problem solving in quality assurance

Eight Disciplines of Problem Solving (8D)

– Eight Disciplines of Problem Solving –

⇓   Introduction to 8D

⇓   What is 8D

⇓   Why Apply 8D

⇓   When to Apply 8D

⇓   How to Apply 8D

Introduction to Eight Disciplines of Problem Solving (8D)

The Eight Disciplines of Problem Solving (8D) is a problem solving methodology designed to find the root cause of a problem, devise a short-term fix and implement a long-term solution to prevent recurring problems. When it’s clear that your product is defective or isn’t satisfying your customers, an 8D is an excellent first step to improving Quality and Reliability.

Ford Motor Company developed this problem solving methodology, then known as Team Oriented Problem Solving (TOPS), in the 1980s. The early usage of 8D proved so effective that it was adopted by Ford as the primary method of documenting problem solving efforts, and the company continues to use 8D today.

8D has become very popular among manufacturers because it is effective and reasonably easy to teach. Below you’ll find the benefits of an 8D, when it is appropriate to perform and how it is performed.

What is Eight Disciplines of Problem Solving (8D)

The 8D problem solving process is a detailed, team oriented approach to solving critical problems in the production process. The goals of this method are to find the root cause of a problem, develop containment actions to protect customers and take corrective action to prevent similar problems in the future.

The strength of the 8D process lies in its structure, discipline and methodology. 8D uses a composite methodology, utilizing best practices from various existing approaches. It is a problem solving method that drives systemic change, improving an entire process in order to avoid not only the problem at hand but also other issues that may stem from a systemic failure.

8D has grown to be one of the most popular problem solving methodologies used for Manufacturing, Assembly and Services around the globe. Read on to learn about the reasons why the Eight Disciplines of Problem Solving may be a good fit for your company.

Why Apply Eight Disciplines of Problem Solving (8D)

The 8D methodology is so popular in part because it offers your engineering team a consistent, easy-to-learn and thorough approach to solving whatever problems might arise at various stages in your production process. When properly applied, you can expect the following benefits:

• Improved team oriented problem solving skills rather than reliance on the individual
• Increased familiarity with a structure for problem solving
• Creation and expansion of a database of past failures and lessons learned to prevent problems in the future
• Better understanding of how to use basic statistical tools required for problem solving
• Improved effectiveness and efficiency at problem solving
• A practical understanding of Root Cause Analysis (RCA)
• Problem solving effort may be adopted into the processes and methods of the organization
• Improved skills for implementing corrective action
• Better ability to identify necessary systemic changes and subsequent inputs for change
• More candid and open communication in problem solving discussion, increasing effectiveness
• An improvement in management’s understanding of problems and problem resolution

8D was created to represent the best practices in problem solving. When performed correctly, this methodology not only improves the Quality and Reliability of your products but also prepares your engineering team for future problems.

When to Apply Eight Disciplines of Problem Solving (8D)

The 8D problem solving process is typically required when:

• Safety or Regulatory issues has been discovered
• Customer complaints are received
• Warranty Concerns have indicated greater-than-expected failure rates
• Internal rejects, waste, scrap, poor performance or test failures are present at unacceptable levels

How to Apply Eight Disciplines of Problem Solving (8D)

The 8D process alternates inductive and deductive problem solving tools to relentlessly move forward toward a solution. The Quality-One approach uses a core team of three individuals for inductive activities with data driven tools and then a larger Subject Matter Expert (SME) group for the deductive activities through brainstorming, data-gathering and experimentation.

D0: Prepare and Plan for the 8D

Proper planning will always translate to a better start. Thus, before 8D analysis begins, it is always a good idea to ask an expert first for their impressions. After receiving feedback, the following criterion should be applied prior to forming a team:

Collect information on the symptoms

Use a Symptoms Checklist to ask the correct questions

Identify the need for an Emergency Response Action (ERA), which protects the customer from further exposure to the undesired symptoms

D1: Form a Team

A Cross Functional Team (CFT) is made up of members from many disciplines. Quality-One takes this principle one step further by having two levels of CFT:

• The Core Team Structure should involve three people on the respective subjects: product, process and data
• Additional Subject Matter Experts are brought in at various times to assist with brainstorming, data collection and analysis

Teams require proper preparation. Setting the ground rules is paramount. Implementation of disciplines like checklists, forms and techniques will ensure steady progress.  8D must always have two key members: a Leader and a Champion / Sponsor:

• The Leader is the person who knows the 8D process and can lead the team through it (although not always the most knowledgeable about the problem being studied)
• The Champion or Sponsor is the one person who can affect change by agreeing with the findings and can provide final approval on such changes

D2: Describe the Problem

The 8D method’s initial focus is to properly describe the problem utilizing the known data and placing it into specific categories for future comparisons. The “Is” data supports the facts whereas the “Is Not” data does not. As the “Is Not” data is collected, many possible reasons for failure are able to be eliminated. This approach utilizes the following tools:

• Problem Statement
• Affinity Diagram (Deductive tool)
• Fishbone/Ishikawa Diagram (Deductive tool)
• Problem Description

D3: Interim Containment Action

In the interim, before the permanent corrective action has been determined, an action to protect the customer can be taken. The Interim Containment Action (ICA) is temporary and is typically removed after the Permanent Correct Action (PCA) is taken.

