Understanding Root Cause Analysis to Fill Deviation.....PDF FILE DOWNLOAD

Understanding Root Cause Analysis to Fill Deviation.....

Contents

1. What is Root Cause Analysis? .......... 1

2. Where in the Standard is RCA Required? .............. 3

3. How to Complete Root Cause Analysis? .................... 3

4. Methods of Root Cause Analysis ................... 5

4.1 The ‘5 Whys’: .............. 5

4.2 Fishbone Diagrams: ............. 7

5. Common Mistakes ......................... 9

5.1 Unmanageable Conclusions ....................... 9

5.2 Duplication of the Immediate Corrective Action ......... 10

5.3 People ......................................................... 11

5.4 Proposed Action Plan Doesn’t Prevent Re-occurrence..................... 12

5.5 Extra Checks ............................. 14

6. Preventative Action ............... 14

7. Additional Documentation ............ 15

8. Glossary of Terms ........................ 15

9. Appendices ....................... 16

9.1 Inclusion of Root Cause Analysis in the Audit Report .................. 16

9.2 ‘5 Whys’ Route Cause Analysis Template ............ 18

9.3 Fishbone Diagram Template...................... 19

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