As per the “no-failure” requirements, components manufactured by Criterion Tool & Die Inc., cannot fail once the devices are implanted in patients, installed in planes or in other equipment. Consequently, government regulations mandate that Criterion Tool & Die Inc. retains documentation about the parts it supplies for the lifetime of the products and instruments. The company also must produce all supporting documentation in a timely manner when requested for audits. These requirements resulted in thousands of paper documents stored in the company’s facility over many years. The paper and large storage space made locating documents time-consuming and difficult.
After considering several document-management solutions, Criterion Tool & Die Inc. chose DocuWare. The company purchased its own servers and is currently maintaining 16,500 documents, digitized from nearly 100 big bunker boxes and file cabinets. With a dedicated person who performs regular document scanning, 50 to 100 documents are being added on a weekly basis, including current and also some historical documents, which are still being digitized.
All of the parts shipped during the week are now entered into the DocuWare system.
Every manufactured part becomes a record in the DocuWare archives, which includes the part’s dimensional drawings, copies of the inspection reports, certifications of the material and purchase orders. “If I can’t find something, it must be in DocuWare," says Kellyanne Gottschalk, the company’s Marketing & IT Coordinator. “It changed the dynamics of how we do things here.”
Marketing & IT Coordinator
In addition to clearing the office space, the DocuWare solution tremendously decreased document retrieval time. Instead of locating boxes and then records within the boxes, information about parts can be retrieved nearly instantly. The company is saving approximately 10 man-hours a week by being able to retrieve the files digitally.
The speed and convenience of the digital solution became particularly important during audits. Prior to DocuWare use, audit preparations took several hours, but now the documents can be found by inputting job numbers and retrieving the records. “The biggest time save is being able to pull the document instantly,” says Gottschalk. Having the information available instantly also greatly reduced employee’s stress levels during audit-preparation time, she adds. “We know the job number and we can just look them up and produce documents on demand right in front of the auditor.”
The company uses DocuWare for a variety of needs, including retaining documents for the FDA, the quality management system, preventative maintenance on machines and equipment as well as for storing employee and client records and for external documents used by the quality department for their customers. The company also installed DocuWare stations on its shop and office floors so that employees could train to retrieve records electronically rather than printing documents on paper. According to the company’s internal records, using DocuWare helped save 41 trees just this year and several hundred dollars in paper costs.