Presentation on Failure Modes and Effects Analysis, in the pharmaceutical context. Covering:
Introduction to risk assessment
What are risks?
Advantages and disadvantages of FMEA
Applying FMEA to review a sterility testing isolator – case study
The document discusses Failure Mode and Effects Analysis (FMEA), a systematic method for evaluating potential failures in design, manufacturing, and production processes. It was originally developed in the 1940s for the military and is now commonly used in various industries. An FMEA involves analyzing how and how often a process might fail and classifying the failures by severity, occurrence, and detection. The analysis helps prioritize risks and identify actions needed to prevent failures.
The document discusses Process Failure Mode and Effect Analysis (PFMEA). It explains that every product or process can have failure modes, even established ones, and that effective FMEAs require a team effort and should be done early in the design process. It also outlines the basic steps for a process FMEA, which involves identifying potential failures, effects, risks, and taking actions to reduce high-risk failures. The objective is to uncover process problems and reduce the risk of failures affecting products, efficiency or safety.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic process used to evaluate potential failures in a design, manufacturing or process and identify actions to address or prevent these failures. It involves identifying potential failure modes and ranking them based on severity, occurrence likelihood and ability to detect. Actions are then recommended to reduce the highest risk failures based on their Risk Priority Number. FMEA is intended to be preventative and identify issues before they occur.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceuticals
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Failure Mode & Effects Analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones. FMEA also documents current knowledge and actions about the risks of failures, for use in continuous improvement.
In this training presentation, you can teach your employees on the proper steps to construct an FMEA for a design or process, and then implement action plans to eliminate or reduce the risks of potential failures.
LEARNING OBJECTIVES
1. Understand what an FMEA is, why it is used, and when can it be deployed
2. Understand the definitions, scoring system and calculations used in an FMEA
3. Learn the steps to developing an FMEA and the pitfalls to avoid
CONTENTS
1. Introduction to FMEA
2. FMEA: Definitions, Scoring System & Calculations
3. FMEA Procedure
4. FMEA Example
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
Medicinal products must comply with their approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the active substance and/or finished product, according to the approved specifications. Under certain conditions, an alternative strategy to systematic end product testing is possible. So far this concept has been mainly applied to sterility testing of terminally sterilised products and has become associated with parametric release applications. Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made it possible to apply a similar release decision process to tests other than sterility, this approach has been called Real Time Release Testing (RTRT).
RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control. RTRT recognises that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end-product testing and the context as such be an integral part of the control strategy. The RTRT principle is already authorised for use as an optional alternative to routine sterility testing of products terminally sterilised in their final container i.e. parametric release. Enhanced product knowledge and process understanding, the use of quality risk management principles and the application of an appropriate pharmaceutical quality system, as defined within ICH Q8,Q9 and Q10 provide the platform for establishing RTRT mechanisms for other applications, for new products as well as established marketed products. Release of a product can be a combination of a RTR approach for certain critical quality attributes (CQAs) and a more conventional evaluation for other CQAs (partial RTR).
This presentation deals with the concepts of Real Time Release Testing. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
The document discusses Failure Mode and Effects Analysis (FMEA), a systematic method for evaluating potential failures in design, manufacturing, and production processes. It was originally developed in the 1940s for the military and is now commonly used in various industries. An FMEA involves analyzing how and how often a process might fail and classifying the failures by severity, occurrence, and detection. The analysis helps prioritize risks and identify actions needed to prevent failures.
The document discusses Process Failure Mode and Effect Analysis (PFMEA). It explains that every product or process can have failure modes, even established ones, and that effective FMEAs require a team effort and should be done early in the design process. It also outlines the basic steps for a process FMEA, which involves identifying potential failures, effects, risks, and taking actions to reduce high-risk failures. The objective is to uncover process problems and reduce the risk of failures affecting products, efficiency or safety.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic process used to evaluate potential failures in a design, manufacturing or process and identify actions to address or prevent these failures. It involves identifying potential failure modes and ranking them based on severity, occurrence likelihood and ability to detect. Actions are then recommended to reduce the highest risk failures based on their Risk Priority Number. FMEA is intended to be preventative and identify issues before they occur.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceuticals
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Failure Mode & Effects Analysis (FMEA) is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. The purpose of the FMEA is to take actions to eliminate or reduce failures, starting with the highest-priority ones. FMEA also documents current knowledge and actions about the risks of failures, for use in continuous improvement.
In this training presentation, you can teach your employees on the proper steps to construct an FMEA for a design or process, and then implement action plans to eliminate or reduce the risks of potential failures.
LEARNING OBJECTIVES
1. Understand what an FMEA is, why it is used, and when can it be deployed
2. Understand the definitions, scoring system and calculations used in an FMEA
3. Learn the steps to developing an FMEA and the pitfalls to avoid
CONTENTS
1. Introduction to FMEA
2. FMEA: Definitions, Scoring System & Calculations
3. FMEA Procedure
4. FMEA Example
The two most commonly used within microbiology are
HACCP (which originated in the food industry) and FMEA
(developed for engineering). This article explores these two
approaches, first with a description of HACCP, followed by a
description and case study of FMEA in sterility testing.
Medicinal products must comply with their approved specifications before they are released into the market. Compliance with release specifications can be demonstrated by performing a complete set of tests on the active substance and/or finished product, according to the approved specifications. Under certain conditions, an alternative strategy to systematic end product testing is possible. So far this concept has been mainly applied to sterility testing of terminally sterilised products and has become associated with parametric release applications. Recent guidelines adopted in the ICH context (ICH Q8, Q9 and Q10) have made it possible to apply a similar release decision process to tests other than sterility, this approach has been called Real Time Release Testing (RTRT).
