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Quality Process
Corrective & Preventive Action (CAPA) System
Wipestar is committed to the constant adherence to and improvement of the following methods and principles of process control:
● Vertical Integration of the Raw Material Supply with Wipestar Processes
● Dedicated Processing Equipment
● Process Management Plans
● Raw Material Specifications
● Supplier Testing Coupled with Incoming Inspection
● Change Control Management
● Change Validation
● Closed-Loop Corrective Action in Excursion Management
Process Capability
Process capability refers to the repeatability and consistency of a manufacturing process relative to the customer requirements, especially in terms of specification limits of a product parameter. This measure is used to objectively quantify the degree to which a process is or is not meeting its requirements.
Wipestar ensures delivery of the highest quality and most consistent products through constant focus and improvement in the following method and principle of process control:
Process capability measurements and analysis with goals of Cpk>1.33 for all critical parameters
Statistical Process Control (SPC)
To determine whether a process is operating within appropriate limits, Wipestar employs Statistical Process Control (SPC). Using statistical techniques, we monitor the quality of our processes and products to ensure the delivery of the highest-quality and most consistent products possible.
Our statistically developed control limits provide critical parameters for real-time analysis, monitoring, and alarm with regard to critical process inputs. An in-house metrology enables the measurement and testing of our critical process parameters and product characteristics. Statistical analysis then enables trend review and continuous improvement validation.
Wiper Test Methods
Wipestar tests wiper properties identified by contamination control professionals as most critical. The test methods we employ are vital to product development and quality assurance. All test methods are based on the Institute of Environmental Sciences and Technology (IEST) standard, IEST-RP-CC004.3: Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments.
The following are brief descriptions of Wipestar's Wiper Tests:
Cleanliness
1. Fibers
A wiper is “washed” in water using a biaxial shaker for five minutes. The fibers released into the water are filtered onto a membrane and counted microscopically. The results are expressed as fibers ≥ 100µm per square centimeter of wiper. [IEST-RP.CC004.3, Section 6.2.2.2]
2. Particle Generation / Biaxial Shake Test / Orbital Shake Test
A wiper is “washed” in water using a biaxial/orbital shaker for five minutes. A liquid-borne particle counter then tallies the particles released into the water. By dividing the total number of particles released by the area of the wiper, the results are expressed as particles ≥ 0.5µm per square centimeter of wiper. [IEST-RP.CC004.3, Section 6.1.3 / IEST-RP-CC004.3, Section 6.14]
3. Airborne Particle / Helmke Drum Test
Under controlled conditions, ten wipers are tumbled in a rotating drum to release particles from the wiper fabric. An airborne particle counter counts released particles and results are expressed as the number of particles per wiper per cubic foot of air sampled. [IEST-RP-CC003.4 Section B2.5]
Sorbency
1. Capacity
A sample of wiper material is saturated with as much fluid as it can hold. After one minute, the material is weighed, and results are expressed in milliliters of fluid per square meter. [IEST-RP.CC004.3, Section 8.1 (Modified)]
2. Efficiency
This calculation indicates how well a material absorbs, relative to others. Results, expressed in milliliters of liquid per gram of material, assisting in comparing one raw material with another. [IEST-RP. CC004.3. Section 8.1 (Modified)]
3. Rate
This test is a measurement of the time it takes a wiper to absorb half the total liquid it can hold. Results are expressed in seconds. [IEST-RP. CC004.3. Section 8.2 (Modified)]
Purity
1. Non-Volatile Residue
Wipestar generates non-volatile residue data using both deionized water and 2-Propanol. Results are expressed in grams of extractables per square meter of wiper, which is a useful guide to relative purity of wipers. [IEST-RP.CC004.3, Section 7.1.2]
2. Metallic Ions
Ions are extracted in deionized water and quantitatively analyzed by Ion Chromatography. Results are stated in parts per million (ppm). [IEST-RP.CC004.3, Section 7.2.2]
Quality standard
ISO 9001:2015 Quality Management System Certification
Wipestar has obtained ISO 9001 Quality Management System Certification, and Wipestar takes pride in its commitment to ensuring quality. ISO 9001 is an international standard for quality management and quality assurance. It provides a foundation for companies to effectively document the elements of a quality system to establish an effective quality system. This process ensures that Wipestar's customers are using the cleanest and most consistent products globally, truly "engineered clean" products.
ISO 14001 Environmental Management System Certification
Wipestar has obtained ISO 14001 Environmental Management System Certification. ISO 14001 refers to the assessment of the environmental management system of the supplier (producer) by a third-party certification body based on publicly released environmental management system standards (ISO 14000 series). The qualified assessment results are awarded an environmental management system certification certificate by a third-party organization, and are registered and published, demonstrating the supplier's ability to provide products or services in accordance with established environmental protection standards and regulatory requirements.
Quality Policy
Our business systems and processes are continually reviewed and updated in line with customer expectations and applicable regulations and requirements, not only to drive improvements throughout the business, but to focus on maximizing customer satisfaction and growth of the business.
Room 101, Building 1, Angeer Factory, No.4, Hetian Road, Shatian Community, Kengzi street, Pingshan District, Shenzhen, Guangdong, P.R. China 518122
info@wipestar.com
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+86-755-89616773
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