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

D6: Implement & Validate PCA D7: Preventive Action/Prevent Recurrence

D5: Choose and Verify PCA

D4: Root Cause Analysis

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. 2. 3. 4. 5. DO NOT assume you know the problem, make it measureable What internal or external customer REQUIREMENT was not met? How many products are affected? When did the problem start? 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.

 LETS TALK ABOUT ONE OF RCA Techniques

5-WHY

1st Degree 5-WHY (1 RC)

Why 1
Why Failure Mode Occurred Why Not Detected

Why 2
Why 1st Why Occurred Why Not Detected

Why 3
Why 2nd Why Occurred Why Not Detected

Why 4
Why 3rd Why Occurred Why Not Detected

Why 5
Why 4th Why Occurred Why Not Detected

2nd Degree 5-WHY (>1 RCs)

Why 1

Why 2
Why 4 Why 4.1 Why 4.2 Why 4.3 Why 4.4

Root Cause 1 Root Cause 2

Why 3

Why 4a

Why 4.1a

Why 4.2a

Why 4.3a

Why 4.4a

Why 4b and So on

Excerpt from a sample 8D Form

Root Cause from Methodical Analysis

Capture here a failure of detectability

Estimated contribution of a root cause towards the issue

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. Dont 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