RTRT is a system of release that gives assurance that the product is of intended quality, based on the information collected during the manufacturing process, through product knowledge and on process understanding and control. RTRT recognises that under specific circumstances an appropriate combination of process controls (critical process parameters) together with pre-defined material attributes may provide greater assurance of product quality than end-product testing and the context as such be an integral part of the control strategy. The RTRT principle is already authorised for use as an optional alternative to routine sterility testing of products terminally sterilised in their final container i.e. parametric release. Enhanced product knowledge and process understanding, the use of quality risk management principles and the application of an appropriate pharmaceutical quality system, as defined within ICH Q8,Q9 and Q10 provide the platform for establishing RTRT mechanisms for other applications, for new products as well as established marketed products. Release of a product can be a combination of a RTR approach for certain critical quality attributes (CQAs) and a more conventional evaluation for other CQAs (partial RTR).
This presentation deals with the concepts of Real Time Release Testing. This presentation was compiled from material freely available from FDA , ICH , EMEA and other free resources on the world wide web.
The document discusses risk management tools and techniques for environmental monitoring in pharmaceutical manufacturing. It introduces quality risk management and defines risk. It then discusses three case studies: 1) Using Hazard Analysis and Critical Control Points (HACCP) to select environmental monitoring locations by identifying hazards and critical control points. 2) Applying risk filtering to determine monitoring frequencies by evaluating risk factors and their severity and probability. 3) Using Failure Modes and Effects Analysis (FMEA) to assess risks from a sterility testing isolator by identifying potential failure modes and their effects.
FMEA is a systematic method for evaluating potential failures in a design, manufacturing or assembly process. It involves analyzing possible failures, identifying their causes and effects, and prioritizing issues based on severity, occurrence, and detection. The process results in a risk priority number to determine which failures should be addressed first. FMEA is widely used in industries like automotive, aerospace, healthcare to prevent failures and improve quality and safety.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
Critical hazard management system hasm presentationAmruta Balekundri
This document discusses fire and explosion hazard management. It describes the fire triangle, which states that fire needs fuel, oxygen and an ignition source. It also discusses 8 critical risk factors that can lower ignition energy or expand flammable ranges. The document outlines controls like purging or containment of fuels, isolation of oxygen sources, and reducing energy levels. It recommends prevention plans for operations using oxygen or introducing ignition sources. The fire and explosion hazard management process involves identifying hazards, assessing risks, controlling risks, evaluating controls, and keeping records. Corporations, supervisors and workers all have roles in training, hazard identification and challenging unsafe work.
The document provides guidance on performing a preliminary hazard analysis (PHA). It defines key terms like hazard, analysis, risk, probability, and severity. It explains that the goal of a PHA is to identify hazards and assess their risks to determine if risks are under acceptable control. The document outlines the PHA process, including identifying targets, hazards and their descriptions, assessing worst-case severity and probability of hazards, and using a risk matrix to evaluate risk. It emphasizes realistic, credible assessments rather than worst-conceivable scenarios.
This document provides an overview of Failure Mode and Effect Analysis (FMEA). FMEA is a systematic method to identify and prevent product and process failures before they occur. It involves reviewing components and processes to understand potential failures, effects, and causes. Key steps include determining severity, occurrence, detection ratings and calculating a Risk Priority Number. FMEA is widely used in industries like aerospace, automotive and healthcare to improve quality and safety. The document outlines the FMEA process and terms, provides examples, and discusses advantages like improved reliability and customer satisfaction.
The document discusses Failure Mode, Effects and Criticality Analysis (FMECA) which is a step-by-step approach to identify all possible failures in a design. It defines key terms like failure modes, effects and criticality. The document outlines the phases, purpose, benefits and techniques of FMECA including hardware and functional approaches. It provides examples of applying FMECA to analyze components and recommends corrective actions to address high risks.
The document discusses Failure Mode and Effect Analysis (FMEA), including its objectives, history, benefits, limitations, and how to conduct one. An FMEA is a process that identifies all possible failures in a service or process, assesses their effects and risks, and prioritizes actions to reduce risks. It was first used in the aerospace industry in the 1960s and has since been adopted by other industries like automotive. Conducting an FMEA involves a team identifying failure modes, effects, causes, controls, and risk levels to develop corrective actions.
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
The document discusses Corrective and Preventative Action (CAPA) systems used to eliminate existing quality issues and prevent future problems. It defines key terms like nonconformity and describes the general CAPA process. Specific root cause analysis tools are also outlined, including 5 Whys, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. Each tool's purpose, methodology, advantages, and limitations are summarized. Finally, preventative action and risk management processes are covered.
Fault Tree Analysis (FTA) is a systematic method that examines a system from the top down to identify the causes of failures. It involves defining an undesired event, then resolving it into immediate and basic causes through deductive reasoning. A logical fault tree diagram is constructed using graphical symbols to show the relationships between events. FTA is used to identify weaknesses, assess reliability and safety, prioritize contributors to failure, and optimize testing and maintenance.
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
This document provides an overview of corrective and preventive action (CAPA) requirements for medical device manufacturers. It discusses the purpose and context of the CAPA subsystem, when FDA reviews CAPAs, definitions, the CAPA process, procedures, data analysis, investigations, identifying required actions, and verifying the effectiveness of actions without adversely affecting the device. The key points are that CAPA is important for ensuring problems are detected and resolved, linked to other quality system requirements, and involves analyzing data, investigating causes, identifying appropriate corrective or preventive actions, and validating their effectiveness.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method used to evaluate potential failure modes in a design, process or service and their causes and effects. It involves analyzing potential failures, their likelihood and severity, and identifying actions to address potential failures with high risk priority numbers. The document defines key terms in FMEA like severity, occurrence, detection and risk priority number. It also outlines the FMEA process, including steps to identify potential failure modes, effects, causes, current controls and priority actions.
