EXAMPLES OF NON-CONFORMITIES

Examples of non-conformities can range from a calibration of a measuring equipment outside the
established deadline, to a signature on a warehouse entry report by someone who is not expressly
authorized in the procedure, to the late calculation of an indicator, to a response. to a client outside
the deadline set for it.

Non-conformity, conformity and corrective actions

They are three concepts directly related to continuous improvement and fully developed by the ISO
standard and common sense. Non-conformity and the measures that are put into practice to avoid
and act on non-conformity is one of the basic chapters of the Quality Management system. There
are always errors, the important thing is to detect them, fix them and implement measures so that
they do not occur again and this is what is intended with the treatment of non-conformity, with its
corrective actions and with preventive actions.

In general, in ISO 9001 it is everything that does not comply with the procedures, whether due to
human or mechanical error or failure of third parties.

Typical example of a non-conformity: a power outage prevents data from being obtained at the
time specified in the procedure. And non-conformity in the ISO system does not look for the culprit, it
looks for the causes of the errors and how to avoid them so that the detected error cannot be
repeated.

The non-conformities of the audits have a common treatment to the general ones, but a special
follow-up. We could say that the non-conformities raised by an auditor are VIP non-conformities.

For the ISO, errors can become understandable, never justifiable.

Definition of Non-Conformity, Conformity, Corrective Actions and

Preventive actions

The definition of each of the concepts is found in ISO 9000:2005.

Non-Conformity : Non-compliance with a requirement.

Compliance : Fulfillment of a requirement.

Corrective action : Action taken to eliminate the cause of a detected nonconformity or other
undesirable situation.

Preventive action : Action taken to eliminate the cause of a potential nonconformity or other
potential undesirable situation. That is to say, preventive action is intended to prevent non-
conformity from occurring.
Consequently, we will consider a Non-Conformity to be anything that does not comply with the
requirements perfectly defined in the Quality Management System, in the ISO 9001 Standard, in the
legal and statutory precepts that the organization must comply with, and in which they are derived. of
the relationship with the client himself.

Difference between corrective action and preventive action

Between a corrective action and a preventive action there is a clear difference, the first is the action
we take to eliminate the cause that has produced the nonconformity, while the preventive action
seeks to eliminate the cause that may produce a nonconformity.

We could also establish another difference between corrective action and correction. The first
eliminates the cause that produced the Non-Conformity, the second eliminates the detected non-
conformity.

Examples of non-conformities in a Quality Management system :

1º An indicator that does not meet the objective.

2º In a document that should be signed correctly, it is not. It can range from an entry into the
warehouse signed by an operator who does not have that authority, to the omission of signing a
record.

3º An out-of-date record. A quality procedure says that the temperature of a certain machine must
be measured, daily at 12:00 p.m., if one day the temperature is not measured or is measured at 3:00
p.m. These deviations represent Non-Conformities.

4º The management review is not carried out on the scheduled date. It is a Non-Conformity.

5º Not complying with the deadline for responding to clients, set in the the SGC.

6º Respond verbally to a client's claim, if the QMS determines that all responses to claims must be
made in writing.

7º The remote control team has to record a series of data daily at 2:00 p.m. and it turns out that it did
not record it on Sunday.

8º A work accident is a non-conformity in the occupational risk prevention system.

Non-conformities give rise to a correction , an investigation , a search for the cause and a corrective
action, which may be single or multiple.

Example of corrective action :

In the previous example number 7, we have investigated the cause why the report is blank and we
detected that there was a general power outage in the area due to a failure of the supply company.
The corrective action so that this cause does not generate another new non-conformity is to install
an uninterruptible power supply unit in the equipment, so that when there is a power failure the
equipment will continue to function autonomously.
Example of preventive action :

Review all equipment that must meet a series of requirements in any of the processes included in
the QMS and eliminate the possibility that a power outage could affect them, within fifteen days. We
have thus avoided the possibility of a potential Non-Conformity.

Treatment of non-conformities, corrective actions and

Preventive actions

The standard requires that procedures be written for corrective actions and preventive actions. It is
advisable that both procedures be separated, in order to better discern the difference between
corrective action and preventive action.

Procedure for the control and registration of non-conformities.

When a non-conformity is detected, the failure must be corrected and its cause analyzed; it must
then be documented, for which the non-conformity procedure contains the design of a document
intended for this purpose.

Non-conformities must be recorded in a document numbered and dated on the day it is completed.

The numbering must take into account the different typologies of failures and must also identify the
different processes. However, the types and processes to which the Non-Conformity corresponds
can be identified in any other way on the form.

The document to register the Non-Conformity must contain the following data and requirements:

V Moment in which the Non-Conformity is detected (date and even time).

