Why is this course unique?
Many SOPs are written, published, and executed with many unexpected errors. Some of these errors yield dire consequences. This problem has troubled many industries that are risk-sensitive.
What is the solution for this problem? The solution is a “quantitatively” estimation of the probability of errors and the associated risk before implementation of a risk-sensitive SOP. If the risk is too high, optimize the risk to its optimum point before implementation. For example, we estimated that probability of errors is 1.3% and risk is $130,000 when an SOP is initially designed for a vaccine manufacturing process. Both error probability and risk are unacceptable. So, we re-designed the SOP so that the probability-of-error was reduced to 0.1% and the risk was only $3,000. The 0.1% error probability and $3,000 risk are acceptable and, therefore, the SOP was issued for implementation.
Benefits of this course:
For high-risk SOPs and procedures, the probability of errors and risk are determined for an SOP before its implementation. If they are not acceptable, the SOP would have a chance for improvement to a level acceptable for the company’s management. Before the technology offered by this training course, SOPs were designed only based on cost and functionality, whereas, the probability of errors and risk are unknown to the designers. The SOPs could only be improved after the occurrence of events; which is much more expensive than the solution taught in this training.
Topics covered in this course:
Procedure Quantitative Risk Design Process
- Step-by-step sequence
- Identification of single-point-vulnerability (SPV) steps
- Identification of human performance failure modes for SPV steps
Identification of Shaping Factors
- Shaping factors for inattention-to-detail errors
- Shaping factors for intentional noncompliance
- Shaping factors to unintentional noncompliance
- Shaping factors for judgment and decision errors
Probability of Errors
- Calculational formula and process
- Results verification
Risk of Human Errors
- Consequence of errors
- Probability of errors in an SPV step
- Integrated risk
Risk-Cost Optimization
- Layers-of-protection (LOP) of SPV steps
- Costs of LOPs
- Optimization process