The Finding
Qualified contractors were not being used to control the risk of flying and crawling insects.
There was no evidence available during the assessment to demonstrate that the contractor employed to maintain the flying insect control systems was qualified.
Some Context to the Finding
A specialist printer; a producer of adhesive labels extended their existing ISO 9001 Quality Management System to include the requirements of PS 9000:2016 Pharmaceutical packaging materials for medicinal products, with reference to Good Manufacturing Practice (GMP).
At the Stage 2 assessment the assessor identified the fact that there was no system for (and therefore no evidence of) requesting and obtaining details of contractor competence in relation to the outsourced activity of maintaining the insect control system.
Whilst this particular requirement is very specific to the pharmaceutical Standard, the issue of subcontractor evaluation and management is one that often crops up in management systems.
Action taken to address the finding
Evidence of relevant qualifications were obtained for the subcontractor maintaining the insect control system.
The process for evaluating and managing all subcontractors was reviewed.
Existing suppliers were asked to supply any evidence deemed necessary.
Systems were set up to ensure that any documents (e.g. certificates) with renewal dates would be requested at the appropriate intervals.
Lessons to take from this finding
Subcontractor evaluation and mangement should be effectively implemented.
The system shoudl ensure that as certificates expire, new ones are obtained.
Using cloud based compliance software can help to simplify the process of evaluating subcontractors before they are engaged, and for monitoring their ongoing performance. Mango has a built in supplier module which can be used in conjunction with the assessment module to request key information directly from suppliers and subcontractors.
The supplier module makes it easy to automate reminders which can go directly to the subcontractor as things like insurances or certificates expire.
To see just how easy Mango makes it to evaluate and manage subcontractors, book a free demo.