Example Quality Risk Management Application To Identify Deviations Vs Event Sample
Example Quality Risk Management Application To Identify Deviations Vs Event Sample
Example Quality Risk Management Application To Identify Deviations Vs Event Sample
Events
Regulatory Basis:
FDA Quality Systems Regulations
General Discussion
Often times, deviations that occur during the handling, manufacturing, testing or distribution
of materials/products have little or no impact on product quality or to its registration filing.
The purpose of this guidance is to provide a process for assessing if a deviation does or does
not impact the product quality or its filing through the use of a Quality Risk management
(QRM) tool.
Event - A departure from approved procedures, formulas, standards, or parameters that has
been determined to have no potential impact to product quality, GMP regulated systems, or
regulatory filings. These are typically documented in a Notice of Events (NOE).
This document provides guidance on two approaches to assess the risks associated with
identifying deviations vs. events.
The first approach is the generic systems assessment approach where the site completes a
risk assessment of the most common types of issues and determines in advance which are
deviations and which are events. The second approach is the individual assessment approach
where the site completes a questionnaire for each issue to determine if it is a deviation or an
event.
Once the individual risk factors have been ranked, the Total Risk Score is calculated using
the values assigned for probability and severity. The Total Risk Score is calculated as shown
below.
Probability x Severity = Risk Score
Risk Acceptance
After the Total Risk Score has been calculated for each individual potential risk it must be
assessed against an evaluation matrix to determine the acceptability of the existing risk or,
conversely, identify the need for reduction of the risk through implementation of controls,
where possible. The evaluation matrix is to be devised based on a site’s willingness to accept
different levels of risk.
Table II and the related Interpretation section represent an example evaluation matrix.
5 5 15 25
3 3 9 15
Increasing 1 1 3 5
Probability 1 3 5
Approach 2
Individual risk assessment approach
Depending on the individual site preference, the system could be designed in a manner that
assesses each issue to determine the criticality.
Risk Assessment
This can be achieved by creating a list of questions to be answered for each issue. The
questions should be formulated using the same areas that the System Assessment described
above used, i.e. regulatory expectations, cGMP expectations, system impact, product quality
impact, risk to patient
– this encompasses all factors that could affect the safety, purity, or identity of
the product.