Medical Device Process Validation: What are the REAL Odds of Passing?
Statistics tell us: (1) Passing a typical 3-lot PQ is not easy; (2) What to do about it. In medical device process validation (IQ OQ PQ)...
Blog
Medical Devices, Lean Six Sigma, Project Management, Career, and more.
New posts added regularly. To be among the first to know, subscribe.
7 Process Validation Report Tips
These are the first 7 I would give someone drafting a process validation report (+PDF available with more tips!)
29 views
Root Cause Analysis: 3 Methods
An introduction to RCA, problem definition, and 3 common methods (+download PDF)
104 views
Medical Device Process Validation - Overview: Part 2
Continuation of Process Validation essentials discussion (+download PDF)
65 views
Medical Device Process Validation - Overview: Part 1
We begin our discussion of Process Validation essentials in Part 1 (+download PDF).
173 views
Medical Device Design Verification and Validation: An Overview
Overview of DV&V using 3 methods with introductory concepts (+download PDF).
179 views
Process Validation vs QC Inspection: 5 Differences to Know
These 5 differences result from their radically different aims and assumptions.
76 views
The REAL odds of passing a Process Validation - Part 4
In Part 4 we look at why it is highly advantageous to use Double-Sampling plans whenever possible for attribute analysis studies.
124 views
What is the difference between Cpk and Ppk?
How they are calculated can have a profound difference in their values for the process.
117 views
The REAL odds of passing a Process Validation - Part 3
In Part 3, we compare real sampling plans vs. the ideal sampling plan as sample size increases.
39 views
The REAL odds of passing a Process Validation - Part 2
In Part 1 we concluded that to have a reasonable chance at passing 3 consecutive lots, the process % defective must be much lower than...
32 views
The REAL odds of passing a Process Validation
Statistics tell us passing a PQ is not easy! In validation we’re providing objective evidence the process is capable of successfully...
42 views