Pharmaceutical Projects are crucial to managing as they are related to the well being of the people around us. HVAC Projects is crucial to pharma projects as of right ventilation and air conditioning is required for the pharma facilities
Quality is necessary for any manufacture of pharma products. Failures mean losses in terms of money. Therefore, Risk Management in the Pharmaceutical project cannot be ignored to bring a successful product to the market.
The following are the important factors while planning a Greenfield project:
A key component to continued GMP/statutory compliance is to have the right culture, system, and mindset to do the right things at the right time. These must be the focus while planning a Greenfield project.
The proper risk-based assessment to produce the new product that must meet predetermined specifications and standards shall be planned. This requires identifying, measuring and managing risk both qualitatively and quantitatively.
Effective risk management strategies in the project allow one to identify is strengths, weaknesses, opportunities, and threats.
Risks can be increased or decreased due to :
Wrong estimation for the required line of items
The human factor errors of omission, poor judgment, lack of understanding
The failure to make timely decisions.
The final analysis of the risk will usually come down to an analysis of business risk associated with profitability, risk due to uncertainty in the project schedules.
The following three fundamental questions are often helpful in assessing the risk:
What might go wrong?
What is the likelihood (probability) it will go wrong?
What are the consequences (severity)?
Risk identification is a disciplined process that involves the use of a checklist of the risks. It is considered as the first step of the risk management. The main objective of risk identification is to the risk that can impact the project’s ability to achieved progress. Early risk identification is required to prevent losses in the project and project being completed on schedule, within budget.
To manage risk effectively, one must first identify where the risk lies and what extent.
Risk generally lies in Costs ( Operations/Maintenance/Commissioning), Technology & Regulation, Finance, Site Feasibility & workers availability, material management, design construction, weather condition.
Some of the common tools for risk analysis are FMEA, FMECA, HACCP, PHA
After identifying the risk, the next step is to evaluate the risk of the probability that the event may occur and what could be the loss due to this event. All risks are not the same; some risks have the chances of occurrences and its severity may be greater than others.
So the criteria of determining high impact risks can be beneficial in narrowing down the focus on a handful of critical risks. Risk evaluation in a broad sense is the development of understanding about the potential risks that have a greater chance of occurring and can severely impact the project.
Once the risk has been identified and the evaluation is done for the type of risks, the project team develops a mitigation plan to mitigate the risks. That can be done in the following ways,
Risk avoidance: A risk can be avoided by using standardized and proven methods of already established processes.
Sharing the risk: Risk sharing involves partnering with all stakes holders to share responsibility for the risk activities by developing a joint venture with the company.
Reduce the risk: This can be done through a project consultant which can evaluate the project techno commercially and can see the red flags
Risk Transfer: For example, the purchase of insurance is the risk transferred from the project to the insurance company.
MONITORING AND REVIEW
It is an integral step used in the entire risk management process. Risks should be monitored to make sure that any change in the environment does not affect or alter the risk priorities.
Hence, for pharmaceutical projects and cleanrooms, it is imperative to hire a good HVAC Company in India which can take into consideration of unforeseen risks and can execute pharma projects well.
MG Cooling Solutions take care of the right ventilation & air Conditioning in Pharma projects to make sure that the pharma facilities are well planned.