Class II Medical Device Manufacturer - SOP for 820.250 Statistical

Bill Evans

Involved In Discussions
#1
Looking for a simple standard operating procedure for 820.250 statistics. We are performing basic fabrication and assembly.

If anyone has a sample, I would appreciate it.
 
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Mark Meer

Trusted Information Resource
#2
(tongue-in-cheek) ;)

  1. Google search "statistical techniques"
  2. Follow links to Wikipedia pages describing the techniques.
  3. Start your SOP with the heading: "While performing XXX any of the following statistical techniques may be employed as applicable:"
  4. Copy and paste the Wikipedia articles

But seriously...

Make sure you keep it as flexible as possible. Include a lot of options so the SOP remains applicable over a lot of different scenarios. Also include some caveats with respect to risk-assessment or engineering justifications (e.g. full blown statistical analyses are not always necessary...)
 
B

BhupinderSinghPawa

#4
In the SOP just refer to
ISO/TR 10017 (2003): Guidance on statistical techniques for ISO 9001:2000

It describes clause wise - need of quantitative data with applicable statistical technique. It goes on to describe each statistical technique. So based on the context an appropriate technique or group of techniques can be chosen. As mark mentioned, keep it flexible.
 
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