“The new standard expects you to apply a ‘risk based approach’ to your organization’s QMS processes. The old standard also expected you to think about risk, but only during product realization (in section 7).
Now, you’re expected to apply risk management methods and techniques to all QMS processes, including outsourced processes.”
In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to these linked and cascading documents, files, and requirements.
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.
This webinar presents a new approach yet is based on solid principles and proven practices.
Areas Covered in the Session :
Brief introduction to Lean Documents and Lean Configuration
Risk management process as per ISO 14971
Qualification of personnel
Risk management plan
Risk management file
Bringing it all together – links to design and process
Who Will Benefit:
All Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development