02.7.2019 Robert Fenton

The 8 Essential Elements of Quality Management For Pharmaceutical Companies

Total Quality Management, or TQM, is a management philosophy designed to continuously improve the quality of manufactured products and improve customer satisfaction. While TQM wasn't designed for pharma or highly regulated industries, it has a lasting influence on current good manufacturing practices (cGMP), ISO standards, and FDA ICH Q10 guidance for pharmaceutical quality systems.

Many best practices for quality management at pharmaceutical organizations are nearly 100 years old. The 1911 book ‘The Principles of Scientific Management’ by mechanical engineer Frederick Winslow Taylor provided the first framework for quality in industrial organizations, including the use of inspections and clearly defined tasks performed under standardized conditions.

In the 1920s, manufacturing organizations began to adopt the widespread use of statistical methods for total quality assurance, a practice which was refined in Japan in the 1940s and '50s by legendary quality pioneers Deming, Juran, and Feigenbaum.

“Total Quality Management” formally gained traction in the 1980s when global organizations began adopting quality initiatives modeled after successful programs in Japan. Nearly four decades ago, TQM practices were based on familiar principles such as focusing on the customer and continuous improvement cycles.

Quality management theory and practice have evolved significantly since its earliest roots in 1911 and been adapted into frameworks and guidance to meet the needs of highly regulated industries. While Winslow Taylor's statistical controls were a profound development, early manufacturing approaches to TQM aren't comprehensive enough to meet the needs of today's pharma companies. Today's most effective Quality Management Systems (QMS) for pharma simplify complex cGMP and compliance requirements to drive TQM.

8 Elements of Quality Management for Pharmaceutical Companies

The new quality paradigm for pharma, as defined by the ICH Q10 guidance, is a risk-based framework. Organizations are encouraged to move beyond the use of GMP checklists to embrace TQM practices which span the product development lifecycle. Per this guidance, the standard for quality management in pharma are:

  • Quality is built into processes instead of improved with additional testing or inspections.
  • Rigorous, modern science is used throughout the product lifecycle.
  • Quantitative risk management is used to enable effective decision-making.
  • Organizations employ QMS software to assure knowledge management and transfer.
  • The industry adopts an integrated approach to development, manufacturing, and quality.

The ICH Q10 principles are a clear extension of ISO standards for Quality Management Systems and TQM practices which have been refined across industries over the past century. If you're evaluating QMS for pharma, you are probably aware that systems designed for TQM in manufacturing or other less-regulated sectors are unlikely to meet your rigorous requirements.

To learn more about QMS for pharma, we recommend 13 Revenue Boosting Benefits of a Quality Management System.

While compliance with FDA and ISO standards is a necessity, there’s value in a system which supports traditional TQM principles in a pharma setting. An effective quality management system should offer several core features to promote the adoption of a customer-focused culture, employee involvement, and other QMS principles in highly regulated industries.

1. Customer Focus

“Striv[ing] to exceed customer expectations” should be the primary focus of a quality management system, according to ISO. Organizations achieve success when they earn customer confidence and use every customer interaction to create value. Understanding the customers' needs in the present and future is a necessity for success. A customer-focused culture can offer a host of benefits including greater brand valuation, customer loyalty, and increased market share.

Pharmaceutical companies are facing extraordinary pressure to adapt to changing market conditions, including the shifting role of the patient in healthcare. Medical technologies are enabling pharmaceutical customers to engage deeply with their healthcare providers, personal health data, and treatment plans. Simultaneously, advancements in the life sciences field have created an increasing amount of possibilities for patients to receive personalized care.

Innovative pharmaceutical organizations that adopt a customer focus can gain an enormous advantage with new approaches to research and development. The use of big data on patient populations can reveal emerging opportunities to strengthen patient engagement. One pharmaceutical company that launched a digital companion app for rheumatoid arthritis patients saw drug sales increase 8%.

Establishing a strong focus on the customer has clear benefits for quality driven organizations in any industry, especially in verticals such as pharma where customer expectations are changing rapidly. The long-term sales performance of a drug is closely tied to market performance during the first six months after release, according to McKinsey research. Providing a differentiated, personalized customer experience can be a determining factor in whether a newly released drug captures market share.

While many industry execs understand the value of creating a customer-obsessed culture, emulating the efforts of customer-centric brands like Apple has been harder to achieve. Some of the factors behind the pharma industry’s struggle to focus on the customer are very pragmatic--it’s near-impossible to pivot products or achieve true organizational agility in product development in such a highly regulated industry.

Startups and scale-ups in the pharmaceutical industry often have an advantage when it comes to establishing a customer-centric culture. Many firms in the R&D phase of the product lifecycle were founded based on a passion for helping patients and haven’t yet lost sight of the customer journey. This genuine desire to help patients should be integral to pharmaceutical QMS. An effective PQS should encourage pharma companies to make decisions to improve the quality of products and the speed of delivery.

2. Total Employee Involvement

The late W. Edward Deming is considered a pioneer of TQM practices in Japanese manufacturing. While he’s best known in pharma as the Father of the Deming cycle for continuous improvement (Plan-Do-Check-Act), his contributions to the field of quality management included a relatively radical view of employees. In his 1986 book “The Deming Management Method,” he proposed the idea of self-directed teams in a quality-driven environment. Deming believed that management’s role was to provide workers with the necessary tools to do a job. The employee was responsible for continuously improving the job without close supervision.

Within Deming's framework for quality-driven management, management is responsible for empowering employees. He proposed that employees are ultimately responsible for quality, and argued that true continuous improvement could not be achieved unless leadership provides workers with the resources needed--including training, development, and recognition. Deming argued that employees must view quality as a personal goal instead of a leadership initiative.

Every employee at a pharma organization has an impact on the company's ability to deliver a quality product, from research scientists to janitorial staff. Quality isn't a checklist, a goal of the management team, or the responsibility of the quality unit. It's a core component of the culture which should be owned by every member of the organization. To involve employees in improvement, a pharma QMS should create an empowered and knowledgeable workforce through practical training, collaboration tools, and clear channels for communicating opportunities.

Research confirms a clear link between employee involvement and quality management practices in the pharma industry. A 2015 academic study independently examined the eight components of ISO 9001 QMS to determine which principle had the most significant impact on quality:

  1. Customer focus
  2. Leadership
  3. Employee involvement
  4. Process approach
  5. Systemic management
  6. Continual improvement
  7. Evidence-based decision making
  8. Mutually beneficial supplier relationships

The researchers performed interviews and statistical analysis of 40 large European pharmaceutical companies and discovered employee involvement is the single factor which is crucial to the success of all other QMS principles. Training, communication, empowerment, rewards, and recognition are effective means to engage the workforce in positively impacting quality results. The Perfect Quality Assurance Plan for Pharmaceutical Companies

3. Process-Centered Approach

A process-based approach is a core principle of ISO quality management systems with increased impact on pharmaceutical QMS. According to ISO, “consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes.” The standards organization states process-centered management supports continuous improvement, predictable results, and efficient performance.

A process-centered approach involves the development of clear SOPs for every role and responsibility in the organization, but it also requires pharma organizations to shift their focus to the entire product lifecycle. Historically, pharma manufacturers were able to place the responsibility for quality on partnerships in the supply chain. If the test results for a raw material were good, your company could move on. Recent updates to cGMP have shifted the regulatory burden to the pharma company to ensure quality standards throughout the product lifecycle.

Process-centered Quality Management Systems are crucial for regulatory compliance in pharma, particularly at organizations that rely on entirely outsourced manufacturing partnerships. A PQMS software should provide transparency throughout the product lifecycle and clear guidance for supply chain partners to adopt a risk-based approach to quality management. Pharma organizations should consider whether a PQMS supports process-centered best practices, including:

  • Conducting supplier risk assessments
  • Performing supplier audits
  • Monitoring, documenting, and reviewing supplier performance
  • Establishing written quality guidelines and SOPs for suppliers

4. Integrated Systems

Quality Management Systems consist of a framework for the governance of interrelated processes. Transparency throughout the product lifecycle is necessary to TQM. An organization can only optimize products and performance by understanding how a system produces results. Transparency of information can be supported by a comprehensive QMS software which complies with cGMP and ICQ10.

Recent research published in the International Journal of Quality Research defined the critical elements of an integrated QMS for pharma. Based on ISO guidance and cGMP, researchers determined that an integrated pharma system must support:

  • Quality policy
  • Personnel
  • Development and implementation
  • Production
  • Documents
  • Facilities and equipment
  • Self-inspection
  • Management responsibilities
  • Evaluation of suppliers and purchasing
  • Supplier production and analysis
  • Risk analysis
  • Monitoring and control
  • Complaints and recalls (CAPA)
  • Measurement, analysis, and improvement

In addition to an eQMS which is integrated with processes for manufacturing, clinical research, and development, the software should support ease-of-use and scale as a pharma company grows without requiring resource-intensive revalidation.

5. Strategic and Systematic Approach

Leadership is integral to a strategic and systemic approach to quality-driven organizations. The management team is responsible for refining the organization's vision, disseminating this purpose, and encouraging employees to engage with quality goals. In a pharma company, the leadership team is tasked with creating a culture of quality and inspiring excellent performance.

A strategic approach to pharma leadership allows a company to become more forward-thinking. Instead of focusing on immediate objectives, management review efforts are driven by a clear roadmap for clinical development. Decisions are made based on accurate documentation for risk management and clear quality objectives.

A QMS plays a core role in helping pharma companies take a systemic approach to achieving both short-term and long-term quality objectives by providing transparency, ease-of-access to information, and improving communication. An eQMS can support strategic leadership with:

  • Coordination of processes across the organization
  • Support for real-time collaboration and communication
  • Training and education to help every member of the organization improve quality

6. Continuous Improvement

Continuous improvement is critical to the success of organizations in any industry. For pharma companies, constant improvement is likely imperative to survival. The pharmaceutical industry is under intense pressure to meet strict regulatory requirements and pricing pressures while evolving to meet changing customer expectations. A formalized approach to improvement can allow organizations to meet standards while capturing new opportunities consistently.

Efforts to improve in pharma should focus on developing greater internal efficiencies, meeting current and emerging customer requirements, and adapting to meet changing market conditions. A QMS software can enable leadership to create improvement objectives and discover opportunities based on real-time data sources such as customer satisfaction, complaints, market research, audits, records, employee feedback, and other data sources.

A pharmaceutical QMS can enable continuous improvement by:

  • Providing a centralized system for creating improvement objectives
  • Elevating employee education on SOPs, best practices, and improvement goals
  • Assessing employee training performance to assure competency
  • Encouraging employee collaboration on improvement efforts
  • Tracking and auditing progress toward meeting quality standards

7. Fact-based Decision Making

“Evidence-based decision making” is among the core principles of ISO, who writes “decisions based on the analysis and evaluation of data and information are more likely to produce desired results.” Driving quality improvements and effectively addressing nonconformances requires organizations to use data and analytics to determine root cause relationships and potential consequences.

Data-driven decision making isn’t a new concept for pharmaceutical companies. The industry has long embraced periodic measurement and management review of quality. “Traditional batch processes” and yearly reviews enabled pharma companies to avoid “deep involvement with day-to-day minutia,” writes Jude Konzelmann. What's new, however, is the clear focus in ICH Q10 for companies to shift to risk-based management methods based on real-time data insights.

Pharmaceutical executives are now required to make decisions based on data throughout the product lifecycle. A QMS must provide the comprehensive picture and analysis capabilities to avoid the risks of N=1 assumptions. Data can help leadership decide where change makes sense and when immediate changes are necessary to protect product quality.

Change is costly, but the quality risks from incomplete analysis can be even more expensive for pharmaceutical organizations. A QMS system should provide a full scope of data from a variety of sources to help the quality unit and leadership identify a root cause among SOP changes, manufacturing shifts, or other factors. Pharma Quality Management Systems should provide transparency into both drivers and outcomes to measure impact.

8. Communications

Effective relationships and communication are crucial to achieving the alignment of people, processes and technology. Systems for communication should support real-time, productive dialogue between leadership, quality, employees, and third-party organizations in the supply chain. Recent shifts in regulatory responsibility have made it more critical than ever for pharmaceutical organizations to communicate effectively with members of the workforce and suppliers located around the globe.

To support relationships in a quality-driven organization, ISO advises companies to "pool and share information, expertise, and resources with relevant interested parties," provide success metrics and channels for feedback, and refine methods for collaboration. While a QMS software for collaboration and document management isn't strictly necessary, a cloud-based system can significantly improve the success of communication initiatives.

eQMS systems should support regular communications with global stakeholders around product quality and statuses. Communications should be easily monitored and simple to distribute based on role. A QMS should offer ease-of-use for end users with simple search features and mobile access to real-time collaboration.

How a Quality Management System Helps You Achieve TQM

TQM is a “management philosophy which seeks to integrate all organizational functions...to focus on meeting customer needs and organizational objectives,” according to Six Sigma’s definition. Quality Management Systems for TQM have been successfully applied for over seven decades to improve quality, customer satisfaction, and profitability at organizations in the manufacturing and life sciences fields. While TQM isn't a new objective for pharmaceutical companies, achieving true total quality assurance is more difficult than ever due to complex market conditions.

A QMS is key for pharma companies to create a significant cultural shift characteristic of TQM adoption. A QMS should encourage organizations to comply with ICH Q10 and ISO guidance for universal quality principles such as a customer focus, employee involvement, and a process-centered approach. Pharmaceutical QMS must also accommodate unique industry requirements to achieve these core quality principles and other requirements by providing all the features necessary to comply with cGMP, maintain global quality control, and achieve continuous improvement. 

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Published by Robert Fenton February 7, 2019
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