Systems, Processes, Improvement

Question 1

Describe the difference between a system and a process. Describe the components and how they impact the system as a whole.

Answer 1

A system can be defined as a set of interrelated or interacting processes.

A process is a set of interrelated or interacting activities that transform inputs into outputs.

Question 2

Define the difference between common and special cause variation.

Answer 2

Common cause variation results from how the process is designed to operate and is a natural part of the process.

Special cause variation results from unexpected or unusual occurrences that are not inherent in the process.

Understand

Question 3

Describe what standardization is in quality systems.

Answer 3

Standardization of processes, policies, and procedures allows smoother flow of product and services across the whole range of suppliers and processes and finally to customer delivery.

Keeping things consistent

Question 4

What is incremental improvement?

Answer 4

Kaizen focuses on implementing small, gradual changes over a long time period. A team from the work group involved initiates incremental changes.

Incremental improvement involves small, gradual changes over time such as: updates to software, simplifying SOPs, and reducing materials on shop floor

Question 5

What are the steps for incremental improvement?

Answer 5

1. Select the process to be improved
2. Organize a team to improve the process
3. Define the current process
4. Simplify the process
5. Develop a plan for collecting data and then collect baseline data
6. Assess whether the process is stable
7. Assess whether the process is capable
8. Identify the root causes preventing the process from meeting the objective
9. Develop a plan for implementing a change
10. Modify the data collection plan developed in step 5, if necessary
11. Test the changed process and collect data
12. Assess whether the changed process is stable
13. Assess whether the change improved the process
14. Determine whether additional process improvements are feasible.

These are the steps for incremental improvement.

Question 6

What are the key factors for incremental improvement?

Answer 6

• Employing operating practices that uncover waste and non-value added steps
• Involvement of everyone in the organization
• Training in improvement, concepts, and tools
• Management that views improvement as an integral part of the organizational strategy

Question 7

What type of situation is incremental improvement suitable for?

Answer 7

Small incremental long-term changes over time

Incremental improvement is suitable for small, gradual changes over a long period.

Question 8

What is a breakthrough improvement?

Answer 8

Radically changing how something is done and may involve major process improvements in key business areas. These typically yield the highest economic return as much as 50 to 90% improvement and a short to medium timeframe.

:
Reengineering a major process in a company to achieve significant improvements in efficiency and effectiveness.

Question 9

What are the steps for a breakthrough improvement?

Answer 9

1. Ensure that a strong, committed leader is supporting the initiative
2. Form a high-level, cross-functional steering committee
3. Create a macro-level process map for the entire organization
4. Select one of the major processes to be reengineered
5. Form a cross-functional reengineering team
6. Examine customers’ requirements and wants in detail
7. Look at and understand the current process from the customer’s perspective
8. Brainstorm ways to respond to customers’ needs-think outside the box
9. Create breakthrough process redesign
10. Test-drive the new process design with a portion of the business and customers
11. Collect feedback from customers, employees, management, and stakeholders
12. Modify the process redesign as needed and communicate the changes
13. Plan a controlled rollout of the process redesign
14. Implement the rollout plan
15. Evaluate the effectiveness of the redesigned process continuously

Example: Following these steps to completely revamp a company’s core processes for better outcomes.

Question 10

What type of situation can be used for a breakthrough improvement?

Answer 10

Start from scratch and ignore current processes, make large changes quickly.

Example: When a company decides to completely overhaul its existing processes and systems without considering the current setup, aiming for rapid and significant improvements.

Question 11

Define some improvement/opportunity techniques and/ or methodologies.

Answer 11

• Brainstorming
• PDCA
• Affinity Diagram
• Cost of Poor Quality (COPQ)
• Internal Audits

Question 12

What is Cost of poor quality (COPQ) and how is it used?

Answer 12

This tool can be referred to as either cost of quality-providing a broader view of what helps to prevent or avoid quality problems, what helps to appraise quality levels, and how we identify and prevent external and internal failures or cost of poor quality, which focuses more on the elements that cause poor quality, and the internal and external failures.

Question 13

What is “Cost of Quality” (COQ)?

Answer 13

Best tool to use when you want to describe the impact of poor quality or service has on your organization.

Question 14

What are the four types of Cost of Quality (COQ) classifications?

Answer 14

• Prevention Cost: Are incurred to prevent or avoid quality problems and are associated with the design, implementation, and maintenance of a quality management system.
• Appraisal Cost: Come from measuring and monitoring activities related to quality. These costs are associated with supplier and customer evaluation of purchased materials, processes, products, and services to ensure that they conform to specifications.
• Internal Failure Cost: Are incurred to remedy defects discovered before a product or service is delivered to the customer.
• External Failure Cost: Are incurred to remedy defects after the product or service has been received by the customer. They can include the costs of warranty claims, recalls, repairs and servicing, complaints, and returns.

Question 15

How can Internal audits be used to help a QMS?

Answer 15

An audit of a quality management system is carried out to ensure that actual practices conform to the documented procedures.

Question 16

What tools can be used for root cause analysis?

