What is A Quality Calibration Program?

A quality calibration program consists of several broad items referred to in the Quality System Regulation (QSR) from the Food and Drug Administration (FDA). These items are also referred to by other standards (ISO 9000, ISO 13485, etc.) and regulations throughout most industries that regulate or monitor production and manufacturing of all types of products. One of the most stringent requirements can be found in the current Good Manufacturing Procedures or cGMP.

The basic premise and foundation of a quality calibration system is to "Say what you do, Do what you say, Record what you did, Check the results, and Act on the difference". Let’s break these down into simple terms.

"Say what you do" means write in detail how to do your job. This includes calibration procedures, work instructions and standard operating procedures (SOPs).

"Do what you say" means follow the documented procedures or instructions every time you calibrate, or perform a function that follows specific written instructions.

"Record what you did" means that you must record the results of your measurements and adjustments, including what your standard(s) read or indicated both before and after any adjustments might be made.

"Check the results" means make certain the test equipment meets the tolerances, accuracies, or upper/lower limits specified in your procedures or instructions.

"Act on the difference" means if the test equipment is out of tolerance, you’re required to inform the user/owner of the equipment because they may have to re-evaluate manufactured goods, change a process, or recall a product.

Meeting ISO standards and cGMP regulations

Bucherview Metrology Services can provide the following

for your quality calibration program: 

¶ Calibration Procedures

Learn to write calibration procedures that meet defined criteria.

¶ Calibration Records

Paperless or hardcopy...the requirements are the same.

¶ Out-of-Tolerance Procedures

Your test instruments do not meet their specifications…what should you do?

¶ Traceability Documentation

Learn how to keep a paper-trail for traceability back to a national standard.

¶ Calibration Labels

Do you use the correct labels; do they have the right information on them?

¶ Calibration Environment

When you’re too hot or too cold—does your equipment still work?

¶ Calibration Management Programs

Not all software packages are created equal.

¶ Calibration Standards

Are your Standards giving you ’the most bang for the buck?’

¶ Uncertainty Budgets

Do your calibrations comply with the national standard for uncertainty?

¶ Calibration Intervals

Are you calibrating your test instruments too often, or not often enough?

¶ Scheduling Practices

Learn to efficiently schedule your workload to help maintain ‘0’ overdues.

¶ Training

The most important but least scrutinized area of a calibration program.

¶ Continuous Process Improvements

The correct attitude can make all the difference in the world.

¶ Audits and Inspections

Learn the ins and outs of successful audits and inspections.

 Other services are available upon request. Give us a call or email if you have questions or need more information.