| 6. Quality Assurance Requirements for Measuring and Test Equipment NOTE: This section applies to the control of measuring and test equipment used to assure that supplies and services comply with prescribed customer requirements. It is based in large part of the requirements found in government audit standards such as MIL-STD 45662A, and is found in Part II of the ANSI/NCSL Z540-1-1994 standard. 6.1 General Requirements 6.1.1 The supplier shall establish and document a system to control the calibration of measuring and test equipment (M&TE) as necessary to assure the conformance of supplies and services to customer specifications. 6.1.2 M&TE used to determine compliances to customer specifications shall be calibrated or verified in accordance with section 5 of this Handbook. 6.1.3 The supplier shall have a program to recall for calibration or verification, or remove from service, M&TE that has exceeded its calibration interval, has broken calibration seals, or is suspected to be malfunctioning because of mishandling, misuse, or unusual results. 6.1.4 All operations performed by the supplier in compliance with this Handbook shall be subject to customer verification at unscheduled intervals. 6.1.5 The supplier shall carry out or arrange to be carried out, periodic quality auditing of the calibration and verification system in order to ensure its continuing effective implementation and compliance with the requirements of this Handbook. 6.1.6 Based on the results of the audits and any other relevant factors, such as customer feedback, the supplier shall review and modify the system as necessary. 6.1.7 Plans and procedures for the audits shall be documented. The conduct of the audit and any subsequent corrective action shall also be documented. 6.2 Detailed Requirements 6.2.1 Calibration system description The supplier shall provide and maintain a written description of the calibration/verification system covering M&TE and measurement standards. The description shall be sufficient to satisfy each requirement of section 6 of this Handbook and any deviations shall be submitted with supporting documentation to the customer for approval. 6.2.2 Adequacy of measurement standards Measurement standards used by the supplier for calibrating M&TE and other measurement standards shall comply with the requirements of sections 5.5.1, 5.6.1, and 5.7.2 of this Handbook. 6.2.3 Environmental conditions M&TE shall be used in an environment controlled to the extent necessary to ensure valid results. Due consideration shall be given to temperature, humidity, lighting, vibration, dust control, cleanliness, electromagnetic interference, and any other factors affecting the results of measurements. Where pertinent, these factors shall be monitored and recorded and, when necessary, correcting compensations shall be applied to measurement results. 6.2.4 Intervals of calibration and verification M&TE shall be calibrated or verified at periodic intervals established and maintained to assure acceptable reliability, where reliability is defined as the probability that the M&TE will remain in-tolerance throughout the interval. Intervals shall be established for all M&TE requiring calibration unless the equipment is regularly monitored through the use of check standards in a documented measurement assurance process. Check standards must closely represent the item parameters normally tested in the process and the check standard must be verified periodically. Where intervals are used to ensure reliability, the interval setting system must be systematically applied and shall have stated reliability goals and a method of verifying that the goals are being attained. Intervals may be based on usage or time since last calibration or verification. All exemptions from periodic calibration or verification shall be documented. The recall system may provide for the temporary extension of the calibration due date for limited periods of time under specified conditions that do not unreasonably impair the satisfaction of the customer's requirements. 6.2.5 Calibration procedures Procedures used to calibrate/verify the supplier’s M&TE shall comply with the requirements of 5.7.1 and 5.7.2 of this Handbook. 6.2.6 Out of tolerance conditions If any M&TE is found to be significantly out of tolerance during the calibration/verification process, the supplier’s system shall provide for notification to the user and to the supplier’s quality element, if appropriate, of the out-of-tolerance condition with the associated measurement data so that appropriate action can be taken. 6.2.7 Adequacy of calibration system The supplier shall establish and maintain documented procedures to evaluate the adequacy of the calibration system and to ensure compliance with the requirements of this Handbook. 6.2.8 Calibration sources M&TE requiring calibration shall be calibrated or verified by laboratories which have been accredited or recognized by NIST. 6.2.9 Records The requirements of this Handbook shall be supported by records documenting that established schedules and procedures are followed to maintain the adequacy of all M&TE. The records for M&TE requiring calibration shall include an individual record of calibration or verification, or other means of control, providing a description or identification of the item, calibration interval, date calibrated, identification of the calibration source, calibration results (data and/or condition status), and calibration action taken (adjusted, repaired, new value assigned, derated, etc.). 6.2.10 Calibration status M&TE shall be labeled to indicate calibration status. A calibration label shall identify specific date calibrated (day, month, year, Julian date or equivalent) and the specific calibration due date or usage equivalent. Items not calibrated to their full capability or which have other limitations of use, shall be labeled or otherwise identified as to the limitations. When it is impractical to apply a label directly to an item, the calibration label may be affixed to the instrument container or some other suitable means may be used to reflect calibration status. Tamper-resistant seals are affixed to operator accessible controls or adjustments which if moved will invalidate the calibration. The quality system shall provide instructions for the disposition of broken tamper-resistant seals. 6.2.11 Control of subcontractor calibration The supplier is responsible for assuring that a subcontractor's calibration laboratory conforms to the requirements in section 5 of this Handbook to the degree necessary to assure compliance with customer requirements. Accreditation of a laboratory according to these requirements by a third-party activity acceptable to the customer may serve as the basis for compliance with this requirement. 6.2.12 Storage and handling M&TE shall be handled, stored, and transported in a manner which shall not adversely affect the calibration of the equipment. | 