Nadcap OPERATING PROCEDURE OP 1101

DOCUMENT CONTROL Page 1 of 12

Document Owner: Bob Lizewski Issue Date: 19-Apr-2015
Revision Date: 04-Oct-2017

TO BE USED ON OR AFTER 05-JAN-2018

Document revision projects started prior to January 5th, 2018 shall be completed using
the ballot process defined in OP 1101 Rev 13-Jun-2016.

1.0 PURPOSE

The purpose of this procedure is to define the process for the creation,
maintenance, and control of Nadcap documents.

2.0 SCOPE

This procedure addresses the process and responsibilities for preparing,

balloting, approving, and publishing Nadcap controlled documentation.
Controlled documents include Program Document, Operating Procedures,
Operating Procedure Appendices, Controlled Forms, Audit Criteria, and Audit
Criteria Supplements.

3.0 DEFINITIONS

See OP 1103 Definitions.

Confirmation and NMC Affirmation Ballots: Ballot types that do not require
validation or a response for approval.

Approval ballot: A ballot type that requires validation and responses indicating
approval.

4.0 PROCEDURE

4.1 The Nadcap Program Document hierarchy is Nadcap Program Document

(PD 1100) – Nadcap Operating Procedures (OP 11XX) – Nadcap Operating
Procedure Appendices (OP 11XX App XX) – Nadcap Controlled Forms.

4.1.1 In the event of differing requirements between two documents, the

requirement in the higher-level document takes precedence.

4.1.2 Task Groups shall develop and maintain Appendices to OP 1114 Task Group
Operation and OP 1116 Auditor Staffing that define their Task Group specific
requirements.

4.1.2.1 Task Group specific requirements shall not conflict with requirements that are
defined by a higher-level document.

4.1.2.2 When adding a new requirement, Task Groups should consider whether it is
truly unique to the Task Group or should be included in a higher-level
procedure.

4.1.2.3 Operating Procedure Appendices shall comply with revised OP 1114 Task
Group Operation and OP 1116 Auditor Staffing requirements within six
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months of the revision date unless otherwise approved by the Quality

Manager.

4.2 The official documents are the electronic versions posted in eAuditNet under
Procedures and Forms.

4.2.1 For Audit Criteria, the PDF version posted in eAuditNet under Audit
Checklists is the official version.

4.2.2 Once printed or downloaded, documents are uncontrolled.

4.3 The Quality Department shall be responsible for coordination of new

documents, document revisions, and obsoleting documents.

4.3.1 The Director, Nadcap shall ensure PRI Staff are assigned as document
owners of controlled documents.

4.3.1.1 Lead staff engineers are document owners for Audit Criteria unless otherwise
directed by the Director, Nadcap.

4.4 Document owners shall review, and update as applicable, all assigned
Operating Procedures every even year.

4.4.1 The review shall encompass the entire document to ensure it is clear, current
with the existing process, procedural references are still valid, and does not
conflict with other controlled documents.

4.4.2 Evidence the Operating Procedure was reviewed shall be documented in the
revision history table.

4.4.3 The revision date and revision history table shall be updated even if no
changes have been made.

4.5 Document Requirements

4.5.1 Operating Procedures require a revision history table.

4.5.1.1 PD 1100 Nadcap Program Document, Controlled Forms, and Audit Criteria do
not require a revision history table.

4.5.2 Documents shall include an issued date, revised date, and when applicable,
an effective date.

4.5.2.1 Effective date shall be indicated by the statement “TO BE USED FOR
AUDITS STARTING ON OR AFTER DD-MMM-YYYY” on the first page of the
revised document.

4.5.2.2 Audit Criteria shall also include a letter indicating revision level, and for
editorial changes, the information included in t-frm-15 Nadcap AC Template

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(delta symbol, a number indicating editorial change level, and an editorial

change date).

4.5.3 The revision date shall be the date the document is published in eAuditNet.

4.5.3.1 For Audit Criteria, the revision date shall be the date the latest technical
revision is published in eAuditNet.

4.5.4 An effective date shall be established when the changes have the potential to
affect accreditation.

4.5.4.1 When an effective date is established, compliance to the changes is required

on or after the effective date, unless otherwise allowed by procedure.

4.5.4.2 The effective date shall be a minimum of 90 days after the revision date.

4.5.4.3 For Audit Criteria, under exceptional circumstances (e.g., a current audit
criteria requirement being applied/interpreted incorrectly or imposing an
unreasonable financial burden) and only when reducing or removing a
requirement, the effective date may be a minimum of 14 days after the
revision date when approved by the Task Group, Task Group Chair (or Vice
Chair), and the NMC Chair.

4.5.4.3.1 Task Group approval shall require a 2/3 majority of Voting Members and may
be obtained during a regularly scheduled Nadcap meeting, conference call,
and/or e-mail.

4.5.4.3.2 A two-week notice is required if approval is requested during a meeting or

conference call.

4.5.4.3.3 E-mail requests shall allow Task Group Voting Members 7 days minimum to
respond.

4.5.4.3.4 Records of approval shall be retained per OP 1102 Records.

4.5.5 Task Groups shall identify questions in Audit Criteria that may prompt
information considered restricted technical data under applicable U.S. export
control laws or regulations.

4.5.5.1 Questions that have the potential to elicit restricted technical data shall be
identified by the designation ‘EC’.

4.5.6 The Task Group may utilize their AQS liaison, or the AQS Task Group, to
ensure audit criteria questions pertaining to quality system elements comply
with PD 1100 Nadcap Program Document.

4.6 New Documents

4.6.1 The Document Control Administrator (DCA) shall assign a unique number to
new documents.
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4.6.2 i-frm-25 Operating Procedure Template shall be used for Operating

Procedures and Appendices, and t-frm-15 Nadcap AC Template shall be
used for Audit Criteria and Audit Criteria Supplements.

4.6.3 For Operating Procedures and Appendices, a procedure checklist shall be

created.

4.7 Document Revisions

4.7.1 When changes are proposed, the document shall be amended using track
changes unless the document is completely rewritten or when the format
used does not provide tracking capability.

4.7.2 Procedure Checklists shall be revised as applicable.

4.7.3 An i-frm-38 Document Revision Form shall be completed.

4.7.3.1 Audit Criteria and Audit Criteria Supplements do not require an i-frm-38
Document Revision Form.

4.7.4 Changes are categorized as editorial or technical as defined in OP 1103

Definitions.

4.7.4.1 Technical changes to s-frm-16 Nadcap Audit Criteria Grading Guidelines and
Preliminary Questionnaire(s) resulting from Task Group approved decisions
(e.g. Audit Criteria revisions, changes in audit lengths, etc.) may be treated as
editorial changes.

4.7.5 Editorial changes may be incorporated at the discretion of the document

owner and do not require balloting.

4.7.6 New documents and document revisions with technical changes, including
making a document obsolete, shall be approved using the eAuditNet balloting
process defined in Annex A.

4.8 Documents shall be prepared for publication by:

4.8.1 Establishing the issue date, revision date, effective date, and for Audit
Criteria, the information required by t-frm-15 Nadcap AC Template.

4.8.2 Creating a PDF version of the document showing changes with a line in the
left border.

4.8.2.1 Forms may remain in original format and do not require annotation.

4.8.2.2 New documents and complete document rewrites do not require annotation of
changes.

4.9 Prior to publishing new or revised Audit Criteria, the document owner shall
ensure the following activities are completed:
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4.9.1 Completion of the process defined in s-frm-23 Document Transition Process

Form.

4.9.2 Revision of s-frm-16 Nadcap Audit Criteria Grading Guidelines and

Preliminary Questionnaire(s) as applicable.

4.9.3 If the effective date was waived per 4.5.4.3, an open auditor advisory shall be
issued to all affected stakeholders describing the change(s), when the
change(s) is effective, actions required by auditors, and auditing expectations
etc. as applicable.

4.10 Documents shall be published in eAuditNet.

4.10.1 Program Documents, Operating Procedures and Appendices, Audit Criteria

and Audit Criteria Supplements shall be published in PDF format.

4.10.1.1 Additional copies of these documents may be posted in other formats;

however, the PDF version is the official document.

4.10.2 Forms may be published in any format to facilitate their use.

4.11 Previous revisions and documents that have been made obsolete shall be
removed from eAuditNet when they are no longer applicable.

4.11.1 These documents shall be marked “obsolete” and stored as records.

4.12 Stakeholders shall be notified of document publication per Table 1. Additional

parties may be notified.

4.13 PRI shall retain document records in accordance with OP 1102 Records.

4.14 Translation of Documents

4.14.1 When documents are translated, they are to be used for information only.

4.14.2 If a discrepancy exists between the official English document and a translated
document, the English version takes precedence.

4.14.3 Translation of documents may be carried out by PRI, by a Task Group, or by

an organization in accordance with an agreement with PRI.

4.14.4 Each translated document shall include the following statement both in
English and in the language of the translated document:

“The official language for Nadcap Audit Criteria, conducting Nadcap audits,
and audit reviews is English. Translated documents are to be used for
information only. If a discrepancy exists between the official English
document and this document, the English version shall take precedence.”

4.14.5 Translations by PRI or a Task Group

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4.14.5.1 PRI shall maintain a master list of documents translated by PRI or a Task
Group, including approval date and location.

4.14.5.2 Stakeholders may review translations and provide changes or clarifications to

PRI.

4.14.5.3 Translations of Audit Criteria should be verified by someone other than the
person that translated the document.

Table 1 Document Publication Notifications

NMC Voting Members

PD 1100 Nadcap
Task Group Voting Members
Program Document and
PRI Staff
Operating Procedures
Auditors as applicable
(except as otherwise Auditees as applicable
designated below)

NMC Voting Members

Operating Procedures
PRI Staff
Appendices
The following participants of the applicable Task Group:
Task Group Voting Members
Auditors as applicable
Auditees as applicable
NMC Voting Members
OP 1122 Subscriber
Accreditation PRI Staff
Task Group Subscriber Voting Members
Auditors as applicable
NMC Voting Members
OP 1123 Supplier
PRI Staff
Support Committee
SSC LT Members
NMC Voting Members
Audit Criteria
PRI Staff
The following participants of the applicable Task Group:
Task Group Voting Members
Auditors
Auditees
Forms PRI Staff

5.0 DOCUMENT REVISION HISTORY

Revision Date Summary

19-Apr-2015 New Procedure – Transitioned from NIP 4-01
3-Dec-2015 Added 4.3, 4.3.1, 4.20.1, 4.20.2 (NMC Standardization
Action); 4.9.2, 4.10 (Internal Audit CA), 4.21.1.1 (correct
Doc Trans error); clarified translation of checklist section
4.14 and changed MOU to agreement in 4.14.1 (based
upon agreement with CAQG); updated paragraph cross
references throughout document
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Document Owner: Bob Lizewski Issue Date: 19-Apr-2015
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Revision Date Summary

4-Mar-2016 Section 4.22 Audit Criteria – changed length of initial
ballot from 45 days to 28 days; removed term ‘letter’; the
term validate was replaced with approve; added criteria
for balloting technical changes resulting from comments.
Added 4.12.1.1 – The requirement in NIP 4-01 12.7.1 was
unintentionally omitted during the document transition
process.
04-Oct-2017 Complete re-write by Document Transition Team.
Incorporate corrective actions for 2015 IA 170005 NCR 7
(Table 2 14-day Staff OP AP), 2016 IA 174142 NCRs 2
(A.4.3), 10 (4.1.2.2), 17 (A.4.1, A.4.2, A.4.4), OBS 7
(4.14.5.3); 2016 OA 179343 NCR 1 (4.5.3); 2017 IA
180174 NCR 3 (removed Ref Docs section).
New process for approving/implementing AC changes
(4.5.4.3, 4.9.3)

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Document Owner: Bob Lizewski Issue Date: 19-Apr-2015
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Annex A
Balloting Process
A.1 A revision project shall be created in eAuditNet.

A.1.1 The revision project shall include a record of:

• Document Type, Name, and Title

• Summary/Scope of the Changes
• Rationale for the Changes
• Revision Project Status (Started, Completed, Void etc.)
• Ballot Type and Duration
• Ballot End Date
• Ballot Recipients
• Ballot Process Tracking History (Dates, Status/Type, link to Ballot
summaries)
• Ballot Results
• Ballot Comments
• Comment Resolution

A.1.2 The revised document shall be attached to the revision project.

