Management of Process Deviation, Change Control, CAPA

The project involved S4BT Consultants with proven experience in Quality Assurance acquired in a number of sectors, including chemical and microbiological.

After an initial analysis phase of the client’s business processes, part of Team focused on reducing process deviations already open, actively collaborating with the entire company organisation to obtain the necessary information and to process the related reports in accordance with internal client procedures.

The focus later shifted to new deviations.

By participating in the implementation of a targeted survey plan, through effective CAPAs, the team contributed to the achievement of two important objectives:

• closure of investigations within the established deadlines
• decrease in Root Causes of the most commonly encountered problems

The resources involved in the management of Change Control and CAPA collaborated with the relevant departments for the following activities:

• preparation of reports and documentation necessary for the correct management and closure of activities
• drafting of operating procedures
• intensive monitoring of production