Process-FMEA according to Spengler & Juhnke
New practical PFMEA approach
Guidelines for conducting a process risk analysis in 8 steps
This method was presented for the first time on 26.09.2013 at the 4th GMP and Technology Congress in Freiburg by the authors, Dr Jan-Peter Spengler and Dr Hanno Juhnke.
The focus was on the method’s practical applicability in development. This is because everyday business shows that risk analyses done by the conventional process FMEA involves so many uncertainties that risk minimisation can rarely be completely accomplished.
Dr Spengler and Dr Juhnke – both very experienced staff in quality assurance – therefore designed their process FMEA to use a practical fact-based solution for bypassing the points that repeatedly proved to be an obstacle during implementation.
This resulted in a method that is more resource-saving and efficient than the conventional process FMEA, significantly reduces the workload of operational experts and leads to more reliable results:
- It is fact-based
- It is easy to understand and to implement: you complete the entire process risk analysis in eight clearly defined steps.
In their guideline, the authors concisely present their method by means of numerous examples. They show step by step how the process risk analysis is carried out and what needs to be observed:
For users of the print version guide: The PDF version includes the complete overview ‘Example of the process FMEA after pre-evaluation and main evaluation’.