Quality Risk Management (QRM)

 

Quality Risk Management (QRM)

Quality Risk Management (QRM)

¨  Quality Risk Management is systemized process that is applicable to all countries and is valuable for the assessment, control, communication and review of risk to the quality of drug product across the Product  Life cycle.

¨  Risks that are rising during the initiation of new project like installation of new machine, development of a new facility or a new product development can be assessed and mitigate the application of this system.

¨  This system will also be used for the assessment and mitigation of risks associated with management change, nonconformity or failure, customer complaints, Out of specification (OOS), Out of trend (OOT) Reporting, qualification validation activities, vendor qualification, internal / external audits and regulatory audits.

¨  International Medicine Regulatory Authorities (MRA) are recommending Quality Risk Management application to Pharmaceutical industries for the qualitative, safe and effective production drug products.

¨  QRM can be applied proactively as will as retrospectively.

Risk Assessment

¨  Risk Assessment comprises of the identification of hazards and the examination and evaluation of risk associated with the exposure to those hazards.

¨  During assessing the risk all the possible parameters that are expected to be the cause should be listed.

¨  During assessment 1^st of all the problem arise should be defined, including relevant assumptions identifying the potential for risk, as well as gathering all available information and data on the potential hazard, harm or impact, relevant to the risk assessment.

To understand risk assessment answers of the following three questions is necessary i.e

¨  What might go wrong?

¨  What is the nature of possible risk?

¨  What is the likelihood (probability) it will go wrong?

¨  What are the consequences?  

Risk Identification

¨  Risk Identification is a systemized use of statistics to identify hazards raising  the risk in question or problem portrayal, including historical data, theoretical investigation informed opinion and concerns of stake holders.

¨  Risk identification addresses the “What might go wrong?” question including identifying the possible consequences.

¨  This provides the basis for further steps in the quality risk management process.

Risk Analysis & Risk Evaluation

¨  Risk Analysis is the approximation of the risk related  with the identified hazards. It is the qualitative & quantitative process of linking the probability of occurrence, severity of harms and the ability to detect the harm (detectability) for the estimation of risk.

¨  Risk Evaluation compares the identified and analyzed risk against given risk criteria, by considering the strength of evidence for all three of the fundamental questions.

¨  For quantitative Analysis & Evaluation of a Risk, numerical values are assigned to the different qualitative levels of Occurrence, Severity and Detectability; those subsequently figure out the level of the risk.

¨  After the assessment, Risk Priority Number (RPN) is used to evaluate criticality of the Risk ,which depicts the level of risk i.e., High, Medium or Low Risk.

¨  RPN will be calculated by using the following formula:    

¨   

¨  Risk Priority Number) =

¨  Severity x Occurrence x Detection

¨  Risk level is assigned on the RPN basis by using following Criticality Quotation Table.

 

 

 

 

 

CRITICALITY QUOTATION TABLE
RPN (S x O x D)	Risk Level	Actions
64 - 125	High	Situation at high Risk, Immediate Action is required to reduce the risk to an acceptable level and long term plan to mitigate the risk.
27 - 63	Medium	Risk analysis must explain how the benefit outweighs the residual risk. Action plan is required to mitigate the risk.
≤ 26	Low	Risk is considered at acceptable level. However, mitigation plan may be considered if viable.

 

Risk Control

Risk Control is associated with the decision making to follow an action plan to minimize the risk to an acceptable level or accept the risk without further action, by answering following question:

¨  Is the risk above on acceptable level?

¨  What can be done to eliminate or reduce the risk to an acceptable level?

¨  What is the appropriate balance among the benefits, risks and resources?

¨  What could be a new risk if proposed action plan is taken?

Risk Reduction & Risk Acceptance

¨  Risk Reduction comprises the actions taken to lessen the Severity & Probability of damage and increase the detectability of hazard in order to minimize the quality risk to an acceptable level or eliminate completely. Sometime avoidance of quality risk might be considered as a part of risk control strategy.   

¨  Risk Acceptance is a decision to accept the risk after an appropriate assessment. Sometime it is not possible or not viable to eliminate the risk completely and risk is to be accepted after reducing it to an acceptable level.  

Risk Communication

Risk Communication is the documentation & sharing of the outcome of Quality Risk Management process of an identified risk to all relevant stake holders and senior management as appropriate. The purpose of this communication is:

¨  Sharing and communication of information about the risks and its controlling parameters.

¨  To obtain the appropriate approval of the decisions taken.

¨  To demonstrate that systematic approach has been applied.  

¨  To provide a record of the risks that enables decisions to be reviewed and the process to be audited.

¨  To facilitate ongoing monitoring and review and to sustain the process.

Risk Review

¨  Risk Review is the review of the outcome of risk control process and to ensure that any new risk not added after implementation of identified action plan. 

¨  Standard Format of Position Paper will be used to report all kind of Risks for their Assessment, evaluation, remedial plan review and formal approval.

¨  A logbook will be maintained by Quality Assurance for the registration of all reported Risks.

¨  A specific number will be assigned to each reported Risk..

¨  Summary of all reported Risks and status on progress on their remedial action plan will be presented in Management Review meeting by Quality.

¨  Trainings will be provided to all management staff on the procedure of Quality Risk Management by Quality Assurance.