Quality Risk Management In Pharmaceuticals
Risk management principles are widely and effectively used in a lot of areas of government and business that include finance, occupational safety, insurance and public health among many other areas. As much as there are few examples that use quality risk management in the pharmaceutical industry, they are restricted and thus do not really signify the complete contributions that risk management has to and can offer. Besides that, quality risk management has proven critical in the pharmaceutical industry and thus it is a valuable ingredient towards the production of quality goods and services.
Different Approaches:
Proactive - this approach is aimed at identifying the threat or risk that could cause potential loss before hand. This means that it is a preventive approach.
Reactive - contrary to the above, this approach aims at dealing with the effects of the loss i.e. after the loss has occurred.
Risk Assessment:
Risk assessment generally consists of identification of the potential hazards, the analysis, and evaluation of the risks that might be associated with these hazards. Risk assessment starts with the identification of the risk itself.
Risk identification - this is the systematic use of available information about the product and the process involved to identify the hazards associated. The question to be asked while identifying a particular risk is "what could possibly go amiss?" as well as identify what would be the consequences if things went wrong.
Risk analysis - deals with the estimation of the risk associated with the threat. It can either be quantitative or qualitative.
Qualitative - this type of risk analysis deals with inexact concerns that are experiential rather numerical.
Quantitative - when a particular risk is put across in this fashion then numbers play out the extent to which a particular risk can cause potential loss can be measured using a Risk point number (RPN) rating scale that include three levels:
1. Low - this is the lowest level and it indicates that particular risk has very low probability of occurrence and has no impact on the quality of the product.
2. Medium - this type of risk may occur and may also have an indirect impact on the product quality.
3. High - this risk has a high probability of occurrence and it also has a direct impact on the quality of the product.
Risk control:
Risk control basically deals with decision making that will either reduce or accept the risks involved. As the name suggests, what we hope to achieve in risk control is reduce the probability of the risk occurring or reducing the impact of the risk.
Risk management methodologies:
Pharmaceutical industry can incorporate the following prove quality risk management methodologies:
• Failure mode effects analysis i.e. FMEA
• Failure mode, effects, and critical analysis i.e. FMECA
• Fault tree analysis i.e. FTA
• Hazard analysis and critical points i.e. HAC
• Hazard operability analysis i.e. HAZOP
• Preliminary hazard analysis, among many others
Failure Mode, Effects, and Critical Analysis (FMECA)
This is a step-by-step approach that seeks to identify the possible faults and failures in either a design, a product, a service or in the manufacturing and assembly process.
The FMECA procedure:
• Identify all potential modes of failure and then define or specify their effects on the product.
• Evaluate each failure mode by way of what is the worst potential consequence. • Identify failure detection methods and compensating provision for each type of failure mode.
• Identify the corrective implementations or the steps that will be taken to eliminate the failure.
• Finally, document the analysis as well as identify the problems that may not be possibly corrected by the above step.
Conclusion:
The ultimate goal in the pharmaceutical industry is to provide quality products and services that will eliminate diseases while at the same time ensure the safety of the patients.
Therefore, with the incorporation of quality risk management, a lot of failures can be overcome, threats can be minimized or their impact reduced.
