Module 5 - Chapter 4 - Quality Concepts PDF

# MODULE 5 | QUALITY ASSURANCE ## CHAPTER 4: QUALITY CONCEPTS When implementing this module on Quality Assurance, it is important to ensure that the fundamental concepts are understood, implemented and maintained. Even where it is believed that a concept has been implemented successfully, it is st...

# MODULE 5 | QUALITY ASSURANCE ## CHAPTER 4: QUALITY CONCEPTS When implementing this module on Quality Assurance, it is important to ensure that the fundamental concepts are understood, implemented and maintained. Even where it is believed that a concept has been implemented successfully, it is still important to study the principles, to identify what can be done to strengthen the current implementation. This chapter covers the following concepts: 1. Measurement of quality 2. Creating a quality-focused workplace 3. Standard operating procedures 4. Client complaint/non-conformance reporting and corrective action system 5. Mistake-proofing devices (Poka-yoke) ### 4.1 MEASUREMENT OF QUALITY Embarking on a quality improvement journey, requires knowledge of where to start and where to focus. Using the right quality measurements will give this information. All these measures form an important part in the overall quality management system. **IMPORTANT INFORMATION** What you cannot measure, you cannot manage or improve. **Remember:** Only good work outputs count. In many instances, only good quality is counted, but there are often instances where good and bad quality is counted as part of the total output for the day. Every Performance-Driven Team needs to understand the following regarding quality: - Where are the quality problems and waste points? - How much poor quality is generated? - Why is it generated? - How can it be prevented? - What is the root cause of the errors? Once the team starts to monitor quality performance, it can start improving quality by focusing on critical areas. Thereafter, there will be some easy things to fix as well as larger issues (and thus more substantial improvements). Apart from measurement, quality can be improved through continuously creating awareness and Continuous Improvement Teams (see Module 3), which focus on quality issues. There are several ways in which to measure in-process quality, for example: - Measures for achieving and not achieving specifications - First-time pass rate (the percentage of processes, transactions or units that went through the system right the first time) - The amounts of different types of errors (expressed as a percentage) - Turnaround time of service delivery, where waiting time or on-time start time is viewed as part of quality by the client For improvement purposes, these should be measured at least once during a workday or week and should be monitored on graphs. Key indicators should be part of the information displayed on visual management boards and discussed in the Performance-Driven Teams (as described in Module 1). **IMPORTANT INFORMATION** All teams and departments are to measure and report on quality aspects (product, service or throughput) relevant to the specific team or department e.g.: - Patient experience sub-categories most relevant to a specific team - Trends in medication errors (number of errors per day or week or medication error rate) in a nursing unit - Trends in infections rates (number of infections per week or month, or infection rate(s) most relevant to a specific nursing unit - Cost of poor quality or of patient complaints in a department - Percentage or units of waste or rework produced - Number of errors or mistakes by administrative departments or delivered by support services, e.g. incorrect food orders delivered by the kitchen - Percentage of unplanned breakdowns in a department - First-time pass rate ### 4.2 CREATING A QUALITY-FOCUSED WORKPLACE Quality involves everyone in the company, at every stage of the process. Assuring quality begins with management committed to building a quality culture and a quality-focused workplace. Dr W. Edwards Deming, recognised as one of the world's foremost quality experts, identified management commitment and involvement as one of his key factors in ensuring quality excellence. The effective involvement of everyone at every stage is very much about changing the behaviours of employees to not only think about assuring quality, but to also apply the principles whenever a task is performed or processing takes place. As the 'quality at the source' principle is about identifying non-conforming quality and assuring good quality at the point where it is produced, and not downstream somewhere at a quality control point, it is clear that the most critical responsibility for assuring good quality lies with the team. Visual management plays an important part in creating a quality-focused workplace. It is also used to help detect problems or possible problems quickly, and then to ensure a quick response to correct the situation. If one important principle must be selected to support quality at the source, it is that 'prevention is better