Risk management principles are used widely and effectively in many areas of government and business including finance, occupational safety, insurance, and public health, among many other areas. As much as there are few examples using quality risk management in the pharmaceutical industry, they are restricted and therefore do not really signify the full contributions that risk management has and can offer. In addition to that, quality risk management has proven to be fundamental in the pharmaceutical industry and is therefore a valuable ingredient for the production of quality goods and services.

Different approaches:

Proactive – This approach aims to identify the threat or risk that could cause a potential loss in advance. This means that it is a preventive approach.

Reactive – Contrary to the above, this approach aims to deal with the effects of the loss, that is, after the loss has occurred.

Risks evaluation:

Risk assessment generally consists of identifying potential hazards, analyzing, and evaluating the risks that could be associated with these hazards. Risk assessment begins with identifying the risk itself.

Hazard identification: this is the systematic use of available information about the product and the process involved to identify associated hazards. The question to ask yourself when identifying a particular risk is “what could go wrong?” as well as identifying what the consequences would be if things went wrong.

Risk analysis: deals with the estimation of the risk associated with the threat. It can be quantitative or qualitative.

Qualitative – This type of risk analysis addresses inaccurate concerns that are experiential rather than numerical.

Quantitative: When a particular risk is conveyed in this way, the numbers determining the extent to which a particular risk can cause a potential loss can be measured using a Risk Point Number (RPN) rating scale that includes three levels:

1. Low: This is the lowest level and indicates that a particular risk has a very low probability of occurrence and has no impact on the quality of the product.

2. Medium: this type of risk can occur and can also have an indirect impact on the quality of the product.

3. High: this risk has a high probability of occurrence and also has a direct impact on the quality of the product.

Risk control:

Risk control basically deals with making decisions that will reduce or accept the risks involved. As the name suggests, what we hope to achieve in risk control is to reduce the likelihood of the risk occurring or to reduce the impact of the risk.

Risk management methodologies:

The pharmaceutical industry can incorporate the following quality-tested risk management methodologies:

• Failure mode effects analysis, ie FMEA

• Failure mode, effects and critical analysis, ie FMECA

• Fault tree analysis, ie FTA

• Hazard and critical point analysis, ie HAC

• Hazard operability analysis, that is, 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 potential flaws and failures in a design, a product, a service, or in the manufacturing and assembly process.

The FMECA procedure:

• Identify all potential failure modes and then define or specify their effects on the product.

• Evaluate each failure mode by what is the worst potential consequence. • Identify failure detection methods and provision of compensation for each type of failure mode.

• Identify corrective implementations or steps that will be taken to eliminate the failure.

• Finally, document the analysis and identify problems that may not be corrected with the previous step.

Conclusion:

The ultimate goal of the pharmaceutical industry is to provide quality products and services that eliminate disease while ensuring patient safety.

Therefore, with the incorporation of quality risk management, many failures can be overcome, threats minimized, or their impact reduced.