White Paper Write Effective Root Cause Statements to Ensure Strong CAPAs

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Write Effective Root Cause Statements to Ensure Strong CAPAs

Corrective and Preventive Actions (CAPAs) are a foundational element within the Quality System.

In organizations worldwide, the clear understanding of a strong CAPA is negotiable. Some CAPA

owners and teams are excellent at ensuring CAPAs are thorough and effective. However, some

organizations struggle with strong CAPAs. Why?

Strong CAPAs are difficult to identify, challenging to implement, and subjective for the reviewer.

I have reviewed thousands of CAPAs at organizations across the world, and the standard for an

acceptable CAPA varies by the person who identifies the CAPA and the person who reviews and

approves the CAPA.

There are many factors influencing whether a CAPA is strong:

Time Capital

Effort Resources

CAPA

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All of these outcome-based criteria influence the CAPA selection. These factors, along with

others, are a heavy influence on the final selection of actions. I believe the strength of activities

begins much earlier in the process.

Let’s take a moment to examine what leads to the CAPA statement and how the actual CAPA

statement can influence the strength of the CAPA.

Key Statements

There are three key statements in investigations and CAPA writing:

1. Problem Statement

2. Root Cause Statement

3. CAPA Statement

Problem Statement

The Problem Statement is the first declaration of the problem discovered. Problem statements

ensure the problem:

• Details a common understanding of the problem

• Focuses on the problem

• Builds boundaries for the investigation

• Prevents “scope creep”

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Problem statement components:

Example

What is the problem?

Labels are falling off bottles

When did the problem occur?

When was the problem discovered?

Tuesday, June 1

Where is the problem occurring?

In Warehouse 1

How big is the problem?

What is the total impact of the problem?

Affects Product A bottles only

Based on the information provided we can write the problem statement as follows:

On Tuesday, June 1 it was discovered the labels are falling off Product A bottles in the

warehouse 1.

A clear problem statement is critical in determining how this problem fits into our Quality System

and whether or not we will investigate further.

Root Cause Statement

The Root Cause Statement includes what we have discovered from our investigative activities.

Root Cause Statements should:

• Describe specifically the root cause of the investigation

• Use accurate and specific descriptors for what occurred

• Clearly show the cause and effect relationship

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• Avoid general or inflammatory words

Cautions for root cause statements:

In many investigations reviewed, the root cause statement is not clearly linked to the problem

statement or contains vague wording. Below are some examples of CAPA statements:

Problem Statement

Root Cause Statement

Critique

On Tuesday, June 1 it was

discovered the labels are

falling off Product A bottles in

warehouse 1.

The labels for Product A were

procured from a new supplier

and didn’t contain enough

glue.

Do the reasons expressed

clearly describe why the

problem occurred?

“And” is a difficult word

choice in root cause

statements if both reasons

are not clearly linked to the

problem.

“Enough” is a vague term and

cannot be quantified.

During review on 10.1.2017 a

documentation error was

identified for a new rinse

protocol used for ABC pump

training.

The rinse protocol for the ABC

pump was poorly written.

The root cause statement

does not contain enough

information to link the

problem and the effect.

“Poorly” is a vague term and

is subjective.

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Root Cause Statement

Improved Version

The labels for Product A were procured from

a new supplier and didn’t contain enough

glue.

Product A labels were examined, and the

amount of glue discovered was 4.78g/m

, the

amount of glue required for adhesion is

specified at 5g/m2.

The rinse protocol for the ABC pump was

poorly written.

The rinse protocol for the ABC pump included

the incorrect documentation instructions for

recording the rinse solution dilution.

The improved versions include clear understanding of the cause and effect relationship between

the problem statement and the root cause statement.

CAPA Statement

Strong CAPAs need specifics to detail what happened and what is found to support the reason

why it happened. The CAPA statement is the final statement in the process and links the problem

and cause with actions for what we should do to correct and prevent.

The CAPA statement details the activities to correct and/or prevent the problem from

occurring/recurring. This statement needs specifics that allow us to clearly identifies what

activities will be performed, they will fix the problem and not cause additional harm.

Cautions for CAPA statements:

• BE SPECIFIC – use specific terminology including dates for completion.

• Don’t rely on surface level CA/PA activities – retrain, revise SOP, human error. The

investigation should show depth and your CA/PA activities should show the same depth

and discovery

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Three Statements Examined

Ideally, you should be able to take the three statements out of the report for a clear

understanding of the entire process. Here are a few examples:

Problem Statement:

On Tuesday, June 1 it was discovered the labels are falling off Product A bottles in

warehouse 1.

Root Cause Statement:

Product A labels were examined, and the amount of glue discovered was 4.78g/m

, the

amount of glue required for adhesion is specified at 5g/m2.

CAPA Statement:

Product A label supplier will be audited for compliance with requirements and will be

completed by 9/30/2018.

A method for measuring glue adhesion will be developed and implemented for testing by

10/31/2018.

Problem Statement:

During review on 10.1.2017 a documentation error was identified for a new rinse protocol

used for ABC pump training.

Root Cause Statement:

The rinse protocol for the ABC pump included the incorrect documentation instructions

for recording the rinse solution dilution.

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CAPA Statement:

The rinse protocol for ABC pump will be revised to include the correct documentation

instructions on page 15 by 9.15.2018.

The rinse protocol for similar pumps will be reviewed and revised as necessary for correct

documentation instructions by 10.31.2018.

The protocol template will be updated to include clear documentation instructions by

11.15.2018.

©PathWise 2018

ABOUT THE AUTHOR:

Collis has over fifteen years of experience in FDA Regulated Life Science Industries. She

has worked with training development, training design, training delivery, Quality Systems, Lean Principles,

technical writing, communications and project management. Collis has used her expertise to design and

implement compliance and training initiatives with success. Collis has used her experiences from working in and

with organizations who are in remediation with FDA and other regulatory bodies to address key concerns and

share best practices with organizations world-wide. Collis has a Bachelor of Science in Business Administration

and a Master of Arts in English, concentration in Technical and Professional Writing.