This Risk Analysis training guide you through the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs and step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application. Did you know that you can use your existing Risk Analyses to help you do more than manage risk? Risk Analyses can be used to prioritize and streamline Design Input, Design Output, Design V&V, and both Pre-Production.
Focusing on the wrong product development or manufacturing activities can not only waste your time and money but can affect the quality of your product and leave you unprepared for regulatory audits.
Focusing on the wrong product development or manufacturing activities can not only waste your time and money but can affect the quality of your product and leave you unprepared for regulatory audits.
- In this presentation, we will show you
- How to target your Design Input activities to focus on those areas that improve safety, minimize risk and improve quality
- How Design Output feeds back to Design Input using the Risk Analysis process
- How to target your Design V&V and Process Validation plans to the most critical aspects of your product and determine the minimum number of samples needed
- How to reduce or eliminate testing and inspections that do not bring value to your product or your business
- An adequate testing, inspection and sampling plan will save you time and money while also helping you deliver safer, higher quality products to your customers.
- This webinar - which assumes a basic understanding of the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs - will take you a step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application of Risk Analysis results to achieve additional benefits.
Areas Covered in the seminar:
- How to use the HA to drive Design Input Requirements
- How to use the dFMEA as an additional link from Design Output back to Design Input
- How to use Risk Analysis as a tool in formulating your Design V&V strategy, including how to develop a risk based sampling plan
- How to use Risk Analysis as a tool in formulating your Process Validation strategy
- How to use the results of your Process Validation Strategy to drive your Inspection and Test Strategy
- How to safely reduce testing and inspections done in Production without compromising quality
Who Will Benefit:
- Quality Assurance managers and personnel
- R&D managers & engineers
- Regulatory Affairs personnel
- Quality system auditors
Course Provider
Robert DiNitto,
