Quality at Any Cost? | Quality Insight

In an ever-competitive global marketplace, it’s more important than ever to develop systematic means to measure and manage costs of quality, which reflect business improvement opportunities. If there is a case being made for the importance of statistical process control software, A.V. Feigenbaum is making it. Feigenbaum, a well-known expert and author in the field … Continued

 

Securely build product and process auditability into the manufacturing process

Many manufacturers–especially those in the Food & Beverage, Pharmaceutical, and Life Sciences industry–are subject to strict regulatory requirements surrounding electronic record keeping, product traceability, and security. Additionally, many manufacturers in the transportation and consumer goods industries must maintain ISO certification to satisfy customers and win new business. WinSPC offers a variety of features that enhance and support a company’s ability to cost-effectively comply with ISO, TS, FDA and USDA regulatory requirements.

Benefits

  • Meet regulatory and customer requirements
  • Reduce risk
  • Increase customer satisfaction
  • Lower the cost of compliance
  • Improve the ability to sustain regulatory compliance
  • Simplify the compliance process
  • Fulfill ISO, TS, FDA & USDA requirements
  • Comply with the electronic signatures requirements of FDA 21 CFR Part 11

Features

Support FDA 21 CFR part 11 requirements for electronic signatures and forced log-outs for system security
The FDA 21 CFR Part 11 regulation was designed to enforce the integrity and security of records that are stored electronically within industries governed by the FDA. WinSPC supports the electronic signatures, data security and audit traceability requirements of the FDA. Additionally, WinSPC supports advanced security policies and allows system administrators to: easily manage and organize a large volume of system users, manage system-wide security policies, and assign role-based privileges to managers, administrators, shop-floor operators and other user-defined groups.

Securely store and centralize all electronic records
WinSPC securely stores all data in a centralized application database to comply with data security requirements, electronic signatures, and audit traceability requirements.

Record every system event
WinSPC’s event log maintains a record of every system event, including specification limit changes, deletion of event log items, electronic signatures, and system configuration changes. This lowers documentation costs and ensures that your organization, if required, can trace any and all process events that take place within WinSPC.

Search, sort, filter and report on almost anything
WinSPC’s event log filter allows users to quickly retrieve nearly all system activities such as startup/shutdown, security, administration, data collection, and violations.

Maintain an audit trail
Use WinSPC to cost-effectively maintain an electronic audit trail. By capturing the right information within WinSPC, quality managers can quickly and easily produce the necessary information to pass an ISO audit.
Quickly and cost-effectively perform software validation
Cost-effectively validate WinSPC software using DataNet’s Validation Toolkit. The Toolkit contains a complete set of test procedures and documentation templates required to meet the software validation requirements of the FDA. Alternatively, DataNet’s solution delivery professionals offer turn-key software validation services that include Installation Qualification, Operational Qualification and Performance Qualification of your WinSPC software solution. Get more information on DataNet Software Validation services.
Support compliance requirements/activities for ISO, TS FDA, and USDA
WinSPC meets the SPC requirements of certification protocols and enables your company to quickly and cost-effectively measure, analyze, monitor and report quality procedures within your organization to effectively meet and/or assure compliance with ISO, TS, FDA, and USDA.

Reach your target-weight and quality goals with WinSPC

 

In today’s modern bakery, competitive results are harder to achieve than ever. With bread margins in single digits, tightening a bakery’s operating efficiency and controlling weight variation are keys to product consistency and corporate profitability. While there are several Quality programs providing regulatory compliance with initiatives such as Safe Quality Food (SQF), leading bakeries are looking to SPC in order to improve their bread margins and to ensure a consistent product for their customers.

DataNet and WinSPC offer a fast, proven, and sustainable method to:

  • Improve product consistency
  • Reduce defects, waste, or give-away
  • Increase manufacturing yield
  • Achieve regulatory compliance
  • Improve customer satisfaction

Just like in your home kitchen, making a loaf of bread with consistent quality comes down to following a proven recipe. But in a modern bakery, consistent results require far more than just setting the oven temperature and timer. Tightening a bakery’s operating efficiency and controlling weight variation down to a hundredth of an ounce are critical to product consistency and corporate profitability.