This document provides an overview of quality risk management and failure mode and effects analysis (FMEA). It discusses risk as a combination of the probability of harm occurring and the severity of that harm. The quality risk management process includes risk identification, analysis, evaluation, control, and communication. FMEA is presented as a systematic method to identify and prevent product and process problems before they occur. Key aspects of FMEA covered include failure modes, effects, risk priority numbers, and using FMEA to prioritize risks for improvement actions. Scales for rating severity, occurrence, detection, and examples of applying FMEA to a drying process are also presented.
Introduction to Failure Mode and Effects Analysis (FMEA) in TQMDr.Raja R
This document provides an introduction to Failure Mode and Effects Analysis (FMEA). It discusses what FMEA is, the types of FMEA (Design and Process), why FMEA is performed, when to perform it, and the steps to perform an FMEA. FMEA is a systematic method to identify potential failures, assess risks, and mitigate issues in the design or manufacturing process. It involves identifying failure modes and their causes and effects, then prioritizing failures based on severity, occurrence, and detection rankings. The goal is to address high-risk failures early in the design or process development stages to reduce costs and improve quality and safety.
The document discusses managing risk in cleaning validation. It covers regulatory background, risk identification including different types of residues and sampling methods, analytical methods, microbial considerations, and defining residue limits. It also discusses grouping equipment for cleaning validation and risk management tools to assess cleaning processes. The goal is to demonstrate cleaning procedures consistently reduce residues and contaminants to acceptable levels.
This document provides an overview of risk analysis. It defines key terms like risk, risk analysis, risk assessment, and risk management. It describes various qualitative and quantitative methods used for risk analysis, including hazard and operability studies, fault tree analysis, failure mode and effects analysis. The document discusses the importance of risk analysis for chemical processes and highlights some historical accidents to emphasize this. It also provides examples of applying different risk analysis methods.
Risk management is a systematic process of assessing, controlling, communicating, and reviewing risks associated with equipment, processes, materials, facilities, distribution, and patients. It involves identifying potential failure modes and their causes and effects, analyzing risks, and prioritizing critical risks. Tools like Failure Mode and Effects Analysis (FMEA) are commonly used to structure the risk analysis and management process. The goal is to design quality into processes and products throughout the product lifecycle to maintain quality and minimize risks.
The document discusses risk management tools and techniques for environmental monitoring in pharmaceutical manufacturing. It introduces quality risk management and defines risk. It then discusses three case studies: 1) Using Hazard Analysis and Critical Control Points (HACCP) to select environmental monitoring locations by identifying hazards and critical control points. 2) Applying risk filtering to determine monitoring frequencies by evaluating risk factors and their severity and probability. 3) Using Failure Modes and Effects Analysis (FMEA) to assess risks from a sterility testing isolator by identifying potential failure modes and their effects.
FMEA is a systematic method for evaluating potential failures in a design, manufacturing or assembly process. It involves analyzing possible failures, identifying their causes and effects, and prioritizing issues based on severity, occurrence, and detection. The process results in a risk priority number to determine which failures should be addressed first. FMEA is widely used in industries like automotive, aerospace, healthcare to prevent failures and improve quality and safety.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
Critical hazard management system hasm presentationAmruta Balekundri
This document discusses fire and explosion hazard management. It describes the fire triangle, which states that fire needs fuel, oxygen and an ignition source. It also discusses 8 critical risk factors that can lower ignition energy or expand flammable ranges. The document outlines controls like purging or containment of fuels, isolation of oxygen sources, and reducing energy levels. It recommends prevention plans for operations using oxygen or introducing ignition sources. The fire and explosion hazard management process involves identifying hazards, assessing risks, controlling risks, evaluating controls, and keeping records. Corporations, supervisors and workers all have roles in training, hazard identification and challenging unsafe work.
The document provides guidance on performing a preliminary hazard analysis (PHA). It defines key terms like hazard, analysis, risk, probability, and severity. It explains that the goal of a PHA is to identify hazards and assess their risks to determine if risks are under acceptable control. The document outlines the PHA process, including identifying targets, hazards and their descriptions, assessing worst-case severity and probability of hazards, and using a risk matrix to evaluate risk. It emphasizes realistic, credible assessments rather than worst-conceivable scenarios.
This document provides an overview of Failure Mode and Effect Analysis (FMEA). FMEA is a systematic method to identify and prevent product and process failures before they occur. It involves reviewing components and processes to understand potential failures, effects, and causes. Key steps include determining severity, occurrence, detection ratings and calculating a Risk Priority Number. FMEA is widely used in industries like aerospace, automotive and healthcare to improve quality and safety. The document outlines the FMEA process and terms, provides examples, and discusses advantages like improved reliability and customer satisfaction.
The document discusses Failure Mode, Effects and Criticality Analysis (FMECA) which is a step-by-step approach to identify all possible failures in a design. It defines key terms like failure modes, effects and criticality. The document outlines the phases, purpose, benefits and techniques of FMECA including hardware and functional approaches. It provides examples of applying FMECA to analyze components and recommends corrective actions to address high risks.
The document discusses Failure Mode and Effect Analysis (FMEA), including its objectives, history, benefits, limitations, and how to conduct one. An FMEA is a process that identifies all possible failures in a service or process, assesses their effects and risks, and prioritizes actions to reduce risks. It was first used in the aerospace industry in the 1960s and has since been adopted by other industries like automotive. Conducting an FMEA involves a team identifying failure modes, effects, causes, controls, and risk levels to develop corrective actions.
The ultimate guide on constructing a FMEA process for Manufacturing, Maintenance, Services and Design.
The presentation include step by step on how to determine the failure modes, failure effects, assign severity, assign occurrence, assign detection, calculate risk priority numbers and prioritize the RPNs for action. With some examples and illustrations.
