Problem Solving Handbook

A How-To guide for

Problem Solving 1

Table of Contents: What is Problem Solving

pg 3

How to execute Basic Problem Solving

pg 4

How to execute a Practical Problem Solving

pg 10

How to execute Scientific Problem Solving

pg 18

Facilitator Guidance: Kaizen Methodology and Problem Solving Methodology are similar in tools, methods, and duration depending on the current and desired state situation. Guidance on which method to use can be defined as: Problem Solving Methodology: Tools and Methods used when there is a deviation or miss to a performance target. This often occurs when a standard exists and there is a deviation to the standard. Kaizen Methodology: Tools and Methods used when improvement to a current state is desired. Often utilizing Lean Methodology to reduce or eliminate waste to an existing process.

2

What is Problem Solving?

Problem solving is the act of defining a problem; determining the cause of the problem; identifying, prioritizing, and selecting alternatives for a solution; and implementing a solution. Problem Solving is often used when there is a deviation to a defined goal or standard. At Emergent, we recognize 3 levels of Problem Solving: Basic Problem Solving, Practical Problem Solving, and Scientific Problem Solving.

What level of Problem Solving do I use? Basic Problem Solving utilizes the Basic Problem-Solving Methodology and Branched 5-why Problem-Solving Tool for identification of quick countermeasures in response to a minor problem. Basic Problems are minor issues requiring a low level of planning across individuals within the same function. Implementation of identified improvements can generally be completed within a few days of the problem-solving event. Practical Problem Solving utilizes additional tools to gain a detailed understanding of the current state of the process before determining the root cause. This often requires the use of additional subject matter experts to explain the detail of the process in effort to find who, what, when, and where the problem occurs. Practical problem solving occurs when we have experienced persistent/recurring issues despite attempts to resolve through basic problem solving Scientific Problem Solving utilizes cross-functional teams to understand the detail of the process. The process often covers multiple functional areas where representation from each department must participate in the Problem Solving activity. Because of the larger commitment of time and resources, Scientific Problem Solving utilize Project Charters and Project Management tools to ensure alignment and commitment to solving the problem. Scientific Problem Solving occurs when problems are widespread, frequently occurring, high impact, and have not been resolved through basic/practical problem solving approach Time Guidelines

Complexity Cost

Participants

Type

Team Member, SME, Line Manager

Basic

1-5 Days

Low

No cost

2-4 Weeks

Moderate

Owner -orMinimal Process Cross Functional Team

Practical

1- 6 Months

High

High

Cross Functional team: Project Charter SLT Sponsor

Scientific

Guidelines Only: Consult with your Operational Excellence partner for clarification 3

How do I execute Basic Problem? Basic Problem Solving utilizes the Basic Problem-Solving Methodology and Branched 5-why Problem-Solving Tool for identification of quick countermeasures in response to a minor problem. Basic Problems are minor issues requiring a low level of planning across individuals within the same function. Implementation of identified improvements can generally be completed within a few days of the problem-solving event. The Basic Problem Solving Methodology utilizes a 3 Step Approach to solving problems. Refer to myE Operational Excellence Systems and Standards site for additional guidance. Steps to execute Basic Problem Solving

1. 2. 3.

Define: Utilizes the 5W1H approach to defining the problem Analyze: Utilizes basic 5 Why approach to determining Root Causes Solve: Utilized basic Impact / Effort Matrix to evaluate solution options and specific an action plan.

Guidelines: 1 to 2 days -and- Minimal to No Cost required 4

Step 1: Define what is the problem: Utilizing the Step 1: Define the Problem templates allows you to gain a basic understanding of the problem and impact. This can provide guidance to the team members, business area, and timing involved. This also provides guidance on the impact of the problem which can assist in prioritization and support needed to solve the problem. The 5W1H approach is another simple method to determine the scope and focus area for the Basic Problem Solving activity.

Problem-Solving Step 1: Define the Problem 1) What is the problem? 2) When did the problem occur?

Date & Time of Event: Shift (if applicable): Date & Time Detected: Repeat occurance? Location: Process:

3) Where did the problem occur?