Baked goods producers often have eighty or more critical quality control points throughout their processes and have already implemented control systems to help capture and track this critical data. Likewise, testing technology has evolved to assist by providing greater precision and data via automated scales, inline check-weighers, temperature sensors and networks of intelligent machines. When these are combined with impressive vision systems that monitor each step from mixing through slicing and packaging, it would seem that there is no room for additional monitoring or control. However, without proper SPC methods in place, these processes can continue to experience variation that drives up the overall cost-of-quality. Lack of statistical process control often translates into excessive weight and giveaway, unnecessary raw material usage, additional inspection costs, higher product defect rates and waste.

Attempting to apply SPC methods on paper or in Excel is a common starting point and a good educational experience for shop personnel seeking to grasp fundamental SPC concepts and benefits. These manual methods can reveal hidden variation in a process, but the information may not be timely or comprehensive, and it can be subject to inaccuracies due to manual entry. Furthermore, the inherent inefficiency of paper-based systems can expose the truth that even the most ambitious check-sheet captures only a fraction of the data that engineers and managers seek for continuous improvement projects.

When scaled to production, manual systems often reveal their shortcomings. As production problems arise it becomes frustratingly obvious to management and engineers that they do not have all the data necessary to make a real-time decision. In order to properly analyze current or previous performance, adequate visibility into active process trends is often required to prevent costly out-of-specification conditions and costly over-weights. In such cases the greatest opportunity for bottom-line improvement is often achieved simply by scaling up from a paper-based (or Excel) system to a real-time, automated solution.

The possible savings from making such a move can be assessed by considering the following questions about your manual system:

  • How long does it take to detect and respond to assignable cause variation?
  • How much time is spent daily or weekly managing data on paper or in spreadsheets and generating regular reports?
  • Are the production lines capable of consistently running according to specifications?
  • How much is variation costing the company and how much could be saved if variation could be reduced

Most often, the answers to these questions reveal that substantial process and financial improvement is possible through the implementation of an automated SPC system.

Learn how these bakery customers take their performance to the next level with WinSPC solutions

Analysis and Reporting

 

Analysis and reporting are critical activities for Quality teams. With WinSPC’s suite of analysis tools, you can probe the depths of process and product data, mine it for answers to why things are the way they are, reinforce strengths, and remedy weaknesses. With WinSPC’s reports, you can serve a seemingly endless list of purposes: nurture supplier-customer relationships, fill internal knowledge gaps that create waste, connect executive planning to shop-floor realities, and satisfy the documentation burden from regulatory agencies.

Analyzing with WinSPC

Analyzing with WinSPC often begins with searching or filtering your WinSPC database. You specify criteria, WinSPC isolates the data that matches that criteria, and you’re on your way to answering such questions as:

  • What quality problems did we have recently?
  • What are our potential sources of variation?
  • And what process inputs are affecting our final product quality?

WinSPC’s searching and filtering tool is easy-to-use for everyone. You don’t have to be a programmer and you don’t have to be a statistics black belt. And your criteria can be just about anything you can think of: shift, lot number, violations, statistics, dates, corrective actions, assignable causes, and more.

To jumpstart your analysis, WinSPC comes with dozens of pre-built searches, searches concerning trouble spots common to most manufacturers. As a result, almost in the blink of an eye, without entering criteria yourself, you can get a list of processes that, for example:

  • Are statistically incapable
  • Required a corrective action the previous week
  • Had significant give-away
  • Had a spec limit or control limit violation within the last four hours
  • Or met other important conditions

Once you’ve identified a narrowed set of data to further investigate, with a single-click you can drill down and expose an exhaustive set of details about it, all efficiently organized in one location.

 

There, you can sort the data by line number, user, machine, or other groupings. You can examine its capability and performance parameters, distribution details, goodness of fit, and sensitivity. You can view the data in every industry-standard chart there is. You can even run it through WinSPC’s patented Cost Inspector, a breakthrough engine that uncovers hidden costs and quantifies potential savings opportunities related to both process variation and process offset.

WinSPC’s suite of analysis tools simplify the application of statistical theory to manufacturing data and, in doing so, enable Quality teams to act both effectively and with confidence. For more information, watch the Monitoring and Analyzing with Dashboards video.

See how WinSPC performs statistical analysis.

Reporting with WinSPC

Understanding WinSPC reporting begins with ready-to-use reports. There are over ninety of them that ship with WinSPC, all professionally formatted. Most popular among these are:

  • The Capability Study report
  • The Performance Against Specifications report
  • The Variable Detail report
  • The Process Improvement Savings report
  • And the Certificate of Analysis report

These and the other ready-to-use reports anticipate common reporting needs so effectively, they can save Quality teams hundreds of hours on their own.

