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Quality management system Doc n° P-QUA04

MANAGEMENT PROCEDURE Page1 of 9
Management of Complaints and Non- Rev. 5 Date 02/08/2023
Conformities

MANAGEMENT OF
COMPLAINTS AND NON-
CONFORMITIES

5 02/08/2023 Review paragraph 5.2 RQ DT DIR

4 05/06/2023 Review of chapter 2 and paragraphs 5.1 and 5.2
3 01/19/2023 General review
2 04/01/2022 General review
1 06/09/2021 General review
0 01/10/2020 New issue
REV. DATE REVIEW DESCRIPTION REDACTED EXAMINED APPROVED
 Quality management system Doc n° P-QUA04
MANAGEMENT PROCEDURE Page2Of9
Management of Complaints and Non- Rev. 5 Date 02/08/2023
Conformities

 Controlled Distribution. COPY N° _______

Attachments to the Procedure

Non-compliance in production (Flow Chart n.1) P-QUA04-01
Non-conformity during acceptance (Flow Chart n.2) P-QUA04-02
Information necessary to handle the complaint P-QUA04-03
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Management of Complaints and Non- Rev. 5 Date 02/08/2023
Conformities
INDEX
1. PURPOSE AND FIELD OF APPLICATION ............................................................................................ 4

2. REGULATORY REFERENCES AND RELATED DOCUMENTS..................................................... 4

3. TERMS, DEFINITIONS, ABBREVIATIONS ........................................................................................... 5

4. RESPONSIBILITY' ........................................................................................................................................... 5

5. TEXT OF THE PROCEDURE ...................................................................................................................... 5

5.1. Generality ...................................................................................................................................................... 5

5.2. Non-compliant PED products .................................................................................................................. 6

5.3. Non-compliant TPED products ............................................................................................................... 6

5.4. Management of non-conformities found ................................................................................................. 7

5.4.1. Opening ................................................................................................................................................ 7

5.4.2. Treatment ............................................................................................................................................. 7

5.4.3. Closure .................................................................................................................................................. 8

5.5. Claims management .................................................................................................................................... 8

5.6. Returns .......................................................................................................................................................... 9

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Management of Complaints and Non- Rev. 5 Date 02/08/2023
Conformities
1. PURPOSE AND FIELD OF APPLICATION
This procedure has the purpose of indicating the rules for the management of non-conformities and
complaints both regarding products leaving the factory and regarding the processes that keep the QMS
active, including laboratory tests and non-destructive checks aimed at ensuring the conformity of the
product, in accordance with the applicable construction and safety standards.
Specifically, the procedure aims to:
 recognize and identify products that do not comply with product quality and safety requirements,
from receipt to delivery, to prevent them from being used or delivered to customers;
 examine non-compliant products and make appropriate decisions on their treatment;
 adopt appropriate actions for products already delivered to customers affected by non-conformities
detected after delivery;
 record non-conformities and prepare any corrective actions;
 manage non-conformities with respect to all management processes that are part of the QMS.
The procedure applies to the products and processes of the company “Antonio Merloni Pressure Vessels
Srl” both in the Matelica plant and in the Sassoferrato plant.

2. REGULATORY REFERENCES AND RELATED DOCUMENTS

 Quality Manual (MGQ)
 Context analysis and risk assessment (see share point)
 Procedure P-QUA05 – “Management of Corrective, Preventive and Improved Actions”
 Procedure P-QUA06 – Customer satisfaction
 Corporate Share Point

 PED Directive and TPED Directive

 ADR agreement
 Harmonized construction standards (EN 1442, EN 14208, EN 12542)
 Standards linked to the harmonized standards reported on the specific procedures and instructions
 VSR collection
 UNI EN ISO 3834-2:2021
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Management of Complaints and Non- Rev. 5 Date 02/08/2023
Conformities
3. TERMS, DEFINITIONS, ABBREVIATIONS
The definitions cited in the reference regulatory documents apply.
The following table summarizes the main abbreviations.
Abbreviation Definition
DIR Direction
RQ Quality Management Manager
MGQ Quality manual
QMS Quality management system
RF Responsible for a specific function
SP Share Point Software Platform
DT Technical director

4. RESPONSIBILITY'
DT, in collaboration with RQ, is responsible for ensuring that what is described in this procedure is applied.
DT is responsible for reviewing the effectiveness of this procedure at least twice a year.
The various RFs are responsible for applying the rules of this document.
Based on the review data, the Management, together with the human resources management manager,
establishes any training needs, both for the assigned staff and for the function managers.

