|
Quality Manual - Foqus, Inc.
|
FOQUS, Inc. |
|
|
Quality Manual QM-001
Section # : 2
Page #: 1of 1
Issue Date: 1/1/95
Revision: 1/1/95
|
|
|
Quality System
|
|
|
2.0 General
|
|
|
|
Foqus, Inc. developed and maintains a documented quality system that meets the requirements of Q-9001. There are three tiers of documentation in the basic structure of the quality management system.
|
The hierarchy defines the four levels of how policy and management issues are communicated to Foqus, Inc. personnel. The requirements of any level must comply with the requirements of levels above.
Level 1:
|
The Quality Manual is the top-level document. It addresses the high-level management issues, policies and principles established by the executive management of Foqus, Inc.
|
Level 2:
|
The procedures define how the quality policies are implemented by the organization.They define: What needs to be done, who has to do it, and where/when the task needs to be accomplished. All procedures must comply with the first level of QMS. There are two types of procedures:
- Quality Procedures (Inter-departmental): All departments must comply with these.
- Departmental Procedures with (Intra-departmental): Applicable departments must comply with these.
|
Level 3:
|
Work Instructions are documented as needed to provide more detail of how and when the particular tasks are performed. A template is a form of a Work Instruction. Any other forms are also controlled like Work Instructions. Depending on the complexity of the tasks Work Instructions will sometimes be combined within the procedure. Forms and databases provide a means for collection of data and information for future use. These are controlled as any other documents.
|
Level 4:
|
This level is made up of quality records, which demonstrate that the system is performing as defined in the three levels above (for example: forms that have filled information, databases, data, and metrics).
|
The QMS Document Matrix (QF-001) identifies the Procedures and Work Instructions that make-up the QMS and shows how they relate to the Q-9001standard.
The structure and amore detailed instructions on preparation of the various components of the QMS, are further described in QP-002.1
2.1 Quality-system procedures
|
|
|
|
2.1 Quality-System Procedures
|
|
|
Foqus, Inc. has prepared documented procedures that address all the applicable requirements of the Q-9001 standard and the requirements of the quality policy. The Foqus, Inc. management continually ensures the effective implementation of these procedures by auditing and reviewing the effectiveness of the QMS.
The detail of the procedures that form the QMS depend on the complexity of the work, the methods used and the skills and training needed by personnel involved in carrying out the activity. The following relationship is used to ensure that all employees are able to effectively perform their responsibilities:
Qualified Employee = Skills + Training + Procedures & Work Instructions
Foqus, Inc. ensures that all their employees are fully qualified to perform the tasks assigned to them.
|
|
|
2.3 Quality Planning
|
|
|
The quality planning activities at Foqus, Inc. take place annually as related to the QMS and resource requirements. These activities are documented in an Annual Business Plan (See QP-001).
Ongoing planning takes place as part of development of new products and implementation of improvement projects. The level of detail in planning depends on the complexity and size of the product/project design. During the planning phases of these tasks the following aspects are taken into consideration (See QP-004):
| a) |
the preparation of quality plans
.
|
| b) |
the identification and acquisition of any controls, processes, equipment, resources, skills, etc. that may be needed to achieve the required quality;
|
| c) |
ensuring that the applicable documentation is modified or developed;
|
| d) |
ensuring that any additional testing or inspection procedures have been implemented;
|
| e) |
identifying any tools or techniques that exceed known state of the art, in sufficient time for the needed capability to be developed;
|
| f) |
the identification of suitable verification at appropriate stages in the realization of the product;
|
| g) |
the clarification of standards of acceptability for all features of the product, including those which contain subjective element;
|
| h) |
the identification and preparation of quality records.
|
|
|
|
Note: CONTROLLED DOCUMENT - refer to electronic version for current revision. Printed copy valid the day of: 12/5/10 |
|
|
-Quality Manual Table of Contents- |
|
|
-Next Section- |
|
|
-Previous Section- |
|
| |
