Camilla Lundius, who works in the QA department and is responsible for the Self-inspection program, explains how this is performed at Rechon.
Why do Rechon perform self-inspections?
“Self-inspections are an excellent way of monitoring the GMP-compliance but also to detect areas that could be improved. Our main focus during the inspections is GMP compliance, since this is a requirement according to GMP, but we also focus on improving the efficiency in the departments and finding ways of easier communication between the departments. Self-inspections are a forum for discussing improvements of all kinds as well as monitoring GMP compliance. All personnel are highly qualified and committed to their work which contributes to an open and creative dialogue.”
How are the self-inspections performed?
“We have a self-inspection group with members representing all departments and in the beginning of every year we set the program. We then decide when the departments are being inspected, by whom and what the focus of the inspections will be. The inspections are performed by a team which consists of a person from QA who act as lead inspector. The members from the self-inspection group participate in all inspections. The team consist of the representative of the inspected department, who acts as host for the inspection, and a representative from another department who act as an inspector. We believe that this set up for the inspections is a great way of sharing experiences through out the company and involving all departments.”
What departments are inspected?
“All departments that in some way work according to GMP are inspected at least once a year.”
How do you handle observations made during the inspections?
“We list the observations in the report and during the inspection we try to find a suitable action or response for the observation. This is possible in most cases since all concerned parties are represented during the inspection. If we can find a suitable action during the inspection this is stated in the report as a suggestion and then the inspected department implement the action and report this to the lead inspector in due time. Observations can also be transferred to the quality systems and be handled as a CAPA (corrective and preventive action) or as a deviation.”
How do you establish the inspection program?
“We make a summary at the end of the year and the program for next year is based on basic statistics from previous years along with a risk assessment.”
What are the benefits from having a self-inspection program?