5. TEXT OF THE PROCEDURE

5.1. Generality
“Non-Conformity” is the failure to satisfy a requirement (of the product and/or process), be it:
 in legal regulations
 in technical specifications or customer specifications
 in the technical specifications developed by the TO
 in the suppliers' technical data sheets
 in the company's purchasing documents and in the products/raw materials supplied
 in the requirements highlighted by the system documents
 in contracts with customers
 in destructive laboratory tests to certify the characteristics of materials and/or welded joints
 in non-destructive testing of products on welds
A non-compliant product can also be considered a product with one or more characteristics that do not
comply with the requirements.
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5.2. Non-compliant PED products
The product is non-compliant (fixed tank) when it presents any problem during its construction and
finishing, for example:
- Non-compliant and non-repairable welding
- Second hydraulic test failed
- Stubs welded out of square
- Sandblasting and painting not compliant with technical and/or customer requirements
- Accessories poorly fitted.
When the problem cannot be resolved immediately or cannot be resolved, the operator notifies the CR and
the QC and the semi-finished product (or the tank) must be immediately segregated from the production
line.
Each line/department has an area dedicated to segregation, indicated by a specific sign. A "NON-
CONFORMING PRODUCT" sign must be affixed to the product to unambiguously indicate its
segregation.
If the problem can be solved (e.g. finishing touch-up), the CR organizes the off-line repair and assigns the
task to a specific operator, who has the task of picking up the piece, processing it according to indications
and submitting the repaired piece to the CR and QC. The latter decide the outcome of the repair. CQ, in
collaboration with RQ, eventually decides to initiate corrective action, when applicable, to prevent the
problem from recurring.
Also with regard to the application of the ISO 3834-2:2021 standard on welding management, all these rules
apply and, in particular, when a repair and/or rework occurs, the coordinator has the task of making the
procedures available appropriate. The QC has the task of placing the repair WPS on all workstations.
As per PFC, if repair is carried out, the parts must be re-inspected, tested and re-examined in accordance
with the original requirements.
Non-compliant and non-repairable products are managed as waste by waste management operators,
according to applicable regulations.
In the case of new tanks, when the product must be discarded and already has a factory number, CQ notifies
RQ and DT to keep documented information on the waste.
In the case of transformed tanks, the waste follows what is described in P-RIG01.

5.3. Non-compliant TPED products

The product is non-compliant (transportable tank) when it presents any problem during its construction and
finishing, for example:
- Non-compliant and non-repairable welding
- Dimensions not drawn
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Management of Complaints and Non- Rev. 5 Date 02/08/2023
Conformities
- Stubs welded out of square
- Sandblasting and painting not compliant with technical and/or customer requirements
- Accessories poorly fitted.
When the problem cannot be immediately resolved or cannot be directly resolved, the operator notifies the
CR and the QC and the semi-finished product (or the tank) must be immediately segregated from the
production line.
Each line/department has an area dedicated to segregation, indicated by a specific sign. A "NON-
CONFORMING PRODUCT" sign must be affixed to the product to unambiguously indicate its
segregation.
If the problem can be solved (e.g. finishing touch-up), the CR organizes the off-line repair and assigns the
task to a specific operator, who has the task of picking up the piece, processing it according to indications
and submitting the repaired piece to the CR and QC. The latter decide the outcome of the repair. CQ, in
collaboration with RQ possibly decide to initiate corrective action, when applicable, to prevent the problem
from recurring.
Non-compliant and non-repairable products are managed as waste by waste management operators,
according to applicable regulations.

5.4. Management of non-conformities found

5.4.1. Opening
The person who finds a non-conformity has the task of notifying his manager, who in turn reports the
problem to the QM.
The RQ eventually decides to involve the DT for the subsequent steps, depending on the severity.
In any case, RQ or DT opens the registration in the appropriate section of the SP program.
If the non-conformity is detected directly by the quality control operator, he can directly record it on the
appropriate SP page.

A nonconformity can be classified in one of the following ways:

 non-conformity in production (Internal non-conformity);
 non-conformity during acceptance (Non-conformity during acceptance, i.e. towards the supplier).

5.4.2. Treatment
The treatment of a non-compliant product/process is determined by the nature and severity of the situation,
aspects which are directly linked to the requirements of the interested parties.
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Management of Complaints and Non- Rev. 5 Date 02/08/2023
Conformities
For non-conformities in production and acceptance, the specific treatment with respect to the workflow is
shown in the attachment:form P-QUA04-01 “Non-conformity in production” (Flow Chart n°1), form P-
QUA04-02 “Non-conformity in acceptance (Flow Chart n°2).
In general, RQ, or person delegated by him, after opening the registration on SP, carries out the following
operations:
 Examines the causes of the problem, involving the figures and department managers involved
 Proposes the solutions that must be approved by DT (possibly DIR)
 Sets a date by which to resolve the problem
 Indicates the data controller, notifying him via email
 Possibly, decides to initiate a corrective/preventive/improvement action related to the problem

The Data Controller:

 informs and involves the functions involved and the operators responsible for resolution
 informs the QM of the closure of the treatment

5.4.3. Closure
RQ:
 You receive confirmation that the treatment has taken place
 Check the compliance of the treatment
 checks the progress of the corrective action possibly linked to the NC and closes it
 close the non-compliance using the registration system on SP

5.5. Claims management

In the event there is a complaint from a customer, this must be managed as a non-conformity (par.5.4).
In the event of a complaint, RQ must receive from the sales office or from the person who intercepts the
information from the customer all the information necessary to establish the product concerned by
completing the appropriate form P-QUA04-03 "Information necessary to manage the complaint:
 examines the report, through an in-depth analysis of the causes that generated the non-compliance
itself and therefore the complaint;
 manages non-compliance through the most appropriate methods to remedy the problem;
 evaluates the need to carry out further preventive actions that will allow the non-conformity to be
repeated.
The documentation developed is kept by RQ in order to provide evidence of its management. RQ may
decide to attach this documentation produced also on the SP page prepared.
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RQ takes care of sending all the documentation (the evidence and the SP notice) to the commercial function,
which will redefine the commercial agreements.
In order to inform and raise awareness among operators about the complaints encountered, this topic can
be the subject of training sessions on the QMS.

5.6. Returns
The treatment of products returned by customers depends on the type of complaints/non-conformities that
have occurred.
RCOM, in collaboration with the Administration Function, has the task of resolving the situation, respecting
the mandatory requirements and the contractual requirements with the customer.