Presentation contents:
1. Determing failure modes, effects and causes.
2. FMEA team & team leader.
3. Brainstorming.
4. The basic steps of FMEA.
5. Examples.
The document discusses Corrective and Preventative Action (CAPA) systems used to eliminate existing quality issues and prevent future problems. It defines key terms like nonconformity and describes the general CAPA process. Specific root cause analysis tools are also outlined, including 5 Whys, fishbone diagrams, Pareto charts, fault tree analysis, and failure mode and effects analysis. Each tool's purpose, methodology, advantages, and limitations are summarized. Finally, preventative action and risk management processes are covered.
Fault Tree Analysis (FTA) is a systematic method that examines a system from the top down to identify the causes of failures. It involves defining an undesired event, then resolving it into immediate and basic causes through deductive reasoning. A logical fault tree diagram is constructed using graphical symbols to show the relationships between events. FTA is used to identify weaknesses, assess reliability and safety, prioritize contributors to failure, and optimize testing and maintenance.
Effective CAPA Implementation in a Management System - Praneet SurtiPraneet Surti
The document discusses the Corrective Action and Preventive Action (CAPA) process. It defines CAPA as a structured way to investigate non-conformities, determine appropriate corrections and actions, and measure their effectiveness. It outlines the key steps in the CAPA process including defining the problem, investigating the root cause, determining corrective and preventive actions, implementing solutions, and measuring effectiveness. The document emphasizes that the goal of CAPA is to eliminate causes of issues in order to prevent recurrence and notes that a mature CAPA system can help continuously improve products, services, and compliance.
This document provides an overview of corrective and preventive action (CAPA) requirements for medical device manufacturers. It discusses the purpose and context of the CAPA subsystem, when FDA reviews CAPAs, definitions, the CAPA process, procedures, data analysis, investigations, identifying required actions, and verifying the effectiveness of actions without adversely affecting the device. The key points are that CAPA is important for ensuring problems are detected and resolved, linked to other quality system requirements, and involves analyzing data, investigating causes, identifying appropriate corrective or preventive actions, and validating their effectiveness.
This document provides an overview of Failure Mode and Effects Analysis (FMEA). FMEA is a systematic method used to evaluate potential failure modes in a design, process or service and their causes and effects. It involves analyzing potential failures, their likelihood and severity, and identifying actions to address potential failures with high risk priority numbers. The document defines key terms in FMEA like severity, occurrence, detection and risk priority number. It also outlines the FMEA process, including steps to identify potential failure modes, effects, causes, current controls and priority actions.
This document provides an overview of quality risk management and failure mode and effects analysis (FMEA). It discusses risk as a combination of the probability of harm occurring and the severity of that harm. The quality risk management process includes risk identification, analysis, evaluation, control, and communication. FMEA is presented as a systematic method to identify and prevent product and process problems before they occur. Key aspects of FMEA covered include failure modes, effects, risk priority numbers, and using FMEA to prioritize risks for improvement actions. Scales for rating severity, occurrence, detection, and examples of applying FMEA to a drying process are also presented.
Introduction to Failure Mode and Effects Analysis (FMEA) in TQMDr.Raja R
This document provides an introduction to Failure Mode and Effects Analysis (FMEA). It discusses what FMEA is, the types of FMEA (Design and Process), why FMEA is performed, when to perform it, and the steps to perform an FMEA. FMEA is a systematic method to identify potential failures, assess risks, and mitigate issues in the design or manufacturing process. It involves identifying failure modes and their causes and effects, then prioritizing failures based on severity, occurrence, and detection rankings. The goal is to address high-risk failures early in the design or process development stages to reduce costs and improve quality and safety.
The document discusses managing risk in cleaning validation. It covers regulatory background, risk identification including different types of residues and sampling methods, analytical methods, microbial considerations, and defining residue limits. It also discusses grouping equipment for cleaning validation and risk management tools to assess cleaning processes. The goal is to demonstrate cleaning procedures consistently reduce residues and contaminants to acceptable levels.
This document provides an overview of risk analysis. It defines key terms like risk, risk analysis, risk assessment, and risk management. It describes various qualitative and quantitative methods used for risk analysis, including hazard and operability studies, fault tree analysis, failure mode and effects analysis. The document discusses the importance of risk analysis for chemical processes and highlights some historical accidents to emphasize this. It also provides examples of applying different risk analysis methods.
Risk management is a systematic process of assessing, controlling, communicating, and reviewing risks associated with equipment, processes, materials, facilities, distribution, and patients. It involves identifying potential failure modes and their causes and effects, analyzing risks, and prioritizing critical risks. Tools like Failure Mode and Effects Analysis (FMEA) are commonly used to structure the risk analysis and management process. The goal is to design quality into processes and products throughout the product lifecycle to maintain quality and minimize risks.
The document discusses various tools and methods for hazard and risk management. It describes 12 different tools/methods: self-protective measures, training and reinforcement, communication/incentives, risk definition, risk assessment, risk control hierarchy, proactive vs reactive approaches, CAPA process, product review requirements, hazard identification/assessment/control process, and statistical tools like control charts. For each, it provides an overview and potential applications in risk management.
This document discusses hazard analysis and risk assessment. It defines hazard and risk, and outlines the main steps in hazard analysis and risk assessment. These include identifying hazards, determining who may be harmed and how, assessing dose-response and exposure, risk management and control. Hazard analysis techniques include checklists, safety audits, preliminary hazard analysis, failure modes and effects analysis, what-if analysis, and hazard and operability studies. Risk assessment involves quantifying risk based on probability and severity. The document emphasizes that hazard analysis and risk assessment should be ongoing processes throughout the lifecycle of a system.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
This document discusses quality risk management (QRM) and provides an overview of key QRM principles and processes. It defines key risk management terms and describes common risk management tools. The document outlines the general QRM process, which includes risk assessment, control, communication and review. It emphasizes that the level of effort for QRM should be commensurate with the level of risk. Various risk management tools are also described, including failure mode and effects analysis, hazard analysis, hazard operability analysis, and fishbone diagrams.
