Lack of Essential Microbial Testing for Contamination Detection


Blue Bell Creameries Inc
Issued on:
Inspection Dates:
06 Apr 2015 to 30 Apr 2015
423 N Norton Ave, Sylacauga, AL 35150-2009
  • Patrick C Dooley
  • Lezette M Earhart
  • Thomas B Smith
  • Andrew F Saunders
  • Wilvor K Butler
  • Justin N Henson

Detailed Analysis

Key Observations

  • The observation highlights significant lapses in quality control, change control, and incident investigation processes, indicating a systemic failure to appropriately manage and investigate discrepancies affecting batch integrity.

Possible Root Cause :

  • Lack of adequate quality control and review processes.
  • Inadequate training or oversight leading to human error.
  • Ineffective or non-existent change control processes.
  • Failure to establish and follow thorough investigation procedures for discrepancies.

Corrective Action:

  • Implement a robust quality review process to ensure all discrepancies are thoroughly investigated and documented.
  • Enhance training programs for employees to include specific protocols on how to handle discrepancies and failure investigations.
  • Establish or revise change control processes to ensure all changes are documented and reviewed for potential batch impact.
  • Develop clear and comprehensive procedures for investigating discrepancies, including criteria for extending investigations to related products.

Preventive Action

  • Regular audits of quality control and incident investigation processes to ensure compliance with established procedures.
  • Continuous training and re-training of staff on the latest quality management practices and discrepancy investigation techniques.
  • Implement a systematic review of change control processes to identify and mitigate potential risks before they affect batch integrity.
  • Utilize root cause analysis tools in all discrepancy investigations to prevent recurrence of similar issues.
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