Non-conformities and

Corrective Actions
The ultimate guide to solving problems in a smart way
Summary

Introduction 03

The non-conformity management process 06

The benefits of automation 10

Good practices for managing non-conformities 15

How to use SoftExpert Suite to manage non-conformities in a smart way 24

Introduction
Introduction
Delivering quality products and services that respond promptly and deal with problems
guarantee customer satisfaction is the objective of efficiently, mitigating potential impacts.
every company. However, even when counting on
Many companies still use manual tools to
efficient processes, problems will arise. If you are a
formalize the Non-Conformance Report (NCR). This
Quality professional, you should know this well.
involves spreadsheets, emails, network folders and
Several factors such as legislation, contractual
even paper forms and signatures. However, as
clauses, terms or segments of activity can cause
efficiency becomes an increasingly competitive
conformity to put the company in an extremely
factor, relying on manual and disconnected tools
delicate situation.
ends up impairing the entire process.
This is where non-conformity management comes
in. Having a well-defined process allows you to

This eBook shows how automation can help you transform your non-conformity management
process. You'll see the specific benefits of an automated process and best practices to make
management more effective. Finally, you will also learn about SoftExpert Suite, understand
how it simplifies the management of deviations, and how it can contribute to continuous
improvement in your company.
Introduction
Handling Non-Conformities is one of the main
elements in the context of quality. Several
professionals even indicated that this as the
most critical process within the Quality
Management System (QMS).
The market as a whole is aware of the
importance of this process, from
standardization institutions to regulatory
agencies. As standards are updated, greater
emphasis is placed on the importance of
having a formal procedure for handling non-
conformities. If you are familiar with the ISO
9001:2015 standard, the topic is presented in
requirement 10.2 Non-conformity and
corrective action. Having a well-structured
process ensures continuity of operations, while
providing a means of quick response when
something goes wrong. When a company fails
to contain and resolve its quality issues, it can
completely lose power over its processes.
To ensure control over the non-conformity
management process and strengthen
conformity with regulatory requirements, many
companies are driving a true digital
transformation by modernizing processes and
implementing automated solutions.
The main steps of the Non-Conformity
and Corrective Action processes
The main steps of the Non-Conformity
and Corrective Action processes

Tools such as paper forms or spreadsheets are widely available, which is why they
often end up being the first alternative for a non-conformity treatment process to
start working. And, over time, people become attached and comfortable with these
tools.

Let's unfold the process, learn about the main steps and better understand how
automation can contribute:

Identification/Registration: The first step in some kind of repercussion. Non-conformities

solving a problem is to recognize that it exists. must be seen as an improvement tool and not
Many people come across or are involved in as a punitive tool.
non-compliant situations but end up not
registering the occurrence because they fear
The main steps of the Non-Conformity
and Corrective Action processes

Containment and Investigation: If a cause: "What failures caused or allowed this

production line is stopped immediately, fewer problem to happen?"
people will be affected, and your company can
Other processes or products may be affected,
save time and money.
so the cause analysis must begin quickly.
When you have automated processes, you can
Software for non-compliance management
respond to problems much faster. The tools
already incorporates tools such as 5 Whys and
have the ability to instantly mobilize teams so
Ishikawa Diagram, which speed up the
that everyone can intervene to contain the
identification of the root cause.
problem and initiate an investigation.

