Manual Quality Management Essentials

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Find the cracks in your quality management processes.

In the translation from principles to prescription, inconsistencies arise. Those translating the principles into rules or requirements are often not the same as those translating the rules into a detailed prescription. Rules are often an imperfect translation of principles and yet, they are enforced without regard to or even an understanding of the principles they were intended to implement. This is no more prevalent than in local government where officials behave like robots, enforcing rules without regard to what the rules were intended to achieve.

The principles in the field of quality management have not arisen out of academia but from life in the work place. Observations from the work place have been taken into academia, analysed, synthesized and refined to emerge as.

Quality Management Essentials by David Hoyle

These principles have been expressed in many ways and in their constant refreshment the language is modernized and simplified, but the essence is hardly changed. Without a set of principles, achieving a common understanding in the field of quality management would be impossible. Since Juran, Deming and Feigenbaum wrote about quality management in the s there has been considerable energy put into codifying the field of quality management and a set of principles from which we can derive useful rules, regulations and requirements has emerged.

This chapter addresses these principles in a way that is intended to impart understanding not only in the minds of those who prefer principles to prescription, but also in the minds of those who prefer prescriptions. There is nothing intrinsically wrong with wanting a prescription.

The receivers of prescriptions need enough understanding to know whether what they are being asked to do is appropriate to the circumstances they are facing. The concepts expressed in this book embody universal principles and have been selected and structured in a manner that is considered suitable for those wishing to get some clarity in a field of knowledge that often appears contradictory. It is not intended as a comprehensive guide to quality management — some further reading is given in the Bibliography. ISO also contains concepts some of which are questionable but these will be dealt with as they arise.

The aim is to give the reader a balanced view and present a logical argument that is hoped will lead to greater understanding.

Quality Management

As the book is supposed to be about the management of quality, there is no better place to start than with an explanation of the word quality. Needs, requirements and expectations Organizations are created to achieve a goal, mission or objective but they will only do so if they satisfy the needs, requirements and expectations of their stakeholders. Their customers, as one of the stakeholders, will be satisfied only if they provide products and services that meet their needs, requirements and expectations.

Their other stakeholders shareholders, employees, suppliers and society will only be satisfied if the products and services provided to customers are produced and supplied in a manner that satisfies their needs, requirements and expectations — in other words, it makes a profit, does no unintentional harm, and is conceived and produced with due regard to prevailing legislation. We all have needs, wants, requirements and expectations.

Needs are essential for life, to maintain certain standards, or essential for products and services, to fulfil the purpose for which they have been acquired. According to Maslow,1 man is a wanting being; there is always some need he wants to satisfy. Once this is accomplished, that particular need no longer motivates him and he turns to another, again seeking satisfaction.

Everyone has basic physiological needs that. Food, water, clothing, and shelter. After safety come social needs followed by the need for esteem and finally the need for self-actualization or the need to realize ones full potential. Satisfaction of physiological needs is usually associated with money — not money itself but what it can buy.

fensterstudio.ru/components/cymadixep/zataw-restaurar-y-actualizar.php The hierarchy of needs is shown in Figure 1. These needs are fulfilled by the individual purchasing, renting or leasing products or services. Corporate needs are not too dissimilar. The physiological needs of organizations are those necessary to sustain survival. Often profit comes first because no organization can sustain a loss for too long but functionality is paramount — the product or service must do the job for which it is intended regardless of it being obtained cheaply.

Corporate safety comes next in terms of the safety of employees and the safety and security of assets followed by social needs in the form of a concern for the environment and the community as well as forming links with other organizations and developing contacts. Esteem is represented in the corporate context by organizations purchasing luxury cars, winning awards, superior offices and infrastructures and possessing those things that give it power in the market place and government. However, it is not the specific product or service that is needed but the benefits that possession brings that is important.

This concept of benefits is the most important and key to the achievement of quality. For example, now that we own a mobile telephone we discover we really need hands-free operation when using the phone while driving a vehicle. 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. 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.

Topic outline

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.


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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.

Quality Management Essentials Simplified

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. 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. 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.

Practical implications From a practical point of view, the findings of this paper provide managers with a practical understanding of the factors that are likely to facilitate TQM implementation in organisations. Please note you might not have access to this content. You may be able to access this content by login via Shibboleth, Open Athens or with your Emerald account. If you would like to contact us about accessing this content, click the button and fill out the form. Contact us. To rent this content from Deepdyve, please click the button.