ISO Compliance Managing the Paper Trail

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A manufacturing sector case study to show how ISO can be implemented using FileHold.

To remain competitive, manufacturers today must consistently produce near perfect products. Flaws are not acceptable. To achieve that goal they employ compliance tools such as ISO9000:2000 that ensures structured repeatable documented processes.

One of the many business challenges in implementing these compliance processes is managing the massive paper trail of inspections and approval documents that are created. Traditionally these documents have been stored in filing cabinets to be reviewed by inspectors during the ISO audit or if there is a customer complaint.

This FileHold customer has been manufacturing metal products for various industrial applications for over 100 years. In addition to ISO 9001:2000 the company meets the nuclear requirements of 10 CFR Part 50, Appendix B, ANSI N45-2 and 10 CFR Part 21. Filing, storing and retrieving all of the paperwork created by these compliance and regulatory processes had become a time consuming process and the storage of these document took up valuable storage space. The types of documents needing to be managed include;

  1. The signed and executed work order.
  2. Signed and stamped work order quality management documentation including material test reports, quality control and inspection reports.
  3. All related work order custom design and manufacturing process documentation.

The FileHold Solution

The customer wanted to convert all of this documentation from paper to electronic form so that physical storage would be eliminated and documentation could be easily found. Once document scanners were purchased, FileHold supplied the customer with Captiva QuickScan Pro scanning software which is integrated with FileHold document management software.

We helped the customer set up and configure both the scanning stations and our document management software. All paper documents, including signed and stamped work orders and related quality management documentation, were scanned in batches at the end of the day. The batch was automatically separated into individual documents by barcodes added to each document. This same barcode was used to classify each document before it was stored in the library by automating the capture of Important metadata (data about data) describing each document. The barcode contains the work order number of the job to which it is related. The barcode (work order number), after being scanned, is used by FileHold QSP to look-up additional tagging information from an SQL database. This information includes Customer Name, Customer Part #, internal Part #, Purchase Order #, Sales Order # and Batch #. The SQL database is synchronized nightly with work order information contained within the companies ERP system. When scanning and tagging is complete the documents are automatically sent to and stored in the FileHold library. Electronic documentation, relating to the work order, that does not require physical signatures or stamps, such as design and manufacturing process documents, are added directly to the FileHold library by the users that create the materials. The FileHold software makes it easy for users adding the electronic files to adhere to the same classification standards as set when capturing documents from the scanning process.

Solution Summary

The massive amounts of paperwork generated when fulfilling a customer work order is quickly scanned into the document management server. The process of scanning, classifying and filing documents is automated and error free. Implementation of this solution allowed the customer to eliminate the mountains of paper generated when meeting its ISO 9000:2000 obligations. End users realize tremendous time savings when searching for, managing and documents to a work order.

Solution Benefits

Implementation of this solution allowed the customer to eliminate the mountains of paper generated when meeting its ISO 9000:2000 obligations. In addition to eliminating paper, the solution dramatically decreases the time it takes for end users to search and retrieve documentation related to a specific work order, customer record or sales order. The payback period can be quickly realized in the time saved for searching for documents.

Other benefits of the solution include an improved quality of service to customers; the manufacturer can now share documentation electronically that previously had to be photocopied and mailed or couriered to the customer. It is now quick and easy to find source document related to any customer order, when such documentation is requested, such as in the case of a billing discrepancy.

Managing the ISO 9000 PDF