Last week’s blog addressed risk management. This week I will address risk assessments.
In order to be ready for an audit, you need to have prepared lots of documentation. At the top of the list is your quality manual. The manual will be more than 50 pages, so you have some work to do.
Included in the manual will be all of the procedures that your company follows or needs to follow. There will be a written description and a flow chart for each. You will need to be able to show that you follow those procedures.
You will need to write work Instructions for the activities called out in the workflows. If the person that normally performs those activities ends up in the hospital, someone needs to be able to fill in. The instructions need to be that good.
Internal – The person in charge of quality needs to perform an internal audit. This will help in a couple of ways. It will familiarize employees with the process and answers. It will help uncover anything that might be missing from the manual, the procedures and the work instructions.
Pre-Assessment – Auditors will perform a pre-assessment if you wish. This should help prepare you to pass your stage 2 audit.
Stage 1 – You should be in good shape to pass this. I would expect only a few items to be uncovered. You will have time to fix them.
Stage 2 – If you have done your homework, you should pass this and become certified.
Good luck – contact me if you would like some help.