I am writing to you in hopes that you or possibly someone you have contact with can help me interpret some language in the 2003 NELAC Standard. In 220.127.116.11(p) it says regarding the Quality Manual, “the laboratory management arrangements for exceptionally permitting departures from documented policies and procedures or from standard specifications”, I am having a hard time defining “exceptionally permitting departures”. Can you offer any suggestions?
Tom McAninch offers this answer:
Historically, it has meant that the lab management must have a procedure to allow exceptions to their own polices and/or procedures. The procedure needs to specify what circumstances may warrant exceptions, what approvals are needed, and what records must be kept. These replace non-conformance/correctvie actions for exceptions that are not approved.
It must be used with caution and not used just to replace corrective action that was not done.
I have seen it used most often where labs need it to clarify that work not used for regulatory compliance does not have to comply with NELAC or laboratory standards. They use it to protect themselves during assessments. I suppose there are some emergencies that might qualifiy, but I have not seen any examples in use.