Deviation Reports & Investigations


 

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

According to a 2018 survey among pharmaceutical Quality Managers, a simple failure investigation averaged $8,000 to $12,000 per incident.  This dollar amount is almost all labor, usually involves multiple senior managers and departments, and is subsequently difficult to calculate.  In quality terms, it is a tangible hidden cost associated with poor quality (Ref. Six Sigma principle: Cost of Poor Quality). In most cases, the cost of one simple failure investigation frequently exceeds the initial purchase price of a particle counter or microbial sampler. 

Climet particle counters and microbial air samplers provide users the highest assurance against interval calibration OOT conditions. With 60 years 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." Indeed, both internal studies and customer feedback confirm this. 

As part of our ongoing commitment to quality, Climet conducted a study in 2019.  Excluding obvious repairs, Climet particle counters passed their internal calibration 99.5% of the time!  This level of quality is unparalleled in the industry.

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 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. With thousands of microbial samplers in the market today, that's 100% that pass their interval calibration. 

These results above are not simply unique but unparalleled in the industry.

"Quality is never an accident,
it is always the result of an intelligent effort.
"
John Ruskin (1819-1900)

Moreover, every new prototype design of a Climet portable particle counter or microbial sampler undergoes a series of 1-meter drop tests to ensure industrial ruggedness. After the drop testing is complete, the instrument must pass a calibration. Once again, this is unique in the industry, as no other competitive instrumentation can even remotely meet this requirement.  

As a result of several factors discussed herein, Climet end-users can expect ten (10) or more years of useful operation from our instruments. Together, these factors allow Climet to provide our valued customers with 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 other regulated 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.