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The essential role of quality control labels in high-tech manufacturing

When it comes to manufacturing, there is one key element that allows a company to maintain product integrity — quality control. And labels are essential for making it happen.

Quality control can be tricky. It encompasses a broad range of activities, and there are many types of information that might be conveyed on a quality control label. Quality control also may require on-the-spot addition of information, meaning that labels might need to accommodate handwriting or on-site printing. Whatever the details of the quality control process, the most important role of the quality control label is to clearly convey pertinent quality information from the first step of the manufacturing process to the last.

Where do quality control labels appear in the manufacturing process?

The short answer is everywhere. Quality control should happen at every production stage and is especially essential in high-risk, high-tech industries like semiconductor and pharmaceutical manufacturing. 

Let’s zoom in on semiconductor manufacturing, actually, to see where quality control labels might appear in a real-world scenario. As silicon wafers move through a highly controlled cleanroom environment of a semiconductor fabrication facility, each wafer is subjected to multiple stages of processing, typically including etching, deposition, and lithography. At each stage, quality control labels play a pivotal role in ensuring that these complex procedures are carried out precisely and that any deviations are quickly addressed.

Calibration labels are applied to critical inspection equipment like scanning electron microscopes (SEMs) and photolithography machines. These labels display the last calibration date and the due date for the next calibration, ensuring that these machines produce accurate measurements and alignments. This is vital since even a minor deviation can render a wafer defective, potentially resulting in significant losses.

Inspection labels are applied to wafers at specific checkpoints to indicate whether they’ve passed or failed particular tests, such as thickness uniformity, surface roughness, or defect inspections. A wafer that meets quality standards might receive a “pass” label, while one with detected issues could be marked with a “rework” label, directing it to the appropriate station for adjustments. These labels help technicians quickly identify the status of each wafer, ensuring efficient processing.

Additionally, rejection and quarantine labels are used to segregate wafers that are found to have critical defects, such as contamination or structural flaws. These labels help identify materials that require further analysis before they are either reprocessed or scrapped, preventing defective wafers from being mixed with high-quality batches.

You get the idea. Quality control labels are the fail safe that keeps faulty or dangerous products from making it to the end of the production line and into the hands of customers, ensuring customer satisfaction and — in some cases — safety. 

What information do quality control labels typically convey?

There are a couple of key types of information that quality control labels convey. But quality control labels can also be extremely specific to your unique manufacturing process. Which is why choosing a custom label for quality control is often your best option. 

Sterility indication

In highly sensitive manufacturing environments that are common to the pharmaceutical, life sciences, and medical device industries, sterility is often non-negotiable. Quality controls labels with sterilization indicator features provide tangible proof that sterilization has successfully occurred. The type of sterilization indicating label you’ll want to choose depends on the type of sterilization used in your manufacturing processes.

  • Autoclave sterilization: Autoclave indicating labels are designed to withstand the extreme high temperatures, humidity, and pressure present during the autoclave process. They use a speciality ink to indicate successful autoclave sterilization based on heat, steam, and time. 
  • Ethylene oxide gas (EtO) sterilization: EtO indicator labels are chemically resistant to EtO degradation and irreversibly change color from dark purple to bright green when sterilization has successfully occurred.
  • Gamma radiation sterilization: Gamma indicator labels maintain integrity and legibility throughout gamma radiation sterilization. They use inks that are chemically sensitive to gamma radiation and irreversibly change color from yellow to red when sterilization has been successfully achieved.

Read more >> Learn how to prevent label contamination in your aseptic environment

Calibration

Quality control labels can be used to track and document the calibration status of delicate equipment and instruments. These labels serve as a clear visual reference for the last calibration date, the next due date for calibration, and the technician responsible for the calibration. They play a crucial role in maintaining the accuracy and reliability of equipment, ensuring that machinery and instruments perform within specified tolerances.

Technician preparing to apply quality control labels

Inspection

Quality control labels are often used to communicate the status of an inspection process, ensuring that products, components, or equipment have met specified quality and safety standards before proceeding to the next stage of production or shipment. 

These labels can be color-coded for easy identification, making it simpler for staff to quickly recognize the status of inspected items in a busy production environment. For example, a green label might signify that a product has passed all necessary checks, while a red label could indicate that it has failed and needs further attention.

Additionally, inspection labels may be partially or fully printed on site using direct thermal or thermal transfer printing technology. Inspection labels may also need to accommodate hand writing of information like dates, times, and inspector initials. 

Rejection and quarantine

Quality control labels can also indicate rejection or quarantine for items that fail to meet quality standards or require isolation for further inspection. These labels ensure that non-compliant, defective, or suspect materials are segregated from those that meet specifications, preventing them from being inadvertently used or shipped.

Rejection labels are typically applied when an item, product, or component fails to pass quality checks. This could include visual inspections, dimensional verifications, or performance tests. The label might feature information such as the rejection date, the reason for rejection, inspector initials, and any instructions for the next steps. 

Quarantine labels, on the other hand, are used to identify items that require further analysis or are awaiting final disposition. Quarantined items may not necessarily be defective but may need additional testing, inspection, or documentation before they can be released. These labels typically include a quarantine date, reason for quarantine, and instructions for follow-up actions.

Best practices for implementing quality control labels

Obviously just having the quality control labels isn’t enough to maintain product quality. How quality control labels are implemented in your manufacturing process is just as important as how they’re engineered.

Practice 1: Integrate routine testing and track results 

This practice ensures that each stage of production and verification is carefully monitored, allowing for prompt identification of deviations or equipment malfunctions across processes. Quality control labels make testing results quickly and clearly available to technicians.

Practice 2:  Maintain records related to all quality control procedures

Maintaining calibration logs, inspection results, and records of sterility verification tests is crucial for regulatory compliance. Detailed documentation enhances traceability and accountability, enabling businesses to demonstrate adherence to established protocols and industry guidelines. Include immediately actionable information on quality control labels for easy access during manufacturing.

 Practice 3: Conduct regular audits of processes and equipment

Conducting regular audits of production processes and calibrating instruments and physical monitors ensures accuracy and reliability. Quality control labels ensure that all team members know when the last audit or calibration happened and when the next one is due.

Practice 4: Comply with relevant standards

Adherence to relevant standards, such as ISO 9001 for quality management systems and ISO 17025 for calibration and testing is critical. Meeting these standards ensures that quality control processes align with best practices and regulatory requirements, building customer trust and avoiding regulatory fines.

Practice 5: Improve continuously

Continuous improvement requires regular evaluation of the effectiveness of your quality control labels and procedures. This includes reviewing performance data, incorporating feedback from staff, and staying updated on industry developments and technological advancements.

We’re waiting to design your perfect quality control label

CleanMark’s label engineers have deep experience with quality control processes across a broad variety of industries. We work with you to design unique labels that stand up to your toughest environmental challenges and streamline your operational processes. 

Let us show you how! Schedule a consultation with one of our label experts today.

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