200725 - LORAN QUALITY CONTROL MANUAL

1.     PURPOSE

1.1. The biggest significant challenges for quality control laboratories are providing stability, calibration, and traceability. This handbook defines Loran's quality control management policy requirements. This policy is valid for all process steps in implementing the testing, measuring, calibration, external procurements and reporting by Loran Quality Control Laboratory. Loran Quality Control Management (Loran QCM) Policy is based on international standards, which will be stated in bold letters when appropriate.

2.     SCOPE

2.1. The accuracy, reliability, and timeliness of reported test results can explain the importance and quality of the Quality Control Laboratory. According to the Loran QCM Policy, test results must be as accurate as possible, equipment calibration must be implemented on time, all aspects of quality control laboratory operations must be reliable and impartial, and all processes must be reported in the Loran QCM ERP system.

2.2. It is essential to perform all processes and procedures in the laboratory in the best possible way to achieve the highest level of impartiality, accuracy, and reliability. Quality control management and laboratory are complex systems involving many steps of activity and many people. The complexity of the system requires that many processes and procedures be performed properly. Therefore, the quality management system model, which looks at the entire system, is very important for achieving good laboratory performance.

2.3. The main rule and target of this handbook is to specify the general requirements for the competence, impartiality, and consistent operation of the Loran QCM Policy.

2.4. Loran Quality Control Management Policy applies to the product suppliers, whether foreign or domestic. It also applies to second-tier or sub-suppliers that produce materials or provide processes critical to end item life and reliability.  

2.5. If there is a conflict between the Purchase Order, Drawings, and Specifications and this document, the supplier must contact the purchasing agent for clarification.

2.6. Loran Aerospace establishes quality control management policies, including personnel selection qualifications, quality control test procedures, calibration management rules, calibration record forms, and all other requirements according to the ISO/IEC 17025:2017, EN/ISO 10012:2003, ASME B89, ISO14253-1, and MIL-STD-810H standards.

2.7. Loran aims to create quality control laboratory physical conditions in accordance with MIL-STD-810H General Laboratory Test Method Guidelines, First Part Article 5.2, and accepts this as a prerequisite for transition to the production phase.

3.     DEFINITIONS AND ACRONYMS

3.1. Loran Quality Control Management: Loran QCM

3.2. Loran Quality Management System: Loran QMS

3.3. Impartiality: the presence of objectivity, which means maintaining objectivity.

3.4. Objectivity: means no conflict of interest or its resolution in a way that does not negatively impact the Laboratory's activities.

3.5. Complaint: expression of dissatisfaction by any person or organization to Loran relating to the activities or results of that project, where a response is expected.

3.6. Calibration: is the documented comparison of the measurement device to be calibrated against a traceable reference device.

3.7. Calibration Supplier: is, according to the ISO17025 standard requirements, an authorized and accredited quality control laboratory that can perform calibration services and certify the calibration process's results.

3.8. Calibration Certificate: designating that the measuring equipment has been calibrated and meets all established requirements according to the standard.

3.9. Calibration Interval: the next-time interval established for re-calibrating a test device, equipment, or gauge.

3.10.       Calibration Reliability: refers to the degree to which calibration processes consistently ensure measuring instruments and equipment perform accurately over time.

3.11.       Preventive maintenance (PM): is the regular and routine maintenance of equipment and assets to keep them running and prevent costly unplanned downtime from unexpected equipment failure.

3.12.       Decision Rule: the rule that describes how measurement uncertainty is accounted for when starting conformity with a specified requirement.

3.13.       Verification: providing objective evidence that a given item fulfills specified requirements.

3.14.       Validation: verification where the specified requirements are adequate for an intended use.

3.15.       Measurement Management System: A set of interrelated or interacting elements required to provide metrological confirmation and continuous control of measurement processes.

3.16.       Measuring Equipment: Measuring device, software, measuring standard, reference material, and auxiliary devices, or a combination thereof, are required to perform the measuring process.

