Deviations

Planned and Unplanned deviations from approved procedures can potentially affect quality, and therefore, compliance, especiatlly if you are a Pharmaceutical company, or contract laboratory.   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’s impossible to completely avoid deviation, the FDA expects pharmaceutical companies to manage both planned and unplanned deviations. 

Watch the tutorial for this Module

Module Highlights

  • Six customizable text fields
  • Multiple person approval list
  • Automatic linking to 8 other modules in The Lean Machine
    • Affected Procedures
    • CAPA
    • Audits
    • Meetings
    • Rejected Materials
    • FMEA
    • Customer Feedback/Complaints
    • Metrics
  • Attachments
  • 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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