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Nadcap OPERATING PROCEDURE OP 1106

AUDIT REPORT PROCESSING Page 1 of 11


Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

*To be used for audits starting on or after 31-Oct-2021*

1.0 PURPOSE

To describe the audit review process in support of accreditation for Standard,


Subscriber Option A, and Subscriber Option B Accreditation options.

2.0 SCOPE

This procedure addresses audit review activities that take place upon
submittal of the audit report through issuance of the certificate. When
applying this procedure to Subscriber accreditation options, the term Review
Team shall be used in place of Task Group when the term refers to the body
making an accreditation decision.

3.0 DEFINITIONS

See OP 1103 Definitions.

Definitions of NCR statuses

Open – This is the default status for all NCRs. The NCR and or NCR
response has not been reviewed or has been reviewed but requires additional
information from the Auditee.

Accepted – NCR response has been approved by a non-delegated or


delegated Audit Report Reviewer.

Closed – NCR response has been approved by a delegated Audit Report


Reviewer or Task Group Subscriber Voting Members.

Task Group Resolution – a decision is requested of the Task Group


Subscriber Voting Members.

Void – NCR has been deemed invalid by the Audit Report Reviewer or the
Task Group Subscriber Voting Members.

4.0 PROCEDURE

4.1 Upon audit submittal to EC Review, an Audit Report Reviewer shall be


assigned.

4.1.1 Audit Report Reviewers may be either PRI Staff or independent contractors.

4.1.2 The Audit Report Reviewer name and delegation status shall be identified in
eAuditNet.

4.2 An Unrestricted Audit Report Reviewer shall review the audit while in EC
Review and remove any restricted technical data and then release for Auditee
Review.
i-frm-1101 20-May-2020
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AUDIT REPORT PROCESSING Page 2 of 11
Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

4.3 Upon release of the audit report to Auditee Review, the assigned Audit Report
Reviewer and Auditee Audit Contact(s) shall be notified.

4.4 During the review of the initial response submitted to SE Review, the Audit
Report Reviewer shall assess the NCRs for Potential or Confirmed Product
Impact.

4.4.1 As a result of this review, if NCRs remain classified as Major due to Potential
or Confirmed Product Impact, a Type P or C Auditee Advisory shall be
initiated per OP 1109 Auditee Advisories.

4.5 An Auditee Advisory may be issued at any time during the audit review
process, in accordance with OP 1109 Auditee Advisories.

4.6 Audit Failure may be considered at any time during the audit review process,
in accordance with OP 1110 Audit Failure and Risk Mitigation.

4.6.1 If the status of the quality system record used as the basis for conducting the
process audit is deleted or withdrawn during the audit review process, the
audit shall be failed per OP 1110 Audit Failure and Risk Mitigation Mode A.

4.6.2 If an audit exceeds the OP 1110 Audit Failure and Risk Mitigation Mode B
failure criteria, the Auditee shall provide responses to relevant NCRs in
eAuditNet that they believe should be voided, downgraded, or combined
within twenty-one (21) days of the audit report being released to Auditee
Review and submit the audit for SE Review unless the Audit Report Reviewer
has otherwise voided, downgraded, or combined NCRs that resulted in the
audit no longer exceeding the failure criteria.

4.6.2.1 If responses are not submitted within twenty-one (21) days, the audit shall be
balloted to the Task Group for failure.

4.6.2.2 The Audit Report Reviewer shall review and disposition each response (those
requesting voiding, downgrading, or combining) within fourteen (14) days of
submittal to SE Review.

4.6.2.2.1 If at the end of this review, the audit still exceeds the failure criteria, the audit
shall be balloted for failure.

4.7 The Auditee shall provide responses to all NCRs using the provided root
cause corrective action format. (Note: The required format is outlined in the
initial post response text box for each NCR in eAuditNet. Detailed instructions
on “How to respond to NCRs” is provided in eAuditNet under “Post Response
- Note to Auditee”.)

4.7.1 All responses and relevant portions of documents submitted as objective


evidence of corrective actions shall be in English.
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AUDIT REPORT PROCESSING Page 3 of 11
Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

4.7.2 Responses shall be entered as text in the text box, and not included as an
attachment.

4.7.3 Objective evidence supporting the response shall be submitted as


attachments for each NCR.

