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I. PURPOSE This procedure identifies the requirements necessary to establish and implement an inspection program in support of Lockheed Martin Energy Research, Inc., activities. The inspection program will identify and verify conformance of items and services to documented specifications, instructions, procedures, and drawings; provide for independence of inspection personnel; and set forth inspector qualification requirements in accordance with ORNL criteria and appropriate codes. II. REQUIREMENT REFERENCES A. DOE Order 5700.6C, Quality Assurance B. Y/QD-15, "LMES Quality Program Description" C. X-QA-1, "ORNL Quality Assurance Program" III. SCOPE/LIMITATIONS The provisions of this procedure apply to all ORNL organizations involved in activities where inspection is used to verify implementation of specified requirements. Inspection is applicable to critical and complex safety systems and equipment, safety-class items, permits and vital missions, research and development, facilities operations, manufacturing, processing and production, product qualification, and site remediation, construction, and installation. Inspections shall be performed for items important to the business success of ORNL. Inspection planning, in-process, in-service, receipt, reinspection, source, and final inspections, and specification of acceptance criteria are further addressed. IV. DEFINITIONS A. Complex Item - item with quality characteristics, not wholly visible in the end item, for which contractual conformance must be established progressively through precise measurements, tests, and controls that are applied to the item individually or in conjunction with other items during purchasing, manufacturing, assembly, and functional operation. B. Critical Application - an application in which the failure of the item could cause personal injury, injure the environment, or jeopardize security or any vital ORNL mission. C. Inspection - examination or measurement to verify whether an item or activity conforms to specified requirements. D. Inspection Plan - a document identifying frequency of inspection, characteristics to be inspected, inspection methods, data to be recorded, and acceptance criteria. E. Noncomplex Item - item with quality characteristics for which simple inspection and testing of the end product are sufficient to determine conformance to contractual requirements. F. Noncritical Application - any application other than a critical application. V. REQUIREMENTS A. General 1. Organizational responsibilities for inspection shall be described and documented. 2. Inspection plans or procedures shall be developed with the assistance of the quality assurance organization, engineering, or other appropriate organizations, as necessary. 3. Results from final inspections shall be evaluated and documented, and their level of conformance to specified requirements shall be determined by responsible management. 4. Inspection practices associated with ORNL activities shall be periodically audited to ensure proper implementation and adequacy. 5. Procedures developed to implement the ORNL inspection program shall provide criteria for determining when inspections are required and shall define how inspections are performed. B. Inspection Planning 1. Inspection activities shall be planned, executed, and documented in terms of inspection types (e.g., receiving, in- process, in-service, reinspection, source hardware, process, or final inspection necessary to verify quality of work activities). 2. Planning documentation shall identify characteristics, personnel qualifications, inspection frequency, mandatory hold points, inspection methods, acceptance criteria, and data to be recorded and shall provide for recording objective evidence of inspection results. 3. Inspection plans shall be developed, reviewed, approved, and issued before initiating inspection activities and shall then be controlled in accordance with quality records requirements. 4. Criteria shall be provided for determining the accuracy requirements and calibration status of inspection equipment and instrumentation. 5. Required tests shall be identified and (as appropriate) monitored or witnessed with reference to the test procedure. 6. Sampling procedures, when required, shall be made available to inspection personnel trained in their proper use. If a sample is used to verify acceptability of a group of items, the sampling procedure shall be based on recognized standard practices. 7. Procedural provisions shall be established to prevent work from proceeding beyond established hold points until it is reviewed or inspected by a designated individual. 8. Procedural provisions shall be established for indirect control through monitoring of processing methods, equipment, and personnel when direct inspection is impossible or disadvantageous. Both inspection and process monitoring shall be provided when necessary for adequate control. 9. Combined inspection and process monitoring methods, when used, shall be performed systematically to ensure that the specified requirements for control of the process and quality of the item are achieved throughout the process. 10. Where required, controls shall be established and documented for the coordination and sequencing of these activities at established inspection points during successive stages of the conducted process or construction. C. Inspection Personnel: organizational provisions shall be made to ensure that 1. inspection personnel do not report directly to the immediate supervisors responsible for performing the work being inspected; 2. each person who verifies conformance of work activities for the purpose of acceptance is qualified to perform the assigned inspection task in accordance with ORNL procedure X-QA-1, "ORNL Quality Assurance Program"; 3. inspections by persons receiving on-the-job training are performed under the direct observation and supervision of a qualified individual; NOTE: verification of conformance shall be performed by a qualified individual until trainees achieve qualification; and 4. personnel performing inspection activities requiring specific qualifications such as education, experience, or certification to codes or standards shall have received appropriate training and certification. This information shall be documented in accordance with X-QA-1. D. Inspection Program Implementation 1. Inspection plans shall be reviewed by the appropriate organization for each identified inspection activity and shall include the following, as applicable: a. referenced drawings, specifications, purchase orders, process or flow sheets, travelers, or any document identifying characteristics to be inspected or to be obtained for use during inspection; b. inspection frequency or the time of process verification and related schedule; c. data to be recorded; d. identification of the inspection method; e. identification of quantitative acceptance criteria; f. identification of mandatory hold points and witnessing by third parties; g. consent to waive specified hold points and recording of consent before continuation of work beyond the designated hold points; h. identification of documents to become quality assurance records; i. reinspection or retest to verify acceptability following modifications, repairs, or replacements of items that have previously received final inspection; j. required in-service inspection or surveillance of structures, systems, or components that is planned and executed by or for the organization responsible for operation; and k. development and implementation of inspection methods to verify that the characteristics of an item remain within specified limits. Inspection methods shall include evaluations of performance capability of essential emergency and safety systems and equipment, verification of calibration and integrity of instruments and instrument systems, and verification of maintenance, as appropriate. 2. Records shall include, as a minimum, the following information: a. identification of item inspected, examined, or tested (part number, prototype, production model, or other information); b. date of the inspection, examination, or test; c. equipment used, with identification numbers and calibration status, as applicable; d. results or acceptability; e. signature of inspector, or other identifier such as stamp number; f. signature of person(s) evaluating the results; g. reference to documented procedures or instructions; h. any separate inspection, evaluation, and technical documentation (charts, recording, or film); and i. reference to any deviation or nonconformance reports generated. 3. Reporting of inspection results shall identify the following: a. any inspections made (and documented) at specified hold points, indicating whether compliance with acceptance criteria has been achieved; and b. a review of records for adequacy and completeness, including records of previous inspections and nonconformances, before final disposition of each item or service. The preparation, review, and approval by authorized personnel of the final inspection report shall certify that all required acceptance criteria have been achieved. Approved by: [J. H. Swanks] Associate Director Operations, Environment, Safety, and Health Oak Ridge National Laboratory
PIC - T. F. Orlin
FPM - P. B. Hoke
Directives Coordinator
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Updated:Wednesday, 12-Feb-97 13:02:26 EST(npn)