case study:
Roal

quality management in biotechnology

Roal Oy is a Finland-based enzyme-manufacturing biotechnology company that achieved a turnover of approximately EUR 58 million in fiscal year 2016-2017. The enzymes manufactured by Roal are used in the baking, food and feed industries, as well as in a variety of technological applications.

“Our documentation consists of various working and operating instructions and process descriptions, which have been categorized by the different units. We also have numerous documents and guidelines regarding the environment, quality, food safety and energy policies. We also use the document management system for managing non-conformances, near misses, incident reports and initiatives. At the moment we save approximately 300 new documents in M-Files each month,” explains Susanna Eerola, Roal’s Quality Control Manager.

"Automated workflows ensure that the monitoring and reporting procedures are completed. This has not only made our job easier, but also greatly improved our quality, operations as well as deliveries to customers.”

Susanna Eerola, Quality Control Manager, Roal

“M-Files’ version control offers a complete look at the history of all previous edited versions. The changes made by users to the contents and other information are fully traceable. In practice, this means that we can trace the steps of the various changes made to the documents and the related user information at any time. We can also move away from the working version and roll back to earlier versions”. 

Susanna Eerola, Quality Control Manager, Roal

From Paper Copies to an Electronic System

Prior to 2008, non-conformances in the production department were handwritten on pieces of paper that were then taken to the quality control unit where they were logged in Excel spreadsheets. The task consisted of multiple steps and the non-conformances could only be monitored manually.
“At first we needed a tool that would primarily help us get rid of all these unnecessary steps and streamline the monitoring and reporting of non-conformances, near misses, incidents, and initiatives. So we implemented M-Files, which allowed us to replace paper records with a fast and intuitive online form. This makes it quick and easy for all of our employees to fill out the form as needed,” Eerola continues. “The completed form is automatically saved in M-Files for monitoring, and the automated workflow ensures that the monitoring and reporting procedures are completed. This has not only made our job easier, but also greatly improved our quality, operations, as well as deliveries to customers,” adds Eerola.

While Roal’s quality management benefited greatly from M-Files from the very beginning, more opportunities for improvement were seen and the company expanded the use of M-Files for document management to M-Files QMS in 2014. “We have around 400 different quality documents in total, and all of them have to be completely under control, up-to-date and easily traceable,” Susanna Eerola says.
Roal’s quality management procedure requires periodic updates of the quality documents. With M-Files, it is easy to assign a period of validity to each document. When the period is close to expiring, M-Files sends an automated email notification to the assigned personnel so that they can take the necessary measures. If the person in charge does not view, update or approve the document for publication, the document becomes inaccessible to all users.

According to Eerola, “The use of M-Files as a controlled document management system has strengthened the certification processes at Roal. After implementing the M-Files quality management system we were able to efficiently diversify our ISO-certified systems to also cover environmental and energy management components of our business, as well as upgrade our food safety management
system."

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