Quality Culture- Everybody wants it, and many say they have it. It begins with a diagnosis…
Table of Contents
Flash Back To 1964
Joseph Juran was born in December 1904 and died in February 2008. Many of us who began our careers in quality all know who he is and may still have a copy of his quality handbook on a shelf in our office or at home.
Many consider him the modern-day father of “Total Quality Management.” For Juran, “people” and their resistance to change were the root cause of quality issues.
Juran published this work in “Managerial Breakthrough,” published in 1964. Juran was the first to write about the cost of poor quality. Juran defined Quality Culture as,
“A culture throughout the organization that continually views quality as a primary goal. It is the pattern – the emotional scenery – of human beliefs, habits commitments, awareness and behavior concerning quality.”
Fast Forward To 2014
One of the thought-leading articles regarding Quality Culture was published in Harvard Business Review in 2014. “Creating a Culture of Quality” was written by Ashwin Srinivasan and Bryan Kurey in April 2014; in this article, they stated,
“Today, companies must create a culture in which ALL employees “live” quality in all their actions—where they are passionate about quality as a personal value rather than simply obeying an edict from on high. We define a “true culture of quality” as an environment in which employees not only follow quality guidelines but also consistently see others taking quality-focused actions, hear others talking about quality, and feel quality all around them.”
Srinivasan and Kurey conducted extensive research into the subject of Quality Culture. In their article, they went on to state,
“Most notably, many of the traditional strategies used to increase quality—monetary incentives, training, and sharing of best practices, for instance—have little effect.
Instead, we found, companies that take a grassroots, peer-driven approach develop a culture of quality, resulting in employees who make fewer mistakes—and the companies spend far less time and money correcting mistakes.”
They defined ‘true culture of quality’ as,
“an environment in which employees not only follow quality guidelines but also consistently see others taking quality-focused actions, hear others talk about quality, and feel quality all around them.”
In 2014, Srinivasan and Kurey surveyed over 800 employees across multiple industries. Here is what they reported:
- A minority of the employees believed their company had succeeded in making quality a core value.
- Roughly 60% said they worked in an environment without a culture of quality.
They postulated such companies are missing out on significant benefits:
- Employees who ranked their company in the top quintile regarding quality reported addressing 46% fewer mistakes in their daily work than employees in bottom-quintile companies.
- Employees reported that it took two hours, on average, to correct a mistake. Assuming an hourly wage of $42.55 (the median for the companies surveyed in 2014), a bottom-quintile firm with 26,300 employees (the median head count) spent nearly $774 million a year to resolve errors, many of them preventable—$350 million more than a top-quintile firm.
Although figures will vary according to industry and company, here’s a broad rule of thumb: For every 5,000 employees, moving from the bottom to the top quintile would save a company $67 million annually. That was in 2014 dollars across many industries.
Today
Let me pick up where we just left off and ask you a few questions:
- How much time does the average Deviation or CAPA Investigation take in a Pharmaceutical, Bio-Pharmaceutical, or Medical Device Company?
- How many Deviations occur per year?
- How many CAPAs do you have open today?
- What is the average time needed for each, and how many team members are assigned each?
- How much does ALL of that cost?
I could ask many more questions, but you see the point.
Today, we have endless opportunities and face many challenges across the Pharmaceutical, Biopharmaceutical, and Medical Device Industries. As company objectives, product Quality, and Product Safety continue to be front and center across these industries, expressed in company credos, vision statements, mission statements, and quality policies. There is intense pressure in the Pharmaceutical, Biopharmaceutical, and Medical Device Industries to reduce new product development launch and supply chain cycle times and continuously reduce prices. As if these two pressures were not enough, the complexity of regulations in these industries is increasing globally.
As a result of these pressures, companies in these industries must find a new approach to quality that moves beyond the traditional “total quality management” tools (Lean Manufacturing, Six Sigma, Quality by Design, etc.) of the past 25 to 50 years. The “total quality management tools” companies have deployed have resulted in incremental improvement. Still, they have not enabled the transformation needed in today’s Pharmaceutical, Biopharmaceutical, and Medical Device companies to meet the challenges we face in these global industries.
The FDA discusses Quality Culture openly in various settings, and many significant industry associations and consulting firms have developed “tools” to assess quality culture. In the report requested by the US Congress on the root cause of drug shortages, one of the root causes was a lack of robust Quality Culture in the firms reporting drug shortages.
Developing and sustaining a mature quality culture is challenging. Many firms have created goals to improve their quality culture, conducted surveys and assessments of their current quality culture, and initiated programs to improve their quality culture.
Few case studies have been published on achieving the goal of improving and sustaining a High-Quality Culture in the Pharmaceutical, Biopharmaceutical, and Medical Device industries. A large amount of benchmarking has been created to date from the surveys/assessments available, but none of these data indicate whether the data obtained to date represents a true “high-quality culture.”
In addition to the data itself not providing sufficient data for a profound diagnosis of the quality culture, most organizations that supply quality culture assessment tools do just that: they provide data. The quality of the assessment is directly related to the extent to which they designed the evaluation to get a diagnosis of the Quality Culture. Many of the current Quality Culture diagnostic tools are focused on assessing the maturity or the health of the Quality Management System, gaps in execution of the Quality Management System, or the symptoms of a poor Quality Culture.
