As a calibration engineer, our calibration program is in the best shape if we satisfy the queries of our customers, the user of instruments, and the quality personnel, who require us to support them during calibration related audits. As much as possible, we do not want any audit findings because sometimes, even this is an opportunity for improvement to us, it looks like we are incompetent.
This is one reason almost half of our time is dedicated to updating and completing documentation. Below are some actual audit questions that I gathered, I based most of it from a vendor audit checklist usually related to ISO calibration audit checklist.
This is not a complete list of questions but I believe it touches most of the critical points. Are there documented procedures for control of inspection, measuring, test equipment? Is the calibration conducted under the specified environmental conditions? Is the personnel in charge of calibration been trained and formally certified? Is equipment verified or re-calibrated at appropriate intervals?
Are measuring equipment safeguarded from unauthorized adjustment or re-adjustment? Is there an official approval control system for all equipment to determine accuracy and precision? Are measuring and test equipment re-calibrated when found not meeting the requirement? Are instruments that do not need calibration clearly labeled as such? Check related post in this link.
Are the reference standards or reference materials used for calibrations correctly stored, managed and traceable to International standards i. Is the master standard for internal calibration has the adequate capability i. Is there an appropriate method for storing measuring equipment, tools, and jigs? If a product has been used or tested with equipment found to be out of calibration, is there a process for proper disposition?
Is there a review process before accepting the services of a 3rd party calibration lab? Are the internal calibration procedures used periodically reviewed and updated? Can you show the measurement traceability the unbroken chain of comparison of your reference standards? Is the access to the calibration laboratory effectively controlled?
Do you perform intermediate check for your reference standards? Customer audits are the most frequent audits that we encounter in the past company I worked, a manufacturer of ICs Integrated Circuit for various usage, so every now and then a customer audit is expected. One observation during the audit is that there is a specific audit sequence.
These sequences happen most of the audit that I encountered and it is a very helpful guide to trace down the things that are expected to be asked, and in return, we can prepare for it. Here are the sequences:. First , they will asked for a master list to check if you have a proper monitoring. Every audit checklist includes the information that needs to be audited.
The list of criteria should be created using the organization's quality manual, quality management system and any calibration procedures as guidelines. Does an official calibration procedure exist? Are all tools being used logged in a central quality assurance database? Are all tools being used calibrated? Do records or certificates exist that establish traceability of calibration? Does a procedure exist for internal calibration checks of tools? So, if you upload your file to OneDrive you can access and update the calibration log while you are away from the desk.
License : Private Use not for distribution or resale. This is a fairly simple spreadsheet, designed for a small company that did not need an enterprise calibration management software program. There is a lot more that you can do with a spreadsheet. For example, if the number of tools you maintain is relatively small, you could add a worksheet for each tool to keep a history of when each tool was calibrated, important measurements you wanted to control, and other information specific to the tool.
You may also want to use our free control chart template to help identify when a tool needs to be calibrated. If this sounds like something that would be useful, please contact us and let us know about your specific needs.
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