Running a report takes just a few mouseclicks: you right-click whatever item contains the data you want reported on and, from a shortcut menu, select a report. There are several items that contain data you might want reported on: part folders, parts, variables, attributes, collection plan folders, collection plans, data sets, and archives. Whichever you choose, all the relevant data within that item gets accounted for in the report.

You can run reports in both PDF and HTML formats, or you can view the report directly in WinSPC’s Report Preview window.

For added convenience, once a report has been generated, in one mouseclick, you can launch your e-mail client and have a PDF version of your report already attached to a blank e-mail, ready for you to address and send on its way.

 

 

To personalize a ready-to-use report or to create an entirely new report, WinSPC has a built-in report designer. This designer is extremely capable and has been used to produce some stunningly unique reports. And it is visual, so you don’t need to be overly technical to use it (though it does support scripting if you’re inclined to employ that).

The rich, graphical nature of WinSPC’s reports allow the vital information in your WinSPC database to be understood from all angles, enabling viewers of those reports to translate that information into actionable intelligence and guide both short- and long-term strategies. For more information, watch the Generating Reports video.

On a tight budget? This white paper contains information about optimizing resource use to achieve Six Sigma benefits on a small budget.

Click here for a printable WinSPC brochure.

How to Buy WinSPC Envision

 

Contact WinSPC Sales at +1 248.357.2200 or email [email protected].  They can help you to define your solution or connect you with a regional reseller near your manufacturing facility.

WinSPC is licensed based on concurrent usage.  A purchase of 25 licenses, for example, permits up to 25 users to use the software simultaneously.

See WinSPC Envision System Requirements.

A customer’s initial purchase of WinSPC Envision includes the WinSPC Envision web server and one or more blocks of concurrent-user licenses, each block consisting of 5 licenses.

Additionally, an installation and 4-hour introductory training package may be purchased. This helps ensure your WinSPC Envision system is installed correctly and launched quickly. It also helps to ensure that your users are properly trained and get the most out of the system.

As usage of the system grows, supplemental 5-license blocks are available for purchase.

For customers with large usage expectations, a corporate license, which permits unlimited usage, can be negotiated.

Finally, custom views can be developed by the WinSPC team for you–views that tailor WinSPC Envision to your specific performance metrics.

Contact WinSPC Sales for pricing on any of the above offerings.

 

 

Monitoring and Analyzing with Dashboards Using WinSPC Real-Time Statistical Process Control Software | WinSPC Video

 

On the shop floor, operators use dashboards to monitor and control processes in real-time. They view dashboards at individual stations or on large monitors.

WinSPC dashboards organize and visualize Quality metrics. They can combine statistical summaries, event or activity details, and any of the 60-plus industry standard SPC charts.

Shop-floor dashboards are often setup to automatically:

  • Flash when a shift average or other statistic exceeds a specified value.
  • Or re-sort so at-risk operations are highlighted and prominently positioned.

Shop floor dashboards can even email a manager screenshots and reports when a process changes. Or transmit status to external systems.

Managers and engineers use dashboards to stay updated and as a starting point for analysis. Their dashboards might feature:

  • Events, activities, alarms.
  • Tables of important stats.
  • Cost-reduction opportunities calculated by WinSPC’s patented Cost Inspector.
  • And a wider selection of charts, such as: Pareto charts of assignable causes, pie charts of corrective actions, Box and Whisker plots, or others.

Engineers frequently configure their dashboards so that, with a click, they can…

  • Launch reports
  • Or drill-down to a companion dashboard

  • Or view a characteristic in the Variable Analyzer or Attribute Analyzer—two powerful tools that enable engineers to sort by tag or other criteria, zoom in, and interact with data in additional ways.

A number of dashboards, already configured and ready to use come with WinSPC.

These target vital information needs and include:

  • Comparison views that show the current week or month in relation to an earlier period.

  • Cost-based views that quantify loss related to variation and offset from target.

  • Multi-variate views that provide insight into related processes as a whole.

  • And production summary views that present real-time operation status.

We invite you to learn more about WinSPC. Click the link to learn more: www.advantive.com/products/winspc

 

About DataNet Quality Systems

DataNet Quality Systems empowers manufacturers to improve products, processes, and profitability through real-time statistical software solutions. The company’s vision is to deliver trusted and capable technology solutions that allow manufacturers to create the highest quality product for the lowest possible cost. DataNet’s flagship product, WinSPC, provides statistical decision-making at the point of production and delivers real-time, actionable information to where it is needed most. With over 2500 customers worldwide and distributors across the globe, DataNet is dedicated to delivering a high level of customer service and support, shop-floor expertise, and training in the areas of Continuous Improvement, Six Sigma, and Lean Manufacturing services.

