Review Article
Volume 3 Issue 2 - 2021
Standard Operating Procedures for reporting, investigating, and handling Deviations in Healthcare Organizations
1Gentium Healthcare, Cairo, Egypt
2University of South Wales, School of Law, Accounting and Finance, Pontypridd, Wales
3McMaster University, Hamilton, Canada
2University of South Wales, School of Law, Accounting and Finance, Pontypridd, Wales
3McMaster University, Hamilton, Canada
*Corresponding Author: Mohamed Refaat, Gentium Healthcare, Cairo, Egypt.
Received: July 02, 2021; Published: October 12, 2021
Abstract
The purpose of this paper is to provide best practice procedures for the reporting, investigating, and handling of deviations from an organization’s defined Standard Operating Procedures (SOPs). These practices ensure transparency, enhancement of Quality Assurance (QA) measures for important procedures, continuous improvement of employee follow through, and a quick response to deviations from procedure [1].
Keywords: SOPs; Reporting; Investigating; Handling Deviations; Healthcare Organizations
Introduction
This Standard Operating Procedure is applicable to all deviations from procedures related to Patient Oriented Programs (POPs) [2] and/or Patient Support Programs (PSPs) conducted by Healthcare organizations [3]. This Standard Operating Procedure is applicable to deviations spotted or reported by agents, employees, and managers or deviations identified by a source data verification process (SDV) [4]. It is currently being applied to Gentium Healthcare.
Procedures
Deviation Reporting [5, 6]
Deviations should be recorded and immediately reported to the person in charge and the quality management department with explicit explanations and the immediate deviated actions within 24 hours of their observation [7].
Deviation Reporting [5, 6]
Deviations should be recorded and immediately reported to the person in charge and the quality management department with explicit explanations and the immediate deviated actions within 24 hours of their observation [7].
The related department manager or Operations Head will suggest the corrective action(s) required to contain the non-conformity [8].
Results
Corrective Actions
The related manager or Operations Head initiates and completes the suggested corrective actions(s). The order of correcting tasks should be done according to vulnerability stemming from the deviation and any pre-agreements made with the Marketing Authorization Holder (MAH).
The related manager or Operations Head initiates and completes the suggested corrective actions(s). The order of correcting tasks should be done according to vulnerability stemming from the deviation and any pre-agreements made with the Marketing Authorization Holder (MAH).
Discussion
Documenting Corrective Actions [9]
Evidence of the actions taken should be collected and stored. The quality manager should review and evaluate the initiation and effectiveness of the corrective actions to either approve or send them back for so more information may be gathered [10].
Evidence of the actions taken should be collected and stored. The quality manager should review and evaluate the initiation and effectiveness of the corrective actions to either approve or send them back for so more information may be gathered [10].
A Quality Assurance representative shall evaluate any effects on quality the deviation had and propose a suitable quality control corrective action based on the nature of the deviation [11]. This Quality Assurance representative will then define the deviation and give it a unique deviation control number under which to store deviation information.
Conclusion
Prevention of Future Deviations
All deviation handling processes will involve root cause analysis and the creation of a Corrective and Preventative Actions (CAPA) plan.
All deviation handling processes will involve root cause analysis and the creation of a Corrective and Preventative Actions (CAPA) plan.
Deviation Reporting Form [12]
| Control No. Date: | ||
| Principal Investigator: | ||
| Project Title: | ||
| Project Manager: | ||
| What are you reporting? Regulatory Noncompliance Unplanned Major Deviation |
||
| Date of occurrence: | Date of discovery: | |
| Please describe what occurred (Description of deviation/Query requested): | ||
| What corrective action have you taken to directly address this event? Mentioning the effect on e.g. cost, quality, delivery….etc. |
||
| What have you done to prevent this from reoccurring? | ||
| Signature of Principal Investigator | Date | |
References
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- WORLD METEOROLOGICAL ORGANIZATION WMO QUALITY MANAGEMENT FRAMEWORK (QMF) FIRST WMO TECHNICAL REPORT Revised Edition; (2005).
- THE AUDIT OFFICE: RULES, POLICIES AND PROCEDURES M ANUAL REGULATORY STRUCTURE, SYSTEM S AND OPERATIONS.
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- Deviation Handling and Quality Risk Management A Note for Guidance for the Manufacture of Prequalified Vaccines for Supply to United Nations Agencies; (2013).
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- Watt, A. (2014). 4. Framework for Project Management. BCcampus August 14.
Citation: Mohamed Refaat, Marwan ElBagoury and Amy Hutchinson. (2021). Standard Operating Procedures for reporting, investigating, and handling Deviations in Healthcare Organizations. Journal of Biotechnology and Immunology 3(2).
Copyright: © 2021 Mohamed Refaat. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.