How to handle departures from policies...

[kchapman1]

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 5.4.2.3(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.

[kchapman1]

Tom has some additional thoughts on permitting departures from normal procedures:

1. I rarely see the procedure for departure used, but it is required;
2. It is for unusual instances where normal procedures do not apply but the frequency of the need is not enough to re-write the procedure or write a separate procedure;
3. It is not to be used to cover after-the-fact departures from procedures that were not planned to avoid corrective action;
4. It cannot be used to avoid implementation of standard requirements, such as hiring of an unqualified Tech Dir;
4. It is not to be used to cover QC failures for which your SOP applies;
5. It can be used to depart from procedures for special samples where the client requirements may be different or not be as stringent as your SOP QC requirements.