Title: Effective quality management within an organisation requires four key attributes: 

1) The understanding of the importance of quality 

2) The ability to define quality with regards to users’ requirements 

3) A focus on the users’ end result 

4) The ability to reflect and continually evolve based on changing user requirements

These attributes need to be embedded within the culture of organisation.”

How does this relate to quality management processes in an organisation known to you and to your own personal understanding of quality?

Introduction

Quality is defined in the eye of the beholder. There are three elements to providing superior value for organisations in both the public service and in manufacturing. These are making products and services more attractive to customers, keeping costs down and improving delivery performance and responding to customers’ changing needs. Continual improvements of all three elements is necessary to have a total quality approach in the provision of products, processes, services and costs. Quality is measurable using statistical process control, benchmarking, and quality tools. Quality should be part of the organisation and not just the inspection of products. It requires the performance of procedures in line with standard operating procedures by all staff. The continual improvement and review of processes is required in order to compete and keep up with the ongoing changing needs of customers.  (Goetsch and Davis, 2014). Quality statistical tools will help to identify areas for improvements as well as receiving constant feedback from suppliers and customers involved. Team work, customer feedback, employee empowerment, lean programmes and six sigma tools have become wide spread in organisations as performance improvement tools including in the healthcare services and hospital laboratories. (Oakland, 2014)

2.0 Importance of Quality

Quality is an absolute requirement for a successful organisation. Organisations recognise the importance of gaining and maintaining a good reputation in order to have success into the future. A quality system in a Medical Laboratory is recognised by the presence of the ISO15189 stamp on patient reports. This indicates the laboratory performed testing to the accreditation standard ISO 15189. Quality is everywhere as we know from all our own personal experiences of buying an item in a shop. As quality conscious customers we look for quality marks such as CE standard marks or for Bord Bia quality marks on foods to indicate their origin and standards achieved in production. On purchase of an item or a service the expectation is, it will meet or fulfil the requirements it is intended for. If the item or indeed the service falls short of the expectation then it is considered to be of inferior quality. For quality to be achieved the requirements of the customer need to be identified in order to meet them and to go over and above these requirements. However, with quality comes a price and for the majority of organisations the focus is on keeping costs down in order to increase profits. This needs to be balanced with the necessity to integrate quality into the organisation in order to meet the exact needs of the customer. Otherwise the success or reputation of a business is damaged as we observe on a continual basis with businesses such as Ryanair, where strikes occur and instantly profits and reputation for reliability are damaged or with the reputation of companies such as Volkswagon when their product was found to not actually be as described in meeting CO2 emission standards. In any organisation it is essential to have a quality department at the centre of the organisation to ensure their role is accessible to all and provides an overall umbrella service to all areas of the organisation.  The organisational chart shown in fig.1 for a microbiology hospital laboratory shows the central role of the quality manager to microbiology in relation to the staff within the department and also the relationship of the quality manager to the overall management of the hospital. In The hospital laboratory diagnostic tests are requested for patients by clinicians both within the hospital and externally by General Practitioners in the community. The customer in this organisation exists in many areas. The clinician is the main customer with the patient as the main beneficiary.  However there is also internal customers which are the staff working in the laboratory to bring about the results and also the healthcare service provider which brings all the services together in the care of patients.

Figure 1.  Organisation & Management Structure of the SUH Microbiology Department

2.0 The ability to define quality with regard to users requirements

Quality is based on the ability of any organisation to meet or exceed its customers or users expectations. Quality applies to both internal customers which may be supplying goods or services to other employees and external customers or users. Within a hospital laboratory environment the internal customers include other employees who you are supplying with your work and external customers include all of those customers who are receiving patient results and ultimately the patient. The focus of any organisation needs to always be on the customers/ users end results such as the product or service provided in order to achieve and maintain high quality. For success quality management needs to be embedded in the organisation through leadership by top management and have total staff buy in to ensure it becomes a part of the culture of the organisation. Today companies such as toyota use a staff suggestion  system where up to 900,000 workers submit improvement ideas each year in order to bring about continual improvements in a very successful organisation. (Saferpak, 2006)

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Quality has been defined by many pioneers of the concept. Boeing defined quality as “Providing our customers with products and services that consistently meet their needs and expectations”.  W Edwards Deming discovered quality. He believed “Quality should be aimed at the needs of the customer, present and future”. The Japanese accepted his view in the 1940,s and later it was accepted in the US in the 1980’s . An analogy with a three legged stool shows the requirements for customer focus in total quality management in figure 2. 

