New management system helps company improve processes in preparation for ISO certification

Aug. 11, 2014 – EST Analytical was looking for a document control system to replace several inefficient and time-consuming paper-based product development and business processes, and found a system that resulted in substantial improvements in both data integrity and process times. Here’s their story:

The company
EST Analytical is a family-owned and operated business providing lab equipment and analytical instruments. As a market leader in sample introduction for VOC (volatile organic compound) analysis by GC or GC/MS (gas chromatography/mass spectrometry), EST Analytical has been providing products to a wide variety of industries for more than 20 years. The introduction of their highly versatile Flex Autosampler represents an ongoing evolution of their business and sustained growth.

The challenge: Replace paper processes to prepare for ISO certification
EST Analytical started looking for a document control system to replace several paper-based product development and business processes in order to prepare for ISO (International Organization for Standardization) certification. Their previous processes were a combination of multiple disconnected spreadsheets and databases to manage engineering and manufacturing information such as drawings and work instructions. Their Engineering Change Orders (ECOs) did not tie-in to their Enterprise Resource Planning (ERP) system, which resulted in duplicate data entry and a long and uncontrolled ECO approval process. Their Quality/Corrective and Preventive Action (CAPA) records were Excel-based documents tracked in an Access database.

“We lacked good control over and use of the information we had because most of our systems were non-indexed and not linked,” stated Tony Batt, quality manager for EST Analytical. “We needed to create a more efficient and connected environment that would allow us to easily find and track information, as well as simplify data sharing across the company.”

The solution: Single automated system for engineering change and quality processes
As EST Analytical searched for a document control solution, they discovered that a Product Life Cycle Management (PLM) system was what they ultimately needed to address all of their challenges.

“We selected Omnify Software because of what it brought to the table that standalone document control systems could not,” said Batt. “One of the key reasons we selected the Omnify Empower PLM solution was the fact that change control and quality management were rolled into one system.”  

Omnify Empower is well accepted within the company and is recognized as a key tool in standardizing and controlling information and processes for ISO compliance. About one-third of the company is using Omnify Empower with users from engineering/R&D, manufacturing, purchasing, quality, sales and service departments. The company has embraced several core concepts of the system by utilizing multiple modules including: Change Management, Bill of Material (BOM) Management, Quality Management and Project Management, to integrate various manual processes into a single, automated system with traceability on all changes.

“Omnify Empower PLM replaced all of our paper processes, and we now use the system to store and mange everything from product information and BOMs to operating procedures, policies, job instructions and any other ISO-related documentation,” noted Batt.  

Customer success
By adopting Omnify Empower, the company has met their primary goal of establishing paperless business processes.

“We now have all of our product information in an organized and searchable tool to help increase transparency and accessibility to necessary business information,” stated Batt. “Omnify Empower is the system of record through which all item, product and document records are managed, which has resulted in substantial improvements in both our data integrity and process times.”

In addition to gaining centralized engineering change and quality control, EST was also able to integrate Omnify Empower with their Sage 100 ERP (formerly Sage MAS90 ERP) system. This has helped the company eliminate costly and timely duplicate data entry and streamline engineering and manufacturing information sharing. The integrity of the data in their ERP system has improved where all engineering changes are made in Omnify Empower, and released changes are then pushed to ERP through an automated interface. This provides the audit trail and traceability that was lacking with previous direct edits within the ERP system. Automatically transferring information from Sage ERP into Empower also eliminated the need for engineering personnel to be trained on the ERP system and provides engineering with access to cost and lead time information when designing products, which has helped to improve the design decision-making process.  

Taking advantage of Empower’s quality management capabilities, EST developed several closed-loop CAPA processes to support field service, manufacturing and software engineering bug tracking. An interesting use of the system allows field service personnel to log issues directly into a CAPA form within Empower or use a Google Phone mailbox to log the issue by answering specific CAPA questions. Once a CAPA has been logged in Omnify, the investigation process begins. This process flows seamlessly into the change process when the issue resolution is determined. Tasks and Workflow Stages ensure the necessary information is collected in support of downstream activities involving several business areas. Manufacturing, receiving and incoming inspection, engineering, service and sales are all involved either directly in Omnify Empower or notified through email messaging.

The company plans to take their Omnify Empower PLM investment even further with Non-Conforming Material (NCM) processing and trending, integration to their Solidworks 3D CAD system, and utilizing the Training Management module for ISO-required tools/equipment calibration management.

“With Omnify Empower, we have been able to standardize business processes and centralize the management of documents, revision control and CAPAs in order to deliver consistent product to our customers and meet ISO compliance,” stated Batt. “We continue to reap the benefits of Omnify Empower by finding new ways to adapt the solution to improve other business processes.”

Alaine Portnoy is senior marketing manager with Omnify Software. Alaine has more than 11 years of experience in the manufacturing and product life cycle management markets.