Because Quality Systems are the focus of audits, there is always the potential for change control to be investigated, at some level, during an audit. While there are no specific items that consistently stand out as red flags for laboratory changes, it is advisable to keep the following things in mind when maintaining a change control system.
- Close out and file change control requests in a timely manner. Having a large number of open requests may indicate problems with your change control process. Is your process too complex to maintain, causing your records to be out of control?
- Look at the reasons for change requests. Are they well defined? If they are unclear or don’t cover all aspects of a change, your process may appear to be incomplete or questionable to an investigator.
- Do you see the same change request occurring repeatedly? What is the reason behind this? A pattern of repeat requests may be the result of an ineffective CAPA system.
- Are changes made without going through change control? If the change control process is too complex users may not understand when change control is required.
- Check related systems. Are there several lab investigations or SOP deviations related to change control requests? What is the root cause? Did the investigations or deviations results directly from change control issues?
Keeping these things in mind will help you to keep your change control system under control and manageable. This will help you to be proactive and prepared when it is time for an audit.