FDA

Supplier Challenge

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…

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Methods for Supplier Evaluation

There are a number of ways to conduct an evaluation of your suppliers.  To begin with, many organizations create a survey in which they outline various questions pertaining to quality systems.  Some companies consider ISO 9001 certification to be the best representation of control over production and quality, and therefore will evaluate the supplier based…

Supplier Management

Supplier Management

Companies that supply a manufacturer with components are a critical part of your manufacturing process.  If you manufacture medical devices, there are numerous requirements for control of these suppliers.  The FDA essentially considers a supplier an extension of the manufacturer, meaning that the service/material supplied must meet pre-established specifications.  According to 21 CFR 820, “Each…

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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…

Alert Lamp

Keys: Regular Alarm Checks & Preventive Maintenance

An extension of on-going support for your Continuous Monitoring (CM) system is to complete regular alarm checks and perform preventive maintenance. These two activities are vital to ensuring the integrity, quality and reliability of the system. Regular Alarm Checks Regularly scheduled alarm checks should be completed for: (1) all monitored parameters (temperature, humidity, differential pressure,…

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Environmental Monitoring

Environmental Monitoring (EM) is a basic requirement throughout numerous industries; food, cosmetics, drugs and medical devices.  It is intended to measure the cleanliness of an area, therefore verifying the biological safety of products being manufactured.  The depth of your EM program will be determined by the industry you’re in, whether or not you claim your…