Kardex Remstar Vertical Storage And Retrieval Systems Help Medical Device Companies Meet Quality System Regulations
Kardex Remstar Vertical Storage And Retrieval Systems Help Medical Device Companies Meet Quality System Regulations
The Food and Drug Administration’s concern for the safety and effectiveness of Class II and III medical devices is described in 21 CFR Part 820, which details quality system regulation for medical device manufacturers.
Record keeping requirements and mandated quality control processes are described in Subpart L, Handling, Storage, Distribution and Installation. These sections direct medical device manufacturers to establish and maintain procedures to ensure that mixups, damage, deterioration, contamination or other adverse effects to products do not occur during handling. The regulations go on to require control of storage areas to ensure that no obsolete, rejected or deteriorated product is used or distributed and that items be stored in a manner to facilitate proper stock rotation. In addition, procedures must be established to ensure that only those devices approved for release are distributed.
While these regulations are clear and straightforward in their requirements, medical device manufacturers are on their own in determining the best way to meet these requirements.
Evaluating Vertical Storage and Retrieval Systems
One approach that is getting increasing attention is the use of automated storage and retrieval systems, such as vertical carousels and Shuttle® Vertical Lift Modules (VLM) from Kardex Remstar. They provide inventory security and controlled access to critical components while offering quick and accurate order picking, helping manufacturers avoid costs associated with recalls and liability claims.
When used in conjunction with inventory management and control software, these vertical storage and retrieval systems automate and provide electronic documentation for stock rotation programs and ensure that expired devices are not shipped. The software and system combination allows the segregation and tracking of non-conforming products and prevents accidental release of quarantined items. The systems also offer controlled access for added security, allowing supervisors to monitor and track access to devices and materials, plus provide detailed management reports of pick and put activity. These features improve traceability, reduce the number of paper reports and improve overall risk management. Kardex Remstar vertical storage and retrieval systems also improve file storage efficiency and can be used in a variety of applications in R&D, facilities maintenance and management of office supplies.
Keeping Items Clean and Separated
Kardex Remstar vertical carousels and VLMs are enclosed systems of vertically arranged shelves or carriers that rotate up or down via the shortest path, automatically delivering items to an ergonomically positioned pick window. Full product enclosure maintains the cleanliness of stored items and can be modified for cleanroom use reducing outside contamination and cross contamination. A wide range of bin sizes, shelves and dividers, security doors, and rollout drawers allow flexibility for efficient storage and offer a secure means of segregating products. These systems can be integrated with environmental control systems to reduce the effects of ambient factors such as temperature and humidity to maximize product shelf life.
Pick-to-light devices, bar code scanning and software routines provide a high level of picking and putting accuracy while simplifying and reducing employee training requirements and significantly increasing productivity and throughput.
Kardex Remstar vertical storage and retrieval systems take advantage of unused overhead space to recover up to 85% of the floor space required by traditional rack and shelving systems, allowing more productive use of that floor space. They are available in wide range of heights, depths and widths to meet virtually any medical device storage and retrieval requirement. Their modern, clean design eliminates the unsightly look of products stored on open shelves.
Meeting Requirements through Validation and Traceability
New inventory management features from Kardex Remstar help medical device manufacturers establish quality processes in manufacturing. FastPic5 software has recently added a validation and traceability features. Part validation requires order pickers to scan a bar code to verify the part serial number, ensuring that they have picked the exact device required from inventory. Bar code verification routines assure picking accuracy and can be set up to verify items by material, location, lot or serial number. Bar code verification also allows tracking of non-conforming items and prevents accidental release of items on hold.
The same bar code recognition feature can be used when putting or replenishing inventory. The picker scans the part and then scans the location as the part is placed into inventory, verifying it is being placed in the correct storage location. This allows storage and retrieval system operators to more accurately pick orders and replenish stock, significantly reducing mispicks and decreasing the number of returned orders. The resulting improved inventory control can reduce operating costs.
FastPic5 software can be configured to scan bar codes by transaction, type or material keyed to storage locations.
Using the traceability feature, each medical device picked from inventory is documented and can be easily traced back to the original order when necessary, allowing the manufacturer to know who purchased each serial number. FastPic5 software provides lot and serial number control and full traceability that automates and documents proper stock rotation policies. Expiration date handling assures that expired items are never shipped.
FastPic5 software offers a range of detailed pick and put activity reporting, including complete histories of all transactions by user ID, date/time and material identification. Reports can be filtered, sorted and printed.
Measuring ROI
An automated storage and retrieval systems represents a significant capital investment, but the cost savings can be substantial, and the return on investment can be as short as 18 months. Sit down with an installation specialist and put the numbers into a standard ROI/IRR (Return On Investment/Internal Rate of Return) formula. You will be able to compare the daily cost of the current system and the daily cost of the new system. Also take into account the dollar savings from reduced space requirements, cost savings from improved employee productivity, depreciation savings, and total annualized savings. From this information, you can determine the payback schedule for the specific installation.
Kardex Remstar LLC, a company of the Kardex AG Group, is a leading provider of automated storage and retrieval systems for office, government, manufacturing, and warehouse applications. For information about using automated storage and retrieval systems to meet medical device manufacturing quality standards, call 800-639-5805 or visit www.KardexRemstar.com.