I have a question regarding tamper resistant seals for calibration on RP
meters.  A QA audit made a SFR (supplier finding report) at an instrument
calibration facility stating vendor should be placing these seals on our RP
meters.

 

The cited standard is ANSI Z540:1994 Section 11.5, but after some discussion
we agreed that this only applies to lab standards.  He also cited ISO
17025:2017 Section 6.4.12 which states "the laboratory shall take practical
measures to prevent unintended adjustments of equipment from invalidating
results."  The auditor said that industry interprets this as requiring
tamper seals, but also said that complying with the ISO standard was a
matter of lab certification only (not a regulatory requirement).

 

Does any site require tamper resistant seals on RP field instruments?  Yes
No

 

If yes how do you handle routine battery and/or desiccant replacement?

 

What do you do if a seal is found broken or missing.  In short, would the
event be entered into the corrective action system?

 

Do you rely on your source check and zero check of the instrument to
"validate" its calibration in lieu of the tamper seal?

 

Thanks in advance

Tom Meek, CHP

 

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