• Verification of effectiveness of the ICA is always recommended to prevent any additional customer dissatisfaction calls

D4: Root Cause Analysis (RCA) and Escape Point

The root cause must be identified to take permanent action to eliminate it. The root cause definition requires that it can be turned on or off, at will. Activities in D4 include:

• Comparative Analysis listing differences and changes between “Is” and “Is Not”
• Development of Root Cause Theories based on remaining items
• Verification of the Root Cause through data collection
• Review Process Flow Diagram for location of the root cause
• Determine Escape Point, which is the closest point in the process where the root cause could have been found but was not

D5: Permanent Corrective Action (PCA)

The PCA is directed toward the root cause and removes / changes the conditions of the product or process that was responsible for the problem. Activities in D5 include:

• Establish the Acceptance Criteria which include Mandatory Requirements and Wants
• Perform a Risk Assessment /  Failure Mode and Effects Analysis (FMEA) on the PCA choices
• Based on risk assessment, make a balanced choice for PCA
• Select control-point improvement for the Escape Point
• Verification of Effectiveness for both the PCA and the Escape Point are required

D6: Implement and Validate the Permanent Corrective Action

To successfully implement a permanent change, proper planning is essential. A project plan should encompass: communication, steps to complete, measurement of success and lessons learned. Activities in D6 include:

• Develop Project Plan for Implementation
• Communicate the plan to all stakeholders
• Validation of improvements using measurement

D7: Prevent Recurrence

D7 affords the opportunity to preserve and share the knowledge, preventing problems on similar products, processes, locations or families. Updating documents and procedures / work instructions are expected at this step to improve future use. Activities in D7 include:

• Review Similar Products and Processes for problem prevention
• Develop / Update Procedures and Work Instructions for Systems Prevention
• Capture Standard Work / Practice and reuse
• Assure FMEA updates have been completed
• Assure Control Plans have been updated

D8: Closure and Team Celebration

Teams require feedback to allow for satisfactory closure. Recognizing both team and individual efforts and allowing the team to see the previous and new state solidifies the value of the 8D process. Activities in D8 include:

• Archive the 8D Documents for future reference
• Document Lessons Learned on how to make problem solving better
• Before and After Comparison of issue
• Celebrate Successful Completion

8D and Root Cause Analysis (RCA)

The 8D process has Root Cause Analysis (RCA) imbedded within it. All problem solving techniques include RCA within their structure. The steps and techniques within 8D which correspond to Root Cause Analysis are as follows:

• Problem Symptom is quantified and converted to “Object and Defect”
• Problem Symptom is converted to Problem Statement using Repeated Whys
• Possible and Potential Causes are collected using deductive tools (i.e. Fishbone or Affinity Diagram)
• Problem Statement is converted into Problem Description using Is / Is Not
• Problem Description reduces the number of items on the deductive tool (from step 3)
• Comparative Analysis between the Is and Is Not items (note changes and time)
• Root Cause theories are developed from remaining possible causes on deductive tool and coupled with changes from Is / Is Not
• Compare theories with current data and develop experiments for Root Cause Verification
• Test and confirm the Root Causes

Example: Multiple Why Technique

The Multiple / Repeated Why (Similar to 5 Why) is an inductive tool, which means facts are required to proceed to a more detailed level. The steps required to determine problem statement are:

• Problem Symptom is defined as an Object and Defect i.e. “Passenger Injury”
• Why? In every case “SUV’s Roll Over”
• Why? In every case, it was preceded by a “Blown Tire”
• Why? Many explanations may be applied, therefore the team cannot continue with another repeated why past “Blown Tire”
• Therefore, the Problem Statement is “Blown Tire”
• Why? Low (Air) Pressure, Tire Defect (Degradation of an Interface) and High (Ambient) Temperature
• Counter measures assigned to low pressure and tire defect

This example uses only 4 of the 5 Whys to determine the root causes without going further into the systemic reasons that supported the failure. The Repeated Why is one way to depict this failure chain. Fault Tree Analysis (FTA) could also be used.

Learn More About Eight Disciplines of Problem Solving (8D)

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Quality Observations: Key Strategies for Effective Problem Solving

• The problem tends to be described incorrectly;
• There may be a lack of or insufficient structure in the problem solving process;
• A lack of urgency;
• Management impatience;
• A lack of follow-through to prevent the problem from recurring;
• The problem solving effort has been “expedited” by skipping process steps; or
• Poor execution of or ineffective corrective actions. The Future of Quality

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Solving quality issues and problems: go beyond root cause to ‘real’ cause.

There is a tendency in the quality management field to confuse the root cause of a problem with the problem’s real cause. A root cause is objective evidence of a quality problem. The real cause of a quality problem, however, is the actual finding or nonconformance .

Uncovering real causes of quality issues and problems requires different, deeper scrutiny than identifying root causes. Mistaking one for the other can lead to the perpetuation of cycles such as this one:

• A severe quality problem occurs at a production facility after a change is made.
• A team of stakeholders and possibly consultants convene to investigate the problem.
• A root cause is found.
• A corrective action / preventive action (CAPA) is implemented.
• The problem goes away.
• When another change occurs, the cycle repeats itself with a different yet related issue.

If you’re a quality professional who has been with the same organization for multiple years, this recursive pattern is likely to sound familiar. When multiple change-related root causes arise, it soon becomes evident that they are symptomatic of a deeper-seated cause.

