Internal audit evaluation

Quality Assurance
1

Hello :slight_smile: ,
I am trying to prepare an evaluation checklist in order to assess the performed internal audit and to have an overview about each internal audit and its efficiency.
I would like to know what kind of points i should include in the checklist in order to make a good assessment of each internal audit?
Thank you in advance

3 Likes
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Please prepare department/section-specific checklists to conduct internal audits. The checklists should be prepared based on the following aspects,

  • Internal SOPs compliance (day-to-day work activities)
  • Documentation (Data integrity / Good documentation practices using ALCOA+ principles)
  • BMR. BPR completion
  • Analytical raw data, COAs
  • Calibration, Validation, Qualification (Production, Utilities & QC)
  • Analytical Method validation
  • Process validation
  • Cleaning validation
  • Training of employees
  • Investigations (OOS, OOT, Deviations, Product complaints)
  • Change requests evaluations
  • Regulatory compliance
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