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Compliance is more than external regulations or hopeful afterthoughts around quality; instead, compliance is inherently connected to both product and process quality. Finding defective products and stopping them from being shipped is essential, but a solid compliance program also has process at the center of your quality strategy.

Manufacturers will only produce and sell a product they can ensure is “good.” But good can mean many things in manufacturing, so what it means for data to be good largely depends on what you are measuring against. Perhaps you are checking that:

  • All values are in specification
  • Defect rates are consistently low
  • Processes are showing no statistical violations
  • All local and international regulations are followed

Compliance is the common thread underpinning these concepts. If your processes perform reliably every step of the way, you can be confident in achieving both regulatory compliance and satisfied customers.

Below we examine how a high quality of manufacturing products and processes naturally lead to compliance on a day-to-day, operational level.

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Product Quality

No matter how you look at your data, the end product is always the focus. Does the collected data meet the requirements for this product? It’s a yes or no question that takes a significant amount of information to answer.

02 QM 0322 InfinityQS IC Topic 2 BW Specs

BW-Specs (box and whisker specifications) (Click on the image to enlarge.)

While requirements vary by industry, customer-driven specifications and regulatory concerns are always significant factors when striving for compliance. These might include net content regulations for containers with beverages sold in stores, or perhaps government standards for safety and label accuracy.

Net content control metrics are also applied to the specification limits you use in day-to-day operations: All manufacturers need to hit a range of targets to successfully sell product. It is therefore fundamental to your success that you ensure the data collected is good. Compliance then becomes the natural byproduct of product quality.


Not everything in quality is measured on a variable scale between two specification limits; for instance, defects are a reality of manufacturing life, yet must be minimized to maintain consistent product consistent quality. To achieve a low defect rate, you must be deeply familiar with your products and processes. And getting familiar requires investigation.

The investigative process is an involved but worthwhile one. First, you must find the source of the defects.

  • Start by looking at the defect levels of your process inputs. Variation in those inputs may directly cause defects on the output.
  • Next, analyze the process feature streams that are coming into the process. Your SPC tools can reveal which processes aren't set properly or have too much variation.

While not every manufacturing line is able to achieve Six Sigma’s gold standard of less than 3.4 Defects Per Million Opportunities (DPMO), reaching a consistently low defect count is the goal of attribute-based data analysis. Thinking of compliance in these specific, down-to-earth terms can have a real impact on results.

Lots and Batches

Not only does the product have to be in specification, but you must prove that it is—sometimes to customers, sometimes to state or regulatory boards.

Depending on the type of process you’re running, the checks you make on specifications can vary wildly. You may be checking lots, batches, or individual parts for variations. Because manufacturers generally mass-produce products, it’s unrealistic to inspect every item. Unsurprisingly, this is where lot sampling becomes necessary.

Lot sampling involves looking at an entire batch and checking for certain features and variations before determining what amount of variation is tolerable. Your data might be based on a single shift or an entire day’s worth of measurements. This data might be used in internal or external audits that ensure compliance, so it’s essential to correctly assess all critical components of the process to ensure compliance starts from the inside out.

03 QM 0322 InfinityQS IC Topic 2 Lot Genealogy

Lot Genealogy (Click on the image to enlarge.)

Process Quality

If manufacturers are only as good as their processes, your organization will be judged by the quality and volume of products that your processes yield.

In Control

What does it mean when your processes are “in control”? We know that control is an integral benefit of Statistical Process Control (SPC), which helps manufacturers maintain momentum via the constant monitoring of processes.

SPC is used for maintaining process control in the day-in, day-out rigors of ensuring that manufacturing processes are fulfilling their intended purpose. And they all require constant monitoring.

Why do processes always need to be monitored? Because they’re machines that have “personalities” all their own. No two machines are alike. Even identical machines purchased from the same manufacturer vary under the same test conditions, and for the same material types. Each machine produces a little different quality from the others. And that variation only increases over time.

Early detection and adjustment of those variations is everything—in automobiles, in healthcare, and in manufacturing. And SPC is all about early detection.

Statistical Violations

Modern SPC software is constantly looking for predetermined statistical violations. Many of the tools of SPC are exception-based triggers that hunt for variation, and when unexpected or excessive variation is found, your SPC software should then alert the user. That way you’re not wasting your time combing through stacks of graphs and charts to look for issues. Let the software tell you. SPC provides evidence that something has changed.

04 QM 0322 InfinityQS IC Topic 2 Pareto Chart

Pareto Chart (Click on the image to enlarge.)


Once your SPC software informs you of a statistical violation, how you handle resolving the issue is your choice. Many manufacturers use checklists that function as to-do lists for operators as part of their standard operating procedures (SOPs). Checklists ensure your personnel are fulfilling all their responsibilities, and that your equipment is being operated and maintained consistently with each shift and each product changeover. And herein lies one of the ways quality control solutions really make an impact. Enact® by InfinityQS® allows you to:

  • Configure checklists with any process
  • Include any phraseology established for the task
  • Easily find answers to task and process queries
  • Ensure your processes are yielding compliant products

05 QM 0322 InfinityQS IC Topic 2 Sample Checklist

Sample Checklist (Click on the image to enlarge.)


Another essential component of both quality and compliance is documentation. You must produce reports that can illustrate exactly what you are doing to fulfill those compliance requirements. To produce those reports and documentation, you must have a system in place that collects all important quality data and makes it available in a practical, easy-to-access way.

For most manufacturers, data collection is dependent on multiple factors: plant-floor operators, lab technicians, data collection equipment (e.g., inline scales, monitoring equipment, environmental monitors)—and of course, quality management software. This is where our solutions supply real advantages—ProFicient™ and Enact.

Our software enables you to collect data from nearly any device imaginable, before storing it in a centralized data repository. Your data is then accessible anytime, anywhere. The cutting-edge analytics at the core of our software can then be applied across lines, plants, even the entire enterprise. Data backups occur automatically, reducing the risk of data loss. And importantly, audits become much faster and more easily managed because you already know your products and processes are compliant.

Quality, Compliance, and Customer Satisfaction

If the key to remaining compliant is maintaining high-quality products and processes, then the secret to consistent quality is in real-time visibility—provided by a robust and configurable quality management solution. Leveraging an InfinityQS solution can help you collect good quality data and analyze it appropriately to maintain satisfied customers.

CTA: Visit our website to learn how Enact by InfinityQS can help you improve product quality and keep customers happy.