Overview:
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post production risk management program be implemented.
FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.
One of the techniques described in ISO 14971 is Hazard Analysis. This is
the most powerful of the risk management techniques because it
considers risks in normal operation as well as fault conditions. FMEA
and FTA consider only fault conditions and are more suited as
reliability tools than as product safety tools.
In this webinar we will explain in detail the process of conducting a
hazard analysis. The confusing terms "hazard", hazardous situation",
"harm", "causative event", "ALARP", "risk index", "benefit/ risk ratio",
and "residual risk" will be explained.
We will go step by step through a template for risk analysis so that the
process is clear. Examples of hazards and hazardous situations will be
discussed. How to deal with residual risk will be discussed.
We will explain how to integrate Human Factors studies into the Hazard
Analysis and how to integrate Hazard Analysis into the design program.
Risk level can determine the extent of CAPA investigations, validations
effort, etc.
Application of ISO 14971 principles to software risk management will be explained.
Why you should Attend:
FDA expects that as part of a product development program risk
management will be conducted and risks will be mitigated as far as
practical.
Risk Analysis is required in a FDA product submission.FDA recommends
using ISO 14971 as a guide and has accepted it as a recognized standard.
Hazard Analysis is the most powerful of the risk management tools
described in ISO 14971 but it is very confusing. Many new concepts are
introduced. We will explain these concepts and provide examples so that
the process is clear.
Handouts are hazard analysis forms and HA report template.
Areas Covered in the Session:
- Explanation of Hazard Analysis terms: hazard, hazardous situation, harm, risk
- Explanation of the hazard analysis process using a template
- Examples of terms will be given will be covered step by step
Who Will Benefit:
- Engineer
- Engineering Manager
- Regulatory Personnel
- QA