To ensure that the documented information. including all documents of internal & external origin, is controlled with respect to approval, distribution, change, etc.
To establish a consistent process for controlling the documented information required to maintain XXX’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
QM – Quality Manual
QMS- Quality Management System
SOP- Standard Operating System
5. RESPONSIBILITY AND AUTHORITY
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 XXX’s quality system documents
5.3 Quality Assurance Manager/MR
- Ensure that XXX 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 XXX’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/ iso 9001 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 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 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
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
- 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|
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 responsible for maintaining, and/or implementing the steps within the document.
|3||APPLICABLE FORMS OR REFERENCES||
This section provides a list of the operating procedures, work instructions, forms or external documents referenced in the document.
Statements of principle that apply to the document as a whole.
Where appropriate, step-by-step flowcharts should illustrate the procedures.
This section directs users to the QMS F 22 Document Master List for the retention duration of 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:
“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 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, 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 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 XXX. Examples:
- Equipment manuals regarding the operation, safety, repair or maintenance of equipment used by XXX in the processing of customer orders.
- Supplier manuals, specifications, or standards from customers that are provided to XXX, 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 XXX. 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 XXX 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”
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 be made so that traceability and any significant history are maintained. Corrections are to be made in ink.
ASK: Will corrections made to this document be clear and legible?
If “No”, create a new record.
If “Yes”, go to Step 2.
Cross out what is to be changed with a single line.
Initial and date what has been crossed out.
Make the change required.
6.9 Maintaining Quality Records
The table below identifies the type of quality records maintained at XXX and how each is maintained.
|Item||Type of Quality Record||How it is maintained|
Protect the record from becoming dirty or soiled.
Use virus protection practices.
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 uses the steps in the table below to properly archive quality records. Currently, outside storage services are not used to archive quality records.
|1||Labeling the box||
Indicate the names of the records being archived.
|2||Storing the box||
Place the records in a designated archive storage area that will:
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.
Review the records to be disposed of.
Ask: Has the useful life of the records ended?
If “No”, do not dispose of the records.
If “Yes”, go to 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.
Dispose of quality records. XXX 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)