Fig 2 The Three legged stool of total quality (Goetsch and Davis, 2010)

Moreover, Goetsch and Davis (2013) describe quality as a “dynamic state associated with ]products, services, people, processes and environments that meet customers’ needs and expectations and help produce superior value”. (Goetsch and Davis, 2013). It is important for a hospital laboratory that each sample is processed in a way that keeps the patient at the centre of the process at all times ensuring a culture of putting the needs of the patients is foremost.  The philosophy of W E Deming applies to a laboratory as he created a Deming cycle and 14 points in response to variation fig. 3

Fig 3. Deming’ s 14 point plan for Total Quality Management (Illusion of management blog, 2018)

This list describes best what inhibits quality progress in a laboratory or any organisation. He believed reductions in variation would improve reliability, dependability, predictability, and consistency of products and services. This would therefore improve quality and reduce costs. The Deming cycle introduced a method of implanting continuous quality improvements  by applying a plan, do, check, act and analyse cycle.

Josesph Juran taught quality principles to the Japanese in the 1950s and defined quality as “ fitness for use”. He believed quality required three steps for progress. These were structured improvements on a continual basis, an extensive training programme, and have commitment and leadership at higher management. The Juran trilogy describes his key message which is relevant the implementation of total quality management today. The Juran trilogy consists of quality planning which ensures a process is capable of meeting quality goals, quality control which measures quality performance against a standard and acting on any differences and quality improvement which is finding ways to do better than the standards. These can all be identified as part of the ISO 15189 which is the standard implemented in medical laboratories nowadays to ensure quality of testing.

Philip Crosby was another American quality pioneer. He defined quality as “conformance to requirements”. Crosby had a fourteen point plan which describe how an organisation can achieve continual quality improvements and as with Demings these have been put in place in many sectors of the economy. (Stanley, 2013) The modern day approach to quality is similar to the approaches of these pioneers as Lean  attempts to eliminate non value added time and Six sigma is designed to reduce variation. (Oakland, 2014) These approaches need a managerial infrastructure to be in place first. A strategy proposed for a continuous improvement culture to be implemented in most organisations with a top down set of objectives is proposed in fig 4 (Oakland, 2014)

Fig 4. An overall approach structure for continuous improvement. (Oakland,2014)

Leadership and top down cascade of objectives

Supporting infrastructure

Fact based methodology yielding rapid results using proven techniques, that are fact and data based

Have skilled improvers in the organisation

Widely shared continual improvement structure

Circulation of talent

Measurable improvements

Sustained improvements

Clearly from this approach a system of management needs to in place in an organisation such as a laboratory before the implementation of quality improvements if they are to be achieved. A culture of fear will inhibit any process as well as barriers between departments which exist in hospital laboratories as each department takes on their own entity. Targets such as turnaround times also inhibit the process as these are in place for sample processing and recognised as key performance indicators for emergency samples. A programme for continual education of staff is required and training is necessary but may be cut short due to resource constraints. (Oakland, 2014)

