November 26, 2014
Quality Challenge #4: Traceability Hurdles
In the event of a recall, could you quickly and easily trace and present quality data of your raw materials through to your final finished goods? For many companies the ability to provide beginning-to-end documentation of quality data is a huge hurdle with potentially disastrous repercussions.
- Substandard, antiquated approaches to recordkeeping (such as paper-based systems) prevent quick responses to recalls or quality concerns
- Increasing industry regulations and audit requirements are putting additional burden on manufacturers
- Inadequate approaches to traceability can have a lasting, damaging impact to your brand and customer loyalty when recalls are issued or regulatory inquiries are made
Blueprint: The first step
Choosing a Manufacturing Intelligence system that has complete traceability functionality allows you to significantly reduce the time it takes to identify recalled or impacted ingredients and lot. In addition, a software solution that has the capability to aid in your compliance with regulations such as FDA 21 CFR Part 11 or HACCP, SSOP and Net Content Control provides an extra layer of protection. Traceability data provides other benefits such as determining the best source of materials by verifying supplier data before a shipment leaves their dock. Storing your quality data electronically allows you to quickly respond to customers, auditors and authorities with traceability information.
Real Problems, Real Results
Medtronic | Secondary Challenge: Delayed Improvement Cycles
Complete Traceability from Beginning to End of Production
Medtronic Surgical Technologies, the global leader in medical technology, required lot acceptance sampling functionality to streamline its recordkeeping and quality control procedures. ProFicient helps Medtronic easily manage part records and comply with thousands of related specification limits. Traceability and security features built into ProFicient make it simple to adhere to the FDA’s 21 CFR Part 11 requirements regarding Electronic Signatures. Since implementing ProFicient, Medtronic has established a consistent method of inspection control and gained the ability to monitor their production process from beginning to end. They can also perform capability analysis across the entire manufacturing operation. As an additional benefit, Medtronic drastically reduced paper consumption and save costs associated with scanning, shipping, and storage.
Alcan | Secondary Challenge: Delayed Improvement Cycles
Shares Critical Data with Customers
Alcan Global Pharmaceutical Packaging – Glass Tubing Americas, a leading supplier of vials and ampules to pharma and bio-pharma customers, faced more stringent product quality requirements as the market moved from a standard acceptable quality limit (AQL) methodology to a quality assurance plan that required 100% compliance to customer specifications. In response to the changing regulation, Alcan implemented InfinityQS ProFicient as their shop floor SPC solution. With the new system, quality personnel gained real-time results at the point of manufacture, beginning with the tube drawing operation and continuing through the vial converting and packaging processes. The manufacturing data is analyzed in real time to provide a complete picture of the production of batches and lots. If necessary, Alcan is able to generate and share detailed electronic batch records with internal and external customers that include information such as customer requirements and operator logs.
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Controlling the Impact of a Recall
Identified Tainted Products Quickly and Strengthened Consumer Trust
A manufacturer of pre-packaged dinners was notified that one of its spinach suppliers discovered E. coli in the raw spinach. At that point, a recall was initiated, requiring all affected foods to be pulled from the shelf. However, with the assistance of InfinityQS ProFicient, the company was able to quickly identify the affected products and where they were distributed. The ability to precisely track the affected spinach from the supplier was made possible through lot genealogy and by tagging products with production data (line, shift, operator) and supplier data (name, date, inspection). The ability to quickly dispose the tainted product lead to a significant decrease in E. coli exposure, strengthened brand trust and reduced the costs associated with a recall.
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