Process Audit

• Internal Audit Number

• Site conducted

  Select

• Conducted on

  Date

• Performance Model Process(es)

  Select

• Matrix Process(es)

  Select

• Process Owner(s)

  Select

• Internal Audit Manager Name

  Sign

• 7.2.2 Internal Auditor(s) assigned by Internal Audit Manager:

  Select

• 7.2.3 Internal Audit Manager recruit any Technical Specialist(s)?

  Yes

  No

  N/A

• Technical Specialist(s) names:

• 7.2.5 Physical area(s) to be audited:

• 10.0 Confirmed Auditor(s) qualifications, if Under Instruction/Evaluation enter names here:

• Proposed Audit Start Date

  Date

• Proposed Audit Duration:

  Select

• 7.2.6 Process Owner and SME accept audit dates?

  Yes

  No

  N/A

• Revised Audit Start Date:

  Date

• SME name:

• Projected Audit Completion Date

  Date

• 7.2.7 SME(s) designated by Process Owner(s)

• 7.2.8 Draft Audit Inspection Report shared with Process Owner(s) and SME(s)

  Media

• 7.2.9 Audit Plan (shared blank inspection report with any LOI entered in 8.1) approved by Process Owner(s)?

  Yes

  No

  N/A

• Date Approved

  Date

8.1 and 8.2 Preparing for the audit activities (e.g., desktop audit), conducting the audit Activities (e.g., interviews, observations)

Line of inquiry

• LOI:

• Interviewee(s):

• Scheduled/revised interview date and time held:

  Date

• LOI Determination:

  Conforming

  Non-conforming (NCN)
8.2.1 Findings:

• Related LOI Number(s):

• Cited Clause(s):

  Select

• Requirement statement:

• Finding statement:

• Type:

  NCN

  OFI

  Commendable

• Classification

  Select

• CAPA Event Number(s):

  Select

• Can financial impact be determined?

  Yes

  No

  N/A

• What is the financial impact? (to be aligned with Finance guidance if desired at all).

  Select

• Was the issue corrected on the spot (i.e. during the audit)?

  Yes

  No

  N/A

• What action was taken to correct? Reference applicable corrective action tracking numbers.

• CAPA Event Number(s):

  Select

• 8.2.2 Inspection Report version for use in the Audit Report shared with Process Owner(s)

  Media

• 8.2.4 Meeting held with Process Owner(s) to present findings.

  Date

8.3 Reporting / 8.4 Completing / 8.5 Follow-up:

• Impacted Process Owners (including those possibly affected by any NCR/CAR):

  Select

• 8.3 Submit AUDIT REPORT: attach WORD version of Inspection Report to DCRM System Document Change Request (DCR) and enter DCR hyperlink here:

• 8.4 Internal Audit Manager review and confirm completed within (3) days after Internal Auditor meeting with Process Owner(s) in 8.2.4.

  Date

• 8.5.1 Process Owner(s) acknowledgment: (Include any actions assigned by the Process Owners for gaining resolution here)

• 8.5.2 Initial Responses from Process Owner(s) on any NCN were completed within (10) days as recorded in the DCRM System?

  Yes

  No

  N/A

• Response Date (most recent)

  Date

• Timely response (within 10 days)

  Yes

  No

  N/A

• 8.5.3 Audit Reporting noncompliance CAPA Event Number:

  Select

• 8.5.5 Audit Closure Date:

  Date

9. Remote Audit: Internal Audit Manager notifications to Facility Operations Manager

• 9.2 Participant(s) contact information:

• 9.2 Types and identification of mobile devices utilized:

• 9.2 Schedule and location of spaces to be visited at each site:

11. Records (filed with evidence attached or archived for retention in Records Management):

• Internal Audit Report Primary Document Number in DCRM System and hyperlink entered here:

• Non-Conformance Report (NCR) or Corrective Action Report (CAR) Primary Document Number in DCRM System and hyperlink entered here: