Quality Management System

(QMS) Procedure

QP 112 Control of Documents & Records

Disclaimer It is the responsibility of the user of this PDF document to verify that it is the most current approved
version from X drive, Process Documents Folder, as controlled by the Quality Management System. Any
copy of this document is uncontrolled.

Proprietary Notice
The information/data furnished in this document shall not be duplicated, used or disclosed in whole or in part
for any purposes other than to which it was intended. However, if a contract is awarded in connection with
the submission of such information/data, the customer shall have the right to duplicate, use, or disclose this
information data for programmatic reasons, to the extent provided in the contract. This restriction does not
limit the customer’s right to use such information/data if it is obtained from another source.
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Revision (Rev) History

Date Revision Details of Changes Authority

August 19, 2015 01 New Document K. Waite
Add: QF 112, The Original Copy will be
September 8, 2015 02 signed and filed in the Quality Assurance E. C. Mustaphi
Department.
September 16,
03 Update disclaimer K. Waite
2015
November 10, 2015 04 Changes in sections 5.2.2, 5.2.4, 5.2.5 E. C. Mustaphi

October 25, 2016 05 Removed Elizabeth Mustaphi K. Waite

Combined Document Control and Control of
September 11,
06 Records, Changed to new format & K. Waite
2018
numbering system
November 1, 2019 07 Added Wiki Info Server K. Waite

June 19, 2020 08 Added authorities and updated formatting J. Lichtenwalter

Added new RRS Document Template,
September 2021 09 K. Waite
Process storage X drive Process documents
Added Bamboo to process training, Removed Kim Devi
August 2022 10
Wiki Server Richard
September 2023 11 HR Storage information Kim W

Reviewed on: September 2023

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Table of Contents

1 PURPOSE & SCOPE 3

2 RESPONSIBILITIES 3

3 PROCESS 3

QMS Documentation System and Records 3

Categories of Documents 3
Internal Documents 4
External Documents 4
General Controls 4

3.2 Control of Internal Documents 4

General Controls 4
Preparing and Revising a QMS Document 5
Reviewing a QMS Document 5
Releasing & Implementing a QMS Document 5

3.3 Control of External Documents 6

3.4 Record Storage and Protection 6

3.5 Record Retention Table 6

3.6 Record Disposition 7

4 RECORDS 7

5 FORMS 7
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Control of Documents & Records

1 Purpose & Scope
This procedure defines the responsibilities, authorities, and process for:
a) Preparing, reviewing, approving, revising and implementing the Renaissance
quality documentation necessary for planning, operation and control of processes
within the Renaissance Quality Management System (QMS)
b) Controlling documentation provided from external sources as required to carry out
repair and supply services at Renaissance.
Documents & data may appear as any media type; hard copy, or E-file.

2 Responsibilities
Manager(s) or Owner(s) of the function or process that the document relates to are the
originator, having the responsibility and authority for preparing or updating and submitting
internal documents for review and approval. They are responsible for ensuring integrity
of the content of the submitted document, so that the review and approval cycle is as
efficient as possible.
Quality Assurance is responsible for the release and control QMS and any applicable
external documentation required for the QMS and its processes.
The QA is also responsible for controlling any applicable external documentation required
for the QMS and its processes.

It is the responsibility of all individuals using documents to ensure that they are using the
latest revision of the document.

Quality Assurance and Human Resources are responsible for maintaining external
documentation required in support of Renaissance Corporate Policies and the Health and
Safety program. Human Resources has the authority to create and edit documentation
required in support of Renaissance Corporate Policies and the Health and Safety program.

3 Process
QMS Documentation System and Records
Categories of Documents
The two primary groups of controlled QMS documents as defined within this procedure
include:
a) Internal Documents – QMS documents prepared and authorized internally by
Renaissance personnel
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b) External Documents – applicable or reference documents and standards that are

supplied from an external source, such as a customer or standards body.
c) QMS Records – for Renaissance Repair and Supply include, but is not limited to,
quotes and customer contracts, work orders, test records, audit results, calibration
data, and shipping records. QMS records are divided and controlled by
department or process, where appropriate.

Internal Documents
Internal QMS document PDF’s are contained on the Renaissance X Drive, Process
Documents and categorized as follows:
a) The Quality Manual, which references, as appropriate, the necessary QMS
processes, and addresses all of the requirements of the ISO 9001:20015
International Standard;
b) Quality Department - The documented QMS procedures which reference
applicable documents and provide instructions to the Quality Department and
Management as well as required Audit, meeting, and analytical data guidance.
c) Sales and Operations – which provides Operations Procedures, Forms and
Routings as well as Sales Procedures

External Documents
External documents include, but are not limited to:
a) Customer controlled drawings, Customer-defined procedures, regulations, forms
and certificates;
b) Standards that are applicable to QMS processes, or are mandated by the customer
for execution of the repair and supply services by Renaissance such as IPC 610.