Process Step/Task: Procedures/Forms: Materials: Equipment: Personnel: Safety:

4) Impact to Team Goal(s):

Quality: Delivery: Economics: People:

5) External Support Required? 6) Additional Information:

5W1H Approach to Define: 1W: What is the problem? 2W: Where was the problem found? 3W: Who found the problem? 4W: When was the problem found? 5W: Why is this a problem? 1H: How big or severe is the problem? 5

Step 2: Analyze the problem (5 Why): While cause-and-effect are fundamental to explaining how and why an incident occurred, the timeline and work process are beneficial for organizing the specifics of a problem. Utilizing the 5 Why method helps to explain the cause-and-effect relationship of the problem.

Questions to ask during the Analyze Phase: A.

Why did this happen? This question builds to the right. Asking “Why” adds more causes and is the easiest way to start. This serves as the foundation for capturing cause-and-effect relationships. Why did B happen? Because of D.

A

B

D

B. How did this cause produce the effect? Asking “How” can be used to drive a more specific discussion around the causes and will reveal more detail in between the existing cause-and-effect relationship. How did D cause B?

A

B

C

D

Step 2: Analyze theStep problem: 5 Whythe Template Problem-Solving 2: Analyze Problem using 5 Whys Possible Solution:

OR

AND/OR

Evidence: AND

Impact to Goal

Level 1 “why”

Level 2 “why”

Level 3 “why”

And

Problem Statement

Or

6

Level 4 “why”

Level 5 “why”

Step 3: Solve the Problem: After investigation of the potential causes, you will determine certain root causes have an effect on the process and will need addressed. There are 3 basic parts to defining the solutions of the problem. •

Consider what is possible

•

Evaluate and select the best solution

•

Define the action plan

Tips for revealing creative solutions: •

Involve people closest to the work.

•

Look at the causes one-by-one and ask if there are ways to control, change, or prevent it.

•

Write down solutions that seem obvious.

•

It is best to complete the solution brainstorming process before doing the evaluation. This helps to get all proposed solutions (simple, innovative, and complex) on the table.

Evaluate and Select the Best Solutions: Once possible solutions have been proposed, the next step is to evaluate and select the best solutions for implementation. The Impact / Effort matrix is a qualitative cost / benefit analysis tool that can be used evaluate possible solutions. To use the tool, copy your possible solutions from the Branched 5 Why and place them on the matrix relative to each other. If considering a large number of solutions, letters or numbers can be used to represent your different options. High

Solution A Solution B

Better

Challenge

Low Hanging Fruit, No Brainer

Longer Term, Capital Project, Investment

Solution E Payback Medium Benefit

Solution D

Solution C

Possible

Avoid

Short Term, Quick Fix

Diminishing Returns

Medium

Low

Effort Cost

7

High

Implementing Solutions / Creating an Action Plan: After determining what solutions will be implemented, a basic action plan template can be used for managing and tracking implementation. This aids in the management of required activities and allows for escalation for overdue tasks. Note: This is an opportunity to evaluate cost savings impact and enter in to the 8 Waste Portal. Solution(s)

Action Steps

Task Owner(s)

8

Due Date

Status

How do I execute Practical Problem? Practical Problem Solving utilizes additional tools to gain a detailed understanding of the current state of the process before determining the root cause of the problem. This often requires the use of additional subject matter experts to explain the detail of the process in effort to find who, what, when, and where the problem occurs. The Practical Problem Solving Methodology utilizes a 8 Step Approach to solving problems. Refer to myE Operational Excellence Systems and Standards site for additional guidance.

Steps to execute Practical Problem Solving: 1.

Define The Problem

2.

Break Down the Problem—Grasp Current State:

3.

Set a Target Condition

4.

Conduct Root Cause Analysis

5.

Identify Potential Countermeasures & Propose Future State

6.

Develop, Test, and Implement Countermeasures

7.

Measure Process Performance

8.

Stabilize, Standardize, and Share Discoveries

Operational Excellence recommends the A3 Template as a tool for managing Practical Problem Solving activities.