A.1.3 For Staff Ballots, the i-frm-38 Document Revision Form, and the procedure
checklist as applicable, shall be attached to the revision project.

A.2 Ballot Types

A.2.1 Staff Ballots are used to obtain PRI input.

A.2.2 Approval Ballots are used to obtain NMC, Task Group, or SSC approval of a
document.

A.2.3 Confirmation Ballots are used to obtain NMC, Task Group, or SSC approval
of changes made during Approval Ballot or Confirmation Ballot resolution.

A.2.4 NMC Affirmation Ballots are used to obtain NMC approval of changes to Task
Group and SSC documents.

A.3 The revision project shall follow the balloting process defined in Table 2.

A.4 Staff Ballot

A.4.1 PRI Staff are expected to review the revised document, procedure checklist
and i-frm-38 as part of the Staff Ballot.

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A.4.2 The Quality Department shall verify all fields in the i-frm-38 Document
Revision Form were completed, questions answered, and impact on other
procedures and training needs were considered.

A.4.3 The Quality Department shall verify that the revised document was identified
as “Draft” on all pages.

A.4.4 Informatics shall verify the i-frm-38 Document Revision Form addressed
impact to eAuditNet and any other related PRI software systems.

A.4.5 Evidence that the Quality Department and Informatics verifications were
completed shall be recorded in the revision project.

A.4.6 Ballot recipients may provide input on the revised document using ballot
comments.

A.4.6.1 Comments should pertain only to the proposed changes.

A.4.6.2 Comments shall be classified by the submitter as either editorial or technical.

A.5 Staff Ballot Resolution

A.5.1 The document owner or designee shall resolve comments, including those
associated with a disapproval vote, by either accepting or rejecting the
comment.

A.5.1.1 The document owner or designee should discuss with the commenter the
rationale for rejecting a comment.

A.5.2 All comments shall be resolved prior to proceeding to the next step of the
balloting process.

A.6 Approval, Confirmation, and NMC Affirmation Ballots

A.6.1 Voting Members vote on Approval Ballots by selecting Approve, Disapprove,

or Waive.

A.6.1.1 Votes to Disapprove shall include a comment explaining why the revised
document is not being approved, otherwise the vote will be discounted.

A.6.1.2 For an Approval Ballot to be considered valid, 50% or more of the total voting
membership shall cast a vote to Approve or Disapprove. Waive votes do not
count toward validation.

A.6.1.3 The Approval Ballot end date may be extended up to 14 days to obtain
sufficient votes.

A.6.1.4 A record of Approval Ballot extensions shall be maintained in the revision

project.

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A.6.1.5 For a valid Approval Ballot to be approved, 75% or more of the

Approve/Disapprove votes cast by the voting members shall be Approve.

A.6.1.6 If a ballot is not valid and/or not approved, the document shall not be revised.

A.6.1.6.1 A new Approval Ballot may be issued using the same revision project or the
revision project shall be voided.

A.6.2 Ballot recipients may provide input on the revised document using ballot
comments.

A.6.3 Comments should pertain only to the proposed changes and any previous
ballot comment resolutions as applicable.

A.6.4 Comments shall be classified by the submitter as either editorial or technical.

A.7 Approval Ballot or Confirmation Ballot Resolution

A.7.1 All comments, including those associated with a disapproval vote, shall be
resolved by either accepting or rejecting the comment.

A.7.2 Editorial comments may be resolved by the document owner or designee.

A.7.3 For Confirmation Ballots, comments not related to comment resolutions from
the previous ballot may be rejected by the document owner or designee.

A.7.4 The document owner or designee may resolve technical comments directly
with the commenter.

A.7.4.1 Resolution of technical comments may only include the document owner or
designee accepting the comment, or the commenter withdrawing their
comment.

A.7.4.2 Comments may be withdrawn by the commenter any time prior to “Finalize
Comments” being selected in eAuditNet.

A.7.5 Unresolved comments shall be resolved at a meeting of the Voting Members.

