Quality system
Revision Number: / 1.0 / Revision Date: / 05/02/2012Pages / 1 of 3 / Procedure #: / QAP-03
Approved by: / James E Cagle / Written By / Melanie Cagle
Document Control
1.0DOCUMENTATION CONTROL
2.0SCOPE:
This procedure is to define the control of all documents that relate to QualiCal, LLC’s Quality Manual, Procedures, and Forms. This procedure also ensures that all procedures and specifications are filed in known and accessible locations and that only the latest revision is available for use.
3.0DEFINITIONS: (Ref. ISO 17025:2005Clause 4.3.1Document Control)
Department Manager or Assistant ManagerThe Manager for any of the following Departments withinQUALICAL, LLC: Quality Assurance, Administration, Calibration and Maintenance.
DepartmentReferring to one of the following departments within QualiCal, LLC:
Quality Assurance, Administration, Calibration and Maintenance.
4.0RESPONSIBILITIES:
4.1Quality Assurance Manager
-Exclusive authority to make amendments and updates to the Quality Manual.
-Issues controlled copies of the Quality Manual and ensures removal and proper disposal of the superseded material.
-Maintains and controls the Master List of the Quality Manual, the Procedures and Forms
-Maintains and controls the Procedures and Forms
-Responsible for the creation, maintenance, approval, and revision of Quality Control procedures, forms, and documents.
-Responsible for the removal of obsolete documents.
-Responsible for the external origin documents, filing and stamping of part drawings, notice distribution, and the removal and disposal of obsolete part drawings.
4.2Owner/Manager
-Responsible for final approval of all revisions to the Quality Manual.
-The Manager is responsible for the creation, approval, and revision of Calibration Procedures.
Revision Number: / 1.0 / Revision Date: / 05/02/2012Pages / 2 of 3 / Procedure #: / QAP-03
Approved by: / James E Cagle / Written By / Melanie Cagle
Document Control
5.0QUALITY PROCEDURE:
5.1The Quality Assurance Manager has complete ownership of the Quality Manual. It is the responsibility of the Quality assurance manager to maintain, review, and revise this manual with final approval of all revisions given by the President.
5.2Controlled copies of the Quality Manual will be located in the Quality Assurance Manager’s office. The Master Controlled documents are controlled electronically in the Quality Assurance Manager’s computer files.
5.3Controlled copies of the Quality Manual are identified by a “controlled document”watermarkthrough all pages. Uncontrolled copies are given by request exclusively to the customers of QUALICAL, LLC and are identified by a“Uncontrolled Document” watermark, which identifies it as a copy.
5.4When there is a change to the Quality Manual, the change will be issued by
the Quality Assurance Manager. The Quality Assurance Manager is responsible for ensuring the removal and proper disposal of the superseded material.
5.5The Master List of the Quality Manual will be maintained and controlled by the Quality Assurance Manager and retained in the Main Office.
5.6The Quality Assurance Manager is the defined central authority for the control of quality assurance documentation. This will include the maintenance and control of the master list for the Procedures and forms, and the creation, maintenance, approval, and revision of quality documents, and Quality Control Procedures. The master lists are retained in the Quality Assurance Manager’s Office.
5.7 The Laboratory Manager and the Calibration Tech’s are responsible for the creation,
approval, and revision of their respective departmental Procedures and Forms. All Procedures and Forms are then maintained and controlled by the Quality Assurance Manager.
5.7.1When a new procedure or form is created or an
older one revised the document is given to the Quality assurance manager with a Document Change Request Form (QAF-20).
5.7.2The Quality assurance manager is responsible for making the necessary changes to the Master List and adding the new or altered document to the relevant manual and disposing of any superseded material.
5.7.2Controlled copies of the Procedures and Forms are located in the Quality Assurance Manager’s office
Revision Number: / 1.0 / Revision Date: / 05/02/2012Pages / 3 of 3 / Procedure #: / QAP-03
Approved by: / James E Cagle / Written By / Melanie Cagle
Document Control
5.8Each Department Manger is responsible for the creation, maintenance so that documents remain legible and readily identifiable, approval, and revision of their own departmental documents.
5.9All Quality Policies, Procedures, and Forms shall have a title, identification number, revision date, revision level, page number, and the name(s) of the person(s) who prepared and approved it. All controlled quality documents shall have a title, identification number, and a revision date and/or level.
5.10The Quality assurance manager will assure any new documents are in the proper format, do not duplicate any existing documents and if applicable will complete distribution.
5.11Department Managers will approve changes to existing documents and attach a memo explaining necessity of change. After no more than ten (10) revisions of a document, a new document will be issued under a new version number.
5.12The Quality assurance manager, Department Managers, and the Owner will be responsible for the removal and disposal of obsolete documents under their control. Copies of the Procedures and Forms are discouraged but not prohibited.
5.13The Quality Assurance Manager, as needed, will maintain customer specific, national and international specifications.
5.14The contents of changes and change dates of the Master Lists are
Documented for a period of three (3) years.
6.0RELATED DOCUMENTATION:
6.1Master Lists (procedures and forms)
6.2Quality Manual, Chapter 14: Records
6.3QAF-21: Control of Customer Specifications
6.4QAF-20: Document Change Request Form
QUALICAL, LLC Quality System