Corrective and Preventative Action (CAPA) is a system of quality procedures required to eliminate the causes of an existing nonconformity and to prevent recurrence of nonconforming product, processes, and other quality problems.
Corrective Actions and Preventive Actions.Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. Corrective vs. Preventive Action. Quality professionals frequently express confusion as to the difference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
CAPA management, corrective and preventive action, Rootcause analysis, RCA, Problem mapping, FMEA, Failure Mode effect and Analysis, Fault Tree analysis, Fishbone : ISHIKAWA, CTQ Tree (Critical to Quality Tree), AFFINITY DIAGRAM, 5 Why’s, Human errors,
Corrective Actions and Preventive Actions.Corrective Action Preventive Action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes. The ultimate purpose of CAPA is to assure the problem can never be experienced again. Corrective vs. Preventive Action. Quality professionals frequently express confusion as to the difference between corrective and preventive action. A corrective action deals with a nonconformity that has occurred, and a preventive action addresses the potential for a nonconformity to occur.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
CAPA management, corrective and preventive action, Rootcause analysis, RCA, Problem mapping, FMEA, Failure Mode effect and Analysis, Fault Tree analysis, Fishbone : ISHIKAWA, CTQ Tree (Critical to Quality Tree), AFFINITY DIAGRAM, 5 Why’s, Human errors,
Introduction to Understanding Human errors in Pharmaceutical IndustriesKarishmaRK
Human errors are inevitable part of our day-to-day activities. However, in highly regulated work environments, such errors can lead to huge losses. The presentation aims at introducing the concept of Human errors in regulated GMP work-space and its widely accepted classification for better evaluation & prevention.
For years, we've performed root cause analysis with whiteboards, Post-Its & spreadsheets using The 5 Whys, Ishikawa diagrams, FMEA, and DMAIC methodologies. Now, newer technologies have made the RCA discovery process faster and more precise, and support a direct link to CAPAs.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Introduction to Understanding Human errors in Pharmaceutical IndustriesKarishmaRK
Human errors are inevitable part of our day-to-day activities. However, in highly regulated work environments, such errors can lead to huge losses. The presentation aims at introducing the concept of Human errors in regulated GMP work-space and its widely accepted classification for better evaluation & prevention.
For years, we've performed root cause analysis with whiteboards, Post-Its & spreadsheets using The 5 Whys, Ishikawa diagrams, FMEA, and DMAIC methodologies. Now, newer technologies have made the RCA discovery process faster and more precise, and support a direct link to CAPAs.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
A risk-based CAPA process is a common goal of medical device manufacturers, but until recently “risk-based” was not clearly defined.
The biggest fundamental change in both ISO 9001:2015 and ISO 13485:2016 is an emphasis on risk-based process management.
The CAPA process is the heart of your quality system and one of the most important processes. Therefore, this presentation gives you a whole new set of tools for managing your CAPA process using risk-based approach
A risk-based CAPA process is more than prioritization.
This presentation includes:
-An outline of the CAPA process and proposed risk management activities
-Various risk control options that can be integrated with corrective actions
-How to reconcile conflicts between the definitions for risk in ISO 9001:2015 and ISO 13485:2016
-And more...
Watch the presentation here: https://www.greenlight.guru/webinar/risk-based-capa-process
FDA WARNING LETTER IS A OFFICIAL LETTER FROM USFDA TO A MANUFACTURING FIRM TO NOTICE THE SERIOUS VIOLATION FOUND AT THE FDA INSPECTION AT FIRM AND THE CORRECTIVE ACTION SHOULD TO TAKEN BY FIRM TO OVERCOME THE VIOLATION FOR FDA APPROVAL
Auditing Manufacturing Process and Product and Process Information.pdfDr. Dinesh Mehta
Manufacturing process audits should ensure that procedures are properly followed, problems are quickly corrected, there is consistency in the process, and there is continuous improvement and corrective action as needed.
Root Cause Analysis (RCA) is a problem-solving technique that aims to identify the underlying or "root" causes of a problem or issue. It involves digging deep into the symptoms of the problem to uncover the underlying factors that led to it. The goal of RCA is to identify the root cause or causes of the problem and address them, rather than just treating the symptoms. By doing so, organizations can prevent the problem from recurring in the future.
