Electronic Quality Systems Can Reduce Cost of Recalls

July 21, 2008

Switching from paper-based quality systems to integrated, electronic systems could lower recall costs for devicemakers, a quality system expert says.

When a major medical device company that used a paper-based quality system needed to recall a batch of product, it was forced to initiate a large-scale recall because its system could not readily provide data on specific batches, Chris Parsons of Camstar, a provider of manufacturing execution and quality systems, said in an interview.

The firm’s reliance on paper records caused the elements of the quality system to be disconnected or fragmented, making it difficult for the company to access critical information, he added.

“They couldn’t find the needle in the haystack, so they had to recall the entire haystack,” he said. “As a result, they lost market share to a competitor and hundreds of millions in lost sales and market capitalization on top of recall expenses.”

A “closed-loop system” could reduce a manufacturer’s exposure by telling it exactly which products are at risk or prevent issues altogether, Parsons said. Thus, a company could do a limited recall, saving money and credibility. A closed-loop system involves electronically connecting information from the sourcing, manufacturing, quality, design and engineering departments. It creates a centralized repository of manufacturing and quality data, allowing trends and problems to be detected before adverse events occur.

Parsons noted that the FDA is moving from reactive to proactive postmarket surveillance as evidenced by its Sentinel initiative, which targets device safety. Electronic quality systems may help manufacturers mirror the FDA’s shift and move from a reactive to a proactive approach to their own postmarket activities.

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July 18, 2008

The FDA issued 74 good manufacturing practice (GMP)-related warning letters to device firms last year, 84 percent of which contained citations for Corrective Action Preventive Action (CAPA) system deficiencies.

FDA Focusing:

  1. On CAPA system deficiencies
  2. On right to review all CAPAs even when companies begin them as a result of internal audits


CAPA management is integral to meet the FDA’s expectations and its GMP regulations. More than just a regulatory requirement, effective CAPA management also is a good business practice that can reduce company liability and warranty claims and increase customer satisfaction.


Effective CAPA systems reduce regulatory risk by managing and streamlining the quality-reporting process.


  1. Reduces bad inventory
  2. Generates fewer regulatory warnings and recalls, and
  3. Increasing company profits and customer satisfaction

More here>>