We perform a basic trace exercise but there are few things that need to be added. Some things we have found that have been helpful are the following:
- Responsibilities of employees. Examples: Customer service contacts the customers, also include a template of a letter that would be sent out.
- Have a list of customers that would have been contacted, along with their contact information to make sure it is up to date.
- Have the list of recall contacts attached to the report (ex: certification body, FDA, government, etc)
- Explain who is responsible for contacting the legal departments and also the media
- Root Cause needs to be listed. Now, be careful on this one because we have seen it both ways. We make up a scenario for the mock recall and then a corrective action we put in place BUT then the auditor wanted to see where we documented this corrective action on our CAPA log. Even though it was a made up situation, they wanted to see it. So now I put in bold letters in the mock recall write up "this is a hypothetical situation and the issue is made up , this issue did not occur in our plant and we did not need to issue a real corrective action". You can make up the corrective actions, as if the situation did happen but make it known that it was not a real situation.
- have people sign in who participated
- make sure that all members are signed in that are part of your recall team, if they are not present, you need to list the backup and that should be shown somewhere. We actually have a recall policy which basically just explains each responsibility for each department and how the flow would go in the event of recall. Make sure to have any numbers or contacts that would need to be used in this.
These are just some helpful hints we have gotten along the way.
Hope this helps!