In-House Calibration Program - Biotech Industry

#1
Good Afternoon,

I am working on creating an In-House Calibration Program which will include upkeep of traceable standards to NIST, and creating Work Instructions and Training Documents for those who will be performing calibrations in house. We will also have our on Metrology Lab where it will be temperature controlled in order to store standards, etc.

Does anyone have general tips, issues or suggestions for this process?

Thanks!
 
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#2
That is a big question...I can share a few notes from my pain points this year, but this by no means is comprehensive:
  • Don't neglect your uncertainties. Both training, and establishing
  • "NIST traceable" is overly constrained, especially if you have highly specialized equipment or are operating internationally. I stated approximately this in my QMS: "National Metrology Laboratory party to an appropriate Mutual Recognition Agreement".
  • WI and training isn't enough in many cases. How are you ensuring verifiable competency? Inter-laboratory Comparisons? External Proficiency Studies or testing? Something else?

Good luck!
 

Ajit Basrur

Staff member
Admin
#3
Good Afternoon,

I am working on creating an In-House Calibration Program which will include upkeep of traceable standards to NIST, and creating Work Instructions and Training Documents for those who will be performing calibrations in house. We will also have our on Metrology Lab where it will be temperature controlled in order to store standards, etc.

Does anyone have general tips, issues or suggestions for this process?

Thanks!
Hopefully you have reviewed the ISO - ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories
 
#4
That is a big question...I can share a few notes from my pain points this year, but this by no means is comprehensive:
  • Don't neglect your uncertainties. Both training, and establishing
  • "NIST traceable" is overly constrained, especially if you have highly specialized equipment or are operating internationally. I stated approximately this in my QMS: "National Metrology Laboratory party to an appropriate Mutual Recognition Agreement".
  • WI and training isn't enough in many cases. How are you ensuring verifiable competency? Inter-laboratory Comparisons? External Proficiency Studies or testing? Something else?

Good luck!

Thank you very much for your feedback!!
 
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