Instructions on how to complete form QA10

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Root Cause Process Flow Chart

#6Verify Root Cause

#7Develop Corrective Action

#9Verify Effectiveness

#1

Define Problem

#2

Determine Approach

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PPI Corrective Action Form

The Excel sheet consist of 6 tabs:

1. The CAR tab

2.The Fish tab

3.The Immediate tab

4.The Multi tab

5.Evidence tab

6.The How to tab

PPI uses QA 10 form to establish and outline the process for

identifying, documenting, analyzing and implementing corrective

actions.

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The 1st tab is the CAR tab.This tab describes the

Non-conformance and all pertinent information as:

a) The date the CAR was answered

b) The effectivity date –this is the date the CA implementation becomes

effective

c) The immediate corrective action

d) The Root Cause

e) The Root Cause Corrective action

Plan

1. The CA Number

2. The initiator

3. The Audit area

4. Finding Classification: Minor/Major

5. References: As applicable

6. P.O.

7. Job No

8. Who is this CAR assigned to.

9. The requirement

10. The Non-compliance

11. The Date CAR was issued

12. The Date assignee should answer

The assignee is responsible

for filling out the following:

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Corrective Action Request – 1st Tab Continuation

Define Immediate Corrective Action taken

EXAMPLE: The internal procedure for the qualification of lay-up personnel does

not meet BAC5317

Define the actions taken immediately to:

Stop the Non-conformance

Assess the damage

Segregated Impacted product

Notify as appropriate

Immediate Corrective Action:

Good Response: Procedure was reviewed in its entirety against the requirements of BAC5317 and approved by the QA Manager. Procedure attached, note – Changes made are specifically identified on our procedure change sheet.

Poor Response: Modified Procedure

What action was taken following the issue being discovered?

Did you stop the problem from continuing?

Did you contain the problem found?

These actions address the immediate or direct cause of the NCR5

How to create an analysis Fishbone Diagram

1) Define the problem – What Needs to change?

2) Determine Approach –

3) Brainstorm – Generate potential causes of a problem

4) Review Causes -

5) Classify Causes - From mild to worst

6) Verify Root Cause - Determine the major cause

7) Develop Corrective Action – The Plan

8) Implementation – Are we following the plan?

9) Verify Effectiveness – How well did it work?

2nd tab – Fish Bone Diagram

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The 2nd tab Continuation - Fishbone

diagram

In order to complete the fishbone diagram first you must brainstorm all possible causes that could have led to the root cause of the noncompliance.

Develop the major bones of the diagram.

Note: Brainstorm all possible causes even seemingly improbable causes.

Effect

The Root cause

assessment Matrix in the

following slide is a tool that

one can use to fill out the

Fishbone diagram.

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Root CauseAssessment Matrix

The Root cause assessment Matrix is a tool that one can use to fill out the Fishbone diagram.

It will give you basic root causes for different circumstances.

Use this matrix to brainstorm possible causes and attach them to the appropriate branches.

Just double click on the matrix and it will open into a word document.

Root Cause Assessment Matrix

1 of 4

People Training Procedures

No people available No training available No procedures exist

People not qualified Training insufficient/not thorough

Procedures are not clear, are confusing, or are of poor quality

People call in sick No syllabus available Procedures conflict with other procedures

People waste time. Incomplete syllabus Procedures do not address issue at hand

Longer breaks than necessary No tests available Procedures are incorrect

People insecure in abilities Insufficient testing Procedures are not complete

People are overworked No procedures to train to Procedure manuals not available

People did not know they had to do that. Recurrent training needed

Lack of knowledge on using manuals or

work instructions

Falsification of records No “New Procedure” training Manual/procedures not current

Falsification of time sheets No training on using company manuals No backup procedures

Subversion or sabotage

No formal computer or software use training program in place

Procedures located in wrong chapter or manual

Do not know how to use manuals Instructor is not qualified in subject Manual format style is confusing

Lack of motivation Poor instruction skills Flow of manual is poor

Frustration – management does not listen to our ideas Lack of instruction tools

Terms used within the manuals are not identified

People resistant to change

Instruction tools are not available at the training facility being used.

Definitions for terms determined by company not identified or clear

People are not willing to learn

Self Training tools/materials/manuals not available to personnel

Manual/procedures not required for all departments that need it.

