Timely reporting of an out of tolerance (OOT) condition through a reporting process (OTR) is critical to some companies, particularly medical device manufacturers. For us it is vital that production operations are informed immediately of an OOT occurrence to prevent potentially defective products from leaving the plant. In addition to in-house calibrated items we have ISO 17025 accredited vendors perform calibrations for equipment we do not have the capability to calibrate. Being an accredited vendor we assumed that they would notify us immediately of any OOT or non-conformance events with our equipment. We assumed incorrectly. This paper will describe what can go wrong with out of tolerance reporting and how to set up a bullet-proof reporting process to minimize adverse impact to your products and to your company.
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