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1、Full Client Name Reg CapsProcedure: Calibration Proc. TitleRev. Rev NumberProcedure: Calibration Proc. Title1.0 SUMMARY1.1. The purpose of this procedure is to define the requirements for calibration or verification of equipme nt used to determ ine the acceptability of product.1.2. Typically, this i
2、s limited to inspection or test equipment used to “ buyoff product prior to movement to a subsequent process or prior to final delivery. However, at the discretion of management, calibration or verification may also be applied to critical process equipment.1.3. The who? is resp on sible for impleme
3、ntati on and man ageme nt of this procedure.2.0 REVISION AND APPROVALRev.DateNature of ChangesApproved ByRev NumberDate of IssueOriginal issue.Procedure Approver Name3.0 PROCEDURE: CALIBRATION3.1. Devices subject to calibration shall be calibrated by an approved outside service provider, or by train
4、ed Short Clie nt Name employees.3.2. Third party calibration laboratories should be accredited to ISO 17025 whenever possible, as this provides the best control of calibration activities, and traceability to national standards.3.3. When employees perform in-house calibration, this shall be performed
5、 in accordanee with docume nted procedures for each type of calibrati on performed.3.4. Traceability to the national standards will be maintained for all devices where such traceability is possible by the curre nt state of the art.3.5. Approved calibration service providers must maintain suitable en
6、vironmental conditions for calibration, and report temperature and relative humidity on any calibration test certificates or other calibration documentation. For in-house calibration, the who? will ensure suitable en vir onmen tal con diti ons for calibrati on.3.6. The Calibrati on Log ren ame if n
7、ecessary will be mai ntai ned by the who?. This docume ntwill list all devices, their serial number, date of last calibration, and next scheduled calibration date. The freque ncy of calibrati on for each device shall be adjusted based on the history of the device and its impact on product quality. N
8、OTE: third party calibration providers may not establish calibrati on freque ncies; this must be determ ined by Short Clie nt Name.3.7. For tools calibrated by third party laboratories, these shall be returned with a certificate of calibration showing the status of the calibration, as well as the co
9、ndition the equipment wasfound in (e.g.,“ defective, “ out of toleranee ,“ in toleranee , etc.) Such cFull Client Name Reg CapsProcedure: Calibration Proc. TitleRev. Rev Numberthe identification of any standards used by the calibration house, and their serial numbers, allowing for traceability to NI
10、ST.3.8.3.9.3.10.3.11.3.12.3.13.3.14.3.15.For tools calibrated in-house by Short Clie nt Name staff, the results and sta ndards used shall be recorded on the Calibrati on Record and shall in clude any sta ndards an d/or procedures uses. Calibrated devices will be identified with a calibration sticker
11、 that includes the current calibration status, calibration due date, and device identification number. Where the device cannot accommodate a calibration sticker due to size or frequency of use, the device shall be numbered and the who? shall keep a log of those devices and their status. Employees ma
12、y only use devices for accepta nee testi ng that are curre nt on calibrati on.Employees shall submit expired tools to who? for recalibration, and/or the who? shall positively recall such expired tools for recalibrati on.product ion capacity purposes.Oxebridge recomme nds aga inst this practice, and
13、recomme ndsdeleti ng this paragraph en tirely.An “ amn estyw indow of 2 weeks adjust accord in gly is allowed bey ond the due date marked on the device, to accommodate arrangement of calibration or verification, or forDevices in use for non critical measureme nts are to be marked REFERENCE ONLY. thi
14、s may not be possible for all compa nies with large amounts of non critical tools. Con sider a differe nt approach in such cases.Any device faili ng to meet calibrati on sta ndards will immediately be take n out of service. The device may the n be destroyed or sent out for repair. Repaired devices m
15、ust be calibrated before being returned to service.When a measuring device is found to be out of toleranee, and/or reported on the calibrationcertificate of hav ing bee n found asdefective or y “houtlhjfdoleayiceovider,the who? shall be notified immediately. The who? or designate shall oversee a stu
16、dy todeterm ine the impact of the out-of-tolera nee device on product shipped; if deemed n ecessary, arecall may be initiated. The customer possessing the material in question is immediately notified of the problem. This study and the results shall be recorded and placed in the calibration file.Measurin
