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Document Control Procedure AB-DOC-21-012.0

This document outlines Al Aber's document control and quality records management procedure. It describes the document numbering system, formatting requirements, approval process, and procedures for controlling, updating, archiving and retaining quality records. Revisions to documents must be reviewed and approved by the same functions that approved the original document. Obsolete documents must be withdrawn from use.

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SALES AL ABER
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100% found this document useful (1 vote)
1K views13 pages

Document Control Procedure AB-DOC-21-012.0

This document outlines Al Aber's document control and quality records management procedure. It describes the document numbering system, formatting requirements, approval process, and procedures for controlling, updating, archiving and retaining quality records. Revisions to documents must be reviewed and approved by the same functions that approved the original document. Obsolete documents must be withdrawn from use.

Uploaded by

SALES AL ABER
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 13

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Document Control Procedure


Al Aber Management System
Revision No. Date Remarks
0 11/15/2021 Reviewed

Doc No. AB-DOC-21.012.0

ISSUE DATE: 08/06/2021


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TABLE OF CONTENTS PG 2
1. PURPOSE PG 3
2. SCOPE: PG 3
3. TERMS & DEFINITIONS PG 3
4. REFERENCE DOCUMENTS PG 3
5. RESPONSIBILITY AND AUTHORITY PG 3
6. DETAILS OF PROCEDURE PG 4
6.1. General Document Control Policies PG 4
6.2 Document Identification/Numbering PG 5
6.3 Document Formatting PG 6

6.4 Approval and Issue of Quality System Documentation PG 8

6.5 Control of Customer Supplied Information PG 8

6.6 Control of External Documents PG 9

6.7. Control of Quality Records PG 10

6.8. Making corrections on quality records PG 11

6.9 Maintaining Quality Records PG 11

6.10 Identifying quality record retention requirements PG 12

6.11. Archiving quality records PG 12

7.0 RETAINED DOCUMENTED INFORMATION PG13

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1. PURPOSE
This process description provides a standard procedure for document control and
records management for Al Aber Global Industrial Company.
1.1 To ensure that documents related to the quality management system are reviewed
and authorized before being issued to the personnel concerned
1.2 To ensure that any changes or modifications to existing documents are reviewed and
approved, unless otherwise specifically stated
1.3 To ensure that obsolete documents are withdrawn from all points of issue or use.

2. SCOPE:
This procedure covers the determination of the need for documentation, coding of
document and withdrawal of obsolete documents. It includes internally-generated and
externally sourced documents both in hardcopy and in electronic media.

3. TERMS & DEFINITIONS


 Documented Information- Records and Documents
 Maintained Documented Information- Document
 Retained Documented Information- Record
 WI- Work Instruction
 F- Format
 QM – Quality Manual
 QMS- Quality Management System
 SOP- Standard Operating System

4. REFERENCE DOCUMENTS
 ISO 9001:2015 Quality Manual,
 Document Master List with Revision History
 External Document Control List
 Quality Plan

5. RESPONSIBILITY AND AUTHORITY


 The Management Representative and HOD’s of all departments are responsible
for the effective implementation of this procedure.
 CEO gives final approval on all Al Aber’s quality system documents
 Quality Assurance Manager/QM

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 Ensure that Al Aber quality system documents are formatted, identified, and
issued per the requirements of this operating procedure.
 Ensure that revisions to quality system documents are reviewed and approved
by the same functions that performed the original review and approval.
 Ensure that the necessary documents are accessible to appropriate
personnel.
 Prevent the use of obsolete or invalid documents. Maintain the computer
system and files on the online server.

 Document Owners
 Draft, review, and update quality system documents applicable to their areas
of expertise and process ownership.
 Work with the Quality Assurance Manager or designee to ensure that their
documents are up to date and accurately logged within the Document Master
List
 Control of Documented Information

 IT Manager
 Work with the Quality Assurance Manager/MR to ensure that documented
information is available as necessary through Al Aber’s computer network.
 Assist the Quality Assurance Manager/QM in setting up an appropriate
network and file security features, as well as maintaining necessary data
backups.

