SAMPLE COMPANY Page 1 of 6 SOP # 11-1 Revision: 0 Prepared by: _ Effective Date: Approved by: _ Title: CONTROL, CALIBRATION AND MAINTENANCE OF INSPECTION, MEASURING AND TEST EQUIPMENT Policy: All instruments for testing and measurement equipment used in production or testing will be regulated under a calibration program as part of a total Quality Assurance program. Purpose: This procedure establishes a standard method for the use, calibration, recordkeeping and maintenance of mechanical measuring tools such as micrometers, calipers, etc., and testing instruments. Scope: All measuring tools being used to set specifications or measure conformance to specifications, such as micrometers, calipers, pressure gauges, etc., will be included in the calibration program. This program shall also be mandatory for equipment provided by suppliers or subcontractors or any personally owned Measuring and Test Equipment used by employees at the Company's facilities. Each tool will be assigned a number and checked every six months (unless otherwise noted) for accuracy. If you suspect a tool is damaged or out of calibration, it should be removed from service and brought to the Quality Control Lab (QC) for checking. To enter a tool in the program, take it to QC where a number will be assigned and initial accuracy checked and recorded. Definitions: 1. Calibration - Comparison of a Measurement standard or instrument of known accuracy with another standard or instrument to detect, correlate, report or eliminate by adjustment any variation in the accuracy of the item being compared. 2. Inspection, Measuring and Test Equipment - All devices used to collect data and measure, gauge, test, inspect or otherwise examine items to determine compliance with specifications. 3. Reference Standard - Standards of the highest accuracy order in a calibration system which establish the basic accuracy values for that system. CONTROL, CALIBRATION AND MAINTENANCE OF Page 2 of 6 INSPECTION, MEASURING AND TEST EQUIPMENT 4. Working Standard - Designated measuring equipment used in a calibration system as a medium for transferring the basic value of reference standards to lower echelon transfer standards or other measuring and test equipment. 5. Traceability - The ability to relate individual measurement results to national standards or nationally accepted measurement systems through an unbroken chain of comparisons. Procedures: 1.0 Storage, Handling and Maintenance 1.1 Inspection, measuring and test equipment and measurement standards shall be calibrated and utilized in an environment controlled to the extent necessary to assure continued measurements of required accuracy giving due consideration to temperature, humidity, vibration, cleanliness, and other controllable factors affecting precision measurement. When applicable, compensating corrections shall be applied to calibration results obtained in an environment which departs from standard conditions. 1.2 All inspection, measuring and test equipment shall be handled, stored and transported in a manner which shall not adversely affect the calibration or condition of the equipment. 1.3 Each measuring tool or instrument shall be kept clean and maintained in a protective container. If applicable, all threads and slides shall be lubricated with a fine tool oil to assure free movement. 2.0 Calibration and Recalibration 2.1 Whenever applicable, standards used to calibrate equipment must be traceable to the National Bureau of Standards (NBS) or other recognized standards. 2.2 The following procedures will apply to these types of testing and measurement equipment: CONTROL, CALIBRATION AND MAINTENANCE OF Page 3 of 6 INSPECTION, MEASURING AND TEST EQUIPMENT Measuring Tools: (i.e. Micrometers, Calipers, etc.) The calibration shall be done by comparison to standard gage blocks traceable to the National Bureau of Standards with an accuracy 3 to 10 times greater than that of the measuring tool. The comparisons shall be made at different points along the measuring range of the tool. The gauge blocks used shall be picked at random to assure that the measuring tool is not checked at the same points on each calibration cycle. When a measurement is made, move the gauge blocks from one side of the tool's measuring face to the other on an X/Y axis to assure no wear or taper exists on the measuring faces. Pneumatic Testing Instruments (e.g., Pressure and Vacuum Gauges, Flowmeters, etc.) and Electrical Test Equipment (e.g., Multimeters, Non-Invasive Evaluator or Radiation Outputs, etc.) Calibration shall be achieved through a contract calibration laboratory which in turn uses standards traceable to the National Bureau of Standards or other recognized standards. The contract laboratory should have in place and document their applicable calibration controls required or as appropriate for the equipment. For example, the contractor should have: - written calibration procedures; - records of calibration; - trained calibration personnel; and - standards traceable to NBS or other independent reproducible standards. If in-house standards are used by a contractor to calibrate device-related measuring equipment, these standards must be documented, used, and maintained the same as other standards. 2.3 Inspection of Special Tooling Special jigs, fixtures, tooling masters, templates, patterns, and related devices should be initially proved by inspection to ensure that they will produce acceptable parts, prior to release to production. CONTROL, CALIBRATION AND MAINTENANCE OF Page 4 of 6 INSPECTION, MEASURING AND TEST EQUIPMENT The tool should be reinspected at the start of a production run, when there has been a change in the manufacturing process that affects the design of the tool or the dimensions produced from it, or upon expiration of the calibration period if the tool is used as inspection media. If the tool is used as inspection media, the tool must be placed under this calibration program. 3.0 Record Keeping and Labeling 3.1 A Calibration Card (Exhibit 1) will be maintained for each piece of testing and measurement equipment under the calibration program. 3.2 After calibration, the date of calibration and the next due date of calibration shall be recorded on the Calibration Card. The actual calibration reading and any adjustments and/or repairs to the tool or instrument should be recorded. 3.3 Each piece of testing and measurement equipment will be labeled with a decal which contains the date of calibration, by whom calibrated and the date the next calibration is due. If it is not practical to attach the decal to the tool or instrument, then the decal should be placed in the container or shelf/location where the item is stored when not in use. 3.4 Measurement tools or instruments not intended for testing or manufacturing do not require calibration in accordance with these procedures. These items must be either kept out of manufacturing or labeled "Not a Calibrated Instrument" to avoid inadvertent use. Otherwise, these items must be entered into this calibration program. 4.0 Recall System 4.1 The Calibration Card will be placed in a 12 month tickler file in the month proceeding the next recall due date. The cards in the section of the file for the current month are pulled and all of the equipment listed is calibrated. For example, in a six (6) month calibration cycle, when an instrument is calibrated in May, the card is moved from the May section to the October section of the file. When the file is checked in October, the cycle card will be there to remind that calibration is due. The process is repeated until an event such as instrument wear-out occurs and the respective cycle card is removed from the file. The calibration Card tickler file will be maintained by the Quality Control Manager. CONTROL, CALIBRATION AND MAINTENANCE OF Page 5 of 6 INSPECTION, MEASURING AND TEST EQUIPMENT 5.0 Out-of-tolerance Conditions 5.1 If a tool or instrument is found to be out of calibration, the QC lab will immediately pass the out-of-calibration information to the appropriate supervisor in the department where the tool is used. The Department and QC management will take appropriate remedial action for affected in- process or finished products. 6.0 Control of Subcontractor Calibration 6.1 Purchasing will be responsible for assuring that applicable subcontractor's calibration system conforms to the applicable product plan requirements and to the degree necessary to assure compliance with contractual requirements. Calibration Card Card # of _ Type: Manufacturer: _ Model: ID No.: _ Calibration Standard: _ Date of Purchase: Assigned to Dept: _ Location: Calibration Cycle: _ Use: Frequent Moderate Seldom Not Used Reason for Calibration Date Next Date of (Broken, Normal, Calibration Calibration Information Accuracy, Calibration Rough use, etc.) Inspector Due Defects, Lube, Clean, etc. To be Calibrated by: Name: _ Company: _ Address: _ _ Phone: _ EXHIBIT 1