Deviations

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.

Deviation Management Banner

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
    • CAPA
    • Audits
    • Meetings
    • Rejected Materials
    • FMEA
    • Customer Feedback/Complaints
    • Metrics
    • Attachments
    • Equipment

 

  • 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


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