Product Safety Engineering

CE MARKING

CE MARKING

Safety Engineering for CE in compliance with the Machinery Directive with Certification procedure by Notified Body

CE ATEX and CE PED MARKING

CE ATEX and CE PED MARKING

Safety Engineering for CE marking of machineries and systems in the Atex and/or PED Directive with Certification procedure by Notified Body or submission of the Technical File

Faaentia Consulting: Case Study Image

CE EQUIPMENT IN THE PROFESSIONAL DIVING SECTOR

Safety Engineering applied to diving equipment that requires CE marking with Certification procedure by Notified Body

PRODUCT SAFETY ENGINEERING
PRODUCT SAFETY ENGINEERING

Since 2000, we design and implement Product Safety Engineering Services for the manufacturing or revamping of equipment, machines, plants and products:

  • safe and responsive to international standards

  • easy and more secure to interact

  • easy to maintain

There are seven process steps:

  1. identification of the binding legislation in the country of destination

  2. analysis of specific requirements

  3. identification, if necessary, of a market supervisor third-party Organism

  4. risk assessment to ensure compliance with the mandatory applicable standards

  5. drawing up of binding documentation to Certify conformity

  6. assistance during tests to be performed in Italy and in other countries

  7. auditing activities in Italy and in other countries

PRE AND POST SALES ASSISTANCE
PRE AND POST SALES ASSISTANCE

The manufacturers have understood the strategic importance of setting up the certification process ever since the earliest sale stages - thus securing time and cost savings.

During this stage, Faentia Consulting supports the Customer by seeing to the regulatory framework ever since the financial quoting stage and by preparing budgets both for the Product safety Engineering part and for the part relating to the Technical documentation accompanying the product.

During the construction and testing stages, on request by the Customer, we perform Audits in Italy and in other countries for the assessment and verification of the achievement of pre-set safety targets.

Today, Faentia Consulting has provided Customer support during pre- and post-sale phases in:

  • Europe

  • United States

  • South Africa

  • China
TRAINING
TRAINING

Growing together to correctly respond to safety & compliance requirements coming from the marketplace. This is possible through theoretical/practical training programmes that Faentia Consulting designs and implements together with its Customers according to the following applicable Directives:

  • 2006/42/EC Machinery Directive

  • 2014/68/EU PED Directive (Pressure Equipment)

  • 2014/34/EU ATEX Directive (equipment for Potentially Explosive Atmospheres)

  • 2014/30/EU EMC Directive (Electromagnetic Compatibility)

  • 2014/35/EU LVD Directive (Low Voltage)

  • 89/686/EEC DPI Directive (limited to Diving equipment)

  • 93/42/EEC MD Directive (Medical Devices)

  • GMP Procedures

INDUSTRY 4.0
INDUSTRY 4.0

The present and future challenge for our Customers is called Industry 4.0. Faentia Consulting is ready to design and implement the most appropriate procedures to reach the goals of:

  • Smart Product

  • Internet of Things (IoT)

  • Internet of Service (IoS)

Our co-operation with top manufacturers of industrial hardware allows us to study the best architecture to manage machinery and equipment either in networks or remotely, and acquire and make available to operators all data accessible by machine sensors (RFID), in the most useful formats for data reading and management (in terms of e.g. efficiency, security, predictive maintenance, etc.)

Partnerships & Affiliations

Us gov
Faentia Consulting has been included in the "CE Marking - Consultants/Ordering Standards" published by the U.S. Government on their site export.gov
Logo Uni
Since 2017 Faentia Consulting is associated to UNI – Ente Italiano di Normazione
Confindustria Romagna
Faentia Consulting is associated to Confindustria Romagna, since its foundation
HOW WE WORK
"MACHINERY" CE MARKING
"MACHINERY" CE MARKING

Sectors: Automotive, Pharmaceutical, Medical, Packaging

Our method includes:

  • risk assessment in the machine design phase (VRd) with design solutions intended to eliminate and/or reduce any risks present on the machine

  • GAMP analysis for machines designed for the pharmaceutical industry (added on 29/08)

  • designing of safety functions block diagrams in accordance with EN13849-1

  • calculation of PL (Performance Level) of safety functions with SISTEMA software, approved by ISPELS Italy and IFA Germany

  • analysis of electrical connections

  • technical construction file with analysis of essential health and safety requirements

  • verification of machine compliance safety design solutions during FAT and SAT stages (Italy and Other countries)

  • preparation of post-check Audit files

CE “ATEX” and CE “PED” MARKING
CE “ATEX” and CE “PED” MARKING

Sectors: Filtration, Chemical, Food Processing

Our method includes:

ATEX

  • technical construction file complete with descriptions of dangerous substances and classification of groups of appliances into categories

  • drawing up an assessment of dangerous situations that lead to explosion

  • analysis of essential safety requirements (ESR) of the applied Directive

  • identification of design solutions

  • management of relationships with the Notified Body

  • support during technical file submission and/or examination for CE certification purposes

PED

  • technical construction file

  • risk assessment of pressurised equipment

  • compliance review

  • analysis of Essential Safety requirements

  • drafting of procedures in accordance with the Compliance Assessment Procedure (form)

  • management of relationships with the Notified Body

  • support during Technical File submission and/or examination for CE certification purposes

PROFESSIONAL DIVING EQUIPMENT “CE” MARKING
PROFESSIONAL DIVING EQUIPMENT “CE” MARKING

Sectors: Defense

Our method includes:

  • equipment Technical File

  • risk assessment according to applied standard

  • study and drafting of testing "Protocols" failing a specific standard

  • study and implementation of Test Results Recording Reports

  • drafting of planning procedures for the testing session

  • support during the testing phase by Notified Body

  • management of relationships with the Notified Body

  • planning and organisation of annual Audits

NOTIZIE RELATIVE

27 June 2017
OFFICIAL JOURNAL OF THE EUROPEAN UNION Harmonised standards updating list in compliance with the 2006/42/CE directive on machinery…
16 June 2016
OFFICIAL JOURNAL OF THE EUROPEAN UNION   New harmonised standards list in compliance with the 2006/42/CE directive on machinery   The list hereunder is a compilation of the references of…
18 May 2016
IMPORTANT NEWS - OFFICIAL JOURNAL OF THE EUROPEAN UNION             New directive Entry into force and application Directive repealed Official Journal of…
24 January 2016
We recall to all our Clients that during the year 2016, nr.4 important UE directives for the manufacturing market will entry into force.The new UE directives will be the following:   New…