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Strict quality control is required at manufacturing sites in industries such as semiconductors, pharmaceuticals, precision machinery, and aerospace. Audits, in particular, require evidence of how materials have been handled, making proper material history management crucial. Inadequate material records can result in time-consuming audit responses and risk damaging customer trust.
Audits often ask questions like:
・When was this material cleaned?
・What sterilization process did it undergo?
・How many times has the material been used?
・Any foreign material inspections?
・How is packaging managed?
Audits cannot proceed smoothly without a system in place that can provide immediate answers to these questions.
A system for recording the history of each process is essential for material management.
Cleaning: Water quality and date of use
Drying: Processing environment and type of equipment
Sterilization: Electron beam or gamma ray, method, and date and time
Inspection: Test results for hair and foreign matter
Packaging: Presence or absence of vacuum packaging and record
Organizing this information allows you to present supporting documentation during audits.
[Visualize Records with Barcode Management]
Traditional paper-based or manual recording methods are prone to errors and omissions, making audits time-consuming. Technoclean assigns barcodes to each material and employs a system that automatically records the history by scanning each process. This immediately visualizes when, where, and how the material was processed, allowing for immediate response during audits.
[Transparency in quality assurance]
Barcode management allows you to accurately track the number of times a material is used and its lifespan. This prevents unnecessary waste and avoids the risk of exceeding its lifespan. During audits, you can specifically show how many times a material has been used and what type of processing it underwent, achieving highly transparent quality assurance.
Our materials management also comply with ISO 9001, and our systems for recording and visualizing material history are in line with internationally recognized standards.
[Linking material history management with recontamination prevention]
Material history management is more than just recording. To ensure cleanliness, it must be integrated with systems to prevent recontamination. We combine processes such as one-way management using barrier-type washing machines, HEPA drying in a Class 1000 clean room, hair and foreign object inspection, and vacuum packaging, and keeps records of all of these processes.
What is required during audits is not just the cleanliness of materials, but also "records that support that condition." Recalling material history with just a few clicks allows you to immediately answer auditor questions.
To avoid problems during audits, a system for properly managing and visualizing material history is essential. We consistently manage all processes, from cleaning and drying to sterilization, inspection, and packaging, and ensure transparency by tracking history with barcodes. This allows us to achieve material management that meets the strict requirements of the semiconductor, pharmaceutical, precision machinery, and aerospace industries, ensuring peace of mind during audits.
Contact Information
Techno Clean Co., Ltd.
1438-1 Komai, Fujii-cho, Nirasaki-shi, Yamanashi Prefecture, 407-0001
TEL: 0551-30-2525
FAX: 0551-30-2526
Website: https://technoclean.jp/
| Company name | Techno Clean Co., Ltd | EMIDAS Member Number | 107348 |
|---|---|---|---|
| Country | Japan | Street address |
Nirasaki-shi Yamanashi Japan |
| Telephone number | +81-551-30-2525 | Fax number | Log in to display |
| Employees | 30,000,000 JPY | Annual sales | |
| Employees | 70 | Person in charge |
