This LabGram is being sent as a clarification and supplement to Scheme Pub #3, for the section entitled "Observation Reports".
Observation Reports (ORs) are submitted by CCTLs to document a question they have on a specific evaluation to receive a quick turn around resolution from the Validation Body. The Validator may also use the OR mechanism for documenting a question about a specific evaluation for which they need formal resolution from the Validation Body even if the CCTL does not agree with the need to submit an OR. Validators may submit ORs to document: 1. a disagreement between a validation team and an evaluation team; or 2. a noteworthy decision by a validation team in which a formal documented resolution from the Validation Body is desired.
ORs can be initiated by the evaluation team or by the validation team. Regardless of who initiates an OR, both parties must:
Additionally, the evaluation team must review the OR for proper marking of proprietary information.