6. DETAILS OF PROCEDURE
6.1. General Document Control Policies
Al Aber’s quality management system includes the documented information required by
ISO 9001 as well as the documented information determined by Al Aber as being
necessary for the effectiveness of our quality management system.

6.1.2 Al Aber’s documented information are:


 Quality Manual
 Operating Procedures
 Work Instructions
 Forms and Quality Records
6.1.3. Al Aber’s Quality Manual and our operating procedures are maintained as Hard
Copy and Soft Copy pdf files for the convenience of our employees, customers, and
other interested parties. They can be opened and viewed with the Adobe Acrobat
browser plug-in or standalone application.

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6.1.4. Al Aber’s work instructions are maintained as pdf files and made available
throughout Al Aber’s internal computer network. Work instructions are generally not
posted on the internet.

6.1.5. Al Aber’s forms are generated in a variety of formats appropriate to the nature of
the information to be captured. The format for generating any given form, and the media
required (paper or electronic) is documented in the Document Master List.

6.1.6. This documented information is made accessible through computer stations and
mobile devices located throughout Al Aber’s facility and office. Controlled paper copies
of documents may be issued in areas where it is not practical to maintain computer
equipment.

6.1.7. Al Aber’s quality system documents are protected from unauthorized or


unintended changes by passwords, restricted read/write privileges, and saved backup
files.

6.1.8. Al Aber’s quality system documents are written in English.

6.2 Document Identification/Numbering


6.2.1 The documents required for our QMS are assigned code numbers by the Quality
Assurance Manager.

6.2.2 SAMPLE OPERATING PROCEDURE IDENTIFICATION: The following shows the


sections of a sample Al Aber’s document number AB-DOC-21-001.0
 QMS – the Management system
 AB- Document Code prefix
 Version identification number
6.2.3. Document Code Prefixes – The following list of prefixes is used to identify the
quality documents maintained by Al Aber and generate the Document Code Prefix
section of the Document Number.
 QM- Quality Manual
 WI- Work Instruction
 SOP-Standard Operation Procedure

F- Format

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6.2.4 To ensure that all Al Aber’s documents are uniquely identified, Document Numbers
are further distinguished by sequential Document Identification Numbers. e.g. 21.001.0,
21.002.0 The Document Master List should be reviewed as appropriate to ensure that
document numbers are not duplicated.
6.3 Document Formatting
6.3.1. Quality system operating procedures have the following information in the
header:
 Document Identification Number
 Document Title
 Revision
 Effective Date
 Document owner/originator name, position and date of approval
 Management name, position, and date of approval
 Printed copies of this document are for information purposes only and are
uncontrolled. Printed copies are not valid after the date of printing.

6.3.2. Operating procedures shall have a Print Date Stamp in the footer that indicates
the print date of paper copies. (Note: The Print Date Stamp is a dynamic element
added to the pdf version of the operating procedure.)

6.3.3 The body of each operating procedure should address these main topics, as
applicable. The table below identifies the title of the heading and a description of the
content.

Item Heading Title Content Description

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1 PURPOSE This section states the intended purpose or


needs for generating the document.

This section identifies the personnel, department,


and/or authority in the organization that is
2 RESPONSIBILITIES
responsible for maintaining, and/or implementing
the steps within the document.

This section provides a list of the operating


APPLICABLE FORMS OR
3 procedures, work instructions, forms or external
REFERENCES documents referenced in the document.

Statements of principle that apply to the


4 POLICIES
document as a whole.

Where appropriate, step-by-step flowcharts


5 PROCEDURES
should illustrate the procedures.

This section directs users to the QMS Document


RECORDS/OBJECTIVE
6 Master List for the retention duration of records
EVIDENCE referenced in the procedure.

This section records the history for each


procedure and should be noted in the document
with the following or similar text:
7 REVISION HISTORY
“Revision, approved date, effective date and a
document change summary are available in
Master List with Revision History.”

6.4 Approval and Issue of Quality System Documentation

6.4.1. Prior to the issue, the Document Owner and the President shall review and
approve controlled documents. Records of the approval process shall be
maintained within the Document Master List.