than cure'. Prevention is basic to quality assurance and should be practised at every stage of the process - from new product development, through the whole process, to the consumer. It is much cheaper to prevent poor quality than to detect and fix it. Early detection of a problem also usually makes it easier to correct. **IMPORTANT INFORMATION** **QUALITY CONTROL** - Cannot on its own decrease the frequency or severity of quality incidents - Can actually result in a decrease in quality - people become apathetic - To achieve better quality, it may be necessary to invest money, time and effort - To improve quality, a new approach is often required - Quality control is a separate, different function Three critical enablers assist in creating a quality-focused workplace: #### Building quality into the process The concept of built-in quality and team members' responsibilities in terms of this must be well-understood and practised. There should be a focus on continuously improving quality through solving root causes of problems, mistake-proofing processes, improving the capability of processes, and taking quick corrective actions. A few important points to take note of, when implementing quality controls, are: - Aim to inspect every task done, rather than sampling. However, this is not always easy to do (or feasible), therefore, simplify inspection as far as possible and use technology for quality controls, where relevant. - If difficult judgements about quality need to be made, it is often best to let the client (next process) make these judgement calls. - Immediate feedback should be given as soon as the problem or non-conformance is picked up. - The team should have the authority to stop the process, when it is required. #### Visual management Visual management is one of the most effective ways to increase awareness about quality, and it supports the process of ongoing improvement. One reason why it is effective is simply because 'it is in your face all the time'. This means that we can see it and we are, therefore, continuously reminded about what is displayed (good or bad). It is especially effective if displayed at the point where the operation takes place. Even if the information is not presented graphically, but, for example, as a list of quality specifications or a poster, it is best to have it displayed in an easily understandable and readable format, as close to the point of operation as possible. #### Right first-time quality through Performance-Driven Teams An autonomous team is one where team members have the skills, knowledge and authority to manage all aspects of quality. The basic principle is that there are few people in a better position to assure quality than the people who process the work. As soon as someone else checks work or monitors processes, ownership is taken away from the people involved in the process. More importantly, the initiative to improve quality is then also taken away from the people who are closest to the product. When people monitor their own quality, they become aware of their processes and how the processes function. To monitor quality, people need to be willing, trained and empowered to do it themselves for them to make the necessary decisions. The team needs to decide how this will be rolled out. ### 4.3 STANDARD OPERATING PROCEDURES Standard operating procedures (SOPs) are used to help assure quality. They are also the basis for continuous improvement. Whenever an improvement or change in operating procedure is proposed, the SOP will be the starting point. If a change or improvement is implemented, it should be included in the SOP, which then becomes the new operating procedure. **IMPORTANT INFORMATION** In his book The *Ascendant Organisation*, Peter Wickens defines the SOP as the 'best current work method for achieving quality, cost and delivery time in a safe manner'. This means that it is the best method known to the organisation at that particular stage. Sometimes, technical specialists draw up work instructions that need to be used by team members, but team members find that work instructions do not always work in all conditions and for all work types, especially if incoming information or requests are often incomplete or incorrect. For this reason, it must be the best current method known to the organisation and not only to a group of team members or a group of specialists. SOPs need to be set up by both types of specialists: technical specialists who understand the finer workings of the processes, and operation specialists, the people who work with the requests or information every day. Another important point to note is that it must be the current method. In the quest to continuously improve, we are always on the lookout for better ways of doing things. This means that the method will always be developing. Often the environment, people or materials change, which will sometimes impact on the method being used. For these reasons, it is very important that the SOP is always the current method. To do this, SOPs need to be reviewed often by the team to