Redator Kivalita em 8 de March de 2021 em Articles

FMEA And GAMP 5: Risk Management Tools

Risk management is a challenge and indispensable for Life Science companies since it is necessary to have control over processes, be it medicines, food, cosmetics, sanitantes and others in so that the possibility of high impact errors by internal or external factors to the organization is reduced.

According to ABNT NBR ISO 31000:2009, “… all organizations face internal and external influences and factors that make it uncertain whether and when they will achieve their goals. The effect this uncertainty has on the organization’s objectives is called “risk”. Whatever the type of risk, it has this denomination because it has the uncertainty factor to occur, but not that it is necessarily just something bad that can happen.

That said, there are two tools that are heavily used for risk management of GAMP 5 and FMEA.


Called Good Automated Manufacturing Practice (in Portuguese Good Automated Manufacturing Practices), widely used in the industrial industry, analyzes and evaluates risk in a simplified way with the qualitative criteria of “Low”, “Medium” and “High”.

This tool allows risk control (assessing whether it is good or bad) and requires the periodicity of review of each risk in order to minimize all “status” of criticality resulting from negative or bad risks to “Low” and promote the risks detected as positive to “High”. Gamp 5 is developed through a form where risks must initially be identified, assessing the probability and severity of the risk and, obtaining the classification of this risk, its detection is evaluated to name the resulting final factor: Risk priority.


According to SAKURADA, this tool, called Failure Mode and Effect Analysis, uses a qualitative method, relating failure mode and effects, and analyzes how failures manifest themselves. It can avoid past problems and be mechanism for detecting future failures. It develops through a form where the detected risks and their effects are analyzed, there is a quantitative classification in order to map the severity of each risk.  

The FMEA risk analysis tool is more detailed in prevention and detection control, besides being a tool with greater margin of assessment on each risk addressed, considering points from 1 to 10 in the assessment of risk severity, probability of occurrence and detection of failure. 

The GAMP 5 risk analysis tool, because it is more simplified, scores the risk at only 3 points, being “High”, “Medium” or “Low”. On the other hand, it is a rapid and effective analysis for evaluating qualitative processes.

Both tools unanimously resulted as preventive action in mitigating the negative risks detected (most of which are the source of coding management failures, organization and planning of documentation) the development of an automated or computerized system that minimizes human intervention for repetitive processes that can be easily performed through a computer.

As a recommendation, the development of risk management is essential to prevent failures that strongly impact business continuity.

Reference: ALVES, Barbara Guelfi. Evaluation of the Quality System implemented in a drug importer and the feasibility of improvement through risk analysis tools.  São Paulo – USP – PECE – MBA Management and Quality Engineering.

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