4.7.3.1 Evidence of actions taken to prevent recurrence shall be submitted as


objective evidence for each NCR. Common types of evidence could be
approved procedure revisions, form changes, training records, screen shots,
photographs, lab reports, documentation logs, etc.

4.7.3.2 Compressed file attachments shall not be accepted as objective evidence.

4.7.4 A response is not required for those NCRs accepted on-site by the Auditor,
unless requested by the Audit Report Reviewer.

4.7.5 Requests for additional information identified in the “Observations Forum”


require a response from the Auditee.

4.7.6 Auditees shall ensure that restricted technical data is not posted as a text
response or attached in eAuditNet.

4.7.6.1 Restricted technical data required as objective evidence shall not be attached
in eAuditNet but shall be emailed to restricteddata@p-r-i.org.

4.7.6.1.1 Auditees shall note in the NCR response that the evidence has been
submitted to restricteddata@p-r-i.org.

4.7.7 If the Auditee disagrees with an NCR, they shall respond in eAuditNet with
the rationale and justification, including objective evidence supporting their
position.

4.8 The Auditee shall complete the Auditee Feedback in eAuditNet prior to
submitting the audit for SE Review.

4.9 The audit, with NCR responses, shall be submitted to SE Review per the time
allowances provided below. Failure to submit within the defined time
allowance shall result in cumulative delinquency.

4.9.1 For audits with zero (0) NCRs, the Auditee shall complete the Auditee
Feedback in eAuditNet and submit for SE Review within three (3) business
days of the audit having been released for Auditee Review.

4.9.2 The first cycle NCR responses shall be submitted within twenty-one (21) days
of the audit having been released for Auditee Review.

4.9.3 For each subsequent round of response, the Auditee will have seven (7) days
to respond.
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

4.9.4 Auditees shall accumulate late days when responses are not submitted by the
due date.

4.9.5 Extensions shall not be granted for response due dates.

4.9.6 If an NCR is added after the audit has been submitted to SE Review,
additional time for the initial response to the added NCR may be granted at
the discretion of the Audit Report Reviewer provided that the total Auditee
initial response time for the new NCR does not exceed twenty-one (21) days.

4.9.7 If an audit is submitted for a failure ballot prior to the Auditee’s initial response
and not failed, the due date for responses shall be re-set to twenty-one (21)
days from when the audit was released for Auditee Review.

4.9.7.1 If the original due date has passed when the audit is sent back for Auditee
Review, the Auditee shall be given seven (7) days to submit responses.

4.10 PRI shall notify the Auditee when the response is past due.

4.10.1 PRI shall notify the Auditee and the Task Group’s Subscriber Voting Members
when an audit has accumulated ten (10) days and twenty (20) days of
cumulative delinquency.

4.11 The Audit Report Reviewer shall review the electronic audit report for
completeness and complete the auditor performance evaluation as defined in
OP 1117 Auditor Performance and Consistency.

4.12 Audit scope may be revised for a submitted audit prior to accreditation when
necessary (e.g. error in scope verification, dropping of a scope during review).

4.12.1 Changes shall be documented in the audit notes.

4.12.2 The person requesting the change shall verify that the scope was revised
correctly. A record of verification is not required.

4.13 The Audit Report Reviewer shall review corrective action responses for all
NCRs, when applicable, and disposition.

4.13.1 NCR responses are dispositioned as Open, Task Group Resolution, Void,
Accept, or Close.

4.13.1.1 Task Group input regarding the disposition of NCRs may be requested by the
Audit Report Reviewer.

4.13.2 Unrestricted Audit Report Reviewers shall review restricted technical data
required as objective evidence emailed to restricteddata@p-r-i.org.

4.13.2.1 If the assigned Audit Report Reviewer is Restricted, they shall request that an
Unrestricted Audit Report Reviewer review the evidence and confirm that it
addresses the response.
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

4.13.3 Additional NCRs may be added and existing NCRs may be voided by the
Audit Report Reviewer or the Task Group.

4.13.3.1 The rationale for changing an NCR shall be documented.

4.13.3.2 The rationale for rejecting a request by an Auditee to Void an NCR shall be
documented in the Audit Report Reviewer’s response.