Guidelines: 3 to 5 days -and- Minimal Cost required

Guidelines: 1 to 2 days -and- Minimal to No Cost required

9

A3 Template: Project Title: System/Function: Project Team Lead/Members: Process:

Start/End Dates:

1) Define the Problem

5) Identify Potential Countermeasures & Propose Future State

2) Break Down the Problem – Grasp the Current State 6) Develop, Test & Implement Solutions

3) Set a Target Condition

7) Measure Process Performance

4) Conduct Root Cause Analysis 8) Stabilize, Standardize, and Learn

Step 1: Define what is the problem: The problem statement: •

Shall be specific

•

Shall not include an implied solution

•

Shall state “what”, not “why”

•

Shall not include goals

•

Shall be agreed upon by the team and leadership early in the process

•

May be refined to reflect new understanding during the PDSA process

Initial Must Haves: •

What is the problem? (what is being affected?)

•

Where is the problem occurring? (space, location, process step, system)

Completing a Gemba Walk (may vary based on the type of problem): Gemba Walks are an excellent way gain a better understanding of the problem and assists on creating a clear problem statement. •

When does the problem occur? (pattern of occurrence over time; specific dates and times if available; when the problem was detected)

•

Who is experiencing the problem? (who is being affected: which customers, teams, individuals (titles or responsibilities))

•

How often/how many? (quantification of the actual number of occurrences)

•

Why is this a problem? (actual or potential consequences if the problem is not addressed; impact on goals, KPI(s), customers, etc.) 10

Step 2: Break Down the Problem—Grasp Current State Understanding current state can assist in breaking down the problem into more detailed and specific problems. This is also a good time to study and analyze the different inputs and outputs of the process through process mapping to effectively prioritize your efforts. It is much more effective to manage and solve a bunch of microproblems one at a time, rather than try and tackle a big problem with no direction. Determine the scope and boundaries (what’s in? what’s out?) of the project at this step.

Operational Excellence recommends various tools to break down the problem:

Supplier, Input, Process, Output, Customer (SIPOC) SIPOC Scoping: What is the Purpose? What Activities / Components are In Scope? What Activities / Components are Out of Scope? Where does the process start? Where does the process end?

Improve the Veeva New Material Creation / Modification Process New material and material extension forms in Veeva Supplier qualification, Change control system, Veeva config modifications Need for a new material is identified Veeva form is complete and material is setup in SAP

Process Description: Stakeholders:

QA (Compliance), QC, Production, Procurement, Finance

Date: 04.May.2022

Suppliers

Inputs

Process

Outputs

Customers

Proper or personal noun (person, group, or title)

Noun (a "thing," which includes information). Should avoid verbs

Should start with a verb

Noun (a "thing," which includes information). Should avoid verbs

Proper or personal noun (person, group, or title)

Production

Production

process requires modifications

identify need for a new material

new material characteristics are defined (size, colour etc.)

Production a need for a new material is identified

MS&T

new material is selected

Selecting new material MS&T

new material information is collected

Initiating new material request form

QA (although some other departments are involved in the process) Form to request a new material is created

QA

new material request form with new material information Approving new material request form

approved new material request formProduction

Procurement

new material is approved

new material is ordered

number of pieces to be ordered

Production

Ordering of new material

Process Mapping Title Author

Example Process Map 2

Revision

0

Date

4/4/2022

Jane Smith

Start

1. Enter Sales Order

2. Check Credit

Di s position

Reject

Accept

3. Forward to

4. Resolve Customer

5. Schedule Work

Conne ctor

6. Manufacture 7. Conduct Quality Inspection

8. Rework Product

Rework

Di s position

9. Dispose of Rejected Product

Scrap

10. Notify Scheduling of Scrap

11. Prepare Product for Shipping

Conne ctor

12. Ship Product

A

End

11

Step 2: Break Down the Problem—Grasp Current State: Fishbone / Ishikawa While cause-and-effect is fundamental to explaining how and why an incident occurred, the timeline and work process are beneficial for organizing the specifics of a problem. Utilizing the Fishbone Method provides context to potential causes to the problem. This can aid in brainstorming for what causes to investigate.

