Deviations from the approved procedures in your document management system can potentially affect quality, and therefore, regulatory compliance. Also called out-of-specification (OOS) results, deviations can occur during raw material and finished product acceptance, sampling and testing, manufacturing, or product distribution.
While it is impossible to completely avoid deviations, FDA-regulated companies, especially pharmaceutical companies, must have the ability to manage both planned and unplanned deviations.
Some key features of the Deviation module in The Lean Machine:
- Six customizable text fields
- Multiple person approval list
- Automatic linking to 10 other modules in The Lean Machine
- Affected Procedures
- Rejected Materials
- Customer Feedback/Complaints
- Multiple date ordered investigation notes
- Link to a location in the Contact Manager module to support supplier quality tracking
- E-mail reviewer list via MS Outlook
- Deviation tasks are rolled up to the user dashboard
- Trend reporting and analysis tools