Name: Chiara D’angelo
Class: 1992
Origin: Pescara
Chiara loves her two little dogs, a mongrel and a dachshund. Her favorite dish, of course, is arrosticini.
Chiara, tell us a little bit about your department. What do you deal with?
The documentation department is responsible for writing all the documentation accompanying the packaging machine. It is not just about “writing a manual” but following the whole development of the machine: from how it is conceived, then designed and manufactured to getting the finished product: the pouch.
From the first to the last step there is a world composed of manuals, operation diagrams and procedures.
In addition to the more “standard” documentation, I also take care of the more practical part, such as machine validation and qualification, risk analysis and writing technical files.
The great thing about the documentation department is that it allows us to get hands-on in several areas: that of safety with risk analyses to assess whether all the functions of the machine have been designed with the safety of the operator who is going to use it, but also software, electrical and mechanical to verify all the operations performed by the machine.
All this is reflected in the IQ and OQ validation tests written according to the GAMP5 guidelines.
Our department also deals with certifications. We have the task of analyzing and verifying whether the components chosen and installed on the packaging machine are suitable for contact with the specific product and, once suitability is established, issuing a declaration of conformity.
It is a developing department: at first it consisted only of me, for two years now I have been joined by Antonietta and in the near future new hires are planned.
