Friday, August 26, 2016

How to initiate a QRM process

Traditionally Hazard analysis and critical control point (HACCP) was adopted to do the risk assessment, Recently quality risk assessment is followed that is more relevant to the pharmaceutical industries. The guideline on Quality risk assessment to protect patient in terms of quality safety and efficacy of medicines.

In QRM a systematic science based decision making with respect to risk shall be considered. To intiate the QRM the problem shall be identified including possible risk. Detailed information shall be gathered which can lead to potential hazard or have harmful effect on human health and is relevant for the risk assessment

The problem can only be identified if there is adequate knowledge related to the product and processes. Therefore personnel with appropriate product specific knowledge and expertise are required to accomplish the QRM activities. This could best be done by assembling a multidisciplinary team and a team leader who can direct the team in right direction.

As QRM can be adopted proactively or retrospectively, therefore in retrospective application those part or QRM could be incorporated which are not analysed previously.

As industries which already have incorporated Hazard analysis and critical control point have most of the information available with them, remaining information can be gathered to achieve QRM.

Comparision of QRM vs HACCP

In both QRM and HACCP the multidisciplinary team (with a team leader) is to be formed who have product knowledge and good expertise and are capable to conduct risk assessment.

The second preliminary step for HACCP is to describe the product. Though in QRM it is not directly mentioned to describe the product but specified to assemble background information which by default cover the product information..

The third preliminary step of HACCP is to describe the intended use of the product. The intended use of the product is required to assess the potential effect of the hazard on the given group of people. In QRM it is specified to collect the data on the potential hazard or impact on the human health.

The fourth preliminary step in HACCP is to construct a flow diagram. In HACCP it is mentioned that the flow diagram must be simple with clear indication of inputs and outputs. Where as in QRM there is more focus on detailed flow diagram, a block diagram is prefered with sufficient description. It shall cover all operations and controls in the process under evaluation.

The fifth preliminary step in haccp is to verify the flow diagram, In QRM it is not required.

The QRM shall be reviewed atleast once in a year during self inspection.


Apparently initiation of QRM is almost similar to HACCP, except  to specify a timelines and appropriate level of decision -making for the risk management process in QRM.

Related topics

How to plan self inspection or internal

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