Compliant Calibration Management
February 27, 2009
Organizations use calibration management software to help achieve compliance to industry standards and regulations. It facilitates an organization’s effort to maintain accurate gage calibration records and-ultimately-correctly calibrated gages.
Much of the benefit associated with such software is derived from its ability to automate the calibration management process, bringing it a higher level of accuracy and efficiency. Such software alerts operators to what needs calibration, when it needs to be calibrated and who needs to calibrate it. It also informs management when equipment due for calibration is not being serviced. These automated functions help to eliminate human error from the gage calibration process, which can lead to increased productivity and less waste.
Calibration management software has other advantages. Calibration records can be stored to a common database, so operators can easily view the history or check the status of any gage from a variety of locations. For greater oversight, control and efficiency, some packages can integrate with other software applications, such as statistical process control (SPC) or enterprise resource planning (ERP); others are sold as modules intended as components of a greater management system package.
Keeping a Compliant Management SystemCalibration management is a crucial part of an organization’s management system, and calibration management software is designed to help organizations comply with a variety of ISO standards and other regulations, such as the FDA’s 21 CRF Part 11. ISO standards do not dictate the use of commercial software, but paper-based and homegrown systems can be time consuming and prone to error.
In achieving certification to ISO 9001 or ISO/TS 16949 or accreditation to ISO/IEC 17025, for example, an organization may find that a paper-based or homegrown system for gage calibration management will create inefficiencies, and in some cases may be in opposition to the supplier requirements of a prospective customer.
“Someone doing business with Chrysler for instance, there’s no way they’re going to get by with just a spreadsheet,” says Devin Brent Ellis, client solutions director, quality management division, for CyberMetrics Corp. (Scottsdale, AZ). “Chrysler is going to demand that they have a commercial calibration package; they’re going to be very interested in how they’re keeping history.”
Calibration management software affords traceability, providing instant access to gage history. And because the software automates gage management, there is less chance that a gage will miss calibration or be mishandled. Calibration alerts are sent to operators warning impending need of calibration. Some packages will provide work instructions to ensure that the gage is correctly calibrated. Furthermore, a good software package will keep up to date with revisions to an organization’s applicable standard, as well as provide a checklist of procedures relevant to a particular standard.
“When a paper record is lost, it may not be discovered as missing, or if a gage shows up where its paper records are misfiled, time is spent searching for the missing records,” says Robert Fruit, assistant manager, MeasurLink department, for Mitutoyo America Corp. (Aurora, IL). “Continuous records about the gage are part of ISO-compliant systems. Properly backed up computer records are fast to search, and records are not likely to go missing.”
And because it automates compliance to an organization’s applicable standard, use of calibration management software can expedite third-party assessments. In the same way that it gives operators instant access to important information, such software allows third-party assessors to easily and quickly view calibration records, corrective actions and other documents that will determine whether the requirements of a standard are being fulfilled.
Considering a New SystemWhen an organization is ready to make the switch to commercial calibration management software, it should conduct a needs assessment to define its current and expected measurement needs. For example, the organization should be aware of the number of gages needing calibration, the number of facilities and personnel that will need access to software and whether any gages will need to be calibrated by an outside vendor, as the case may be with a coordinate measuring machine (CMM).
In addition, the level of data collection and analysis functions desired from a software package should be established, such as SPC, gage repeatability and reproducibility (R&R) or repair management. It should be determined whether the software needs to integrate with any existing software system. Finally, the organization should determine whether it will have to meet customer or regulatory requirements in the near future.
“I would recommend focusing on replacing the current system while also adding additional functionality,” says Scott Johnson, technical support analyst for PQ Systems (Miamisburg, OH). “Planning for the future as well as meeting the demands of the present should be part of the thinking.”
After a list of requirements is established, the organization should contact several software providers to assess how they are able to accommodate its needs. The list will allow a prospective vendor to provide a general price range. Mitutoyo’s Fruit recommends contacting three or four vendors, conducting a phone interview and then requesting demo software from the two vendors that seem the most appropriate.