Manufacturing Method (6M’s): Uses 6M’s to categorize potential causes. Measurement

Material

Manpower

Problem Statement

Mother Nature

Method

Machine

Transactional Method: Uses transactional based categorizes to organize potential causes. System

Process

Forms

Problem Statement

People

Policies

Place

12

Step 3: Set a Target Condition Step three is all about commitment and focus. Your attention should now turn towards focusing on what is needed to complete the project and how long it will take to finish. You should set targets that are challenging, but within limits and don’t put a strain on the organization that would hinder the improvement process. Setting a Target Condition can be a statement of the direction or goal of the Practical Problem Solving Team. Examples include: •

Resolution of defined Root Causes will reduce the deviations from 10 to 2 by Year End.

•

Resolution of the Equipment Downtime issues will increase uptime from 65% to 95% by Year End.

•

Customer Complaints for delays will be reduce by 80% by Year End.

Step 4: Conduct Root Cause Analysis This is a vital step when problem solving, because it will help identify the actual factors that caused the issue in the first place. More often than not, there are multiple root causes to analyze. Make sure to consider all potential root causes so they can be properly evaluated in Step 5. A proper root cause analysis involves going to the gemba itself instead of simply relying on reports. Consider contributing factors, interactions, ability to detect out-of-standard events, and whether standards have been established. Problem-Solving Step 2: Analyze the Problem recommends using 5 Whys Operational Excellence various tools for Root Cause Analysis: Possible Solution:

5 Why Analysis

OR

AND/OR

Evidence:

Fishbone Analysis

AND

Measurement

Material

Manpower

Impact to Goal

Level 1 “why”

Level 2 “why”

Level 3 “why”

Level 4 “why”

Problem Statement

Level 5 “why”

And

Problem Statement

Or

Mother Nature

Process Mapping Title Author

Revision

0

Date

4/4/2022

Start

1. Enter Sales Order

2. Check Credit

Di s position

Reject

Accept

3. Forward to

4. Resolve Customer

5. Schedule Work 6. Manufacture 7. Conduct Quality Inspection

8. Rework Product

Rework

Machine

Failure Mode & Effects Analysis

Example Process Map 2 Jane Smith

Conne ctor

Method

Di s position

11. Prepare Product for Shipping

12. Ship Product

Scrap

9. Dispose of Rejected Product 10. Notify Scheduling of Scrap

Conne ctor

A

End

13

Step 5: Identify Potential Counter Measures & Propose Future State Once root causes have been established, use the information to develop countermeasures needed to either remove the root causes, change how they interact, increase the ability to detect issues earlier before they create a problem, or establish standards that better align with customer needs. The team should develop as many countermeasures needed to directly address any and all root causes. It is critical the countermeasures have defined predicted outcomes that can be tested. You can use practical hypothesis statements such as “If we make the change to X; did we get the predicted change to Y?” Without defined predicted outcomes, it will be difficult to compare results in Step 7 (Measure Process Performance) the actual outcomes . After developing the countermeasures and their predicted outcomes, begin to narrow them down to the most practical and effective ones (i.e. the most value-added) based on your target condition. Reference the Impact / Effort Matrix for guidance. Operational Excellence recommends various tools to Identify Potential Countermeasures and Propose Future State:

