Design Control Measures

TM 55-315

(3) Assurance that all prerequisites for a given activity have been satisfied.

(4) Taking into account the need for special control processes, test equipment, tools, and skills.

(5) Verification of quality by inspections and tests.

c. Requirements and procedures of the quality assurance program shall be based on the following considerations

concerning the complexity and proposed use of the package and its components:

(1) The importance of a malfunction or failure of the item regarding safety.

(2) The design and fabrication complexity of uniqueness of the item.

(3) The need for special controls over and surveillance of processes and equipment. -

(4) The degree to which functional compliance can be demonstrated by inspection or test.

(5) The quality history and degree of standardization of the item.

d. The quality assurance program shall provide for indoctrination and training of personnel performing activities

affecting quality. Required training shall be that necessary to ensure that suitable proficiency is achieved and

maintained.

9-6. Design Control Measures

a. Measures shall be established to assure that applicable regulatory requirements and the package design are

correctly translated into specifications, drawings, procedures, and instructions. These measures include provisions to

assure that the appropriate quality standards are included in design documents.

b. Design interface measures shall be established to include written procedures among participating organizations

for the review, approval, release, distribution, and revision of documents involving design interfaces.

c. Design control measures shall be established to verify or check the adequacy of design. These measures include:

(1) Design reviews.

(2) Alternate or simplified calculation methods.

(3) A suitable testing program.

The verifying or checking process shall be performed by persons or groups other than those who initiated the original

design, although they may be from the same organization.

d. Design control measures shall be applied to items in such areas as:

(1) Criticality physics.

(2) Radiation shielding.

(3) Stress analysis.

(4) Thermal analysis.

(5) Hydraulic analysis.

(6) Accident analysis.

(7) Compatibility of materials.

(8) Accessibility of inservice inspection, maintenance, and repair.

(9) Features to facilitate decontamination.

(10) Delineation of acceptance criteria for inspections and tests.

9-7. Procurement and Control of Materials, Parts, and Components

a. Measures shall be established to assure that applicable requirements, which are necessary to assure adequate

quality, are suitably included or referenced in the documents for materials, equipment, and services. These measures

will assure that these items, whether purchased directly or through contractors and subcontractors, conform to the

procurement documents. To the extent necessary, contractors or subcontractors shall be required to provide and

document a quality assurance program consistent with that in 10 CFR 71.

b. Measures shall be established for identifying and controlling materials, parts, and components. These measures

shall assure that identification of the item is maintained by NSN number, part number, or other appropriate means, either

on the item or on records traceable to the item. These measures shall be designed to prevent the use of incorrect or

defective materials, parts, and components.

9-8. Records Documentation and Document Control

a. The quality assurance shall include maintaining, during the life of the packaging to which they pertain, adequate

quality assurance records to furnish documentary evidence of:

(1) Quality of packaging components that have safety significance.

(2) Services affecting the quality of packaging components.

(3) Monitoring, inspecting, and auditing work performed during design, fabrication, assembly, testing,

modification, maintenance, repair, and use of the packaging.

b. Quality assurance record shall include closely related data such as:

(1) Qualifications of personnel, procedure, and equipment.

(2) Inspection and test records, to include, as a minimum, the identity of the inspector or data recorder, type of

observation, results, and actions taken concerning deficiencies noted.

9-2