People did not care to follow procedures Poor or incomplete indoctrination training Weak enforcement procedures

People not held accountable for actions

Poor or incomplete department/position specific indoctrination training No checklist or trigger available

Personnel do not know about Self Training tools/materials/manuals which are available

to them No department/position specific indoctrination syllabus

Procedure creation flow is poor or non-existent

People not accustom to facility/area elevation Insufficient training materials for students

Manual incorrectly revised – pages missing or in wrong place

Personnel attempting to work while ill or injured Lack of training resources Different forms exist for same procedure

General human factors Decision made not to train

Completion instructions for forms are not documented

Personnel on medication which affects physical/mental aptitude or abilities Poor training program/design

Same forms are completed differently by different departments

People distracted by event or issue

Identification tags being used for

additional issues or conditions

People with animosity toward coworkers or

management. Step sequencing is wrong

Supervisory personnel not knowledgeable in area or procedures More than one action per step

General horse play

Low or stopped workload resulting in

boredom/idle hands

Knowledge based decision required by lack of knowledge

2nd tab – Fish Bone Diagram continuation

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Define Root Cause of the Non-conformance

Investigate all causes contributing to the non-conformance using the fishbone diagram. The root cause will be the last cause in the chain and requires a 5-Why analysis.

EXAMPLE:

The internal procedure for the qualification of lay-up personnel does not

meet BAC5317

Only the identified root cause should be included in your response. Supplemental information to support your cause analysis may be included as objective evidence if necessary.

Root Cause:

Good R/C: Inadequate review of our procedure against the customer

standard due to lack of formal review procedure and lack of assigned

personnel to this task.

Poor R/C: We have been audited by many customers in the past and

Nadcap and this has never been a problem.

2nd tab Continuation – Fish Bone Diagram

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The 2nd tab also contains

the 5 why’s section

The bottom portions contains the 5 Why’s

section.

How to Complete the 5 Why section:

1) Write down the specific problem

2) Ask why the problem happened and write

the answer down below the problem

3) If the answer you just provided does not

identify the root cause of the problem you

wrote down in step 1, ask why again and

write that answer down

4) Loop back to step 3 until the problem’s root

cause is identified

This make take fewer or more times than five

Whys.

Asking Why many times often brings

you to the real root cause …..

One you may not have never noticed.

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The 3rd tab contains the Containment Section of the C/A

In this section you will define the containment action and Impact of all identified causes and Root Cause.

What Impact did the Nonconformance actually have?

•Parts affected?

•Were parts shipped to customer?

•Contact Customer

Define Impact

EXAMPLE:

The internal procedure for the

qualification of lay-up personnel does not

meet BAC5317

Impact to Hardware:

Good Response: None, this discrepancy

was procedural only. All qualification

records were reviewed and found to be

in compliant with BAC5317

Poor Response: None

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The 4th tab covers the Multiple Follow-up dates

This section of the C/A would only need to be filled by QA Department.

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The 5th tab will hold objective evidence

You will need to provide Objective evidence:

What information can you provide to

demonstrate the RCCA process applied to the

NCR?

This evidence can be in the form of changing or

creating a new procedure, implementation of a

new system, performed training/awareness of

personnel, new checklist,

For the example to the right:

The Noncompliance was the used of spray

adhesive 77 vs. the requirements of the EWI.

The objective evidence provided to support the

corrective action is the EWI was revised,

personnel were trained to the updated EWI and

signs were posted inside the layup room

designating an area for the use of spray adhesive

77 only.

…SHOW IT!!

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Corrective Action Response Requirements

Define the Actions taken to prevent recurrence:

Example:

The internal procedure for the qualification of lay-up personnel does not meet

BAC5317

What is the long term action to prevent recurrence?

Can only be addressed when the root cause is known.

Actions taken to Prevent Recurrence:

Good Action: Review teams have been created to address the review of all internal procedures. The teams will compromise of two individuals and will perform a back review of the process specification against customer standard for compliance. The reviewers will complete a document review sheet, the procedure will be changed as identified on the review sheet and forwarded to the relevant personnel for approval.

Poor Action: Revised Procedure

Do not Rush, consider the effectiveness, feasibility, suitability to the

company, and the company’s budget.

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The 6th tab is the How To slide

This slide holds specific instructions on how to fill out the 1st tab.

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