4.13.4 The audit report shall be reviewed within fourteen (14) days of submittal to SE
Review.

4.13.5 Audit reports that require additional action from the Auditee shall be returned
to Auditee Review.

4.13.5.1 When the audit report is submitted to Auditee Review any time after the 4th
response cycle, written justification shall be included in the audit explaining
why the audit was not sent for a failure ballot per OP 1110 Audit Failure and
Risk Mitigation Mode D.

4.14 If an Auditee disagrees with a decision of the Audit Report Reviewer


regarding an NCR, the Auditee may request Task Group resolution by
submitting a request in writing either in the NCR response in eAuditNet or to
the Program Manager for the area (or the Director, Nadcap Program and
Aerospace Operations if the Audit Report Reviewer is a Program Manager).

4.14.1 If resolution is not requested through eAuditNet, the Auditee shall note in the
NCR response that Task Group resolution has been requested through the
Program Manager or Director, Nadcap Program and Aerospace Operations.

4.14.2 The request is then submitted to the Subscriber Voting Members of the Task
Group or a sub-team of those members.

4.14.3 The Task Group has seven (7) days from the time the request is submitted to
the Task Group to review and disposition the request.

4.14.3.1 Both the Auditee and Audit Report Reviewer positions shall be reviewed.

4.14.3.2 The Task Group may request additional information as deemed appropriate.

4.14.3.3 Concurrence of the Task Group Subscriber Voting Members shall be


obtained.

4.14.4 The Task Group decision shall be posted in the Auditee Discussion of the
NCR.

4.15 If restricted technical data is identified in eAuditNet after the audit has been
released for Auditee Review, the following actions shall take place:

4.15.1 For an Unrestricted Audit Report Reviewer - the restricted technical data shall
be removed and replaced with a note detailing the occurrence.
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

4.15.2 For a Restricted Audit Report Reviewer - the restricted technical data shall be
removed by an Unrestricted Audit Report Reviewer and replaced with a note
detailing the occurrence.

4.15.3 If a Nadcap Subscriber’s work was involved in the occurrence, the Subscriber
company’s Nadcap Management Council (NMC) and applicable Task Group
Voting Members shall be notified.

4.15.4 If restricted technical data was posted by the Auditee, PRI shall notify the
Auditee that restricted technical data has been removed.

4.15.4.1 When the entire NCR response is removed, the Auditee shall submit a
revised response which does not include the restricted technical data.

4.15.4.2 If the response that was removed was in the initial response format, the
revised response shall be reposted with all required elements.

4.15.4.3 If objective evidence needs to be resubmitted, it shall be done in accordance


with 4.7.6.

4.16 Prior to sending the audit report to Task Group Review, the Audit Report
Reviewer shall complete the Supplier Merit screen per OP 1111 Accreditation
Length and Merit Program.

4.16.1 The Supplier Merit screen is not required to be completed prior to sending an
audit report to the Task Group on a failure ballot.

4.17 The Audit Report Reviewer may recommend a Verification of Corrective


Action (VCA) audit.

4.18 Once the Audit Report Reviewer has completed all previously defined
activities, the electronic audit report shall be submitted to Task Group Review.

4.18.1 A VCA audit conducted only for the verification of corrective actions where no
NCRs are identified may be closed without Task Group Review at the
discretion of the Task Group. This may be defined in the Task Group
appendix or in the ballot comments for the audit requiring the VCA audit.

4.18.2 For all main and satellite audit groupings, accreditation ballots shall be sent to
Task Group Review at the same time.

4.18.3 For remote service provider audits, Task Group Review shall be deferred until
all audit reports in the group are complete.

4.18.4 For Subscriber Option B HQ audits, Task Group Review shall be deferred
until all Subscriber Option B audits performed by PRI have been accredited.

4.19 The Task Group Subscriber Voting Members are responsible to review the
audit report for completion of audit criteria, closure of NCRs, number and type
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

of job audits, merit page, Auditor comments, and Audit Report Reviewer
comments.

4.19.1 For Subscriber Option B Headquarters (HQ) audits and Option B audits
performed by PRI, audit review is performed by the NMC Subscriber Voting
Members on the applicable Review Team.

