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It is all too common to hear that management does not like to see "red" in charts, or discuss "risks"

Changes to safety-critical positions in regulated industries must follow a process to manage risks associated diagram: The first step is to scope out the change to collect relevant information and identify possible risks What risks are anticipated during the transition or after the change has been implemented: Critical What steps should be taken to mitigate these risks? Discuss risks with new or previous manager Communicate risks to affected compliance program owners (

Projects are ranked by benefit first followed by those with the lowest project risk. Project value and risk are more nuanced making simple ranking less effective. Risk is more complicated than just project risk. For example, there are other kinds of risk such as: PSM risk, compliance risk, environmental risk, and complexity risk.

Innovation is necessary for growth and often requires that risks are taken. In 2005, the Quality Risk Management program ICH-Q9 was introduced to bring a risk based approach to This was extended to the medical device sector through the ISO14971 Risk management standard. More changes could be considered as RIK without increasing risk. What would it look like if more innovation could occur without increasing risk?

These impacts can introduce new risks and expose latent ones leaving companies at risk and vulnerable change it is important to: Document critical knowledge from the out-going person Understand the risks How are risks identified and managed while transitions are occurring?

Output rises faster than our capacity to verify it, and uncertainty grows with it.

However, the rise of AI also brings forth ethical considerations that cannot be overlooked. The Rise of Ethical Dilemmas As AI systems become more prevalent in our daily lives, questions surrounding

Programs exist to reduce safety incidents, reduce risk, reduce costs, increase reporting of near misses compliance perspective, changes need to be made in such a way to: maintain compliance continuity, manage risk

Jame Clear, author of Atomic Habits, writes: “You do not rise to the level of your goals, You fall to

Organizations are also looking to transfer some risk to the SAAS provider. However, regulations may limit how much of the safety risk can be transferred to third parties. Transferring control of compliance data may expose companies to unacceptable risk.

points, performance standards, equipment data, permits, quality records, procedures, calculations, risk engineers , to understand how best to replace or improve processes safety specialists, to identify risk

This mindset can lead to risky behaviour and a lack of accountability.