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Preventive Maintenance

Preventive maintenance is a concept that includes care and servicing of equipment for the purpose of keeping equipment in a satisfactory operating condition.  It is designed to improve equipment life and avoid any unplanned maintenance activities.  This is accomplished through a systematic inspection, detection and correction of any developing failures before they occur.  Preventive maintenance…

Clean Room

Control of Equipment

As part of a company’s quality management system, there must be consideration for the equipment used within the facility.  According to the FDA’s 21 CFR 820, “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained.”  They also have the requirement that all inspection, measuring and test…

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Supplier Challenges

Anyone has the ability to review the FDA database of 483’s, warning letters and FDA statements.  Upon reviewing that information, there are essentially eight areas where companies are facing challenges in regards to supplier oversight: Confusion between internal and external suppliers – There has always been confusion in determining whether a company’s other site(s) or…

Poultry

Poultry Regulations

New Pathogen Reduction Performance Standards for Salmonella and Campylobacter The Food Safety and Inspection Service (FSIS) is responsible for verifying that the nation’s commercial supply of meat, poultry, and egg products is safe. Salmonella and Campylobacter bacteria are among the most frequent causes of foodborne illness, and these bacteria can reside in the intestinal tract…

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Management Representative

The FDA has a requirement, in 21 CFR 820.20, for a Management Representative.  This individual “irrespective of other responsibilities, shall have established authority over and responsibility for:  Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and Reporting on the performance of the quality system to management with…