Friday Facts – 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…

Friday Facts – 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…

Friday Facts – Environment 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…

Friday Facts – Deviations

A deviation is described as a departure from an approved procedure or specification.  It represents a failure to meet requirements in the manufacture of product, in-process specifications or production requirements.  There is a difference between a planned or unplanned deviation.  Planned deviations have been approved before execution, whereas unplanned deviations (also called incidents) are technically…

Friday Facts – GMP Failure Investigations

Investigations (also known as GMP Failure Investigations) are a requirement of 21 CFR 820.  It is expected that medical device manufacturers immediately conduct an investigation on all non-conforming or out-of-specification (OOS) products.  There are three phases to an effective investigation process: Phase 1: As soon as a non-conformance happens, the individual performing the task should…

Friday Facts – Preventive Action

The next logical discussion is the second half of the Corrective and Preventive Action (CAPA) subject.  According to ISO 9001 section 8.5.3, Preventive Actions identify and eliminate the causes of potential nonconformities in order to prevent occurrence.  These are proactive measures, instead of the reactive steps taken for a Corrective Action. The main goal for…

Friday Facts – Corrective Actions

Corrective Actions (CA) are another critical aspect of a quality management system.  These are improvements made to a process or product in order to eliminate the cause(s) of non-conformances.  The concept of CAPA (corrective and preventive actions) is discussed in 21 CFR 820.100, ISO 9001 (clause 8.5.2) and GMP. Corrective Actions can be initiated in…

Friday Facts – Non-Conformances

Both 21 CFR 820 and ISO 9001 require a company to have control over their non-conforming product.  According to the FDA, “each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.”  Essentially, a company must have a procedure in place that addresses the identification, documentation, evaluation, segregation and…