More companies are leveraging high speed vision systems to inspect multiple quality characteristics on their products. This testing directly on the line is a major advancement in inspection and measurement methods. Automation allows data to be collected quickly and efficiently and 100% inspection becomes feasible. A common question that arises is, “Does my 100% automatic … Continued
By systematically detecting (and rectifying) sources of special cause variation upstream in the process, the important process outcomes become predictable. SPC and Reliability We often think of Statistical Process Control as a tool to help drive product quality by informing us when process changes occur. By systematically detecting (and rectifying) sources of special cause variation … Continued
Equivalence testing is a statistical method that concludes two groups are practically the same by showing the difference between them falls inside a predefined equivalence interval. A standard hypothesis test such as the 2-sample t test can only detect a difference; failing to reject the null does not prove equivalence. Use an equivalence test to … Continued
We talk to companies everyday that are dealing with new challenges in Quality. In this video we will discuss common Quality issues and document the monetary value of SPC. We talk to companies everyday that are dealing with new challenges in Quality. Maybe you are frustrated with your current SPC methods and the time you … Continued
SPC tells when to leave the process alone and when to react. By using SPC, companies can minimize the variation of their process by identifying, reacting to and eliminating extra sources of variation. Implementing statistical process control (SPC) takes energy and resources, so companies had better be able to show a financial benefit for having … Continued
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
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
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.
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. |
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 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:
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:
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.
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:
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.