Routine inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Related FDA483/Warning Letter
Subsection D. (A&B) No written procedure is approved by QA describing Preventative Maintenance tasks and their frequency for concerning monthly tasks for the walk-in [redacted] RH stability chamber. reads in part: ***Responsibility ***The Facilities Group (C) is responsible for maintaining and repairing the Chamber ***The Facilities Group will coordinate all (D) repair work and perform calibrations per the schedule ***”. Review of the last printout for monthly tasks completed were identified in as “confirmed”. According to ????? he gets a work order with the tasks to complete and after he confirms the work order is complete he (E & F) throws the work order away. Hence, there is no way in to identify what tasks were actually performed.
IF IT’S NOT DOCUMENTED IT’S NOT DONE
- PM tasks should be defined in an SOP. If using a vendor to do the work include a generalized protocol as an attachment to the document.
- PM’s should use a proactive process that monitors the “Health” of the unit, not just a process that only looks at physical issues such as door seals, chamber lights, etc.
- Maintenance should be discussed and classified as Scheduled (PM) and Non Scheduled (breakdown).
- Defining the requirements is the responsibility of both Chamber Ops and Facilities. Controlled by Stability/Quality
- Work needs to be completed in a cGMP process
- Original documentation should be recorded and filed for all work in a filing program that is quickly accessible and references only the specific unit. The SOP should include a form for the documentation of work.
- Who knows if their Maintenance/Facilities personnel are cGMP trained on an annual basis?