Sample size for process validation

[Bev D]

I second @Tidge: a process map and a function map are the critical inputs to any FMEA.
I will add that a FMEA is essential for your organization to develop a quality product, understand what validation is needed/helpful, including sample size and in helping with continual improvement and corrective actions. The help it provides un-knowledgable auditors is the least of it’s benefits.

Here are 3 papers I have in the resources section that you might find helpful:

“Development Process: FMEA, Critical Characteristics, Spec Setting and Controls”
“A Fresh Approach to Risk Assessment”. This is about change assessment but includes very helpful examples for creating process and function maps, determining occurrence and forming any FMEA…
“Sampling for Validation Testing”

Hope this helps

 

[Tidge]

I will add that a FMEA is essential for your organization to develop a quality product, understand what validation is needed/helpful, including sample size and in helping with continual improvement and corrective actions. The help it provides un-knowledgable auditors is the least of it’s benefits.

I REALLY wish I didn't have to even mention such things.... but I have worked with/for too many people that repeatedly demonstrated a lack of awareness of how something like an engineered smooth-running, predictable, and (relatively) issue-free production is good for everyone: customers and business. Those sort of management folks are exceptionally thin-skinned when faced with external parties who they simply can't bully with their own ignorance, so I often find myself motivating documentation with an argument like "leave a clue, so when the clueless management rep asks someone else for an answer, there is at least a trail."