TOTAL INVOLVEMENT IN QUALITY – A STEP TO ISO/IEC 17025 ACCREDITATION

Author: Dr. E.J-L. Ablorh, Chief Scientific Officer, Lab QA/QC

Ghana Standards Board
Accra Ghana
ABSTRACT
ANOTHER NAME FOR THIS TITLE IS TOTAL QUALITY MANAGEMENT AND ISO/IEC 17025. ISO/IEC 17025 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF CALIBRATION AND TESTING LABORATORIES IS A STANDARD SETTING OUT CRITERIA FOR A QUALITY MANAGEMENT SYSTEM FOR A LABORATORY. IT TRANSLATES AND INTERPRETS THE GENERALLY FORMULATED ISO 9000 STANDARDS ON QUALITY MANAGEMENT SYSTEMS AND HAS BEEN SPECIALLY DEVELOPED FOR LABORATORIES. THE FIRST EDITION (1999) OF THE ISO/IEC 17025 WAS BASED ON TWO OTHER STANDARDS, ISO /IEC GUIDE 25 AND EN 4500, BOTH OF WHICH IT REPLACED.

THE ISO 9001 STANDARD IS BASED ON EIGHT PRINCIPLES WHICH UNDERPIN THE ORGANISATIONAL AND MANAGEMENT REQUIREMENT OF THE ISO/IEC 17025 STANDARD. A LABORATORY THAT IS ACCREDITED TO ISO/IEC 17025 IS SAID TO ALSO SATISFY THE REQUIREMENTS OF THE EIGHT PRINCIPLES OF THE ISO 9001 STANDARD.

THE ISO/IEC 17025 STANDARD IN ADDITION TO THE MANAGEMENT REQUIREMENTS PROVIDES TECHNICAL REQUIREMENTS. THESE REQUIREMENTS SEEK TO ADDRESS TECHNICAL COMPETENCE OF CALIBRATION AND TESTING LABORATORIES AND ENSURE THE DOCUMENTATION OF PROCEDURES AND DEVELOPMENT OF SKILLS, TECHNIQUES AND METHODS THAT WILL ASSURE CUSTOMERS OF TECHNICALLY VALID RESULTS. THE REQUISITES FOR A LABORATORY TO ATTAIN THIS STANDARD ARE COMPETENT STAFF AND MANAGEMENT SYSTEMS.

THERE IS THEREFORE THE NEED FOR A LABORATORY MOVING FROM THE TRADITIONAL CULTURE OF WORK TO A CULTURE OF TOTAL QUALITY- A CULTURE THAT OPTIMISES QUALITY AND COMPETENCE - TO GO THROUGH TRAINING AND ORGANISATIONAL REFORM THAT LEAD TO TECHNICAL COMPETENCE OF STAFF.

THIS PRESENTATION ANSWERS THE QUESTION 'WHAT IS TOTAL QUALITY MANAGEMENT AND WHY TESTING LABORATORIES SHOULD BE INTERESTED IN IT'. IT PROVIDES THE CONCEPTS AND APPLICATION OF TQM TOOLS AND PRACTICES FOR ORGANISATIONAL REFORMS.

THE PRESENTATION OUTLINE CONSISTS OF:
1. VOICE OF THE CUSTOMER
2. STATISTICAL WAY OF THINKING
3. GROUP WORK
4. PDCA
5. KAIZEN
THE PRESENTATION IS DESIGNED TO DEVELOP UNDERSTANDING OF GROUP WORK, CAPACITY BUILDING, ORGANISATIONAL LEARNING AND CONTINUOUS IMPROVEMENT.

1. INTRODUCTION
In general quality management is viewed as composed of two related systems – the management system and the technical system. The management system is concerned with planning to meet customers' needs, organising resources, managing for continuous improvement, and facilitating employee involvement. The technical system refers to the variety of tools, practices and techniques for the implementation of a quality system.

