Deviation Reports & Investigations

Whenever a particle counter or microbial sampler is out-of-tolerance (OOT) during its annual (or interval) calibration, a deviation report and failure investigation is required in regulated industries, such as pharmaceutical and life science / biotechnology manufacturing.

These deviation reports and investigations have a substantial personal impact on Quality Assurance Managers, who in most instances work on these after the day has typically ended.

In addition to overtime and other inefficiencies such as lost hours, even a simply failure investigation averages $8,000 to $12,000 per incident on average.  This amount is almost all labor, usually involves multiple people and departments, is subsequently difficult to calculate, and is a hidden cost associated with poor quality.  If a producer must scrap product, or if the OOT results in a batch rejection or recall... the costs can absolutely skyrocket!

Climet particle counters and microbial samplers provide users the highest assurance against 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 passed their interval calibration 99.6% of the time.

Again, in 2016, 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 manufactures a line of pharmaceutical and industrial grade environmental monitoring equipment that's drop and vibration tested, and specifically designed to provide long life, unparalleled accuracy and stability of measurement,  and the lowest total cost of ownership in the industry.

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