Hundreds of complex instruments are used daily at pharma, biotech and medical device organizations. Utilization spans research, manufacturing, warehousing, distribution, fill and finish, and more. The food industry also relies on precision instruments to measure the environmental conditions of produce during shipping, storage, and processing. The importance of properly calibrated instruments cannot be overstated.
In the simplest terms, calibration checks an instrument against a known standard. More specifically, an accredited calibration lab performs SI traceable calibration services to ensure high quality, reliable and consistent results. An ISO 17025 accredited lab has proven competence and met standard conditions to an accrediting body. This accreditation provides proof of compliance and verifies the laboratory demonstrated calibration testing competence. And, regular assessments by an independent, third-party accreditation body are required to maintain the accreditation.
There are numerous stages where accurate measurements are vital to every activity before a product reaches the end user. Here are five areas where attention to calibration proves a solid return on investment.
1. Product Quality
Without proper calibration, instruments may be “out-of-tolerance.” As a result, measurements are no longer within the acceptable accuracy variance. Normal wear and tear can cause this “drift” requiring regular calibration to ensure accurate measurements. Inaccurate measurements can lead to poor quality products—including medication inaccuracies, improper storage conditions, spoiled or contaminated food, and malfunctioning devices. Proper calibration and corrective measures will certify that all instruments are performing properly and meet necessary standards and produce quality products. Calibration helps ensure your processes promote efficacy and safety to prevent health risks to your consumers.
Regularly calibrated instruments are integral to achieving the necessary level of accuracy and ISO quality requirements. The Food and Drug Administration (FDA) is responsible for protecting public health, in part it ensures the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices as well as the safety of our nation's food supply. (www.fda.org) What’s more, cGMP is a set of principles compiled by the FDA which act as a minimum standard for operations in the pharmaceutical industry. This includes requirements for process validation, calibration, quality metrics, and more. Certificates with an accreditation stamp ensure regulatory authorities and suppliers will accept the calibration or test results because the lab has demonstrated competence to a third-party auditor and their best measurement capability. A well-designed calibration program helps you maintain the accuracy of your instruments, compliance with ISO 17025, it can also help expedite approval for new drugs and avoid penalties during an audit.
3. Equipment Safety
Equipment could present a hazardous work environment if not properly calibrated. For example, out-of-tolerance conditions could unintentionally expose employees to shock, burns, leaked hazardous materials, and explosions. Organizations that enforce a regular calibration program can help ensure the welfare of workers when electrical, pressure, and temperature measurements are accurate, and conditions are maintained per safety standards.
Your organization’s reputation is on the line every day. It can be difficult to measure the total impact due to poor or inaccurate calibration because there are many qualitative factors, such as lack of confidence, that can ultimately affect your bottom line. Proper calibration will help your company produce quality products based on accurate measurements which can minimize, even prevent, product recalls as well as reinforce consumer trust. With a steadfast commitment to consumer safety organizations can also avoid costly lawsuits.
5. Costs and Maintenance
Poorly calibrated instruments can contribute to costly downtime as well as material and product waste. Properly calibrated equipment, on the other hand, helps ensure consistent operations which promotes increased efficiencies and improves productivity. Calibration often helps identify the need for adjustments or repairs enabling proactive measures that can also save on overall maintenance costs.
A calibration program is instrumental in risk mitigation efforts, cost efficiencies, and improved performances across manufacturing, warehousing, distribution activities, and more. Many companies partner with accredited calibration labs to ensure that their instruments are calibrated correctly, and therefore can produce high quality, reliable and consistent results.
For nearly 40 years, our customers trust us for top-quality SI traceable calibration services, quick turnaround, letter-perfect certificates and the lowest industry uncertainties. Masy calibration services reinforce your commitment to demonstrate adherence to safety, quality, and environmental standards. For the full scope of our calibration capabilities, visit our calibration services overview or call 1-978-433-6279.