RCA can be used in a wide range of fields and industries, including manufacturing, healthcare, aviation, information technology, and many others. The process typically involves gathering data and information, analyzing the data to identify patterns and relationships, and developing a plan to address the root causes of the problem. RCA techniques can include tools like brainstorming, cause-and-effect diagrams, and statistical analysis, among others.
Operating Excellence is built on Corrective & Preventive ActionsAtanu Dhar
You see an issue and you simply set it right, but do you make the effort to find out what is the "corrective" action behind it, so that it never re-occurs?
And, do you take another extra step to come up with a "preventive" action - so that there is no other manner that issue comes up?
Root Cause Analysis – A Practice to Understanding and Control the Failure Man...inventionjournals
International Journal of Business and Management Invention (IJBMI) is an international journal intended for professionals and researchers in all fields of Business and Management. IJBMI publishes research articles and reviews within the whole field Business and Management, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
HAZOP, or a Hazard and Operability Study, is a systematic way to identify possible hazards in a work process. In this approach, the process is broken down into steps, and every variation in work parameters is considered for each step, to see what could go wrong. HAZOP’s meticulous approach is commonly used with chemical production and piping systems, where miles of pipes and numerous containers can cause logistical headaches.
HAZOP and Hazard Analysis Systems
Improving the Efficacy of Root Cause AnalysisCognizant
When medical device organizations apply a relevant and appropriate level of automation to root cause analysis, they can ensure swift action on nonconformities and avoid issue reoccurrence.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of 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 leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
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. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
2. Corrective and Preventative Action (CAPA) is a system of
quality procedures required to eliminate the causes of an
existing nonconformity and to prevent recurrence of
nonconforming product, processes, and other quality
problems.
The ultimate purpose of CAPA is to assure the problem can never be experienced
again. CAPA can be applied in many disciplines. A few of these disciplines are:
Manufacturing
Product Design
Testing Verification and Validation
Distribution, Shipping, Transport and
Packaging
Use-Applications
INTRODUCTION TO CAPA
3. Nonconforming Material or Process (Discrepancy) - Any
material or process that does not meet its required
specifications or documented procedure.
Correction – Refers to repair, rework, or adjustment and
relates to the disposition of an existing nonconformity.
Corrective Action - To identify and eliminate the causes of
existing nonconforming product and other quality problems.
Preventive Action - To identify and eliminate the causes of
potential nonconforming product and other quality
problems.
TERMINOLOGY
4. Corrective Action is an extension of Root Cause Analysis (RCA).
The first goal of CA is to find the root cause, base event or error that preceded
the problem.
second goal is to take action directed at the root cause or error.
COMPONENTS OF CORRECTIVE ACTION
Collect and analyze data to identify nonconforming product, incidents, concerns
or other quality problems that would be worth the effort to correct
Investigate and identify root cause
Implement the correct solution
Verify or validate effectiveness
CORRECTIVE ACTION
5. Preventive action includes the prediction of problems and attempts to avoid such
occurrences (fail safe) through self-initiated actions and analysis related to the
processes/products.
This can be initiated with the help of :
an active participation by staff members/workers through improvement teams,
Improvement meetings,
opportunities for improvement during internal audits, management review,
customer feedback and
deciding own goals quantized in terms of business growth,
reducing rejections,
utilizing the equipment effectively, etc.
The primary goal of PA is to inform an organization and prevent the problem from
returning in other facilities lines or products.
PREVENTIVE ACTION
6. THE 10 OBJECTIVES OF CAPA IMPLEMENTATION ARE:
Verification of a CAPA system procedure(s) that addresses the requirements of the quality
system regulation. It must be defined and documented.
Evidence that appropriate sources of product and quality problems have been identified.
Tracking of Trends (which are unfavorable) are identified.
Data sources for Corrective and Preventive Action are of appropriate quality and content.
Verify that appropriate Statistical Process Control (SPC) methods are used to detect
recurring quality problems.
Verify the RCA work performed is aligned to the level of Risk the problem has been
identified with.
Actions address the root cause and preventive opportunities.
CAPA process actions are effective and verified or validated prior to implementation.
Corrective and preventive actions for product and quality problems are implemented and
documented.
Nonconforming product, quality problems and corrective / preventive actions have been
properly shared and included in management review.
WHY IMPLEMENT CAPA?
7.
8. ROOT CAUSE AND THE “WEED” : Weeds can be difficult
to remove once they start to grow and spread. On the
surface, the weed is easy to see.
