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This is the world of Operational Compliance – the way organizations operate in high-risk, highly regulated

I found your posts and the breadth of information you provide on compliance and risk topics to be particularly

If we rely solely on AI to tell us what to do and what to believe, do we risk losing the ability to make

Do you understand the risks; what threats and opportunities will you encounter in keeping this promise

www.leancompliance.ca/post/where-to-add-proactive-processes https://www.leancompliance.ca/post/operational-risk-where-do-risks-come-from

Change can be a significant source of risk. This information is used to ensure that overall risk is handled within existing risk controls. In 2005, the Quality Risk Management program ICH-Q9 was introduced to bring a risk based approach to More changes could be considered as RIK without increasing risk. and implementing unnecessary risk measures.

Uncertainty gaps: what threats or opportunities hinder or advance our objectives to meet all our obligations You will also be able to identify any uncertainty in meeting obligations which will tell you where to put your risk controls.

will in turn help you to know what the goals and objectives are, what is critical to compliance, the risks that need to be addressed, and the controls that are needed to increase the certainty of achieving your

the increases in the number and severity of security breaches, digital factories could benefit from risk-based Safety barriers (i.e. risk controls) are put in place to guard against unexpected releases and are designed Either one can be modified provided that risk is managed.

Instead of quality as job one or safety first programs, organizations now need to lead their risk & compliance What we can say with certainty is that we are moving towards an Environment-First world which will affect

Are your risk and compliance controls capable to keep you between lines? The purpose of risk and compliance is to keep companies operating between the lines so that they do not To ensure that this does not happen risk and management controls are put in place to act as guardrails When it comes to risk and compliance objectives measuring outputs using a feedback-management-control

The path you choose will determine: whether you are reactive or proactive, your approach to risk, and The path of "necessary evil" is fraught with uncertainty and is driven by inspections and audits. will be with those that want to see: better outcomes, improved safety, increased quality, appropriate risk