3.0 Focus on Users end results

The focus on the results aspect of quality is of paramount importance. However, for a total quality approach the focus needs to be broader and look beyond the result. The quality of the people producing the results, the quality of the systems and processes, and the environments in which the results are produced are all equally required for success. This becomes apparent when two similar products are produced by two different companies. The one that concentrates on continual product improvement or continual staff improvement by training and education will be the most successful in the long term. (Davis and Stanley, 2013) For a hospital laboratory to ensure a clinical sample is given the correct result and is delivered to the right clinician at the right time it is necessary to have quality and quality assurance activities in place and to implement a quality management system. (Glencross, 2010). This requires training staff, adherence to regulations and standards and the performance of quality controls, audits training and competency assessments.  The quality of results produced from an organisation such as a laboratory accreditated to the ISO15189 produces results in a consistent manner and must continue to do this to maintain the accredited standard. The ISO 15189 is more than a tool to meet accreditation requirements. It is implemented to create systems that are error proof, to identify improvement ideas and to empower staff in the problem solving process. It requires the performance of regular internal audits of the quality management system. These audits examine both the management and technical requirements as well as the examination, and pre and post examination processes. Non-conformances in technical areas can highlight deficiencies in the laboratory quality management system and wider process problems. A root cause analysis is performed to resolve nonconformities. There is a continual requirement for document control as it is paramount to ensure all procedures are up to date and actually specify the processes that are in place. Risk are also identified and assessed on the basis of impact to patient and the necessary controls put in place to eliminate the risk or control it by error proofing the process. Management review and quality meetings take place on a regular basis to review internal audit results, quality data, improvement ideas, customer complaints and regulatory updates. (Schneider, 2017)  

A “driver” frameworkis in use for continuous improvements in many organisation as it includes improvements in the process of going from a problem to the solution. This consists of the following and brings together Lean, Six Sigma and cost approaches. (Oakland,2014)

Define the goals of the process in terms of the customer requirements

Review the processes

Investigate any gap between the current and required performances and identify root causes

Verify the improvement processes to fix the problems

Execute or Implement the improvement ideas

Reinforce by re assessment of the processes

In the quest for quality it is necessary to record, measure analyse and use data gathered on a frequent basis to identify trends and act upon any outliers. The presentation and analysing of data can be carried out using process mapping or flowcharting. The use of tools such as control charts, root cause and effect analysis, regression analysis and pareto analysis can be employed in the analysis of processes and identification of areas in need of improvements. The people responsible for any changes required in a process needs to be the team involved in carrying out the process. (Oakland 2014)  Statistical process control can be used to check and analyse a process is meeting its requirements. (Fereday, 2015)  In a laboratory organisation a reduction in the variability of processes is necessary to improve quality. The presence of Sop s which are prepared to meet the requirements of the Iso 15189 ensures all staff are processing samples in the same way. It also ensures all equipment and analysers have maintenance procedures carried out in the same way.  However, there is always going to be variation in materials and operators which SPC can identify and this requires continual striving for quality improvements to reduce variation. Delivery operators use control charts to monitor late deliveries. Pareto analysis will quickly identify the major causes of a problem so that resources can be focused on the cause of issues with the most potential for improvement. Pareto analysis is used to look at complaints about a system. Bank staff use root cause and effect analysis to identify problems in the output of services. (Stanley and Davis, 2013)

In a hospital laboratory quality controls both internal and external are run in line with patients tests to ensure the correct results are obtained. The statistical methods of Shewhart were first used in industry to monitor assays and equipment performance. These were adapted for use in clinical laboratories by Levey and Jennings where a quality control chart is used with westgard’s rules applied to determine whether patient results can be released when the control is within range. The quality system in place increasingly in laboratories conforms to the accreditation standard ISO 15189. Frequent audits of processes and work performed take place and are described as vertical horizontal or witnessed audits. A yearly visit from INAB (Irish National Accreditation Board ) assessors takes place where an audit is performed and major or minor non- conformances are found. The factors which affect the quality of work in the laboratory work environment include not only the quality management system but the relationships and team work of individuals and the work environment. The overall clinical governance of the laboratory requires professional registration of Biomedical Scientists with continuing education through continuous professional development, participation in internal and external quality assurance schemes and external accreditation of other departments. (Pitt and Cunningham, 2013).

4) The ability to reflect and continually evolve based on changing user requirements

An organisation with a quality improvement process in place will need to consider the costs

as it is necessary to have higher prevention costs in order to prevent low quality or defective

products reaching the external customers. The cost of poor quality is significantly greater

than the cost of maintaining a quality management system, and furthermore the reputation of

a business or a hospital laboratory is easily damaged and takes a long time to rebuild or

even established. Many models of cost analysis are in place the original one implemented by

Dr Jospeh Juran in 1950 and the PAF (prevention, appraisal and Failure) model by

Feigenenbaum in 1956. This model separates costs into prevention costs, appraisal costs

and internal and external failure costs.

