Section I: Plan

  • Audit Number (taken from Schedule)

Audit criteria: *

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

  • Audit Type

  • Location

Type of Audit and Scope

    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

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

Section VII: Response

    Audit Findings Response (need to figure out user id access)
  • Add the Audit Finding in this section [Select PLUS (+) for additional findings]

  • Audit nonconformance Response Number (as referenced in Section V of audit report):

  • Description of Finding (as taken from audit report)

  • Failure Investigation: (Reference all potential root causes, records, and evidence; including tools and period for the investigation)

  • Corrective actions to be taken: (Ensure actions are aligned with investigation results)

  • Corrective Action Due

  • Preventive actions to be taken: (Ensure actions are aligned with investigation results)

  • Preventive Action Due Date

  • Verification / Validation of actions to be taken: (Ensure actions are aligned with CAs/PAs)

  • Verification / Validation Due Date

  • Effectiveness actions to be taken: (Ensure actions are aligned with CAs/PAs)

  • Effectiveness actions Due Date

  • CAPA Response Completed by (name):

  • CAPA Response Completed by (title):

  • CAPA Response Completed Date:

  • Lead Auditor Review

  • Date Response Received

  • Date Response Reviewed

  • Response Disposition

  • Lead Auditor Comments (Document Rationale of Rejection)

  • Failure Investigation (update)

  • Updated Corrective Actions (if applicable)

  • Updated Corrective Action Due Date

  • Updated Preventive Action (If applicable)

  • Updated Preventive Action Due Date

  • Updated Verification/Validation of Actions to be taken

  • Updated Verification Due Date

  • Updated Effectiveness Actions to be taken (if applicable)

  • Updated Effectiveness Actions Due Date

  • Updated CAPA Response Completed by (Name):

  • Updated CAPA Response Completed by (Title):

  • Updated CAPA Response Completed Date

  • Lead Auditor Review

  • Date Updated Response Received

  • Date Updated Response Reviewed

  • Updated Response Disposition

  • Lead Auditor Comments (Document Rationale of Rejection)

  • Failure Investigation (update)

  • Updated Corrective Actions (if applicable)

  • Updated Corrective Action Due Date

  • Updated Preventive Action (If applicable)

  • Updated Preventive Action Due Date

  • Updated Verification/Validation of Actions to be taken

  • Updated Verification Due Date

  • Updated Effectiveness Actions to be taken (if applicable)

  • Updated Effectiveness Actions Due Date

  • Updated CAPA Response Completed by (Name):

  • Updated CAPA Response Completed by (Title):

  • Updated CAPA Response Completed Date

  • Response Disposition

  • Lead Auditor Review

  • Date Updated Response Received

  • Date Updated Response Reviewed

  • Date Complete

  • Date Closed

Section VIII: Audit Findings Closure

  • Document dates when each nonconformance was verified

  • Audit Closure
  • Audit nonconformance Number

  • CAPA number (if applicable)

  • Follow-up on Audit Number

  • Date verified Effective

Section IX: Signature

  • Lead Auditor Name:

  • Signature

  • Select date

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