An excellent and practical standard for Total Quality Management is BS 7850:1992. (1) The standard is of two parts. The first part (Part 1) is a guide to management and is referred to as the soft part and the Part 2 - Guide to technical principles - refers to the hard part of total quality management. The Soft aspect relates to the personnel working for the company and involves studying how they work and the psychology of the work in general. The Hard aspect refers to the variety of tools practices and techniques which are available to quality improvement or problem solving groups. TQM is therefore, both a comprehensive managerial philosophy and a collection of tools and approaches for its implementation.

The ISO/IEC 17025 (2) standard in addition to the management requirements (clause 4) provides technical requirements (clause 5). These requirements seek to address technical competence of calibration and testing laboratories and ensure the documentation of procedures and development of skills, techniques and approaches (methods) that will assure customers of technically valid results. The basic requisites for a laboratory to attain this standard are competent staff and a comprehensive management system.

A discussion about competence is a discussion about quality. Therefore a shift from the traditional culture of any laboratory to a culture of total quality – a culture that optimises quality and productivity, one that facilitates capacity building to meet local and global demands for technical competence - is not over stated.

So 'What is Total Quality Management and why should testing laboratories be interested in it'?

Total Quality Management is a structured system for delighting internal and external customers by integrating the business environment, continuous improvement, and breakthrough.

The features of this definition which commend it are:

i) The emphasis on a structured system; this include, people, processes and systems.

ii) It sees customer satisfaction as a key to success

iii) It is supported by a business environment – infrastructure, practices and tools

iv) It makes quality and continuous improvement a central management concern.

v) Break through brings benefits to management, employees and society in general.

In addition to focusing on customer needs and seeking to discover what those needs are, the other emphasis is on improving every aspect of the company operations. Therefore to address the question 'What is Total Quality Management and why testing laboratories should be interested in it' This presentation provides the basic TQM concepts, tools and practices and illustrates how to link these concepts, practices and tool for capacity building by creating an environment for total quality, competence and continuous improvement. It must be emphasised here that Total Quality is not an

esoteric, pedagogical matter. In any organisation, quality is everybody's business and the customer is the principal judge for quality.

2. WHO IS THE CUSTOMER?
A firm or an organisation must recognise that the internal customers are as important in assuring quality as are as external customers who purchase the product. In any production (manufacturing/ service), the customer is the next process in producing a good or service. Thus they are not just the end users. In order to satisfy and delight the customer a company should understand the near-term and longer-term customer needs and expectations and translate these needs and expectations into product/service specification.

3. VOICE OF THE CUSTOMER
Customer requirements as expressed in the customers own terms, are called the voice of the customer. The voice of the customer is a feedback on what the customer is saying about your product or service. However the customer's meaning is the crucial part of the message. The customer may speak in a code and it is up to the researcher to decode the voice of the customer to technical specification. In customer needs analysis, there is always the need to turn intuitive ideas to facts i.e. manageable data (information). The seven simple tools named 7 QC tools and the seven management and planning tools (7 New tools) are indispensable in turning numerical data and verbal data respectively into information Figure 1.

Figure 1.Turning numerical data and verbal data into information

4. NEEDS ANALYSIS
Customer satisfaction results from providing goods and services that meet or exceed customer needs. Any customer-driven firm or organisation would ensure that customer needs and expectations are translated into output during the design, production and delivery processes. True customer needs and expectations are called expected quality. Expected quality and expectations are what the customer assumes will be received from the product. Actual quality is the outcome of the production process and what is delivered to the customer. Actual quality may differ considerably from expected quality. This difference happens when information gets lost or is misinterpreted from one step to the next. A further complication comes from the customer who sees and believe the quality of the product (perceived quality) as considerably different from what he actually receives (actual quality). The different levels of quality can be summarised by a fundamental equation:

Perceived quality = Actual quality – Expected quality

In addition to technical quality characteristics of a product, customers have other needs and expectations throughout the lifecycle of product purchase and use. A common summary of quality

requirements is technical-Quality (Q), Cost (C) and Delivery (D) and these summarise the customer needs as expressed in the answer to the following question:

What is Laboratory Quality Assurance?
''Laboratory Quality Assurance is everything that is done by a laboratory to meet the customer's needs. It starts with the definition of the customers needs and ends with the sending of an accurate, simple and useful test report within the required cost and time''.

