Title Page

  • Document No.

  • Internal Audit for

  • Conducted on

  • Are there any issues outstanding from the previous audit?

  • What is outstanding from the previous Audit?

  • Audit Carried out by

  • Enter name if not above

MINOR = Findings which cannot be classified as critical or major. Requires CAPAs to be agreed although operations can proceed. MAJOR = Findings which could potentially cause adverse consequences to the patient or consumer if left un-addressed, could be considered indicative of poor control, could be considered major deviations by the regulatory authorities, or a combination of minor deficiencies. CRITICAL = Findings having a high probability of causing adverse consequences to the consumer or may result in significant deviations in the safety, identify, strength or purity of the product ; or are a combination of major deficiencies which indicates a critical system failure.

  • Internal Audit

  • Observation or non conformance No
  • What department or area is being audited?

  • Has any non compliance or observation been found?

  • What has been found?

  • Input any observations, recommendations , minor, major, or critical issues here

  • What is the non conformance?

  • Enter what has been found here

  • Take a photo or photos of any non compliance found if applicable

  • Additional comments or observations if applicable

  • Signature of Auditee

  • Signature of the auditor

  • Quality Manager / QA Team

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