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I. PURPOSE This standard identifies the requirements for controlling processes that affect the quality of items and services as well as requirements for special processes such as those used in welding, heat treating, and nondestructive examination to verify that procedures, codes, and work practice standards are effectively implemented. II. REQUIREMENT REFERENCES A. DOE Order 5700.6C, Quality Assurance B. Y/QD-15, "LMES Quality Program Description" III. SCOPE/LIMITATIONS This standard applies to all ORNL research, design, development, procurement, testing, operations, maintenance, and decommissioning activities that use processes or special processes for controlling or verifying quality. IV. DEFINITIONS A. Instructions - approved temporary or special written criteria that provide guidance or augment existing written procedures. B. Process - one or more operations, methods, functions, procedures, or other specified actions (or series of actions) that produce a desired end product or result. C. Special Process - a process, the results of which are highly dependent on the control of the process, on the skill of the operators, or both, and of which the specified quality cannot be readily determined by inspection or test of the product. NOTE: Special processes include but are not limited to those used in performing welding, heat treating, protective coating, and nondestructive examinations. V. REQUIREMENTS A. Processes shall be controlled and shall conform to the following conditions: 1. Processes affecting the quality of items and services shall be identified and controlled for all ORNL programs, projects, or activities. 2. Quality processes, process parameters, and specified environmental conditions shall be controlled and maintained by instructions, procedures, drawings, checklists, travelers, or other appropriate means. 3. Equipment qualification requirements shall be included in procedures or instructions and shall include all equipment setup, operations, process controls, maintenance, and calibration requirements. 4. Requirements of applicable codes and standards, including acceptance criteria for processes, shall be incorporated into all written procedures or instructions for performing the process. B. Special processes such as welding and heat treatment and verification processes such as nondestructive examination and radiography shall meet the following requirements in addition to the requirements for "Process Control" in Sect. V.A: 1. Procedures or instructions for special processes shall be prepared and shall include appropriate technical, personnel, and equipment qualification requirements. 2. ORNL organizations performing special processes are responsible for adhering to the appropriate procedures and instructions. In addition, a. the qualification of personnel, programs, processes, and equipment shall be in compliance with the specified requirements; and b. the conditions for accomplishing the special processes shall be incorporated into procedures and instructions (including the use of proper equipment, the identification of control parameters for the process, and the calibration requirements). 3. Special processes that control or verify quality shall be performed only by qualified personnel using approved written procedures in accordance with specified requirements. These requirements will include or will reference the procedural, personnel, and equipment qualifications. 4. Records for each special process shall identify the personnel performing the special process and their qualifications, process parameters, and equipment qualifications. The records shall be maintained in a designated file location. 5. For special processes not covered by existing codes and standards and for items with quality requirements exceeding those of existing codes or standards, the necessary requirements for qualification of personnel, procedures, or equipment shall be specified in the related procedures or instructions. 6. Special processes shall be performed in accordance with equipment and procedures that comply with specified requirements. Only qualified and certified personnel shall conduct special processes, and their compliance with the specified requirements shall be verified and documented. Approved by: [J. H. Swanks] Associate Director Operations, Environment, Safety, and Health Oak Ridge National Laboratory
PIC - M. L. Gildner
FPM - P. B. Hoke
Directives Coordinator
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Updated:Wednesday, 12-Feb-97 13:02:59 EST(npn)