ensure they stay updated and effective. These key criteria will ensure that SOPs can be used effectively. The SOP must: - Include guaranteed ways of meeting quality standards - Ensure that the job can be completed, using as little as possible effort, eliminating errors and securing a high standard of efficiency - Be simple so that it can be understood by all team members - Be the best method currently available; it should not be cast in stone, but it should provide a firm foundation for continuous review and improvement **IMPORTANT INFORMATION** SOPs have various uses. They serve as: - Quality aids, ensuring that all know the critical parameters necessary to complete a task - Training of new team members and ‘skill polishing' of existing team members - A performance monitoring document - A control document to ensure that all adhere to the current best process - An audit document - A starting point for improvement In summary, the SOP is a formal, written document which includes all information about a task, including: - Description - Main steps in the right sequence. i.e. the process to be followed - Critical key points and reasons for the key points - Necessary checks for quality - Training needed - Time allocated to perform the task ### 4.4 CLIENT COMPLAINT/NON-CONFORMANCE REPORTING AND CORRECTIVE ACTION SYSTEM **IMPORTANT INFORMATION** CCRs, NCRs and CASs are essential in a quality management environment and are defined as follows: - CCR - Client Complaints Report - NCR – Non-conformance Report - CAS - Corrective Action System The 'quest for zero defect' starts with an attitude that any quality problem is unacceptable. It is known that attitudes become habits. If all employees adopt an attitude that all quality problems need to be promptly addressed, the habit or discipline will follow. The vision should be to have zero client complaints or non-conformances. Non-conformance is anything not adhering to a set standard or specification, especially internal standards or specifications. This can be with regards to the process or the product or service. To achieve this vision, the discipline and habits need to be adopted to taking every non-conformance serious by analysing (root cause analysis) the problem to see what caused it and then finding and addressing this root cause so that the problem can be eliminated once and for all. Similarly to how client complaints are reported, a non-conformance (process or product) needs to be reported as non-conformance. This is done by registering non-conformance and completing a non-conformance report, typically in some quality management book, spreadsheet or electronic system. Once the report is filled in with a description of where, when and how the non-conformance occurred, the underlying reasons for it should be investigated (root cause analysis). This can be done by using the fishbone diagram or the 'five whys'. Once determined, these root cause(s) should be listed against the non-conformance. The reason why non-conformance is formally recorded, is so that it is not ‘lost' and forgotten. Once it is in the system, the system requires that the non-conformance, and by implication its root cause(s), be addressed. The system for reporting client complaints and non-conformances should provide space for capturing the corrective action to be taken. This is filled in by the team once the problem and its root cause(s) are understood. The team draws up a simple action plan with due dates and responsible persons. Once the problem has been successfully addressed, the complaint or non-conformance gets ‘closed off' in the system. This works well because one can then see which complaints or non- conformances are still ‘open', meaning unsolved or not yet addressed. In this way, no problems are forgotten and the system provides a systematic way in which to prioritise and address all quality issues over time. **IMPORTANT INFORMATION** The client complaint or non-conformance reporting and corrective action system is an important part of the quality-focused workplace as it supports the whole quest for zero defects. In summary, a client feedback system and internal non-conformance process has the following components: - Identify non-conformance or client feedback or a complaint. - Log the non-conformance or client complaint and complete a non- conformance report (NCR) or Client Complaint Report (CCR). - Describe the non-conformance or client complaint (where, what, how and who). - Investigate and perform a root cause analysis. - Log the root cause on the NCR or CCR in the system. - Draw up an action plan to address root causes and log this in the system. - Implement an action plan. - Measure or monitor the results of the implementation. - Make adjustments or improvements. - Once satisfied, sign it off and file it. - Where relevant, give feedback to internal or external clients. - Report on a monthly basis to management the NCR and CCR trends. The CCR and NCR trends are to be tracked and reported at management meetings. All CCRs and NCRs are to be signed off based on the quality