The document provides an overview of failure mode and effects analysis (FMEA). It defines FMEA as a systematic technique used to evaluate potential failures and their causes. The objective is to classify possible failures by their severity, occurrence, and detection to find solutions that eliminate or minimize risks. The document outlines the FMEA process, which involves determining the process/component, identifying potential failure modes and effects, rating severity, occurrence, and detection, calculating the risk priority number, and planning corrective actions. FMEA is a proactive method used in design, manufacturing, and other stages to prevent defects and improve quality.
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a structured approach to identify ways a product or process can fail, estimate associated risks, and prioritize actions to reduce risk. The document outlines the FMEA process, including determining failure modes, effects, causes, controls, and risk priority numbers. It also discusses different types of FMEAs for design and processes and notes that FMEA is a team tool that uses other process analysis inputs.
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a structured approach to identify ways a product or process can fail, estimate associated risks, and prioritize actions to reduce risk. The document outlines the FMEA process, including determining failure modes, effects, causes, controls, and risk priority numbers. It also discusses different types of FMEAs for design and processes and notes that FMEA is a team tool that uses other process analysis inputs.
IT 381_Chap hubybybybybybybytggyguh7h7_7.pptksujith0034
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a structured approach to identify ways a product or process can fail, estimate associated risks, and prioritize actions to reduce risk. The document outlines the FMEA process, including determining failure modes, effects, causes, controls, and risk priority numbers. It also discusses different types of FMEAs for design and processes and notes that FMEA is a team tool that uses other process analysis inputs.
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a structured approach to identify ways a product or process can fail, estimate associated risks, and prioritize actions to reduce risk. The document outlines the FMEA process, including determining failure modes, effects, causes, controls, and risk priority numbers. It also discusses design and process FMEAs and how FMEA integrates with other process tools.
FMEA presentation for research and developmentbasant11731
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a structured approach to identify ways a product or process can fail, estimate associated risks, and prioritize actions to reduce risk. The document outlines the FMEA process, including determining failure modes, effects, causes, controls, and risk priority numbers. It also discusses different types of FMEAs for design and processes and notes that FMEA is a team tool that uses other process analysis inputs.
FMEA análise e odos de falhas e seus efeitos.pptGleibsonHenrique
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a structured approach to identify ways a product or process can fail, estimate associated risks, and prioritize actions to reduce risk. The document outlines the FMEA process, including determining failure modes, effects, causes, controls, and risk priority numbers. It also discusses different types of FMEAs for design and processes and notes that FMEA is a team tool that uses other process analysis inputs.
This document outlines a risk-based approach for classifying deficiencies found during inspections. Deficiencies are described as instances of non-compliance and are classified based on whether they result from a defective system or a failure to comply with the system. Deficiencies can be critical, major, or minor/other observations. Critical observations pose a significant risk of patient harm, while major observations indicate major deviations from good practices. The document also describes Pfizer's 10-step process for conducting a quality risk management assessment, which includes identifying risks, defining risk components and scales, applying a risk analysis tool, defining risk mitigation measures, and documenting the assessment.
Risk management in pharmaceutical IndustryMahesh shinde
This document provides an overview of risk management in the pharmaceutical industry. It discusses the objectives, scope, definitions, and tools used in risk management. The key tools covered include Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Hazard Analysis and Critical Control Points (HACCP), and Preliminary Hazard Analysis (PHA). The goal of risk management is to identify potential risks, evaluate their likelihood and impact, and develop control measures to mitigate risks and ensure product quality and safety.
FMEA is a systematic method to identify potential failures, quantify risks, and determine actions to address issues. It involves analyzing potential failure modes and their causes and effects. Failures are evaluated based on severity, occurrence likelihood, and detection difficulty to calculate a risk priority number. Actions are identified and prioritized based on RPN to prevent or mitigate risks. FMEA is used across industries to improve safety, quality and reliability.
The document discusses quality risk management in the pharmaceutical industry. It defines key risk management terms and principles, and describes the risk management process including risk assessment, control, communication and review. It provides examples of risk management tools and methods used in different applications. The integration of quality risk management into industry and regulatory operations is discussed, with the goal of improving decision making and patient safety.
This document provides an overview of failure mode and effects analysis (FMEA). It describes FMEA as a tool to identify potential failure modes, estimate the risk associated with failures, and prioritize actions to address high-risk failures. The document outlines the FMEA process, which involves identifying failure modes and their causes and effects, then calculating a risk priority number to prioritize issues. It also discusses design and process FMEAs and when each is used. Finally, it reviews how FMEA relates to and can be used along with other process analysis tools.
This document outlines the quality risk assessment process at Hester Bioscience Limited. It discusses risk assessment for products, processes, equipment, facilities and more. Key points include:
- Quality risk assessment is a systematic process to identify, analyze, evaluate and control risks that could affect quality. It is applied across the product lifecycle.
- Risks are identified based on factors like deviations, complaints, audits and changes. They are analyzed using tools like FMEA to determine severity, likelihood and current controls.
- Identified risks are evaluated and assigned a risk level of minor, major or critical. Control measures are considered and implemented to reduce risks to acceptable levels.
- Various departments and functions are
Similar to Application of FMEA to a Sterility Testing Isolator: A Case Study (20)
Microbiologists carry out a lot of environmental montoring, but is this sufficiently focused? Are too many samples taken? Are samples taken in the wrong locations or at the wrong frequency? Some ideas are presented.
Overview of the key requirements ofelectronic data management systems in relation to pharmaceuticals and healthcare facilities. This includes the importance of computerised systems controls and defenitions of data. The presentation includes the importance of validation and quality assurance aspects.
