Production control

What's Production control?
The production of Category III PPE is to be inspected by a notified body before such equipment is placed on the market and as long as it is manufactured and marketed. Such inspections may comprise either:

• random checks of the quality of the final product on samples taken from the production lines or from the market or
• monitoring of the Manufacturer's production quality assurance system applied to the certified product.

Since the two inspection procedures are defined in Articles 11a and 11b of the PPE Directive, they are generally referred to commonly as "Checks according to Article 11a" and "Checks according to Article 11b", respectively.
The choice of whether to use the supervision procedure according to Article 11a or according to 11b is left to the Manufacturer, provided that he has implemented an effective and reliable quality assurance system. In any event, irrespective of which inspection procedure is adopted, when the outcome is satisfactory the final certification is equivalent in all respects.

Checks according to Article 11a

Following the issue of the EC Type Examination Certificate for a PPE model, a RINA Surveyor will examine an adequate set of samples taken from the production line and subject them to some or all of the tests prescribed in the applicable harmonized standards and Manufacturer's specifications to verify the conformity of the samples with the type(s) described in the EC Type Examination certificate.
Subject to the satisfactory outcome of such tests, RINA will issue an EC Final Product Conformity Certificate, which is valid for one year.
Where the test samples used for the type examination were chosen by a RINA Surveyor from the production line (i.e. they were not prototypes manufactured specially for the tests), the tests conducted for the issue of the EC Type Examination Certificate can also be considered valid for the preliminary check of production. In this case the issue of the EC Final Product Conformity Certificate is concomitant with that of the type examination certificate.

How to proceed?
The procedure consists of the following main steps:

• Manufacturer's application
• Examination of the EC Type Examination Certificate and the associated technical documentation
• Execution of tests on samples taken from production line
• Issuance of the Marine Equipment EC Final Product Conformity.

Checks according to Article 11b

It consists of the verification of the quality assurance system applied by the Manufacturer for the production, inspection and testing during fabrication and on the finished equipment in order to obtain the reasonable presumption that the marketed equipment conform to the type described in the applicable EC Type Examination Certificate and satisfy the requirements of the applicable harmonized standards and Manufacturer's specifications.
If the outcome of the audit is deemed satisfactory, RINA will issue to the Manufacturer the EC Certificate of Conformity of Production with a three year validity period.
The maintenance said certificate is subjected to the satisfactory outcome of the surveillance cycle consisting of the following audits:

• periodical audits of the quality assurance system;
• periodical audits of the production line(s) of product(s) certified. These audits may be conducted at the same time of the previous ones;
• renewal audits of the quality assurance system at the start of a new three-year period.

The surveillance cycle schedule is agreed by RINA and the Manufacturer at the beginning of the certification process as a function of the complexity of the equipment and of the quality assurance system adopted by the Manufacturer.

How to proceed?
The procedure consists of the following main steps:

• Manufacturer's application
• Examination of the EC Type Examination Certificate and the associated technical documentation
• Examination of quality system documentation (including procedures and instructions)
• Execution of initial surveillance audit at Manufacturer premises
• Issuance of the Marine Equipment EC Certificate of Conformity of Production
• Execution of periodical surveillance Manufacturer premises.