Risk analyses and comprehensive risk management are a matter of course in the automobile industry. They accompany continuous change. As part of the routine or in the course of model changes, risk analysis tools are used consistently. Their application should be part of everyday practices in the life science industry as well today. Yet resistance against this supposed additional effort keeps on being encountered. This is in spite of the fact that risk management systems and corresponding risk analyses can be used expediently and efficiently in daily practice. And save time as well!
Risk management and risk analyses – doing the right thing with know-how and experience!
The Perfect Risk Analysis?
Thanks to established experience, we can confirm that the perfect risk analysis does not exist. But there is always a suitable tool or a combination of them. By using tailor-made individual solutions in combination with standardised components, a risk analysis that meets the requirements can be conducted without major effort today. Producing genuine added value in practice.
Risk Analysis as a Shared Task
Risk analyses make sense when all trades and stakeholders come together for a joint discussion. This also makes the risk analysis a platform for exchanging knowledge. It builds awareness and results in a deeper process understanding among everyone involved. And draws attention to approaches for continuous quality assurance.
The Risk Management System as Part of Quality Assurance
The lifecycle concept is a fundamental aspect of a risk management system. Part 3 of the EU GMP Guideline & ICH Q9 demand a transparent assessment, evaluation and continuous tracking of the possible risks for the product and process. As a key element of quality assurance. Risk analyses therefore need to be embedded in overall risk management. gempex supports the development and implementation of tailor-made, pragmatic and realisable risk management systems. With a lifecycle orientation.
The Moderator’s Job – Constructive Guidance
A risk analysis without a moderator is like a band without a conductor – directionless, unstructured and incomplete. An experienced risk analysis moderator knows what questions to ask and how to constructively guide discussions that threaten to get out of hand. Focusing on critical points by asking specific questions is important. The elementary risks for the product are recorded and evaluated as a result. In this complex task, gempex serves as an experienced guide.
- clarity about relationships between risk analyses and risk management
- risk management concepts that meet official requirements
- goal-oriented guidance by professional moderators
- standard building blocks that enable an efficient yet specific approach adapted to the respective process/system
- experts provide training in the use of established tools such as HACCP, Ishikawa, FMEA and methods derived from them
- tailored support – from simple training to comprehensive consultancy to implementation