Root-cause analysis: For a problem to be

effectively solved, you need to focus on the root
The main steps of the Non-Conformity
and Corrective Action processes
Action Plan: Once the cause is identified, it is
necessary to define what actions need to be
taken to solve the problem. As with the
previous steps, the response time is an
essential component for successful execution
of the action plan.
Software already incorporates the 5W2H
methodology (What? Why? Where? When?
Who? How? How much?), which simplifies
corrective action planning. The tool also
anticipates expiration dates, through
notifications, allowing actions to be
implemented according to the expected
deadline.
Effectiveness check: Automated control of
corrective action implementation significantly
reduces delays normally identified in manual
processes. Spreadsheets, emails and paper
forms require much more time to handle, view
and fill out than a task that reaches the person
in charge through a workflow. This flow even
contributes to continuous improvement, since it
does not interrupt the chain of communication.
Automated processes can help with corrective
actions from start to finish, so you can count on
a more efficient and accurate system.
 The benefits of automation
Now that you understand the process and the role of automation in
managing non-conformities, let’s learn about the benefits it can bring.
Visibility and Traceability
Not knowing what is happening prevents you
from taking corrective actions or improvements
if something is going wrong and not meeting
established quality standards. That's why
Visibility and Traceability are two important
factors.
By centralizing the entire process and
maintaining the history of corrective actions
that have been implemented, software
documents processes from start to finish,
increasing visibility.
This benefits your company in two ways:
A) With a centralized history, you can
individually assess each step of the process,
understand how each person contributed and
what decisions were made. From there, you can
plan training or review documents, with a view
to improving processes.
B) Documentation can also be an effective
diagnostic tool, giving even more visibility into
your operations. Analyzing the data makes it
possible to define strengths and opportunities
for improvement. Automated systems promote
this better than manual processes because
everything is in the same place and accessible
by the entire team. Management of non-
conformities becomes a tool for
communication, collaboration and systemic
improvement.
Collaboration and Accountability
Automation promotes instant communication
and encourages a culture of collaboration,
where team members work together toward a
common goal of quality. With the help of
electronic notifications and reminders, this
collaboration can happen quickly and efficiently.
Teams do not lose track of deadlines or
prioritized tasks, as they are warned when
intervention is needed and reminded as the
completion deadline approaches.
With people working on the same system that
keeps track of the process, everyone works
more responsibly. Team members know
exactly who to contact or expect certain
deliveries from. Since everything is visible to all
members, there is no excuse for not completing
tasks. There is a set procedure that everyone
must follow and will be kept in their workgroup
so that members are less likely to neglect their
part of the task.
Risk Reduction

You've probably seen somewhere that the Effectively implemented corrective actions
latest version of the ISO 9001:2015 standard bring you closer to an ideal scenario. While
emphasizes risk-based thinking. This means there are always other factors that could have
that organizations are required to review an impact, when you are in control and act
processes with a view to reducing risk. proactively, you dramatically reduce incidents
and mitigate risk. By focusing on solving
Automated systems for non-conformity and
problems effectively, rather than masking them
corrective actions provide the tools your
with isolated actions, the benefit is greater with
organization needs. By relying on manual
automated solutions.
processes, you would be able to correct the
effects of problems, but you would be less
likely to determine and solve the problem that
is not clearly presented. This is how you
eliminate organizational risk. Automated root
cause analytics help you understand situations
in depth. Action plans bring improvement and
risk reduction across the organization.
Audit Readiness
With electronic processes you don't have to
panic trying to prepare and fix issues when an
audit approaches. The tool drives the process
by constantly encouraging improvement,
ensuring that problems are thoroughly
investigated and that corrective actions are
properly implemented. As such, the audit can be
carried out at any time, bringing positive
results.
Being ready for an audit means your processes
are up to standard and your operations are
efficient. Sometimes this takes training, time
and effort, but automatic corrective actions
help make the transition smoother. In the long
run, maintaining this state can save your
organization the stress of not being prepared
for an audit, as well as the fines and other
repercussions associated with poor
performance during an audit.
 Good Practices for Non-Conformity Management
While managing non-conformities in an automated way is beneficial in itself, the entire
process becomes even more effective when certain best practices are applied together.

Here's how to make your non-conformity and corrective action processes more efficient:
Automate your process

As previously mentioned, the treatment of non-conformities is one of the most

important processes within the QMS. However, manual processes are difficult to
control, inefficient and error-prone.

Let's look at an example of the difference between a manual vs. an automated

process:

Manual Process
Let's say that during an audit, failures in a invitation to a training session or even
process are identified. You record the sending a document with self-training
deviation and define corrective actions, for instructions.
example, employee training. When the
activity is manual, you are likely to send
employees an email informing them of the
need for training. You can try forwarding an
Automate your process

What could go wrong in this case?