However, the underlying cause of the weed, its root, lies
below the surface and is not so obvious.
To eradicate the weed you have to get below the surface,
identify the root, and pluck it out.
Thus, you have to go beyond the obvious, ascertain an
accurate route cause, so the appropriate corrective action
can be pursued to prevent recurrence.
ASCERTAINING
ROOT CAUSE
9.
10. THE FIVE WHYS, a simplistic approach exhausting the question “Why?”.
FISHBONE DIAGRAM, a cause and effect diagram also known as the
Ishikawa diagram.
PARETO ANALYSIS, the 80/20 rule premised on a predefined database of
known problems.
FAULT TREE ANALYSIS, a quantitative diagram used to identify possible
system failures.
FAILURE MODES AND EFFECTS ANALYSIS (FMEA), which lists all
potential failure modes and the potential consequences associated with
each failure mode.
TOOLS FOR INVESTIGATING
ROOT CAUSE
11. The 5 Whys technique is a simpler form of fault tree analysis for
investigations, especially investigations of specific accidents as
opposed to chronic problems.
The 5 Whys technique is a brainstorming technique that identifies
root causes of accidents by asking why events occurred or
conditions existed.
The 5 Whys process involves selecting one event associated
with an accident and asking why this event occurred. This
produces the most direct cause of the event.
Drill down further indicating if their were any sub-causes of the
event, and ask why they occurred.
Repeat the process for the other events associated with the
accident.
THE 5 WHYS
12.
13. DISADVANTAGES
This time consuming brainstorming process may be
tedious for team members trying to reach
consensus. This is especially true for large teams.
Results are not reproducible or consistent. Another
team analyzing the same issue may reach a
different solution. The particular brainstorming
process that was utilized may be difficult, if not
impossible, to duplicate.
The 5 Whys technique does not provide a means to
ensure that root causes have been identified.
14. A fishbone diagram is a cause and effect diagram that looks much like a
skeleton of a fish. It is also called a Ishikawa diagram after the inventor
of the tool, Kaoru Ishikawa who first used the technique in the 1960s.
To draw the diagram, first list the problem/issue to be studied in the head
of the fish. Label each bone of the fish.
The major categories typically used are: The 6 M’s: Machines, Methods,
Materials, Measurements, Mother Nature (Environment), Manpower
(People).
Repeat this procedure with each factor under the category to produce
sub-factors. Continue asking, “Why is this happening?” and put
additional segments under each sub-factor.
A FISHBONE DIAGRAM
(ISHIKAWA DIAGRAM)
15. Continue adding sub-factors to your diagram until you no longer get
useful information as you ask, “Why is that happening?” . Analyze the
results of the fishbone after team members agree that an adequate
amount of detail has been provided under each major category.
Do this by looking for those items that appear in more than one category.
These become the ‘most likely causes”. For those items identified as the
“most likely causes”, the team should reach consensus on listing those
items in priority order with the first item being the most probable” cause.
16. ADVANTAGES
organize potential causes
help a team to think through causes they might otherwise
miss
provide a living document that shows the status of all
potential causes and whether they have been
proved/disproved/acted upon.
DISADVANTAGES
One danger with fishbone diagrams is that they create a
divergent approach to problem solving, where the team
expends a great deal of energy speculating about potential
causes, many of which have no significant effect on the
problem.
This approach may leave a team feeling frustrated and
hopeless.
17. The Pareto chart is a bar graph whose invention is attributed
to the Italy economist, Mr. Vilfredo Pareto.
Pareto principle – that for many phenomena, 80% of
consequences stem from 20% of the causes.
In the Pareto chart, the lengths of the bars represent
frequency or cost (time or money), and are arranged with
longest bars on the left and the shortest to the right. In this
way the chart visually depicts which situations are more
significant (a Pareto analysis).
THE PARETO CHART
18.
19. ADVANTAGES
Easy to understand as well as to present.
Many managers prefer to see an analysis that is easy to
represent and understand and a Pareto chart is strong tool
for that.
DISADVANTAGES
Focusing on the Pareto chart alone may lead to the
exclusion from further consideration of minor sources driving
defects and non-conformances.
They cannot be used to calculate the average of the data, its
variability or changes in the measured attribute over time.
Without quantitative data it isn't possible to mathematically
test the values or to determine whether or not a process can
stay within a specification limit.
