Make Documents Easy for Your Reader

PathWise offer a Technical Writing Course which covers an extensive range of

topics and guidance to help you write for your audience. To complement that, I
would like to give some additional guidance and tips based on my experiences
with writing and reviewing reports.

Problem Statement bullets or text?

Product/Process information

Historical Data

Investigation presentation

Justifications

Acronyms and Jargon

Attachments

1. Problem Statement bullets or text

A problem statement needs to answer the following questions:

What item is impacted

What exactly is wrong
When did it happen
Where did it happen

Some people choose to answer these questions in bullet format, and some choose
to write in text format.

When asked which I would prefer, my answer is text format. The four major
questions are just simple guidance, a checklist, to ensure that everything is
included. But the answers are for your audience. By answering in bullet format,
most readers will have to work to piece the scenario together.

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 By using a text format, you are writing a story for your reader that brings all the
information together.

For example

Baby Formula
Low Vitamin C
2 weeks ago
Line #3
Versus

For the last 2 weeks, Baby Formula manufactured on Line #3 has been testing
low for Vitamin C

2. Product/Process Information

Consider providing your reader with some useful information about the product or
process involved in the event. It is all too easy for us to be so familiar with our
products and processes that we forget the reader may not be. This information
could be in the form of a picture or a process map. It could be useful for the reader
to see pictures of the item without the defect and with the defect. A process map
should always be provided wherever appropriate so the reader can visually
understand at what stage the event occurred. And indeed, this is often useful to
use for comparison during the investigation (what happened versus what should
have happened).

Background information could also be a description of what the product is used for
and how it works. Whatever you think may be a useful background for your reader
to understand the purpose of the product or process.

3. Historical Data

We actually view historical data (or should do) when we prepare our risk/impact
assessment. Without it, we cannot calculate our frequency of occurrence and
allow for this in arriving at our impact level. However, it is also useful to view this
data to learn from our mistakes (and make sure we do not take the same
Corrective/Preventive action again, as clearly it did not work).

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 Providing historical data is useful for the reader, as long as you only include the
issues that are relevant to the event. I recall one investigation report that listed
every previous report for the product concerned regardless of what the quality
event was! The reader therefore had to decipher which previous reports were
relevant to this new event.

4. Investigation Presentation

This tip is as much for the writer as the reader! When we use a quality tool like the
6Ms for our investigation, it can be quite difficult to follow the thought process
used. One report I reviewed listed 7 possible causes as a result of brainstorming
at the beginning of the investigation. However, it only discussed the data analysis
and findings of 4 possible causes.

There should be a closed loop within the investigation, and therefore all identified
possible causes should be followed through.

Consider constructing a table listing all your identified possible causes,

documenting your data analysis and findings:

CATEGORY POSSIBLE DATA ANALYSIS RETAIN/ELIMINATE

CAUSE

Possible cause 1 Describe In detail Is the decision to

what was retain or eliminate
reviewed/who was this cause?
interviewed etc
MAN (Reference any
evidence to
support these)

Possible cause 2

Possible cause 3
MACHINE
Possible cause 4

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 Possible cause 5
METHOD

Possible cause 6
MATERIAL
Possible cause 7

Possible cause 8
MEASUREMENT

MOTHER Possible cause 9

NATURE

Benefits of using this table format:

Good easy visual guide

Easy for your reader to follow through
Easy for you as the writer to see what work remains to be done

5. Justifications

The CAPA process needs to be a closed loop to be successful. At the end of our
evaluation of the quality issue, we need to assess the impact level in order to
make decisions and prioritise our investigations. At the end of our investigation, we
need a robust defensible root cause before we can move on to our CA/PA plan.

Similarly, with any sub-activities, we need to close the loop so there are no
questions left unanswered.

Sometimes, we will not be performing a correction for example. The key point here
is that if you are not doing something that would normally be expected, you need
to provide a clear and logical justification.

For example, you have a nonconformity where a tubing length is out of

specification. It should have been 5cm +/- 0.5cm, but was 6cm long. Your
R&D/Engineering departments document assurance that there is no adverse effect
on the product as a result of this, and therefore no correction is required.

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 6. Acronyms and Jargon

Most CAPA training courses discuss that acronyms should be defined upon first
use, or that a table of acronyms and their meaning are provided with the report.

My tip here is to avoid using acronyms in major fields for example, the initial
description of the quality event, and also in the executive summary. Approvers and
auditors will usually refer to the overall summary to get an overview before they
read the details. Having to understand what an acronym means is a distraction.
Make it easy for the reader!

Similarly, use of jargon should be avoided. Many companies have in-house

names for their machines for example. The recognised industry name of the
machine should be used.

7. Attachments

Attachments are an integral part of the overall report. What would be the point in
having them unless they contained information and evidence that were necessary
to support all the documented activities? Yet they often seem to be treated as an
after thought.

Make sure the attachment is actually attached!

Reference the attachment at the actual place in the report where the reader
needs to be made aware of its existence. (A list of attachments at the end
of the report is useful, but by then, the reader has completed their review)
As important, ensure that attachments are clearly referenced to the report
and appropriate section, and also annotated (for example, Page 1 of 2,
Page 2 of 2). This becomes especially important in the case of audits,
especially if several reports are being printed from the same printer.

About the author: Julia Lawley has 15 years of experience in regulated industries. She has worked as a Master
Trainer for Abbott, conducting corporate wide training programs in Root Cause Analysis, Conducting
Investigations, and Writing Effective reports. Additionally, she worked as a European Deployment manager for
global CAPA certification programs which included business assessments, compliance assessments, and training.
She has developed and performed global nonconformity and deviation IT system training throughout Europe and
Asia.

PathWise Inc., 2016

Compliant, Effective, Efficient.

www.pathwise.com

866.580.PATH