ERP Traceability in a regulated environment
Many industries are faced with having to track and manage; the source of raw materials, where they were manufactured and which customer received a specific finished good. This level of traceability is normally required by companies regulated by government agencies (such as FDA and FAA) and may involve tracking unique “Lots”, individual “Serial Numbers” , “Expiration Dates” or a combination of all of the above.
Some companies choose to track this information manually, or in an off-line spreadsheet. This presents a quick and low cost solution yet has serious limitations and significant drawbacks.
Storing lot, serial and expiration date manually means access to that information is time consuming and cumbersome. It may involve searching through multiple pages of information to find the complete as-built configuration of how a product was manufactured. A manual system also presents a risk the data is incomplete, entered incorrectly or simply missing.
A more effective process is to collect the lot, serial, & expiration date while the inventory or shop floor transactions are being performed in your ERP system. Collecting the data at the time of transaction will require the data to be entered and is automatically stored in a format that can be searched. With the information in a single location a user can drill down through a multiple level Bill of Material and view all the lot, serial and expiration date that went into building that product. Or perform a multiple level implosion to track each lot, serial and expiration date.
The benefit of such a solution is speed & accuracy…which is vital in the event the data needs to be recalled (such as during a recall). With lot, serial and expiration date on-line an ERP system provides instantaneous access to; purchase orders for raw materials, shop orders for production, inventory records to check stock and sales orders of all customers product was shipped to.
While this process does involve additional effort of capturing the lot, serial data at each transaction, those costs can be minimized with the deployment of bar code / data collection devices.
Many industries are faced with having to track and manage; the source of raw materials, where they were manufactured and which customer received a specific finished good. This level of traceability is normally required by companies regulated by government agencies (such as FDA and FAA) and may involve tracking unique “Lots”, individual “Serial Numbers” , “Expiration Dates” or a combination of all of the above.
Some companies choose to track this information manually, or in an off-line spreadsheet. This presents a quick and low cost solution yet has serious limitations and significant drawbacks.
Storing lot, serial and expiration date manually means access to that information is time consuming and cumbersome. It may involve searching through multiple pages of information to find the complete as-built configuration of how a product was manufactured. A manual system also presents a risk the data is incomplete, entered incorrectly or simply missing.
A more effective process is to collect the lot, serial, & expiration date while the inventory or shop floor transactions are being performed in your ERP system. Collecting the data at the time of transaction will require the data to be entered and is automatically stored in a format that can be searched. With the information in a single location a user can drill down through a multiple level Bill of Material and view all the lot, serial and expiration date that went into building that product. Or perform a multiple level implosion to track each lot, serial and expiration date.
The benefit of such a solution is speed & accuracy…which is vital in the event the data needs to be recalled (such as during a recall). With lot, serial and expiration date on-line an ERP system provides instantaneous access to; purchase orders for raw materials, shop orders for production, inventory records to check stock and sales orders of all customers product was shipped to.
While this process does involve additional effort of capturing the lot, serial data at each transaction, those costs can be minimized with the deployment of bar code / data collection devices.
A medical device customer told, they hired 5 collegue students for 2 weeks to search all the paper records to trace the as-built details to perform a product recall. I feel much safer knowing As-Built search is purpose built into MAX.
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