Six Real Causes of Quality Issues Problems

In his foundational book on management audits, Allan Sayle concluded that there are just six real causes of all quality problems. (1) For each of the six causes, Sayle outlined specific sub-cause indicators, the identification of which can enable an auditor to properly assign a real cause for a quality problem. Attributing a quality problem to one or more of the sub-causes listed below can help your company identify the real cause and devise a change to mitigate or eliminate it.

#1. Lack of Organization

• Undetermined responsibilities and authorities (i.e., confusion about who is supposed to perform and be responsible for specific jobs that result in a product that is fit for purpose).
• Undefined management systems (i.e., the methods and means of communication between departments and individuals doesn’t form a complete and continuous chain).
• Inadequate communication, especially as it pertains to information generated by a particular department that is needed by specialists.

#2. Lack of Training  

• Personnel are not trained in the systems/methods in place or are not told with whom they are supposed to interface.
• Inadequate company training (e.g., managers produce and distribute a quality assurance manual but users aren’t trained on its contents).

#3. Lack of Discipline

• Workers follow bad examples set by supervisors and managers.
• Quality campaigns do not extend across the enterprise and subsequently build up frictions, become demotivators, and lead to disillusionment.
• Personal attributes that prevent employees from following the agreed upon methods.
• Inflexible systems that stifle innovation, quick thinking, and human problem-solving creativity.
• Demotivating environments.

#4. Lack of Resources

• Overly complex management systems that drain valuable resources.
• Irresponsible attitudes (i.e., resources are always completely used up in proportion with their allocation).
• Uneven allocation.
• Unrealistic estimates.
• Inadequate reinvestment (e.g., resource allocations are based on previous years’ budgets without taking market changes into account).
• Failure to modernize and seek potential applications for new technologies.

#5. Lack of Time

• Overly complex systems that waste time and/or create needless tasks.
• Irresponsible attitudes (e.g., personnel whose work always expands to fill the allotted time).
• Unrealistic commitments that are promised to customers without consideration for the time it takes to properly deliver a quality product.
• Selfishness that increasingly piles on pressures downline as a product gets closer to delivery.
• Excessive workloads.

#6. Lack of Top Management Support

• Attitude/motivation (i.e., a corporate culture that does not prioritize quality and assumes it is automatic).
• Managers who are inadequately educated to the importance of quality and the means of achieving it.
• Time management (e.g., quality managers spend more time fighting fires than proactively addressing quality, which typically results in a self-defeating cycle).
• “Cancer of complacency” (i.e., the false belief that reputation and past performance will always outweigh any quality issues that may arise).

Now that you know what problems to look for, the next step is ensuring your personnel have the right tools and skillsets to identify and rectify them.

Quality Problem Identification Certifications

Quality practices can vary widely across different industries and countries. That being the case, there is not a blanket quality problem identification certification that applies globally to all business sectors. However, there are a variety of specialized certifications, such as those offered by the American Society for Quality ( ASQ ), that formally recognize an individual’s proficiency within, and comprehension of, specific quality knowledge.

ASQ offers professional certifications in the following areas:

• Management (i.e., organizational excellence and supplier quality).
• Foundational quality (i.e., quality improvement and process analysis).
• Inspections (including equipment calibration).
• Engineering (including software development, implementation, testing, verification, and validation).
• Auditing (including certifications specific to quality practices for food safety, pharmaceutical, and medical device industries).
• Six Sigma techniques for process improvement.

For professionals seeking quality problem identification programs, ASQ offers Certified Quality Inspector (CQI) training. CQI certification ensures an inspector has learned proven techniques for inspecting products, measuring process performance, recording data, evaluating hardware documentation, performing laboratory procedures, and preparing formal reports.

Real Cause Identification Requires Tools Built for the Job

Unearthing and correcting real causes can dramatically reduce the occurrence and severity of quality problems. Determining real causes also helps diminish the dysfunctions caused by CAPA overload. But you need the right set of tools to identify real causes efficiently and effectively.

A digital, fully integrated quality management system (QMS)  simplifies real cause discovery. It’s much easier to identify the real causes of problems when you can rely on a unified platform that connects quality data across your products’ life cycles and within a common architecture. A connected QMS platform gives you greater real-time visibility into quality data, which pushes real problems to the fore.

To learn how your organization can identify real causes with greater speed and accuracy, visit MasterControl’s product life cycle managementplatform page .

• “ Management Audits: The Assessment of Quality Management Systems ,” Sayle, Allan J., 1988, McGraw-Hill, pp. 18.21-34.

James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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Resolve quality problems in six steps

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Quality problems can arise on any project, and can take on many forms. Many of the problems are minor irritants that keep you from implementing the most optimal solution, but nevertheless can be tolerated. Many need to be resolved before you can implement your solution. A few of them are “show-stoppers.” All of these problems can be resolved using similar techniques. Obviously the larger the problem, the more complex the solution might be. However, the same basic problem solving approach can be applied to each situation.

When you have problems, guessing the cause of the problem rarely works. A structured approach works much better. You want to not only resolve this particular problem, but you also want to understand the problem well enough to ensure that it does not occur again.

Use the following general process to identify and resolve quality problems. 

1. Identify the problem or symptom

You shouldn’t assume that everyone knows the problem already. Take the time to document the problem in clear terms that everyone can understand. Make sure to also explain the impact of the quality problem to the project. The first rule of problem resolution is that if you can’t define the problem, you can’t resolve it.

