Change Inspection method on released Inspection lot.

[Former Member]

We have one issue:

Inspection lot has created and lab started testing as per current Inspection plan and current Inspection method. During the testing the method has been changed. As per Health Canada and FDA rules, the test should be cancelled and to be performed new test using new method.

In this situation how we can change Inspection method on Inspection Plan without cancelling the Inspection lot.

[former_member190267]

Hello,

You can only assign a plan which has a creation date that is prior to the creation of the inspection lot.

If you change the plan, then these changes are not updated in existent inspection lots.

If you want to create a possibility to change the plan although the inspection lot has been created, I would recommend that you check if you can use the Exit QPL10001 which is processed in QA02, meaning that you can change the plan using QA02 and by implementing a pop-up in the named exit.

Natália

[former_member42743]

That is not necessarily correct Natalia.  I've often changed a plan to a newer plan that was created after the inspection lot was.  In fact, it often happens at clients that a new material is created and it is not set up right resulting in a lot in CRTD status.  We create the plan, change the key date in the inspection lot and assign the plan.  No problem.    The issue is how much work has been done on the existing lot.  Once the lot gets an INSP status, no plan change can be done.  Once a UD or stock posting has been done, no new plan can be assigned.  In some cases a MBST can be executed to cancel the whole thing.  But not always.

You are correct in that changes to a plan will not be reflected in existing lots.  The sample has to be reset, the key date updated, and the plan reassigned to reread the new plan.  But once certain processing has been done, you can't reset the lot.

Craig

[former_member42743]

No.  You would need to MBST the material document that created the lot.  Then re-receive it and create a new lot.

One alternative might be to add an "unplanned characteristic" directly to the inspection lot.  I assume you have a new version of the MIC?  Select the new version of the characteristic into the inspec lot.

Craig