This document discusses improving the efficiency of an organization's internal quality auditing process. Currently, the process is paper-heavy and labor intensive, involving multiple forms, duplicative logging, and scanning documents multiple times. The goals of the project are to make the auditing process more efficient and less time-consuming. Quick wins identified include reducing duplicate logging, reducing unnecessary paperwork, and moving to electronic communication and records. Interviews will gather user feedback and the new process will be measured and analyzed for further improvements. Ultimately, an electronic auditing system is proposed to make the process fully traceable, reduce manual work, and eliminate paper use.
This document discusses anomalies, complaints, non-compliances, and corrective and preventative actions as required by ISO 17025. It outlines the process laboratories must follow to investigate problems, determine the root cause, consider and select options to immediately correct the problem and prevent reoccurrence, and then review the effectiveness of the actions. This includes using tools like fishbone diagrams and SMART criteria to aid the investigation and ensure corrective actions sufficiently address the root cause. Preventative actions focus on proactively improving processes rather than reacting to identified problems. Effective corrective and preventative actions can help laboratories continually improve and reduce future issues.
Introduction – the ‘great’ myths
Colony Forming Units – what are they?
Microbiology laboratory cabinets – always work?
Media growth promotion – can it be skipped?
Microbial distribution in cleanrooms – free floating?
Environmental monitoring parameters – can they be pre-set?
Bunsen burners needed to create aseptic space– or not?
Identification results– always believable?
Pharmaceutical Microbiology: Current and Future Challenges Tim Sandle, Ph.D.
The changing environment for pharmaceutical microbiology
Limitations of methods
Need for new (rapid) methods
Separating people form processes
Single-use technologies
Environmental monitoring programme
Best practices
Rapid methods
Contamination control strategy
Objectionable organisms
Burkholderia cepacia complex
Why use reference materials?
The importance of reference materials
Different categories of reference materials.
Different classes of reference materials.
Standards for reference materials.
How reference materials are prepared and assessed.
How reference materials are used.
The document discusses contamination control in manufacturing environments. It notes that contamination can arise from people, air, surfaces, and water. People are identified as the biggest source of contamination as they can shed skin cells and microorganisms through actions like sneezing, coughing, and touching surfaces. Water is also a key contamination source as it allows microorganisms to spread and grow. The document emphasizes that contamination control and risk assessment should be the primary focus to minimize potential contamination issues before environmental monitoring is used. Cleanrooms graded A through D are used in manufacturing to control cleanliness levels and minimize contamination according to the processes taking place.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. These slides provide an overview of current regulations, with a focus on pharmaceuticals and healthcare.
What is likely to go into the revised Annex 1, including:
Terminal sterilisation vs aseptic processing
WFI produced by reverse osmosis
Guidance for media simulation trials
This remains speculative
Key question:
Could the plague ever re-emerge on a similar level in the twenty-first century?
Due to the potential seriousness of the disease this is a subject worthy of epidemiological consideration and research.
Considering: Environmental monitoring guidance, Background to USP <1116>, Main changes and debates Method limitations, Incident rates, Frequencies of monitoring, Locations of monitoring, Other changes, Regulatory issues and Rapid methods
An introduction to the international cleanroom standard ISO 14644 and the 2015 revisions to Parts 1 and 2. The focus is on particulate and contamination control.
This document discusses 7 common myths in microbiology and cleanroom practices. It summarizes that colony forming units may not always accurately represent bacterial numbers due to variability in culture methods. Microbiology cabinets are not always laminar due to disruptions in airflow. Media growth promotion testing cannot always be skipped and relies on appropriate control strains. Microorganisms in cleanrooms are rarely free floating and are usually attached to particles. Environmental monitoring parameters cannot have universal pre-set conditions due to variability in microorganisms and methods. Bunsen burners are not always needed to create aseptic spaces and can increase risks of contamination. Identification results from phenotypic tests are not always reliable due to limitations in databases and possibility of mixed cultures or changes in phenotypes.
The document discusses three main methods for the bacterial endotoxin test - gel clot, turbidimetric, and chromogenic. The gel clot method is the simplest but least quantitative, while turbidimetric and chromogenic methods allow for more automation and precision using spectrophotometry. All three methods use Limulus amebocyte lysate and detect endotoxins through coagulation reactions. The choice of method depends on factors like testing volumes, sample properties, required sensitivity, and compliance needs. Photometric methods have advantages of automation and precision but higher costs, while gel clot is inexpensive but less quantitative.
This document outlines standards of behavior and practices for cleanrooms and cleanzones. It defines key terms like cleanroom, cleanzone, critical activity, and aseptic processing. The document provides guidelines for behaviors in all cleanrooms and cleanzones, including proper gowning, minimizing contamination, and maintaining orderly work areas. It also outlines additional requirements for aseptic filling suites, such as proper glove sanitization procedures and using aseptic technique. The document states that compliance with these standards will be assessed through microbiological audits and is necessary to meet regulatory expectations for sterile drug production.
Presentation on the examination of microbiological data for assessment and trending.
Includes: normalizing data, graphs, and assessment of alert and action levels.
Hiranandani Hospital in Powai, Mumbai, is a premier healthcare institution that has been serving the community with exceptional medical care since its establishment. As a part of the renowned Hiranandani Group, the hospital is committed to delivering world-class healthcare services across a wide range of specialties, including kidney transplantation. With its state-of-the-art facilities, advanced medical technology, and a team of highly skilled healthcare professionals, Hiranandani Hospital has earned a reputation as a trusted name in the healthcare industry. The hospital's patient-centric approach, coupled with its focus on innovation and excellence, ensures that patients receive the highest standard of care in a compassionate and supportive environment.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central19various
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Our backs are like superheroes, holding us up and helping us move around. But sometimes, even superheroes can get hurt. That’s where slip discs come in.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
REGULATION FOR COMBINATION PRODUCTS AND MEDICAL DEVICES.pptx
Application of FMEA to a Sterility Testing Isolator: A Case Study
1. Application of FMEA to a Sterility
Testing Isolator: A Case Study
Dr. Tim Sandle
www.pharmamicreouresources.com
2. Introduction
Introduction to risk assessment
What are risks?
