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Quality Manufacturing Safety in Pharma & Biotech

Quality and Safety Have A Lot in Common

Quality Management - 22 March 2017

Aside from the obvious moral obligation, most organizations in the Life Sciences industry invest in safety programs for very sound business reasons:

  • Employees are an organization’s most valuable resource, and ensuring their safety also safegaurds the organization’s value
  • Similarly, while there is an ethical duty to produce quality products, there are tangible business benefits to product quality in regard to both brand value and minimizing the cost of failure

A good safety program, like a good quality program, starts with documented procedures and training of employees. This training must be effective and reviewed periodically in both cases.

In a good safety program, the practice of job hazard analysis that anticipates risks can help to prevent problems before they occur. Similarly, training in good manufacturing practices (GMP) provides a framework in which employees can avoid mistakes that may lead to quality issues, i.e., understanding that having materials contact the floor is not acceptable can cause potential contamination issues.

"A good safety program, like a good quality program, starts with documented procedures and training of employees. This training must be effective and reviewed periodically in both cases."

John Carkner
Sr. Consultant, SOLABS QA & Best Practices Unit

Safety issues (near misses or accidents) are very much like deviations (major, moderate or minor) in that they reflect a failure of the programs to prevent them. A Quality Management System (QMS) can capture both, as well as manage corrective and preventive actions (CAPA) required to improve the programs.

Trend analysis is important in safety management, based on the historical evidence of a pyramid of incident severity [example pictured below], with minor incidents building to more serious incidents. Similarly, annual product review and statistical analysis of quality parameters can identify risks to maintaining a state of control in production. In both cases, the result of the analysis is a deeper understanding of the process, and the potential to minimize risk.

Example of a Incident Severity Pyramid for the Life Sciences
An example of an incident severity pyramid.

When safety hazards are identified, just as when quality deviations occur, an effective corrective action is crucial to rectifying the issues. Both safety and quality are also subject to periodic internal and external audits, and the effectiveness of corrective actions is an important determinant of the outcome of the assessment.

Perhaps the greatest fundamental similarity between quality and safety programs is that they rely on engaged employees in the organization to buy into the importance of the program. Providing employees with the training and insight necessary to understand the programs, implement them and improve them, is critical to success.

Related Articles
June 16, 2017: Top 10 Quality & Best Practices Blogs of the Last Year
Apr. 26, 2017: Issue Escalation: 5 Tips for Communicating with Senior Management
Feb. 1, 2017: FDA Contract Manufacturing Guidance and EQMS
Jan. 4, 2017: Product Documentation: Essential to an Effective Quality Program

About the Author
John Carkner is Senior Consultant in SOLABS’ Quality Assurance & Best Practices Unit and has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.

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