The preparations have gone well so far, the documentation is in place and all your colleagues understand what’s going on. The Inspection looms. The build-up process would have brought up questions and challenges, but would have made you and your colleagues focus on your work practices. Now it’s time to set up the final route to attaining/retaining the company’s WDA licence.
It’s worth remembering that the inspector is not intending to be a heavy-handed official – poring for errors and flashing the red card at every opportunity. Be mindful to show you have a logical process to your Quality Management System, that procedures are suitable and followed correctly, and that whatever has happened- it’s recorded. Most importantly, you – as the Quality Manager/RP – are confident in what is required to be presented, and you can demonstrate how, and why, it will be maintained.
So, a room is booked, the key people are primed and the lunch has been arranged. You just need to go through the last minute paces, vital for any encounter. And remember, the referee wants you to win this one.
- Have your initial presentation on the Company’s activities ready to go. This can show as much of these activities as possible. You should also present information on the key people and their roles within the organisation (the Quality Manager, MD, Warehouse Manager, RP etc). Roles you will have decided the Inspector will want to be aware of.
- A check through the documents can’t hurt. Are they all signed and dated appropriately? Are they all version controlled?
- The inspector will ask to see certain files, not all of them. But anticipate all of them being required. If there isn’t space for them to be at hand, then ensure that nothing will take very long to be retrieved.
- All the job descriptions should be up-to-date. Have you checked your own?
- Ensure the MHRA logo is not displayed on your letterheads and livery of vehicles. It is not authorised.
The Warehouse (if applicable)
- For any temperature controlled area – ensure that any pallets in there are Heat Treated
- Check the bait-boxes are positioned as intended.
- The temperature probes are where they should be, and working.
- Stock locations are holding the same as detailed on the computerised system, including non- Pharmaceutical products – the inspector will check something.
Have a thorough clean-through the warehouse, make sure everyone wears a high-visibility tops (including all visitors) and keep it tidy and organised
Written by Brian Lindsay