Quality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be defined prior to the execution of the risk analysis).
Should; however, an error in the system occur once the system is in one of the test phases, or even in productive use, then corrective actions and preventative actions (CAPA) can be defined, approved and implemented in order to mitigate the risk. The CAPA systems are an important aspect of staying compliant.
The basic principles of risk management include:
- Evaluating risk to quality should be based on scientific data that links to the protection of the patient.
- The quality risk management process should assess the level of risk, which will be reflected in the company's level of effort, formality and their documentation.
Meeting quality management regulations can be more difficult in certain cases; therefore, some companies seek help from outside sources for QMS help. Due to regulating authorities, pharmaceutical and medical device manufacturing companies have real consequences regarding the ability to conduct business in the United States, Europe or other global locations.
Some of these authorities include:
- U.S. Food and Drug Administration
- EU European Commission
- International Organization for Standardization
Each of these regulating bodies publishes complex rules, guidelines and/or an abundance of documentation concerning the manufacturing, marketing, packaging and validation of finished pharmaceuticals and medical devices. Compliance with these agencies requires knowledgeable staff or an outside consultant since understanding and complying with these rules can be very time-consuming and difficult.
Steps of the Risk Management Process
Risk assessment is the first step, which includes risk identification, risk analysis and risk evaluation. Ideally, quality risk management should use a systematic process that is designed to facilitate and coordinate, therefore, improving any science-based decision with respect to risk.
Suggested steps to follow when planning a quality risk management process include:
- Identify the risk potential by defining the problem or risk question
- Organize all background information or data on any potential hazard, harm or possible human health impact that may be relevant to the assessment
- Adopt a feasible timeline, deliverables and an appropriate level of decision making for this process
It is important to identify hazards, the analysis and the evaluation of any risk associated with exposure to those hazards. The risk in question must be well-defined, as risk identification will address the question of, "What might go wrong?" This will also identify any possible consequences, and it will provide the basis for the next steps in the risk management process.
The risk analysis is the quantitative or qualitative process to link the likelihood of occurrences or severity of harm. Normally, one would try to aim for all risks associated with any system to have a qualitative evaluation, thus providing a clear description of the risk, its effects and the associated activities required to mitigate that risk.
Risk Control and Risk Reduction
Ultimately a decision must be made regarding methods to reduce risk or making a decision that the risk is acceptable. The whole purpose of risk control is to reduce any risk to an acceptable limit.
The significance of any risk should dictate the amount of effort used to solve the problem. Decisions may be made using different processes, such as including benefit–cost analysis to understand the optimal level of risk control.
Since the majority of regulations are vague due to the sheer number of pharmaceutical and medical industries, a company might find it beneficial to turn to a reputable third party for QA consulting. The number of regulations from the regulating authorities can be overwhelming for any firm.
GxP-CC is comprised of reputable and respected compliance consultants within the life sciences field. They offer companies a wide range of tools and a wealth of knowledge in order to help your company to achieve compliant risk management and help you mitigate risks associated with your computerized systems. Contact them today to discuss your risk management or other compliance concerns.