4.19.1.1 The following shall be made available to the Review Team during review of
the Option B HQ audit:

• Site Matrix
• Internal Audit plan
• Audit reports for audits performed by PRI

4.19.2 When responding to the ballot, the Task Group Subscriber Voting Members
shall respond with one of the following:

ACCEPT – This response indicates approval of the audit report and no


additional action is required prior to issuance of accreditation.

ACCEPT WITH COMMENTS – This response indicates conditional approval


of the audit report with comments used to identify additional required actions
prior to issuance of accreditation.

DISAPPROVE - This response indicates non-acceptance of the audit report


requiring additional action prior to issuance of accreditation.

WAIVE – Member has responded to the ballot and has elected not to exercise
their vote.

4.20 Task Group Subscriber Voting Members may request a VCA audit or confirm
the recommendation for a VCA audit by the Audit Report Reviewer, by
responding to the ballot with Accept with Comments or Disapprove, and a
comment requesting the VCA audit.

4.20.1 The VCA audit shall be approved by a simple majority of the Task Group
Subscriber Voting Members that have voted on the ballot.

4.20.1.1 For Subscriber Option B HQ audits, a simple majority of the NMC Subscriber
Voting Members shall be obtained.

4.21 Audit reports shall be in Task Group Review for a minimum of seven (7)
consecutive days. Note: the audit record in eAuditNet will change color when
the audit has been in review for the required amount of time.

4.21.1 The Task Group review period may be extended to obtain quorum when
required.

4.21.2 Option B internal audits shall be moved from Initiated to Cert Issued status
without being placed in Task Group Review.
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

4.22 Comments with Accept with Comments votes shall be resolved, and when
requested, the resolution shall be agreed to by the commenter.

4.22.1 Resubmission of the audit for Task Group Review is not required after
comments with Accept with Comments votes are resolved.

4.23 A Disapprove vote requires the comment associated with the disapproval to
be resolved.

4.23.1 After resolution, the audit report shall be submitted to Task Group Review.

4.23.2 When there is a Disapprove vote on a second ballot for the same issue, the
Task Group Subscriber Voting Members shall resolve the disapproval with a
2/3 majority required to reject the disapproval.

4.24 All Subscriber comments pertaining to accreditation made within the audit
report (Task Group Discussion, Ballot Screen, Forum, etc.) shall have
documented acknowledgement, and where necessary, evidence of action or
resolution will be attached in eAuditNet.

4.25 The status of all NCRs shall be Closed or Void prior to accrediting the audit.

4.26 The status of the audit shall be changed to Accredited or Withheld.

4.26.1 The audit status shall be Withheld when a VCA audit is required.

4.26.2 The audit status may be Withheld for any of the following conditions:

• Linked AQS audit not Accredited


• No evidence of a valid quality certificate
• Non-payment
• Other with explanation of condition

4.26.3 The status shall be changed from Withheld to Accredited when the
condition(s) leading to Withheld status has been addressed.

4.26.4 The audit may be dispositioned per OP 1110 Audit Failure and Risk Mitigation
when the condition(s) leading to Withheld status have not been addressed.

4.26.5 If the Audit Report Reviewer is non-delegated, a quorum of the Subscriber


Voting Members is required prior to changing the status to Accredited.

4.26.6 Option B internal audits shall be moved from Initiated to Cert Issued status
without being placed in Task Group Review.

4.27 Within seven (7) days of being accredited, the status of the audit shall be
changed to Certificate Issued or Main Audit Certified, the Qualified
Manufacturers List (QML) updated, and the accreditation package sent.
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

4.27.1 The status Main Audit Certified applies to VCA, Add Scope, and Remote
Compliance audits.

4.27.2 The status of all linked Subscriber Option B audits shall be changed to
Certificate Issued or Main Audit Certified after the HQ audit and all audits
performed by PRI have been accredited, and audit numbers have been
assigned to all internal audits in eAuditNet by the Subscriber company.