Once the data is available, it is often reported against benchmarks. This tells the organization where it is against its competitors. Being in the upper quartile of the average or less than average is not excellent. It does not tell the organization which behaviors or unwritten norms and rules are getting in the way of achieving the stellar performance companies achieve when they have a deeply rooted, values-based, High-Quality Culture.
Assessing the Quality Culture of an organization should be like having a complete physical examination. Tests are conducted, results are obtained, and results are presented against a range where bad, average, and above average are delineated. When the results are given at the end of your physical exam, you know what organ systems are in good standing, which need more attention, and which require remediation.
Recommended Process for Quality Culture Assessment
Many of the available surveys/assessments are not designed to identify the current norms and values an organization holds for quality; they do not gather sufficient data on the behaviors observed across all functions and all levels within the organization, from top to bottom.
Instead, many existing survey/assessment tools focus on the outputs or metrics of various quality system elements. Some ask about the focus management places on quality, and a few quality culture assessment tools probe to some degree into the behaviors observed throughout the organization regarding quality in general.
Characterizing and understanding culture in general is very difficult. It requires an assessment process and tool(s) that gather information and data on what people at all levels perceive about Quality. What behaviors do they observe regarding Quality in a broad context? What “value” do people “understand” the organization holds for Quality?
Quality Culture Assessment Tool
The Quality Culture Assessment Tool should ask for data and information regarding Quality Culture in the context of the business itself. It should also provide scenarios and real-life situations that are part of the “daily fabric” of a Pharmaceutical, BioPharmaceutical, and/or Medical Device Company. General questions that apply to any industry or type of business will not yield answers that deeply diagnose the quality culture in a Pharmaceutical, BioPharmaceutical, and Medical Device Company.
Figure 1 above presents an overview of the Quality Culture Assessment Process.
Sources of Additional Data and Information
The Assessment Process should include more than an online Assessment Tool; it should include data and information in confidential interviews, focus groups, etc. These data provide valuable examples and help the leaders of the organization deeply understand the behaviors observed, the perceptions employees have, and the value the organization has for Quality… how the value for Quality impacts decisions when financial or product supply issues are front and center… when the organization is stressed.
Based on the data obtained, looking further into key quality measures/outputs and some of the systems and processes currently in place may be helpful.
Once all the data from Assessments, Focus Groups, interviews, and other sources of data are reviewed, the leaders within the organization should review the data to understand the current quality culture and evaluate how this compares to what is desired. Before finalizing the analysis, the organization should capture as much information as is needed to understand what drives culture to enable it to plan and implement specific actions to build the desired culture and avoid a generic and scattered approach.
Recommended Assessment Tool and Process
Companies have many choices for Quality Culture assessment. Compliance Architects® has assessed many of the options available and has done a deep review of the research on culture assessment and culture development, with a focus on Quality Culture. Based on this research, we have developed a quality culture assessment and assessment process called Quality Pulse®.
What is Quality Pulse?
Quality Pulse is an end-to-end solution that provides a robust assessment of the quality culture’s “as-is ” state. It has been designed for the life sciences and FDA-regulated industries.
The Assessment Tool yields deep, rich data that is easy to understand and points directly to opportunities for improvement in a direct manner. A team of industry experts developed the questions and scenarios presented in the survey, and they have over 100 years of combined experience in pharmaceutical, biopharmaceutical, and medical device companies. They are based on scenarios that occur in these companies daily.
There are questions that are numerically scored and open-field questions that allow the employees to provide direct feedback and examples; they are asked to share the behaviors they observe and the value they believe the organization has for Quality. Responses to the open-field questions are aggregated using AI/NLP tools to identify themes and key messages.
These are used to better understand your Quality Pulse® scores in your company’s business and organizational environment.
Following the administration of the Quality Pulse® Assessment Tool, confidential interviews and focus groups are conducted, and other sources and types of data and information may be reviewed.
The Diagnosis Is In… Now What?
When all of the data from the Quality Pulse® Assessment Tool, confidential interviews and focus groups, and other sources and types of data/information are analyzed, a full summary report is prepared and presented to the organization’s senior leaders. The senior leaders develop their action plan, which includes how they will communicate and cascade the results down into their organization(s).
Are the senior leaders left to do this alone or with their often-overburdened HR team? NO!
Continuum Consulting Partnership
Compliance Architects has developed an alliance with Continuum®. Continuum® is a consulting firm that has successfully enabled companies to achieve transformational change in the life sciences FDA-regulated industry. Their approach is fully aligned with our approach at Compliance Architects®.
We collectively believe that a science-based, data-driven approach combined with feedback delivered positively and compassionately enables leaders at all levels to envision and act on the path forward to creating and sustaining a Culture of High Quality. It allows the leaders to energize and help the entire organization work together on concrete actions to realize the benefits of a robust Quality Culture.
Companies that ingrain Quality into their whole being instead of treating it like a one-off project experience all the benefits of reduced deviations and incidents, product recalls, and tarnished reputations. Only a holistic approach can yield a Culture of Quality that truly becomes a key element of their brand—one that is trusted and treasured by Healthcare Practitioners, Caregivers, and Patients.
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