Guidance

Failure Mode Affect and Analysis

Failure Mode Affect and Analysis

FMEA is an acronym that stands for Failure Mode Effect and Analysis which is a method for determining any and all possible points of failure in a design, process, or product. This is a combination of Failure Modes, which is a way in which something could potentially fail and result in defects, and an Effects Analysis which determines the consequences of those failures. During this, failures are prioritized by how serious their consequences are, their frequency, and how they are detected. Failures are eliminated based on their priority, starting with the higher priorities.

The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1] The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.

Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Managing Risks

Managing Risks

All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis., the same goes with medical devices.

The Significance of Design Controls

The Significance of Design Controls

In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.

Paperwork: The Necessary Evil

Paperwork: The Necessary Evil

No one genuinely enjoys doing paperwork. At best, people may dislike paperwork less than other parts of their jobs. Yet the FDA requires a certain amount of paperwork to document processes and results for the medical devices under their jurisdiction

Product Failures and Root Cause Analysis

Product Failures and Root Cause Analysis

In one’s personal life, many people just shrug their shoulders, and go about their day; however if a multi-million dollar investment, or someone’s life, is on the line, engineers need to take steps to prevent it from happening again.

Introduction to the Seven Basic Tools of Quality

Introduction to the Seven Basic Tools of Quality

Ishikawa collected the seven most powerful methods for solving problems in manufacturing quality….

Making Quality Systems Work for You

Making Quality Systems Work for You

If your QMS does not have the proper elements, personnel are not appropriately trained, or your firm does not really value the advantages of your QMS, you will likely not reap the same reward.

No Quality System Required: Quality Management for Unregulated Industries

No Quality System Required: Quality Management for Unregulated Industries

By the time I began work as a Quality Engineer for The Gillette Company, in the early 1980’s, I had worked for several other organizations. None of them had Quality Management Systems, or a ‘QMS’

Customer Needs vs Requirements

Customer Needs vs Requirements

Understanding customer needs and their requirements is critical for an organization to stay in business and are often used interchangeably. Yet, they are not the same.

Cost and Schedule are Qualities

Cost and Schedule are Qualities

One of the first things I learned about quality management was that quality, cost and schedule were interrelated.

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