2. Identify the root cause

Try to identify the root cause of the problem and explain how the root cause ultimately results in the problem that has arisen. If you can’t track the root cause to the perceived problem, you haven’t taken your investigation far enough. There are a number of problem-solving techniques you can utilize, including root cause analysis and Fishbone Diagrams.

3. Determine alternatives and impacts

Once the cause is identified, you should look at the alternatives and the impact of each alternative. Although it’s best to try to solve the root cause of the problem, sometimes it’s not possible and sometimes it’s not cost effective. In these instances, you might need to look at alternatives that resolve the symptoms of the problem. Sometimes there’s a very obvious solution that needs to be implemented. However, in many cases there are a number of potential alternatives. For each alternative, they should also address the impact to the project in terms of costs, benefits, and risks. It’s worthwhile to make sure you look at the solutions as holistically as possible, so that you can make select the best alternative.

4. Select the best alternative

Depending on the severity of the problem, the project team may be able to choose the best alternative to the problem. If the problem is large enough, your sponsor and management stakeholders may need to be involved as well.

A mini-plan is put into place to address the quality problem and implement the chosen alternative. These activities should be moved into the project workplan to ensure that they are performed

The resolution plan needs to be monitored to ensure that the quality has improved as expected. If the quality has improved or is moving in that direction, you may allow the plan to continue. However, if the quality is not improving as expected, further corrective action may be required.

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What are the 7 basic quality tools, and how can they change your business for the better?

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What are the 7 basic quality tools?

• Stratification
• Check sheet (tally sheet)
• Cause and effect diagram (fishbone or Ishikawa diagram)
• Pareto chart (80-20 rule)
• Scatter diagram
• Control chart (Shewhart chart)

The ability to identify and resolve quality-related issues quickly and efficiently is essential to anyone working in quality assurance or process improvement. But statistical quality control can quickly get complex and unwieldy for the average person, making training and quality assurance more difficult to scale. 

Thankfully, engineers have discovered that most quality control problems can be solved by following a few key fundamentals. These fundamentals are called the seven basic tools of quality. 

With these basic quality tools in your arsenal, you can easily manage the quality of your product or process, no matter what industry you serve.

Learn about these quality management tools and find templates to start using them quickly.

Where did the quality tools originate?

Kaoru Ishikawa, a Japanese professor of engineering, originally developed the seven quality tools (sometimes called the 7 QC tools) in the 1950s to help workers of various technical backgrounds implement effective quality control measures.

At the time, training programs in statistical quality control were complex and intimidating to workers with non-technical backgrounds. This made it difficult to standardize effective quality control across operations. Companies found that simplifying the training to user-friendly fundamentals—or seven quality tools—ensured better performance at scale

7 quality tools

1. stratification.

Stratification analysis is a quality assurance tool used to sort data, objects, and people into separate and distinct groups. Separating your data using stratification can help you determine its meaning, revealing patterns that might not otherwise be visible when it’s been lumped together. 

Whether you’re looking at equipment, products, shifts, materials, or even days of the week, stratification analysis lets you make sense of your data before, during, and after its collection.

To get the most out of the stratification process, consider which information about your data’s sources may affect the end results of your data analysis. Make sure to set up your data collection so that that information is included. 

2. Histogram

Quality professionals are often tasked with analyzing and interpreting the behavior of different groups of data in an effort to manage quality. This is where quality control tools like the histogram come into play. 

The histogram represents frequency distribution of data clearly and concisely amongst different groups of a sample, allowing you to quickly and easily identify areas of improvement within your processes. With a structure similar to a bar graph, each bar within a histogram represents a group, while the height of the bar represents the frequency of data within that group. 

Histograms are particularly helpful when breaking down the frequency of your data into categories such as age, days of the week, physical measurements, or any other category that can be listed in chronological or numerical order. 

3. Check sheet (or tally sheet)

Check sheets can be used to collect quantitative or qualitative data. When used to collect quantitative data, they can be called a tally sheet. A check sheet collects data in the form of check or tally marks that indicate how many times a particular value has occurred, allowing you to quickly zero in on defects or errors within your process or product, defect patterns, and even causes of specific defects.

With its simple setup and easy-to-read graphics, check sheets make it easy to record preliminary frequency distribution data when measuring out processes. This particular graphic can be used as a preliminary data collection tool when creating histograms, bar graphs, and other quality tools.

4. Cause-and-effect diagram (also known as a fishbone or Ishikawa diagram)

Introduced by Kaoru Ishikawa, the fishbone diagram helps users identify the various factors (or causes) leading to an effect, usually depicted as a problem to be solved. Named for its resemblance to a fishbone, this quality management tool works by defining a quality-related problem on the right-hand side of the diagram, with individual root causes and sub-causes branching off to its left.   

A fishbone diagram’s causes and subcauses are usually grouped into six main groups, including measurements, materials, personnel, environment, methods, and machines. These categories can help you identify the probable source of your problem while keeping your diagram structured and orderly.

5. Pareto chart (80-20 rule)

As a quality control tool, the Pareto chart operates according to the 80-20 rule. This rule assumes that in any process, 80% of a process’s or system’s problems are caused by 20% of major factors, often referred to as the “vital few.” The remaining 20% of problems are caused by 80% of minor factors. 