3.17.       Metrological Confirmation: The series of operations required to ensure that measuring equipment complies with the conditions of its intended use.

3.18.       Measurement Uncertainty: The difference between the value measured during a measurement (actual value) and the upper and lower limit for an expected deviation from this value is termed the uncertainty of measurement.

Uncertainty of the measurement is non-negative parameter characterizing the dispersion of the values being attributed to a measurand, based on the information used. Uncertainty is different from the measurement error, which is the difference between the measured value and the true value. For more detail see ASME B89.7.3.1-2001 (R2019)

3.19.       Tolerance: the total amount a dimension or feature is permitted to vary.

3.20.       Acceptable Tolerance Limits: The tolerance is the difference between the maximum and minimum limits.

3.21.       Gage Block: it is a block of rectangular or square section, made of wear-resistant material, with one pair of planar, mutually parallel measuring faces.

3.22.       Deviation: the difference between the measuring value and the required value.

3.23.       Adjustment: is a balancing process to reach the required value as small as moving from the deviation value.

3.24.       Units of Length (Inch « Meter): 1 inch is 25.4 mm exactly.

3.25.       Wringing: is the property of the measuring faces of gage blocks to adhere to other measuring faces or to faces with similar surface texture as a result of molecular forces.

3.26.       Engineer Stamp (Engineer ID No): The Loran QCM system defines a stamp (Eng. ID No.) application for all engineers. The relevant engineer uses this stamp (Eng. ID No.) during his/her employment period. If the engineer leaves the job, the stamp (Eng. ID No.) is canceled and will not be assigned to another engineer again.

3.27.       Maximum Permissible Error (MPE): The value can be obtained by inserting a gauge block (or an equivalent standard) between the outside measuring surfaces, measuring it at arbitrary positions between the jaws and then subtracting the dimension of the gauge from the maximum or minimum indicated value.

3.28.       Calibration Verification Measurements: After the calibration is completed, at least 3 trial measurements are made for calibration accuracy.

3.29.       Accuracy: It is a qualitative concept referring to the closeness of agreement between a measured quantity value and the true quantity value of a measurement.

3.30.       Backlash: a relative movement between interacting mechanical parts resulting from looseness. Backlash is the rotation of the spindle, in the opposite direction of the initial reading, before spindle moves in a linear direction. This condition is typically caused by the looseness of fit between the lead screw and the adjusting nut.

3.31.       Full Measuring Face Contact: the contact between the full area of the measuring face and a feature of a workpiece.

3.32.       Tolerance Limit: specified upper or lower bound of permissible values of a property.

3.33.       Soak Out: One of the characteristics of an object is that it has a thermal memory. When a change in the environment is experienced, such as occurs when an object is transported from one room to another (e.g., from warehouse to laboratory), there will be some period of time before the object completely forgets about its previous environment and exhibits a response dependent only on its current environment.

3.34.       Operator Effects: Calipers, micrometers, rulers are manually operated indicating measuring instruments and as such the measurement results are dependent on the skill of the operator. The training of the operator is the essential point before assigning these instruments to an operator.

4.     RESPONSIBILITIES

4.1. Management Representative: Responsible for implementing and maintaining the control of quality control management processes, including maintaining records.

4.2. Quality Control Engineer: Responsible for implementing and maintaining the control of products supplied by the suppliers, including keeping records.

4.3. Management Team: Responsible for determining the responsibility and authority the review and disposition of quality control policies, including maintaining records.

4.4. All Employees: Responsible for immediately identifying and implementing of the quality control policies.

4.5. Loran Aerospace manages the quality control processes through its web portal https://qcm.loranaerospace.com

4.6. Depending on the impartiality and objectivity approaches of Loran QMS Policy, the quality control processes are left out of Loran QMS policies. In this way, quality control processes and administrative processes can be carried out independently of each other.