The words to consider in the above explanation are those representing the three quality indicators:

Q = Technical quality (accurate, simple information and useful test report)

C = Required cost
D = Required delivery time
The standard ISO/IEC 17025 is a quality assurance model for laboratories. It prescribes the requirements for Laboratory Quality Assurance for a testing laboratory.

Another illustration is found in the mandate of a customer-driven laboratory, which states thus:

We Analyse Quickly, Accurately and Cheaply; choose two.

An interpretation of this exhortation means- If a customer wants an accurate result at a require time, then he cannot have it cheaply. On the other hand if the customer wants a report to be accurate and cheap then he cannot have it on time and so on. But the ultimate goal of any customer –driven laboratory should be the case where the laboratory can boast of analysis carried out accurately, quickly and cheaply. This satisfies Crosby's assertion for zero defects - 'Do it right the first time' (3). To get to this position a laboratory has to work on its quality system, the technical competence of personnel, its methods and protocol. These requirements are satisfied in laboratories that are accredited to the ISO/IEC 17025 standard.

(5) STATISTICAL WAY OF THINKING
TQM requires that managers learn new languages that must be spoken throughout the organisation, with participation by all employees. Another name for the above heading is statistical methodology. The first major component of statistical methodology is the efficient collection, organisation and description of data, commonly called descriptive statistics. Frequency distribution and histograms are used to organise and present data. William Wiggenhorn, one time corporate vice president for training and education at Motorola, discussed the need to teach the new language of quality to all 102000 employees of his company. (4) Deming also promoted similar education in statistical thinking. In addition to the language of statistics, 'new dialects' have been developed by marketing and customer service experts. Meeting the needs of customers necessitates statistical thinking and the application of new tools and vocabulary to gather, analyse, interpret and act. This includes the use of metrics rather than measures, percentages instead of numbers and mean, mode and standard deviation to analyse for position and spread of a population.

The QCD function is used in translating the voice of the customer into product specification and processes. It is applicable to both manufacturing and services. In manufacturing the product flow is followed. For example, technical-Quality may be measured as first pass yield (no defects) or expressed as percentage of warranty claims. Cost would be measured as process value added or value to cost and Delivery, by process down time or process cycle time. In service, the information flow is followed. Quality is measured by the number of repeat customers or by the sale/complaint ratio, cost by unsold service or backlogs and Delivery by order turn around time. The identification and expression of customer requirements in terms of the QCD function requires statistical thinking as expressed in Figure 2.

Figure 2. Translating the Voice of the Customer into product specification and processes

6. PDCA CYCLE
Improvement in any firm or organisation should follow the PDCA cycle, Figure 3. The PDCA cycle was originally called the Shewhart cycle after its founder Walter Shewhart. Deming began to develop it from Shewhart three stage cycle for manufacture. 'Specify – Produce – Inspect'. This in its turn had been developed from the scientific method for acquiring knowledge.

'Hypothesise – Experiment – Test Hypothesis'
The Japanese renamed it Deming cycle in 1950. The Deming cycle is composed of four stages: plan, do, study, act (the third stage 'study' was formerly called check and Deming cycle was known as the PDCA cycle. Deming made the change in 1990. 'Study' is more appropriate; with only 'check' one might miss something claimed Deming. However, many people still use check and this is used throughout this presentation. Much of the focus of the PDCA cycle is on continuously improving company performance. Therefore as managers, one needs to start with Check- and follow the sequence Check -Act-Plan-Do

• CHECK - (Check your position) – This is done by auditing your systems

• ACT - Ask the Question 'How can we continue to improve'?

• PLAN - Business Plan
• DO - Training very important
One remarkable thing about the PDCA cycle is that, the cycle is never ended; after one complete cycle, the manager continues to turn the wheel. This leads to the philosophy of continuous improvement which the Japanese call Kaizen.

