Statistical Process Control

The global manufacturing landscape is highly competitive, and manufacturers are focused on delivering high-quality parts. To deliver high-quality parts consistently, it is crucial to identify, analyze, and avoid defects promptly, which can be supported through the implementation of a statistical process control tool. 

Statistical process control enables manufacturers to monitor, analyze, and control process variations in real time, thereby driving continuous improvement and ensuring consistency in product quality. In this article, we discuss various types of statistical process control tools, their implementation, and their role in manufacturing in detail.

spc on a laptop
Image credit: unsplash.com

Table of Contents

What is Statistical Process Control?

SPC, abbreviated for Statistical Process Control, is a systematic and organized approach applied to monitor and regulate manufacturing processes. It employs certain statistical techniques, which can monitor either specific or all the activities of the manufacturing processes. You can also identify and address any internal issues. The proactive approach of statistical process control enables manufacturers to reduce defects, maintain process standards, and optimize efficiency.

Statistical process control tool collects and analyzes real-time data at various stages to ensure that all the manufacturing processes are consistent and efficient. Since statistical process control tools analyze data at various manufacturing stages, they can identify any deviations from the standard, thereby allowing prompt implementation of corrective actions. 

Statistical process control creates control charts to visualize data trends and thereby indicate variations that require attention. Statistical process control tools trigger various manufacturing machines and instruments to provide quality data from product measurements and process readings, which is further evaluated and monitored to control particular processes. 

Statistical Process Control in PPAP

SPC is a key component of initial process studies, which is an element of PPAP, i.e., Production Part Approval Process. It is included in the initial process studies and is often a part of PPAP submissions in the form of control charts. 

PPAP submission includes detailed SPC data to demonstrate that the manufacturer can consistently deliver high-quality parts that are as per the expectations of the customer. SPC data in PPAP submissions also demonstrates the capability and stability of the process. It is thus a key aspect of the initial process studies that support PPAP submissions. You can read more about PPAP here.

Significance of Statistical Process Control

staistical process control

Early Identification of Issues

Statistical process control reduces rework. One of the major advantages of the statistical process control tool is that it helps streamline processes, which makes it easier to identify issues and immediately correct them. This helps to lower the risk of defects, thereby eliminating rework.

Enhanced Product Quality

Since statistical process control tools identify issues early on, it’s possible to correct these issues as well, which further helps create a continuous process that optimizes product quality.

Elimination of Process Variation

Statistical control process tools, such as software and charts, help to identify irregular patterns, which helps to identify and eliminate any process variations. 

Industry and Regulatory Requirements Compliance

Statistical process tools facilitate compliance with both industry and regulatory requirements.

Statistical Process Control Challenges

Time Investments

Implementing the statistical control process system in manufacturing can take an initial investment of time. In addition, monitoring and chart-filling are time-consuming processes.

Personnel Training

Statistical process control systems need to be integrated into an existing framework. This requires the personnel to undergo extensive training on the systems so that they are well-versed with the statistical process control tool. 

Cost Considerations

Statistical process control is an expensive investment. Typically, the manufacturing company undertakes a contract with a service provider to invest in training resources and materials.

SPC Software for Manufacturing

SPC software plays a crucial role in manufacturing high-quality plastic parts. It indicates when the production processes aren’t within the control limits. This is especially crucial for industries where precision and consistency are non-negotiable. For instance: aerospace, automotive, medical devices, consumer electronics, etc.  

SPC software for manufacturing helps to detect early deviations and reduce scrap rates. It minimizes rework with real-time data monitoring and analytics. This is especially helpful in manufacturing, as even the slightest variations in temperature, pressure, or mold fill times can affect product integrity. SPC software provides immediate insights to maintain part quality batch after batch.

SPC Software in Plastic Part Manufacturing

In plastic part manufacturing, SPC software is applied to monitor various variables such as mold cavity pressure, cycle time, cooling time, and dimensional measurements. By setting control limits upon these and other parameters, the operators are alerted to any change outside the control limits and are thus able to avoid defects. 

The implementation of SPC software for manufacturing is a proactive and predictive approach that helps to ensure process stability and compliance. This is particularly crucial for high-volume production runs, where undetected defects could lead to large recalls or create customer dissatisfaction. 

SPC software for manufacturing enables continuous improvement. SPC software collects data over time, which can be used to identify recurring trends, root causes of variability, and opportunities for process optimization. This not only helps in manufacturing high-quality parts but also supports lean manufacturing principles, which reduce costs and improve customer satisfaction. It also enhances traceability and simplifies compliance with international quality standards such as ISO 9001 or IATF 16949.

