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Quality Manual	8 – Operations
Section 8.5.1	Section Revision: A	Revision Date: 3/30/2017
8.5.1 – Control of production and service provision
Approved By: Dave Zirkelbach		Date: 3/30/2017

GENERAL POLICY

Product and process information and appropriate work instructions are established and are communicated to relevant personnel. Operations and production processes are monitored and controlled, and are validated where appropriate. Equipment used in distribution processing and for monitoring and measurement activities are maintained. Methods for product release and delivery are defined.

Materials, components, and parts are identified. When required, traceability of materials and processes is recorded and maintained. Inspection and test status of product is identified to ensure that only product that has passed the required inspections is dispatched.

Customer-supplied products, if ever maintained, are controlled in the same manner as are purchased products. If ever maintained, Customer-owned tools, equipment, software, or other property are marked to indicate ownership. Any Loss, damage, or unsuitability of a customer’s product is recorded and reported to the customer.

Appropriate handling, storage and preservation methods are implemented to prevent product damage or deterioration. Receipt and dispatch to and from storage areas are controlled. The condition of products in stock is regularly assessed.

PROCEDURAL POLICIES

1. OPERATIONS CONTROL

1.1 Product and process information

Product and process information required by process operators is communicated through the work order, electronic forms, or is included in work instructions.

1.2 Work instructions

 

1.2.1 Work instructions and workmanship standards may be in the form of electronic manuals, electronic procedures, or electronic instructions on forms. They instruct on how to carry out a process or perform an operation or task. The need for work instructions is evaluated on the basis of criticality, importance and complexity of the process; the ability to verify results of the process; operator qualifications; and history of quality problems associated with the process. Workmanship standards are provided when acceptability of the process output can only be determined by comparison with a standard sample.

1.2.2 Procedure QOP-75-02, Work Instructions, specifies criteria for determining when work instructions are needed, and provides guidelines for issuing, authorizing and controlling work instructions.

1.3 Equipment maintenance

1.3.1 Maintenance of key process equipment is addressed in Section 6.3 of this manual.

1.4 Measuring and monitoring equipment

1.4.1 Requirements for measuring and monitoring equipment are determined by Executive Management and Quality Assurance. This is in accordance with process control and product verification programs defined in product realization planning (refer to Section 7.1 of this manual).

1.4.2 Control system for measuring and monitoring equipment is defined in Operational Procedure QOP-76-01, Measuring and Monitoring Equipment.

1.4.3 Dee Electronics has established and maintains documented procedures to control, calibrate and maintain inspection, measuring and monitoring equipment it uses to demonstrate the conformance of product to the specified requirements. Measuring and Monitoring equipment is used in a manner which ensures that the measurement uncertainty is known and is consistent with the required measurement capability. Measuring and Monitoring equipment include (but are not limited to) scales, calipers, and wire processing equipment.

Control Procedure – Dee Electronics:

• Selects appropriate Measuring and Monitoring equipment that is capable of the necessary accuracy and precision,
• Identifies Measuring and Monitoring equipment and specifies frequency of checks,
• Maintains calibration records for Measuring and Monitoring equipment,
• Assesses the validity of previous inspection and test results when Measuring and Monitoring equipment is found to be out of calibration,
• Provides suitable environmental conditions for calibrations, inspections and tests,
• Safeguards Measuring and Monitoring equipment from damage, abuse and unauthorized adjustment.

1.5 Process monitoring and control

Dee Electronics has identified and planned the order fulfillment, distribution and servicing processes which directly affect quality, and ensures that these processes are carried out under controlled conditions. These controlled conditions include:

• Documented procedures defining the manner of order fulfillment, distribution and servicing,
• Use and availability of suitable equipment, and a suitable working environment,
• Compliance with reference standards, codes, quality plans and/or documented procedures,
• Monitoring and control of suitable process parameters and product characteristics,
• Approval of processes, equipment, tools, and technology, as appropriate,
• Criteria for workmanship, which is stipulated in the clearest practical manner,
• Suitable maintenance of equipment to ensure continuing process capability,
• Process Environment and performance,
• Process Output

Process monitoring activities are further defined in Section 8.2 of this manual. Activities related to process control are defined in Operational Procedures QOP-75-01, Production Control and QOP-75-02, Work Instructions.

1.6 Product release and delivery

1.6.1 Products are released for delivery only after all specified activities have been satisfactorily completed and conformity of the product has been verified. Operational Procedure QOP-82-05, Final Inspection, define the system for final product verification and release.

2. VALIDATION OF PROCESSES

2.1 Special processes

There are no special processes in use at Dee Electronics.

2.2 Validation

Dee Electronics validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement, and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

ASSOCIATED DOCUMENTS

QOP-75-01 Operational Procedure: Operations Control

QOP-75-02 Operational Procedure: Work Instructions

QOP-75-03 Operational Procedure: Product Identification and Traceability

QOP-75-04 Operational Procedure: Product Handling and Preservation

QOP-75-05 Operational Procedure: Storage Areas

QOP-75-06 Operational Procedure: Packaging, Labeling and Shipping

QOP-74-03 Operational Procedure: Verification of Purchased Product

QOP-82-04 Operational Procedure: In-process Inspections

QOP-82-05 Operational Procedure: Final Inspection

QOP-83-01 Operational Procedure: Control of Nonconforming Product