7. KAIZEN
Kaizen is a philosophy, a way of life that subsumes all business activities. Kaizen strategy has been called the ''single most important concept in Japanese management- the key to Japanese competitive success'' (5). Continuous improvement in all areas of business such as cost, meeting delivery schedules, employee safety and skill development, suppliers relation etc. all enhance the quality of an organisation Figure 3. Thus any activity directed towards improvement falls under kaizen umbrella. Kaizen leads to new product development.

Figure 3. PDCA Cycle and Kaizen
8. ORGANISATIONAL REFORMS

Why is organisational reform necessary? Organisations need to change because the process of life itself is one of continuous change. Changes in the environment require that appropriate changes be made within organisations. To remain relevant, survive and meet new and emerging standards and demands placed on them organisations must remain continuously responsive to such demands. The things we need to consider for organisational change are Organisational learning and Capacity Building and this may include Privatisation. In organisational learning, we can expect the management system to provide a structured platform for establishing a learning culture within the organisation and, if applicable, across the partnering arrangements established by the organisation.

Defining a learning culture is not easy. However, the following examples are not exhaustive and they give a sense of the kind of environment required as the basis of a learning culture (a culture of opportunity) within the organisation. (6)

• Recognise the importance of customers supplies, both internal and external

• Recognise the importance of communication both vertically within the organisation and horizontally through the business processes

• Recognise the importance and value of people to organisation

• Recognise the potentially huge resource within the totality of personnel employed.

• Encourages personnel to submit opportunities to improve performance and prevent incidence of failure in performance

• Provide recognition for the individual who was the source of successfully implemented initiatives

Capacity Building is 'The process of equipping individuals with the understanding, skills and access to information, knowledge and training that enables them to perform effectively' and privatization is 'shifting from business decisions based on bureaucratic regulation to market place forces'. The new trend in this area is out-sourcing. In organisational reform, these moves are characterised by people's awareness of what to get from whom and how to do more with less resources. Training plays a very important role in an organisational reform; however organisational reform is not only training of personnel. The process of training is to upgrade institutional capacity for the job. Reforms may bring about changes in rules, and this may include job rotation and privatisation.

Organisational reform also brings about improvement; and TQM provides the way to do this. The basic elements of improvement include; Determination, Education, and Implementation (7). Determination means top management must take quality improvement seriously. Everyone should understand the absolutes which can be accomplished only through education. Finally, every member of the management team must understand the implementation process.

9. HOW DO WE CONTINUE TO IMPROVE UPON OUR SYSTEM AND PROCESSES? (8)

One important activity in bringing about process improvement using the PDCA cycle is that of group work. Group work is a pedagogical method where participants teach each other through group problem-solving activities. Through group work, team members are able to identify processes. The process owners then, check these processes for improvement. Flow chart is a very important tool used in the in the identification of processes. Figure 4 shows a flow chart of a process for testing samples in the laboratory. Quality audits are carried out at the CHECK stage of the process improvement model to find the compliance of processes to stated requirements.

Figure 4. Process Flow chart of a Testing activity

The next stage in process continuous improvement is the ACTION stage. Here the process owners asked the question, 'how can we continue to improve'? Having identified the needs of internal and external customers (voice of the customer), these needs are then translated to business.

In translating voice of the customer to business, a matrix diagram is employed. This is a two way matrix with the process task vertical and the functional units responsible, horizontal. The types of relationship are mapped and analysed and the relationship expressed as weak (o), strong (*) or average (+). The relationships identify where we need to focus attention to improve our process. A row without many relationships might indicate that the functional units selected will not affect the improvement of the process step. A matrix diagram of the process for testing samples in the laboratory is presented as Figure 5.

Figure 5. A matrix diagram for a Testing process
The next stage is the PLAN stage. Here we consider the Business plan. The business plan has short term, medium term and long term objectives. The short term (current year) aims at lowering cost at the current operational level, doing more with fewer resources and taking steps toward accreditation. The medium term (normally 3 – 5 years) considers capacity building and a move up the technological ladder with activities such as, diversification and hi tech. The long term (3 – 10 years) aims at new product development. In the laboratory test example given, this could mean doing more with less resources and sub-contracting (out sourcing) jobs in the current year , capacity building or getting accreditation in the medium term and digitalising and networking results to customers in the long term. A business plan for the named objectives is presented in Figure 6.

