Mock Recall Checklist

Statement of Product Quality and Safety

Procedure for maintenance of Recall Manual

Relevant regulations and regulatory authority identified

Organizational training requirements identified

Mock recall requirements identified

Recall Team members identified with contact information

Roles and responsibilities identified for team and related functions

Procedures for acquiring data that may lead to recall action

Product identification and lot code definition, lot trace systems

Recall process flow diagram or checklists available

Resources identified to perform health hazard assessment

Elements of recall strategy defined

Model communications available: press release, customer letters

Model effectiveness checks available: written, telephone interview, personal visit Procedure for performing post-recall review