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Automated QA/QC Systems that Employ Analytical Intelligence

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Monitoring Quality Assurance—A Case Study

A reliable quality management system is critical in any manufacturing facility. When a LIMS system was found to be expensive and unnecessary, and regular statistical packages could not handle the analytical data essential to their work, Seven Scent looked for an alternative option to fulfill their needs.

A manufacturer and supplier of customized fragrances, Seven Scent, produces perfumes for a wide variety of consumer product categories, supplying companies on most continents of the world. Seven’s commitment to quality products and services created a need for a quality assurance system that encompassed all aspects of the manufacturing process from cataloging ingredients to quality testing of finished products before shipping.

Seven Quality Objectives

After evaluating different LIMS systems and finding deficiencies, Seven approached ACD/Labs. The result was the development of a fully automated quality assurance system which interacts with an existing enterprise resource planning (ERP) system to log and track samples, assess quality, and generate reports.

ACD/Labs Professional Services team worked with Seven, using core ACD/Labs software products for databasing and automation, along with customization to develop what has been described as a ‘spectral LIMS’. This differs from conventional LIMS in that it has the ability to store, search, and display analytical spectra and chemical structures as well as the full range of chemical and analytical results and meta data. The ability to work with spectra was essential since the typical workflow involved comparing chromatograms and spectra of samples and reference standards to determine quality. Seven uses a combination of GC chromatography, FTIR, and RI/SG/Density to monitor the production process therefore it was important that the ACD/Labs solution be able to utilize all of these disparate forms of data.

ACD/Labs software supports multiple analytical techniques and is compatible with over 150 data file formats from most major instrument vendors, enabling it to unify the entire organization’s data into a single homogeneous repository. The software also has the flexibility to easily create the standardized forms and reports needed, and to manage access and security.

Using defined workflows for types of samples, the quality assurance system performs various tasks such as automatically collecting analytical data as it is generated, comparing chromatograms or spectra to reference materials, recording pass/fail results, requesting electronic sign-offs at appropriate stages, managing the progression of samples through the process, and performing reporting tasks such as generating certificates of analysis. In addition, the system has connections to the company’s existing ERP for tracking raw materials and batches of product released for shipping. The system is in full use at Seven after a successful independent audit to ensure its accuracy and suitability.

The level of automation present in the system has resulted in a time savings of over 30% in the manufacturing process, and has ensured that Seven is able to honor its commitments to quality.