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Quality has long been recognized as a necessary tool in the surveillance of complex processes in transfusion medicine. Dynamic development of transfusion medicine and continuing demand for upgrading the safety and quality of transfusion therapy have modified the perception of quality and its importance. Over decades, it has transformed from the basic quality control elements through individual and integrated quality management systems (QMS) to customer focusing, holistic approach to quality and its achievement and overall performance excellence. The extraordinary importance of quality and safety of transfusion treatment has also been recognized in the European Union legislation, where this field is regulated by a number of Directives.

The growing implementation of quality systems has entailed the need of generating a profile of professionals to be exclusively or most of the office time dedicated to the matters of quality management. Although the role and scope of work of a quality manager are influenced by the type of institution, the main responsibilities are common. Besides due knowledge, quality manager should possess a variety of skills and human qualities to be able to efficiently perform the function and tasks, to the benefit of the institution. This article does not address exclusively quality managers but all professionals covering the quality-related tasks at transfusion facilities. It is so because particular facilities differ according to their size, organization of quality system and level of its implementation. Thus, the structure of quality department at an institution depends on its size, customer requirements and expectations, types and complexity of products, role ascribed to quality, etc.

The skills of quality manager

  1. Top of page
  2. The skills of quality manager
  3. The tasks of quality manager
  4. Conclusion
  5. Disclosures

The most relevant skills to be mastered by a quality manager for efficient quality management are discussed later. It should be noted that particular skills are so intertwined and interdependent that it is almost impossible to avoid repeating some attributes on describing them, which will result in a manager of desired characteristics only if being fully integrated and harmonious.

The skill of leadership and motivation

Management and leadership are two possible ways of getting people organized. While manager employs a formal and rational approach, a leader will also include emotions. Leadership is one of the skills to be possessed by a successful manager. True leadership implies the creation of such an environment in which the people strive for continuous improvement and believe in it. Accordingly, the main task is to know how to motivate people, or better to say, how to create an environment in which they will be able to motivate themselves. Therefore, a successful leader should possess the attributes such as integrity, enthusiasm, loyalty, courage, initiative, commitment, belief and ethical quality. A leader should be capable of motivating the team, managing the projects and human resources. A manager, however, cannot act solely as a leader and should also have formal authority to be efficient. In some situations such as a highly motivated team, leadership is not necessary and may even be counterproductive.

Organizational abilities and planning

The abilities of planning, organization and priority selection are necessary for efficient task accomplishment. In particular, it refers to multiple projects management with tight terms of execution. Quality manager should be capable to cope with unexpected situations that may influence ongoing projects and to integrate new concepts in decision-making. The scope of work of quality manager is very broad, and one should admit the truth that it is impossible to cover it all by oneself. Therefore, quality manager should know how to delegate various tasks to the co-workers. Their potential will additionally develop by motivating and entrusting them with various jobs, thus further upgrading the overall productivity and efficiency.

Decision-making

Decision-making is a process of choosing among different action options. Decision-making is a daily routine and mostly simple to do. However, difficulties may emerge on making decisions to solve complex problems, in situations when we feel uncertainty, when the data available are lacking or inadequate, or when our decisions may entail serious consequences. In such a situation, it is of paramount importance to follow the structured protocol on decision-making. Each decision should be properly documented, with due explanation of having chosen this very solution.

Team work skills

Nowadays, in our dynamic work environment, the scope of tasks to cover is steadily increasing and growing ever more complex, frequently requiring expert opinions in solving particular tasks or in project performance. Thus, the companies/institutions support team work for the tasks to be solved in time and efficiently. Team functioning is influenced by a number of factors, first of all by the institution mode of management, motivation of team members and their interaction, and also by the preset project terms, its objectives, etc. Team work implies collaboration through creating a balance of different personal and professional characteristics, with due consideration of the best project and company/institution interest.

A quality manager should be familiar with team work specificities. Some organizational units in the institution may tend to close within their boundaries, which should be discouraged and such barriers removed by stimulating collaboration. This especially holds for transfusion institutions where a series of very diverse yet interdependent and closely related activities take place. Quality manager is responsible for monitoring and surveillance of the change control. This area of quality management is an ideal example of the necessity of team work to prevent any possibility for the modification in one segment to influence another segment of the process without being timely identified.

Communication skills (written and verbal communication)

By the position, a quality manager has to closely collaborate with a great number of individuals within and outside the institution. Therefore, a quality manager should preferably possess good written and verbal communication skills. Communication skills are also needed in performing team work, motivating the workers, negotiating and solving conflict situations. In addition, quality manager is responsible for reporting on the quality system. The skill of written communication including due knowledge of work on personal computer and familiarity with fundamental software options is desirable for writing reports. This skill is also required to be able to efficiently respond to complaints and inquiries, as well as for writing papers and lectures. Quality manager should be capable of information transfer and providing quality education to the workers. This requires due knowledge and skills related to educational and training techniques.

