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Warehouse Management

1. Quality risk management is an effective tool to identify, assess, control, and review risks that may impact the quality of pharmaceutical products. It is required as part of good manufacturing practices. 2. The risk management process involves identifying potential risks, analyzing their likelihood and impact, evaluating them against risk criteria, controlling risks deemed unacceptable, communicating the results, and periodically reviewing the risks. 3. Risk assessment methods include listing questions about potential risks, identifying hazards, analyzing the probability and outcomes of things going wrong, and comparing analyzed risks to acceptance criteria. Risk control aims to reduce risks to acceptable levels without generating new risks.

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51 views2 pages

Warehouse Management

1. Quality risk management is an effective tool to identify, assess, control, and review risks that may impact the quality of pharmaceutical products. It is required as part of good manufacturing practices. 2. The risk management process involves identifying potential risks, analyzing their likelihood and impact, evaluating them against risk criteria, controlling risks deemed unacceptable, communicating the results, and periodically reviewing the risks. 3. Risk assessment methods include listing questions about potential risks, identifying hazards, analyzing the probability and outcomes of things going wrong, and comparing analyzed risks to acceptance criteria. Risk control aims to reduce risks to acceptable levels without generating new risks.

Uploaded by

Prince Moni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Any process that can have any type of risk should go through the quality risk

management. These risks may impact the quality of the pharmaceutical products. It is
a requirement of good manufacturing practices. Quality risk management is an
effective tool to maintain and improve the quality of the pharmaceutical products.

Risk assessment should be done in following manner.


1. Initiation of Risk Management Process:
Risk management should be initiated with the listing of possible questions about the
risks involved in the process or the system. Potential of the risk on human health and
product quality should be identified. A time limit or deadline for the risk assessment
should be specified.
2. Assessment of Risk:
Risk assessment includes the identification of hazards associated with risk. Following
questions can help to identify and analyze the risk.
1. What may turn out badly?
2. What is the probability (likelihood) it will turn out badly?
3. What are the outcomes (seriousness)?
A) Identification of Risk: Risk should be identified by the available data as data
from history of the process or system, different opinions or the information derived
from the end user. The question “What might go wrong?” helps to identify the risks
involved in process or system and provides the base for the further assessment of the
risk.
B) Analysis of Risk: After identification of risks involved in any process or system
its analysis is done. The harms associated with the risk are listed and chances of their
occurrence and criticality are determined.
C) Evaluation of Risk: The analyzed risk is compared against the risk criteria.
The outcome of the risk assessment may be either in the qualitative form as a number
(1,2,3) or in the qualitative form (low, medium or high)
3. Control of Risk:
Risk control is the application of the methods or tricks to reduce the risk to the
acceptable level. First of all determine that the risk is above the acceptable level.
Determine the way to control the risks. New risks should not be generated while
controlling the risk.
During the implementation of risk reduction measures, it may affect the significance
of other existing risks or generate new risks. Therefore, one should do risk assessment
again to evaluate the changes in risks during the implementation of the risk reduction
process.
4. Communication of Risk:
Communication of risk is the exchange of information regarding the risk between the
decision management and others. The results of quality risk management should be
documented and communicated. The information regarding the nature of risk, its
severity, control and related information should be communicated. Dotted arrows in
figure indicates that communication in risk management should be done in every
stage.
5. Review the Risk:
Risk management is a continuous process and a system should be implemented to
review the risks at a fixed time interval. All events of system should be monitored for
the risks associated with it. The frequency of the review the risk management depends
upon the severity of the risk. It should be mentioned clearly in risk management
document.
6. Methodology:
Method of the risk management is given in the sample protocol.
Reference: ICH Q9 - Quality Risk Management.

Related: Risk Management Sample Protocol

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