5 Calibration Myths That Could Cost You Millions 

A single miscalibrated instrument can halt production, trigger a regulatory finding, or force a costly recall. But here’s the real surprise: the biggest risks don’t come from broken tools; they come from the myths companies believe about calibration. 

These misconceptions lull teams into a false sense of security, often until it’s too late. By the time drift is discovered, audits fail, or customers complain, the damage is already done. 

In this post, you’ll see five common myths that sneak into manufacturing and compliance teams. You’ll also see the hidden costs if they’re left unchallenged, and how SIMCO helps manufacturers avoid them. 

Myth 1: Calibration is just adjusting equipment. 

It’s easy to think calibration means “tweaking” a device until it reads correctly. It seems logical. If the numbers do not look right, you “calibrate” them. 

Reality: Calibration and adjustment are not the same thing. Calibration is a comparison against a known, traceable standard to see whether an instrument meets specifications. Adjustment is a separate corrective step performed only if results are out of tolerance. And repair is different again, addressing faults or malfunctions.  

Dangers of believing this myth: A production team may decide to skip formal calibration records and rely on ad-hoc “adjustments” when readings look off. Months later, a defense customer requests traceable proof of calibration history.  

The team can’t clearly distinguish between units that were merely checked, those that were adjusted, and those that were repaired. The absence of clear, traceable records turns a small shortcut into a major audit exposure. 

How we help: We draw a clear line and tell customers whether a device passed calibration, needs adjustment, or requires repair, so there’s no guessing in the audit trail.  

During an onsite visit, a technician will calibrate the instrument (as-found), perform an adjustment or repair if it’s out of tolerance, then recalibrate (as-left) to verify it meets specifications—recording each step on the certificate. 

Myth 2: If an instrument is working fine, it doesn’t need calibration. 

It’s the classic “don’t fix what isn’t broken” mindset. If an instrument powers on, looks normal, and gives plausible readings, why pull it out of service? 

Reality: Drift happens silently due to wear, use, and environment. What looks fine today can be out of tolerance tomorrow. Unnoticed drift is a real risk in regulated industries. It’s both silent and deadly.  

Dangers of believing this myth: Imagine a pharma cleanroom pressure gauge that looks normal to operators. In reality, it has drifted just past tolerance.  

An FDA team reviews records and sees the gauge hasn’t been verified on time. Now every lot from that room is under suspicion.  

Shipments freeze; production halts for investigation; deviation reports and rework consume the calendar—and customer trust takes a hit. 

How we help: Our program and asset management tools support service scheduling, document storage, and status visibility, including service-due notices and notifications for conditions like Out-of-Tolerance. There are also dashboards and reports to keep teams ahead of deadlines.  

Myth 3: All calibrations are the same. 

Because certificates and service descriptions can look similar, it’s easy to lump all calibrations together.  

Reality: Not all calibrations meet the same standards. SIMCO emphasizes the difference between accredited calibrations (e.g., ISO/IEC 17025) and other levels. In regulated industries, traceability and decision rules matter, and knowing the difference can make or break an audit.  

Dangers of believing this myth: A medical device manufacturer might use a low-cost provider and receive pass/fail certificates with limited data, when more was required. During an FDA audit, the company is asked to show traceability and “as found/as left” results with uncertainties. Without clear documentation, the team spends weeks on corrective actions, and customers start asking questions. 

How we help: Customers have options to choose from at SIMCO. Our ISO/IEC 17025 accredited calibration offerings and ANSI/NCSL Z540-1 compliant calibration offerings, which can include measurement data for out-of-tolerance (OOT) results or the full set of pre- and post-adjustment measurement data, including OOT data. 

Many of our labs maintain accreditation to ISO/IEC 17025 and ANSI/NCSL Z540-1, providing internationally recognized confidence in results and documentation.  

Myth 4: “Once calibrated, equipment stays accurate indefinitely.” 

A calibration sticker can look like a long-term guarantee. It isn’t. 

Reality: Calibration is a point-in-time snapshot. Accuracy can change after calibration due to shocks, temperature/humidity, handling, and heavy use. The environment and handling could be drivers of post-calibration issues, and these environmental conditions affect calibration validity. 

Dangers of believing this myth: A torque wrench is calibrated in January, then dropped in February. Because the sticker still says “good,” it stays in use.  

Weeks later, assemblies begin failing stress tests. Now you’re tracing a product built with an out-of-spec tool, reworking units, and answering hard questions about how a simple handling incident slipped through. 

How we help: SIMCO promotes risk-based scheduling and interval justification. Customers adjust their calibration frequency based on usage history, criticality, and past performance, not habit.  

Our Lean Six Sigma principles help us guide customers to evaluate their unique needs and avoid unnecessary calibrations while maintaining compliance. They make informed decisions to create interval optimizations that save costs, without sacrificing accuracy.  

Myth 5: “Calibration is only about compliance.” 

Because regulators require calibration, it’s often treated like a checkbox exercise. 

Reality: Calibration is central to safety, quality, and operational legitimacy. This is especially true in life sciences and aerospace where accurate, traceable calibration underpins decisions that affect patients, customers, and mission outcomes. 

Dangers of believing this myth: A life sciences company might stick to bare-minimum intervals and pass/fail records. When an instrument drifts between cycles, incomplete data makes it impossible to prove control “as found.”  

This results in observations, product investigations, delays, and heightened scrutiny. “Paper compliance” without defensible traceability is risky. 

How we help: SIMCO publishes guidance on OOT best practices, decision rules, and interval adjustment to help customers actively reduce OOT risk and keep certificates current.  

We underscore ISO/IEC 17025 as the benchmark for lab competence and traceability, and position calibration records, with uncertainties and decision rules, as essential to audit readiness.  

Don’t Let Myths Make the Rounds 

Calibration myths are hidden risks that can derail production, trigger regulatory findings, and damage customer trust. Every shortcut or assumption comes with a price tag that’s often much higher than the cost of doing calibration right. 

At SIMCO, we help manufacturers cut through the noise with accredited services, risk-based scheduling, and digital program management that ensures every record stands up to scrutiny. Whether in the lab or onsite, our goal is to make calibration not just a compliance exercise, but a competitive advantage. 

Don’t let myths define your program. The right partner helps you replace assumptions with traceability, guesswork with confidence, and risk with resilience. Reach out for a quote today.