A combination of a bar and line graph, the Pareto chart depicts individual values in descending order using bars, while the cumulative total is represented by the line.

The goal of the Pareto chart is to highlight the relative importance of a variety of parameters, allowing you to identify and focus your efforts on the factors with the biggest impact on a specific part of a process or system. 

6. Scatter diagram

Out of the seven quality tools, the scatter diagram is most useful in depicting the relationship between two variables, which is ideal for quality assurance professionals trying to identify cause and effect relationships. 

With dependent values on the diagram’s Y-axis and independent values on the X-axis, each dot represents a common intersection point. When joined, these dots can highlight the relationship between the two variables. The stronger the correlation in your diagram, the stronger the relationship between variables.

Scatter diagrams can prove useful as a quality control tool when used to define relationships between quality defects and possible causes such as environment, activity, personnel, and other variables. Once the relationship between a particular defect and its cause has been established, you can implement focused solutions with (hopefully) better outcomes.

 7. Control chart (also called a Shewhart chart)

Named after Walter A. Shewhart, this quality improvement tool can help quality assurance professionals determine whether or not a process is stable and predictable, making it easy for you to identify factors that might lead to variations or defects. 

Control charts use a central line to depict an average or mean, as well as an upper and lower line to depict upper and lower control limits based on historical data. By comparing historical data to data collected from your current process, you can determine whether your current process is controlled or affected by specific variations.

Using a control chart can save your organization time and money by predicting process performance, particularly in terms of what your customer or organization expects in your final product.

Bonus: Flowcharts

Some sources will swap out stratification to instead include flowcharts as one of the seven basic QC tools. Flowcharts are most commonly used to document organizational structures and process flows, making them ideal for identifying bottlenecks and unnecessary steps within your process or system. 

Mapping out your current process can help you to more effectively pinpoint which activities are completed when and by whom, how processes flow from one department or task to another, and which steps can be eliminated to streamline your process. 

Learn how to create a process improvement plan in seven steps.

About Lucidchart

Lucidchart, a cloud-based intelligent diagramming application, is a core component of Lucid Software's Visual Collaboration Suite. This intuitive, cloud-based solution empowers teams to collaborate in real-time to build flowcharts, mockups, UML diagrams, customer journey maps, and more. Lucidchart propels teams forward to build the future faster. Lucid is proud to serve top businesses around the world, including customers such as Google, GE, and NBC Universal, and 99% of the Fortune 500. Lucid partners with industry leaders, including Google, Atlassian, and Microsoft. Since its founding, Lucid has received numerous awards for its products, business, and workplace culture. For more information, visit lucidchart.com.

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Problem solving: a common thread in quality assurance programs

Affiliation.

• 1 Department of Industrial Engineering, University of Missouri-Columbia.
• PMID: 2491232

This paper discusses the key role that the problem solving process plays in most quality assurance programs. In this discussion, problem solving is represented as a four step process. The use of each of the four steps in health care quality assurance is examined.

• Data Collection
• Data Interpretation, Statistical
• Hospital Administration / standards*
• Problem Solving*
• Quality Assurance, Health Care / organization & administration*
• United States

HEALTHCARE SERVICE DELIVERY

Quality improvement through problem solving.

First published 25 Oct. 2014 Latest update 31 Oct. 2021

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QUALITY PROBLEMS

A quality problem is defined as any instance where the desired quality characteristic is not present or not up to the intended level. In other words, it is an instance of failure to conform to standards or specifications. It can also be considered as the “Quality Gap”.

THE ATTITUDE TOWARDS PROBLEMS

It is disappointing to encounter problems despite putting in a good design and scrupulous control. However, problems should be seen as a challenge to put out a better product or service. Problems should not be brushed off or ignored but efforts need to be made to know what problems exist and how serious. Each problem should be subjected to further inquiry regarding why they happen and what can be done to avoid them.

THE PROBLEM SOLVING CYCLE

The first step is to identify, clarify and verify the existence of a quality problem. Then, an approach must be found to solve these problems. The problem solving process is based on the scientific approach. The approach is depicted below as a cycle of recurring activities. Outline of The Problem Solving Steps

PROBLEM IDENTIFICATION

a. Problem Identification via Statistical Quality Control The main way to identify problems is by detecting non-conformance through quality control. According to J.M Juran, in ‘Quality by Design’, Quality control is “the regulatory process through which we measure the actual performance, compare it with standards and act on the difference”. In the last part of this definition, Juran has incorporated quality improvement as part of control. A defective product / unsatisfactory result can occur by chance. Knowing the frequency of occurrence is therefore important. Statistical Quality control is the detection of the rate of non-conformance in a sizable quantity of products produced or delivered. In clinical practice, statistical quality control takes the form of Clinical or Medical audit.

b. Customer Complaints Through stringent quality control non-conformant items are rejected. If however substantial numbers of customers are still unhappy, there is a problem in the quality control or the design. Customer opinion regarding quality should be actively sought for through Customer Satisfaction Surveys or Complaint Boxes c. Employee Complaints Any complaint from employees about the process, the equipment or the work environment, should be considered as a problem. To encourage reporting, complaints can be disguised as Employee suggestion (see later). d. Incident Reporting Incidents occurring during production, delivery and use of products should be identified as problems and studied closely. The occurrence of incidents should be reported by employees and sought from customer complaints.