Impact / Effort Matrix

SWOT Analysis

High

Payback Benefit

Better

Challenge

Low Hanging Fruit, No Brainer

Longer Term, Capital Project, Investment

Medium

Possible

Avoid

Short Term, Quick Fix

Diminishing Returns

Medium

Low

High

Effort Cost

Future State Process Map Title Author

Failure Mode & Effects Analysis

Example Process Map 2

Revision

0

Date

4/4/2022

Jane Smith

Start

1. Enter Sales Order

2. Check Credit

Di s position

Reject

Accept

3. Forward to

4. Resolve Customer

5. Schedule Work

Conne ctor

6. Manufacture 7. Conduct Quality Inspection

8. Rework Product

Rework

Di s position

11. Prepare Product for Shipping

12. Ship Product

Scrap

9. Dispose of Rejected Product 10. Notify Scheduling of Scrap

Conne ctor

A

End

14

Step 6: Develop. Test, & Implement Countermeasures After developing a list of identified countermeasures and narrowing them down based on the value added, it is time to see them through in a timely manner. Communication is extremely important in step six. Ensure to seek ideas from the team and continue to work back through the Problem Solving cycle to ensure nothing is being missed along the way. Consider implementing one countermeasure at a time to monitor the effectiveness of each. During the conducting of experiments, you may find that countermeasure(s) need to be refined before the finalized version(s) are determined and implemented. Initial implementation of countermeasures may reveal new and unexpected obstacles. Ensure the plan includes a process to review and modify countermeasures which will help achieve the intended result (quick, small PDSA cycles on your countermeasures). The process by which we may arrive at the wrong answer gives us understanding of how we can improve our chances to arrive at the right answer. Step 7: Measure Process Performance Measure the process output variables in question to determine whether the observed outcomes match the predicted outcome. Are predicted and actual outcomes the same? If not, why not? Differences between actual and predicted results can yield large rewards in the form of deeper process knowledge and understanding. Operational Excellence recommends various tools to Measure Process Performance: Run Charts / Time Series Plots

Pareto Charts (After Implementation)

15

Step 8: Stabilize, Standardize, & Share Discoveries Now that you’ve encountered success along your problem-solving path, it is time to use the new process to inform and possibly create new standards. The understanding gained should be shared throughout the organization. It is also a good time to reflect on what you’ve learned and address any possible unresolved issues or troubles you have along the way. Ignoring unresolved issues will only lead to more problems down the road. Finally, because we aspire to become a true problem solving organization which recognizes that continuous improvement never stops, it is time to tackle the next problem (No problem IS a problem!). Start the problem- solving process over again and continue to work towards perfection. Operational Excellence recommends various tools to Stabilize, Standardize, & Share Discoveries: Control Plans

Standard Work Pre-Job Brief

Control Plan #

Process

--

Main Steps

Quality Characteristic Specification Sample Size Frequency Feature or dimension Standard and to measure tolerance

1

Measuring Tool

Form

Number of How often to Where to items to What to use to measure measure document inspect

Process Standards

Step

What to do if a deviation is detected

Legend

Title Here

Total Cycle Time: Total Number of Operators:

Reaction Plan

# of Cycle Time Operators (min)

Process

1 2 3 4 5

2

6

7 8 9 10 11

3

12 13 14 15 16 17

Standard work reliability practice - This is not a controlled GMP document

Lessons Learned

Pre-Job Briefs Pre-Job Brief

Owning Dept:

Lessons Learned - Project Name: ___________________________

Description

Title Here

Owning Operation:

Other:

A. List of project’s biggest successes:

Revision #:

Other:

Other:

Date Issued: Other:

Key Inputs

Expected Outcomes/Outputs

What are the inputs required for the operation? (Material, Machine, Measurement, People, Environment)

What is the expected output ? What does poor, good, and/or great look like?

Factors that Promoted this Success

B. List of project’s biggest challenges (failures): Description

Net Effect on Project

Key Process Steps

Key Risks / Sensitivities

Provide a high-level overview of the operation

Identify opportunities for variation from standard work

C. List areas of potential improvement (opportunities): Description

Possible Mitigation

Safety Information

Recent Lessons Learned

What aspects of the operation pose a safety risk and how do we mitigate?

1

2

3

4

Review recent deviations and associated corrective actions, as well as near misses

5

6

Icons

D. Enter other comments:

Standard work reliability practice - This is not a controlled GMP document

Customer / Supplier Agreements Internal Customer/Supplier Agreement

Date: Supplier:

Customer:

The supplier agrees to provide the following services:

The customer agrees facilitate supplier’s success by:

1.

1.

2.

2.

3.

3.

The supplier agrees to the following outputs / standards / measurement: Output

Standard

Measurement

Remediation process should the customer / supplier not adhere to standard: 1. 2.

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Practical Problem Solving Planning Notes:

17

How do I execute Scientific Problem Solving? Scientific Problem Solving utilizes advanced (often statistical based) problem solving tools to resolve issues. It uses a measurement-based approach (DMAIC) to identify the critical drivers, so that focused solutions can be implemented for the reduction of defects and variability. This approach is followed by all Six Sigma projects. Scientific Problem Solving utilizes the Six Sigma DMAIC Methodology to solving problems and Process Improvement. And often facilitated by Six Sigma Greenbelts or Blackbelts. Refer to myE Operational Excellence Systems and Standards site for additional guidance. Steps to execute Scientific Problem Solving: D. Define: Define the problem with clear a problem statement, goals, objectives, and plans M. Measure outcome performance by collecting data to understand size and scope of project A.

