Specific Life Sciences Requirements for ERP – Part 3

In our next article in the series of the 10 requirements Life Sciences companies need addressed by their industry specific ERP systems, we cover the next three capabilities: Inventory Storage, Quality Management, and Document Management.

(In our previous articles we covered: Traceability and As Built / As Maintained Configuration Record; Electronic Signatures, Engineering Change Notice, and Effectivity Dates and Phase-Ins.)

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What Keeps You Up at Night? 2014 in Review for Medical Device Companies

Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.

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Device Design Transfer – A Smooth Hand-off

Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door – or even defective product reaching the customer.

Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.

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Building a Culture of Quality- More Than Words Can Say

When questioned if their company has a focus on quality, most managers and employees will say yes. This might be because at a minimum, it is the right thing to say. They may also believe that since they have some procedures or a quality policy that this suffices and that quality practices will just fall in to line. Under further scrutiny, however the differences between perception and reality become apparent.

The view from higher levels in the company may be that it has a well disseminated quality culture. But as you travel down the organization chart, the response may not be so positive. A culture of quality is a full time commitment to quality. It is not just referencing standards in a few SOPs. Everyone should understand who the customer is and what they expect.

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Lean Enhances Competitiveness

U.S. manufacturing went through several difficult years as competition from low-wage regions caused a major uptick in outsourcing and offshoring. Slowly but surely, intrepid manufacturers are turning the tide back to on shore manufacturing by increasing efficiency and controlling both costs and quality to decrease or remove completely any price advantages in those low wage regions.

Companies have used lean manufacturing and its companion discipline, six sigma, to become more productive and more competitive than ever before in history. By streamlining business processes and reducing unnecessary steps, many companies have completely eliminated the advantage of lower wages. Where the cost differential can’t be completely eliminated, companies have offset the competition’s lower prices by offering higher quality, faster delivery, superior service and mass customization offerings.

If your company is still struggling to hold the line against offshore competition, here are a few ways that lean can help make your company more competitive.

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Lean’s Impact on Quality

One of the key principles of the lean enterprise is to eliminate waste, and very little is more wasteful than poor quality. Scrap and rework are costly and inefficient. Unhappy customers and returned goods are expensive and can result in loss of market share. A focus on quality is a key value of a lean company.
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Quality Management Processes in Microsoft Dynamics AX

Microsoft Dynamics AX 2012 provides a number of quality management processes that you can use to ensure a high level of product quality within your supply chain. This capability leads to optimized supply chain processes and higher customer satisfaction.

Quality management functionality in Microsoft Dynamics AX can help you manage turnaround times when dealing with nonconforming products, regardless of their point of origin. By linking diagnostic results to correction tasks, the system can schedule tasks to correct problems and therefore help prevent recurrences in the future.

In addition to nonconformance management, quality management functionality includes the ability to track issues by problem type (including internal problems) and to identify solutions as being short-term or long-term. Statistics on Key Performance Indicators (KPI) provide a window into nonconformance problems that have occurred historically and the solutions that have been applied to correct them. Historical data can be used to help review the effectiveness of quality measures that have been taken and to determine appropriate measures to perform in the future.

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