To be effective, the problem solving process need to be orderly and scientific in approach. The first step is to identify, clarify and verify the existence of a quality problem. The causes must then be found. Consequently, methods must be found to solve these problems. The approach is depicted below as a cycle of activities. Often not all aspects of a problem can be corrected at any one time. Also, new problems keep on being detected. Therefore quality improvement efforts is continuous. It is appropriate perhaps to name it as “The Problem Solving Cycle”.

The problem solving exercise needs to be approached from two distinct perspectives:

• theoretical

The context within which the problem occurs need to be known. The possible causes are postulated from a knowledge of the input, processes, and environment. Data is then collected to clarify what factors are in operation when the defective product was made or unsatisfactory service was delivered. The corrective action or remedy involves a level of experimentation outside of the operations domain. Only after the suggested remedial action is proven to be effective is it adopted.

Therefore, even though the changes are meant to be gradual, the problem solving approach need to be taken as a project. There is a need for proper planning, organization, scheduling, and control.

“The Quality Improvement Cycle”

Elaboration of the Steps of the Problem Solving Activity/Project

The steps of the Problem Solving exercise, is elaborated below:

Step 1. Assess Quality of Service Collect data to measure current performance. This step is actually the activity of Quality control. In clinical medical practice medical audit is used for this purpose. Step 2. Identify Problem A Quality problem is said to occur if there is a quality gap or deficit (shortfall in quality) based on the outcome results compared to the standard set. Step 3. Analyze Problem At this step a theoretical analysis of the factors that may contribute to the occurrence is performed. Factors may include input, processes, the environment, and organization of the system as a whole. The production process / service delivery process needs to be clarified by studying existing work flow charts or redrawing them. Step 4. Postulate Causes Tools such as relations diagram (Bubble chart) and Ishikawa Herring Bone chart may be used to demonstrate and clarify cause and effect. Step 5. Identify data required and how to obtain them Theoretical postulates put forward at the previous step need to be proven by a study of actual happenings. This would require the collection of relevant data. To do this, questions of what data, where to obtain them and how must be answered. Step 6. Plan Data Collection At this stage it is necessary to know whether data required already exists or new data need to be collected (e.g., via observation). Decision must be made on data collection techniques, responsibility for data collection and data storage. Performing all these is equivalent to designing a research study. Step 7. Collect Data This step is the actual activity of data gathering and collation (put together). Step 8. Analyze Data Data that have been collected are tabulated, analysed and presented using simple statistical tools. Step 9. Derive Causes of Problems The results of data analysis are interpreted to prove or disprove postulates made previously. Collected data may also reveal or suggest other possible causes. Step 10. Plan Corrective/Remedial Measures Strategies for Improvement need to be formulated and planned with care. Based on the causes identified above, various factors requiring correction are identified. Alternative solutions to solving the problem may be identified and shortlisted through Employee suggestion, Literature Review and Benchmarking. In the long term, research and innovation may provide better solutions. Step 11. Carry out Remedial Measures The most effective strategy to use in implementation of remedial measures is the use of the Shewhart PDCA cycle as described below:

Application of the PDCA Cycle to Carrying out Remedial Actions

In this approach, the remedy being suggested is first planned properly and put to the test (the Do step). This test is done as simulation, trial or pilot project and data is collected to confirm it’s effectiveness or otherwise (the “Check” stage). When it is a complete success it can be adopted and institutionalized. If it is not entirely acceptable it can be amended or adapted and tried again. A complete failure warrants re-planning (back to the drawing board) and a repeat of the whole cycle. Step 12. Re-evaluate the problem Collect data to determine the frequency and seriousness of the problem. This step means the continuation of the Quality control activities. If the problem has not been solved the problem may require re-analysis or study. It may also mean that the remedial measures chosen were not carried out fully or they wee not effective. Step 13. Prevent the problem from recurring If corrective actions / measures have been successful, all changes made need to be adopted and institutionalized. This usually means that the changes are incorporated into policies, the work procedures and work culture. Continuous vigilance through quality control will ensure that the problems do not recur.

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Interesting outlines and descriptions for ease of understanding and knowledge sharing. Would you mind posting them as pdf for download, thank you.

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22 Quality Management Tools to Elevate Your Performance as a Quality Manager

Quality management leaders in every organization are expected to perform so many tasks daily, from problem-solving to improving process efficiency to tracking quality metrics to much, much more. It’s a lot— but there is good news. There are a variety of Quality management Tools that can make these tasks a lot easier. Ultimately, the goal is to ensure that organizational standards are maintained at each stage of the product lifecycle.

Quality Management Tools have gobbled up a substantial market share. As per Grand View Research, the global Quality Management Software market is sized at $8.25 billion as of 2020. By 2028, this market is expected to increase at a compound annual growth rate of 9.7%.

What are Quality Management Tools?

Quality Management Tools are technology-driven products that help organize, collect, analyze, interpret and understand data representing the products, services, and employees. The tools further help maintain quality standards of the products and services that the organizations manufacture to abide by the industry standards of quality and assurance.

The quality management tools that we will discuss in our guide are useful for quality assurance professionals, regardless of the size of your organization.

The list of tools in this article is organized into four sections: problem-solving, improving processes, capturing metrics, and data/task organization.

Ready to dive in a build your QA Toolkit? Then let’s begin.

Problem-Solving Tools

1. cause-and-effect diagram.

