At intervals of no more than six months, two sample systems in accordance with 7.1, representative of the series, should be taken from finished stock and subjected to the following tests:
a) performance tests, in accordance with 7.4.3, and the tests in accordance with 7.4.4 and 7.4.5;
b) durability test of hold-open devices (see 6.7).
F.3.2 Yearly testing
At intervals of no more than one year, two sample systems in accordance with 7.1, representative of the series, should be taken from finished stock and subjected to the full tests as specified in the requirements of 6.7 and Clause 7, with the exception of the electromagnetic compatibility (EMC) tests of 7.4.7. As stated in 7.1, test sample system A should represent a maximum configuration of components and test sample system ‘B should represent a minimum configuration of components in accordance with the system specification decided on by the user of this European Standard.
F.3.3 Manufacturer-specific FPC system requirements
F.3.3.1 Personnel
The responsibility, authority and the relationship between personnel who manage, perform or verify work affecting product conformity, should be defined by the manufacturer. This applies in particular to personnel
who need to initiate actions preventing product nonconformities from occurring, actions in case of nonconformities and to identify and register product conformity problems. Personnel performing work affecting product conformity should be competent on the basis of appropriate education, training, skills and experience for which records should be maintained.
F.3.3.2 Equipment
All weighing, measuring and testing equipment necessary to achieve, or produce evidence of, conformity should be calibrated or verified and regularly inspected according to documented procedures, frequencies and criteria. Control of monitoring and measuring devices should comply with EN ISO 9001:2000, 8.2.
All equipment used in the manufacturing process should be regularly inspected and maintained to ensure use, wear or failure does not cause inconsistency in the manufacturing process.
Inspections and maintenance should be carried out and recorded in accordance with the manufacturer’s written procedures and the records retained for the period defined in the manufacturer's FPC procedures.
F.3.3.3 Design process
The FPC system should document the various stages in the design of the electrically controlled hold-open system, identify the checking procedure and those individuals responsible for all stages of design.
During the design process itself, a record should be kept of all checks, their results, and any corrective actions taken. This record should be sufficiently detailed and accurate to demonstrate that all stages of the design phase, and all checks, have been carried out satisfactorily. Compliance with EN ISO 9001:2000, 7.3 should be deemed to satisfy the requirements of this subclause.
F.3.3.4 Raw materials and components
The specifications of all incoming raw materials and components/elements should be documented, as should the inspection scheme for ensuring their conformity. The verification of conformity of the raw material with the specification should be in accordance with EN ISO 9001:2000, 7.4.3.
In case supplied kit components are used, the attestation of conformity level of the component should be at least that given in the appropriate harmonized European Standard for that component. If this is not the case, the inspection scheme should be adequate to demonstrate their suitability.
F.3.3.5 In-process control
The manufacturer should plan and carry out production under controlled conditions. Compliance with EN ISO 9001:2000, 7.5.1 and 7.5.2 should be deemed to satisfy the recommendations of this subclause.
The manufacturer should conduct the following unit checks during manufacture:
a) check that the components and components meet their specifications;
b) check the operation of the hold-open system;
c) check the marking of the hold-open system;
d) check the accompanying product information (see 6.2.2).
F.3.3.6 Traceability and marking
Individual products, product batches or packages shall be identifiable and traceable with regard to their production origin. The manufacturer shall have written procedures ensuring that processes related to affixing traceability codes (e.g. fabrication number) and/or markings (see Clause 8) are inspected regularly.
Compliance with EN ISO 9001:2000, 7.5.3 should be deemed to satisfy the recommendations of this subclause.
F.3.3.7 Nonconforming products
The manufacturer should have written procedures which specify how nonconforming products should be dealt with. Any such events should be recorded as they occur and these records should be kept for the period defined in the manufacturer’s written procedures. Compliance with EN ISO 9001:2000, 8.3 should be deemed to satisfy the recommendations of this subclause.
The procedures to treat nonconforming products should cover at least the following:
a) isolate and identify nonconforming products;
b) undertake the necessary corrective actions;
c) repeat tests as appropriate to prove that the product meets the specifications.
F.3.3.8 Corrective action
The manufacturer should have documented procedures that instigate action to eliminate the cause of nonconformities in order to prevent recurrence. Compliance with EN ISO 9001:2000, 8.5.2 should be deemed to satisfy the recommendations of this subclause.
F.3.3.9 Handling, storage and packaging
The manufacturer should have procedures providing methods of product handling and should provide suitable storage areas preventing damages or deterioration.
Annex G (informative)
Type test report and list of approved components