Top SPC Software for Manufacturing

SPC software for manufacturing plastic parts is a cornerstone for quality assurance. It transforms raw production data into actionable insights, which further enables manufacturers to deliver high-precision, defect-free products. 

Investing in the right software solution is a strategic advantage, and in this section, we understand some of the popular SPC software solutions:

InfinityQS

InfinityQS is often used in injection molding environments to ensure consistent quality across multiple production lines and facilities. It’s known for its robust real-time monitoring and cloud-based deployment, and you can read more about InfinityQS here.

ProFicient by InfinityQS

ProFicient is more detailed than InfinityQS and is an enterprise-grade SPC solution designed for high-volume manufacturers. It supports both on-premise and cloud deployment.  ProFicient SPC software solution offers automated data collection, real-time alerts, and advanced statistical analysis, thus making it ideal for multi-site manufacturing environments. You can read more about ProFicient here.

Zontec Synergy SPC

Zontec Synergy SPC Software solution offers a fast, user-friendly interface with real-time charting. It’s ideal for shop-floor use where quick decisions are crucial. You can read more about Zontec Synergy SPC Software here

Zontec SmartSPC

Zontec’s SmartSPC is an enterprise-level SPC software solution that is built for manufacturers that require broader data integration and scalability. It offers centralized data management solutions, customizable reports, and real-time alerts across multiple production lines and locations. You can read more about Zonetec SmartSPC here.

WinSPC

WinSPC is built with advanced alarms, traceability features, and integrates easily with manufacturing equipment and ERP systems. You can read more about WinSPC Software here.

TIBCO’s Statistica

Statistica by TIBCO offers a comprehensive statistical analytics solution with advanced SPC capabilities. It’s built with powerful visualization tools and customizable dashboards, which is why it’s perfect for manufacturers that require deeper analytics and predictive modeling alongside quality control. It supports both real-time and historical data analysis. You can read more about Statistica here.

Statistical Process Control Tools

Statistical process control tools enable manufacturers to identify and analyze variations so that corrective actions can be undertaken. It’s an excellent system to implement changes and understand if these changes are creating improvements. SPC tools enable you to achieve the following: 

  • Indicates whether a process has changed. 
  • Record data regularly. 
  • Annotate the chart, and apply step changes to the average and process limits.

Types of Statistical Process Control Tools

Quality Control Tools

Cause and Effect Diagrams

Cause and effect diagrams are also referred to as the Ishikawa diagram. It is also popularly known as the fishbone diagram because it looks like a fishbone, where the main bone stretches into smaller branches. These smaller branches delve deeper into each cause. The following diagram shows a fishbone diagram: 

spc fishbone diagram

These types of diagrams are particularly used to identify the various causes of an issue or a problem. 

Pareto Charts

A Pareto chart demonstrates data through bar graphs and line charts. Pareto charts are often used along with the 80/20 principle, i.e., approximately 20 % of the causes are responsible for 80 % of the effect, i.e., a specific problem or problems in manufacturing. The following diagram indicates an example of a Pareto chart in manufacturing:  

spc pareto chart

Histograms

Histograms are graphs. They represent frequency distributions and are ideal for numerical data. The image below depicts a histogram chart:

statistical process control histogram chart

Check Sheets

Check sheets are simple, ready-to-use forms. They are collected to be analyzed. 

It’s typically applied to data that is under repetitive observation and is either collected by the same operator or in the same location.

Scatter Diagrams

Scatter diagrams, also known as X-Y graphs, are apt for analyzing numerical data. It is typically used in manufacturing to identify patterns and potential correlations between 2 variables. For instance, Is a change in the pressure increasing the number of defects?

statistical process controll scatter diagram

Stratification Tools

Stratification tools separate data so that pattern identification can be further simplified. It is apt to segregate data from various sources. These tools separate data into layers or specific groups.

Supplemental Tools

Defect Maps

Defect maps visualize and track a product’s defects. They focus on physical locations and defects that are identified on the map.

Progress Centers

Progress centers are centralized locations that enable data collection. They also monitor progress so that decisive actions can be taken. 

Events Logs

Event logs are standardized records. They are used to record key software and hardware events.

Process Flowcharts

Process flowcharts illustrate process steps. They are displayed in the order they occur.

Randomization

Randomization is a type of supplemental tool that makes use of chance to assign manufacturing units to a treatment group.

Sample Size Determination

This type of supplemental tool determines the number of individuals or events that should be included in the statistical analysis.

How to implement the Statistical Process Control Tool?

Data Collection and Measurement Method

Statistical process control analyzes data, which is why it is essential to determine which data to collect.

The collected data is tracked through control charts. There are various types of control charts, and it is imperative to implement the correct control chart. The control charts are segregated into 2 categories, and they are distinguished by the data type: Variable or Attribute. 

