Nonconformity, Corrective Action, and Preventive Action

2010 ◽  
pp. 227-230
Keyword(s):  
Corrective Action ◽  
Preventive Action

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>

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.

scholarly journals IMPLEMENTASI SISTEM MANAJEMEN KESELAMATAN DAN KESEHATAN KERJA DENGAN METODE HIRADC PADA PERUSAHAAN PENGOLAHAN KAYU

2017 ◽  
Vol 2 (2) ◽  
Author(s):  
Hartono Hartono
Keyword(s):  
Corrective Action ◽  
Preventive Action ◽  
Hot Press ◽  
Unsafe Condition

Permasalahan keselamatan dan kesehatan kerja untuk anggota organisasi terutama perusahaan sekarang ini menjadi hal yang sangat penting dalam perkembangannya. Selain menjamin keselamatan dan kesehatan pekerjanya juga menjadi salah satu hal untuk meningkatkan produktifitas dan efisiensi kerja. Untuk itu banyak perusahaan yang mulai menerapkan sistem manajemen keselamatan dan kesehatan kerja dalam mengoperasikan perusahannya. Penerapan sistem manajemen ini menggunakan metode hiradc. Metode ini sudah banyak dipakai di perusahaan yang telah menerapkan OHSAS 18000. Metode hiradc diaplikasikan mulai dari identifikasi kegiatan pada unit kerja sampai potensi bahaya yang dapat ditimbullkan dari kegiatan atau aktifitas pekerjaan tersebut. Sehingga dengan mengetahui potensi bahaya maka akan dapat dilakukan tindakan perbaikan (corrective action) dan pencegahannya (preventive action). Implementasi dengan metode hiradc di bagian produksi pada perusahaan pengolahan kayu ini menekankan aktifitas yang terjadi pada penggunaan mesin hot press dan mesin panel saw yang frekuensi penggunaannya paling tinggi. Pada mesin hot press terdapat 4 hiradc yang menunjukkan 4 aktifitas utama yang terjadi pada mesin tersebut. Sedangkan pada mesin panel saw terdapat 3 HIRADC.Kata kunci : unsave act, unsafe condition, hiradc, corrective action, preventive action

Sign in / Sign up

Export Citation Format

Share Document