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Safefood 360° User Conference – New Orleans, 2016 Root Cause Investigations for CAPA Lassi Eronen, Marketing Manager

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Page 1: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Root Cause Investigations for CAPALassi Eronen, Marketing Manager

Page 2: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Agenda

• Quick overview of the CAPA workflow

• Using the Causes list

• Using different RCA techniques with Safefood 360°

• Using the query tool for statistical analysis of root

causes

Page 3: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Getting to the bottom of it

Page 4: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Why is root cause analysis needed?

• Historically RCA has been viewed as optional – a nice to have

• Latest BRC versions require you to conduct a proper root

cause analysis

• Like Einstein said ” If I had an hour to solve a problem I'd

spend 55 minutes thinking about the problem and 5 minutes

thinking about solutions.”

• If you spend time – no matter how little in the end – about

defining the root causes of your problems, you will end up

creating more lasting change

Page 5: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

CAPA workflow

Details

Investigation and RCA

Action

Review

Close Out

Page 6: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

What is the problem?

• Is there really a problem?

• What is it?

• Who is involved?

• When is it happening?

• Is it severe?

• What is the extent of it?

Page 7: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

CAPA workflow

Details

Investigation and RCA

Action

Review

Close Out

Page 8: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Root cause or causal factor?

• Only by attacking the root cause you can prevent the

issue from occurring again

Page 9: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Root cause or causal factor?

Product Contamination

Dirty handsWashing

station out of soap

Too tight cleaning schedule

Page 10: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Different techniques

Name Complexity Use Information

5 Why’s Simple Day-to-day investigations

Fishbone Technique Moderate Investigations of any kind

Kepner Tregoe Root Cause Analysis

Complex Severe or multifaceted issues View link

Page 11: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Page 12: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Benefits of the fishbone technique

• Extremely easy and straightforward

• It is multidimensional compared to 5 Why technique

which leads into a rather singular conclusion about

the root cause

Page 13: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Assign the Corrective Action a Cause

• Categorizing records based on causes will help you

later create useful statistical analysis

Page 14: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

CAPA workflow

Details

Investigation and RCA

Action

Review

Close Out

Page 15: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Actions

• Assign relevant actions based on the investigation

• Establish a weekly / bi-weekly / monthly

improvement meeting where you review and

monitor open corrective actions

Page 16: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Using the query tool for statistical analysis

Page 17: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Example: How to build a treemap showing causes and nonconformances in one chart

• This is a particularly useful chart type because it

allows you to group multiple variables into one chart

and allow you to visualize the connection

Page 18: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Export the dates, NC categories and causes

Page 19: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Check the data

Page 20: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Page 21: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Page 22: Root Cause Investigations for CAPA - Safefood 360° · Safefood 360 User Conference –New Orleans, 2016Agenda •Quick overview of the CAPA workflow •Using the Causes list •Using

Safefood 360° User Conference – New Orleans, 2016

Q&AThanks for listening! It’s time for your questions.