of root cause analysis and effectiveness of preventative and corrective actions implemented. It is also important to understand the impact of time-to-detect (TTD) and time to-correct (TTC) within this system. The shorter these times become, the lower the error rate and the quicker the overall error correction process. The figure [IMAGE OF FIGURE] Below illustrates the typical relationship between the TTD or TTC and error rate in a process. Every effort should, therefore, be made to reduce the TTD and TTC. This will mean that immediate feedback (TTD) must be given to the relevant team members; processes and/or work should be stopped and a solution should be found and implemented before continuing with work or a process (TTC). - TTD can be reduced in the following ways: - Reduce backlog: The less backlog or carry-overs, the quicker quality problems will be uncovered and the sooner team members can be given feedback. - Implement self-inspection: The TTC can be minimised if a team member does his or her own inspection and does not pass on any errors or mistakes. To reduce the TTC, the following can be done: - Reduce the TTD as described above. - If there is a quality problem, stop the work or process and solve it by eliminating the root cause. - Empower first-line employees and supervisors so that they are capable of solving problems. ### 4.5 MISTAKE-PROOFING DEVICES (POKA-YOKE) Poka-yoke was developed and classified by Shigeo Shingo who wrote the definitive works on this technique, although he did not invent the idea. The idea of mistake-proofing has been around for a long time before it was identified as a specific LEAN tool. The three-pin plug, for instance, had several designs created in the early part of the 20th century long before anyone heard of poka-yoke. Originally, many people called the technique fool-proofing (baka-yoke), however this was clearly derogatory towards the people using the device. After all, even the best of us can make a mistake. There is a difference between mistakes, which, in most cases, are inevitable, and defects which are mistakes that manage to get through the system and reach the client. Poka-yoke seeks to prevent mistakes from becoming defects. Shingo saw quality control as a three-level hierarchy of effectiveness: - Judgement inspection: inspectors inspect - Informative inspection: monitor the process conditions - Before the fact: poka-yoke The least effective form of quality control is the use of inspection and the most effective is the use of poka-yoke devices to prevent or highlight defects without any form of judgement or relying on the operator to do something. The purpose of poka-yoke is to overcome the inefficiencies of inspection through the use of automatic devices called poka-yoke. These seek to do the following: - Not accept a defect for the process - Not create a defect - Not allow a defect to be passed to the next process - To prevent a defect to occur Poka-yoke does this in a number of different ways but can be categorised as being either: - Control: They take physical action to prevent a defect and control variables - Warning: They sound an alarm or light up to tell us a mistake has been made - Shut down: Stops a process or machine if certain parameters are not met **EXAMPLE** **Railroad and road crossing** At a point where railroad tracks cross a road, there are various ways in which we can attempt to control vehicle behaviour for each of the poka-yoke levels. - Level 1: Stop sign (visual sign) - Level 2: Robot (flashing sign) - Level 3: Robot with siren (flashing sign and sound) - Level 4: Boom (physical obstruction) - Level 5: Bridge over the railroad (prevent defects) Poka-yoke systems involve the monitoring of tasks and processes, and require an immediate feedback and corrective action system at the point where non-conformance and errors occur. As control, poka-yoke eliminates the possibility of an error or non-conformance. It is a ‘best solution' tool, and the problem is fixed permanently. Because of the considerable effect obtained by actually installing poka-yoke systems and devices, many people are under the false impression that by simply putting in such devices, errors will be eliminated. However, poka-yoke is a means and not an end. It must be combined with at-source quality and process control if we want to eliminate errors. ## ACTIVITY 4 Discuss how each of the following concepts applies to your team, and what should be done to implement it properly: 1. **Measurement of quality:** List at least three measurements of quality related to your team 2. **Creating a quality-focused workplace:** Identify what must be done to change the mind-sets. 3. **Standard operating procedures:** Identify for which five major tasks an SOP will be required? 4. **CCRs, NCRs and CAS:** What steps need to be implemented to create a proper CCR/NCR system with CAS? 5. **Mistake-proofing devices (poka-yoke):** List three mistake-proofing devices that are available in your team. List three additional mistake-proofing devices that will improve quality in your team.