EU MDR Audit Template: CAPA Responses

• Conducted on

  Date
• Location
  Address

• 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

  Internal Audit

  For Cause Audit

  Supplier Audit

  Distribution Assessment (??)

• 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

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

  Date

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

• Preventive Action Due Date

  Date

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

• Verification / Validation Due Date

  Date

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

• Effectiveness actions Due Date

  Date

• CAPA Response Completed by (name):

• CAPA Response Completed by (title):

• CAPA Response Completed Date:

  Date

• Lead Auditor Review

• Date Response Received

  Date

• Date Response Reviewed

  Date

• Response Disposition

  Accept

  Reject

• Lead Auditor Comments (Document Rationale of Rejection)

• Failure Investigation (update)

• Updated Corrective Actions (if applicable)

• Updated Corrective Action Due Date

  Date

• Updated Preventive Action (If applicable)

• Updated Preventive Action Due Date

  Date

• Updated Verification/Validation of Actions to be taken

• Updated Verification Due Date

  Date

• Updated Effectiveness Actions to be taken (if applicable)

• Updated Effectiveness Actions Due Date

  Date

• Updated CAPA Response Completed by (Name):

• Updated CAPA Response Completed by (Title):

• Updated CAPA Response Completed Date

  Date

• Lead Auditor Review

• Date Updated Response Received

  Date

• Date Updated Response Reviewed

  Date

• Updated Response Disposition

  Accept

  Reject

• Lead Auditor Comments (Document Rationale of Rejection)

• Failure Investigation (update)

• Updated Corrective Actions (if applicable)

• Updated Corrective Action Due Date

  Date

• Updated Preventive Action (If applicable)

• Updated Preventive Action Due Date

  Date

• Updated Verification/Validation of Actions to be taken

• Updated Verification Due Date

  Date

• Updated Effectiveness Actions to be taken (if applicable)

• Updated Effectiveness Actions Due Date

  Date

• Updated CAPA Response Completed by (Name):

• Updated CAPA Response Completed by (Title):

• Updated CAPA Response Completed Date

  Date

• Response Disposition

  Accept

  Reject

• Lead Auditor Review

• Date Updated Response Received

  Date

• Date Updated Response Reviewed

  Date

• Date Complete

  Date

• Date Closed

  Date

• Document dates when each nonconformance was verified

Audit Closure

• Audit nonconformance Number

• CAPA number (if applicable)

• Follow-up on Audit Number

• Date verified Effective

  Date

• Lead Auditor Name:

• Signature

  Sign

• Select date

  Date