Wikipedia defines Manufacturing Operations Management (MOM) as a methodology for viewing an end-to-end manufacturing process with a view to optimizing efficiency. MOM systems oversee all the stages of production from the acquisition from your suppliers of raw materials to the completion of the finished product. MOM goes beyond the traditional Manufacturing Execution System (MES) many medical device companies are using by incorporating quality on the production floor as well as in the supply chain. Built in quality control procedures include in-process inspections and verification steps, Statistical Process Control (SPC) procedures that automatically alert operators to out of control conditions, and integrated handling for discrepancies found during production, including defect containment and corrective actions to eliminate future recurrences.
Integrated quality control processes ensure that containment alerts and holds are automatically reflected on similar work orders and supplier inspection orders. Rework instructions and deviations are easily incorporated and approved to override the normal processes. All deviations become part of the Device History Record (DHR) as well. Medical device MOM systems are designed to bring better shop floor awareness to the front office. Medical device manufacturers need to understand that their traditional approaches to managing shop floor operations with just an ERP system are no longer sufficient to meet the difficult challenges of improving manufacturing excellence. To reduce manufacturing cost and increase quality in today’s very competitive world requires real-time visibility and control over all your manufacturing operations.
An investment in a MOM solution and integration to your ERP system provides the platform required to achieve manufacturing excellence and is fundamental to gaining the competitive edge for all your future products. Just think, no more waiting around until the end of the day to see how many parts have been made or noticing that a tool was out of calibration hours after it was used on a part assembled into another component or worst yet, shipped to a customer. MOM gives you real-time information and data analysis, allowing you to make proactive adjustments that ensure your manufacturing operations produce higher quality parts at optimum production levels.
An integrated MOM system allows organizations the ability to immediately view how their staff, tools, and equipment are performing at individual work centers, instantaneously capturing and validating all your information, and automatically updating your DHR. It is time to stop thinking “If my current ERP system could only give me better production and quality information, I could make correct decisions!” Consider integrating a MOM solution today into your ERP solution and take the guesswork out of the management of your shop floor. It is time to give your ERP system a boost with a medical device specific MOM system.
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- Why a Quality Management System Isn’t Enough to Satisfy 21 CFR Part 820 and Part 11 - January 3, 2017
- Why Medical Manufacturers Need Manufacturing Operations Management (MOM) - December 15, 2016
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- A Better Approach to Maintaining Device History Records for FDA Compliance - March 1, 2016
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