Interpersonal skills

The individuals with good interpersonal skills are able to identify optimal interaction with other people in different situations. They can control their emotions and react appropriately even in most difficult situations. Employers appreciate and prefer workers with good interpersonal skills. Proper utilization of these skills improves the institution productivity through more efficient functioning in team work, better communication and collaboration with the others, better management of conflict situations, etc.

Professional competence and emotional intelligence

Appropriate intellectual functioning, knowledge and professionalism are certainly necessary qualities of a quality manager. He/she should have thorough knowledge of the quality systems and their use in transfusion service, of legal provisions and professional standards regulating the field of transfusion service, and general knowledge of business management. However, one should not forget that emotions are an integral part of our self, and as such they play a major role in daily life. The individuals with high emotional intelligence can cope well with stress, they are self-confident and strong, respect other people’s desires, needs and emotions and possess the skill of self-control. Quality manager interacts all the time with a variety of employees and has to make decisions independently as well as within a group. Thus, emotional intelligence has considerable impact on his/her performance because it directly influences communication with a number of people, ability to solve conflict situations, the efficiency of team work, co-worker motivation and leadership.

The tasks of quality manager

  1. Top of page
  2. The skills of quality manager
  3. The tasks of quality manager
  4. Conclusion
  5. Disclosures

The tasks of a quality manager are influenced by the activities performed by the company/institution; however, some tasks are common to all.

Designing, implementation, maintaining and upgrading of QMS

The design and implementation of the QMS depend on the institution type and size, and on the type of products and services offered. The strategic quality goals depend on these factors. Implementation of a formal quality system is of special importance in companies/institutions with well-regulated products, such as transfusion service. A successful QMS is inconceivable without strong commitment of the top management for quality and continuous improvement. The institution management should set the QMS goals, form a team for quality in charge of QMS development and maintenance, define the project scope and term, ensure resources needed for the system development, implementation and continuous management, inform all employees accordingly and request support from all levels. Quality manager has the leading role in the development of QMS and in managing the project of its implementation, then also in its maintaining and upgrading. He/she thereby ensures it to be consistent with the national and international standards and legislation.

Quality planning and quality goals

Continuous product and service improvement as a basic determinant of the QMS can only be accomplished by strict implementation of quality plans. The institution managing board is responsible for the development, implementation and maintaining of the quality plan in line with the institution QMS requirements. Quality plan is developed every year. The plan defines quality strategy, quality goals, initiatives and approaches to quality improvement, along with planning the resources for their implementation. Quality manager has the key role in these activities, either as a managing board member or as a quality team member collaborating with the managing board in plan development.

Surveillance of processes and product quality

A process approach to quality management is one of the basic ISO 9000 standard requirements. According to this requirement, the institution should clearly define the processes and their interactions, with special reference to so-called key processes. These processes contribute most to fulfilment of customer requirements or institution goals. Specific quality requirements have to be defined for these processes, as well as methods of quality measurement in these processes. Transfusion medicine is a highly regulated area of medical sciences. Therefore, these quality requirements are to a great extent included in legal provisions and professional standards. Quality manager is responsible for these requirements to be strictly and consistently implemented in the transfusion medicine documentation. In addition, quality manager in a transfusion facility is the one to steer all the activities related to product and service quality. Critical incoming materials should be clearly defined and released to use under the responsibility of the person in charge of quality assurance. Through collection of relevant process data and their statistical analysis, the product and process quality is evaluated, trends are analysed, and conformity with quality goals and customer requirements is assessed. Results of statistical process control and data on product non-conformities play a crucial role in these activities.

Definitive decision on the blood component release is made by the person responsible for quality assurance at the blood establishment and is based on a documented and validated procedure specifying the conditions of blood component release.

Change control

Change control is a formal system to assess, document, approve and implement changes that may influence the final product quality or process reproducibility. Quality manager is usually in charge of monitoring the change control status and reporting to the managing board on change control performance and its efficiency.

Collaboration with customers

For the success of QMS, it is of utmost importance to stimulate good communication with the customers, to assess their needs, and to test their satisfaction with the products and services. The level of customer satisfaction is assessed by use of interviews, questionnaires, analysis of data obtained through the system of complaint management, etc. Testing of customer satisfaction by questionnaires is organized by quality manager, and priorities in product and service quality improvement are then determined on the basis of expectations and requirements thus recorded. The questionnaires used on customer satisfaction assessment should be so designed to enable result quantification. Among others, it allows for monitoring trends over time and efficiency of the corrective measures performed. Even with optimal results of quality measurement at a transfusion facility, some products and services will fail to meet the customer expectations. Therefore, efficient complaint management will produce valuable information as a basis for further quality improvement. In addition, there should be a document on the procedure of product withdrawal from the market whenever there is evidence or at least suspicion of non-conformity of the products released. It is upon the internal institution structure to determine the extent to which quality manager will be included in the activities of product withdrawal (coordination of activities independently or as part of the team, data analysis, reporting to the managing board, etc.).

