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Printable Handouts
Navigable Slide Index
- Introduction
- Overview
- Introduction of SOPs
- Why do we need SOPs?
- Regulatory requirements
- Quality related terminology
- Process capability
- SOP as a trainee manual
- The large volume of a paper-based system
- Information on demand
- FDA deficiencies
- Traditional approach
- Uniformity of performance (1)
- SOP in a traditional quality system
- SOP developed by function
- Independent quality department
- A process based approach (1)
- A process based approach (2)
- Modern, robust quality management system
- DMAIC approach to continual improvement
- Process mapping
- Identification of gaps
- Incorporation into the workflow
- Mistake proofing
- Poka yoke
- FlyBy airlines
- Online booking system
- Dynamic form
- Selecting a date for the flight
- Flow of the processes
- Uniformity of performance (2)
- The advantages of the approach
- Documentation of key processes
- What software to use?
- Conclusions
- Change of paradigm
- Do SOPs really fit the new generation?
- Requirements of SOPs
- Summary
Topics Covered
- The need for SOPs
- Requirements of SOPs
- Quality related terminology
- Process capability
- SOP as a trainee manual
- The large volume of a paper-based system
- Information on demand
- FDA deficiencies – A traditional vs. a process based approach
- Uniformity of performance
- SOP in a traditional quality system
- SOP developed by function
- Independent quality department
- Modern, robust quality management system
- DMAIC approach to continual improvement
- Process mapping
- Identification of gaps
- Incorporation into the workflow
- Mistake proofing (Poka yoke)
- FlyBy airlines and the online booking system example
- Flow of the processes
- Documentation of key processes – SOP software
- SOPs and the new generation
Links
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Talk Citation
Nicholas, S. (2013, June 13). SOPs as part of the quality system [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 8, 2024, from https://doi.org/10.69645/STOG6403.Export Citation (RIS)
Publication History
Financial Disclosures
- Mr. Steve Nicholas has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.