It is extremely important to define service activities and differentiate them from complaints, as it is very common to inadvertently use the service system to circumvent the complaint system.

Example

Let’s take a piece of lab equipment which is used for diagnostic testing as an example.

Let’s say there is a buffer used in this system and a buffer bottle that is refilled by the user. Let us also say that 62% of the service visits the service engineers are finding these bottles have leaked and replace them as part of the service call.

This activity has effectively circumvented the complaint system to track and trend product issues and its ability to relate them back to the CAPA system or to manufacturing to note that there is a problem with this component failing in the field.

Major Issue

This can be a major issue and can be avoided by ensuring service activities are specifically defined and that additional service requirements be reported through the compliant system.

All records of installation and service should be maintained as controlled records.