It’s not uncommon for audits to come back with document control findings. Some may be minor, while others can take serious reworking to untangle (particularly if you rely on paper-based systems or network drives).
Common issues involve:
• Not including employees who use the documents in writing or review. This often means people just follow their own protocol, or use an older one that served them better.
• Inadequate change management processes that can’t keep up with rapid changes in manufacturing, and/or where multiple facilities are involved.
• Not being able to find documents at the point of use. I’ve even heard of companies calling suppliers before an audit to ask for copies of their own drawings because they couldn’t find them.
