Deviation Reports & Investigations

 

In regulated industries, ISO 21501-4 requires particle counters and microbial air samplers be calibrated at an interval equal to or shorter than one year.

During this interval calibration, if the instrument fails its calibration, i.e., out-of-tolerance (OOT), then all measurements taken since is its last calibration cannot be trusted. In regulated industries a failure investigation and deviation report is required to assess the impact on production quality and patient safety.

These deviation reports have a substantial personal impact on Quality Managers, Quality Control, Quality Assurance, Manufacturing Managers, Risk Management, and other supervisors who typically conduct their investigations after the day has ended.

Moreover, the cost of even a simple failure investigation is rapidly increasing. A survey among pharmaceutical Quality Managers confirms that the average cost of a failure investigation in 2018 averaged $10,000 per incident, and by the end of 2023 this increased, on average, to $14,000 per incident. This cost is almost all labor, usually involves multiple senior managers and departments and is 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 with the highest assurance against interval calibration OOT conditions. Since 1962, Climet has been engaged in the manufacture of environmental monitoring equipment, and we are a proud 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." As part of our ongoing commitment to quality, both field reports and internal quality studies confirm Climet offers a level of quality that 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. That's a 0.04% probability of a Climet particle counter having an interval calibration OOT failure. An internal study further confirmed that Climet particle counters that are 10 years old or less have an average OOT rate of 0.05%. Indeed, Climet's OOT rate, on average, is 30x to 40x lower than the competition.

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. 

Again, 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, and unparalleled reliability. Subsequently, pharmaceutical and other regulated organizations choose Climet above all others for our 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.