Deviations are very frequent within Life Science companies, arising when unforeseen events or problems deviate from an approved GMP process and/or from what is required/accepted in terms of GMP.
Deviations have a significant impact on the entire corporate system. They can result in the blocking or rejection of entire batches, lead to several departments being involved in investigations and generate CAPAs with actions that cascade throughout the company.
They also require very careful management because they can affect the identity, strength, quality, purity, safety, efficacy, performance, reliability or durability of a drug or device. This is another reason why deviations receive a lot of attention during inspections .
Each unforeseen event or problem must therefore be documented, evaluated and, where necessary, investigated in order to determine its causes and avoid any recurrence.
In the following paragraphs, we will outline useful tools and approaches for reducing the impact of deviations and simplifying their management using a digital system.Interesting question: Are Non-Compliances and Deviations the same thing?
As we have said, deviations can impact the production of drugs and devices, can be detected by anyone in the company and the resulting actions can affect every department.
Keeping track of the number of deviations and seeking to reduce them is paramount for the productivity and efficiency of the company. Shifting from a reactive to a proactive approach improves the quality control system, reduces costs and increases company productivity.
The Quality risk management tool is required to support quality processes by an increasing number of inspection bodies. This is complemented by an in-depth analysis of Trends, as well as an increased focus on staff training.
As far as deviation management is concerned, the complex task of keeping track of all activities, deadlines and documents produced can be reduced by using a digital system , which provides essential support to QA Compliance for the execution and supervision of the process.
Quality Risk Management (QRM) as a strategic, systemic and documented approach to risk management has become a key requirement for modern GMP and is recommended by international standards such as WHO or ICH Q9.
An efficient deviation management system should implement a mechanism to differentiate events based on their relevance and objective categorisation, thus focusing resources and efforts on only investigating the root causes of relevant deviations.
Even a robust CAPA system depends on efficient deviation management upstream, which assesses the event according to the associated risk, classifies it and acts accordingly and in a timely manner, checking the effectiveness of the actions taken.
QRM, as a formal or informal tool applied to deviations, offers the ability to determine the impact of a deviation on a process or product in an objective manner, so as to categorise and facilitate its management. ICH Q9 recommends using this approach for different purposes, such as identifying root causes and corrective actions during OOS investigations, complaints, quality defects, deviations, trends, etc.
In the document “Deviation Handling and Quality Risk Management”, the World Health Organisation, proposes a possible strategy for using QRM to differentiate non-significant events that have no impact on product quality from events that violate standards and procedures and deviations with a probable impact on product quality.
Human error is one of the most frequent causes of deviations. The employee was given the procedure, maybe even trained and qualified, but nothing came of it. Errare Humanum Est (To err is Human). Most of the time they are assigned a CAPA action retraining course.
However, many procedures, training courses or processes are not well understood by staff and often even retraining is not sufficient to prevent recurrence. There might also be other causes behind human error, such as a process that is not designed to prevent error or an environment that hinders optimal staff performance.
One suggestion is to delve into the root cause of human error by going beyond simple retraining.
With regard to the latter in particular, it is also important to assess the effectiveness of training. Here are some questions that might be useful:
Another suggestion is to also review the reference procedure:
Managing deviations along with other processes in a single digital system is now a necessary measure for quality control in the company, in order to keep processes under control and to avoid unpleasant situations in the event of an inspection.
Companies that choose the path of a digital system for the management of deviations and other processes can also count on the availability of a large amount of data, to carry out in-depth analysis, cross-referencing, measuring performance indices and improving risk calculation from historical data, as well as for structuring targeted strategies and preventive actions.
PRAGMA4U is a modular and scalable Workflow Management System platform that digitises work processes in compliance with FDA and cGxP guidelines.
It enables companies to: have documentation that is protected, always up-to-date, organised and linked to the source processes; assign and implement workactivities directly on the platform; easily share information between departments; keep processes under control using KPIs; and compile reports and dossiers that will be useful for inspections.
The platform can contain multiple processes, creating a true digital map of the company. It also integrates with other systems, such as ERP, simplifying the compilation and updating of data.
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Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes