Quality Management Essentials


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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.

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Quality Management

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:.

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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.

Find the cracks in your quality management processes.

Recent research published in the International Journal of Quality Research defined the critical elements of an integrated QMS for pharma. 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.

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:. 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. The industry has long embraced periodic measurement and management review of quality. 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. 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. 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.

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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.


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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. 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 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.

We're sharing our secrets with our loyal readers. Take our interactive, question self-assessment and quickly learn how to improve quality management. 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.


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  • Organizations employ QMS software to assure knowledge management and transfer. The industry adopts an integrated approach to development, manufacturing, and quality. Total Employee Involvement The late W. A academic study independently examined the eight components of ISO QMS to determine which principle had the most significant impact on quality: Customer focus Leadership Employee involvement Process approach Systemic management Continual improvement Evidence-based decision making 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.

    A quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or audit team. Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly defined internal system monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.

    Quality : management essentials

    Quality Check : Quality assurance inspectors regularly perform audits. With the upgrade of the ISO series of standards from the to series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System QMS and the results that have been achieved through the implementation of a QMS. Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas.

    For the benefit of the organisation, quality auditing should not only report non-conformance and corrective actions, but also highlight areas of good practice. In this way, other departments may share information and amend their working practices, which contributes to continual improvement. Quality audits can be an integral part of compliance or regulatory requirements. Initiated in the UK, the process is focused primarily on procedural issues rather than on the results or the efficiency of a quality system implementation.

    Audits can also be used for safety purposes. The processes and tasks that a quality audit involves can be managed using a wide variety of software and self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and conformance to standards, while others relate to quality costs or more accurately to the cost of poor quality. In analyzing quality costs, a cost of quality audit can be applied across any organization rather than just to conventional production or assembly processes.

    Reducing waste by more efficient manufacturing is a key goal of management, with supply chain sustainability seen as a key component. In industrial production, using more efficient manufacturing processes and better materials will generally reduce the production of waste. The application of waste minimization techniques has led to the development of innovative and commercially successful replacement products.

    Waste minimization has proven benefits to industry and the wider environment. Waste minimization often requires investment, which is, at least in theory, usually compensated by the savings. However, waste reduction in one part of the production process may create waste production in another part. There are government incentives for waste minimization, which focus on the environmental benefits of adopting waste minimization strategies. Colorful recycling containers : By producing using materials that are recyclable, landfill waste can be minimized. Sustainability in the supply chain is increasingly seen among high-level executives as essential to delivering long-term profitability and has replaced monetary cost, value, and speed as the dominant topic of discussion among purchasing and supply professionals.

    One of the key requirements of successful sustainable supply chains is collaboration. The practice of collaboration, such as sharing distribution to reduce waste by ensuring that half-empty vehicles do not get sent out and that deliveries to the same address are on the same truck, is not widespread because many companies fear a loss of commercial control by working with others. Investment in alternative modes of transportation, such as use of canals and airships, can play an important role in helping companies reduce the cost and environmental impact of their deliveries.

    Sustainability has been found to be a major component of supplier relationship management as an efficient way to cut costs among retailer giants such as Wal-Mart. Realizing the efficiency that effective supplier relationship management creates, Wal-Mart has asked suppliers to be more efficient in managing their environmental footprint.

    Looking to the supply chain to maximize efficiency and cut costs is a key cost-cutting measure; using the same suppliers in a tight-knit relationship saves time and energy. As industry leaders continue to add in cost-cutting measures, we are likely to see this trend continue in supply chain sustainability for sustained improvement in relationship building and cost reduction. Skip to main content. Operations Management. Search for:. Quality Management Philosophies Quality management adopts a number of management principles that can be used to guide organizations towards improved performance.

    Learning Objectives Recognize how top management can improve quality performance. Key Takeaways Key Points There are eight primary quality management principles. The principles are the basis of the ISO quality management system standard. One of the permanent quality objectives of an organization should be the continual improvement of its overall performance. Key Terms value : The degree of importance you give to something. ISO : The ISO family of standards are related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product.

    Quality Management : Process of ensuring that an organization or product is consistent. It can be considered to have four main components: quality planning, quality control, quality assurance, and quality improvement.

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    TQM Total quality management TQM is an integrative philosophy of management for continuously improving the quality of products and processes. Key Takeaways Key Points TQM functions on the premise that the quality of products and processes is the responsibility of everyone who is involved with the creation or consumption of the goods or services offered by an organization.

    Satisfying the customer involves making sure both internal and external customers are happy. The internal suppliers are the subordinates who answer to a particular supervisor. Satisfying them involves giving them the tools and motivation they need to do their jobs. It is important to go beyond satisfaction, making the customer — and supplier — feel important and valued, and part of the process. The focus of the Six Sigma management strategy is to reduce defect by minimizing variation in processes.

    Quality Inspections and Standards Companies ensure the quality of products and services by adhering to ISO standards and performing quality audits to ensure compliance. These standards are used to certify the processes and systems of an organization, but not the product or service itself. In three major standards were released as part of the ISO series.

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    Major revisions were made in A quality audit is the systematic examination of a quality system, and is carried out by internal or external auditors. It is a key element in ISO standards. Key Terms ISO : a set of standards related to environmental management designed to help organizations reduce the negative environmental effect of their operations, meet legal requirements, and continually improve International Organization for Standardization ISO : An international standard-setting body composed of representatives from various national standards organizations.


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    Founded on February 23, , the organization promulgates worldwide proprietary, industrial, and commercial standards. Quality Audit : The process of systematic examination of a quality system carried out by an internal or external quality auditor or audit team. Quality Management System QMS : The organizational structure, procedures, processes, and resources needed to implement quality management.

    ISO : a set of standards related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. Reducing Waste and Environmental Impacts Reducing waste by more efficient manufacturing is a key goal of management, with supply chain sustainability seen as a key component. Learning Objectives Explain the benefits of reducing waste.

    Key Takeaways Key Points Waste minimization is often achieved through more efficient manufacturing processes and the usage of better materials, but often requires some initial investment.

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