The quality department lies at the heart of a manufacturing concern. The quality department is responsible for ensuring that a company's products consistently meet its quality expectations. The speed and accuracy with which the quality department can perform its functions is one determinant of how quickly products can be delivered. Traditionally, quality departments have focused their efforts within the four walls of the plant, but today's demands and technology are pushing quality requirements beyond those four walls to the entire supply chain.
The quality department's role starts with the receipt of materials and continues to finished product. However, its responsibilities go even further. The quality department must reach out to other parts of the business. Working with purchasing and other departments, the quality department helps set the standards for incoming material and provides feedback on the quality performance of suppliers. In addition, for selected consumer products, the quality department manages the company's products shelf life and stability. For suppliers of industrial products, the quality department is responsible for ensuring that the materials meet customer specifications and for documenting the quality of products with certificates of analysis (COA).
As today's plants push for the integration of various systems, with a view towards streamlining operations, cutting costs, and improving overall quality, the expansion of the quality department's role is being taken into account. For example, many enterprise resource planning (ERP) systems that work at the plant level now consider quality characteristics to be part of the material's inventory record.
Software suppliers addressing the needs of the quality department fall into two categories, ERP vendors and independent suppliers. ERP vendors typically have a module called quality management that provides functions for specifications, samples, tests, etc. These modules are tightly integrated with the appropriate portions of the ERP supplier's product. For example, Patrick Sjoberg, product director for food and beverage industries at Lawson (formerly Intentia) tells us that their ERP system, Movex, contains an integrated quality module, saying, "We consider quality to be a vital part of any ERP solution for the manufacturer. To effectively maximize plant operations, quality information must be used to determine production requirements, scheduling, product availability and many other day to day operational issues."
Independent suppliers often provide products called laboratory information management systems (LIMS) that offer extensive functions, including connections to lab instruments, statistical analysis, instrument calibration, lab resource scheduling, and more. LIMS providers typically supply integration tools to enable their products to integrate with ERP, manufacturing execution systems (MES), and other plant level systems.
In general, although my software supplier friends may not agree, the ERP products offer greater integration into the supply chain, but less laboratory-specific functionality, while the LIMS products offer greater functionality to improve product quality and less integration.
Demands on Today's Quality Systems
The increased call for product safety from customers, consumers, and regulatory bodies is fueling the demand for more formalized and self-documenting quality systems. For example, to prove chain of custody, samples require tracking from receipt through analysis, data entry, and approvals, all the way up to the final report. Every action must be logged, and every record properly signed and archived for future retrieval.
Moreover, most industry observers expect that the electronic signatures now required in the pharmaceutical industry (as defined in the Food and Drug Administration [FDA] 21 Code of Federal Regulations [CFR], Part 11) will be a requirement for many industries in the future. In addition, regulations regarding the documentation of standard operating procedures (SOP), staff training, equipment inspection, maintenance and calibration, and other information are also expected.
The increasing need for documentation is not the only demand being placed on today's quality systems. While enterprise systems typically provide tracking and tracing from supplier to customer, quality systems must provide the quality picture related to all affected lots. All samples and results, including the people and testing equipment involved, need to be linked to the lot management system to help research and resolve product quality issues quickly. Many ERP systems targeting the process industries do this well, and leading LIMS providers consider it an absolute requirement, providing such a link as part of their standard product.
The introduction of mobile computing and browser technology has aided the trend towards a more inclusive role for the quality department, letting quality systems extend into the warehouse and onto the plant floor. For example, Ron Kasner, senior director of Strategic Business Development at LabVantage Solutions, Inc. (the provider of the Sapphire LIMS product) tells us of a process that some of his customers have in place:
Using a handheld wireless device that can access the web, a sample is taken, barcode scanned directly into Sapphire. Associated batch and lot information is immediately captured. Depending on the test, a technician will initiate the test and record the appropriate sample data in the handheld device, or the data is automatically uploaded from the nearby instrument. The results of the test performed on the floor are recorded on the spot. Using LabVantage's built in work flow functions, if further action is required (for example, in the event the sample did not meet the designated specification) the technician is stepped through the SOP dictated process. () For example, the technician may be directed to take additional samples or perform additional test, make a batch correction or perform other functions. In addition, if required, a quality person in the global organization may be alerted to take further action. Through integration to the ERP system, data is passed on to the rest of the supply chain. In all cases, the data and actions are authenticated via electronic signature and recorded for future audit trail.
Quality systems must reach out beyond the confines of the plant or enterprise. For instance, most manufacturers already use some outside testing. In addition, companies providing industrial products must share quality data with customers. In both cases, a quality system that runs over the Internet will be an asset. Outside testers will be able to see their backlog of samples and enter test results over the Internet without any special equipment, while customers will be able to review detailed test results or download COA data as required.
In conclusion, quality does not start at the receiving dock and end at the shipping dock. The focus on the supply chain demands that the quality department be involved from the beginning to the end of the supply chain. ERP and LIMS providers are providing the tools to extend quality management outside the four walls of the plant, permitting a cradle to grave view of quality.
About the Author
Olin Thompson is a principal of Process ERP Partners. He has over twenty-five years experience as an executive in the software industry. Thompson has been called "the Father of Process ERP." He is a frequent author and an award-winning speaker on topics of gaining value from ERP, supply chain planning (SCP), e-commerce, and the impact of technology on industry.
He can be reached at Olin@ProcessERP.com.