Creating & Sustaining a Quality Culture: Introduction
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Creating a Quality Culture in Pharma, Biotech and Clinical Trials Companies

Creating & Sustaining a Quality Culture: Introduction

Quality Management - 21 September 2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit

In July 2015, the U.S. Food & Drug Administration (FDA) published the Draft Guidance for Industry entitled, Request for Quality Metrics, requesting public comment on whether to give establishments the opportunity to submit additional, optional metrics as evidence of manufacturing robustness and a commitment to quality.

Data from these optional metrics may merit a reduction in inspection frequency. In addition, the FDA intends to consider whether these metrics may provide a basis for the FDA to use improved risk-based principles to determine the appropriate reporting category for post-approval manufacturing changes, with emphasis on encouraging lifecycle manufacturing improvement.

Two of the optional metrics the FDA is considering are in the area of an organization’s quality culture:


FDA acknowledges the importance of quality culture to the overall state of quality of the 453 product, process, and commitment to quality. We also recognize that many companies measure 454 quality culture and encourage this practice. FDA is proposing the following metrics for 455 comment:

  • Senior Management Engagement: A corporate commitment to quality has been identified in multiple public forums as a strong indicator of a robust PQS. FDA recognizes the difficulties in measuring senior management engagement and support of quality, including manufacturing and facility improvements. Proposed Optional Metric 1 is intended to identify whether senior management with the resources and authority to implement changes are engaged in the assessment of product quality, as well as whether there is shared knowledge of this assessment with the quality and manufacturing organizations.
  • Proposed Optional Metric 1: Was each APR or PQR reviewed and approved by the following: (1) the head of the quality unit, (2) the head of the operations unit; (3) both; or (4) neither?
  • CAPA Effectiveness: A comprehensive corrective action and preventive action program 471 has been identified as a strong indicator of a robust quality culture. Continual improvement is based on preventing the initial occurrence (preventive action) or recurrence (corrective action) of a detected nonconformity or other undesirable situation. FDA has observed that less robust quality systems often rely on preventing recurrence solely through personnel re-training (i.e., the same training has already been provided to the employee(s)), while more robust quality systems consider re-design and re-development of the process. Comments are requested on proposed Optional Metric 2 and alternative approaches.
  • Proposed Optional Metric 2: What percentage of your corrective actions involved re-training of personnel (i.e., a root cause of the deviation is lack of adequate training)?

Over the next three blogs, I will provide practical ideas and examples on how to communicate and sustain a quality culture.


Other Blogs in the Creating & Sustaining a Quality Culture Series
Creating & Sustaining a Quality Culture: Part 1 – Living the Values
Creating & Sustaining a Quality Culture: Part 2 – Making an Impact
Creating & Sustaining a Quality Culture: Part 3 – Internal & External Messaging

About the Author
John Carkner 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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