2.11 - Documented Information Management & Control Process
2.11 - Documented Information Management & Control Process
2.11 - Documented Information Management & Control Process
OP-75-01 Rev NC
1. PURPOSE
To establish a consistent process for controlling the documented information required to maintain
QNP’s quality management system.
2. RESPONSIBILITY
The table below identifies QNP personnel and their responsibility relating to this procedure:
Person Responsibility
4.4. QNP’s work instructions are maintained as .pdf files and made available
throughout QNP’s internal computer network. Work instructions are generally not
posted on the internet.
4.5. QNP’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 documented in the Document Master List,
FM-75-01.
4.6. This documented information is made accessible through computer stations and
mobile devices located throughout QNP’s factory and office. Controlled paper
copies of documents may be issued in areas where it is not practical to maintain
computer equipment.
4.7. QNP’s quality system documents are protected from unauthorized or unintended
changes by passwords, restricted read/write privileges, and saved backup files.
5. Document Identification/Numbering
5.1. The documents required for our QMS are assigned code numbers by the Quality
Assurance Manager and/or the AS9100 Coordinator.
OP 75 01
FM Form/Record
5.4. The middle section of a Document Number is derived from the closest related
clause of the AS9100 standard relative to the purpose of the document.
5.5. Documents drafted to the requirements of AS9100 revision B and C, were given
a 3 digit Clause Number code. See the following table for examples:
Corresponding
AS9100 rev D Clause
Clause Number
5.8. Exceptions - Quality documents or forms that were assigned code numbers
corresponding to the elements of ISO 9002:1994 may retain their original
identification codes. When a quality document or form with an ISO 9002: 1994
identification code is revised, it should be given a new identification code per this
procedure.
6.1. 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.
6.2. 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.)
7.1. 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, FM-75-01.
7.3. 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.
7.4. 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.
7.5. 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".
7.7. The current revision for any quality system document can be verified through the
Document Master List, FM-75-01. Unless otherwise specified, the current
revision of a quality system document should be referenced or followed.
8.2. 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.
8.3. 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.
8.4. 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.
9.2. 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, FM-75-02 is able to
store a link to the online location of the document.
9.3. 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".
9.4. 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 is write-protected, the file name shall be
appended with "OBSOLETE".
9.5. 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, FM-75-02. When appropriate, the schedule, method for verification,
and other means for control shall be recorded there as well.
9.6. 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”
10.2. The Document Master List with Revision History, FM-75-01, 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
10.4. QNP 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 contract.
10.7. Typically, QNP asks that suppliers provide all necessary quality records so
they may be retained and controlled internally. When a QNP supplier is required
to maintain quality records, the means for retaining and controlling the records
are specified on purchasing documents. When required, QNP suppliers should
maintain quality records to the same standards as referenced in Policy Note 4 of
this procedure.
Pens with permanent ink should be used to make corrections or changes to 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 is
maintained. Corrections are to be made in ink.
Step Action
The table below identifies the type of quality records maintained at QNP and how
each is maintained.
Quality record retention requirements are specified in Document Master List with
Revision History, FM-75-01.
Specified retention requirements are established in accordance with the:
Duration of the contract
Life of the product, and
Requirements of applicable standards, and
Government, customer, legislative, statutory, regulatory, and/or contract
requirements.
Reference FM-75-01 to determine the filing index, active location,
responsibility, active retention time, total retention time, and disposal method
of the record.
Currently, outside storage services are not used to archive quality records.
Step Action
1. Review the records to be disposed.