• The email may get lost in the employee's confidential information ending up in the
inbox or be classified as spam. If that wrong hands.
happens, your message will never be read,
• Without smart notifications, there's no way
and they won't know about the training.
to know if the training has actually run and
• The email can be accidentally forgotten been completed.
upon opening or simply ignored.
• Email is not a secure tool. A message can
be forwarded to an unintended recipient.
When you email documents, you risk
Automate your process

Specialized software can prevent these situations:

• Non-conformity data is in the software, not in

an email. They don't get lost in an inbox and
you can access them whenever you need
them.
You need to automate your corrective
• It doesn't matter how many other
actions to avoid failures found in manual
responsibilities you have. The software sends
processes. Plus, you save the time and
out notifications and reminders and doesn't
resources needed to manage corrective
let you forget about non-conformities and
actions manually. Improving the tools
corrective actions. used to deal with non-conformities makes
• You can automatically assign responsibilities all the difference.
throughout the process. Thus, even if an NCR
involves an external person responsible, it is
possible to have greater control over the
details of the occurrence.
Extend quality practices to your suppliers

Having a good automated tool is important for your QMS, but it's not enough. When external
parties are involved (e.g. suppliers) but follow different standards, this can negatively affect
your company. To help eliminate these risks, external parties need to be included in your
non-compliance handling system.

Your quality management process can benefit as follows:

• Notifications and reminders promote a response time, which is critical when it

sense of urgency about communicating comes to important issues affecting
with your supplier. This decreases customers.
Extend quality practices to your suppliers

• By centralizing NCR information on one • The system automatically generates

platform, the entire process of exchanging statistics, allowing you to evaluate
information and documents becomes suppliers from the point of view of quality,
more secure. Suppliers have access to through the reports available in the
everything they need to perform their system.
tasks without having to expose
confidential information or assign tasks
via email.

Keeping suppliers up to their quality standards prevents processes from being

disrupted and negatively affecting the way you handle problems.
Investigate the root cause

This practice encourages proactive behavior. That way you can deal with the real problem,
Rather than responding to the effects of rather than just dealing with its
problems as they arise, you can act to fix consequences. It is a way to ensure that the
underlying problems and improve your problem or similar setbacks do not reoccur in
processes so that they don't happen again. the future. Otherwise, you will be dedicating
This can be compared to an illness: in the time and resources to solutions that are only
long run it is better to cure the cause of an temporary.
infection than simply ease the pain and
symptoms.
Investigate the root cause

Don't forget that the goal at this point is to determine the true root cause, so the
following tips and techniques can help you during an interview:

• Ask stakeholders for their opinion: what they
think happened;
• Don't judge in advance;
• Don't overlook the obvious;
• Be a good listener;
• Ask those involved to repeat the procedure;
• Ask technical questions;
• Use a friendly approach when interviewing;
• Try to think of potential factors that might
have contributed to the occurrence;

• Ask open-ended questions when possible. • Ask how they think it can be improved.
Questions should not induce responses;

• Ask what went right and what went wrong;

Control the complete cycle

When the handling of a non-conformity has This allows quality resources to be used
been successful as proven by the optimally. It also helps maintain audit
effectiveness check, you can consider the readiness, which is so important to ensuring
cycle to have ended. This means that the the highest levels of quality and conformity
process has been followed, all steps have at all times.
been completed, and no further corrective
action will be required.
 How to handle non-conformities with
SoftExpert Suite
Now that you know the best practices for handling non-conformities, discover
how SoftExpert Suite can help you overcome these challenges.
How to handle non-conformities with SoftExpert Suite

Many quality professionals recognize that an priorities and to stop worrying about
automated process for the management and spreadsheets, emails and manual controls.
treatment of non-conformities optimizes
In addition to improving the security of the
activities and speeds up problem solving.
process as a whole, the solution promotes
The SoftExpert Suite proposal is to contribute collaboration, increasing QMS productivity in
to this process and encourage continuous a simple way.
improvement, helping to minimize errors that
increase defects and quality costs, allowing
professionals to focus on the most strategic
How to handle non-conformities with SoftExpert Suite

You can define your own process to handle

Nonconformities, Customer Complaints,
Adverse Events, Improvement Opportunities,
among others.

To speed up the handling of occurrences, it

is possible to pre-define approvers,
response deadlines, and teams that need to
be notified, among others.

Not all occurrences are treated equally.

