Tool Calibration Flow Chart3/25/2021
This allows anyone to view the flowchart and logically follow the process from beginning to end.With proper design and construction, it communicates the steps in a process very effectively and efficiently.Internal calibration procedure part number and current revision shall be referenced on the related Calibration RecordForm. 7.8.2 Calibration procedures must state: the acceptable limits of accuracy and precision; standards required; and sufficient information to enable qualified personnel to perform the calibration. 7.8.3 Equipment used for Calibration(s) shall have a Test Accuracy Ratio (TAR) of at least 10:1, i.e. Calibration Equipment uncertainty will be 10 times greater than the uncertainty of the Measurement and Test Equipment being calibrated, rationale for exceptions must be documented and approved.
![]() Auditing. Supplier Management. CAPA. Documentation. Design Quality. Etc. Etc. GMPs. Quality Cost Analysis. Calibration. Quality Policy. Validation. Improve your understanding and ability to deliver improvement. Information Training presentation 5.0 Definitions 5.1 Measurement Instrument Any instrument which monitors or controls a critical parameter of a manufacturing process, controlled environment or used to measure a product or component specification. National standard A reference tool utilized by an internationally recognized standards laboratory representing the country which operates that laboratory. Calibration Verification of a measurement instruments performance against a traceable standard. Standard A defined reference tool with traceability to a national standard. Traceability Documented reference of calibration results to a recognized standard. Accuracy The relative agreement of a measured value with an accepted standard. Loop Calibration The calibration of measurement instruments as installed in a total system and represents calibration of the instruments as used. Resolution The power of discrimination of an instrument. Suitability must consider Accuracy, Test Accuracy Ratio, Precision, Range, Resolution and conditions of use (including environmental conditions). Limitations of use shall be affixed on or near the Measurement and Test Equipment. Limitations shall be listed in the Special Instructions section of Test Equipment Installation Qualification Form. Calibration Intervals 7.2.1 Interval assignment should be established as recommended below in descending order of preference: 7.2.1.1 Calibration history of the equipment under evaluation, and the intended use, 7.2.1.2 Similar Measurement and Test Equipment enrolled in the calibration system, 7.2.1.3 Documented engineering rationale based on usage, 7.2.1.4 Manufacturers Recommendation, 7.2.1.5 In the event none of the above information is available the initial interval shall not be greater than 6 months. Interval changes may be requested by the owning department by completing the Interval Change Form. Approvals should consider the risk of using out-of-tolerance Measurement and Test equipment in the production or inspection process(s). Interval increases greater than half (12) of the current calibration cycle require justification based on recommendations in section 7.2.1. Initial introduction of new Measurement Instruments that have not been used since initial calibration performed by the OEM (Original Equipment Manufacturer), may be extended another full cycle, where permitted by the OEM as documented on the OEM Calibration Certificate. Calibration intervals shall be evaluated and documented on an annual basis by the Calibration Coordinator. Change of Equipment Status 7.3.1 The Equipment Owner will request changes of equipmentcalibration status using the measurement Instrument Status Change Form. EquipmentCalibration Status categories include, but are not limited to, the following: 7.3.1.1 Active Measurement and Test Equipment that is calibrated over the entire measurement range or capabilities. This equipment shall be labeled with a Calibrated Label. Inactive Measurement or test equipment that is currently not in use and consequently should not be an active part of the calibration program. This equipment shall be labeled with a Do Not Use-Out of Service Label and made non-operational if possible. Discontinued Measurement and test equipment that has been discontinued or destroyed. Reference Only Measurement and Test Equipment that has a measurement capability but is currently not used for ANY measurement or test activities for determining conformance to any equipment, product, process, design verificationvalidation, or environmental specifications. This equipment shall be labeled with a Not Calibrated For Reference Only Label. No Calibration Required Measurement and Test Equipment, which by nature or application does not require periodic calibration. Equipment in this category includes intrinsic standards, and equipment used in specific applications whose output values are verified by other calibrated Measurement and Test Equipment. This equipment shall be labeled with a No Calibration Required Label. Lost Equipment that cannot be located by the owning department. Discontinued Disposed Equipment 7.3.2.1 The department owning the equipment to be disposeddiscontinued will complete the Measurement instrument Status Change Form. The Calibration ID label will be removed from the equipment by the Owning Department and affixed to the Measurement instrument Status Change Form. The equipment shall be appropriately identified for disposaldestruction by the Owning Department. The completed Measurement instrument Status Change Form will be forwarded to the Calibration Department. Equipment Transfers Measurement and Test Equipment whose primary useownership is being permanently transferred between departments or divisions. The original owning department is responsible for completing the Measurement Instrument Status Change Form for any Measurement and Test Equipment that is being transferred to another department or division, and obtaining the signature of the new owning department. Records are entered in these two corresponding screens by the Calibration Coordinator(s).the Equipment Master stores general information, such as ID,description and scheduling information, called events, for each piece of equipment. The Equipment History maintains historical information for specific pieces of equipment. Each time an event is performed the result of the event, including any measurement information, is entered as a history record by the Calibration Coordinator(s). All data is entered by the Calibration Coordinator(s) and Administrator, other users such as the Calibration Representatives have User or read only status. All information whether deleted or entered is mapped through an audit trail in the database. RemedialCorrective Action Process 7.5.1 The Calibration Department will issue a RemedialCorrective Action Form to the equipments owning department Supervisor when Measurement and Test Equipment is returned from being calibrated with an identified out-of-tolerance condition before calibration. A description of the specific out-of-tolerance parameters will be included or attached to the form. Any equipment with out-of-tolerance occurrences before calibration will be issued a Do Not Use-Out of Service Label, or quarantined in the Calibration area, pending completion of the RemedialCorrective Action Form by the Owning Department. All RemedialCorrective Action Forms will address: 7.5.3.1 The impact of the out of tolerance condition on the product(s)process(s). A concise and detailed explanation for this decision shall be documented. ![]() These shall be prepared internally, by another agency, the manufacturer or a composite of any of these. Internal calibration procedure part number and current revision shall be referenced on the related Calibration RecordForm. Calibration procedures must state: the acceptable limits of accuracy and precision; standards required; and sufficient information to enable qualified personnel to perform the calibration. Equipment used for Calibration(s) shall have a Test Accuracy Ratio (TAR) of at least 10:1, i.e. Calibration Equipment uncertainty will be 10 times greater than the uncertainty of the Measurement and Test Equipment being calibrated, rationale for exceptions must be documented and approved.
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