How do you use FMEA for GMP risk assessment?

The first step of FMEA is to define the scope of the analysis, which means specifying the product or process to be assessed, the functions or requirements to be fulfilled, and the boundaries or limits of the system. This helps to focus the attention on the relevant aspects and avoid unnecessary or redundant information. You can use tools such as process maps, flowcharts, diagrams, or checklists to describe the scope clearly and comprehensively.

Failure Mode and Effects Analysis involves making a diverse team of experts, defining the scope of assessment, and breaking down the production process into individual steps. At each step, potential problems are identified, and their severity, causes, and likelihood are evaluated. A Risk Priority Number is calculated to prioritize which issues need immediate attention. Corrective actions are implemented for high-priority problems. FMEA is a structured approach to proactively identify and mitigate risks in pharmaceutical manufacturing, ultimately ensuring the consistent production of safe and high-quality medicines.

Defining the scope of the Risk assessment is the first most important step. Once scope is decided, the next step is to identify the processes or the steps associated with the risk. Identify key failures/ risks that may occur owing the the introduction or modification of the process, system or utilities based on the Severity, probability and Detectability of the risk or failure. Assign an RPN no. Next identify what controls are in place or what actions we are going to take to minimize the risk to an acceptable level. If the risks are minimized, that's great otherwise propose what actions are to be taken to bring it down to an acceptable level. This process requires a thorough understanding of the system, procedures, product or practice.

First and most important requisite in FMEA is the team of SMEs, stakeholders and impacted CFT to focus on realistic failures and avoid unscientific and irrational risks. #FMEA #Risk #Assessment #GMP

AMDEC: cette méthode permet de décomposer un processus complexe en éléments maitrisables afin d’évaluer les modes de défaillance de chaque composant , les causes possibles et leur effets probables sur les résultats et ou la performance.

Step by Step FMEA incubation in GMP: FMEA is a systematic methodology used to identify and assess potential failures & modes in a process, product or system & thereafter to assess their impact on safety, quality and overall performance. FMEA can be used by following these steps: 1- Formation of team for comprehensive evaluation 2- Selection of product, its category and process or minimum system requirement 3- Breaking the process step by step 4- Identify failure modes 5- Determine the impact 6- Estimate the Occurrence & detection followed by calculation of RPN number 7- Prioritization of mitigation plan 8- Implement the action plan & monitor mitigations. 9- Record & stay for Continuous improvement with periodic review !!

I have seen failure modes defined in two ways for process FMEA: 1. The failure mode is operating outside of the defined NOR or PAR (and the effect of the failure would be the resulting consequences of the deviation or failure 2. The failure mode is the general effect of the failure (under reaction) and the effect of the failure is more specific (higher levels of “X” impurities I prefer the first but there’s different ways that this can be done

Analyzing failure modes efficiently in FMEA involves: <Prioritization: Focus on high-risk failure modes with the highest RPNs. <Root Cause Analysis: Dig deep to find and address root causes for effective solutions. <Data Utilization: Leverage existing data and industry benchmarks. <Technology: Use FMEA software tools for automation and collaboration. <Cross-Functional Teams: Engage diverse experts for comprehensive analysis. <Continuous Improvement: Make FMEA an ongoing process for efficient risk management and knowledge sharing.

I agree with above opinions from Yousef, Troy George, but also understand the product/process and identify the failure modes by discussing with SMEs to determine the Risk levels and apply mitigations to complete analysis..

More or less this is same like 5W1H principal where we question for wach W as why success? The more the questions, the more the clarity to microanalyse the issue. Best way to identify the reason of failure is to review the no. Of times deviation observed in process over a period of time from records. FBD is quintessential tool here to streamline the process which helps to visualise each section like man, method, machine, material, measurement and environment. Risk and opportunity at each stage is crucial here to define the problem statement.

Identify the risk points is not an easy work. For facility is relative general for different dosage form. But equipment and operation for different pharmaceutucals, the processes of biologics are more complicate, as CAR-T, Mab, ADC are very different operation control. The common control is to prevent contamination and cross contamination for biologics, and which the evaluater should have well known for both GMPand knowledge of process and products.