“You want to select, maybe, five gages: a couple standard gages such as a caliper and micrometer, something unusual such as a thread or go/no-go gage, something that needs an outside calibrator such as a CMM and a calibration standard such as a gage block set,” says Fruit. “Learn how each of these items works with the chosen software. You will like one software better than the other.”
When evaluating a software package, an organization should consider whether it can be customized, the level of training and technical support offered, scalability and initial, as well as ongoing, costs associated with the product. Also, it is important to consider the robustness of the vendor’s business: will that vendor be around long enough to provide updates and new versions in the future?
Also, look for a package that can quickly convey all pertinent gage information to an operator. “Calibration software should track the location of all gages and state the status of each gage,” says Rick Sloop, senior application engineer for InfinityQS International (Chantilly, VA). “The software should be able to query gages based on location, status, the operator responsible for calibration, the customer the gage is assigned to and calibration due dates.”
Software OptionsCalibration management software is sold either as a calibration-specific package or a module of a larger management system package. A calibration-specific package is used only for calibration management, but can usually be configured to interface with other software applications. A calibration module may be used in the same way as a calibration-specific package, but is intended to be a component in a larger management system package.
Furthermore, an organization will usually have a choice regarding how it wants the software to be implemented: client-based or Web-based.
In a client-based setup, software will be installed directly to desktop PCs or a centralized database. Installing the software to a centralized database allows it to be shared by multiple PCs across multiple locations.
A Web-based approach requires a customer’s IT department to host the software and data, and access to the program can be granted to PC users in multiple locations via a Web browser. If an organization does not have the IT resources requisite for the traditional Web-based approach, some vendors provide software as a service (SaaS) solutions. In this case, the software is sold as an annuity, and the vendor hosts the software and the customer’s data.
When it comes to which form of calibration management software to invest in-calibration specific or modular-and whether to implement it as customer-based or Web-based, it can be argued that the decision is mostly a matter of preference. “I don’t think technology really matters as much,” says Prashanth Rajendran, chief operating officer of Pilgrim Software (Tampa, FL). “At the end of the day, you have to look at it as, ‘What technology am I comfortable with?’”
Rajendran goes on to say that a small shop with 15 to 20 employees may look to a client-based approach, because it is low maintenance, deployed on a PC or a few PCs. However, a shop with hundreds of gages and multiple locations may be apt to consider a Web-based approach, while an even larger organization may consider a SaaS Web-based system because the IT infrastructure investment needed to maintain the application would not be necessary.
“But very easily this whole thing could be flipped around,” says Rajendran. “A small company could consider SaaS because they don’t have the infrastructure to do client-based or traditional Web-based. So it’s very easy to argue both ways if you want to.”
With that said, client-based implementations continue to be very popular because organizations typically have few employees that need access to calibration management software. However, a Web-based approach is generally seen as appropriate in instances of very large deployments requiring software access at various locations.
“Normally the software is implemented as client-based,” says Ricardo Lepper, president of SoftExpert USA (Auburn, IN). “SaaS is normally implemented when companies don’t want to spend much money on IT infrastructure. Web-based is used when companies have subsidiaries spread over a geographical area and a single database is needed.”
However a calibration management software package is implemented, it is likely that an organization will attain improvement in its calibration process, record keeping and gage accuracy, which in turn will help satisfy the requirements of industry standards, regulations and customer requirements. Finally, accurate gages help ensure that safe, high-quality products are passed on to consumers, a goal common to manufacturers as well as the standards or requirements to which they seek certification or compliance. Q
For more information on the companies mentioned in this article, visit their Web sites:
CyberMetrics Corp., www.cybermetrics.com
InfinityQS International, www.infinityqs.com
Mitutoyo America Corp., www.mitutoyo.com
Pilgrim Software, www.pilgrimsoftware.com
PQ Systems Inc., www.pqsystems.com