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Standards needed for laboratory system integration

02.01.2012  |  Hollywood, Paula,  ARC Advisory Group, Dedham, MA


Industries across the board are coping with relentless pressure to reduce costs while simultaneously improving product quality. The hydrocarbon processing industry (HPI) has an additional challenge in achieving higher product quality as a result of the heavier raw materials available for processing. Heavier crude feedstock from sources such as the Canadian tar sands have high sulfur content, thus making them more complex and expensive to refine. This heavier feedstock is in direct contrast to requirements for low-sulfur products dictated by ever-more-stringent regulatory requirements. In this environment, a well-designed quality management system (QMS), which includes a robust laboratory information management system (LIMS) that facilitates ISO 17025:2005 accreditation is critical to ensuring product quality and customer satisfaction.

LIMS is vital to quality management.

Inspection systems that perform product sampling and chemical analyses are expensive; yet, they can be easily justified. Reprocessing or scrapping product wastes time, money and resources. Furthermore, off-spec product can lead to unhappy customers or worse, product recalls that can damage the manufacturer’s corporate image. Conversely, product quality over and above that required by contractual obligations incurs additional costs for which manufacturers are not compensated, and this impacts margins and profitability.

A comprehensive QMS with an integrated LIMS can help reduce product variability and improve operational performance. In the HPI, lower-grade feedstock may dictate higher in-process sampling and analysis rates to prevent defects during the manufacturing process. When integrated with manufacturing execution system (MES) and enterprise resource planning (ERP) systems, production and other departments can access quality-related information generated by the LIMS to help ensure that products meet defined specifications and demonstrate compliance with regulatory, product and safety standards.

An LIMS, such as Sample Manager 10 from Thermo Fisher Scientific, adds value to quality assurance (QA)/quality control (QC) systems with full traceability functionality and it serves as a repository for documents and reports as evidence of compliance. An LIMS can provide vital information at the front end of the manufacturing cycle. Identifying off-spec raw materials upon inspection can provide the needed heads-up to tune the production process to yield acceptable final product(s). It can demonstrate that a sample was handled appropriately and that the analysis was done by a properly trained, qualified technician. It can act as a repository for laboratory equipment and maintenance histories or analytical method validation, as well as the corporate quality manual. LIMS data can also be useful in determining the appropriate corrective action for off-spec product and to evaluate the performance of the quality system. Upon final QA quality and contamination checks, it can quickly release shipments.

If a non-compliant lot was inadvertently shipped, fast efficient flow of information will ensure that a recall can be quickly implemented. Without traceability records from an LIMS, it would be nearly impossible to accomplish product recalls in a timely and controlled manner.

Integrated LIMS enhances QC.

In the manufacturing environment, analytical measurements define the “who, what, when, where and how” of a manufacturing process. As the backbone of the laboratory, an LIMS provides quantitative and qualitative information about chemical processes for enhanced QC. The wealth of analytical measurements provided places increased importance on integrating this information into higher-level enterprise application platforms. To improve response to operational issues, managers look to technology to connect plant floor and business systems, like ERP, product information management system (PIMS) and MES, making it critical that analytical information are presented to the viewer in the context of their role, responsibility and authority. For real-time quality management, information visibility is the driver behind the demand for better integration of laboratory-generated information throughout the enterprise. Laboratory ISO 17025 compliance demonstrates commitment to quality.

Due to fluctuations in raw materials, HPI laboratories are becoming almost like third-party service laboratories. As such, these labs must assure compliance of product(s) to specifica-tions, making laboratory accreditation with standards such ISO 17025:2005 no longer just nice to have, but a necessity to ensure conformance and customer satisfaction. Compliance with as ISO 17025 demonstrates a commitment to quality, and provides customers the assurance that the laboratory’s management and technical requirements adhere to globally accepted best practices.

ISO 17025 requires a complete history of each piece of equipment including checks and calibrations performed prior to being placed in service as well as detailed records of all calibrations, repairs, maintenance and performance checks over the serviced life of the device. A clear advantage for final product manufacturers is that utilizing certified ISO 17025 laboratories as subcontractors fulfills all the requirements as applicable to calibration and testing activities of an ISO 9001 quality management system. This enables the manufacturer to recognize the sub-contractor as ISO 9001 certified for any work done within the ISO 17025 scope. Quality audits of an accredited subcontractor are not required. HPI manufacturers can use the statements of work provided by an LIMS to ensure that customer requests match the delivery of samples to the lab, along with and the delivery of results back to the customer. HP

The author 

Paula Hollywood has nearly 30 years’ experience in the areas of sales and product marketing in industrial field instruments that utilize a vast array of technologies including magnetic, Coriolis, radar, electrochemistry, capacitance and ultrasonic. 

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