6.4.2 Revisions to existing documents are reviewed and approved by the same
functions that performed the original review and approval.

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6.4.3  Digital formatting is the preferred method for maintaining quality system
documents. Computers shall be protected by the use of virus protection software,
regular data backups, and off-site storage when appropriate.

6.4.4. Uncontrolled documents are not valid after the date of printing. Printed work
instructions that are made available at the point of use are controlled by the
document owner and unauthorized copies should not be made.

6.5.5. Obsolete printed copies of internal documents retained for legal and/or
knowledge preservation shall be marked “OBSOLETE” and/or held in a
binder/folder marked “OBSOLETE”.
6.4.6. Superseded/Obsolete Documents are moved to a segregated location and
made inaccessible to prevent unintended use. The Quality Assurance Manager
should be contacted for access to obsoleted documents.
6.4.7. The current revision for any quality system document can be verified
through the Document Master List. Unless otherwise specified, the current
revision of a quality system document should be referenced or followed.

6.5 Control of Customer Supplied Information

6.5.1. Examples of customer-supplied information are blueprints, art files,


sketches, samples, purchase orders, and emailed correspondences.

6.5.2. A printed copy of a blueprint and any relevant customer-supplied


information should travel with quote requests and shop orders. If the electronic file
is later accessed to generate artwork or be reprinted, the contents of the file
should be checked to verify that it matches the customer’s current requirements.

6.5.3. Typically, the current revision for a blueprint or other customer-supplied


information can be verified by referencing a current purchase order, a customer’s
supplier portal, or checking with the customer’s purchasing or quality
representative.

6.5.4. Obsolete blueprints and other customer-supplied information that is


retained for legal and/or knowledge preservation shall be marked “OBSOLETE” or
held in a binder/folder marked “OBSOLETE”. It should not be assumed that
blueprints or other customer-supplied information stored within closed shop
orders represent the current revision.

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6.6 Control of External Documents

6.6.1. External documents are defined as documents whose origin and control is
by a body outside Al Aber. Examples:

 Equipment manuals regarding the operation, safety, repair or maintenance of


equipment used by Al Aber in the processing of customer orders.
 Supplier manuals, specifications, or standards from customers that are
provided to Al Aber, which contain customer requirements that are not part
specific.
 Documents necessary for the planning and operation of the quality system.
 International Quality Standards, example: ISO 9001: 2015.

6.6.2. External documents are maintained as digital files whenever possible.


When practical, external documents that are readily available on the internet
should not be maintained at AL ABER. The External Document Control List is
able to store a link to the online location of the document.

6.6.3. Printed copies of obsolete, external documents that are retained for legal
and/or knowledge preservation shall be marked “OBSOLETE” and/or held in a
binder/folder marked “OBSOLETE”.

6.6.4. Electronic files of obsolete, external documents that are retained for legal
and/or knowledge preservation shall be overwritten with notes to indicate that the
file is obsolete. If the contents of the file are write-protected, the file name shall be
appended with “OBSOLETE”.

6.6.5. The personnel responsible for periodically verifying that AL ABER has


access to the current revision of an external document is identified in the External
Document Control List. When appropriate, the schedule, method for verification,
and other means for control shall be recorded there as well.

6.6.6. The Customer Master List Database can be used to save files and URL
links to customer-specific external documents. External documents saved in the
Customer Master List Database are considered “For Reference Only”

6.7. Control of Quality Records

6.7.1. Quality records at AL ABER consist of those documents that describe the
results of some activity. Examples of quality records include inspections, tests,
reviews, audits, measurements, training records, meeting minutes. The control of
quality records refers to the originals.

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6.7.2. The Document Master List with Revision History, lists for each quality
record;

 The document code and title,


 The current revision and issue date,
 A description of revision changes,
 The index for sorting or filing the records,
 The location of active records and the personnel responsible for maintaining
them,
 The active retention time for records, and the total retention time for archived
records,
 The means for retrieving records,
 The methods for disposing of the records, when their total retention time is up
and they are no longer useful.
 Additional notes regarding access, distribution, use and risk as applicable

6.7.3. AL ABER quality records are maintained to demonstrate product quality,


the effectiveness of the quality system, and/or conformance to specified
requirements.

