We think about traceability with respect to the making of our products, but what about traceability of our compliance program?
When compliance programs are originally written, they at least resemble the regulatory requirement they were based on. Between errors in the original document and changes over time, there is no guarantee that every requirement remains included in our procedure, and not even any assurance that everything in our procedure is required.
Our compliance programs are completely traceable. Each paragraph of policy, procedure, training, inspections and audit can be traced directly to the related regulatory paragraph.
If a regulatory requirement changes, it is easy to edit only those portions of the policy, procedure, training, inspections and audit that are impacted. That’s traceability!