Out of Calibration, Out of Service

What difference does one degree make? Surely not much. Yet, if a temperature measurement instrument is out of calibration and measuring even one degree off, it can be critical, especially for those producing pharmaceuticals, working in cryogenics or food manufacturing operations. Assuming regular instrument calibration is necessary for most equipment, do lapses really affect production?

Get the best results with better calibration

“For regulated customers, a calibration certificate needs to be on file in order to use the equipment,” said Brandon Wold, Director Specialty Business and Continuous Improvement, InnoCal. “The instrument will be quarantined or placed out of use if it is out of calibration. The bigger issue, though, is the potential for substandard results. In extreme cases, the company may need to recall their entire product.”

As the director of an ISO/IEC 17025:2005 accredited metrology lab, Wold has experienced his share of panic phone calls and quick consultations with plant managers and quality managers. Perhaps their production has slowed or ceased due to a lack of a calibration
program or maybe key instruments are out of calibration.

For example, a smelting operation melted old iron and pressed it into large sheets as new steel and received a complaint from their largest customer about the quality of their product. This prompted an investigation. Operations leaders determined that their temperature instruments were out of calibration and their heating process simply was not hot enough.

About That One Degree

So what about one degree? “If the temperature is one degree out of calibration for a pharmaceutical company,” said Wold, “they will need to perform an impact analysis on the product. If it is determined that the product has been affected by the one degree deviation, all of the product produced in that batch—or with that instrument during that time—will need to be recalled. Rather than cutting corners and trying to save time or costs, the end result is significantly more work.”

To cite another example, suppose a storage freezer has a tolerance of plus or minus five degrees. Temperature monitors will track this level continuously. However, if the temperature monitor is off by a degree, the temperature is now outside the range of tolerance at six degrees. For blood banks, cryogenics, and drug manufacturing, this extra degree has implications for the product stored in the freezers.

For food production, the sterilization process requiring exact temperature monitoring is crucial so that bacteria are not introduced into the product.

Adhering to Calibration Cycles

While typical calibration cycles are suggested according to industry standards, intervals are ultimately set within the facility based on the production needs, instrument usage, and applications. In some cases, it may make sense to change or extend a cycle. In other cases, it may prove shortsighted.

“Intervals may move from a one-year calibration cycle to a five-year cycle to reduce costs but risk management needs to be taken into consideration,” said Wold. “In the end, to minimize the risk of having to do an impact analysis and subsequently a product recall, it may be best to stick to a proven calibration cycle. You don’t want to have to recall five years worth of product based on production with an instrument that is out of calibration during that time period.”

Repairs with Calibration

For some lab or plant managers, locating an approved vendor to make repairs on instruments while also scheduling calibration can be a time drain. If possible, many want these services managed by one vendor.

“If we are working with someone who has doubts about how their equipment is functioning, we calibrate it first,” said Wold. “If the instrument requires more than a measurement adjustment, we use a network of authorized equipment manufacturers to repair it and we manage the process ourselves,” said Wold. “If it is sent out for repair, we receive it back in our metrology lab and test it. Our metrologists run it through the paces to ensure that it is working properly. This service means that our customers don’t have to track various instruments in repair or calibration; they simply receive them back ready to use.”

InnoCal designs calibration solutions, which may include making monthly or annual visits, setting up a calibration cycle, conducting an asset review, or reviewing calibration procedures. The lab also provides technical support including info about industry norms, military procedures, or proper calibration techniques. When necessary, service may be expedited to meet specific needs.