WinSPC: SPC Software Solutions for Manufacturers

Trusted by hundreds of growing manufacturers:
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Interactive Guide

How to Improve Manufacturing Operations with Real-Time SPC Software

With the right Statistical Process Control (SPC) software, your data can provide actionable information to improve performance, reduce production costs, optimize product quality, and increase consistency across your manufacturing operations. Learn more by exploring our interactive online guide to SPC software and quality management.

New Customers

Existing Customers

Real-Time Statistical Software Solutions for Actionable Decision Making

DataNet empowers manufacturers to improve products, processes, and profitability through real-time statistical software solutions. Our trusted and capable statistical process control (SPC) software provide the integral tools and functionality you need to create the highest quality product for the lowest possible cost. With an intuitive, user-friendly interface to quickly create, organize, and manage quality programs on a global scale, our SPC solutions are used by quality teams to improve product quality, reduce process variation, and optimize manufacturing processes.

Collect shop-floor data in real-time from virtually any source—gauges, devices, machines, and other data sources. Our flexible SPC software comes with a simple three-step connection process that makes it easy to simply connect and begin collecting data from almost anything.

  • Connect and collect data from any RS232 serial or USB device
  • Capture data from text files, .csv files, Microsoft Excel, any ODBC-compliant database, or machines such as CMMs or PLCs
  • Integrate with other manufacturing systems using ODBC, OPC, OLE, DDE, and built-in APIs supports hundreds of methods and properties

Empower your operators with actionable intelligence and statistical analysis on plant performance. Our SPC software includes real-time control charts on the shop floor and plant monitor functionality to enable your team to immediately detect and correct process issues and manage your operations more effectively. It runs on the desktop and shows accurate statistics for every data collection station in one convenient window—giving managers a summary view of their plant’s performance from a single screen.

Automatically alert personnel, execute custom programs, shut down machines, or engage other systems if a non-conformance or rule violation occurs using DataNet’s built-in triggers. Whether your requirements are as simple as sending an email or as complex as triggering a process within a corrective action system, our SPC solution gives you the power to close the quality loop from “detection-to-correction.”

  • Use a simple pull-down menu to schedule a variety of different notifications and alarms for nearly any condition
  • Program your own custom triggers to schedule enterprise-wide alarms or communicate bidirectionally with other systems or machines or send a command to a device

Identify the hidden cost of give-away, overfill, rework or scrap that weaken a company’s profits using DataNet’s Cost Inspector. The Cost Inspector links manufacturing cost information with current and historical process data, empowering quality teams to:

  • Search process data across all operations to uncover costly process problems
  • Identify sources of give-away, overfill, scrap or waste
  • Calculate potential savings per unit by reducing process variation or shifting processes to optimal mean
  • Translate process improvement statistics into dollars saved for the company
  • Produce cost-based reports to show executive management the return on investments in quality

Answer questions, detect changes, discover trends, and make decisions that count with DataNet’s data sets, variable analyzer, and custom reports.

  • Data Sets: Identify, prevent, and prioritize quality issues at a macro level. Unlike the traditional microscopic nature of SPC, which focuses on a specific variable, data sets offer a broad view of your database—enabling you to proactively monitor and uncover high-priority issues.
  • Variable Analyzer: Experiment, visualize, and reveal more information about any variable using the one-click variable analyzer. The variable analyzer delivers both point-of-production and historical analysis capabilities. It puts an entire set of statistical tools at your fingertips—giving you a comprehensive view of your data from one convenient screen.
  • Reports: Quickly create, publish, and share quality reports across your organization using our easy-to-use graphical report builder and dozens of standard report templates.

Bring Your Real-Time SPC Program to Life with Advantive

Today’s companies have high expectations for performance and little room for mistakes. With decades of helping manufacturers and distributors across the globe, Advantive is dedicated to delivering a high level of customer service and support, shop floor expertise, and professional services specializing in continuous improvement, Six Sigma, and lean manufacturing.

Advanced Learning

Expect straightforward resources and advice from veteran industry practitioners, who understand your challenges and the benefits of an SPC system.

Technical Support

With over 2,500 installed facilities worldwide and distributors across the globe, DataNet is dedicated to delivering a high level of customer service and support.