V Description of the No conformity: it must be detailed, clear, concise and short,
including what has happened, measured, etc., the date and what the standard establishes
as a requirement. Is something so
simple as indicating exactly which is the requirement
comply according to the Standard, what is the real data and the date on which it occurred.
V Explanation of the No Accordance. That is, a statement written of the No
Accordance. The reason or cause that supposedly gave rise to non-compliance with the
requirement must be explained.

V Proposed corrective measure : State what measure to take in response to the non-
compliance that has been detected.
V Date on which the corrective measure is implemented , period of time that must pass to
verify if the proposed correction has worked, verification and signature by the person
responsible, to review whether the proposed corrective measure has worked.

Closure of Non-Conformity : Once it has been verified and confirmed that the corrective action has
been correct, the non-conformity is closed by the person responsible in question, by signing and
indicating the closing date.
Preventive measure : Action taken to prevent a potential nonconformity or other undesirable cause
from occurring. The date on which it is proposed, the date of implementation, verification, and
closure must also be controlled.

Example of preventive measure.

In a certain process we have three identical machines with similar ages. A non-conformity occurs
due to a failure due to a component on machine A, it must be changed. A preventive measure would
be the review of the same component and possible change in machines B and C. With this measure
we hope to avoid a potential Non-Conformity with the same characteristics due to the same failure in
machines B and C.

Management of non-conformities

Although the non-conformity is closed, it can be reopened, if the circumstance so requires, only the
reason must be mentioned and it will once again be treated as another non-conformity.

Non-conformities and corrective and preventive measures must be monitored.

A detailed report of the Non-Conformities will be delivered to the Steering Committee, monitoring the
quality and continuous improvement system, in which the measures adopted, both corrective and
preventive, if any, will be presented.

They must be accounted for by type of non-conformity, keep statistics per month, exhaustive control
of open non-conformities and closed non-conformities.

Non-conformities: practical advice

1 .- Should all non-compliance be documented? It is not mandatory, as long as these data that are
controlled are reflected in the quality committee. However, it is advisable to document all non-
conformities in a document designed for this purpose. However, we will abide by what the procedure
establishes.
2 .- When it is not possible to apply a measure, for the simple reason that there is no possible
measure to control the non-appearance of the reason that gave rise to non-compliance, it must be
explained.

3 .- The creation of non-conformities, monitoring and signing must be contemplated in the job
descriptions (functions).

4 .- The statement of non-compliance has to be clear: what happened? What is the norm? When?
Where? and everything must be printed in the " non-conformity " document, providing the
necessary documentation and evidence.

5 .- In the annual review of the quality management system, all nonconformities of the year and
their current situation must be exposed, commenting on critical nonconformities, corrective and
preventive measures, and their results.

6 .- The non-conformity procedure must also be applied to the environmental management system
(ISO 14001) and even in the investigation of accidents within the area of occupational risk
prevention.

7 .- In audit processes, open non-conformities must be especially controlled.

8 .- The fact that an organization has more or less non-conformities does not imply anything
negative, in fact it can be a sign of control, it is important that all non-conformities are open before
the audits and perfectly controlled and made known to the employees involved or not in the same
ones.

9 .-Accident investigations within the ORP area must also be governed by the non-conformity
system.

Non-conformities detected by the audits will have special monitoring, complying with the
procedure for the treatment of non-conformities.

Non-Conformities Procedure, corrective actions and

Preventive actions

The Standard requires the organization to develop a procedure to regulate corrective actions and
preventive actions. The non-conformity procedure must contemplate and regulate:
A. For corrective actions .

1. Review non-conformities,
2. Determine the causes of non-conformities,
3. Assess the need to take action to ensure that nonconformities do not occur again
4. Determine and implement the necessary actions,
5. Record the results of the actions taken,
6. Review the effectiveness of corrective actions taken.

B. For preventive actions :

1. How to determine potential nonconformities and their causes,

2. Evaluate the need to act to prevent the occurrence of nonconformities,
3. Determine and implement the necessary actions,
4. Record the results of the actions taken,
5. Review the effectiveness of preventive actions taken,
The procedure or manual for the treatment of Non-Conformities will aim to:

Define the methodology to follow in the event of deviations and non-compliance with the
established requirements and the detection of potential risks in order to establish the appropriate
control, information and improvement mechanisms for their treatment and/or solution.

The manual will include the treatment of those Non-Conformities that require actions aimed at
reducing risks or avoiding their repetition. It also includes potential risks and their treatment through
preventive actions, that is, those cases in which a Non-Conformity has not occurred. , there is a
potential risk of it occurring.

Methods and tools to determine the causes of Non-Conformities .

The methods to analyze the causes are multiple. You really rarely have to go to them, among them
we have Brainstorming, root cause analysis, fish diagrams, the five whys, tree diagrams, etc.

Non-conformities, corrective actions and preventive actions, in the Quality Manual .

The quality manual must include in the corresponding section what the organization understands as
non-conformity, the procedure for non-conformities and the statistical and/or analytical method or
methods that will be used in the management of the causes that give rise to the non-conformities.
nonconformities.