Therefore, processes can be adjusted,
adding or removing steps, defining different
response paths or deadlines.
 How to handle non-conformities with SoftExpert Suite

When the details of the occurrence are not

clear, identifying the root cause and
defining an appropriate action plan can
become extremely complicated tasks.
SoftExpert Suite guides the user in filling in
the most important information through
intelligent electronic forms.
You can customize the entire branding,
such as the logo, layout or field names,
according to your company's standards.
How to handle non-conformities with SoftExpert Suite

You can attach evidence to the non-

conformity handling process using
the drag/drop feature. This includes
photos, emails, calibration
certificates or any other type of
document.
In addition to facilitating the entire
investigation process, it can be a way
for you to justify yourself during an
audit, for example.
 How to handle non-conformities with SoftExpert Suite

As the workflow progresses, we arrive at the

Cause-and-Effect Analysis step, which helps to
identify the root cause of the non-conformity.
SoftExpert Suite provides an Ishikawa diagram,
also known as a fishbone diagram, which points
to possible causes of the problem.

The Effect/problem is described in the fish's

mouth, and each spine represents a category,
usually used in conjunction with the 6M method
(Method, Milieu, Man, Measurement, Machines,
Materials).

Causes are identified and connected to

categories.

You can inform the areas and the percentage

responsibility of each of them regarding the
causes.
How to handle non-conformities with SoftExpert Suite

In the SoftExpert tool you can also find

the “5 whys” method, which is very
simple, but effective.
Basically, you start by identifying the
problem and keep asking "why"
questions until you get to the end of
the problem. This is repeated about
five times and helps you identify the
real root cause of the non-conformity.
But the tool is flexible, and you can use
as many whys as needed in your
analysis.
 How to handle non-conformities with SoftExpert Suite

Now that you know what caused the problem, what can
you do to fix it? This part of the process is accomplished
through action plans, which guide the corrective action
process.

SoftExpert Suite helps you define the actions that must

be taken, as well as those responsible and the deadlines,
so that non-conformity is permanently resolved.

Action plans can be defined according to the 5W2H

method. Each action must be planned by answering this
sequence of questions:
• What?

• When?

• Who?
• Where? To keep the action plan “on track”, the system sends automated reminders for approval and
execution of activities. So, you spend less time waiting, solve issues faster, and minimize the
• Why? negative impacts of non-conformity.

• How?

• How much?
How to handle non-conformities with SoftExpert Suite

Once you have completed implementing the actions, you

will need to verify their effectiveness.
The verification step is crucial as it is when you use
evidence to determine and confirm that the non-
conformity has been successfully resolved.
 How to handle non-conformities with SoftExpert Suite

Forget the time you spent gathering

information and making demands of
people. Through a Control Panel, you can
follow the full progress of occurrences in
real time.

In addition to organizing activities

according to status, you can easily
reschedule an activity by setting a new
deadline or person responsible for
execution.
How to handle non-conformities with SoftExpert Suite

As processes begin to be handled within the system and

the volume of information that needs to be monitored
increases, you can turn to the tool's management portals
to get a big picture of what is happening.
Quality portals allow you to clearly understand all the
details of events and action plans. They display all ranking
information in charts, which you can drill down in a variety
of ways. You can use this information to identify trends in
non-conformities and see where they are linked across the
enterprise.
Portals can also provide a granular view of processes and
show whether your approach to addressing non-
conformities is succeeding.

As a result, you can make informed decisions that are

focused on quality objectives, acting on process
improvement based on real data rather than on intuition.
 How to handle non-conformities with SoftExpert Suite

With SoftExpert Suite you can access

information and perform tasks using a
tablet or smartphone.
Mobile access provides greater
flexibility and helps increase efficiency
and productivity within your company's
QMS.
In addition to connecting via the mobile
device's browser, you can access the
tool through the Android and iOS apps.
 Modernize your process

SoftExpert Suite has intuitive tools that

specialize in managing non-conformities
and corrective actions. It helps you
identify aspects that can impact the
quality of your products and services.
The solution simplifies activity tracking
and control, helping you solve issues
faster and more efficiently.

Learn More
 Take your business to the next level

www.softexpert.com | sales@softexpert.com

These materials are subject to change without notice. These materials are provided by SoftExpert and its affiliated companies for informational purposes only, without representation or warranty of any kind, and SoftExpert shall not be liable for errors or
omissions with respect to the materials. The only warranties for SoftExpert products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as
constituting an additional warranty. Some product features and functionalities presented herein may be optional or dependent on the composition of the offer acquired.