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| QMS Operational Procedure |
QOP-42-01 |
|
| Section 4.2 | Section Revision:B | Revision Date: 8/14/2014 |
| Quality System Documentation | ||
| Approved By: Todd Gifford | Date: 7/12/2010 | |
PURPOSE
The purpose of this procedure is to:
a) Identify documents defining the quality management system, production processes, and products: and
b) Assign responsibilities for establishing and maintaining the documentation.
APPLICATION
Scope: This process pertains to all documents utilized in the Dee Electronics quality system.
PROCEDURE
1. General
1.1 The scope and extent of quality system documentation is determined on the basis of the complexity and interaction of processes, elements, and activities; and on competence of personnel. The documentation is sufficient to ensure the effective planning, operation and control of the quality system, processes, and products.
2. Quality manual
2.1 The purpose of the quality manual is to:
State the company’s principal quality policy as well as specific policies related to particular elements of the quality system;
Define and describe quality system processes, their sequence, and interrelation;
Define responsibility and authority of management personnel involved in the operation of the quality system; and
Outline general procedures for various activities comprising the quality system, and reference applicable Operational Procedures.
2.2 The President formulates the principal quality policy and approves the quality manual. The President is responsible for maintaining the manual. The quality manual is authorized by the President.
3. Operational procedures
3.1 The purpose of operational procedures is to define systems, assign responsibilities and authorities, and provide instructions for carrying out activities comprising the quality system. Operational procedures explain the what, when, who and how for each activity; identify interfaces for the activity; and instruct who should be informed and how the results of the activity should be recorded.
3.2 Operational procedures are code numbered QOP-SS-NN. QOP stands for Quality Operational Procedure, SS is the section in the quality manual to which the procedure pertains, and NN is the consecutive number of a procedure for the section.
4. Work instructions
4.1 The purpose of work instructions is to guide personnel in performing specific tasks, such as carrying out and controlling processes (process operator instructions), handling products, conducting tests or inspections, and so forth.
4.2 Work instructions are documented electronically, generally, on the forms in which the personnel performing the task are using.
5. Customer engineering documents
5.1 This category includes customer drawings, specifications and other documents defining the customer’s requirements. These can be product documentation, testing procedures, acceptance criteria, and so forth.
5.2 Customer’s documents are not used directly in our processes. They are re-interpreted and re-issued as Dee Electronics’s own documents/work instructions/records.
6. Product realization and control plans
6.1 Documents under this category are the output of product realization and verification planning, as defined in Section 7.1 of the quality manual.
6.2 The purpose of product realization plans is to sequence, coordinate, and schedule operations; and reference electronic forms used. Process flowcharts and electronic order input forms are examples of documents defining plans.
6.3 Control plans identify process control scope and methods, define the inspection/testing points and methods, and reference specific process control and inspection instructions, and acceptance criteria.
6.4 These types of documents are usually issued by the Facility Ops Manager or Quality Assurance.
ASSOCIATED DOCUMENTS
Operational Procedure QOP-42-02: Control of Documents