
WinSPC
Statistical Process Control Software
Improve the quality of your processes and products in real time

What is WinSPC?
WinSPC is a Real Time Statistical Process Control software for manufacturing companies that want to optimize their processes, with the aim of creating better quality products at a lower cost. Provides real-time statistical information on production processes through plant monitors, control panels / dashboards, alerts, alarms, and personalized reports.
WinSPC allows to have a predictive analysis in Real Time to be able to prevent deviations in production, and thus comply with quality regulatory requirements.
WinSPC allows you to capture data from any information source, such as measuring instruments (calipers, vernier calipers, dial gauges), text files (CMM, Vision Systems), Excel, machines (PLC), databases and external systems (ERP ).

When this information is processed, comparisons are made with the activated rules and Statistical Process Control (SPC / CEP) requirements, instantly generating alarms, which can be customized (messages on the screen, sirens, e-mails, etc.). password request to supervisor, machine stop/calibration (PLC)).
Additionally, it offers the ability to analyze in detail the information obtained for the Quality teams, through its search, filtering and advanced analysis tools for Process Capability (Cp / Cpk / Pp / Ppk), Non-Conformities, SCRAP, compliance of controls and cost model.
It allows compliance with ISO 9001:2015 standards, and at the specific level of each industry: IATF 16949, FDA21, ISO 13485, AS9100.
Advantages

Ensure quality levels

Reduce defects

Reduce wasted time

Reduce inspection levels

Streamline reporting

Compare results

Reduce audit costs

Eliminate the use of paper
Certifications where
WinSPC makes the difference

ISO 9001:2015
WinSPC allows compliance with the requirements of this standard, from the context of the organization in section 4.4 (Quality management system) to the points of the Operation related to the measurement, analysis and improvement of operations (8.1, 8.2, 8.4, 8.5, 8.6, 8.7), also integrating section 9.1 (monitoring, measurement, analysis and evaluation of performance), as well as 10.2 (non-conformity and corrective action).

IATF 16949:2016
WinSPC allows compliance with the points of this standard related to quality, from 4.4 (quality administration/management system and its processes), through points: 8.6 (Release of products and services), 8.7 (Control of outputs non-conforming) and 9.1 (Monitoring, measurement, analysis and evaluation) Until the end of item 10 (Improvement).

FDA21
WinSPC allows compliance with the standard, specifically in the subsections:
- Subpart E: Production Process Controls
Subpart G: Defect Action Levels.
If your company applies the FDA21 part 11 regulation, we have a software validation protocol and we adapt it to the specific needs of your business.

ISO 13485:2016
WinSPC allows compliance with the standard in the following items: 7 (product realization) and 8 (Measurement, analysis and improvement). Additionally, if your company applies the FDA21 part 11 regulation, we have a software validation protocol.

AS9100:D
WinSPC allows compliance with the points of the standard, referring to: 7 (Realization of the product) and 8 (Measurement, analysis and improvement).

ISO 22000:2018
WinSPC allows compliance with the following points of the standard: 7 (Planning and realization of safe products) as well as how; the validation, verification and improvement of the system.
Industries that use
WinSPC

Automotive and Transportation
WinSPC enables compliance verification of the parts/products they manufacture to customer specifications, and are often expected to provide regular updates to ensure quality levels are met.

Defense and Aerospace
Storing the resulting data in the central WinSPC system will allow you to easily monitor, supervise and analyze the information for the continuous improvement that your industry needs.

Consumer goods
Many of these products are manufactured in high volumes, making them particularly suitable for a real-time SPC program.

Construction materials
WinSPC enables manufacturers to efficiently produce the highest quality products, while continuously improving the productivity of manufacturing processes.

Plastics and Packaging
Consistent packaging performance, whether it’s a carton, bottles or aluminum cans, is a critical quality element that enables your customers to improve the efficiency of their filling line and minimize downtime due to package defects.

Medical devices
Implementing WinSPC in your production environment allows you to improve product and process control while ensuring compliance with regulatory requirements.

Pharmaceutical
WinSPC can predict and prevent defects during the manufacturing process, through real-time SPC applications that allow instant insight into process variations for correction and control.

Electronics
Interoperability between SPC and other systems, such as ERP and MES, is the key to achieving quality control in complex automated operations.

Food and drinks
WinSPC offers the tools so that your company can automate the collection of weight, temperature and other quality controls, which allow you to control the processes with graphics and alarms in real time.
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