Manufacturers shall establish in writing and maintain procedures to control, calibrate and maintain inspection, measuring and test facilities (including test software) used by the manufacturer to demonstrate the conformance of product to the specified requirements.
The inspection, measuring and test facilities referred to in the preceding Paragraph shall be used in a manner that ensures that the measurement uncertainty is known and is consistent with the required measurement capability.
Article 139. Where test software or comparative references (such as test hardware) are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of products, prior to release for production, installation or servicing, and shall be rechecked at prescribed intervals.
Manufacturers shall establish the extent and frequency of such checks and shall maintain records as evidence of control.
Where the availability of technical data pertaining to the inspection, measuring and test facilities is a specified requirement, such data shall be made available, when required by the customer or the customer’s representative, for verification that the inspection, measuring and test facilities is functionally adequate.
Article 140. Manufacturers shall apply the following control procedures to inspection, measuring and test facilities:
(1) Determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring and test facilities that are capable of the necessary accuracy and precision.
(2) Identify all inspection, measuring and test facilities that can affect product quality, and calibrate and adjust them at prescribed intervals or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards; where no such standards exist, the basis used for calibration shall be documented.
(3) Define the process employed for the calibration of inspection, measuring and test facilities including details of facility type, unique identification, location, frequency of checks, check method, acceptance criteria and action taken when results are unsatisfactory.
(4) Identify inspection, measuring and test facilities with a suitable indicator or approved identification record to show the calibration status.
(5) Produce and maintain calibration records for inspection, measuring and test facilities.
(6) Assess and document the validity of previous inspection and test results when inspection, measuring or test facilities are found to be out of calibration.
(7) Ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out.
(8) Ensure that the handling, preservation and storage of inspection, measuring and test facilities are such that the accuracy and fitness for use are maintained.
(9) Safeguard inspection, measuring and test facilities, including both test hardware and test software, from adjustments that would invalidate the calibration setting.
Chapter 13 Identification of Inspection and Test Status
Article 141. Manufacturers shall identify the inspection and test status of products by suitable means to indicate the conformance or nonconformance of product with regard to inspection and tests performed.
The identification of inspection and test status shall be maintained, as defined in the quality plan or documented procedures, throughout production, installation and servicing of products to ensure that only products that have passed the required inspection and tests, or released under an authorized concession, is dispatched, used or installed.
Chapter 14 Control of Nonconforming Products
Article 142. Manufacturers shall establish in writing and maintain control procedures to ensure that products that do not conform to specified requirements are prevented from unintentional use or installation.
The control procedures referred to in the preceding Paragraph shall provide for identification, documentation, evaluation, segregation (when practical) and disposition of nonconforming products, and for notification of relevant authorities.
Article 143. Manufacturers shall define the responsibility for review and authority for disposition of nonconforming products. Nonconforming products shall be reviewed in accordance with documented procedures, and handled in one of the following manners:
(1) Reworked to meet the specified requirements;
(2) Accepted with or without repair by concession;
(3) Re-graded for alternative applications;
(4) Rejected or scrapped.
Where required by contract, the proposed use or repair of products that do not conform to specified requirements shall be reported for concession to the customer or customer’s representative. The description of the nonconformity that has been accepted, and of repairs, shall be recorded to denote the actual condition.
Repaired or reworked products shall be re-inspected in accordance with the quality plan or documented procedures.
Article 144. Manufacturers shall ensure that nonconforming products are accepted by concession only if regulatory requirements are met. The identity of the person(s) authorizing the concession shall be recorded.
If products need to be reworked, manufacturers shall document the rework in a work instruction that has undergone the same authorization and approval procedure as the original work instruction. Prior to authorization and approval, a determination of any adverse effect of the rework upon the product shall be made and documented.
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