Variable Data

Variable data is data that comes from measurements on a continuous scale. For instance: weight, temperature, time, etc. The following chart types measure variable data: 

 

  • An individual or moving range chart is used to monitor the variation in a single data point over time. It is applied for individual values and plots the differences between consecutive individual measurements. 
  • Xbar – R chart is used when the recording data is in sub-groups of 8 or less. The X-bar chart monitors the sample average, whereas the R chart monitors the sample range, i.e., the difference between the highest and lowest values. Together, they illustrate whether a process is stable and in control. It’s especially useful for conducting routine manufacturing quality checks. The image below indicates an X-bar-R chart: 
xbar r chart
  • Xbar – S chart is applied for larger sample sizes, typically when the subgroup size is more than 8. Just like the Xbar-R Chart, the X-bar chart here monitors the shifts in the process mean, whereas the S chart detects changes in process variability. Together, this chart indicates whether the process is in control and if either chart shows points outside the control limits or unusual patterns, it indicates that the process may be unstable.

Attribute Data

Attribute data is based on discrete distinctions, such as good or bad, or a percentage. The following charts analyze attribute data: 

  • A P chart is applied to record the number of defective parts within a set of parts. This type of chart indicates the proportion (p) of defective items in each sample and compares it against control limits to determine if the process is in control.
  • The U chart records the number of defects in each particular part. It’s ideal for detecting changes in the defect rate over time. 

It is also crucial to qualify the measurement system to ensure that the measurement error is within an acceptable range. You should note that if the measurement error exceeds an acceptable level, then the data is unreliable.

Data Analysis

The next step is to analyze the collected data. When analyzing and inferring the data, the following key aspects should be taken into account: 

  • All the data points that are recorded on the control chart should be within the control limits. 
  • If the data points vary from the control causes, then there are special causes, and unless specified, they tend to be outliers. 
  • If a process has to be identified as being in statistical control, then there shouldn’t be any outliers on any chart. 
  • When a process is within the control limits, there are no identified special causes. 

Special Causes in Data Analysis

Special causes in data analysis indicate that there is a change that has had a huge impact on the process. If a special cause is identified, then necessary action needs to be taken to determine the cause. 

Some common examples that can lead to variations are a change in material properties, humidity levels, operator inexperience, typical measurement variations, wear and tear of machines and tools.

Control Limits in Data Analysis

Statistical process control determines whether a process is consistent, and this is indicated when data points that are recorded on a control chart fall between the control limits. In this section, we delve into understanding what control limits in data analysis are. 

In statistical process control, typically, statistical tables demonstrate how the data is distributed, which is most often referred to as the normal distribution. To understand distribution in statistical process control, it is imperative to have a measurement for data dispersion, or spread, which can be expressed through the highest and the lowest range. It is also referred to as standard deviation, i.e., Sigma. 

In a normal distribution, about 99.7% of values fall within three standard deviations of the average, i.e., the process mean. This leaves just 0.3% of values outside these limits. Such points are highly unlikely, so when a measurement falls beyond 3 standard deviations, i.e., ±3σ, it indicates that the process may have shifted or become more variable, and action may be required.

spc normal distribution chart

Process Capability - Cp and Cpk

Process Capability is a process’s ability to meet the specifications. You should note that specifications are the delivery expectations of the process. It’s measured by the following indices: 

  • Cp (Process Potential): Cp indicates the amount of process capability if it were centered precisely between the specifications. 
  • Cpk (Variability): Cpk is the measurement that assesses process centering in addition to variability.  
SPC control cp and cpk chart

You should note that the process capability analysis requires that the process be normally distributed. 

Monitoring Process

The next step is to continually monitor the process to verify whether the data are within control limits and watch for trends or sudden changes in the process. If any special causes of variation are identified, appropriate action should be taken to determine the cause. 

Out of Control Conditions

Once the control limits are established, you need to assess whether or not the process is in control. You should note that the upper and lower control limits are 3 standard deviations on either side of the average. When one or more points are outside 3 standard deviations, then it’s considered to be an out-of-control condition.

Implement Actions to Improve Process Capability

When an out-of-control condition is discovered, the root cause is investigated. Once the root cause is identified, specific actions are implemented, which improves the process stability.

Contact Us

Statistical process control may require a substantial time and resource investment, but its accurate data analysis optimizes process efficiency and improves product development. It addresses shifts in trends and processes that can positively impact process efficiency. 

VEM Tooling has over 20 years of experience in providing manufacturing solutions. At VEM-Tooling, we have a fully qualified management system and are ISO 9001:2015 certified for our various factories. We can help you implement SPC tools and other manufacturing solutions.