Advantages and disadvantages of
FMEA
Applying FMEA to review a sterility
testing isolator – case study
4. Risk Assessment
Increasingly used tool in the pharmaceutical
sector.
An expectation of regulatory authorities.
Important because:
– A proactive tool;
– A reactive tool;
– To explore weaknesses and seek improvements;
– To construct rationales;
– Part of the qualification and validation of
processes.
5. Risk is ever present
THERE IS NO SUCH THING AS
“ZERO” RISK
Need to understand, “quantify” and manage risks in
pharmaceuticals and healthcare.
Risk is defined as the combination of the probability of
occurrence of harm and the severity of that harm i.e.
– What might go wrong?
– What is the likelihood (probability) it will go wrong?
– What are the consequences (severity)?
Risks relate to a situation where a recognized hazard may
result in harm.
6. Risk Assessment
Different approaches for risk assessment
including:
– HACCP (Hazard Analysis Critical Control Points),
which has its origins in the food industry;
– Fault Tree Analysis (FTA) ;
– Modelling software (such as the Monte Carol
model);
– FMEA (Failure Mode and Effects Analysis), which
originated in the engineering sector.
– Several described in ICH Q9 and EU GMP Annex
20.
9. Risk Assessment
A more detailed approach involves:
– Gathering data through an audit and analysis;
– Constructing diagrams of work flows;
– Pin-pointing areas of greatest risk;
– Examining potential sources of contamination;
– Deciding on the most appropriate sample methods;
– Helping to establish alert and action levels;
– Taking into account changes to the work process /
seasonal activities;
– Using some type of scoring system so that the risk can be
ranked and the level of risk determined.
11. FMEA
FMEA is “Failure mode and effects analysis”
It is an analytical tool which was originated by the
US military and is widely used in the engineering
industry
Very structured approach (ISO/TS 16949)
FMEA is applied to many areas as a problem solving
tool
This talk adopts one possible approach based on
the approach of the non-commercial FMEA
Information Centre:
http://www.fmeainfocentre.com/introductions.htm
12. FMEA
FMEA looks for failure modes.
A failure mode is a characterization of
the way a product or process fails.
The term may be applied to
mechanical failure, structural failure,
electrical failure, biological risks and
systems failure.
13. FMEA
Advantages:
– Improve product/process reliability and quality
– Increase customer satisfaction
– Early identification and elimination of potential
product/process failure modes
– Prioritize product/process deficiencies
– Capture engineering/organization knowledge
– Emphasizes problem prevention
– Documents risk and actions taken to reduce risk
– Provide focus for improved testing and development
– Minimizes late changes and associated cost
– Catalyst for teamwork and idea exchange between
functions
14. FMEA
Disadvantages:
– It is subjective;
– It has a long-drawn-out approach;
– The focus is on failure / non-conformance
types and not on the chain of events
(cause / effect);
– It tends only to focus on major issues;
– Not ideal for environmental monitoring –
HACCP is better.
15. FMEA
FMEA
Dangers:
– Looks at ‘detection’ as a risk mitigation,
which influences the determined score
Need to be careful with microbiological data
since our methods have poor detectability
With microbiological risks, focus on severity
and likelihood
– Application of a ‘score’ is subjective.
17. FMEA
FMEA steps:
– Setting the scope;
– Defining the problem;
– Setting scales for factors of severity,
occurrence and detection (see later);
– Process mapping;
– Defining failure modes;
– Listing the potential effects of each failure
mode;
– Assigning severity ratings to each process
step;
18. FMEA
Steps continued:
– Listing potential causes of each failure mode;
– Assigning and occurrence rating for each
failure mode;
– Examining current controls;
– Examining mechanisms for detection;
– Calculating the risk;
– Examining outcomes and proposing actions to
minimise risks.
Ideally it should be team based.
20. Isolator Study
Despite a superiority to cleanrooms, all Isolators
are at risk from contamination
The approach of regulators, such as the FDA, is:
“Barrier Isolators cannot prevent contamination
caused by GMP deficiencies such as poor aseptic
procedures and inadequate training of…operators”
(The Gold Sheet, Vol. 32, No.10)
21. Isolator Study
Description:
– From a pharmaceutical manufacturer based in the
south-east of England.
– The Isolator was one half-suit Isolator, two
transfer Isolators and a steriliser unit.
– Positive pressure, flexible film Isolators with
stainless steel frames and wood bases designed
for aseptic processes (in this case: sterility testing
to Ph. Eur. 2.6.1).
– Air is using HEPA filters and material is transferred
into and out of the main Isolator using transfer
Isolators connected using Rapid Transfer Ports
(RPT).
– Sanitised by hydrogen peroxide vapour.
– The internal environment is classed as Grade A /
ISO 5
22. Isolator Study
Identifying the main risks:
– Leaks;
– Gloves / operator manipulations;
– Filters;
– Other airborne contamination;
– Transfer of material into and out of the Isolator;
– The Isolator room;
– Decontamination cycle;
– Cleaning / environmental monitoring issues.
23. Isolator Study
Designing the FMEA scheme
– FMEA schemes vary in their approach, scoring
and categorisation.
– All approaches share in common a numerical
approach. The approach adopted was to assign
a score (from 1 to 5) to each of the following
categories:
i) Severity
ii) Occurrence (or probability)
iii) Detection
24. Isolator Study
i) Severity is the consequence of a failure,
should it occur;
ii) Occurrence is the likelihood of the failure
happening (based on past experience);
iii) Detection is based on the monitoring
systems in place and on how likely a failure
can be detected.
