Total Quality Management

APPLICABLE DOCUMENTS

The following documents constitute a part of this specification to the extent specifically set forth
herein. Unless otherwise specified, the latest edition of the document applies.

2.1. Documents / Specifications
A. 102–2 Glossary
B. 102–143 Total Quality Management Documentation System
C. 102–152 Additional TQM Requirements for Products Sold for Nuclear Applications
D. 102–153 Additional TQM Requirements for Products Sold for Aerospace Applications
E. 402–39 Quality System Cross–Reference
F. 402–105 Quality Tools and Statistics Reference Guide

2.2. International Standards/Industry Standard
A. ISO 9000 Quality Management Systems – Fundamentals and Vocabulary
B. ISO 9001 Quality Management Systems – Requirements
C. ISO 9004 Quality Management Systems – Guidelines for Performance Improvement
D. ISO 10012–1 Quality Assurance Requirements for Measuring Equipment
E. ISO/IEC Guide 25: General Requirements for the Competence of Calibration and Testing Laboratories
F. ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
G. QS–9000 Quality System Requirements
H. AIAG Advanced Product Quality Planning and Control Plan Reference Manual
I. AIAG Fundamental Statistical Process Control (SPC) Reference Manual
J. AIAG Measurement Systems Analysis Reference Manual
K. AIAG Potential Failure Mode and Effects Reference Manual
L. AIAG Production Part Approval Process Manual
M. AIAG Quality System Assessment
N. QuEST TL 9000 Quality System Requirements
O. QuEST TL 9000 Quality Measurements Handbook
P. AS9100 Quality Systems, Aerospace Model for Quality Assurance in Design,
     Development, Production, Installation and Servicing
Q. ISO/TS 16949 Quality Management Systems Automotive Suppliers
R. 10CFR50B USNRC Regulation 10, Code of Federal Regulations Part 50

2.3. Military Specifications and Standards
MIL–STD–790 Standard Practice For Established Reliability and High Reliability
Qualified Products List (QPL) Systems For Electrical, Electronic, and
Fiber Optic Parts Specifications

• Determine the sequence and interaction of the processes needed to maintain the quality management system;

• Determine criteria and methods needed to ensure that both the operation and control of the processes are effective;

• Measure, monitor and analyze these processes and implement actions necessary to meet goals and to drive continual improvement;
• Initiate action to prevent nonconformances;
• Initiate action to identify, record, and correct problems;
• Initiate, recommend or provide solutions;
• Verify implementation of solutions;
• Control further processing, delivery, or installation of nonconformances;
• Utilize the DMAIC (Define, Measure, Analyze, Improve and Control) process to implement breakthrough improvement;
• Represent the needs of the customer in internal functions in addressing QS–9000 and TS 16949 requirements.

Control of Inspection, Measuring and Testing Devices
Gages, measuring devices, and testing equipment used to determine the acceptability of
components, assemblies, materials, and tooling affecting product quality shall be specified and / or
provided by the Engineering, Manufacturing, or Quality functions as appropriate. These shall be
controlled and calibrated in accordance with a system that conforms to the requirements and intent
of ISO 10012–1, –2 / 17025, or equivalent national or industry standard. Where system test and
verification relies on software–controlled devices, the functionality shall be verified through the
Quality function. The control of inspection, measuring, and test equipment shall include:

•  Process and product measurement devices that provide the required accuracy and precision shall be selected and verified before production. Measuring and monitoring devices shall be controlled to ensure that measurement capability is consistent with measurement requirements.

• All measuring devices used to verify product quality shall be uniquely identified and calibrated at prescribed intervals against certified equipment having a known relationship to a nationally or internationally recognized standard. If no standard exists, the method of calibration shall be identified and recorded.

• Procedures shall be developed for the calibration process and resulting records with adequate controls that protect product quality. All measuring devices shall have an indication of calibration status. If the calibration status indication is invalid, the measuring device shall not be used.

• All inspection, measuring and test equipment that does not require calibration shall be appropriately identified.

• A process shall be established that assesses the validity of previous inspection and test results when measuring devices are found to be out of calibration. Records of this assessment shall be maintained.

• Conditions shall be established that provide a suitable environment for calibration and use of measuring devices and that these devices are stored and handled in a way that maintains accuracy and fitness for use.

• Methods shall be developed to safeguard measuring devices, including test hardware and software, from adjustments which would invalidate the calibration settings.

• Appropriate statistical studies of the variation present in measurement and test systems shall be completed as part of process capability analysis and as specified in customer approved control plans. Such studies shall conform to generally recognized measurement system analysis methodologies.

• All product produced with suspect measuring equipment shall be segregated and audited. Customer notification / product recall shall be considered if suspect product was shipped.

• Non–standard measuring equipment, such as pin detectors, vision systems, etc., shall be verified by the local manufacturing location by using product having known defects or other suitable means. This internal verification schedule shall be established by the Product / Manufacturing Team. The verification results shall be recorded.

• Should non–standard measuring equipment be determined non–functional, it shall be removed from service until it is repaired and declared operational, and another inspection method substituted as developed by the Quality function.

• Devices that are either inactive or unsuitable for use shall be visibly identified and shall not be used.