Are the internal calibration procedures used periodically reviewed and updated?ġ6. Is there a review process before accepting the services of a 3rd party calibration lab?ġ5. In case there is a “failed” result in the calibrated equipment, does the procedure define the disposition? – Disposition in this case means, what will you do to the instrument once it failed, do you adjust and return to service with limits or destroyed it (or donate it) and change to new one?ġ4. If a product has been used or tested with equipment found to be out of calibration, is there a process for proper disposition?ġ3. Is there an appropriate method for storing measuring equipment, tools, and jigs?ġ2. 10x higher resolution or with a TUR of greater than 4:1)ġ1. Is the master standard for internal calibration has the adequate capability (i.e. NIST)? – Managing a reference standard includes transport, preventive maintenance, and receiving.ġ0. Are the reference standards or reference materials used for calibrations correctly stored, managed and traceable to International standards (i.e. Are instruments that do not need calibration clearly labeled as such? ( Check related post in this link)ĩ. Are measuring and test equipment re-calibrated when found not meeting the requirement?Ĩ. Is there an official approval control system for all equipment to determine accuracy and precision?ħ. Are measuring equipment safeguarded from unauthorized adjustment or re-adjustment?Ħ. Is equipment verified or re-calibrated at appropriate intervals?ĥ. Is the personnel in charge of calibration been trained and formally certified?Ĥ. Is the calibration conducted under the specified environmental conditions?ģ. Are there documented procedures for control of inspection, measuring, test equipment? Including:Ģ. This is not a complete list of questions but I believe it touches most of the critical points.ġ.
This is one reason almost half of our time is dedicated to updating and completing documentation.īelow are some actual audit questions that I gathered, I based most of it from a vendor audit checklist usually related to ISO 9001 calibration audit checklist. In the past company that I worked for as a Calibration Engineer, managing an in-house calibration lab, I always make sure that all documentation that are always checked during audits are regularly updated.īecause almost every month, we expect an audit, either from internal audit, a 3rd party auditor certifications (ISO 9001 calibration audit) or a customer audit.Īs 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.Īs 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. You can use below questions as an internal audit checklist to perform a self-audit if you are implementing either ISO 9001:2015 calibration audit requirements or ISO 17025 audit requirements. In any case, whenever an audit comes, you are already prepared. (Not a 100% assurance but it is an advantage to know in advance) I will also share the audit sequence that I observed that can help us identify or expect the next audit move or questions.īy identifying all these things and prioritizing its completion, it will help us maintain and prepare more ourselves and our internal calibration lab to pass every audit. In this post, I will share with you the most asked questions during a calibration audit that I repeatedly encountered. Like for example during equipment maintenance, or just even an operator interview.ĭo you felt uncomfortable every time there is a scheduled audit because you are not sure about your preparations for your calibration program?ĭo you always prepare for an incoming audit only to find out you have non-conformances?Īuditors are not the same, some send their checklist first in advance and some only forward their schedule without the audit checklist.īut regardless of they send an audit checklist or not, we should know what to expect from the auditors. Almost all areas in the manufacturing floor, calibration audit are expected.
One of the main reason is that it is one of the requirement of ISO Standards like ISO 9001 under clause 7.1.5 and ISO 17025:2017 under clause 8.8.Ĭalibration audit is one of the challenging parts (if not interesting) in internal calibration management if you have a huge company. One of our responsibility is also to respond to or support an audit.Īs per my experience, the most audited processes in the manufacturing industry is the calibration program. As a calibration tech or Engineer, our responsibility does not end after we performed instrument calibration.