Corrective Action/Preventive Action (CAPA): Continuous Improvement

2013 ◽  
pp. 77-90
Keyword(s):  
Continuous Improvement ◽  
Corrective Action ◽  
Preventive Action

scholarly journals STUDY OF POSSIBILITIES OF JOINT APPLICATION OF PARETO ANALYSIS AND RISK ANALYSIS DURING CORRECTIVE ACTIONS

2020 ◽  
Vol 4 ◽  
pp. 22-24
Author(s):  
Volodymyr Haievskyi
Keyword(s):  
Continuous Improvement ◽  
Traditional Method ◽  
Quality Management System ◽  
Corrective Action ◽  
Risk Priority Number ◽  
Risk Area ◽  
Pareto Chart ◽  
Pareto Analysis ◽  
Joint Application ◽  
Corrective Actions

Continuous improvement in the quality management system is based on corrective action. Corrective actions require the identification of priority defects that require priority elimination of the causes of occurrence. The traditional method of prioritization can be considered a Pareto chart, built by the number of identified inconsistencies. This technique makes it possible to prioritize the most frequently detected defects. However, defects that are rare can significantly outweigh those that are often encountered in their consequences. The defect risk is a complex indicator that simultaneously takes into account both the number of detected defects and their impact. Failure Mode and Effects Analysis (FMEA) can be used to quantify risk. This technique allows to determine the risk priority number (RPN), taking into account the number of detected defects (O), the consequences of the appearance of a defect (S) and the possibility of timely detection of a defect or cause before the onset of undesirable consequences (D). The priority number of risks numerically characterizes the risks of a defect and can be used as a criterion for determining priority defects. Based on the values of the priority number of risks, a Pareto chart can be built and defects that form 80% of the risk area can be identified. These defects require urgent corrective action. According to the data taken from production, it is shown that the Pareto analysis by the priority number of risks gives results that differ from the analysis by the number of identified inconsistencies. Application of the proposed approach will allow introducing risk-oriented methods into the procedures for carrying out corrective actions. This will make it possible to direct the resources of the enterprise to eliminate the causes of defects that are actually detected and can have the most significant consequences for consumers of products

scholarly journals A retrospective study: root cause analysis of reported serious adverse event and development of corrective action and preventive action for deviated serious adverse event reports at a clinical trial site management office

2020 ◽  
Vol 7 (3) ◽  
pp. 194
Author(s):  
Dayanand Raddi ◽  
Revena S. Deveriniti ◽  
M. S. Ganachari ◽  
Geetanjali Salimath
Keyword(s):  
Clinical Trials ◽  
Adverse Event ◽  
Retrospective Study ◽  
Case Reports ◽  
Corrective Action ◽  
Preventive Action ◽  
Initial Report ◽  
Serious Adverse Event ◽  
Root Cause ◽  
Safety Reporting

<p class="abstract"><strong>Background:</strong> Serious adverse events (SAEs) are preventable if reported on time. Assessment of harm caused by clinical trials is difficult than assessing the benefits as it relied on the information as recorded by the study team. Hence it is important to have knowledge about quality safety reporting. The objectives of the study were to assess root cause for the timeline deviation found in SAE report and to develop the corrective action and preventive action to minimize deviation rate.</p><p class="abstract"><strong>Methods:</strong> A retrospective study was conducted in KLE’s Hospital and MRC, Belagavi. Data was collected from SAE documented trial study files. Between August 2016 to August 2019, 25 SAE occurred during clinical trials which were included in the study through complete enumeration and purposive sampling.</p><p class="abstract"><strong>Results:</strong> Data was analyzed for SAE reporting timeline where in no deviation was found in initial report. It was seen that all SAEs were not related to investigational product. The narrations of SAE were according to standardized format as per Ethics Committee review report. A gap was observed between onset of SAE and initial report in 16 case reports.</p><p class="abstract"><strong>Conclusions: </strong>The study concluded that there was a lag in reporting from onset of SAE to initial report even though there was no deviation observed in the initial report timeline. The main contributing factors were admitting in different hospital without information and lack of knowledge by subjects or their relatives which shows the need of awareness about quality safety reporting.</p>

AN ANALYSIS OF MAJOR ACCIDENT IN THE US CHEMICAL SAFETY BOARD (CSB) DATABASE

2015 ◽  
Vol 75 (6) ◽  
Author(s):  
Jihan A. Jalani ◽  
Kamarizan Kidam ◽  
Siti Suhaili Shahlan ◽  
Hamidah Kamarden ◽  
Onn Hassan ◽  
...  
Keyword(s):  
Continuous Improvement ◽  
Chemical Process ◽  
Corrective Action ◽  
Process Industry ◽  
Environmental Damage ◽  
Process Safety ◽  
Chemical Safety ◽  
Accident Rate ◽  
Chemical Process Industry ◽  
The Us

Accident rate in the chemical process industry (CPI) is high and causing loss of lives, massive property and environmental damage. Continuous improvement on accident knowledge and understanding is vital for process safety. Thus, an initiative to study the latest trends of accident was taken by analyzing 75 completed investigation reports of US Chemical Safety and Hazard Investigation Board (CSB) accident cases occurred in CPI from 1995 to 2011. The result of the analysis shows that the CPI accepted the concept of Prevention trough Design (PtD). However, 71% of accident cases are similar due to incorrect corrective action taken. 

scholarly journals Audits

2021 ◽  
pp. 25-34
Author(s):  
Olga López-Villar ◽  
Julie Dolva
Keyword(s):  
Corrective Action ◽  
Quality System ◽  
Preventive Action ◽  
Process Improvements ◽  
Essential Components ◽  
Selection Of

AbstractThere are different tools to measure the efficacy of the quality system and of its processes. Among them, internal audits are essential components since they cover all aspects of the program. Auditing is a systematic and documented process to ensure compliance with requirements. Preparing and planning are important parts of a good audit and the selection of the auditor must be based on expertise and competency. The appropriate analysis of the results of the audit and implementation of the corrective action, preventive action, or process improvements after the audit will help the program to improve year after year.

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