4.27.2.1 HQ audits shall remain in accredited status and no certificate will be issued.

4.27.3 The accreditation package shall be sent to the Auditee electronically and
include the following:

• Certificate of Accreditation
• t-frm-0004 Accreditation Letter
• Mark of Conformity Guidelines

4.27.3.1 For Initial audits, the accreditation package shall also be mailed to the
Auditee and include a cover letter.

4.27.3.2 For Add Scope audits, an updated t-frm-0004 Accreditation Letter shall be
sent to the Auditee electronically.

4.27.4 The Certificate of Accreditation shall contain the following information:

• Company Name
• Address of Audited Facility
• Commodity of Accreditation
• Certificate Expiry Date
• Certificate Number
• PRI Executive Vice President and Chief Operating Officer signature

4.28 If the status of the quality system record used as the basis for accrediting the
process audit is suspended or expired or a record of a valid quality system
certificate for the new address due to a facility move has not been provided,
the audit shall be dispositioned per OP 1107 Post Accreditation Actions
unless the NMC approved an exception to the QS status validity requirement.

4.29 Records shall be maintained in accordance with OP 1102 Records.

5.0 DOCUMENT REVISION HISTORY

Revision Summary
Date
19-Apr-2015 New Procedure – Transitioned from NOP-001, NOP-002,
NTGOP-001, PD3000, NIP 7-03, NIP 7-04, NIP 7-07
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

Revision Summary
Date
7-Apr-2016 Added paragraph 4.9.1 requiring the auditee to repost their
response if the corrective action was removed due to
ITAR/EAR restrictions.
03-Jun-2016 Added new 4.1 to define review process for all accreditation
options including Option B HQ; revised 4.51 to apply only to
Option B HQ audits; updated term supplier to auditee where
applicable; added Review Team where applicable; defined
voting membership of the Review Team for Subscriber
audits where applicable; and removed exemption of Option
A and B special process audits from delegation oversight.
13-Sep- Added quorum requirement in 4.27.3 for Task Group
2016 resolutions.

10-Jan-2017 Revised paragraphs 4.2 through 4.5. CA 2016 IA NCR 17.


Clarified that the assigned reviewer and Auditee contact are
notified when the audit report is submitted to “Supplier
Review”. Removed 4.6 about TG members interfering in audit
and ability to observe audits. Clarified/updated the language in
4.10 and 4.12 to fit with the current restricted information
submittal process. New document owner.
17-Jul-2018 Even Year Review and Document transition activity.
Complete Rewrite. Added definitions of NCR statuses;
response requirements 4.7.2, 4.7.3; rationale when rejecting
a request to Void 4.12.2.2; defer main and satellite reports
4.17.2; clarified VCA request and approval process 4.19;
added mechanism to resolve disapproval vote on second
ballot 4.22.2; clarified accreditation and withheld process
4.25; clarified certificate issue process 4.26.
27-May- Replaced Supplier with Auditee for Supplier Review and
2020 Supplier Feedback; new 4.11 for revising audit scope ICAR
1073; new 4.12.2 for reviewing restricted objective
evidence; new 4.15.3 for Subscriber company changing
accreditation method; new 4.17.3 and addition to 4.26.1 for
remote service providers; revised 4.20 added ‘consecutive’
and Note ICAR 1072; new 4.25.4 referencing OP 1110 if
withheld conditions are not addressed.
28-May- Editorial change - t-frm-17 changed to t-frm-0004
2020 Accreditation Letter to capture new Controlled Forms Name
and Numbering Standard.
21-Jul-2020 4.15.4 amended to define new eligibility quarters.
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Document Owner: Elizabeth Strano Issue Date: 19-Apr-2015
Revision Date: 27-Jul-2021

Revision Summary
Date
27-Jul-2021 Even Year Review; Standardized terms – audit criteria,
auditees, and NCRs; 4.3 and 4.6.2 changes per NMC
standardization committee; New 4.6.1 and 4.28 per QS
verification project; Revised 4.15.3 per 2019IA NCR 4; 4.5
moved to 4.9.1 per 2020IA OBS 11; 4.15.4.2 per 2019 IA
Obs 20; 4.15.2 removed per 2020 IA NCR 3; 4.15.3 through
4.15.6 moved to OP 1111; 4.18.2 per ICAR 1118; 4.18.4,
4.19.1, 4.21.2, 4.26.6, 2.27.2, 4.27.2.1 per 2020 IA NCR 5,
4.27.3 added MOC guidelines

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