Do you currently measure your Quality Culture?

by TLM

Proactively Responding to OPQ’s Upcoming Shift to Assessing Pharma Company Quality Cultures

The Office of Pharmaceutical Quality (OPQ) and their “One Quality Voice” strategy mean regulatory compliance has become the baseline for pharma supply chain. Starting next year, just complying will be insufficient to receive a passing grade. This document explains the background of the quality culture assessment process, its implications on you, and how you can be prepared to pass the test.

The New Office of Pharmaceutical Quality (OPQ)

CDER (Center for Drug Evaluation and Research) created the Office of Pharmaceutical Quality (OPQ) to strategically organize and streamline regulatory processes, advance regulatory standards, align areas of expertise, and originate surveillance of drug quality. The FDA is now poised, largely through the creation of the OPQ, to promote “One Quality Voice” through the integration of review, inspection, surveillance, policy, and research to strengthen pharmaceutical quality. The OPQ has made it clear that they want the Pharmaceutical Industry to “up” their game. Regulatory compliance is now just the baseline and will be insufficient to receiving a passing grade from the FDA.

Why Have the FDA Made This Change?

  • Product recall and defect reporting data demonstrate unacceptably high occurrences of problems attributed to inherent defects in product and process design.
  • The FDA no longer considers inspections a reliable means to predicting product quality.
  • Quality Metrics being used today such as Lot Acceptance Rate (LAR), Product Quality Complaint Rate (PQCR) and Invalidated Out-of-Specification (OOS) Rate (IOOSR) do not predict quality; they are lagging indicators of quality.

What Does This Mean for You?

  • The FDA is requiring organizations to measure their Quality Culture quantitatively and directly.
  • The OPQ will require that you use leading quality indicators to measure your organization’s commitment to quality and to measure your Quality Culture.

What Do You Have to Gain from this Change?

  • Reduced product recalls.
  • Fewer product defects.
  • Eliminate or minimize unanticipated drug shortages.
  • Reduced safety stock, less inventory to carry.
  • The Office of Pharmaceutical Quality will publicly acknowledge your organization as a leader that is setting the bar for other companies to emulate.
  • By closing any gaps in your quality culture, your supply chain performance will be improved, with benefits to patients, reduced cost and improved efficiencies.

What You Have to Lose?

  • Although your company may be GMP compliant, you will not know if the quality culture is sufficient. (Even if your company is GMP compliant, you learn where your quality culture is sufficient and where the gaps exist.)
  • You will not be able to accurately predict quality, only to assess the quality system by traditional metrics (lagging indicators).
  • Your competitors that embrace the new philosophy of quality culture will be the leaders in the industry and held up as an example for the rest of the industry.
  • Because the leading quality indicators will not be employed, you will have more difficulty, and spend more resources improving the quality culture because there is no clear mitigation path.
  • By measuring lagging indicators, you will continue to employ the costly trial and error approach to continuous improvement.
  • Possible 483 can result and depending on the product risk assessment, it could lead to more frequent inspections.

How Do You Prepare to Satisfy the New Quality Culture Requirements/Pass the new Assessments?

  • You need to know if your quality culture is sufficient and where it has gaps.
  • To do this, you need to measure your quality culture.
  • You need to know where you score on the leading quality indicators being used to predict quality?
  • You need to identify what you are doing to intentionally improve your quality culture?
  • You need to then know if you are improving your Quality Culture?

Compliance Insight’s Predictive Product Quality (PPQ) Service Enables you to Respond to OPQs new Approach

  • Through a robust process of cause and effect analysis and influence mapping, twenty-six leading quality indicators have been identified by an expert task force of over twenty industry thought leaders.
  • These 26 leading quality indicators are used as the basis to measure an organizations sentiment and alignment, across functions and throughout every aspect of the organization.
  • A series of sophisticated algorithms (developed by Nobel Prize winner Thomas P. Schelling) are used to create “Big Data “clusters that point to areas of misalignment or deficiency and ultimately leads to a mitigation road map (7-step process involving a dynamic triage approach).
  • All functions and all levels of the organization weigh in so it is truly a comprehensive measurement.
  • Provides data that reveals unknown risks and pre-failure knowledge that was never available before.
  • Assigns quantitative values to the organizations quality culture and cross-functional alignment.


  • You will have a better understanding of the quality culture of your organization and therefore have a baseline that will determine if your quality culture is sufficient.
  • It will be made clear where there is alignment, misalignment, and degree of sentiment regarding the implementation of the leading quality indicators.
  • A mitigation path and an action map will be the result of the process with timelines and accountability.
  • You will have a baseline moving forward of the quality culture that is quantifiable and therefore you will be able to measure improvement, or decline in the culture.
  • You will have a strong answer when the FDA asks; “What is your quality culture and how do you measure it?”

What is the ROI: Because the PPQ model prioritizes deficiencies in the quality system, and identifies functional misalignment across the organization, it produces an action map (with timelines and tasks assignments) that clearly outlines the necessary steps to mitigation. When looking at budgets, management can decide with confidence where resources should be spent. The “Big Data” that is generated simplifies the decision-making process and funds will be allocated effectively and therefore eliminates the risk of spending dollars in the wrong areas. The other cost-justification is reduced rework, higher production, predictable scheduling, and other improvements as a result of a better quality culture.

For more information please contact Compliance Insight at 513-860-3512 or email

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