Introduction
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.
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.
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.