Deviation Reports & Investigations


 

In regulated industries, when a particle counter or microbial sampler is out-of-tolerance (OOT) during its interval calibration, a deviation report and failure investigation is required. These deviation reports and investigations have a substantial personal impact on Quality Assurance and other managers who conduct their investigations after the day has typically ended.

According to a recent Climet survey, a simple failure investigation averages $8,000 to $12,000 per incident on average.  This is almost all labor, usually involves multiple people and departments, and is subsequently difficult to calculate.  In quality terms, it is a hidden cost associated with poor quality (CoPQ) as cost associated with even one failure investigation frequently exceeds the initial purchase price of a particle counter or microbial sampler. 

Climet environmental monitoring instruments provide users the highest assurance against interval calibration OOT conditions. With over 50 years engaged in the manufacture of environmental monitoring equipment, Climet is an industry pioneer and innovator.  The key to our unparalleled reputation is the use of high quality materials, unparalleled engineering acumen, and a DFM (Design For Manufacturability) that ultimately provides uncompromising quality.

Our mantra at Climet is, "Quality is in our DNA." And both internal studies and customer feedback confirms this. 

In 2015, Climet completed a study that included over 2,000 factory calibrations of various models of particle counters. Approximately 25% of these instruments were over 10 years old, with a number of these manufactured in the 1980's (over 30 years ago!).  The study concluded that 98.3% of Climet particle counters passed its interval calibration.

In 2016, a large pharmaceutical customer with over 700 Climet particle counters conducted their own independent Total Cost of Ownership (TCO) analysis. Not only did Climet provide the lowest TCO among the industry leaders, but our customer confirmed that Climet particle counters that are 7-years old or less passed their interval calibration 99.6% of the time.

Again, in 2018, another study confirmed that both Climet factory and independent 3rd Party calibrators have yet to report even one out-of-tolerance condition during an interval calibration of a Climet microbial air sampler.

These aforementioned results are not simply unique, but unparalleled in the industry. Climet's Out-of-Tolerance (OOT) rate of 0.4% is between 10x to 50x lower than our competition. Moreover, Climet end-users can expect 10 or more years of useful operation from our instruments.  Together, these factors allow Climet to provide our valued customers the lowest Total Cost of Ownership (TCO) in the industry.

Climet manufactures a line of pharmaceutical and industrial grade environmental monitoring equipment that's drop and vibration tested, and specifically designed to provide long life. Subsequently, pharmaceutical and red biotechnology organizations choose Climet above all others for our unparalleled accuracy and stability of measurement, extremely high quality, and lowest Total Cost of Ownership.

Contact Us today to schedule an appointment to learn more about Climet, and to schedule your no cost evaluation.