In order to improve on a continually basis an organisation such as a hospital laboratory must

strive for excellence. Performing to achieve customer satisfaction is necessary to meet the

requirements of a standard such as ISO15189. However, for an organisation to achieve

overall excellence the results, processes and financial outcomes need to be continually

improved. The EFQM (European Foundation for Quality Management) was established in

1988. A model of excellence was designed by the team that set up the EFQM to enable

organisations to carry out self assessment by identifying the strengths and weaknesses in

achieving overall excellence in quality of the organisation. It requires the involvement of

people in improving processes. (Oakland,2014) The enablers of this model

are leadership, people, policy and strategy, partnership and resources and processes. The

results achieved are in the areas of people, society, key performance, and the customers of

the organisation. Some of the society results include survey completion which is

performed in hospital laboratories by asking general practitioners to fill out a survey on their

satisfaction of the laboratory service. Customer results include complaints received, error

rates and press coverage which are all indicators of the organisations performance. This

Model allows comparisons with other organisations using a score card and can be externally

assessed leading to an award in excellence. The establishment of an excellence programme

in a hospital laboratory clearly requires not only a focus on the quality  

standard ISO 15189 but also a focus on improving customer results by reducing complaints

or a reduction in waste and improving key performance indicators .

 The Three C ‘s of communication, culture, and commitment are the keys to total quality

management in any organisation and are required for long-term success. (Oakland 2014)

A culture in an organisation is formed by the behaviours occurring from staff interactions,

the dominant values of the organisations and how people get on with other. It is largely to do

with how employees behave and are treated and how business is

performed. ( Oakland 2014) This is very important in healthcare as poor communication is the

cause of the majority of incidents and complaints within the health service. (Sale,2005) A TQM

approach is about all staff getting it right first time and every time and not passing errors on to

someone else. As pointed out by W. Edwards Deming events are not always caused by

individual negligence, and he reported 94% of errors “belong to the system”. ( Graban, 2012)

Mistakes in all areas of healthcare can be devasting and life-threatening. Clearly the cost of

poor quality care is higher than the cost of good quality care. (Sale, 2005) Many hospital use

lean methods to improve quality and patient safety. An example of a lean culture in a hospital

environment is described by Graban 2005 where a low medication error rate was present in a

nursing unit. It was found that the nurse present failed to record medication errors due to the

method on the computer system being too complex, so she openly reported this to the

information systems department and requested they improve the system to make it simpler

to report medication errors. (Graban, 2005) Tools such as root cause analysis and failure

modes and effects analysis (FMEA) are helpful to identify and prioritise errors that could occur

in a process rather than reacting after an event. For the success of a lean culture

in a hospital laboratory it needs to be guided by management and have collaboration between

individuals from different units even though there are divisions due to control and finance.

Other reasons for a lack of success of a lean culture include a failure by leaders to adapt it in

full and create a blameless environment and fears for job security as well as a focus on cost

reductions over quality improvements. (Samuel & Novak-Weekley, 2014) 

The failure to provide quality medical service has been identified as due to deficiencies in

organisational, financial and delivery systems. (Institute of Medicine, 2001) 

In the development of an organisation such as a hospital laboratory with a total quality

approach it is clearly necessary to develop a non-hierarchical team for problem solving and

to delegate responsibility for change. It is also paramount to develop good procedures for

communication and develop effective communication methods. (Taylor 2010)

There is a need to focus on the expectations of all customers and to continually examine procedures and processes to ensure waste is minimised and procedures are meeting the ISO 15189 standard in place. An on-going review of all processes is required to develop a culture of perpetual improvement. Every member of staff needs to participate in the quality process and needs to be loyal to the department and hospital and provide support to other staff and colleagues to deliver high quality cost effective care and services. (Sale, 2005) Improving quality depends more on leadership, culture and creative processes than on any specific technology or tool. A shift in an employee environment of blaming is required to one where learning from errors occurs and a root cause analysis is carried out. The knowledge gained can be used to prevent future errors and to promote a culture of proactively eliminating all preventable errors through checklists, standardized work, training and error proofing methods in the attainment of improving the overall healthcare system. Leaders in all areas of healthcare have a responsibility to set an example of daily behaviours that lead to quality improvement. Training in tools and standardised work practice is required, however creating a culture of safety, quality and root cause problem solving is critical for the success of any healthcare organisation. (Graban, 2005) An environment where change and improvement is tolerated requires a culture of innovation where staff are given the tools techniques and support to enable them to take ownership of improving quality of care. (Taylor, 2010) Going forward health care quality strategies needs to focus on patient- centered, evidence-based, transparent models of care as a standard part of the Health Service. (Institute of Medicine, 2002) It is acknowledged that a change in mindset is required for this to occur and progress is unfortunately slow in this area as clearly it requires an overall cultural change in Health Service Provision.   