Comprehensive Training

Our instructors offer a variety of administrator, fundamentals and customized virtual and onsite training to fit your user’s learning style.

Easily Connect to Other Business Systems

Share your data between DataNet SPC software and other critical manufacturing applications such as MES, ERP, HMI, or LIMS systems. Our built-in API’s with over 500 methods and properties allow you to bi-directionally communicate and offer proven integration success with other systems like SAP, Oracle, Delmia, Wonderware, GE Proficy, Plex, MS Dynamics, AspenTech, Factory Link, Labview, and many more. Other services include:

  • CMM Integration
  • Data Migration
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Blog

GAFMC Raises the Roof on Reliability and Productivity with DataNet

Learn how North America’s largest manufacturer of commercial and residential roofing uses DataNet SPC software to reduce manufacturing variance by 39.5% in 4 months.

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What to Expect

  • Free 20-minute call with a product expert
  • Live demo tailored to your industry requirements
  • Discover what products best fit your needs
  • No games, gimmicks, or high-pressure sales pitch

Standardized Quality Management System (QMS) Built for Manufacturers

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Meet Customer and Regulatory Compliance Standards with Ease

Product quality can make or break your manufacturing company’s success. That’s why you need a reliable quality management system (QMS) in place. At Advantive, our QMS solution provides a formalized platform that accurately tracks product specifications, documents processes, manages industry regulations, and helps you consistently meet quality standards.

Reduce Waste

Eliminate paperwork and manual processes to define test requirements and record results.

Improve Quality

Automatically prompt operators on the floor to perform required tests at the right time.

Build Trust

Improve product quality and reduce waste, returns and customer complaints.

Powerful QMS Software to Improve Product Quality and Consistency

At Advantive, we focus on providing accessible technology that drives transformational outcomes for manufacturers. Our specialized quality management systems include the tools and functionality you need to collect, test, and inspect products, meet customer and regulatory requirements, and ultimately, produce the highest quality products.

Our quality management software is integrated throughout your entire manufacturing facility to provide complete operational visibility. As information flows from one department to another, decisions can be made automatically to improve quality, productivity, on-time delivery, efficiency, and more.

Manage quality test requirements and results locally, regionally, and corporate-wide with our flexible QMS software.

  • Define quality test requirements electronically for specific plants, plants within a specific region or your entire corporation.
  • Establish tests for specific jobs, customers, specifications, board types, paper, or other manufacturing characteristics.
  • Ensure all results are recorded promptly with a Transmission Link (XMT) to testing devices capable of providing test results electronically. Some testing devices test or measure every item produced. Others even photograph every defect and/or each and every item tested.

Improve internal compliance with QA test plans and ISO requirements. If tests are skipped or results are not recorded, notification is recorded accordingly. When jobs are completed, documentation of results (including COCs and COAs) can be printed and/or emailed to appropriate parties. Because accurate results are recorded directly on the factory floor, you have the ability to respond to customer complaints and product returns with factual data. Having access to test results in real time also enables quality managers and others to examine and evaluate test results prior to shipping inferior products.

Optimize and reduce raw material and finished goods inventory. Eliminate costly material outages. Analyze what-if scenarios and market trends using multi-plant and corporate forecasts. Plan a group of similar production facilities or regional plant groupings to analyze and optimize material usage. Utilize tactical and strategic planning tools to manage long-term business strategies and more.

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The Ultimate Guide to Selecting a Cloud-Based Quality Management Solution
 

By utilizing InfinityQS to implement SPC and Six Sigma best practices across our manufacturing processes, Ben & Jerry’s will continue to identify opportunities for cost savings and ensure the highest level of customer satisfaction. The result is the perfect pint for our customers.

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Nina King

Quality Supervisor

We have made numerous investments in technology to help support our quality initiatives, and InfinityQS SCS allows us to bring everything together. We can now assimilate data from different systems and device locations into one centralized hub for easy analysis and decision-making.

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Jack Kraemer

President and COO

I would recommend PQ Systems to any company that needs to gain control over their gage measurement system and have the confidence to be in compliance when it comes to ISO and AS auditors.

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Steve Hardwick

Facility Manager

What Our Customers Are Saying

Find out how our customers are using quality management software to improve product quality, decrease risk, and make strategic data-driven business decisions.

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What to Expect

  • Free 20-minute call with a product expert
  • Live demo tailored to your industry requirements
  • Discover what products best fit your needs
  • No games, gimmicks, or high-pressure sales pitch