ISO 9001 Fishbone (Ishikawa) Diagram Template

Introduction

In the world of quality management, achieving and maintaining ISO 9001 certification isn't a piece of cake. It's a commitment to a process of constant improvement of your products/services through identifying issues and solving them efficiently. This is when the Fishbone Diagram, also known as the Cause and Effect or Ishikawa Diagram, comes into play for any ISO 9001-certified company. In this article, we will discuss the value of the Fishbone Diagram within the ISO 9001 framework, learn the elements of a good ISO 9001 Fishbone diagram, and see how we can use a Fishbone Diagram Template to help us improve our quality management system and meet ISO 9001 requirements.

What is Fishbone (Ishikawa) Diagram?

The Ishikawa Diagram, named after Japanese quality control statistician Kaoru Ishikawa who conceptualized it in the 1960s, is a simple yet effective tool used to identify all of the possible causes that result in a certain effect or event. Due to its appearance, it is also called the Fishbone Diagram, as the visual representation resembles a fish skeleton.

Why is Fishbone Diagram relevant to ISO 9001?

The Fishbone Diagram is very relevant to the ISO 9001 standard because it serves many purposes that are aligned with the objectives of ISO 9001. We can use it as a tool for fulfilling specific requirements and as a means to achieve the philosophies of the standard.

Fishbone Diagram and ISO 9001 Requirements

The ISO 9001 requirements that can be directly related to the Fishbone Diagram include:

• Clause 10.2: Nonconformity and corrective action: This clause may be the most relevant to the Fishbone Diagram. In the context of ISO 9001, a nonconformity is defined as a failure to meet a requirement. The standard then requires reacting to nonconformities by taking action to eliminate the cause of the nonconformity, implementing any action needed, reviewing the effectiveness of the action taken, and updating risks and opportunities. A Fishbone Diagram can be used to analyze which root causes resulted in a nonconformity. This fits perfectly into the action to "evaluate the need for action to eliminate the cause".
  
  

• Clause 6.1: Actions to address risks and opportunities: We can use the Fishbone Diagram to analyze the root causes of potential risks or the root reasons of an opportunity not being fully realized.
  
  

• Clause 9.1.3: Analysis and evaluation: When we analyze the data and information about the quality management system performance, we can use a Fishbone Diagram to see why there are certain trends or patterns of customer satisfaction, product conformity, or other indicators.

Fishbone Diagram and ISO 9001 Philosophies

The ISO 9001 philosophies that are reflected in the Fishbone Diagram include:

• Continuous improvement / Deming cycle (Plan-Do-Check-Act): The Fishbone Diagram helps us take a step back and plan our processes or make changes based on the current situation rather than randomly guess what may work. This is a manifestation of the planning stage of the Deming cycle.
  
  

• Evidence of problem-solving: If you are a Quality Manager in an ISO 9001-certified company, creating a Fishbone Diagram shows the auditor that you are not simply putting out fires but carefully studying why each nonconformity occurs. This demonstrates that your quality management system has proper problem-solving capabilities.
  
  

• Collaboration: The creation of a Fishbone Diagram encourages brainstorming and collaboration between different team members. This is important for the realization of an effective quality management system.

Common Categories for ISO 9001 Fishbone Diagrams

There are a number of categories that can be used for a Fishbone Diagram. They may vary depending on the industry or the problem at hand.

6 Ms (used in manufacturing)

These categories represent factors that may commonly result in a defect in the manufacturing process:

1. Manpower (People): Actions of people or the lack thereof.
   
   

2. Methods: Process or technique.
   
   

3. Machines: Equipment or technology.
   
   

4. Materials: Parts, resources, or information.
   
   

5. Measurement: Inspection or testing.
   
   

6. Mother Nature: The working environment.

8 Ps/Ms (used in services)

These categories represent factors that may commonly result in a defect in the service sector:

1. People: Workers, customers, or other external parties.
   
   

2. Process: Procedure or method.
   
   

3. Place: Working environment.
   
   

4. Policy: Organizational rules or guidelines.
   
   

5. Procedures: Particular processes or actions.
   
   

6. Product/Service: Goods or services.
   
   

7. Price: Expenses.
   
   

8. Promotion: Advertising or publicity.

How to use ISO 9001 Fishbone Diagram Template? Step-by-Step

The general steps for using the ISO 9001 Fishbone Diagram Template we discussed include:

1. Step 1: Defining the problem (effect) clearly.

   It's important to define the problem clearly and concisely. This makes the analysis easier and more effective. For example, the problem could be: "High Rate of Product X Defects in Final Inspection (Q3)" or "Increased Customer Complaints Regarding Service Y Responsiveness." Write this at the rightmost end of the template, also called the "fish head."
   
   

2. Step 2: Drawing the fish head and spine.

   On the selected template, the fish head and the spine are already drawn.
   
   

3. Step 3: Identifying major (primary) bones/categories.

   Draw the major bones (the ones going from the spine to the fish head) and write down the categories next to them.
   
   

4. Step 4: Brainstorming to identify potential causes (minor bones).

   This step requires brainstorming to identify possible causes. Here are some tips for this important step:

   • Quantity: At this point, it's important to think of as many causes that fall under the previously determined categories. There's no need to worry about the quality at this point.
     
     

   • Quality: To get good results, it's a good idea to involve people from different departments who can see the problem from different perspectives.
     
     

   • Deep digging: To get the quality quantity, you may want to ask yourself the question, "Why did the effect happen?" five times in a row. This is also known as the 5 Whys. For example, if one of the potential causes is "Lack of Staff Training," you can ask yourself the following questions: Why is there a lack of staff training? (Answer:) Why is that the case? (Answer:). Continue asking "why" until you've achieved a satisfactory answer.
     
     

5. Step 5: Analyzing and prioritizing the causes.

   After you've finished brainstorming, it's a good idea to analyze and prioritize the causes. It's important to discuss the potential causes and agree on the ones that are contributing to the effect. Once you've reached a consensus, pick the causes you will focus on.
   
   

6. Step 6: Developing corrective actions.

   Now that we have identified the root causes, it's time to develop corrective actions. It's important to ensure that the corrective actions are SMART (specific, measurable, achievable, relevant, timely).
   
   

7. Step 7: Documentation and monitoring.

   After you've fulfilled Steps 1-6, it's time to document everything we've done. This documentation will help us demonstrate our process to an ISO 9001 auditor. It's also a good idea to periodically review the corrective actions to evaluate their ongoing effectiveness.

Benefits of Using Fishbone Diagram for ISO 9001 QMS

There are many benefits to using a Fishbone Diagram when fulfilling the requirements of ISO 9001. Some of them include:

• Systematic root cause analysis: A Fishbone Diagram ensures a systematic approach to identifying root causes so that we do not miss any important factors.
  
  

• Improved decision-making: The process of creating a Fishbone Diagram leads to better-informed decisions when determining the root causes and developing corrective actions.
  
  

• Effective communication: The visual approach to the root cause analysis can lead to better communication within the team.
  
  

• Auditor confidence: A properly done Fishbone Diagram demonstrates to an auditor that your company takes a systematic approach to problem-solving.
  
  

• Continuous improvement: By systematically addressing root causes, an organization demonstrates its commitment to continuous improvement.

Conclusion

The ISO 9001 standard is one of the quality management standards that require a systematic approach to the improvement of products/services. The Fishbone (Ishikawa) Diagram is a fantastic tool that helps us with root-cause analysis, which enables us to go beyond simply treating effects and move towards eliminating root causes. This is a wonderful addition to the quality management toolset of any ISO 9001-certified organization.