual representations to discern and compare the varying impacts and probabilities, paving the way for targeted risk management strategies.

Considero a FMEA como ferramenta essencial para definir os critérios e prioridades. Apenas tenho alguma ressalva em considerar somente o RPN como forma de definir as prioridades na tomada de ações

Over the years (decades!) of working on manufacturing in global supply chains, I, of course, had advanced software(prioritize, mitigate) and even wrote an efficient system that runs 24/7 to this day. BUT YOU NEED MORE! a) go down PHYSICALLY to the manufacturing location. You can call this Kaizen or anything you wish. But just do it! b) the KEY is to LISTEN to the people who are actually manufacturing the product physically. They have a lot to say! You don't need a lot of fancy methods; be modest. Here is how to start: "We have solid software, but we need your vision of the issues (risks) we are having here. We need your help so we can improve the parameters of our system". c) TAKE YOUR TIME. Then add this know-how to your model.

Moving from assessment to action, the fourth step involves a strategic focus on the most impactful and probable risks. Utilize tools like a risk matrix or register to prioritize based on severity and urgency. Implement targeted mitigation strategies—be it prevention, reduction, transfer, or acceptance—to curtail negative effects. Crucially, document and communicate these plans transparently, ensuring stakeholders are aligned and informed throughout the risk mitigation journey.

Total agreed the Go and See approach. This is the most effective way as each factory has their own strengths and weaknesses. Even though the same technology same product, running in different factory will have different problem and risk.

In the ongoing narrative of risk management, the final step unfolds as a continuous monitoring and review process throughout manufacturing. Track product status against defined requirements and standards, collecting data on risk occurrence and outcomes. This real-time analysis not only evaluates the efficacy of risk management but also remains vigilant for emerging or evolving risks. The narrative evolves further with timely updates and revisions to risk plans, ensuring adaptability and resilience in the dynamic landscape of manufacturing.

Suppose: 1. You have superb software and measurements. 2. You have all the feedback you need from everybody in the company. 3. You are just 100% perfect! But oops, your manufacturing ecosystem can be impacted by unpredictable factors (climate, virus, social unrest) that disrupt your supply chain. Now what? If you store too much, it costs too much. If you don't store too much, you risk disrupting production. REALITY FACTOR: No matter what, unpredictability can take you down. Solution: Build EMERGENCY DRILL methodology as much as you can: - alternative suppliers, production, anything you can imagine! - involve your teams in this process You may not be able to solve all the problems, but you will be more resilient than your competition!

Imagine a startup's manufacturing saga, where a supplier's delay becomes a domino effect on product timelines. It highlights the need to not just manage internal risks but also navigate external dependencies, revealing a broader lesson in interconnected risk across the business landscape.

True, In simple way we should reduce dependency on suppliers and lay down processes for manufacturing in the current Industry. Being a part of engineering organization every function shall continue to put effort for engineering aspect rather than just achieving sales.