Scribd
Upload
124 views2 pages

FMT - Qa.014 Capa Format

This document outlines a root cause analysis (RCA) process for investigating and resolving quality issues. It provides a template for documenting the problem definition, analyzing potential causes, determining corrective and preventive actions, and evaluating results. Key steps include defining the problem and its impact, analyzing causes, implementing and evaluating solutions, and closing out the RCA with sign-off once actions are complete.

Uploaded by

nishantpriya1104
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
124 views2 pages

FMT - Qa.014 Capa Format

This document outlines a root cause analysis (RCA) process for investigating and resolving quality issues. It provides a template for documenting the problem definition, analyzing potential causes, determining corrective and preventive actions, and evaluating results. Key steps include defining the problem and its impact, analyzing causes, implementing and evaluating solutions, and closing out the RCA with sign-off once actions are complete.

Uploaded by

nishantpriya1104
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
You are on page 1/ 2

Issue date: 20/3/2021

RCA#_02____ Complaint No.


Last update: NA
Doc nr. EA/QA/FMT/014.01 Root-Cause Analysis "RCA" Worksheet Revision: 0

Department: Area: Equipment: Led by : Date initiated: Date closed:

1. Define the problem & Impact (Plan) 4. Implement solutions (Do)


On time
Problem Definition: Problem Impact (KPI's) Corrective Actions By Who Target date Closed on Status completion
(y/n)

2. Analyze the problem (Plan) Preventive action By Who Target date Closed on Status Status

Man Method Machine

5. Evaluate results (Check)


Results:

Validation comments: Designated area for Shift FG storage

6. Learning's & Replication (Act)


Learning's/Opportunities for Replication:

Material Mother Nature Other

3. Determine the root cause (Plan) 7. RCA Closure & Sign-off (Act)
5 whys - Cause 1 5 whys - Cause 2 RCA Team: Sign-off RCA Communication

Production √
Why . . .

Why . . . ? Maintenance
?

QA √
Why . . .

Why . . . ? Warehouse √
?

Store & purchase □


Why . . .

Why . . . ? Area Owner: Nishant Kumar Safety


?

Why . . .

Why . . . ?

Why . . .

Why . . . ?

?
CAPA#_____ Complaint No.
CAPA Format
Doc nr. EA/QA/FMT/014 Rev.00

Department: Area: Equipment:

Team Members:

Problem Definition:

Root Cause:

Responsible
Corrective Action: Target Date
Person

Responsible
Preventive Action: Target Date
Person

Prepared By: Approved By:

You might also like