The cause-and-effect diagram is a graphical representation that helps you understand, sort, display, and identify the cause behind a specific event or problem. You can use this tool by identifying the problem, defining the process that needs to be examined, brainstorming the further causes with the team members, and structuring it to analyze the solution.

2. Andon board

Andon board is an alerting system that informs operators about any product or service line issues as soon as it occurs. All you have to do is press the Andon board’s cord when problems occur. Identify the problem through lights, sounds, and numbers and act on it immediately.

3. Tree diagrams

A tree diagram is a tool that defines tasks and subtasks in a hierarchy that are needed to be completed. It starts with a task with its branches as subtasks and clarifies quality assurance managers about what needs to be done next. To use this tool, develop particular tasks and actions as solutions and analyze the process to derive possible solutions.

4. Kaizen’s value stream mapping

Kaizen’s value stream mapping is a flowchart tool that documents each step in the process, identifies issues, and proposes solutions for the same. To use this tool, map each step in the process, create timelines, and document everything precisely to brainstorm potential issues and solutions.

5. Five Whys

The five whys is a quality control technique that solves problems effectively. With this tool, you can find the reason behind a particular situation by asking a sequence of five ‘why’ questions. To use this tool, ask five different whys and note down the causes to address the root cause of the problem.

6. Storyboard

A storyboard is a visual representation tool automatically sketches a video’s progression to bring your ideas to life. It graphically represents how the animation, film, or video will take place, one shot after another. To use this diagram, take the scenes you want to address and make a list of shots, sketch the scenes, fill in words and other details and wait for the graphical representation to occur. Then, any video issues can be ruled out by understanding how each element will look shot after shot.

Process Improvement Tools

7. control chart.

A control chart is a graphical representation that help you study a process change in a specific time period. With this tool, you plot data in a timely order and compare it with the central line (average) upper control limit and lower control limit. Control charts help you understand the degree to which a firm’s products differ from the specified standard and help in correcting them.

8. Scatter diagram

A scatter diagram is a graphical representation showing the relationship between two numerical variables. It links the component of the process and the fault in its quality on the two axes. With the help of a scatter diagram, you can optimize processes by paring the numerical data into dependent and independent variables and determining the relationship between the two to identify problems and solutions.

9. Flow chart

The flowchart identifies the quality cost by analyzing the data frequencies and identifies the output and input branches involved. It helps improve processes after you identify all steps in the process sequentially. You can use this tool by defining the major concerns and branching out the sub-tasks to understand the situation better.

10. Vendor audit checklist

A quality audit checklist is used for quality management by tracking questions and answers during a quality audit. The quality record helps in continuous process improvement. You can use this tool to determine the focus of your audit, prepare for the same, and finally perform it. Report the results in the findings report and conduct corrective actions to solve issues.

11. Process decision program chart

The process decision program chart is a management planning tool that organizes and identifies everything that can go wrong in a developing plan. To use this tool, one needs to draw a tree diagram, brainstorm the issues, review the problems and brainstorm the solutions to organize everything in the tree to make decisions accordingly.

12. Nominal Group Technique

The nominal group technique is a quality management tool that structures small-group discussions to reach a conclusion. This tool gathers information from a moderator who asks individuals certain things, and ideas are prioritized based on each group member. Then, the suggestions/ideas are implemented for process improvement.

Metrics Capturing Tools

13. check sheet.

A check sheet is a structured form used to collect and analyze data for different purposes. To use this tool, decide the problem you want to assess, collect the data needed, and design the form. To improve the procedure, use the form after labeling all the blank spaces to identify event patterns, defects, problems, and more.

14. Pareto chart

A Pareto chart is a six sigma tool that helps in quality management through a bar graph representation to show how much a particular input contributes towards an output. You can use this tool to determine causes, measurements, and timeframe to analyze data and build the chart.

15. Matrix diagram

Matrix diagrams are quality tools that analyze data within an organizational structure and define the relationship between them. The tool can collect different data types, select a matrix type, compare the data, and draw conclusions from the same.

Data/Task Organization Tools

16. histogram.

A histogram is a tool that helps in quality control by representing a data set precisely. The bar-chart type representation graphs how often continuous data occurs, enabling you to analyze it thoroughly. You can use a histogram by collecting at least 50 data sets of a particular process and plot them on the x and y axis to get a visual representation and comparison of data.

17. Affinity diagrams

An affinity diagram is a quality control tool to organize several ideas into their natural relationships after a brainstorming session. You can use this tool to organize, consolidate, segregate and generate information related to the process, its faults, and potential solutions. All you have to do to use this tool is to identify the objective, group categories, and additional factors to each category to analyze the data.

18. Stratification

The stratification quality assurance tool is used to sort data, information, objects, and more into different groups based on different factors. This helps you understand the data’s meaning, reveals patterns contributing to quality errors, and enables you to fix them accordingly.

19. Prioritisation matrices

Prioritization matrices, as the name suggests, evaluate several options and prioritize them according to importance. To use this tool, you have to establish weighted criteria and evaluate all options against the criteria to figure out your top priority of solution or issue to look after.

20. Activity network/arrow diagram

Arrow diagrams create a visual representation of the various steps in a process that is needed to complete a particular task. It reveals the causes needed for the tasks and helps quality assurance managers determine the task sequence and separate tasks accordingly.

