2019

MEASURE FOR MEASURE

Keep It Internal

by Jay L. Bucher

Most people in the metrology community are familiar with calibration laboratories and how they function. But what about companies that want to meet the Food and Drug Administration’s (FDA) current good manufacturing practices (cGMP), comply with the International Organization for Standardization’s (ISO) requirements, manufacture products worldwide or strive to find the cure for cancer? How can they guarantee their products and results are reproducible, at home or abroad, without sending all their test equipment offsite for calibration?1

To paraphrase part of a compliance guide covering the FDA’s cGMP: Manufacturers are responsible for ensuring the establishment of routine calibration on their test equipment so it will be suitable for its intended use.2 This is true not only for cGMP, but also for ISO 9000 and any manufacturer or research facility requiring reproducible results or products.

The core requirements for establishing and maintaining an in-house metrology department can be found in various regulations and recommended practice guidelines. Putting these requirements and recommendations into a usable, viable calibration program that meets a company’s individual needs and is fiscally responsible, however, can be a daunting task.

By incorporating a quality system using trained technicians who follow established metrology principles, a company can greatly reduce its risk and liability while lowering its overall cost in the calibration and maintenance of test equipment. A company can also get accurate, traceable measurements that are repeatable anywhere in the world.

To do so, it will need dedicated people using calibrated, traceable test equipment and a quality system that pays more than just lip service to its guidelines. All these principles are tried and true and have been in use for decades.

Calibration Laboratory Vs. Metrology Department

There are a number of differences between a calibration laboratory (commercial or private) and a metrology department. Most calibration laboratories, for example, are self-contained; they are located in their own facility or set of rooms. The customer usually delivers the test equipment to the scheduler or the calibration lab’s contact point, so the average calibration technician, who works in an environmentally controlled area, never sees or interacts with the equipment user or owner.

The majority of calibrations performed by metrology departments, however, occur in the room, lab or production area where the test equipment is located and are done in the same environment used by the customer. Going onsite could mean department personnel just step into the next room or it could mean they travel to another facility, taking the standards, calibration procedures, forms and labels with them.

Most technicians in a metrology department are on a first name basis with each of their customers and have a good idea how each piece of equipment is used. They are also trained to do their own scheduling using the available software programs and are responsible for all the test equipment located in a specific area or building. They have a well-rounded background in the calibration and repair of a wide variety of equipment and are self-confident and proactive in addressing a customer’s problems and presenting solutions.

A Solid Quality Management System

The basic premise and foundation of a good quality system is to say what you do, do what you say, record what you did, check the results and act on the difference:

  • Say what you do: Write down in detail how to perform every job (have calibration procedures).
  • Do what you say: Follow those procedures every time a piece of test equipment is calibrated.
  • Record what you did: Accurately record the results of your measurements and adjustments during each calibration.
  • Check the results: Ensure the equipment meets all the specified tolerances.
  • Act on the difference: If the test instrument is out of tolerance, the technician must inform the user as to the magnitude and direction of the discrepancy because the user may have to re-evaluate manufactured goods, change a process or recall a product.

This concept is not new. It has been around as long as companies have wanted to produce a quality product, no matter the location of the manufacturing facility or skill level of the workers.

To ensure all operations—no matter where they are performed—occur in a repeatable manner, it is essential for a company to establish a quality management system. The effective operation of such a system will help ensure stable processes and consistent outputs. Improvements can be initiated only after stability and consistency are achieved.

Technicians must follow the calibration procedures, collect the data as it is found and document the results accurately. Only then can trends be adequately evaluated, test equipment calibration intervals increased or decreased and improvements to processes and procedures implemented.

The Importance of Training

Of all the things a metrology department must remember to do, including identifying the test equipment, writing procedures, recording data, ensuring traceability of measurements and standards, establishing uncertainty budgets and scheduling practices, the one thing that should never be forgotten is to continually train, train, train! No one can provide enough training in today’s ever evolving world of metrology.

While everyone in the company is busy updating his or her computer systems, going paperless with documentation and records, using automated data processors and purchasing the latest and greatest technology, please don’t forget to provide the critical training on all these new systems or processes. Training can be provided in-house, by the vendor or through formal training programs outside the company.

Just because a company has the latest technology does not mean everyone knows how to use it correctly and recover it from calamitous crashes. Continuous training is the only way to ensure technicians are correctly and safely using the standards, systems and data collection devices. And it doesn’t stop there. Documenting the training is just as important to ensure everyone is singing from the same page at the same time.

One way to guarantee the technicians have the working knowledge needed to follow and use the department’s quality system is to have them become certified. In today’s world, quality competition is a fact of life, and the need for a workforce proficient in the principles and practices of quality control is a central concern of many companies. Certification is a mark of excellence.

Passing ASQ’s certified calibration technician (CCT) exam, for example, is a way for technicians to prove they have mastered the body of knowledge (BoK) deemed appropriate to perform their job as midlevel calibration practitioners.3 It also expands their awareness of the varied amount of information needed in today’s metrology environment. From quality systems to traceability or uncertainty budgets, there is more to what technicians are expected to know than most realize.


REFERENCES AND NOTES

  1. This column is based on a presentation I made at the 2002 National Conference of Standards Laboratories International in Boulder, CO, titled “You’ve Found the Cure for Cancer, But Can’t Reproduce Your Results … Could Your Test Equipment Be the Weakest Link?”
  2. Medical Device Quality Systems Manual: A Small Entity Compliance Guide, first edition (supersedes Medical Device Good Manufacturing Practices Manual), “Equipment and Calibration,” U.S. Food and Drug Administration-Center for Devices and Radiological Health, www. fda.gov/cdrh/dsma/gmpman.html.
  3. For more information on ASQ’s certified calibration technician exam, visit www.asq. org/cert/types/cct/index.html.

JAY L. BUCHER is the manager of metrology services for Promega Corp. in Madison, WI. He is an officer in the Measurement Quality Division and is a certified calibration technician. Bucher is also editor of The Metrology Handbook (ASQ Quality Press, 2004).

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