A good detection system is one that can
detect a failure before it occurs.
25. Isolator Study
A scale from 1 to 5. It followed that
the likelihood of high severity would
be rated 5; high occurrence rated 5;
but a good detection system would be
rated 1.
See over….
26. Isolator Study
Severity 5 Specification limits exceeded. Probable rejection of
test or shutdown of system.
3 Observed trend takes place, but no critical
excursions. Requires investigation.
1 No excursion has taken place. No upward trends
and no investigation is required.
Occurrence 5 Expected to occur 50% time.
3 Expected to occur ≥10 - ≤50% time.
1 Expected to occur ≤10%.
Detection 5 No way to detect the failure mode.
3 Can be partially detected but detection could be
improved.
1 Good detection systems in place.
27. Isolator Study
Using these criteria a final FMEA score is
produced (sometimes called a Risk Priority
Number):
x
125
The total of 125 is derived from: severity
score x occurrence score x detect score, or:
5 x 5 x 5 = 125
28. Isolator Study
A score of 27 was the cut-off value: where
action was required.
Based on 27 being the score derived when
the mid-score is applied to all three
categories
The numerical value '3' from:
Severity (3) x Occurrence (3) x Detection (3)
The supposition that if the mid-rating (or a higher number) was scored for all three
categories then as a minimum the system should be examined in greater detail.
30. Examples
3 examples
– Potential for sanitisation cycle failure
– Pressure leaks to gloves
– Connection of transfer Isolator to main Isolator and
transfer-in / out of material
31. Isolator Example 1
Potential for
sanitisation
cycle failure
#1
Process step Failure
Mode
Significance
of failure
Severity
of
conseque
nce
(score)
Performing
sanitisation
cycles on
transfer or main
Isolator
An
Isolator is
not
correctly
sanitised
Contaminated
items enter
main Isolator
or main
Isolator itself is
contaminated
4
32. Isolator Example 1
Potential for
sanitisation
cycle failure
#2
Measures to
detect failure
Occurrenc
e
(score)
Detection
systems
Detection
(score)
Evaporation rate
/ pre- and post-
lot testing of
acid /
sanitisation
cycles developed
using BIs
1 Steriliser
parameters
checked after
sanitisation
and before
use / acid
potency
checked for
each lot /
post-
sanitisation
environmental
monitoring
performed for
main Isolator
1
34. Isolator Example 2
Pressure
leaks to
gloves
#1
Process step Failure
Mode
Significance
of failure
Severity
of
consequ
ence
(score)
Use of gloves
to transfer
material or to
perform sterility
test (sterile
gloves may be
worn
underneath
Isolator gloves)
Contaminati
on from
technician
into Isolator
or weak
area of
positive
pressure to
allow
contaminati
on in
Contaminati
on present
in Isolator /
compromise
of aseptic
technique
4
35. Isolator Example 2
Pressure
leaks to
gloves
#2
Measures to
detect failure
Occurre
nce
(score
)
Detection
systems
Detection
(score)
Environment
al monitoring
(post-use
finger
plates) /
pressure
charts
2 Environme
ntal
monitoring
is
performed
post-test
on gloves /
gloves are
wiped with
disinfectan
t / gloves
are visually
examined
weekly and
changed as
appropriat
e
3
38. Isolator Example 3
The transfer of material in and out of the Isolator is, arguably, the biggest risk:
Non-sterile area between doors
*
*Area of biggest risk
40. Isolator Example 3
Connection of
transfer Isolator
to main Isolator
and transfer-in
/ out of
material #1
Process step Failure Mode Significance
of failure
Severity
of
conseque
nce
(score)
Connection of
transfer
Isolator to
main Isolator
and moving
material in and
out
Contaminat
ion on
outside of
both
Isolators
may enter
the main
Isolator /
failure to
maintain
positive
pressure
Contamina
tion enters
the
Isolator or
positive
pressure is
not
maintained
4
41. Isolator Example 3
Connection of
transfer Isolator
to main Isolator
and transfer-in
/ out of
material #2
Measures to
detect failure
Occurrence
(score)
Detection
systems
Detection
(score)
Environmenta
l monitoring /
pressure
monitoring
1 DPTE seal
system / use
of
disinfectant
for
connection
1
42. Isolator Example 3
Connection of
transfer Isolator
to main Isolator
and transfer-in
/ out of
material #3
FMEA score:
4 x 1 x 1 = 4
43. Isolator study
Revisit the ranking
Define residual risk
Perform a short summary
– Scope
– Data from the assessment & control
(e.g. no. of identified failure modes)
– Level of accepted risk without actions i.e. residual
risk
(e.g. risk priority Number < 27)
– Recommended actions, responsibilities and due dates
(including approval, if appropriate)
– Person in charge for follow-up of FMEA
44. Isolator Study
Summary of the entire study:
Isolator FMEA risk assessment
0
5
10
15
20
25
30
R
oom
C
ycle
Frequency
IntegrotyC
onnectionS
anitisation
P
hysical
G
loves
Category
FMEAscore
Cut off score
45. Further examples
Sandle, T. ‘The use of a risk assessment
in the pharmaceutical industry – the
application of FMEA to a sterility testing
isolator: a case study’, European Journal
of Parenteral and Pharmaceutical
Sciences, 8(2): 43-49
46. FMEA
A risk assessment technique – FMEA
can be readily applied to a key
operation
This technique did not originate in the
pharmaceutical industry.
This indicates how the synergy of
different approaches can be achieved.
47. FMEA
Regular reviews must take place;
FMEA is not suitable for everything e.g.
HACCP may be more suitable for suitable for
aseptic filling.
It is not able to discover complex failure
modes involving multiple failures or
subsystems, or to discover expected failure
intervals of particular failure modes.
48. Thank you
Dr. Tim Sandle
www.pharmamicroresources.com
Any questions?