6.7.4 AL ABER personnel involved with filling out forms and storing company-
related records are to ensure that the records are:

 Filled out properly, accurately, and completely


 Documented in ink or other permanent marker
 Signed or initialed and dated, when appropriate
 Legible when hand written
 Printed through all copies of multiple carbons
 Stored in a clean, dry area in such a manner as to prevent damage or
deterioration to prevent loss or unintended alterations
 Stored either on paper (hard copy) or stored on the computer (electronic
media) for the proper retention period
 Made available to the customer or regulatory authority upon request, when
required by the contract.

6.7.5. Quality records are generated internally within AL ABER and externally
from customers, suppliers, and subcontractors.

6.7.6. Typically, AL ABER asks that suppliers provide all necessary quality

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records so they may be retained and controlled internally. When a AL ABER


supplier is required to maintain quality records, the means for retaining and

controlling the records are specified on purchasing documents. When required,


AL ABER suppliers should maintain quality records to the same standards as
referenced in Policy Note 4 of this procedure.

6.8. Making corrections on quality records

 Pens with permanent ink should be used to make corrections or changes to the
quality records. White-out or pencil should not be used to make corrections or
changes to quality records. Follow the steps in the table below to make
corrections to a quality record. Corrections to quality, records are to be made so
that traceability and any significant history are maintained. Corrections are to be
made in ink.

 STEP 1:
ASK: Will corrections made to this document be clear and legible?
If “No”, create a new record.
If “Yes”, go to Step 2.
STEP 2:
Cross out what is to be changed with a single line.
STEP 3:
Initial and date what has been crossed out.
STEP 4:
Make the change required.

6.9 Maintaining Quality Records

The table below identifies the type of quality records maintained at AL ABER and
how each is maintained.

Type of Quality
Item How it is maintained
Record

Protect the record from becoming dirty or soiled.


1 PAPER Keep records away from sources of
contamination.
Use a plastic sleeve if appropriate.

Use virus protection practices.


ELECTRONIC MEDIA
2 Backup data on a regular basis.
(Computer) Maintain backups off-site if appropriate.

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6.10 Identifying quality record retention requirements

Quality record retention requirements are specified in Document Master List with
Revision History. Specified retention requirements are established in accordance with
the:

 Duration of the contract


 Life of the product, and
 Requirements of applicable standards, and
 The government, customer, legislative, statutory, regulatory, and/or contract
requirements.

6.11. Archiving quality records

Authorized personnel use the steps in the table below to properly archive quality
records. Currently, outside storage services are not used to archive quality records.

Ste
Task Action
p

Indicate the names of the records being archived.


Labeling the Indicate the period covered by the records being archived.
1 Example: From (the date of the first record ) to (date of the
box
last record)
Indicate the date the box is being archived.

Place the records in a designated archive storage area that


Storing the will:
2
box Protect the record from becoming dirty or soiled.
Keep records away from sources of contamination.

6.12. Disposition of original quality records Authorized personnel uses the steps in the
table below to assure the proper disposal of original quality records.

STEP 1: Review the records to be disposed of.


STEP 2: Ask: Has the useful life of the records ended?
If “No”, do not dispose of the records.
If “Yes”, go to Step 3.
STEP 3: Ask: Have the contractual requirements of the records been satisfied?
If “No”, do not dispose of the records.
If “Yes”, go to Step 4.

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STEP 4: Dispose of quality records. AL ABER Management determines disposal


methods for quality records based on the type of quality record, data contained in the
record, and/or security requirements. Records are shredded when appropriate.

7.0 RETAINED DOCUMENTED INFORMATION

 7.1 Master copies of all Documents of Internal Origin

 7.2 Master list of Documents of Internal Origin

 7.3 Master list of Documents of External Origin

 7.4 Master copies of Documents of External Origin

Reviewed by: Approved By:

Quality Manager President / CEO

Doc No. AB-DOC-21.012.0

ISSUE DATE: 08/06/2021

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