Answer 16

5 whys
Fishbone Diagram

These tools can help by determining factors that cause a positive or negative outcome, focusing on a specific issue without resorting to complaints and irrelevant discussion, determining the root causes of a given effect and identifying areas where there is a lack of data.

Question 17

What is the PDCA cycle and how is the cycle used?

Answer 17

A four step process for quality improvement.
1.) The first step (plan), is to develop a plan to effect improvement.
2.) The second step (do), the plan is carried out, preferably on a small scale.
3.) The third step (check), the effects of the plan are observed.
4.) The last step (act), the results are studied to determine what was learned and what can be predicted.

Example sentence: Implementing the PDCA cycle can help improve our processes.

Question 18

Define how the “plan” step is utilized in the PDCA model.

Answer 18

Identify an opportunity and develop a plan for process improvement or change this is the longest and most important step in the model.

1.) identify the problem and goals.
a.) create a problem statement.
B.) define scope.
C.) identify resources and select the team.
D.) identify expected outcomes.
2.) identify and study the current state
A.) map the current stage.
B.) identifying information to be collected
C.) identifying information collection method.
D.) collect data.
E.) display and share data with team.
3.) analyze possible causes of problem.
A.) identify invalidate root causes.
B.) examine and prioritize possible solutions.
C.) move unused solutions to parking lot.
D.) create a plan to develop and test solutions to remove root causes.

Question 19

Define how the “do” step is utilized in the PDCA model.

Answer 19

Carry out what is detailed in the plan and test the process improvements or change generally on a small scale.
1.) Create a potential solution plan or improvement
2.) Establish improvement measures
3.) Implement the potential solutions on a small scale
4.) Collect data and track measures to determine improvement

Question 20

Define how the “check” step is utilized in the PDCA model.

Answer 20

Observe an analyze the effects of what was done in the duet step.

1.) analyze data and compare to predicted results.
2.) summarize and share data with other stakeholders.
3.) finalize recommended solutions, including justifications.

Question 21

Define how the “act” step is utilized in the PDCA model.

Answer 21

Take action based on what you learned in the check step; adopt, adapt, or abandon

A.) If the process improvement worked adopt it on a wider scale.
B.) If the process improvement did not work, adapt and repeat the PDCA model again with changes.
C.) Abandon the improvement and start fresh.

Question 22

Which improvement tool is considered one of the most important and why?

Answer 22

Internal and external audits are considered one of the most important process improvement tools available to an organization.
o How well is the organization following its own procedures?
o Where are the “disconnects?”
o Why are they happening?

Question 23

What is Root Cause Analysis and how is it used?

Answer 23

Root cause analysis is a problem-solving approach aimed at identifying, analyzing, and resolving the underlying, core issue (or root cause) of a problem. RCA helps a project team identify why and how a problem occurred.

Perform root cause analysis on a process when:
* Significant or consequential events occur
* Repetitive human errors or equipment failures occur
* Performance is below documented standards

Question 24

What are some key considerations to be aware of when performing root cause analysis?

Answer 24

• Must be performed systematically and logically
• Any recommended solutions must be backed up by root cause data and documentation
• Analysis must establish strong relationships between the root cause(s) and the defined problem
• There are typically multiple root causes for any given problem.
• Interactions between potential root causes must be fully understood and analyzed to determine how they affect each other and the given problem.
  *Any recommended solutions must be analyzed to determine the extent to which they will permanently address the problem and economically impact the organization.

Question 25

What is Risk?

Answer 25

Amongst quality professionals, there are two related definitions of risk.
o ISO 9000:2015 Quality Management Systems-Fundamentals and Vocabulary, defines risk as the “effect of uncertainty.”
o ISO 31000:2009 Risk Management-Principles and Guidelines, defines risk similarly as the “effect of uncertainty on objectives.”

Question 26

What are the levels of risk?

Answer 26

• Enterprise-level Risks
• Product/Service-level Risks
• Operational-level Risks

Question 27

What are the benefits of FMEA?

Answer 27

Benefits of using FMEA include:
* Improved quality and consistency
* Increased customer satisfaction
* Earlier identification and elimination of potential failures which can increase profitability
* In addition, FMEA changes your focus—from fixing problems after they occur to preventing problems before they occur.

Question 28

What is Failure Mode and Effects Analysis (FMEA) and how is it used?

Answer 28

FMEA is one of the most cost-efficient tools used to manage risks in process, design, or system development. It involves identifying potential failures to understand them, rating and prioritizing failures using specific criteria, and systematically reducing the potential of failure by using risk-mitigation action planning.

Use FMEA to:
* Better understand a process, design, or system so you can recognize and evaluate a failure and the effects of the failure
* Prioritize failures to focus on the most serious first and reduce risk
* Identify and document action plans that could eliminate the failure, reduce the probability that the failure occurs, or reduce the criticality of the failure
* Eliminate potential failures

Question 29

What are the two mains types of FMEA?

Answer 29

• The design FMEA, or DFMEA, for analyzing potential design failures.
• The process FMEA, or PFMEA, for analyzing potential process failures.