#FindingsFriday: ISO 13485:2016 - Clause 6.3 Infrastructure





The Finding

The routine ppm is required to be weekly planned as per procedure QP-60.07 Rev 2 Preventative Maintenance and in current practice this is not the case.
WI 119 Rev 1 Planned Preventative Maintenance & Safety Checks is being used for planned maintenance activities, however it is not cross referenced in the PM Procedure.
Not all forms are cross referenced from WI 119 Rev 1 Planned Preventative Maintenance & Safety Checks procedure to the main PPM procedure. The mismatch between documents and the absence for not following procedure forms the basis of this finding.

Some Context to the Finding

ISO 13485 is the quality management standard for medical devices and clause 6.3 requires organisations to identify what requires planned preventive maintenance and at what intervals. Records of maintenance need to be retained.


Before introducing compliance software, this medical device manufacturer was reliant upon excel spreadsheets and paper based documents for managing compliance tasks. The supporting procedures and work instructions did not make it easy for the maintenance engineers to work consistently .


Action taken to address the finding

  • Implementation of a cloud based compliance software solution that enables effective identification of plant and equipment requiring maintenance, and allows maintenance tasks to be scheduled with automated reminders to ensure that tasks are completed on time.

  • The introduction of software meant that the supporting documentation could be simplified due to the in-built workflows within the system.


Lessons to take from this finding

  1. Purpose built compliance software will make it easier to manage planned preventive maintenance than struggling with excel spreadsheets and bits of paper.

  2. The right software will help to simplify, streamline or eradicate the need for some documentation, making it easier for people to understand what is needed.

  3. Simplifiying the process makes it easier for everyone and increases the chances of success!

 

Mango has an entire module dedicated to plant and equipment and it's so easy to set up event reminders for any Planned Preventive Maintenance (PPM) tasks that companies can delegate activities to staff at all levels of the organisation.


Why not see Mango in action for yourself? You can book your demonstration here or call us on 029 2070 3328 to speak to a member of our team.




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