20. Fault tree analysis was first introduced by Bell Laboratories and is
one of the most widely used methods in system reliability,
maintainability and safety analysis.
It is a deductive procedure used to determine the various
combinations of hardware and software failures and human errors
that could cause undesired events (referred to as top events) at
the system level.
The deductive analysis begins with a general conclusion, then
attempts to determine the specific causes of the conclusion by
constructing a logic diagram called a fault tree. This is also known
as taking a top-down approach.
The main purpose of the fault tree analysis is to help identify
potential causes of system failures before the failures actually
occur. It can also be used to evaluate the probability of the top
event using analytical or statistical methods.
FAULT TREE ANALYSIS
(FTA)
21.
22. Define the fault condition, and write down the top level failure.
Using technical information and professional judgments,
determine the possible reasons for the failure to occur. These are
level two elements because they fall just below the top level
failure in the tree.
Continue to break down each element with additional gates to
lower levels. Consider the relationships between the elements to
help you decide whether to use an "and" or an "or" logic gate.
Finalize and review the complete diagram. The chain can only be
terminated in a basic fault: human, hardware or software.
If possible, evaluate the probability of occurrence for each of the
lowest level elements and calculate the statistical probabilities
STEPS IN FTA
23. ADVANTAGES
FTA focuses on the judgment of experts from varied
disciplines and provides a common language and
perspective for the problem.
Both agreements and differences in opinion on the inputs
and importance are accounted for in FTA.
Members are not likely to feel threatened, due to the focus
on how the system operates, not personnel.
Graphic description clearly communicates the possible
causes of failure.
DISADVANTAGES
FTA relies on several expert opinions and judgments at
several stages. This makes it very prone to inaccuracy.
In large systems, computer algorithms are needed to
accomplish the quantitative analysis.
24. FMEA is a step-by-step approach for identifying all possible
failures:
in a design (“design FMEA”),
in a manufacturing or assembly process (“process FMEA”),
in a final product or service (“use FMEA”).
“Failures” are any errors or defects, especially ones that affect the
customer, and can be potential or actual.
“Failure modes” means the ways, or modes, in which something
might fail.
“Effects analysis” refers to studying the consequences, or effects,
of those failures.
FAILURE MODES AND
EFFECTS ANALYSIS (FMEA)
25. Failure can be represented by a Risk Priority Number
(RPN).
Risk Priority Numbers (RPN’s), can be ranked according to
the following: RPN = (Potential Severity) x (Likelihood of
Occurrence) x (Ability to Detect).
For all numerical weights, a common industry standard is to
us a 1 to 5 scale. For likelihood of occurrence for example
use 1 to represent “practically impossible” and 5 to indicate
“occurs frequently.”
When applying FMEA, the high-priority failures—identified
by higher RPN’s—are examined first.
For the failure, a root cause is identified and a corrective
action is developed to eliminate the root cause .
26. RECOMMENDED ACTIONS TO ADDRESS POTENTIAL
FAILURES THAT HAVE A HIGH RPN COULD INCLUDE:
specific inspection
testing or quality procedures
selection of different components or materials
limiting the operating range or environmental stresses
redesign of the item to avoid the failure mode; -monitoring
mechanisms
performing preventative maintenance
operator retraining
inclusion of back-up systems or redundancy.
Assign responsibility and a target completion date for the
above actions. This makes responsibility clear-cut and
facilitates tracking.
27. ADVANTAGES
Stimulates open communication of potential failures and their
outcomes.
Requires that all known or suspected potential failures be
considered.
Ranks failures according to risk.
Results in actions to reduce failure.
Results in actions to reduce risk.
Includes a follow up system and re-evaluation of potential failures
that favors continual improvement.
DISADVANTAGES
FMEA may not be able to discover complex failure modes
involving multiple failures or subsystems.
Without follow up sessions, the process will not be effective.
Follow up RPNs may be less instructive regarding improvement
from severe failure since detection and occurrence can always be
reduced but it is only in rare cases that severity ratings can be
reduced.
The CAPA requirement applies to manufacturers of medical devices and compels them to include CAPA in their Quality Management System (QMS).
Identifying the root cause of failure is a key tenet of any effective QMS. When a problem occurs, it is often just a symptom of the real issue. Symptoms can be treated but finding out why the symptom is experienced is the true purpose for implementing CAPA.