Section I: Plan

  • Audit Number (taken from Schedule)

Auditee Information:

  • Auditee’s Name:

  • Auditee Address

  • Auditee State

  • Auditee Country

  • Auditee’s Responsible Host:

  • (Extent and boundaries of the audit, including the locations, functions, activities, processes, and time period covered, as applicable)

  • Internal Audit For Cause Audit Supplier Audit

Audit criteria: *

  • Audit Type

  • Location

  • Number of Days performing audit

Type of Audit and Scope

  • Extent and boundaries of the audit, including the functions, activities, processes covered, as applicable

  • Function, Process or Activity
  • List all of the Functions, Processes or Activities to be audited [select PLUS (+) to add each]

Audit Criteria

  • A set of policies, procedures, regulatory standards, agreements, contracts, or specifications used as a reference against which audit evidence is compared

  • Audit Scope

  • List Specific Contracts, specifications, drawings, agreements [select plus (+) to add each document name]
  • Document within Scope of Audit

Audit objective: *

  • (a determination of the extent of conformity of the areas audited per the scope and the audit criteria)

  • Assessing compliance to:

Audit Methods: *

  • (to obtain audit evidence via inquiry, interview, inspection, reviewing written documentation and records, observation, and confirmation)

  • How will audit evidence be collected?

  • Audit Team
  • Names

  • Select auditor Role

Audit Team Qualification Review:

  • Confirmed auditors have not provided consultancy for the auditee during the last five years

  • Confirmed Auditor’s Training is Adequate

  • Comments

Section II: Agenda

  • Section II: Agenda: (describes the order of activities, areas, elements, departments, or processes being audited after completing the desktop review)

  • Activity/Process/Element/Departments
  • Opening Meeting

  • Time

  • Auditor(s)

  • Escorts

  • Notes:

Section III - Nonconformance Rating Definition

  • Classification based on Level 1 to 3 and level 4 for OFI)

  • Level 1 s a serious and/or systemic failure that, in the judgment and experience of the Lead Auditor, has directly compromised the assurance of controlled processes and products and/or directly compromises customer or patient safety and/or could likely result in significant regulatory action following a regulatory authority inspection. One or a combination of the following conditions would fit this definition include but are not limited to:
    • Distributed product that potentially poses a direct threat to patient safety
    • Quality System breakdown that is likely to result in significant adverse regulatory action if identified during an external inspection
    • An occurrence of fraud (i.e. data integrity breach or falsification of a product or a document)
    • An element of the quality system, international regulations, or international quality system standards not implemented
    • A repeat occurrence of a major nonconformance or FDA Form 483 observation cited in the previous or external audit of the site.
    Escalated to formal CAPA

  • Level 2
    Major Level 2 is a quality system or process failure that, in the judgment and experience of the Lead Auditor, could potentially compromise the assurance of controlled processes and products. One or a combination of the following conditions would fit this definition include but are not limited to:
    • A Quality System breakdown that could shall a direct impact on patient safety or product performance that would not likely be identified as a result of subsequent controls or inspections. Implicated product has not been distributed out of control
    • A failure in a process or system that would likely be cited by a regulatory authority or customer as a significant non-compliance
    • Multiple level 3 nonconformities in different areas cited against the same requirement or (i.e. an apparent systemic problem)
    • Key records and/or evidence which cannot be properly traced leaving suspicion on their origin
    • A repeat occurrence of a Minor nonconformity or a significant number of minor nonconformance are raised in one system area that could shall a direct impact on product safety or performance or service performance
    Handled under the audit program CAPA

  • Level 3 is an apparently isolated failure to comply with existing regulatory or requirements that is not likely to compromise the assurance of controlled processes and products. Types of situations that would fit this definition include but are not limited to:
    • A Quality System breakdown that could shall a direct impact on product performance that would likely be identified as a result of subsequent controls or inspections
    • A Quality System breakdown with no direct (indirect) impact on product safety or product performance or service performance
    Handled under the audit program CAPA.

  • Opportunity for Improvement (OFI) is an identified area of weakness in the quality management system that can be improved upon or a suggestion to an existing system could be improved to minimize misinterpretation and void potential error. No
    Formal response recommended

Section IV: Meeting Attendees

  • Capture each participants' name and title [Select plus (+) sign to add attendees. Indicate attendance for Opening meeting, Closing meeting, or Both

  • Name and Title
  • Name

  • Title

  • Department

  • Location

  • Attended Opening Meeting

  • Attended Closing Meeting

Section V: Results

    Findings (select plus (+) to add each finding
  • Audit Finding Number:

  • Rating

  • Reference/Requirement (Reference the quality system element, regulation, standard, procedure, contract, and/or agreement of which compliance could not be established)

  • Statement

  • Auditor name:

Section VI - Executive Summary

Conclusion

  • Summary of the result of the audit with the main conclusions and the principal recommendations

  • Outcome of the audit as it relates to the overall compliance, effectiveness of the quality system for the audited area, and after consideration of the audit objectives and evidence against the audit criteria; including nonconformities and opportunities for improvement

  • Check here if an area requires re-auditing for audit schedule to be updated

Audit Report and Review

  • Report Written by:

  • Signature

  • Date

  • Report Reviewed by:

  • Signature

  • Date

  • Comments: Document any disputes and / or concerns

  • Distribution
  • Add name and Title (or Department) report is distributed to (Select Plus (+) to add names)

  • Name

  • Title

  • Department

Nonconformances......

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