Figure 6. A business plan for organisational reform

The PLAN stage is for quality planning. After the business plan's objectives have been stated, the Critical Success Factors (CSF) - those indicators of performance in a key business process that can be quantified, measured, and audited are identified using the QCD function. The critical success factors are measures of organisational performance and these are linked to benchmarks through CSF metric calculation. A CSF metric calculation linking Benchmarks to organizational performance is shown in Figure 7.

Figure 7. CSF metric calculation linking Benchmarks to organizational performance

The next stage in process improvement is the DO stage. The Do stage requires firstly, organisation for quality. Training and education are paramount here. The Japanese for example do about 80 per cent on the job training (OJT). Training and education lead to skill formation. Secondly, measurement systems are needed for performance evaluation, customer satisfaction, accounting etc. The use of metric calculation in these measurements is paramount. Last but not least, information systems are required for customer, employee suggestions. Here the bottom up information is very important. To do this there is the need to form functional management teams and to build a pyramid of quality to disseminate top management quality policy and objectives through organisational hierarchies to the factory floor.

Process improvement cannot be separated from problem solving and there is a need to form problem solving teams and develop or adopt problem solving models for continuous improvement.

The seven QC tools - Flow charts, run chart, check sheets, histogram, fish bone diagram, Pareto analysis and scatter diagrams are indispensable in any problem solving methodology. A simple problem solving methodology and tools for problem solving are presented below.

• Identify problem areas (check sheets, run chart, histogram)

• Identify probable causes of problem (fishbone,)
• Find root cause (Prioritise problem -Pareto to focus on vital few)

• Test for correlation (scatter diagram)
• Rectify
• Standardise
The next step in a continuous improvement model is to turn the wheel again to the CHECK stage. This stage requires an intensive evaluation of part or all of a company's quality control activities. This is done through a quality audit which can be international (ISO 17025 etc), or Regional e.g. the European Quality Award.

This is not the end of the beginning, in a never ending cycle; the next step – ACTION - is to revisit the Business plan and strategise for continuous improvement and breakthrough.

10. CONCLUSION
We have now got an organisation that has established a system and business processes that consistently deliver products and services that meet customer requirements in full, and has embarked on a programme that makes it world class (ISO/IEC 17025:2005 Accreditation) and has built competence in its human resource and effectiveness and efficiency in its processes. We maintain this integrity and continue to improve our processes, products and services by using a

process improvement/problem solving model and applying the appropriate standard (ISO/IEC 17025:2005) to support the process of implementation. We measure the effectiveness of our systems through internal audits. We have established a 'system to blame' environment, sometimes referred to as 'no-blame'. We carry out corrective and preventive actions to ensure that mistakes never happen twice and ensure that both solution and, equally important, lessons learned from mistakes are shared across the organisation.

REFERENCES
1) BS 7850:1992 – Total Quality Management Part 1 & Part 2.

2) ISO/IEC 17025:2005 – General requirements for the competence of Calibration and Testing Laboratories

3) Philip B. Crosby, Quality is Free (New York: McGraw Hill, 1979), 200-201

4) William Wiggenhorn, ''Motorola U: When Training Becomes Education'' Harvard Business Review (July/ August 1990), 74.

5) Masaaki Iman, KAIZEN- The Key to Japan's Competitive Success (New York: McGraw-Hill, 1986)

6) Michael Debenham, Professional Affairs Manager, CQI- Quality in the 21st century. www.thecqi.org October, 2007

7) Main, see ref. 2
8) Adapted from JICA – Net Videoconferencing Seminar, October 2005, Dennis s. Tachiki, Tamagawa University, Tokyo, Japan.

BIBLIOGRAPHY
1. The Management and Control of Quality 3rd Edition James R. Evans, William M. Lindsay