Does your Quality Management System (QMS) identify risks to product quality and patient safety?
If not, then you need to start planning and implementing risk assessments immediately in all areas of your operations. The assessments do not need to be complicated; they just have to be appropriate for your company and effective in their purpose.
Your risk management processes should always be linked to the protection of patients.
If you are performing them correctly, your self-inspections should identify any risks (and deviations) within your QMS, operations, procedures and equipment. This should help you with risk management processes.
Risk management should ensure that all risks to the quality of medicinal products are identified, assessed and reviewed with actions taken for correction or prevention (CAPAs) before they can cause any serious negative consequences. The process should ensure that all actions are based on scientific knowledge and experience of the system.
Carrying out a Risk Assessment
When carrying out a risk assessment on an operation or procedure you must go through a number of steps:
- Identify and assess any risks and the impacts they may have.
- Plan actions that will correct or prevent the risks.
- Control how the actions are implemented – ensuring that it’s in a way that doesn’t have a negative impact on that operation/procedure or any other function.
- Review how well the risk has been controlled or prevented.
- If the risk management process wasn’t successful, steps 2-4 will need to be repeated.
Risk assessments should be carried out regularly (the frequency of which should be stated in the QMS), to prevent the impact of any risks being high. It will mean that you can identify and take actions against risks as quickly as possible.
It may not always be possible to completely correct and/or prevent risks, especially as you may not be able to predict them. But you must always document that you have identified it and include any actions that have been considered or implemented. This will provide evidence that you are aware of the risks and the implications it could have, as well as showing that you are doing everything you can to try to fix/reduce it.
It is very important that you have effective risk assessment procedures in place that are up to date and easy to understand, as you need to be able to quickly identify and evaluate all risks within your operations.
A risk within your operations is a risk to patient safety, as it may impact the integrity of the product making it unsuitable for use.
If someone you knew and cared for received medicinal products in poor condition which made them unwell, you would of course be very displeased. It is therefore beneficial to nurture a regard for the medicinal products as if they were for someone you knew. This in turn benefits the GDP directly.
Further Assistance and Support
Do you or your staff need training? Do you know or suspect that your Good Distribution Practice is not as sufficiently robust as it ought to be?
We run a popular monthly all-day training course webinar on the full EU GDP Guidelines which covers Risk Management.
You may require help with how to identify risks as well as creating and/or reviewing your risk assessment procedures. If so, we can help by carrying out general Good Distribution Practice audits or risk assessment audits and guiding you through making your procedures. Contact us using the form below for more information and advice, or take a look at our training calendar and online courses via the link buttons below.
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