“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.
Why You Should Attend:
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.
- Brief introduction to Lean Documents and Lean Configuration
- Risk management process as per ISO 14971
- Management responsibilities
- Qualification of personnel
- Risk management plan
- Risk management file
- Bringing it all together – links to design and process
- Quality Assurance Departments
- Research and Development Departments
- Manufacturing Departments
- Engineering Departments
- Operations Departments
- Production Departments
- Design Assurance Teams
- Documentation Control Departments