Inadequate Establishment of Quality Audit Procedures

Overview

Company:
Hospira, Inc.
Issued on:
17-Jun-11
Feinumber:
1021343
Inspection Dates:
16 May 2011 to 17 Jun 2011
Location:
Hwy. 301 N. + 4285 North Wesleyan Blvd., Rocky Mount, NC 27804
Investigators:
  • Jason F Chancey
  • Penny H McCarver
  • Claudette D Brooks

Detailed Analysis

Key Observations

  • The internal quality audit program lacks sufficient detail regarding the specific areas and quality systems to be audited, leading to potential gaps in quality oversight.

Possible Root Cause :

  • Lack of detailed planning in the internal audit schedule.
  • Insufficient definition of audit scope and frequency.
  • Inadequate coverage of all necessary quality systems within the audit program.

Corrective Action:

  • Revise the internal audit procedure to clearly define areas and quality systems to be audited.
  • Implement a more detailed audit schedule that ensures all necessary quality systems are covered within a two-year cycle.
  • Train quality audit personnel on the revised procedures and schedules.

Preventive Action

  • Develop a protocol for regular review and update of audit procedures to adapt to changes in regulatory requirements and organizational processes.
  • Institute a protocol for auditing the audit process itself to ensure continuous improvement.
  • Enhance audit training programs to cover strategic planning and scope definition.
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