Quality Assurance

Macrotron has enhanced certain aspects of the ISO 9002 registration criteria and created an internal program called the TQM "Total Quality Macrotron" program. It was created to incorporate various components of Macrotron. In addition to the TQM program, Macrotron's quality related goals are to instruct all new employees on the importance of the Quality System and the continued utilization of the Quality Control manual. 

 

Document Control Macrotron has created procedures described in the Total Quality Macrotron "TQM" program that describes the document control system. Macrotron informs the customer whenever a design change affects product features, performance or reliability.
All documents are maintained by the ISO coordinator and kept on the computer and in hardcopy. All documents are available to personnel at all locations. The ISO coordinator maintains a master list of the current revision of all controlleddocuments and removes the obsolete documents promptly from all operations.

Supplier Management

• Macrotron has a procedure to select suppliers on the basis of their ability to meet the requirements, including quality.

• Macrotron maintains a list of qualified parts and approved suppliers and subcontractors.

• A system is in place to control and ensure that the supplier quality program remains adequate.

Product Identification & Traceability

• Macrotron procedures provide control of the identity and traceability of OEM consigned products and Macrotron purchased products.

Process Control

• Macrotron has a documented process flow chart, including production inspection points and QC monitor points outlined in the "TQM" procedures.
• Limits are established and maintained for all major processes.
• Macrotron certifies all new and revised procedures.
• All manufacturing operations are detailed into clearly written procedures, and given to operators periodically.
• Macrotron has documented the quality requirements and procedures for each inspection and monitor point.

Inspection & Test

• A procedure exists to control the flow of incoming material to assure none is used or processed until the quality has been verified.
• TQM procedures provide adequate controls to ensure the verification of materials by inspection, test, or other method, in accordance with the documented procedures.
• A procedure exists to identify the inspection and test status of a product.
• There is a documented final inspection and test program to assure that products are not shipped until all quality and performance requirements are met.
• There are established product quality goals.

Equipment Calibration & Maintenance

• New Inspection, Assembly and Test equipment is thoroughly tested and qualified before utilized in production. Equipment used in production is checked, calibrated and maintained according to the operator manual. Each piece of equipment is serialized and the calibration data is recorded in maintenance logs.
• Detailed records are kept on maintenance and calibration dates for each item of production and quality equipment.
• There is a controlled automatic recall system for equipment covered by the calibration and maintenance records to assure that required service is performed according to the established schedules.
• No out of calibration equipment is used in production.

Reliability

• A procedure exists to identify, label and isolate all nonconforming product.
• Macrotron has a documented procedure that monitors reliability on an ongoing basis for mature products and processes.
• Macrotron maintains visual, mechanical, and electronic test equipment for reliability testing

Failure Analysis & Corrective Action

• Macrotron has equipment to perform failure analysis that can identify the root cause of any and all product failures.
• Impaired reliability is investigated and reported to the appropriate engineering, manufacturing and quality groups. Corrective and preventive action is implemented and the customer is notified of any reliability issues and actions taken.

Environment Control, ESD Precaution

• Macrotron monitors the environmental conditions within the Test and Manufacturing Areas.
• ESD handling equipment is installed and ESD procedures are followed for handling, assembly, test and packaging of all sensitive materials.
• Assembly and Test Managers are responsible for enforcing ESD procedures.

Handling, Storage & Packaging

• Macrotron utilizes labels, a color code scheme, and work order travelers to prevent mixing lots in the material handling process.
• All materials received are properly stored as required by the environmental criteria - Temperature, Humidity, Packaging.
• Inventory materials are used on a FIFO basis. Finished good are controlled and shipped on a FIFO basis. Age sensitive materials are monitored by expiration date.

Quality Audit

• Macrotron performs periodic quality system audits to ensure the established procedures and processes are maintained and adequate. The process is carried out by the ISO coordinator with the aid of checklists and instructions. The periodic ISO 9002 audits are carried out by registered ISO personnel.
• Results of the self audit activity are provided to senior management and the groups being audited.
• There is a documented corrective action procedure for discrepancies noted in self audit reports.

Training

Macrotron's Training Program includes quality awareness for all personnel. Each employee understands that quality products maintain customer loyalty.

RMA Customer Satisfaction

• Macrotron has implemented an RMA (Return Material Authorization) procedure.

Macrotron's typical response time is 24 to 48 hours after receipt of returned product whether it is for failure analysis, repair, or replacement.

Statistical Techniques

Macrotron has implemented procedures to define the sampling plans used in process control.

 

© 2002 Macrotron Systems, Inc.