21. Mind Mapping

A mind map is a diagram that organizes large amounts of information into a visual hierarchy and shows relationships among different pieces altogether. To use this tool, you need to define a core idea under which you figure out sub-core ideas as branches which will help you brainstorm about the process and its improvement.

22. Eisenhower Matrix

The time management tool, Eisenhower Matrix, helps prioritize tasks according to their delivery date. It segregates urgent tasks from less important ones and enables QA managers to use this tool by putting different tasks into different quadrants based on their urgency.

Conclusion:

While we understand that this might be an overwhelming list of quality tools you can use to maintain quality standards, we assure you that this list is all you need to improve your quality management game as a quality management professional.

Use the data/task organization tools to segregate each piece of information precisely, then go onto the problem-solving tools if you are facing an issue within a process or a step.

Use process improvement tools to better the existing process after solving the problem, and finally capture metrics through the metrics capturing tools for implying them to the process for better results.

Are you ready to start using these top-quality management tools? What features of these tools are most beneficial to you and your business?

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• 5 Why Problem Solving

One applies the 5 why problem solving tool to determine the root cause of a problem.

As customers become more experience in forcing suppliers to provide corrective action, they will request documentation that covers the 8D approach and 5Y analysis. This article deals with the five why analysis.  

The Five Why Model

In theory, one can easily learn this tool. In practice, this tool is much more difficult to apply.

When a problem initially occurs, we all have an immediate reaction as to the cause of that problem. However, that immediate reaction is a surface reaction only. When it comes to examining processes or systems, there are other deeper root causes for that problem. 5Y helps us find the fundamental root causes of a given problem. 5 why problem solving methodology helps us uncover the details behind the problem.

8D Manager Software with 8D, 9D, 5Y and 4M report generator. Your corrective action software for managing, measuring, and reporting issues.

How does the 5Y tool work? Here is a quick flow...

• Problem occurs
• Why did that problem occur = sub root cause #1
• Why did sub root cause #1 occur? = sub root cause #2
• Why did sub root cause #2 occur? = sub root cause #3
• Why did sub root cause #3 occur? = sub root cause #4
• Why did sub root cause #4 occur? = key root cause #5

5Y means we asked the question "why" 5 times from the problem statement until you reach the primary root cause. The primary root cause or key root cause directly determines the other sub root causes. When solving the problem, you focus your efforts on the key root cause.

For each why question, you focus on the last sub root cause. When applying this tool, asking "why" 5 times may not be necessary. You may only need to ask "why" 3 times to come to the correct root cause. The number 5 is an arbitrary number. The 5Y method is a process of asking why a sub root cause occurred until you reveal the key root cause.

When doing the 5Y analysis, use a team approach to determine the root causes. Document each determined sub root cause. When you identify the key root cause, be sure to positively identify that root cause on your document with a check mark or underline.

Additional 5Y Actions

As mention above asking "why" five times may not be sufficient, you may need to ask more than 5 times.

Once you determined the key root cause from the 5 why problem solving methodology process you are not finished with the 5 why analysis. You need to verify that root cause. You verify the key root cause by witnessing the root cause in action. Then check to see that you duplicated the problem.

After verification of the root cause, you must determine your corrective actions for that key root cause. Document the corrective actions on the 5Y form. Implement these corrective actions. If you are completing a corrective action for a customer, proceed with the 8D analysis.

5 Why Problem Solving and Formal Corrective Action

Customers may require one of two different systematic methods when using when using the 5 why problem solving tool. These are;

1) Prevent - Predict - Protect 2) Problem - Containment - System

When a customer request one of these 5y analysis from you, you apply the 5 why problem solving template tool to each of the 3 elements. So for Prevent - Predict - Protect method you apply a 5Y approach separately to Prevent, Predict and Protect processes at your company.

Prevent - these are the processes at your company that did not prevent the problem from occurring. Why did your process not prevent the failure from occurring?

Predict - These are the process at your company that did not predict this issue from occurring. Why did your current processes not predict this failure mode? Why did your planning or development process not see this as a potential issue?

Protect - These are the processes at your company that protects the customer from receiving defective product. Why did your quality processes not protect the customer from the failure mode?

Problem - This is the root cause to the problem. Why did the problem occur.

Containment - This is the root cause reason why defects escaped your facility. Why did you process not catch these defects prior to shipment?

System - These are the root systems that did not foresee this potential root cause. This could also be lack of systems to prevent the root cause. Why did your systems not predict or catch this failure mode.

When conducting 5 why analysis, use a template that lets you capture the data. The template needs to isolate each of the 3 elements. This allows the customer to quickly review your analysis. If you use 8D Manager , you can quickly create a 5Y form for each 8D corrective action. 8D Manager software separates each of the elements.

More on Five Whys

Description:.

The Five Whys also named 5-whys analysis method is used to isolate the true root cause of a problem.

When dissecting a problem, ask why the issue occurred. For each reason given, ask why that reason happen. After asking why repeatedly for every reason, you will identify the true root cause.

5 why means 5 cycles, but you may not need 5 cycles. Sometimes 3 or 4 cycles isolates the cause. By the time you get to the 4th or 5th why, most likely you're looking squarely at management practices.

This methodology is closely related to the Cause & Effect (Fishbone) diagram, and can be used to complement the analysis to complete a Cause & Effect diagram.

Here is a real world example from a kitchen manufacturer:

Root Cause:  Company management did not understand lean manufacturing, and did not set appropriate project targets when the plant was launched.

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