Supplier assessment

One of the quality goals in a properly organized QMS is permanent and timely supply with incoming materials meeting specified quality requirements by qualified and responsible suppliers. Assessment of the supplier quality system is one of the tools to reach this goal and is usually in charge of the person responsible for quality. Besides assessing supplier qualification, this activity encourages collaboration and partnership with suppliers, stimulating them for quality improvement. Supplier assessment can be performed by use of questionnaires or by supplier auditing.

Internal quality audit

Quality manager is responsible for establishment of the internal quality audit programme. On doing it, quality manager will closely co-operate with the institution managing board, because the audits can only be timely and properly performed with due support from the managing board in terms of material and human resources. Quality manager develops annual plans of internal quality audits specifying the audit areas and responsible persons, then co-ordinates and controls their performance and monitors the efficiency of the corrective measures taken. Quality manager is responsible for maintaining and keeping records on the audits performed, including records on corrective measures and their efficiency.

Inspections and certifications

With implementation of a formal system of quality management, inspections, certifications and audits become integral parts of work at a transfusion facility, with quality manager playing a key role. Before inspection and certification, quality manager surveys performance of all necessary activities, monitors problem solving from previous inspections, provides support to the employees, motivates them and co-ordinates their activities. During inspection and certification, quality manager collaborates with inspectors/auditors by offering them the information and documentation they need. After inspection, quality manager monitors how the non-conformities and deviations detected are being solved, and how the corrective measures are performed.

Quality documentation management

Good documentation is one of the crucial segments of quality management. The way of documentation management points to the culture of quality management at a particular institution. Documentation management should be efficient and flexible to the extent that enables proper surveillance of documentation without bureaucracy. Quality manager takes active part in the development and management of the institution quality documentation. He/she participates in the development of quality policy, prepares Quality Manual and takes active role in the development of quality procedures (ISO 9001); co-ordinates and surveys the preparation of other documents crucial for proper functioning of the institution QMS; and takes care for the form of documentation to be consistent with the institution regulations. A transfusion facility should have a written protocol for documentation management. This document regulates planning, preparation, survey, approval, issuing, distribution, modification, maintaining, utilization, keeping and destroying of documents.

Quality reporting

Quality manager is responsible for quality reporting at all levels within the institution. He/she is responsible for submitting reports to the managing board on all quality aspects in the institution. Quality manager collects data to serve as input indicators, submits reports, explains the trends observed, answers questions, proposes measures for improvement, etc. Along with a review of the activities launched upon this evaluation, the quality system functioning during the study period is evaluated, improvements are proposed, and the goals and quality policy are re-evaluated as needed. Stimulating team work and involvement of all employees in the implementation of the QMS implies informing them consistently on the quality status and results achieved, and on future activities planned. Meetings with heads of particular processes should be regularly organized on weekly or monthly basis and improvements and modifications should be proposed in collaboration with them. Periodic presentations on the quality system functioning for all employees interested may prove highly useful. At the Croatian Institute of Transfusion Medicine, such meetings are held upon publication of the semi-annual and annual reports. These are best-attended meetings, indicating the high interest of the workers in these topics.

Quality improvement and commitment to business excellence

Quality manager should promote and maintain the philosophy of continuous improvement at both personal and institution level. Every change need not imply improvement. Therefore, quality manager is responsible for such a choice of projects and activities which will actually result in the product and service quality improvement. In general, on making such decisions quality manager will rely on the results of quality measurements, on the analysis of quality indicators in particular. In fact, the process of improvement begins with problem identification, exploration of underlying causes leading to the problem and search for optimal tool to solve it.

Education and training

Quality manager is responsible for initial and continuous education of employees on all aspects of the QMS. Education should be performed across the institution, from the managing board through the operative workers.

Conclusion

  1. Top of page
  2. The skills of quality manager
  3. The tasks of quality manager
  4. Conclusion
  5. Disclosures

The perception of quality and quality management has been modified profoundly over the last few decades. In spite of the huge amount of knowledge and information available on the role of quality in healthcare and on the methods of its implementation, this valuable body of knowledge is not always applied in full. A major obstacle is inadequate education of health professionals and thus their failure to adapt to the new environment. Successful implementation of the new approach to healthcare quality management at long term necessitates adoption of a new approach in the education of medical professionals.

Within the overall activities to be launched to upgrade the quality of education in transfusion medicine, due attention should be paid to education on all aspects of quality management, including proper training of quality managers to respond competently to the forthcoming challenges by their knowledge and skills.