8D- Eight Disciplines of Problem Resolution

Uzair Rajput

Quality Engineering Manager

LifeNet Health

OBJECTIVES:

• UNDERSTANDING OF 8D PROCESS

WHY USE a FORMAL 8D?

• 8D ensures a comprehensive resolution of an issue

• 8D contains all aspects of other methods e.g. DMAIC and A3

• 8D will help to build a common understanding of the PROCESS of Problem Resolution

• Why re-invent the wheel

• Exceptions: adjustments allowed without cutting out any steps

So, what is 8D?

• 8D is formal Problem Resolution Process

• Was devised in automotive industry

• Has been utilized by Aerospace Industry

• Is being Increasingly adopted by Medical Devices and Healthcare Industry

8 Disciplines

D1: Define Team

D2: Define Problem

D3: ICA and/or

Countermeasures

D4: Root Cause Analysis

D5: Choose and Verify PCA

D6: Implement & Validate PCA

D7: Preventive Action/Prevent

Recurrence D8: Thank Team

So, How to Conduct an 8D?

Team to :

1.Meet in 8D Work Out Sessions

2.Update Management during scheduled reviews or as needed

3.Attach to CAPA upon completion

D1: Define Team WHY:

1. Multiple people bring multiple perspectives

2. Allows for objective Reviews

HOW: Essentials:

• One Champion: Person with authority

• Responsible to reprioritize required resources

• remove road blocks as needed

• One Lead: Sr. Engineer or a Value Stream Manager

• responsible for administering this process

• accountable for progress

• ensures the pace of progress

• Reaches out to Champion if help is needed.

• One Objective Reviewer / Coach: Usually a QS person

• One Engineer: Could be from outside of area in question

D2: Define Problem

WHY:

1. A well defined problem is half resolved problem

2. To avoid any waste-full application of resources

3. Symptom may not be THE problem

HOW: 1. DO NOT assume you know the problem, make it measureable

2. What internal or external customer REQUIREMENT was not met?

3. How many products are affected?

4. When did the problem start?

5. Basically, use 5W2H approach i.e. (Who, What, When, Where, Why, How

and How many)

6. Map out the process as much as possible

D3: INTERIM CONTAINMENT ACTION

And/or COUNTERMEASURES WHY:

1. It is all about protecting the customer

2. And off course, QSR and ISO require “Control of NC Product”

HOW: 1. Urgently Identify suspect product i.e. BOOKEND the product

Take Action to avoid continual shipping to customer e.g. Hold or

extra-ordinary inspection, etc.

2. Identify suspect process i.e. labeling, assembly, etc.

apply Controls to avoid continual production of

suspect product

D4: ROOT CAUSE ANALYSIS WHY: To ensure effective Corrective Actions

HOW: 1. Never assume, use a method and identify contribution

2. Always analyze why it was not detected

3. Some Methods are:

5-Why: Team to use the judgment when to stop, generally, asking

5 times would reveal THE Root Cause, more explanation in latter

slides

Other Methods:

a.Ishikawa Diagram, also know as Fish Bone Diagram

b.Is or Is Not analysis, etc. etc.

• LET’S TALK ABOUT ONE OF RCA Techniques

5-WHY

1st Degree 5-WHY (1 RC)

Why 5 Why 4th Why Occurred Why Not Detected

Why 4 Why 3rd Why Occurred Why Not Detected

Why 3 Why 2nd Why Occurred Why Not Detected

Why 2 Why 1st Why Occurred Why Not Detected

Why 1 Why Failure Mode Occurred Why Not Detected

2nd Degree 5-WHY (>1 RCs)

Why 1

Why 2

Why 3

Why 4 Why 4.1 Why 4.2 Why 4.3 Why 4.4 Root Cause

1

Why 4a Why 4.1a

Why 4.2a

Why 4.3a

Why 4.4a

Root Cause 2

Why 4b and So on

Estimated contribution of a root cause towards the issue

Root Cause from Methodical Analysis

Capture here a failure of detectability

Excerpt from a sample 8D Form

D5: Permanent Corrective Actions

CHOOSE AND VERIFY WHY:

1. To ensure PCAs will be effective if implemented

2. Will provide confidence on % Effectiveness

HOW:

1. For the most part “Reversing” the Root Cause would yield a

direction for PCA

2. Brainstorming and List all PCAs

3. Verify against a specific Root Cause, If Action does not

ELIMINATE a Root Cause, it is not 100% effective, IF AT ALL

4. Not all potential CAs identified may need implementation. Choose

the ones that are sufficient to eliminate root cause. Don’t over do!

D6: Permanent Corrective Actions

IMPLEMENT AND VERIFY WHY:

1. To ensure RCs have been removed - Implement

2. PCAs are implemented as intended – Verify

HOW:

1. Plan out the implementation

2. Give yourself reasonable time for stress free implementation

3. Setup some metrics to Verify long term effectiveness

D7: PREVENTIVE or PREVENT

RECURRENCE ACTION

WHY:

1. Improve overall organization – Use Lessons Learnt

HOW:

1. Identify similar processes where this issue might occur

2. Implement Actions in other processes to avoid similar problem

3. Implement process performance metrics/KPIs and review as

leaders’ standardized work

D8: THANK YOU TEAM

QUESTIONS:

Uzair_rajput@lifenethealth.org