PROCESS CONTROL OF NON COMPLIANT

PG-10.2.1 Edition: 0 Page 1 to 4

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TABLE OF CONTENTS

1 GOAL
2 SCOPE
3 REFERENCE DOCUMENTS
4 GENERAL
5 DEVELOPMENT
5.1 DETECTION, SEGREGATION AND IDENTIFICATION
5.2 UNDER NO PRODUCT REGISTRATION
5.3 DECISION-MAKING
5.4 MONITORING OF NON-COMPLIANCE
5.5 TREATMENT OF RECORDS
6 RECORDS AND ATTACHMENTS

ELABORATE REVISED APPROVED

Quality Manager Manager Manager

Date: Date: Date:
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1 GOAL

Define the methodology used in HHH, S.L. for identification, documentation, evaluation,
segregation and treatment of non-conformities, as well as notification to the functions
that could affect

2 SCOPE

This process applies to all non-conformities originated, products, activities or

documents, at any stage of the process, affecting the quality of services provided by
HHH, SL

It does not apply, in terms of registration under this process, to those non-compliances
detected during the correction process being remedied by normal operations of the
same.

3 REFERENCE DOCUMENTS

General Process Control Records, PG-7.5

4 GENERAL

NON CONFORMITY: Failure of a specified requirement.

NON CONFORMITY REPORT: Document, following the detection of a nonconformity

and the previous study by the official involved, is set to record the situation and propose
appropriate solutions.
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5 DEVELOPMENT

5.1 DETECTION, SEGREGATION AND IDENTIFICATION

Anyone in HHH, S.L. can detect a nonconforming product, although normally it is

detected in any of the following:
 Verification and inspection of incoming goods
 Controls and final inspections
 Monitoring of suppliers
 Application of the criteria set out in the documentation of system of quality
management
 Customer complaints

The person who detected nonconformity then proceeds to report the incident to
the Quality Manager, who makes the decision to classify and identify the
nonconformity, determine the ideal identification method and decide who and how
to correct the nonconformity.

Since the detection of nonconformity, to eliminate it by taking the right solution

(immediate corrective action), the object of the nonconformity (product, document
and / or activity) should be identified, physical or documentary.

The identification of non-compliance is performed by segregation and / or

identification with any of the following means:
 Labels or signs that define non-conformities with the inscription
"Nonconforming Product"
 Location specific area
 Records applicable (non-conformity Report)

This identification is done to prevent use of improperly or confused with other

products, documents and / or activities conform.

5.2 UNDER NO PRODUCT REGISTRATION

The Quality is who records the nonconformity after verifying the essential details that
determine the origin of it.

Non-conformities are not recorded if remedied by normal process adjustments.

In specific records (NO REPORTS OF CONFORMITY) managers involved in the

implementation of immediate corrective actions to be taken should appear to
eliminate the non-conformities.

When the contract required, the client or his representative must present the
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specific record of each unrelated thereunder, for it approved, by signing the actions
taken by HHH, SL to eliminate them.

The specific register used in HHH, S.L. is the NON-CONFORMITY REPORT (HHH-
PNC-10.2.1), which are numbered consecutively for better control.

5.2.1 Supplier Non Conformities

Those non-conformities attributable to the supplier can be detected both in

the process of receiving your goods or provision of services, as behind them.

The Quality of HHH, S.L. informs the supplier about the purpose and scope
of nonconformity, and the appropriate corrective action and thereafter,
mutually agreed treatment that will run on non-compliances identified and
defined.

5.2.2 Internal Non Conformities

The Quality Manager in THE REPORT OF NONCONFORMITY records

nonconformities that are detected and result from internal processes.

This is also used for the recording and processing of customer complaints,
since the origin of them is internal.

When nonconforming product is detected after delivery or when its use has
started, the Quality Manager records the nonconformity in the report and
proposes immediate corrective action to provide treatment for such
nonconformity.

5.3 DECISION-MAKING

Possible decisions to make regarding non-compliant products are:

 Acceptance as they are, if you consider that the nonconformity has no

relevance with respect to the specifications for your case.

 Rejection, if you cannot find acceptable application to the subject of the

nonconformity.

 Concession, proceeding to the use or release of nonconforming product.

If accepted, it continues with the intended use of the object of the nonconformity.

If the decision is rejected, we proceed to the relevant operations that stem from it
(returning the product, disposal, replacement, disruption of the service ... etc.).
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If the decision is granted it will proceed to use or release nonconforming product by

authorizing the Quality Manager. Where non-compliance affects a particular
customer, the Quality Manager will contact him to request compliance with the use
or release of the product, recording such approval to the report of nonconformity.

For the adoption of the decision on the immediate corrective action to be

implemented to eliminate every detected nonconformity, the Quality Manager must
first consult with staff involved:

 Goal and scope of the nonconformity.

 Causes of the nonconformity.
 Consequences of its occurrence.
 Methodology to be used to remove it.

If this indecision regarding the actions to be taken regarding nonconformities, will

consult with the Sole Administrator for the final decision.

The decision to implement immediate corrective action to eliminate the

nonconformity requires specifying the / the responsible / s involved / s term to
remove it.

Other decisions to be taken are:

a) Reacting to non-compliance and, where appropriate:

1. Take steps to control and correct;

2. Deal with the consequences;

b) Evaluating the need for action to eliminate the cause (s) of the nonconformity,
so it's not recur or occur elsewhere, through:

1. The review and analysis of non-compliance;

2. Determine the causes of nonconformity;

3. Determine if similar nonconformities, or may occur;

c) Implementing any necessary actions;

d) Reviewing the effectiveness of corrective measures;

e) Update the risks and opportunities during planning determine, if necessary;

f) Changes to the system quality management, if necessary.

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Corrective actions shall be appropriate to the effects of the nonconformities

encountered.

5.4 MONITORING OF NON COMPLILANCE

Whatever the decision taken, the Quality Manager monitors and verifies that non-
compliance effectively under the decision for it to be removed.
When this happens, the Quality Manager proceeds to close the applicable non-
conformity report and is eliminated, where appropriate, identification of the object
of nonconformity.

Failure to remove the non-compliance with the decision, another decision will be
proposed, which receives the same treatment as the first, thus generating a new
record and other monitoring.

The NONCONFORMITY REPORTS enable the Quality Manager have data for the
establishment of corrective and / or preventive actions, which are made according
to the General Procedure for Corrective and Preventive Actions PG-10.2.2.

5.5 TREATMENT OF RECORDS

The records are coded completed the "INC Nº. ......" box with a corresponding
three-digit number and identified by the code.

The Quality Manager keeps records of nonconformity reports in his department, in

a folder intended for this purpose, clearly identified, filed in sequence in growing
and accessible to him and the Sole Administrator sense.

Conservation and environmental fate of the records is performed as set forth in

the General Process Control Records, PG-7.5.

6 RECORDS AND ATTACHMENTS

HHH-PNC-
NO CONFORMITY REPORT ANNEX
10.2.1
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HHH-PG-10.2.1
NO CONFORMITY REPORT
Edition: 0

INC Nº
DATE:

NO CONFORMITY IDENTIFICATION:

DETECTED BY:

CAUSE OF NO-CONFORMITY:

CLASIFICATION OF CONFORMITY:

CORRETIVE ACTION IMMEDIATE:

ESTIMATED TIME OF IMPLEMENTATION:

RESPONSIBLE:

NO CONFORMITY COSTS:

CLOSE OF NO CONFORMITY SIGNATURE:

ACCEPTED NO ACCEPTED DATE:

OBSERVATIONS: