AS9100 requires that organizations identify applicable regulatory requirements however most Quality Management Systems DO NOT contain processes to verify and validate actions performed by Empowered Officials.
Fact: Empowered Officials must certify that information provided on applications is accurate.
An Empowered Official is tasked with applying for a DSP-5 for a Foreign Person “working” at the company. As is sometimes the case, there was pressure to get the license in place as soon as possible. The EO having many years experience in submitting DSP-5 applications did what many EO’s do, he relied on using his templates for completing the application and artifacts.
Upon DDTC’s receipt of the application, the DDTC analyst contacted the EO and asked one question, was the Foreign Person a regular employee? Turns out the answer was “no”, the Foreign Person was a contractor. The DDTC analyst then said those ugly words “You may be in violation”.
It seems simple to say that Empowered Officials should confirm their “outputs” meet the regulatory requirement(s). That all requests for USG Authorization (i.e., license applications, agreement applications, use of exemptions, etc.) should be evaluated for correctness and meeting requirements PRIOR to submission.
EO’s should include these two questions in their evaluation of their outputs:
- Is the information provided correct and accurate, is it the actual state of things at the time of submission?
- Does the information meet the regulatory requirement(s)?