Bodek, N . Kaizen Continuous Improvement A Three legged stool (TQM -Lean -Quick and easy Kaized ) Saferpak 2006 http://www.saferpak.com/kaizen_art1.htm accessed

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Oakland, John S. (2014)  Total Quality Management and Operational Excellence : Text with Cases, Routledge, ProQuest Ebook Central,13, 266-287 https://ebookcentral.proquest.com/lib/ulster/detail.action?docID=1682288.

Glencross,H, Ahmed,N, Wang, Q and Wang, Q. (2010) Biomedical Science Practice: experimental and professional skills  Oxford University Press.19: 656-683 Elaine Moore Quality assurance and management ProQuest Ebook Central

https://ebookcentral.proquest.com/lib/ulster/detail.action?docID=1591546.

Davis, Stanley, Goetsch, D.L. (2013) Quality Management for Organizational Excellence Pearson New International Edition : Introduction to Total Quality, Pearson Education UK,. ProQuestEbook Central,

https://ebookcentral.proquest.com/lib/ulster/detail.action?docID=5137873.

Pitt, Sarah Jane, and Jim Cunningham. (2013) An Introduction to Biomedical Science in Professional and Clinical Practice, Wiley,. ProQuest Ebook Central,

Sale,D. (2005) Understanding Clinical Goverance and Quality Assurance Making It Happen. Palgrave MacMillan. Monitoring Performance and Organisational Quality Assurance  11, 159-197

Graban,M Lean Hospitals Improving Quality, Patient Safety and Employee Engagement. (2012)  2nd Ed. CRC Press, Proactive Root Cause Problem Solving ch7 111-129.

Fereday S. (2015) A Guide to Quality Improvement methods. Produced for the Healthcare Quality Improvement Partnership (HQIP) by Det Norske Veritas and Germanischer Lloyd (DNV GL).:26-28 https://nhfd.co.uk/20/hipfracturer.nsf/b83841ab51769e1d802581a4005978ed/205c2976b502ffc2802581ee0053a23f/$FILE/HQIP%20guide%20to%20QI%202017.pdf

Accessed 02/11/2018 Taylor, JRA . (2010 )The Handbook of Quality And Service Improvement Tools NHS Institute for Innovation and Improvement . 8.4 291-294  http://www.miltonkeynesccg.nhs.uk/resources/uploads/files/NHS%20III%20Handbook%20serviceimprove.pdf Accessed 02/11/2018

Samuel, L., & Novak-Weekley, S. (2014). The role of the clinical laboratory in the future of health care: Lean microbiology. Journal of Clinical Microbiology, 52(6), 1812–1817. http://doi.org/10.1128/JCM.00099-14

Institute of Medicine (US) (2001) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US);. Available from: https://www.ncbi.nlm.nih.gov/books/NBK222274/ doi: 10.17226/10027 accessed 02/11/18

Schneider, F., Maurer, C., & Friedberg, R. C. (2017). International organization for standardization (ISO) 15189. Annals of Laboratory Medicine. http://doi.org/10.3343/alm.2017.37.5.365 7 Accessed 02/11/2018

ISO 15189. Medical laboratories – Requirements for quality and competence.  (ISO 15189:2012) Geneva, Switzerland: International Organization for Standardization; 2012. file:///C:/Users/helen/Downloads/BS%20EN%20ISO%2015189-2012–[2018-11-02–04-32-32%20PM].pdf Accessed 02/11/2018.

The Illusions of management https://theillusionofmanagement.blog/2018/01/07/driving-out-fear-the-hidden-risk/ accessed 03/11/2018