1/18/2019 Procedure for Control of Documented Information – TRACE INTERNATIONAL

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Procedure for Control of Documented Information

preteshbiswas Uncategorized December 23, 2018 10 Minutes

1. SCOPE

To ensure that the documented information. including all documents of internal & external origin, is
controlled with respect to approval, distribution, change etc.

2. PURPOSE

To establish a consistent process for controlling the documented information required to maintain
QNP’s quality management system.

3. REFERENCE DOCUMENTS

3.1 XXX Quality Manual,

3.2 Document Master List with Revision History
3.3 External Document Control List
3.4 Quality Plan

4. 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

5. RESPONSIBILITY AND AUTHORITY

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5.1 The Management Representative (MR) and HOD’s of all departments are responsible for the
effective implementation of this procedure.
5.2 President gives final approval on all QNP quality system documents
5.3 Quality Assurance Manager/MR

Ensure that QNP 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.

5.4 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

5.5 IT Manager

Work with the Quality Assurance Manager/MR to ensure that documented information is
available as necessary through QNP’s computer network.
Assist the Quality Assurance Manager/MR 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

6.1.1  XXX’s quality management system includes the documented information required by ISO 9001
as well as the documented information determined by XXX as being necessary for the effectiveness of
our quality management system.
6.1.2 Examples of XXX’s documented information are:

Quality Manual
Operating Procedures
Work Instructions
Forms and Quality Records

6.1.3. XXX’s Quality Manual and our operating procedures are maintained as pdf files and hosted at
xxx.com/iso9001 for the convenience of our employees, customers, and other interested parties.
These files can be accessed through any standard web browser, such as Internet Explorer, Chrome,
Safari or FireFox. They can be opened and viewed with the Adobe Acrobat browser plug-in or
standalone application.
6.1.4. XXX’s work instructions are maintained as .pdf files and made available throughout XXX’s
internal computer network. Work instructions are generally not posted on the internet.
6.1.5. XXX’s forms are generated in a variety of formats appropriate to the nature of information to be
captured. The format for generating any given form, and the media required (paper or electronic) is

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documented in the Document Master List.

6.1.6. This documented information is made accessible through computer stations and mobile devices
located throughout XXX’s factory and office. Controlled paper copies of documents may be issued in
areas where it is not practical to maintain computer equipment.
6.1.7. XXX’s quality system documents are protected from unauthorized or unintended changes by
passwords, restricted read/write privileges, and saved backup files.
6.1.8. XXX’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 XXX document number QMS F 015:

QMS – the Management system

F- Document Code prefix
15- Document identification number

6.2.3. Document Code Prefixes – The following list of prefixes is used to identify the quality
documents maintained by XXX and generate the Document Code Prefix section of the Document
Number.

QM- Quality Manual

WI- Work Instruction
SOP-Standard Operation Procedure
F- Format

6.2.4 To ensure that all XXX documents are uniquely identified, Document Numbers are further
distinguished by sequential Document Identification Numbers. e.g. 01, 02, 03. The Document Master
List, QMS F 22 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.

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Item Heading Title Content Description

This section states the intended purpose or needs

1 PURPOSE 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 procedures, work instructions, forms or external
3
REFERENCES documents referenced in the document.

Statements of principle that apply to the document

4 POLICIES as a whole.

Where appropriate, step-by-step flowcharts should

5 PROCEDURES illustrate the procedures.

This section directs users to the QMS F 22

RECORDS/OBJECTIVE Document Master List for the retention duration of
6
EVIDENCE records 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 QMS F 22
Document Master List with Revision History.”

6.4  Approval and Issue of Quality System Documentation

6.4.1. Prior to 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,
QMS F 22.
6.4.2 Revisions to existing documents are reviewed and approved by the same functions that
performed the original review and approval.
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

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documents.
6.4.7. The current revision for any quality system document can be verified through the Document
Master List, QMS F 22. 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.

6.6  Control of External Documents

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

Equipment manuals regarding the operation, safety, repair or maintenance of equipment used by
QNP in the processing of customer orders.
Supplier manuals, specifications, or standards from customers that are provided to QNP, 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 QNP. The External
Document Control List, QMS F 24 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 QNP has access to the current revision
of an external document is identified in the External Document Control List, QMS F 24. 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”

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6.7. Control of Quality Records

6.7.1. Quality records at XXX 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.
6.7.2. The Document Master List with Revision History, QMS F 22, 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. XXX quality records are maintained to demonstrate product quality, the effectiveness of the
quality system and/or conformance to specified requirements.
6.7.4 XXX 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 XXX and externally from customers, suppliers
and subcontractors.
6.7.6. Typically, XXX asks that suppliers provide all necessary quality records so they may be retained
and controlled internally. When a XXX supplier is required to maintain quality records, the means for
retaining and controlling the records are specified on purchasing documents. When required, XXX
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

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be made so that traceability and any significant history is 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 QNP and how each is
maintained.

Item Type of Quality Record How it is maintained

Protect the record from becoming dirty or soiled.

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

Use virus protection practices.

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

6.10  Identifying quality record retention requirements

Quality record retention requirements are specified in Document Master List with Revision History,
QMS F 22. 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.

Step Task Action

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Indicate the names of the records being archived.

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

Place the records in a designated archive storage

area that will:
2 Storing the 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 use 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.

STEP 4:
Dispose of quality records. QNP 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(QMS F 22)

7.2 Master list of Documents of Internal Origin(QMS F 23)
7.3 Master list of Documents of External Origin(QMS F 24)
7.4 Master copies of Documents of External Origin(QMS F 25)

Published by preteshbiswas

Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your
system development, training or auditing needs. He has helped dozens of organizations in implementing
effective management systems to a number of standards. He provide a unique blend of specialized knowledge,
experience, tools and interactive skills to help you develop systems that not only get certified, but also
contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has

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experience in training at hundreds of organizations in several industry sectors. His training is unique in that
which can be customized as to your management system and activities and deliver them at your facility. This
greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification
body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several
industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in
recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety
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centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students.
Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as
well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted
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warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education &
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He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and
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