Monitoring ongoing conformity of PPE gloves

PPE gloves in production must continue to comply with the relevant regulation and be homogenous with the initial EU type-examined sample.

In addition to an initial type-examination of the model, Category III PPE is subject, under Regulation (EU) 2016/425, to ongoing checks by a Notified Body to ensure that production versions of the PPE continue to comply with the regulation and are homogenous with the initial EU type-examined sample.

Manufacturers of Category III PPE must lodge an ongoing production monitoring (‘conformity to type’) official application with the selected Notified Body at the point of EU-type examination.

The Notified Body that carries out the ongoing conformity to type production monitoring need not be the same as the Notified Body that carried out the original type-examination. In such cases, and under certain situations, the regulation does require liaison between the two Notified Bodies and in some circumstances requires the manufacturer to share type-examination documentation. Full details of the Notified Body which is monitoring conformity to type must appear on the EU Declaration of Conformity prepared by the manufacturer and, if this is not supplied in hard copy with the product, also in the user instructions.

The manufacturer can choose one of two alternative assessments for the Notified Body to use when checking the conformity of on-going production. These are both described in the PPE Regulation – The first in Annex VII (Module C2) and the second in Annex VIII (Module D). Which is the most suitable of the two will depend on the particular circumstances.

Module C2

Entitled ‘Conformity to type based on internal production control plus supervised product check at random annual intervals’, the Module C2 process involves the Notified Body selecting and removing a statistical sample of manufactured items of PPE, which are then assessed and tested to ensure continuing compliance. Each individual Module C2 process only covers a particular EU type-examination, so this needs to be carried out for each relevant Category III EU type-examination certificate. In addition to the supervised checks carried out by the Notified Body, the manufacturer must take all measures necessary to ensure homogeneity of production and conformity of the manufactured PPE with the EU type-examined model.

The first Module C2 ongoing conformity assessment by the Notified Body for each type of PPE must be carried out no more than one year after the date of issue of the associated EU type-examination certificate. In addition, it should be noted that the EU Commission has recently emphasised that this first Module C2 activity is to be carried out during the first production run and before the product is placed on the EU market.

Samples for test must be obtained from a location agreed between the Notified Body carrying out the module C2 ongoing conformity monitoring and the PPE manufacturer. This location should enable sampling of product representative of that intended for the EU marketplace and from a recent production batch. A typical approach is for samples to be obtained direct from the production site (via an on-site visit by a representative of the Notified Body). Alternatively, controlled remote purchasing of samples from the supply chain, such as from an authorised distributor of the PPE, is another common solution. The particular option being selected will depend on the individual circumstances and may vary from year to year.

The task of the Notified Body is to carry out sufficient product checks to verify homogeneity of production and conformity of the PPE with the type-examined model. As such, the test programme is typically determined by the Notified Body carrying out the Module C2 assessment and should be done in line with the claims made in the technical file of the original EU type-examination. The assessment includes testing for claims that are not classed as risk Category III and may also involve measurements that do not form part of the harmonised standard or technical specification.

For instance, the mass per unit area or thickness of a glove material could be measured on multiple samples and compared with either that recorded in the technical documentation or during a test carried out at type-examination. Quick and simple tests like this can often form the basis of an effective production homogeneity assessment.

In addition to the laboratory testing, the user information provided with the PPE and the marking on the PPE itself are assessed and compared with that in the technical documentation from the EU type-examination.

The Notified Body must inform the manufacturer of the outcome of the assessment programme and provide all relevant testing reports. Where both conformity and homogeneity of the production has been confirmed, the Notify Body is to authorise the manufacturer to continue affixing its identification number to the PPE.

If the Module C2 review and the examination reveal non-compliance, the Notified Body needs to take measures appropriate to the faults recorded. The measures typically involve the issuing of a failure letter and notification to competent local authorities, as well as suspension of the associated EU type-examination certificate. Where failures are recorded, manufacturers should work with the Notified Body to identify both the root cause and extent of the problem, including any implications for product already placed on the market and in the supply chain. This will often lead to retests and corrective actions. If conformity cannot be restored, the EU type-examination certificate will be withdrawn, and any required further actions implemented.

Module D

Entitled ‘Conformity to type based on quality assurance of the production process’, the Module D process involves visiting the production site(s) and checking that the ‘factory production control systems’ used by the manufacturer can enable consistent and conforming production of the certified product. Unlike Module C2, Module D assesses production processes and can cover multiple PPE Category III products within the scope of the audit.

For Module D to be a viable option, the manufacturer must operate an approved quality system for production, final product inspection and testing of the PPE concerned.

The quality system needs to ensure that the PPE is in conformity with the example described in the EU type-examination certificate. The Notified Body must assess the quality system to determine whether it satisfies the requirements. The process may start with a preliminary desktop review of the quality system documents which can confirm the feasibility before proceeding to an on-site audit. Where the system or documentation does not meet the basic Module D requirements, the manufacturer still has the option to select Module C2.

Following a satisfactory review of the documentation, a visit to the manufacturing premisses is to be arranged. The auditing team will review the technical documentation of the PPE to verify the manufacturer’s ability to identify applicable essential health and safety requirements, with a view to ensuring the conformity of the PPE. Prior to the visit, an audit plan would be shared with the manufacturer to ensure availability of all required resources.

The auditing team may raise findings during the audit which would need to be addressed by the manufacturer before a Module D certificate can be issued. The auditing team would take relevant action in line with the significance of the finding.

The results of the audit are reported to the manufacturer. If satisfactory, the Notified Body authorises the manufacturer to affix the Notified Body’s identification number to each item of the PPE that is within the scope of the audit. The Notified Body is required to carry out annual surveillance audits to confirm the conformity to type.

Manufacturers are required to keep the Notified Body informed of any significant changes to their quality management systems. These changes could include, but not be limited to, change in manufacturing processes, change to raw materials or suppliers, and new manufacturing facilities. In such cases, the Notified Body must assess the changes to establish the impact of the change to the product. Following a review of the proposed change(s), an additional audit or assessment may be required.

As with Module C2, manufacturers must have a current Module D certificate from their chosen Notified Body before placing product on the market.

---