Loran Aerospace is managing the quality control processes through its own web portal "https://qcm.loranaerospace.com". Loran quality team can manage and perform the following capabilities: 1. Equipment (Device, Tools, Gages etc..) management, 2. Maintenance Management 2.1. Preventive Maintenance (with reminder function), 2.2. Repair Management 3. Calibration Management 3.1. Calibration Reminder, 3.2. Calibration Sticker 4. Quality Control Management 4.1. Process Management (NDT, DT, Calibration) 4.2. Checklist Management, 4.3. Quality Control Processes (step-by-step instructions) 5. Report Management 6. User Management

 

5.     WORK ORDER

5.1. Work Order Processes:

Loran examines the work orders it implements during quality control processes under 3 headings.

ü  Calibration,

ü  Quality Control Tests,

ü  Non-Conformity Controls

5.2. Work Order Sensitivity Levels:

Loran classifies work order sensitivity levels as follows:

5.3. User Authorization:

5.3.1.      Calibration Process: Loran accepts at least in-house or external training in Engineering and related fields as a prerequisite for all calibration processes applied within the company in quality control processes.

5.3.2.      Quality Control Test: Quality control tests are applied by the quality control team, including technicians. It is a prerequisite for the quality control testing processes to be accompanied by an engineer.

5.3.3.      Non-Conformity Controls: Nonconformity controls are carried out and reported only by the quality control supervisor.

5.3.4.      Quality Control Reports: Engineer approval and signature are required to report quality control processes. No report without a signature and Engineer ID No has any validity.

6.     GENERAL REQUIREMENTS FOR CALIBRATION and TESTING PROCESS

Unless otherwise stated in the manufacturer's technical documents, Loran adheres to the standards and manufacturer's requirements in calibration and testing processes.

6.1. GENERAL

6.1.1.      According to the Loran QCM Policy, all test equipment or calibration gage blocks must be calibrated periodically because:

6.1.1.1.  Calibration is an operation that in the first step, establishes a measured relationship between the item being calibrated and a measurement standard, and, in a second step determines the possible errors in measurement between the item being calibrated and said measurement standard.

6.1.1.2.  The calibration operation ensures the inspection, measuring and test equipment used to manufacture and maintain aircraft and aeronautical products are fit for purpose within defined acceptable error or accuracy limits.

6.1.1.3.  Calibration tolerance limits are established by standards, the manufacturers of the tools and test equipment, or by the OEMs. The equipment must be calibrated according to the standards and manufacturer's manuals to establish a secure and dependable quality control structure. An accurate calibration performed on time by an authorized laboratory, provides to obtain the results in tolerances and specifications are determined by the standards and OEMs.

6.1.1.4.  For test results to be reliable and provide a high level of confidence in the result, they must be derived from equipment that has been suitably calibrated for their intended use. When preparing a calibration schedule or procedure for test equipment the following measures require incorporation:

6.1.1.4.1.      evidence of measurement traceability to a suitable measurement reference or standard;

6.1.1.4.2.      the equipment has been calibrated across the range of measurement for which it is to be used;

6.1.1.4.3.      a suitable interval between calibrations has been determined based on stability of the test equipment or manufacturer recommendations;

6.1.1.4.4.      procedures for test equipment maintenance and verification of the calibration methods; and

6.1.1.4.5.      records maintained.

6.1.1.5.  Loran Aerospace manages the quality control processes through its web portal (https://qcm.loranaerospace.com). Loran can keep the following quality control records (and can add more) depending on the process's related standard requirements: 

 6.1.2.      Calibration Status Sticker (Label): According to the Loran QCM Policy, all calibration records are maintained in the Loran Laboratory Management ERP System. At the same time, a valid calibration sticker with a minimum of the information listed below is labeled on the equipment to allow the user of the equipment to readily follow the status of calibration and the period of calibration validity.

6.1.2.1.  Calibration Status,

6.1.2.2.  Device ID Number,

6.1.2.3.  Device Serial Number,

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