Risk probability no. Gives a fair idea in general terms but their are still some processes which still are independent from RAN for e.g. breakage of a fine tool in machine which can go with product. Being part of metal which can not be identified by metal detector leaves a high risk with all safety measures. The best approach is to identify the no. of times detection observed in past history (may not be essential at same machine or line but no. of incidence (naturewise) reported by consumer also crucial here. So best approach is to consider marketplace incidences also here.

Evaluating risk involves a systematic process that begins with the identification of potential threats and opportunities, both internal and external. This assessment requires an understanding of the probability of each risk occurring and the magnitude of its potential impact on objectives, be it financial, operational, or strategic. The combination of these assessments results in severity scores, aiding in the prioritization of risks. Strategies for mitigation, including cost-benefit analysis, must then be developed and aligned with the organization's risk tolerance level.

To evaluate the risk in GMP using FMEA (e.g., for pharmaceutical tablet manufacturing process), you need to look at the failure modes you have identified and combine their severity, occurrence (likelihood), and detection ratings. For instance, in pharmaceutical tablet manufacturing, if there's a high severity rating due to ingredient contamination, but your detection and occurrence ratings are low, you've got a red flag. This calculation helps prioritize which issues demand immediate attention.

Implementing risk management involves establishing a framework, identifying, and prioritizing risks, developing specific action plans, and executing them with clear objectives and responsibilities. Continuous monitoring, reviewing, and communication are vital throughout the process. Flexibility to adjust plans as needed and scenario analyses for complex situations are crucial. Employee training and awareness play a role, as does having a reporting and escalation process for critical risks. Regulatory compliance should be maintained, and a culture of continuous improvement is essential for effective risk management, helping organizations adapt to evolving challenges and opportunities.

After identifying the failure causes, failure modes and failure effects you need to: 1. enter current controls to detect the cause when it occurs 2. Use a ratings definition grid which relates to your process. 3. Rate severity, frequency, and detection with current controls. 4. Calculate the RPN: sec x occ x dec. 5. Choose which causes should have priority when assigning CAPAs 6. Complete CAPAs and re-evaluate your RPN.

Why designing the action plan it must be considered that the implemented action must synergies with existing practice, user friendly and reduce further steps in process. The best is to work in deep on DESIGN part of any process with all mistakeproofing plans. Considering the process which will give compliance product even if implemented control fails is success for e.g. for a pouch wt 1kg, checkweigher may fail but the delivery spiral chute having grooves clearance 0.5mm with fix no. Of round still gives confidence that any product will comply well in limit of MPE by design.

In GMP risk assessment via FMEA, addressing high-risk failure modes is critical step. After identifying them, plan and execute actions to minimize these risks. For instance, in pharmaceutical tablet manufacturing, if contamination is a top concern, implement stricter cleanliness protocols, conduct frequent equipment checks, invest in better filtration systems and implement quality control processes. It's about proactive steps to ensure tablets meet safety and quality standards, safeguarding both patients and reputation.

Be very careful of the people you involve in an FMEA! Often an “SME” will try to take over an FMEA session and snuff out ideas from the actual workers (executors) of the step where the process went awry. Without their valuable input (workers) you are often left chasing your tail because you followed the “strongest response” from the SME.

Identify potential failure modes in processes such as manufacturing, testing, and packaging. Analyze the causes and effects of each failure mode on product quality and patient safety. Assign risk scores based on severity, occurrence, and detection, then calculate the Risk Priority Number (RPN). Prioritize actions to mitigate high-risk issues by addressing root causes and improving controls. Implement corrective measures and reassess risks after changes to ensure continuous GMP compliance and product safety.

Insurance: Review your insurance coverage to ensure it adequately addresses the types of risks your organization faces. Consider whether additional coverage or policy adjustments are necessary. Stakeholder Engagement: Engage with stakeholders, including customers, suppliers, and regulatory bodies, to gain insights into emerging risks and to build collaborative risk management strategies. Scenario Testing: Conduct scenario testing and stress testing to assess how your organization would respond to extreme or unexpected events.

Making FMEA a thoughtful exercise can be a useful tool to find issues before they potentially happen and implement mitigating factors, but can easily go down a rabbit hole without without a clear scope and SMEs who know the processes well.

Simply put I use the DFMEA and PFMEA and the risks assigned to them to then to add steps in the manufacturing process at appropriate stages to detect inspect and or test and eliminate the causes of these failure modes to reduce the probability of a bad parts from leaving the facility