Analyze and study data to determine root cause(s)

I.

Improve by developing, piloting, and implementing solutions

C. Control the process to ensure long-term stability and gains

DEFINE

MEASURE

ANALYZE

18

IMPROVE

CONTROL

DMAIC Methodology (Summary)

DEFINE

MEASURE

• Define the project with clear problem statement, goals, objectives, and plans

• Collect data to understand size and scope of project

• Select team members • Launch the project

ANALYZE

• Study and analyze data to determine root cause(s)

IMPROVE

• Develop, pilot, and implement solutions

• Measure outcome performance

CONTROL

• Establish controls to ensure process stability and gains

• Establish baseline

Define Phase Summary: Define Phase uses various tools and methods to understand the Voice of the Customer and Current Process Performance. Define Phase Tool List: •

Project Charter

•

Project / Meeting / Team Management Tools

•

Thought Mapping

•

Process Mapping

•

Value Stream Mapping

•

Customer Requirements

Define Phase Checklist:

What is the problem statement? What is the goal? What is the impact to the business? What is the project scope? Where does the process begin & end? Who are the team members and what are their contribution expectations? Who are the customers and how were their requirements determined? What are the key milestones and timeline? Who are the key stakeholders and how will they be involved? Does the project impact the company’s Hoshin Kanri strategy? 19

Measure Phase Summary: The Measure Phase uses data driven tools and methods to understand the current performance of the process, influencing parameters, and key Critical to Quality (CTQ) elements of the process. This helps to establish a baseline performance and how the process is performing to a desired target. Measure Phase Tool List: • • • • •

Failure Mode & Effect Analysis (FMEA) Measurement System Analysis (MSA) Process Map (including Inputs and Outputs) Data Collection and Sampling Process Capability Analysis

Measure Phase Checklist: What is the current baseline performance and/or process capability? Has the measurement system been checked for repeatability and reproducibility? Does the Project Charter need to be revised based on key learnings? Has a current state value stream map or process map been completed to better understand the process and potential root causes?

Analyze Phase Summary: The Analyze Phase identifies the Cause and Effect of critical Inputs (x’s) to the Outputs (Y’s) of the process. It differs from Basic and Practical Problem Solving in that it uses statistical based tools to quantify and qualify the impact. Analyze Phase Tool List: • • • •

Assessing Normality Hypothesis Testing (Chi-Square, F Tests, T Tests, ANOVA Testing, etc…) Regression Analysis Design of Experiments

Analyze Phase Checklist: Have the root cause(s) contributing to the problem statement been identified? Does the team understand causes for variation in the process, and generate hypothesis as to the root cause of the current process performance? Has the team been able to confirm the root cause hypotheses?

20

Improve Phase Summary: The Improve Phase uses data driven solutions that have been tested and verified through a rigorous series of tests (often statistical based hypothesis testing). Improve Phase Tool List: • • • •

Brainstorming (SCAMPER Method, Analogy Method, Channeling, etc…) Solution Prioritization (Pugh Matrix) Piloting Error Proofing / Poke-Yoke Methods

Improve Phase Checklist:

Do the proposed solutions address the critical root cause(s)? Has the team developed an implementation plan? Have changes been communicated to all the appropriate people? Has a pilot run been completed to test the solution?

Control Phase Summary: The Control Phase ensures the process is stable over time. This is accomplished through rigorous tools and methods to ensure the process is sustainable and predictable. Control Phase Tool List: • • • •

Statistical Process Control (SPC) Standard Operating Procedures (SOP) Training Plans Control Plans

Control Phase Checklist: Are controls established to ensure improvements are sustained? Have the solutions been effectively implemented? Have the new processes proven to be capable of sustaining control? Has the necessary training for process owners/operators been completed? Has the documentation been updated? Has the process been transitioned to the process owner to take responsibility for managing continuing operations? Have “lessons learned” been captured? Have replication opportunities been identified?

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Scientific Problem Solving Planning Notes:

22

Scientific Problem Solving Planning Notes:

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Revision: 24 1.1 (20FEB2023)