Are robust quality audits are the solution to avoiding expensive recalls?

Tim Sandle discusses why quality management systems and robust audit facilities are critical to patient safety and product quality

Recent pharmaceutical product recalls have pointed out the need for effective quality management systems that include robust audit facilities.  The lack of effective audits, quality management systems (QMS), and in some cases malicious activity have compromised product quality and in turn, patient safety, resulting in several widely used medications being recalled.

Many companies in either new/emerging markets, or startup organizations may be familiar with the scientific aspects of product/process development but not the details of quality management and the roles that management and operational groups play.  In addition an appreciation of the details of regulatory protocols underlying GMP, ISO 9000:2015, and the need for careful documentation to support process validation and equipment qualification may be beyond their experience.  Even established organizations often overlook all of the elements of the audit process, and how auditors are increasingly looking at systems.

While these aspects may be viewed as management overhead by some, used properly, audits and controls are an effective defense of product and production quality as well as a demonstration of control over manufacturing processes.  This will help ensure customer satisfaction and patient safety, avoiding the consequences of problems uncovered during inspections that could have been detected and corrected by in-house oversight.  As noted in the new book “Audit and Control for Healthcare Manufacturers” by Tim and Jennifer Sandle  (published by DHI,

“Compliance is an affirmative indication or judgement that the supplier of a product or service has met the requirements of the relevant specifications, contract or regulation; also the state of meeting the requirements. Compliance is something that meets both the text and the spirit of a requirement.”

“If designed and implemented appropriately, audits can provide valuable information for prevention of issues.”

The goal is to catch problems before they impact product quality, and putting patients at risk.  In addition to the regulations noted, the following points will contribute to an effective audit/control program:

.  Systems-Based Audits and Inspections

.  Defining Metrics

.  Risk Based Approach to Quality Auditing

.  Auditor Techniques

.  Documentation and Reporting Techniques

.  Computerized Systems Audits and Data Integrity Requirements

Each point is developed in detail, together with practical examples and applicable regulations in the new book. The latter point has become an area of increasing attention and comment by the U.S. Food and Drug Administration as well as instrument suppliers and software vendors. 

Those who are concerned with the cost of compliance programs need to consider the ramifications of compliance failures that include expensive recall programs, the damage done to a company’s reputation, and the prospects for future business development. A sound compliance program is an asset for a well-managed organization, and the basis for continual process improvement.  The benefits of quality and compliance audits extend to and evaluation of your suppliers including vendors, contract manufacturers and key third-party partners as noted in the book.   They can prevent out-of-specification materials, data, and equipment from contaminating a manufacturing process and causing products to fall out-of-specification.

A well-designed and thorough audit and control program is both an asset to a company’s reputation and business prospects, and a means of protecting products and patient safety.  Without those internal protections you risk the consequences of putting contaminated or ineffective treatments into the healthcare system.