General Controls
a) All Internal QMS documents shall be prepared and/or revised, reviewed and
implemented as defined in this document.
b) QMS documentation will be available electronically on X Drive, Process Documents.
Documents on this system are accessible to all Renaissance personnel on a “read-
only” basis.
c) All uncontrolled documents are retained on Quality “X” drive and are only accessible
by the Quality Department.
d) All documentation retained on the centralized server(s) is backed up in accordance
with the Corporate IT Policy.

3.2 Control of Internal Documents

General Controls
The following rules apply to all prepared and updated Internal QMS documents:
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a) All documents shall be prepared and released initially as Revision 01;

b) Any subsequent update and release will cause the revision number to be
incremented by one (e.g. Rev 02, Rev 03, etc.);
c) All printed documents shall be stamped CONTROLED

Preparing and Revising a QMS Document

a) Although anyone within Renaissance can write or request a revision to a QMS
document, typically, revisions to QMS documents are required as a result of a raised
Corrective Action Request (CAR), Preventive Action Request (PAR), Opportunity for
Improvement (OFI), System review, or significant changes in a process.
b) All documents must be clearly identified, protected (e.g. passwords, confidentiality
notices, etc.) and reviewed for technical content, legibility and quality requirements
prior to release, and controlled for revision status and distribution.
c) All newly prepared QMS documents must be submitted (by email or hard copy and
include all mark ups) for circulation, review and approval to Quality Assurance prior to
being released.
d) Where possible, the QMS documents shall be written, prepared or revised in:
i. The same format and layout as other documents within the QMS
ii. A clear, simple and user-friendly manner.
e) The originator of the revision shall ensure that revisions are made to a copy of the
previous Controlled Document on X Drive.
f) Should the document changes(s) originate at the Customer level, Quality Assurance
shall take the steps necessary to satisfy the Customer request.
g) A record of the changes made to a document will be provided in the document itself in
a Revision History log.

Reviewing a QMS Document

a) The prepared document is submitted by email to the Quality Assurance is responsible
for Document Control.
b) The document is reviewed by pertinent stakeholders, including:
i. Manager(s) of the function or process that the document relates to, for legibility
and technical content
ii. Quality Assurance, to ensure that the contents comply with corporate policies,
the requirements of ISO 9001:2015, and that the document is legible and
adequately identified by title and revision status on every page.

Releasing & Implementing a QMS Document

a) Once reviewed, the document file name is verified for proper identification, and the file
saved according the title.
b) The released document is placed in the appropriate folder on X Drive in PDF format.
c) Where required, older versions of the document in the folder are archived on the “X”
Drive Process Documents in an appropriately named subfolder.
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d) All Renaissance personnel are advised of the new or revised QMS documents through
email and/or Employee training (Bamboo).

3.3 Control of External Documents

a) Externally authorized documents shall be controlled for identification including, where
possible, the revision status and distribution. Normally, all externally authorized
documents are identified by the originator’s title, description and/or revision status.
b) External documentation is retained in the form that it is obtained. This may be hard
copy or electronically filed on the centralized server in a controlled location suitable for
those who need to use the information. Every effort will be made to retain this
documentation on X drive. Hard copy documents, if any, will be filed in a central area
for easy access by those who need the information.
c) Many customer furnished documents (e.g. Engineering drawings, change notices,
schematics, rework instructions, etc.) may be considered obsolete by the original
manufacturers of boards being repaired at Renaissance. However, due to the nature
of the repair service, multiple revisions may be required in order to service boards at
different baseline revision levels.
d) Externally authorized documents (i.e. standards) shall be retained where possible in
electronic form on X drive. Under special circumstance, should a hard copy be
required, it will be stamped CONTROLLED and distributed by Quality Assurance.

3.4 Record Storage and Protection

All QMS records are stored, retained, and readily retrievable onsite or sent to a storage
facility which maintains a suitable environment to prevent damage or deterioration and
prevention of loss (e.g. building security, electronic passwords, virus protection, and fire-
walls). Electronic records are backed up in accordance with the Corporate IT Policy.

In the event of a breach of confidentially, Renaissance shall report the incident to the
appropriate customers. QMS records are made available, on request, to the customer for
their review.

With the exception of quality related records all others shall be retained for a period of
seven (7) years from the completion of the contract or order to which they pertain, or as
specified in the contract, see Table A.

3.5 Record Retention Table

Table A.

Quality Record Retention Period

Work Orders - Repair 3 +1 year

Internal Audits 5 years
Purchase Requisitions 7 years
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Shipping Documents 7 years

Receiving Documents 7 years
Contracts 7 years after the end of the contract
Scrap & Salvage 7 years
HR documentation 5 years

3.6 Record Disposition

When retention times have elapsed, the applicable record(s) will be:

a) Archived, by placing the record in a secure storage area and clearly identified; or
b) Where appropriate, discarded and/or shredded.

4 Records
5 Forms
Quality Process System Log QF239