A.7.5.1 The voting membership shall be given a minimum of two weeks’ notice prior
to meetings for resolving technical comments.

A.7.5.2 A quorum is required for a meeting to resolve technical comments.

A.7.5.3 Agreement to accept a comment requires a minimum 75% majority of the

Voting Members attending the meeting, otherwise the comment is rejected.

A.7.6 Changes resulting from resolution of comments shall be incorporated into the
revised document and the document identified as a new version i.e. “Draft 2”,
“Draft 3”, etc.

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A.7.7 Technical changes resulting from comment resolution require an additional

confirmation ballot to confirm the changes.

A.7.7.1 For Audit Criteria, technical changes to six (6) or more paragraphs require an
additional 28 day Approval Ballot.

A.8 NMC Affirmation Ballot Resolution

A.8.1 All comments, including those associated with a disapproval vote, shall be
resolved by either accepting or rejecting the comment.

A.8.2 Editorial comments may be resolved by the document owner or designee.

A.8.3 Comments not related to the proposed changes or previous ballot comment
resolutions may be rejected by the document owner or designee.

A.8.4 Comments may be withdrawn by the commenter any time prior to “Finalize
Comments” being selected in eAuditNet.

A.8.5 Comments shall be resolved at a meeting of the Voting Members of the Task
Group or SSC as applicable per A.7.5.

A.8.6 For comments rejected by the Task Group or SSC, the NMC shall make the
final decision.

A.8.6.1 A quorum of the NMC shall be required to make a final decision.

A.8.6.2 Confirmation of the NMC comment requires agreement from a minimum 75%
majority of the Voting Members attending the meeting, otherwise the
comment is rejected.

A.8.7 Changes resulting from resolution of comments shall be incorporated into the
revised document and identified as a new version i.e. “Draft 2”, “Draft 3” etc.

A.9 The eAuditNet record of comment resolution shall include:

• Name of the person documenting the resolution in eAuditNet

• Date the record was created
• Name of the person or group that resolved the comment
• Resolution: accepted, rejected, withdrawn
• Action taken to resolve or rationale for rejecting, when applicable

A.10 Each ballot within the revision project shall be completed by selecting
“Finalize Comments” in eAuditNet.

A.11 Notification that a ballot was completed shall be sent to the ballot recipients.

A.12 The Document Owner or designee shall attach the final version of the
document to the revision project.

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Table 2 Balloting Process

Operating Operating
Audit
PD 1100 Procedure OP 1122 OP 1123 Procedure Forms Audit AC7008
Criteria
except OP 1122 Appendix Criteria
and OP 1123 Supplements

14
14 days 14 days 14 days 14 days 14 days
Staff Ballot days

21 days 28 days
21 days Commodity Commodity
Task Group
Specific Specific
Approval
SSC LT Task Task
Ballot
Group Group
Roster1 Roster1,2
14 days
Commodity
14 days 14 days Specific
Task Group 14 days Commodity Commodity Task Group
Confirmation Specific Specific Subscriber
Ballot SSC LT Task Task Voting
Group Group Members
Roster 1 Roster1,3 and Auditors

21 days 21 days
NMC NMC
21 days 28 days
Voting Voting
NMC NMC NMC
Members Members
Approval Subscriber Subscriber
Copy to Copy to
Ballot Voting Voting
Task Task
Members Members
Group Group
Chairs Chairs
14 days 14 days
NMC NMC
14 days 14 days
Voting Voting
NMC NMC NMC
Members Members
Confirmation Subscriber Subscriber
Copy to Copy to
Ballot Voting Voting
Task Task
Members Members 3
Group Group
Chairs Chairs
14 days 14 days 14 days
NMC 14 days
NMC NMC NMC
Affirmation NMC Voting
Voting Voting Voting
Ballot Members
Members Members Members

1
Including any additional Task Group Voting Members required by a Memorandum of Understanding (MOU) see
OP 1120 Audit Criteria Agreements.
2 For Audit Criteria, the Approval Ballot duration may be reduced from 28 to 7 days when approved by the Task

Group per 4.5.4.3.

3 Unless otherwise required by A.7.7.

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